Administrative practices and procedures (21 CFR 10.1-10.206)

135 Food and Drug Administration, HHS Pt. 10 law enforcement purposes and may in clude inter- and intra-agency memo randums. (1) Notwithstanding the rule estab lished in § 20.21 of this chapter, no record related to a section 305 presen tation is available for public disclosure until consideration of criminal pros ecution has been closed in accordance with paragraph (b) of this section, ex cept as provided in § 20.82 of this chap ter. Only very rarely and only under circumstances that demonstrate a compelling public interest will the Commissioner exercise, in accordance with § 20.82 of this chapter, the author ized discretion to disclose records re lated to a section 305 presentation be fore the consideration of criminal pros ecution is closed. (2) After consideration of criminal prosecution is closed, the records are available for public disclosure in re sponse to a request under the Freedom of Information Act, except to the ex tent that the exemptions from disclo sure in subpart D of part 20 of this chapter are applicable. No statements obtained through promises of confiden tiality shall be available for public dis closure. (b) Consideration of criminal pros ecution based on a particular section 305 notice of opportunity for presen tation of views shall be deemed to be closed within the meaning of this sec tion and § 7.85 when a final decision has been made not to recommend criminal prosecution to a United States attor ney based on charges set forth in the notice and considered at the presen tation, or when such a recommenda tion has been finally refused by the United States attorney, or when crimi nal prosecution has been instituted and the matter and all related appeals have been concluded, or when the statute of limitations has run. (c) Before disclosure of any record specifically reflecting consideration of a possible recommendation for crimi nal prosecution of any individual, all names and other information that would identify an individual whose prosecution was considered but not rec ommended, or who was not prosecuted, shall be deleted, unless the Commis sioner concludes that there is a com pelling public interest in the disclosure of the names. (d) Names and other information that would identify a Food and Drug Admin istration employee shall be deleted from records related to a section 305 presentation of views before public dis closure only under § 20.32 of this chap ter. [44 FR 12168, Mar. 6, 1979] PART 10—ADMINISTRATIVE PRACTICES AND PROCEDURES Subpart A—General Provisions Sec. 10.1 Scope. 10.3 Definitions. 10.10 Summaries of administrative prac tices and procedures. 10.19 Waiver, suspension, or modification of procedural requirements. Subpart B—General Administrative Procedures 10.20 Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure. 10.25 Initiation of administrative pro ceedings. 10.30 Citizen petition. 10.33 Administrative reconsideration of ac tion. 10.35 Administrative stay of action. 10.40 Promulgation of regulations for the ef ficient enforcement of the law. 10.45 Court review of final administrative action; exhaustion of administrative remedies. 10.50 Promulgation of regulations and or ders after an opportunity for a formal evidentiary public hearing. 10.55 Separation of functions; ex parte com munications. 10.60 Referral by court. 10.65 Meetings and correspondence. 10.70 Documentation of significant deci sions in administrative file. 10.75 Internal agency review of decisions. 10.80 Dissemination of draft Federal Reg ister notices and regulations. 10.85 Advisory opinions. 10.90 Food and Drug Administration regula tions, recommendations, and agree ments. 10.95 Participation in outside standard-set ting activities. 10.100 Public calendar. 10.105 Representation by an organization. 10.110 Settlement proposals. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00145 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 136 21 CFR Ch. I (4–1–16 Edition) § 10.1 10.115 Good guidance practices. Subpart C—Electronic Media Coverage of Public Administrative Proceedings; Guideline on Policy and Procedures 10.200 Scope. 10.203 Definitions. 10.204 General. 10.205 Electronic media coverage of public administrative proceedings. 10.206 Procedures for electronic media cov erage of agency public administrative proceedings. AUTHORITY: 5 U.S.C. 551–558, 701–706; 15 U.S.C. 1451–1461; 21 U.S.C. 141–149, 321–397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264. SOURCE: 44 FR 22323, Apr. 13, 1979, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 10 appear at 68 FR 24879, May 9, 2003. Subpart A—General Provisions § 10.1 Scope. (a) Part 10 governs practices and pro cedures for petitions, hearings, and other administrative proceedings and activities conducted by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and other laws which the Commissioner of Food and Drugs administers. (b) If a requirement in another part of title 21 differs from a requirement in this part, the requirements of this part apply to the extent that they do not conflict with the other requirements. (c) References in this part and parts 12, 13, 14, 15, and 16 to regulatory sec tions of the Code of Federal Regula tions are to chapter I of title 21 unless otherwise noted. (d) References in this part and parts 12, 13, 14, 15, and 16 to publication, or to the day or date of publication, or use of the phrase to publish, refer to publica tion in the FEDERAL REGISTER unless otherwise noted. [44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 69 FR 17290, Apr. 2, 2004] § 10.3 Definitions. (a) The following definitions apply in this part and parts 12, 13, 14, 15, 16, and 19: Act means the Federal Food, Drug, and Cosmetic Act unless otherwise in dicated. Administrative action includes every act, including the refusal or failure to act, involved in the administration of any law by the Commissioner, except that it does not include the referral of apparent violations to U.S. attorneys for the institution of civil or criminal proceedings or an act in preparation of a referral. Administrative file means the file or files containing all documents per taining to a particular administrative action, including internal working memoranda, and recommendations. Administrative record means the docu ments in the administrative file of a particular administrative action on which the Commissioner relies to sup port the action. Agency means the Food and Drug Ad ministration. Chief Counsel means the Chief Coun sel of the Food and Drug Administra tion. Commissioner means the Commis sioner of Food and Drugs, Food and Drug Administration, U.S. Department of Health and Human Services, or the Commissioner’s designee. Department means the U.S. Depart ment of Health and Human Services. Division of Dockets Management means the Division of Dockets Management, Office of Management and Operations of the Food and Drug Administration, U.S. Department of Health and Human Services, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Ex parte communication means an oral or written communication not on the public record for which reasonable prior notice to all parties is not given, but does not include requests for status reports on a matter. FDA means the Food and Drug Ad ministration. Food and Drug Administration em ployee or Food and Drug Administration representative includes members of the Food and Drug Division of the office of the General Counsel of the Department of Health and Human Services. Formal evidentiary public hearing means a hearing conducted under part 12. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00146 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 137 Food and Drug Administration, HHS § 10.3 Interested person or any person who will be adversely affected means a person who submits a petition or comment or objection or otherwise asks to partici pate in an informal or formal adminis trative proceeding or court action. Meeting means any oral discussion, whether by telephone or in person. Office of the Commissioner includes the offices of the Associate Commissioners but not the centers or the regional or district offices. Order means the final agency disposi tion, other than the issuance of a regu lation, in a proceeding concerning any matter and includes action on a new drug application, new animal drug ap plication, or biological license. Participant means any person partici pating in any proceeding, including each party and any other interested person. Party means the center of the Food and Drug Administration responsible for a matter involved and every person who either has exercised a right to re quest or has been granted the right by the Commissioner to have a hearing under part 12 or part 16 or who has waived the right to a hearing to obtain the establishment of a Public Board of Inquiry under part 13 and as a result of whose action a hearing or a Public Board of Inquiry has been established. Person includes an individual, part nership, corporation, association, or other legal entity. Petition means a petition, applica tion, or other document requesting the Commissioner to establish, amend, or revoke a regulation or order, or to take or not to take any other form of ad ministrative action, under the laws ad ministered by the Food and Drug Ad ministration. Presiding officer means the Commis sioner or the Commissioner’s designee or an administrative law judge ap pointed as provided in 5 U.S.C. 3105. Proceeding and administrative pro ceeding means any undertaking to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative ac tion. Public advisory committee or advisory committee means any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup of an advisory committee, that is not composed wholly of full-time employ ees of the Federal Government and is established or utilized by the Food and Drug Administration to obtain advice or recommendations. Public Board of Inquiry or Board means an administrative law tribunal constituted under part 13. Public hearing before a public advisory committee means a hearing conducted under part 14. Public hearing before a Public Board of Inquiry means a hearing conducted under part 13. Public hearing before the Commissioner means a hearing conducted under part 15. Regulations means an agency rule of general or particular applicability and future effect issued under a law admin istered by the Commissioner or relat ing to administrative practices and procedures. In accordance with § 10.90(a), each agency regulation will be published in the FEDERAL REGISTER and codified in the Code of Federal Regulations. Regulatory hearing before the Food and Drug Administration means a hearing conducted under part 16. Secretary means the Secretary of Health and Human Services. The laws administered by the Commis sioner or the laws administered by the Food and Drug Administration means all the laws that the Commissioner is au thorized to administer. (b) A term that is defined in section 201 of the Federal Food, Drug, and Cos metic Act or part 1 has the same defi nition in this part. (c) Words in the singular form in clude the plural, words in the mas culine form include the feminine, and vice versa. (d) Whenever a reference is made in this part to a person in FDA, e.g., the director of a center, the reference in cludes all persons to whom that person has delegated the specific function in volved. [44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50 FR 8994, Mar. 6, 1985; 54 FR 6886, Feb. 15, 1989; 54 FR 9034, Mar. 3, 1989; 59 FR 14363, Mar. 28, 1994; 69 FR 17290, Apr. 2, 2004] VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00147 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 138 21 CFR Ch. I (4–1–16 Edition) § 10.10 § 10.10 Summaries of administrative practices and procedures. To encourage public participation in all agency activities, the Commis sioner will prepare for public distribu tion summaries of FDA administrative practices and procedures in readily un derstandable terms. § 10.19 Waiver, suspension, or modi fication of procedural require ments. The Commissioner or a presiding offi cer may, either voluntarily or at the request of a participant, waive, sus pend, or modify any provision in parts 12 through 16 applicable to the conduct of a public hearing by announcement at the hearing or by notice in advance of the hearing if no participant will be prejudiced, the ends of justice will thereby be served, and the action is in accordance with law. Subpart B—General Administrative Procedures § 10.20 Submission of documents to Di vision of Dockets Management; computation of time; availability for public disclosure. (a) A submission to the Division of Dockets Management of a petition, comment, objection, notice, compila tion of information, or any other docu ment is to be filed in four copies except as otherwise specifically provided in a relevant FEDERAL REGISTER notice or in another section of this chapter. The Division of Dockets Management is the agency custodian of these documents. (b) A submission is to be signed by the person making it, or by an attor ney or other authorized representative of that person. Submissions by trade associations are also subject to the re quirements of § 10.105(b). (c) Information referred to or relied upon in a submission is to be included in full and may not be incorporated by reference, unless previously submitted in the same proceeding. (1) A copy of an article or other ref erence or source cited must be in cluded, except where the reference or source is: (i) A reported Federal court case; (ii) A Federal law or regulation; (iii) An FDA document that is rou tinely publicly available; or (iv) A recognized medical or sci entific textbook that is readily avail able to the agency. (2) If a part of the material submitted is in a foreign language, it must be ac companied by an English translation verified to be complete and accurate, together with the name, address, and a brief statement of the qualifications of the person making the translation. A translation of literature or other mate rial in a foreign language is to be ac companied by copies of the original publication. (3) Where relevant information is contained in a document also con taining irrelevant information, the ir relevant information is to be deleted and only the relevant information is to be submitted. (4) Under § 20.63 (a) and (b), the names and other information that would iden tify patients or research subjects are to be deleted from any record before it is submitted to the Division of Dockets Management in order to preclude a clearly unwarranted invasion of per sonal privacy. (5) Defamatory, scurrilous, or intem perate matter is to be deleted from a record before it is submitted to the Di vision of Dockets Management. (6) The failure to comply with the re quirements of this part or with § 12.80 or § 13.20 will result in rejection of the submission for filing or, if it is filed, in exclusion from consideration of any portion that fails to comply. If a sub mission fails to meet any requirement of this section and the deficiency be comes known to the Division of Dock ets Management, the Division of Dock ets Management shall not file the sub mission but return it with a copy of the applicable regulations indicating those provisions not complied with. A deficient submission may be corrected or supplemented and subsequently filed. The office of the Division of Dockets Management does not make decisions regarding the confidentiality of submitted documents. (d) The filing of a submission means only that the Division of Dockets Man agement has identified no technical de ficiencies in the submission. The filing of a petition does not mean or imply VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00148 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 139 Food and Drug Administration, HHS § 10.20 that it meets all applicable require ments or that it contains reasonable grounds for the action requested or that the action requested is in accord ance with law. (e) All submissions to the Division of Dockets Management will be consid ered as submitted on the date they are postmarked or, if delivered in person during regular business hours, on the date they are delivered, unless a provi sion in this part, an applicable FED ERAL REGISTER notice, or an order issued by an administrative law judge specifically states that the documents must be received by a specified date, e.g., § 10.33(g) relating to a petition for reconsideration, in which case they will be considered submitted on the date received. (f) All submissions are to be mailed or delivered in person to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. (g) FDA ordinarily will not acknowl edge or give receipt for documents, ex cept: (1) Documents delivered in person or by certified or registered mail with a return receipt requested; and (2) Petitions for which acknowledg ment of receipt of filing is provided by regulation or by customary practice, e.g., § 10.30(c) relating to a citizen peti tion. (h) Saturdays, Sundays, and Federal legal holidays are included in com puting the time allowed for the submis sion of documents, except that when the time for submission expires on a Saturday, Sunday, or Federal legal hol iday, the period will be extended to in clude the next business day. (i) All submissions to the Division of Dockets Management are representa tions that, to the best of the knowl edge, information, and belief of the person making the submission, the statements made in the submission are true and accurate. All submissions are subject to the False Reports to the Government Act (18 U.S.C. 1001) under which a willfully false statement is a criminal offense. (j) The availability for public exam ination and copying of submissions to the Division of Dockets Management is governed by the following rules: (1) Except to the extent provided in paragraphs (j)(2) and (3) of this section, the following submissions, including all supporting material, will be on pub lic display and will be available for public examination between 9 a.m. and 4 p.m., Monday through Friday. Re quests for copies of submissions will be filed and handled in accordance with subpart C of part 20: (i) Petitions. (ii) Comments on petitions, on docu ments published in the FEDERAL REG ISTER, and on similar public docu ments. (iii) Objections and requests for hear ings filed under part 12. (iv) Material submitted at a hearing under § 12.32(a)(2) and parts 12, 13, and 15. (v) Material placed on public display under the regulations in this chapter, e.g., agency guidance documents devel oped under § 10.115. (2)(i) Material prohibited from public disclosure under § 20.63 (clearly unwar ranted invasion of personal privacy) and, except as provided in paragraph (j)(3) of this section, material sub mitted with objections and requests for hearing filed under part 12, or at a hearing under part 12 or part 13, or an alternative form of public hearing be fore a public advisory committee or a hearing under § 12.32(a) (2) or (3), of the following types will not be on public display, will not be available for public examination, and will not be available for copying or any other form of ver batim transcription unless it is other wise available for public disclosure under part 20: (a) Safety and effectiveness informa tion, which includes all studies and tests of an ingredient or product on animals and humans and all studies and tests on the ingredient or product for identity, stability, purity, potency, bioavailability, performance, and use fulness. (b) A protocol for a test or study. (c) Manufacturing methods or proc esses, including quality control proce dures. (d) Production, sales distribution, and similar information, except any compilation of information aggregated and prepared in a way that does not re veal confidential information. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00149 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 140 21 CFR Ch. I (4–1–16 Edition) § 10.25 (e) Quantitative or semiquantitative formulas. (f) Information on product design or construction. (ii) Material submitted under para graph (j)(2) of this section is to be seg regated from all other submitted mate rial and clearly so marked. A person who does not agree that a submission is properly subject to paragraph (j)(2) may request a ruling from the Asso ciate Commissioner for Public Affairs whose decision is final, subject to judi cial review under § 20.48. (3) Material listed in paragraph (j)(2)(i) (a) and (b) of this section may be disclosed under a protective order issued by the administrative law judge or other presiding officer at a hearing referenced in paragraph (j)(2)(i). The administrative law judge or presiding officer shall permit disclosure of the data only in camera and only to the ex tent necessary for the proper conduct of the hearing. The administrative law judge or presiding officer shall direct to whom the information is to be made available (e.g., to parties or partici pants, or only to counsel for parties or participants), and persons not specifi cally permitted access to the data will be excluded from the in camera part of the proceeding. The administrative law judge or other presiding officer may impose other conditions or safeguards. The limited availability of material under this paragraph does not con stitute prior disclosure to the public as defined in § 20.81, and no information subject to a particular order is to be submitted to or received or considered by FDA in support of a petition or other request from any other person. [44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 49 FR 7363, Feb. 29, 1984; 54 FR 9034, Mar. 3, 1989; 59 FR 14363, Mar. 28, 1994; 64 FR 69190, Dec. 10, 1999; 65 FR 56477, Sept. 19, 2000; 66 FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 25285, May 12, 2003] § 10.25 Initiation of administrative proceedings. An administrative proceeding may be initiated in the following three ways: (a) An interested person may petition the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action. A petition must be either: (1) In the form specified in other ap plicable FDA regulations, e.g., the form for a color additive petition in § 71.1, for a food additive petition in § 171.1, for a new drug application in § 314.50, for a new animal drug applica tion in § 514.1, or (2) in the form for a citizen petition in § 10.30. (b) The Commissioner may initiate a proceeding to issue, amend, or revoke a regulation or order or take or refrain from taking any other form of adminis trative action. FDA has primary juris diction to make the initial determina tion on issues within its statutory mandate, and will request a court to dismiss, or to hold in abeyance its de termination of or refer to the agency for administrative determination, any issue which has not previously been de termined by the agency or which, if it has previously been determined, the agency concluded should be reconsid ered and subject to a new administra tive determination. The Commissioner may utilize any of the procedures es tablished in this part in reviewing and making a determination on any matter initiated under this paragraph. (c) The Commissioner will institute a proceeding to determine whether to issue, amend, or revoke a regulation or order, or take or refrain from taking any other form of administrative ac tion whenever any court, on its own initiative, holds in abeyance or refers any matter to the agency for an admin istrative determination and the Com missioner concludes that an adminis trative determination is feasible with in agency priorities and resources. [44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989] § 10.30 Citizen petition. (a) This section applies to any peti tion submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a par ticular matter. (b) A petition (including any attach ments) must be submitted in accord ance with the following paragraphs, as applicable: VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00150 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 141 Food and Drug Administration, HHS § 10.30 (1) Electronic submission. Petitions (in cluding any attachments) may be elec tronically submitted in accordance with paragraph (b)(3) of this section and § 10.20 through http:// www.regulations.gov at Docket No. FDA 2013–S–0610. It is only necessary to sub mit one copy. (2) Mail, delivery services, or other non electronic submissions. A petition (in cluding any attachments), that is not electronically submitted under para graph (b)(1) of this section, must be submitted in accordance with para graph (b)(3) and § 10.20 and delivered to this address: Division of Dockets Man agement, Department of Health and Human Services, Food and Drug Ad ministration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is only necessary to submit two copies. (3) Petition format. A petition sub mitted under paragraphs (b)(1) or (b)(2) of this section must be in accordance with § 10.20 and in the following format: CITIZEN PETITION Date: llllllllllllllllllll The undersigned submits this petition under ll (relevant statutory sections, if known) of the ll (Federal Food, Drug, and Cosmetic Act or the Public Health Service Act or any other statutory provision for which authority has been delegated to the Commissioner of Food and Drugs) to request the Commissioner of Food and Drugs toll (issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action). A. Action Requested ((1) If the petition requests the Commis sioner to issue, amend, or revoke a regula tion, the exact wording of the existing regu lation (if any) and the proposed regulation or amendment requested.) ((2) If the petition requests the Commis sioner to issue, amend, or revoke an order, a copy of the exact wording of the citation to the existing order (if any) and the exact wording requested for the proposed order.) ((3) If the petition requests the Commis sioner to take or refrain from taking any other form of administrative action, the spe cific action or relief requested.) B. Statement of Grounds (A full statement, in a well-organized for mat, of the factual and legal grounds on which the petitioner relies, including all rel evant information and views on which the petitioner relies, as well as representative information known to the petitioner which is unfavorable to the petitioner’s position.) C. Environmental Impact (A) Claim for categorical exclusion under §§ 25.30, 25.31, 25.32, 25.33, or § 25.34 of this chapter or an environmental assessment under § 25.40 of this chapter.) D. Economic Impact (The following information is to be sub mitted only when requested by the Commis sioner following review of the petition: A statement of the effect of requested action on: (1) Cost (and price) increases to industry, government, and consumers; (2) productivity of wage earners, businesses, or government; (3) competition; (4) supplies of important materials, products, or services; (5) employ ment; and (6) energy supply or demand.) E. Certification The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it in cludes representative data and information known to the petitioner which are unfavor able to the petition. (Signature) lllllllllllllllll (Name of petitioner) llllllllllll (Mailing address) llllllllllllll (Telephone number) lllllllllllll (c) A petition which appears to meet the requirements of paragraph (b)(3) of this section and § 10.20 will be filed by the Division of Dockets Management with the date of filing and assigned a unique docket number. The unique docket number identifies the docket file established by the Division of Dockets Management for all submis sions relating to the petition, as pro vided in this part. Subsequent submis sions relating to the matter must refer to the assigned docket number as signed in this paragraph and will be filed in the established docket file. Re lated petitions may be filed together and given the same docket number. The Division of Dockets Management will promptly notify the petitioner of the filing and unique docket number of the petition. (d) An interested person may submit comments to the Division of Dockets Management on a filed petition, which comments become part of the docket file. The comments are to specify the docket number of the petition and may support or oppose the petition in whole VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00151 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 142 21 CFR Ch. I (4–1–16 Edition) § 10.30 or in part. A request for alternative or different administrative action must be submitted as a separate petition. (e)(1) The Commissioner shall, in ac cordance with paragraph (e)(2), rule upon each petition filed under para graph (c) of this section, taking into consideration (i) available agency re sources for the category of subject matter, (ii) the priority assigned to the petition considering both the category of subject matter involved and the overall work of the agency, and (iii) time requirements established by stat ute. (2) Except as provided in paragraph (e)(4) of this section, the Commissioner shall furnish a response to each peti tioner within 180 days of receipt of the petition. The response will either: (i) Approve the petition, in which case the Commissioner shall concur rently take appropriate action (e.g., publication of a FEDERAL REGISTER no tice) implementing the approval; (ii) Deny the petition; or (iii) Provide a tentative response, in dicating why the agency has been un able to reach a decision on the peti tion, e.g., because of the existence of other agency priorities, or a need for additional information. The tentative response may also indicate the likely ultimate agency response, and may specify when a final response may be furnished. (3) The Commissioner may grant or deny such a petition, in whole or in part, and may grant such other relief or take other action as the petition warrants. The petitioner is to be noti fied of the Commissioner’s decision. The decision will be placed in the pub lic docket file and may also be in the form of a notice published in the FED ERAL REGISTER. (4) The Commissioner shall furnish a response to each petitioner within 90 days of receipt of a petition filed under section 505(j)(2)(C) of the act. The re sponse will either approve or dis approve the petition. Agency action on a petition shall be governed by § 314.93 of this chapter. (f) If a petition filed under paragraph (c) of this section requests the Com missioner to issue, amend, or revoke a regulation, § 10.40 or § 10.50 also apply. (g) A petitioner may supplement, amend, or withdraw a petition without Agency approval and without prejudice to resubmission at any time until the Commissioner rules on the petition, unless the petition has been referred for a hearing under parts 12, 13, 14, or 15 of this chapter. After a ruling or refer ral, a petition may be supplemented, amended, or withdrawn only with the approval of the Commissioner. The Commissioner may approve with drawal, with or without prejudice against resubmission of the petition. (h) In reviewing a petition the Com missioner may use the following proce dures: (1) Conferences, meetings, discus sions, and correspondence under § 10.65. (2) A hearing under parts 12, 13, 14, 15, or 16. (3) A FEDERAL REGISTER notice re questing information and views. (4) A proposal to issue, amend, or re voke a regulation, in accordance with § 10.40 or § 12.20. (5) Any other specific public proce dure established in this chapter and ex pressly applicable to the matter. (i) The record of the administrative proceeding consists of the following: (1) The petition, including all infor mation on which it relies, filed by the Division of Dockets Management. (2) All comments received on the pe tition, including all information sub mitted as a part of the comments. (3) If the petition resulted in a pro posal to issue, amend, or revoke a regu lation, all of the documents specified in § 10.40(g). (4) The record, consisting of any transcripts, minutes of meetings, re ports, FEDERAL REGISTER notices, and other documents resulting from the op tional procedures specified in para graph (h) of this section, except a tran script of a closed portion of a public ad visory committee meeting. (5) The Commissioner’s decision on the petition, including all information identified or filed by the Commissioner with the Division of Dockets Manage ment as part of the record supporting the decision. (6) All documents filed with the Divi sion of Dockets Management under § 10.65(h). VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00152 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 143 Food and Drug Administration, HHS § 10.33 (7) If a petition for reconsideration or for a stay of action is filed under para graph (j) of this section, the adminis trative record specified in § 10.33(k) or § 10.35(h). (j) The administrative record speci fied in paragraph (i) of this section is the exclusive record for the Commis sioner’s decision. The record of the ad ministrative proceeding closes on the date of the Commissioner’s decision unless some other date is specified. Thereafter any interested person may submit a petition for reconsideration under § 10.33 or a petition for stay of ac tion under § 10.35. A person who wishes to rely upon information or views not included in the administrative record shall submit them to the Commissioner with a new petition to modify the deci sion in accordance with this section. (k) This section does not apply to the referral of a matter to a United States attorney for the initiation of court en forcement action and related cor respondence, or to requests, sugges tions, and recommendations made in formally in routine correspondence re ceived by FDA. Routine correspond ence does not constitute a petition within the meaning of this section un less it purports to meet the require ments of this section. Action on rou tine correspondence does not con stitute final administrative action sub ject to judicial review under § 10.45. (l) The Division of Dockets Manage ment will maintain a chronological list of each petition filed under this section and § 10.85, but not of petitions sub mitted elsewhere in the agency under § 10.25(a)(1), showing: (1) The docket number; (2) The date the petition was filed by the Division of Dockets Management; (3) The name of the petitioner; (4) The subject matter involved; and (5) The disposition of the petition. [44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 50 FR 16656, Apr. 26, 1985; 54 FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28, 1992; 59 FR 14364, Mar. 28, 1994; 62 FR 40592, July 29, 1997; 66 FR 6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001; 78 FR 76749, Dec. 19, 2013] § 10.33 Administrative reconsideration of action. (a) The Commissioner may at any time reconsider a matter, on the Com missioner’s own initiative or on the pe tition of an interested person. (b) An interested person may request reconsideration of part or all of a deci sion of the Commissioner on a petition submitted under § 10.25. Each request for reconsideration must be submitted in accordance with § 10.20 and in the following form no later than 30 days after the date of the decision involved. The Commissioner may, for good cause, permit a petition to be filed after 30 days. In the case of a decision pub lished in the FEDERAL REGISTER, the day of publication is the day of deci sion. (Date) llllllllllllllllllll Division of Dockets Management, Food and Drug Administration, Department of Health and Human Services, rm. 1–23, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. PETITION FOR RECONSIDERATION [Docket No.] The undersigned submits this petition for reconsideration of the decision of the Com missioner of Food and Drugs in Docket No. ll. A. Decision involved (A concise statement of the decision of the Commissioner which the petitioner wishes to have reconsidered.) B. Action requested (The decision which the petitioner requests the Commissioner to make upon reconsider ation of the matter.) C. Statement of grounds (A full statement, in a well-organized for mat, of the factual and legal grounds upon which the petitioner relies. The grounds must demonstrate that relevant information and views contained in the administrative record were not previously or not adequately considered by the Commissioner. (No new information or views may be in cluded in a petition for reconsideration.) (Signature) lllllllllllllllll (Name of petitioner) llllllllllll (Mailing address) llllllllllllll (Telephone number) lllllllllllll (c) A petition for reconsideration re lating to a petition submitted under § 10.25(a)(2) is subject to the require ments of § 10.30 (c) and (d), except that it is filed in the same docket file as the petition to which it relates. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00153 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 144 21 CFR Ch. I (4–1–16 Edition) § 10.33 (d) The Commissioner shall promptly review a petition for reconsideration. The Commissioner may grant the peti tion when the Commissioner deter mines it is in the public interest and in the interest of justice. The Commis sioner shall grant a petition for recon sideration in any proceeding if the Commissioner determines all of the fol lowing apply: (1) The petition demonstrates that relevant information or views con tained in the administrative record were not previously or not adequately considered. (2) The petitioner’s position is not frivolous and is being pursued in good faith. (3) The petitioner has demonstrated sound public policy grounds supporting reconsideration. (4) Reconsideration is not outweighed by public health or other public inter ests. (e) A petition for reconsideration may not be based on information and views not contained in the administra tive record on which the decision was made. An interested person who wishes to rely on information or views not in cluded in the administrative record shall submit them with a new petition to modify the decision under § 10.25(a). (f) The decision on a petition for re consideration is to be in writing and placed on public display as part of the docket file on the matter in the office of the Division of Dockets Manage ment. A determination to grant recon sideration will be published in the FED ERAL REGISTER if the Commissioner’s original decision was so published. Any other determination to grant or deny reconsideration may also be published in the FEDERAL REGISTER. (g) The Commissioner may consider a petition for reconsideration only before the petitioner brings legal action in the courts to review the action, except that a petition may also be considered if the Commissioner has denied a peti tion for stay of action and the peti tioner has petitioned for judicial re view of the Commissioner’s action and requested the reviewing court to grant a stay pending consideration of review. A petition for reconsideration sub mitted later than 30 days after the date of the decision involved will be denied as untimely unless the Commissioner permits the petition to be filed after 30 days. A petition for reconsideration will be considered as submitted on the day it is received by the Division of Dockets Management. (h) The Commissioner may initiate the reconsideration of all or part of a matter at any time after it has been decided or action has been taken. If re view of the matter is pending in the courts, the Commissioner may request that the court refer the matter back to the agency or hold its review in abey ance pending administrative reconsid eration. The administrative record of the proceeding is to include all addi tional documents relating to such re consideration. (i) After determining to reconsider a matter, the Commissioner shall review and rule on the merits of the matter under § 10.30(e). The Commissioner may reaffirm, modify, or overrule the prior decision, in whole or in part, and may grant such other relief or take such other action as is warranted. (j) The Commissioner’s reconsider ation of a matter relating to a petition submitted under § 10.25(a)(2) is subject to § 10.30 (f) through (h), (j), and (k). (k) The record of the administrative proceeding consists of the following: (1) The record of the original petition specified in § 10.30(i). (2) The petition for reconsideration, including all information on which it relies, filed by the Division of Dockets Management. (3) All comments received on the pe tition, including all information sub mitted as a part of the comments. (4) The Commissioner’s decision on the petition under paragraph (f) of this section, including all information iden tified or filed by the Commissioner with the Division of Dockets Manage ment as part of the record supporting the decision. (5) Any FEDERAL REGISTER notices or other documents resulting from the pe tition. (6) All documents filed with the Divi sion of Dockets Management under § 10.65(h). (7) If the Commissioner reconsiders the matter, the administrative record VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00154 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 145 Food and Drug Administration, HHS § 10.35 relating to reconsideration specified in § 10.30(i). [44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59 FR 14364, Mar. 28, 1994; 66 FR 6467, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001] § 10.35 Administrative stay of action. (a) The Commissioner may at any time stay or extend the effective date of an action pending or following a de cision on any matter. (b) An interested person may request the Commissioner to stay the effective date of any administrative action. A stay may be requested for a specific time period or for an indefinite time period. A request for stay must be sub mitted in accordance with § 10.20 and in the following form no later than 30 days after the date of the decision in volved. The Commissioner may, for good cause, permit a petition to be filed after 30 days. In the case of a deci sion published in the FEDERAL REG ISTER, the day of publication is the date of decision. (Date) llllllllllllllllllll Division of Dockets Management, Food and Drug Administration, Department of Health and Human Services, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. PETITION FOR STAY OF ACTION The undersigned submits this petition re questing that the Commissioner of Food and Drugs stay the effective date of the following matter. A. Decision involved (The specific administrative action being taken by the Commissioner for which a stay is requested, including the docket number or other citation to the action involved.) B. Action requested (The length of time for which the stay is requested, which may be for a specific or in definite time period.) C. Statement of grounds (A full statement, in a well-organized for mat, of the factual and legal grounds upon which the petitioner relies for the stay.) (Signature) lllllllllllllllll (Name of petitioner) llllllllllll (Mailing address) llllllllllllll (Telephone number) lllllllllllll (c) A petition for stay of action relat ing to a petition submitted under § 10.25(a)(2) is subject to the require ments of § 10.30 (c) and (d), except that it will be filed in the same docket file as the petition to which it relates. (d) Neither the filing of a petition for a stay of action nor action taken by an interested person in accordance with any other administrative procedure in this part or in any other section of this chapter, e.g., the filing of a citizen pe tition under § 10.30 or a petition for re consideration under § 10.33 or a request for an advisory opinion under § 10.85, will stay or otherwise delay any ad ministrative action by the Commis sioner, including enforcement action of any kind, unless one of the following applies: (1) The Commissioner determines that a stay or delay is in the public in terest and stays the action. (2) A statute requires that the matter be stayed. (3) A court orders that the matter be stayed. (e) The Commissioner shall promptly review a petition for stay of action. The Commissioner may grant or deny a petition, in whole or in part; and may grant such other relief or take such other action as is warranted by the pe tition. The Commissioner may grant a stay in any proceeding if it is in the public interest and in the interest of justice. The Commissioner shall grant a stay in any proceeding if all of the following apply: (1) The petitioner will otherwise suf fer irreparable injury. (2) The petitioner’s case is not frivo lous and is being pursued in good faith. (3) The petitioner has demonstrated sound public policy grounds supporting the stay. (4) The delay resulting from the stay is not outweighted by public health or other public interests. (f) The Commissioner’s decision on a petition for stay of action is to be in writing and placed on public display as part of the file on the matter in the of fice of the Division of Dockets Manage ment. A determination to grant a stay will be published in the FEDERAL REG ISTER if the Commissioner’s original decision was so published. Any other determination to grant or to deny a stay may also be published in the FED ERAL REGISTER. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00155 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 146 21 CFR Ch. I (4–1–16 Edition) § 10.40 (g) A petition for a stay of action submitted later than 30 days after the date of the decision involved will be de nied as untimely unless the Commis sioner permits the petition to be filed after 30 days. A petition for a stay of action is considered submitted on the day it is received by the Division of Dockets Management. (h) The record of the administrative proceeding consists of the following: (1) The record of the proceeding to which the petition for stay of action is directed. (2) The petition for stay of action, in cluding all information on which it re lies, filed by the Division of Dockets Management. (3) All comments received on the pe tition, including all information sub mitted as a part of the comments. (4) The Commissioner’s decision on the petition under paragraph (e) of this section, including all information iden tified or filed by the Commissioner with the Division of Dockets Manage ment as part of the record supporting the decision. (5) Any FEDERAL REGISTER notices or other documents resulting from the pe tition. (6) All documents filed with the Divi sion of Dockets Management under § 10.65(h). [44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 54 FR 9034, Mar. 3, 1989; 59 FR 14364, Mar. 28, 1994; 66 FR 6468, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001] § 10.40 Promulgation of regulations for the efficient enforcement of the law. (a) The Commissioner may propose and promulgate regulations for the ef ficient enforcement of the laws admin istered by FDA whenever it is nec essary or appropriate to do so. The issuance, amendment, or revocation of a regulation may be initiated in any of the ways specified in § 10.25. (1) This section applies to any regula tion: (i) Not subject to § 10.50 and part 12, or (ii) if it is subject to § 10.50 and part 12, to the extent that those provi sions make this section applicable. (2) A regulation proposed by an inter ested person in a petition submitted under § 10.25(a) will be published in the FEDERAL REGISTER as a proposal if: (i) The petition contains facts dem onstrating reasonable grounds for the proposal; and (ii) The petition substantially shows that the proposal is in the public inter est and will promote the objectives of the act and the agency. (3) Two or more alternative proposed regulations may be published on the same subject to obtain comment on the different alternatives. (4) A regulation proposed by an inter ested person in a petition submitted under § 10.25(a) may be published to gether with the Commissioner’s pre liminary views on the proposal and any alternative proposal. (b) Except as provided in paragraph (e) of this section, each regulation must be the subject of a notice of pro posed rulemaking published in the FEDERAL REGISTER. (1) The notice will contain: (i) The name of the agency; (ii) The nature of the action, e.g., proposed rule, or notice; (iii) A summary in the first para graph describing the substance of the document in easily understandable terms; (iv) Relevant dates, e.g., comment closing date, and proposed effective date(s); (v) The name, business address, and phone number of an agency contact person who can provide further infor mation to the public about the notice; (vi) An address for submitting writ ten comments; (vii) Supplementary information about the notice in the form of a pre amble that summarizes the proposal and the facts and policy underlying it, includes references to all information on which the Commissioner relies for the proposal (copies or a full list of which are a part of the docket file on the matter in the office of the Division of Dockets Management), and cites the authority under which the regulation is proposed; (viii) Either the terms or substance of the proposed regulation or a descrip tion of the subjects and issues in volved; (ix) A reference to the existence or lack of need for an environmental im pact statement under § 25.52 of this chapter; and VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00156 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 147 Food and Drug Administration, HHS § 10.40 (x) The docket number of the matter, which identifies the docket file estab lished by the Division of Dockets Man agement for all relevant submissions. (2) The proposal will provide 60 days for comment, although the Commis sioner may shorten or lengthen this time period for good cause. In no event is the time for comment to be less than 10 days. (3) After publication of the proposed rule, any interested person may re quest the Commissioner to extend the comment period for an additional spec ified period by submitting a written re quest to the Division of Dockets Man agement stating the grounds for the re quest. The request is submitted under § 10.35 but should be headed ‘‘REQUEST FOR EXTENSION OF COMMENT PE RIOD.’’ (i) A request must discuss the reason comments could not feasibly be sub mitted within the time permitted, or that important new information will shortly be available, or that sound pub lic policy otherwise supports an exten sion of the time for comment. The Commissioner may grant or deny the request or may grant an extension for a time period different from that re quested. An extension may be limited to specific persons who have made and justified the request, but will ordi narily apply to all interested persons. (ii) A comment time extension of 30 days or longer will be published in the FEDERAL REGISTER and will be applica ble to all interested persons. A com ment time extension of less than 30 days will be the subject either of a let ter or memorandum filed with the Di vision of Dockets Management or of a notice published in the FEDERAL REG ISTER. (4) A notice of proposed rulemaking will request that four copies of all com ments be submitted to the Division of Dockets Management, except that indi viduals may submit single copies. Com ments will be stamped with the date of receipt and will be numbered chrono logically. (5) Persons submitting comments critical of a proposed regulation are encouraged to include their preferred alternative wording. (c) After the time for comment on a proposed regulation has expired, the Commissioner will review the entire administrative record on the matter, including all comments and, in a no tice published in the FEDERAL REG ISTER, will terminate the proceeding, issue a new proposal, or promulgate a final regulation. (1) The quality and persuasiveness of the comments will be the basis for the Commissioner’s decision. The number or length of comments will not ordi narily be a significant factor in the de cision unless the number of comments is material where the degree of public interest is a legitimate factor for con sideration. (2) The decision of the Commissioner on the matter will be based solely upon the administrative record. (3) A final regulation published in the FEDERAL REGISTER will have a pre amble stating: (i) The name of the agency, (ii) the nature of the action e.g., final rule, notice, (iii) a summary first paragraph describing the sub stance of the document in easily under standable terms, (iv) relevant dates, e.g., the rule’s effective date and com ment closing date, if an opportunity for comment is provided, (v) the name, business address, and phone number of an agency contact person who can pro vide further information to the public about the notice, (vi) an address for the submission of written comments when they are permitted, (vii) supple mentary information about the regula tion in the body of the preamble that contains references to prior notices re lating to the same matter and a sum mary of each type of comment sub mitted on the proposal and the Com missioner’s conclusions with respect to each. The preamble is to contain a thorough and comprehensible expla nation of the reasons for the Commis sioner’s decision on each issue. (4) The effective date of a final regu lation may not be less than 30 days after the date of publication in the FEDERAL REGISTER, except for: (i) A regulation that grants an ex emption or relieves a restriction; or (ii) A regulation for which the Com missioner finds, and states in the no tice good cause for an earlier effective date. (d) The provisions for notice and comment in paragraphs (b) and (c) of VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00157 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 148 21 CFR Ch. I (4–1–16 Edition) § 10.40 this section apply only to the extent required by the Administrative Proce dure Act (5 U.S.C. 551, 552, and 553). As a matter of discretion, however, the Commissioner may voluntarily follow those provisions in circumstances in which they are not required by the Ad ministrative Procedure Act. (e) The requirements of notice and public procedure in paragraph (b) of this section do not apply in the fol lowing situations: (1) When the Commissioner deter mines for good cause that they are im practicable, unnecessary, or contrary to the public interest. In these cases, the notice promulgating the regulation will state the reasons for the deter mination, and provide an opportunity for comment to determine whether the regulation should subsequently be modified or revoked. A subsequent no tice based on those comments may, but need not, provide additional oppor tunity for public comment. (2) Food additive and color additive petitions, which are subject to the pro visions of § 12.20(b)(2). (3) New animal drug regulations, which are promulgated under section 512(i) of the act. (f) In addition to the notice and pub lic procedure required under paragraph (b) of this section, the Commissioner may also subject a proposed or final regulation, before or after publication in the FEDERAL REGISTER, to the fol lowing additional procedures: (1) Conferences, meetings, discus sions, and correspondence under § 10.65. (2) A hearing under parts 12, 13, 14, or 15. (3) A notice published in the FEDERAL REGISTER requesting information and views before the Commissioner deter mines whether to propose a regulation. (4) A draft of a proposed regulation placed on public display in the office of the Division of Dockets Management. If this procedure is used, the Commis sioner shall publish an appropriate no tice in the FEDERAL REGISTER stating that the document is available and specifying the time within which com ments on the draft proposal may be submitted orally or in writing. (5) A revised proposal published in the FEDERAL REGISTER, which proposal is subject to all the provisions in this section relating to proposed regula tions. (6) A tentative final regulation or tentative revised final regulation placed on public display in the office of the Division of Dockets Management and, if deemed desirable by the Com missioner, published in the FEDERAL REGISTER. If the tentative regulation is placed on display only, the Commis sioner shall publish an appropriate no tice in the FEDERAL REGISTER stating that the document is available and specifying the time within which com ments may be submitted orally or in writing on the tentative final regula tion. The Commissioner shall mail a copy of the tentative final regulation and the FEDERAL REGISTER notice to each person who submitted comments on the proposed regulation if one has been published. (7) A final regulation published in the FEDERAL REGISTER that provides an op portunity for the submission of further comments, in accordance with para graph (e)(1) of this section. (8) Any other public procedure estab lished in this chapter and expressly ap plicable to the matter. (g) The record of the administrative proceeding consists of all of the fol lowing: (1) If the regulation was initiated by a petition, the administrative record specified in § 10.30(i). (2) If a petition for reconsideration or for a stay of action is filed, the admin istrative record specified in §§ 10.33(k) and 10.35(h). (3) The proposed rule published in the FEDERAL REGISTER, including all infor mation identified or filed by the Com missioner with the Division of Dockets Management on the proposal. (4) All comments received on the pro posal, including all information sub mitted as a part of the comments. (5) The notice promulgating the final regulation, including all information identified or filed by the Commissioner with the Division of Dockets Manage ment as part of the administrative record of the final regulation. (6) The transcripts, minutes of meet ings, reports, FEDERAL REGISTER no tices, and other documents resulting from the procedures specified in para graph (f) of this section, but not the VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00158 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 149 Food and Drug Administration, HHS § 10.45 transcript of a closed portion of a pub lic advisory committee meeting. (7) All documents submitted to the Division of Dockets Management under § 10.65(h). (h) The record of the administrative proceeding closes on the date of publi cation of the final regulation in the FEDERAL REGISTER unless some other date is specified. Thereafter, any inter ested person may submit a petition for reconsideration under § 10.33 or a peti tion for stay of action under § 10.35. A person who wishes to rely upon infor mation or views not included in the ad ministrative record shall submit it to the Commissioner with a new petition to modify the final regulation. (i) The Division of Dockets Manage ment shall maintain a chronological list of all regulations proposed and pro mulgated under this section and § 10.50 (which list will not include regulations resulting from petitions filed and as signed a docket number under § 10.30) showing— (1) The docket number (for a petition submitted directly to a center, the list also includes the number or other des ignation assigned by the center, e.g., the number assigned to a food additive petition); (2) The name of the petitioner, if any; (3) The subject matter involved; and (4) The disposition of the petition. [44 FR 22323, Apr. 13, 1979, as amended at 52 FR 36401, Sept. 29, 1987; 54 FR 9034, Mar. 3, 1989; 56 FR 13758, Apr. 4, 1991; 62 FR 40592, July 29, 1997; 66 FR 6468, Jan. 22, 2001; 66 FR 12848, Mar. 1, 2001] § 10.45 Court review of final adminis trative action; exhaustion of admin istrative remedies. (a) This section applies to court re view of final administrative action taken by the Commissioner, including action taken under §§ 10.25 through 10.40 and § 16.1(b), except action subject to § 10.50 and part 12. (b) A request that the Commissioner take or refrain from taking any form of administrative action must first be the subject of a final administrative deci sion based on a petition submitted under § 10.25(a) or, where applicable, a hearing under § 16.1(b) before any legal action is filed in a court complaining of the action or failure to act. If a court action is filed complaining of the action or failure to act before the sub mission of the decision on a petition under § 10.25(a) or, where applicable, a hearing under § 16.1(b), the Commis sioner shall request dismissal of the court action or referral to the agency for an initial administrative deter mination on the grounds of a failure to exhaust administrative remedies, the lack of final agency action as required by 5 U.S.C. 701 et seq., and the lack of an actual controversy as required by 28 U.S.C. 2201. (c) A request that administrative ac tion be stayed must first be the subject of an administrative decision based upon a petition for stay of action sub mitted under § 10.35 before a request is made that a court stay the action. If a court action is filed requesting a stay of administrative action before the Commissioner’s decision on a petition submitted in a timely manner pursuant to § 10.35, the Commissioner shall re quest dismissal of the court action or referral to the agency for an initial de termination on the grounds of a failure to exhaust administrative remedies, the lack of final agency action as re quired by 5 U.S.C. 701 et seq., and the lack of an actual controversy as re quired by 28 U.S.C. 2201. If a court ac tion is filed requesting a stay of admin istrative action after a petition for a stay of action is denied because it was submitted after expiration of the time period provided under § 10.35, or after the time for submitting such a petition has expired, the Commissioner will re quest dismissal of the court action on the ground of a failure to exhaust ad ministrative remedies. (d) Unless otherwise provided, the Commissioner’s final decision con stitutes final agency action (review able in the courts under 5 U.S.C. 701 et seq. and, where appropriate, 28 U.S.C. 2201) on a petition submitted under § 10.25(a), on a petition for reconsider ation submitted under § 10.33, on a peti tion for stay of action submitted under § 10.35, on an advisory opinion issued under § 10.85, on a matter involving ad ministrative action which is the sub ject of an opportunity for a hearing under § 16.1(b) of this chapter, or on the issuance of a final regulation published in accordance with § 10.40, except that VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00159 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 150 21 CFR Ch. I (4–1–16 Edition) § 10.45 the agency’s response to a petition filed under section 505(j)(2)(C) of the act (21 U.S.C. 355(j)(2)(C)) and § 314.93 of this chapter will not constitute final agency action until any petition for re consideration submitted by the peti tioner is acted on by the Commis sioner. (1) It is the position of FDA except as otherwise provided in paragraph (d)(2) of this section, that: (i) Final agency action exhausts all administrative remedies and is ripe for preenforcement judicial review as of the date of the final decision, unless applicable law explicitly requires that the petitioner take further action be fore judicial review is available; (ii) An interested person is affected by, and thus has standing to obtain ju dicial review of final agency action; and (iii) It is not appropriate to move to dismiss a suit for preenforcement judi cial review of final agency action on the ground that indispenable parties are not joined or that it is an unconsented suit against the United States if the defect could be cured by amending the complaint. (2) The Commissioner shall object to judicial review of a matter if: (i) The matter is committed by law to the discretion of the Commissioner, e.g., a decision to recommend or not to recommend civil or criminal enforce ment action under sections 302, 303, and 304 of the act; or (ii) Review is not sought in a proper court. (e) An interested person may request judicial review of a final decision of the Commissioner in the courts without first petitioning the Commissioner for reconsideration or for a stay of action, except that in accordance with para graph (c) of this section, the person shall request a stay by the Commis sioner under § 10.35 before requesting a stay by the court. (f) The Commissioner shall take the position in an action for judicial re view under 5 U.S.C. 701 et seq., whether or not it includes a request for a de claratory judgment under 28 U.S.C. 2201, or in any other case in which the validity of administrative action is properly challenged, that the validity of the action must be determined sole ly on the basis of the administrative record specified in §§ 10.30(i), 10.33(k), 10.35(h), 10.40(g), and 16.80(a) or the ad ministrative record applicable to any decision or action under the regula tions referenced in § 16.1(b), and that additional information or views may not be considered. An interested person who wishes to rely upon information or views not included in the administra tive record shall submit them to the Commissioner with a new petition to modify the action under § 10.25(a). (g) The Commissioner requests that all petitions for judicial review of a particular matter be filed in a single U.S. District court. If petitions are filed in more than one jurisdiction, the Commissioner will take appropriate ac tion to prevent a multiplicity of suits in various jurisdictions, such as: (1) A request for transfer of one or more suits to consolidate separate ac tions, under 28 U.S.C. 1404(a) or 28 U.S.C. 2112(a); (2) A request that actions in all but one jurisdiction be stayed pending the conclusion of one proceeding; (3) A request that all but one action be dismissed pending the conclusion of one proceeding, with the suggestion that the other plaintiffs intervene in that one suit; or (4) A request that one of the suits be maintained as a class action in behalf of all affected persons. (h)(1) For the purpose of 28 U.S.C. 2112(a), a copy of any petition filed in any U.S. Court of Appeals challenging a final action of the Commissioner shall be sent by certified mail, return receipt requested, or by personal deliv ery to the Chief Counsel of FDA. The petition copy shall be time-stamped by the clerk of the court when the origi nal is filed with the court. The petition copy should be addressed to: Office of the Chief Counsel (GCF–1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. The Chief Counsel requests that the purpose of all petitions mailed or delivered to the Office of Chief Counsel to satisfy 28 U.S.C. 2112(a) be clearly identified in a cover letter. (2) If the Chief Counsel receives two or more petitions filed in two or more U.S. Courts of Appeals for review of any agency action within 10 days of the VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00160 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 151 Food and Drug Administration, HHS § 10.50 effective date of that action for the purpose of judicial review, the Chief Counsel will notify the U.S. Judicial Panel on Multidistrict Litigation of any petitions that were received within the 10-day period, in accordance with the applicable rule of the panel. (3) For the purpose of determining whether a petition for review has been received within the 10-day period under paragraph (h)(2) of this section, the pe tition shall be considered to be re ceived on the date of delivery, if per sonally delivered. If the delivery is ac complished by mail, the date of receipt shall be the date noted on the return receipt card. (i) Upon judicial review of adminis trative action under this section: (1) If a court determines that the ad ministrative record is inadequate to support the action, the Commissioner shall determine whether to proceed with such action. (i) If the Commis sioner decides to proceed with the ac tion, the court will be requested to re mand the matter to the agency to re open the administrative proceeding and record, or on the Commissioner’s own initiative the administrative pro ceeding and record may be reopened upon receipt of the court determina tion. A reopened administrative pro ceeding will be conducted under the provisions of this part and in accord ance with any directions of the court. (ii) If the Commissioner concludes that the public interest requires that the action remain in effect pending fur ther administrative proceedings, the court will be requested not to stay the matter in the interim and the Commis sioner shall expedite the further ad ministrative proceedings. (2) If a court determines that the ad ministrative record is adequate, but the rationale for the action must be further explained: (i) The Commissioner shall request either that further explanation be pro vided in writing directly to the court without further administrative pro ceedings, or that the administrative proceeding be reopened in accordance with paragraph (i)(1)(i) of this section; and (ii) If the Commissioner concludes that the public interest requires that the action remain in effect pending fur ther court or administrative pro ceedings, the court will be requested not to stay the matter in the interim and the Commissioner shall expedite the further proceedings. [44 FR 22323, Apr. 13, 1979, as amended at 54 FR 6886, Feb. 15, 1989; 54 FR 9034, Mar. 3, 1989; 57 FR 17980, Apr. 28, 1992; 65 FR 56477, Sept. 19, 2000; 69 FR 31705, June 4, 2004] § 10.50 Promulgation of regulations and orders after an opportunity for a formal evidentiary public hear ing. (a) The Commissioner shall promul gate regulations and orders after an op portunity for a formal evidentiary pub lic hearing under part 12 whenever all of the following apply: (1) The subject matter of the regula tion or order is subject by statute to an opportunity for a formal evidentiary public hearing. (2) The person requesting the hearing has a right to an opportunity for a hearing and submits adequate justifica tion for the hearing as required by §§ 12.20 through 12.22 and other applica ble provisions in this chapter, e.g., §§ 314.200, 514.200, and 601.7(a). (b) The Commissioner may order a formal evidentiary public hearing on any matter whenever it would be in the public interest to do so. (c) The provisions of the act, and other laws, that afford a person who would be adversely affected by admin istrative action an opportunity for a formal evidentiary public hearing as listed below. The list imparts no right to a hearing where the statutory sec tion provides no opportunity for a hearing. (1) Section 401 on any action for the amendment or repeal of any definition and standard of identity for any dairy product (including products regulated under parts 131, 133, and 135 of this chapter) or maple sirup (regulated under § 168.140 of this chapter). (2) Section 403(j) on regulations for labeling of foods for special dietary uses. (3) Section 404(a) on regulations for emergency permit control. (4) Section 406 on tolerances for poi sonous substances in food. (5) Section 409 (c), (d), and (h) on food additive regulations. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00161 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 152 21 CFR Ch. I (4–1–16 Edition) § 10.55 (6) Section 501(b) on tests or methods of assay for drugs described in official compendia. (7) [Reserved] (8) Section 502(h) on regulations des ignating requirements for drugs liable to deterioration. (9) Section 502(n) on prescription drug advertising regulations. (10)–(11) [Reserved] (12) Section 512(n)(5) on regulations for animal antibiotic drugs and certifi cation requirements. (13) Section 721 (b) and (c) on regula tions for color additive listing and cer tification. (14) Section 4(a) of the Fair Pack aging and Labeling Act on food, drug, device, and cosmetic labeling. (15) Section 5(c) of the Fair Pack aging and Labeling Act on additional economic regulations for food, drugs, devices, and cosmetics. (16) Section 505 (d) and (e) on new drug applications. (17) Section 512 (d), (e) and (m) (3) and (4) on new animal drug applications. (18) Section 515(g) on device pre market approval applications and prod uct development protocols. (19) Section 351(a) of the Public Health Service Act on a biologics li cense for a biological product. (20) Section 306 on debarment, debar ment period and considerations, termi nation of debarment under section 306(d)(3), suspension, and termination of suspension. [44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 58 FR 49190, Sept. 22, 1993; 60 FR 38626, July 27, 1995; 63 FR 26697, May 13, 1998; 64 FR 398, Jan. 5, 1999; 64 FR 56448, Oct. 20, 1999; 67 FR 4906, Feb. 1, 2002] § 10.55 Separation of functions; ex parte communications. (a) This section applies to any matter subject by statute to an opportunity for a formal evidentiary public hear ing, as listed in § 10.50(c), and any mat ter subject to a hearing before a Public Board of Inquiry under part 13. (b) In the case of a matter listed in § 10.50(c) (1) through (10) and (12) through (15): (1) An interested person may meet or correspond with any FDA representa tive concerning a matter prior to publi cation of a notice announcing a formal evidentiary public hearing or a hearing before a Public Board of Inquiry on the matter; the provisions of § 10.65 apply to the meetings and correspondence; and (2) Upon publication of a notice an nouncing a formal evidentiary public hearing or a hearing before a Public Board of Inquiry, the following separa tion of functions apply: (i) The center responsible for the matter is, as a party to the hearing, re sponsible for all investigative func tions and for presentation of the posi tion of the center at the hearing and in any pleading or oral argument before the Commissioner. Representatives of the center may not participate or ad vise in any decision except as witness or counsel in public proceedings. There is to be no other communication be tween representatives of the center and representatives of the office of the Commissioner concerning the matter before the decision of the Commis sioner. The Commissioner may, how ever, designate representatives of a center to advise the office of the Com missioner, or designate members of that office to advise a center. The des ignation will be in writing and filed with the Division of Dockets Manage ment no later than the time specified in paragraph (b)(2) of this section for the application of separation of func tions. All members of FDA other than representatives of the involved center (except those specifically designated otherwise) shall be available to advise and participate with the office of the Commissioner in its functions relating to the hearing and the final decision. (ii) The Chief Counsel for FDA shall designate members of the office of Gen eral Counsel to advise and participate with the center in its functions in the hearing and members who are to advise the office of the Commissioner in its functions related to the hearing and the final decision. The members of the office of General Counsel designated to advise the center may not participate or advise in any decision of the Com missioner except as counsel in public proceedings. The designation is to be in the form of a memorandum filed with the Division of Dockets Management and made a part of the administrative record in the proceeding. There may be VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00162 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 153 Food and Drug Administration, HHS § 10.60 no other communication between those members of the office of General Coun sel designated to advise the office of the Commissioner and any other per sons in the office of General Counsel or in the involved center with respect to the matter prior to the decision of the Commissioner. The Chief Counsel may assign new attorneys to advise either the center or the office of the Commis sioner at any stage of the proceedings. The Chief Counsel will ordinarily ad vise and participate with the office of the Commissioner in its functions re lating to the hearing and the final deci sion. (iii) The office of the Commissioner is responsible for the agency review and final decision of the matter, with the advice and participation of anyone in FDA other than representatives of the involved center and those members of the office of General Counsel des ignated to assist in the center’s func tions in the hearing. (c) In a matter listed in § 10.50(c) (11) and (16) through (19), the provisions re lating to separation of functions set forth in §§ 314.200(f), 514.200, and 601.7(a) are applicable before publication of a notice announcing a formal evidentiary public hearing or a hearing before a Public Board of Inquiry. Following publication of the notice of hearing, the rules in paragraph (b)(2) of this sec tion apply. (d) Except as provided in paragraph (e) of this section, between the date that separation of functions applies under paragraph (b) or (c) of this sec tion and the date of the Commis sioner’s decision on the matter, com munication concerning the matter in volved in the hearing will be restricted as follows: (1) No person outside the agency may have an ex parte communication with the presiding officer or any person rep resenting the office of the Commis sioner concerning the matter in the hearing. Neither the presiding officer nor any person representing the office of the Commissioner may have any ex parte communication with a person outside the agency concerning the mat ter in the hearing. All communications are to be public communications, as witness or counsel, under the applica ble provisions of this part. (2) A participant in the hearing may submit a written communication to the office of the Commissioner with re spect to a proposal for settlement. These communications are to be in the form of pleadings, served on all other participants, and filed with the Divi sion of Dockets Management like any other pleading. (3) A written communication con trary to this section must be imme diately served on all other participants and filed with the Division of Dockets Management by the presiding officer at the hearing, or by the Commissioner, depending on who received the commu nication. An oral communication con trary to this section must be imme diately recorded in a written memo randum and similarly served on all other participants and filed with the Division of Dockets Management. A person, including a representative of a participant in the hearing, who is in volved in an oral communication con trary to this section, must, if possible, be made available for cross-examina tion during the hearing with respect to the substance of that conversation. Re buttal testimony pertinent to a writ ten or oral communication contrary to this section will be permitted. Cross examination and rebuttal testimony will be transcribed and filed with the Division of Dockets Management. (e) The prohibitions specified in para graph (d) of this section apply to a per son who knows of a notice of hearing in advance of its publication from the time the knowledge is acquired. (f) The making of a communication contrary to this section may, con sistent with the interests of justice and the policy of the underlying statute, result in a decision adverse to the per son knowingly making or causing the making of such a communication. [44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989; 64 FR 398, Jan. 5, 1999] § 10.60 Referral by court. (a) This section applies when a Fed eral, State, or local court holds in abeyance, or refers to the Commis sioner, any matter for an initial ad ministrative determination under § 10.25(c) or § 10.45(b). VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00163 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 154 21 CFR Ch. I (4–1–16 Edition) § 10.65 (b) The Commissioner shall promptly agree or decline to accept a court refer ral. Whenever feasible in light of agen cy priorities and resources, the Com missioner shall agree to accept a refer ral and shall proceed to determine the matter referred. (c) In reviewing the matter, the Com missioner may use the following proce dures: (1) Conferences, meetings, discus sions, and correspondence under § 10.65. (2) A hearing under parts 12, 13, 14, 15, or 16. (3) A notice published in the FEDERAL REGISTER requesting information and views. (4) Any other public procedure estab lished in other sections of this chapter and expressly applicable to the matter under those provisions. (d) If the Commissioner’s review of the matter results in a proposed rule, the provisions of § 10.40 or § 10.50 also apply. § 10.65 Meetings and correspondence. (a) In addition to public hearings and proceedings established under this part and other sections of this chapter, meetings may be held and correspond ence may be exchanged between rep resentatives of FDA and an interested person outside FDA on a matter within the jurisdiction of the laws adminis tered by the Commissioner. Action on meetings and correspondence does not constitute final administrative action subject to judicial review under § 10.45. (b) The Commissioner may conclude that it would be in the public interest to hold an open public meeting to dis cuss a matter (or class of matters) pending before FDA, in which any in terested person may participate. (1) The Commissioner shall inform the public of the time and place of the meeting and of the matters to be dis cussed. (2) The meeting will be informal, i.e., any interested person may attend and participate in the discussion without prior notice to the agency unless the notice of the meeting specifies other wise. (c) Every person outside the Federal Government may request a private meeting with a representative of FDA in agency offices to discuss a matter. FDA will make reasonable efforts to accommodate such requests. (1) The person requesting a meeting may be accompanied by a reasonable number of employees, consultants, or other persons with whom there is a commercial arrangement within the meaning of § 20.81(a) of this chapter. Neither FDA nor any other person may require the attendance of a person who is not an employee of the executive branch of the Federal Government without the agreement of the person requesting the meeting. Any person may attend by mutual consent of the person requesting the meeting and FDA. (2) FDA will determine which rep resentatives of the agency will attend the meeting. The person requesting the meeting may request, but not require or preclude, the attendance of a spe cific FDA employee. (3) A person who wishes to attend a private meeting, but who is not invited to attend either by the person request ing the meeting or by FDA, or who oth erwise cannot attend the meeting, may request a separate meeting with FDA to discuss the same matter or an addi tional matter. (d) FDA employees have a responsi bility to meet with all segments of the public to promote the objectives of the laws administered by the agency. In pursuing this responsibility, the fol lowing general policy applies where agency employees are invited by per sons outside the Federal Government to attend or participate in meetings outside agency offices as representa tives of the agency. (1) A person outside the executive branch may invite an agency rep resentative to attend or participate in a meeting outside agency offices. The agency representative is not obligated to attend or participate, but may do so where it is in the public interest and will promote the objectives of the act. (2) The agency representative may request that the meeting be open if that would be in the public interest. The agency representative may decline to participate in a meeting held as a private meeting if that will best serve the public interest. (3) An agency representative may not knowingly participate in a meeting VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00164 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 155 Food and Drug Administration, HHS § 10.75 that is closed on the basis of gender, race, or religion. (e) An official transcript, recording, or memorandum summarizing the sub stance of any meeting described in this section will be prepared by a represent ative of FDA when the agency deter mines that such documentation will be useful. (f) FDA promptly will file in the ap propriate administrative file memo randa of meetings prepared by FDA representatives and all correspondence, including any written summary of a meeting from a participant, that relate to a matter pending before the agency. (g) Representatives of FDA may ini tiate a meeting or correspondence on any matter concerning the laws admin istered by the Commissioner. Unless otherwise required by law, meetings may be public or private at FDA’s dis cretion. (h) A meeting of an advisory com mittee is subject to the requirements of part 14 of this chapter. [66 FR 6468, Jan. 22, 2001] § 10.70 Documentation of significant decisions in administrative file. (a) This section applies to every sig nificant FDA decision on any matter under the laws administered by the Commissioner, whether it is raised for mally, for example, by a petition or in formally, for example, by correspond ence. (b) FDA employees responsible for handling a matter are responsible for insuring the completeness of the ad ministrative file relating to it. The file must contain: (1) Appropriate documentation of the basis for the decision, including rel evant evaluations, reviews, memo randa, letters, opinions of consultants, minutes of meetings, and other perti nent written documents; and (2) The recommendations and deci sions of individual employees, includ ing supervisory personnel, responsible for handling the matter. (i) The recommendations and deci sions are to reveal significant con troversies or differences of opinion and their resolution. (ii) An agency employee working on a matter and, consistent with the prompt completion of other assign ments, an agency employee who has worked on a matter may record indi vidual views on that matter in a writ ten memorandum, which is to be placed in the file. (c) A written document placed in an administrative file must: (1) Relate to the factual, scientific, legal or related issues under consider ation; (2) Be dated and signed by the au thor; (3) Be directed to the file, to appro priate supervisory personnel, and to other appropriate employees, and show all persons to whom copies were sent; (4) Avoid defamatory language, in temperate remarks, undocumented charges, or irrelevant matters (e.g., personnel complaints); (5) If it records the views, analyses, recommendations, or decisions of an agency employee in addition to the au thor, be given to the other employees; and (6) Once completed (i.e., typed in final form, dated, and signed) not be al tered or removed. Later additions to or revisions of the document must be made in a new document. (d) Memoranda or other documents that are prepared by agency employees and are not in the administrative file have no status or effect. (e) FDA employees working on a matter have access to the administra tive file on that matter, as appropriate for the conduct of their work. FDA em ployees who have worked on a matter have access to the administrative file on that matter so long as attention to their assignments is not impeded. Rea sonable restrictions may be placed upon access to assure proper cataloging and storage of documents, the avail ability of the file to others, and the completeness of the file for review. § 10.75 Internal agency review of deci sions. (a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the em ployee’s supervisor under the following circumstances: (1) At the request of the employee. (2) On the initiative of the super visor. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00165 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 156 21 CFR Ch. I (4–1–16 Edition) § 10.80 (3) At the request of an interested person outside the agency. (4) As required by delegations of au thority. (b)(1) The review will be made by consultation between the employee and the supervisor or by review of the ad ministrative file on the matter, or both. The review will ordinarily follow the established agency channels of su pervision or review for that matter. (2) A sponsor, applicant, or manufac turer of a drug or device regulated under the act or the Public Health Service Act (42 U.S.C. 262), may request review of a scientific controversy by an appropriate scientific advisory panel as described in section 505(n) of the act, or an advisory committee as described in section 515(g)(2)(B) of the act. The rea son(s) for any denial of a request for such review shall be briefly set forth in writing to the requester. Persons who receive a Center denial of their request under this section may submit a re quest for review of the denial. The re quest should be sent to the Chief Medi ator and Ombudsman. (c) An interested person outside the agency may request internal agency re view of a decision through the estab lished agency channels of supervision or review. Personal review of these matters by center directors or the of fice of the Commissioner will occur for any of the following purposes: (1) To resolve an issue that cannot be resolved at lower levels within the agency (e.g., between two parts of a center or other component of the agen cy, between two centers or other com ponents of the agency, or between the agency and an interested person out side the agency). (2) To review policy matters requir ing the attention of center or agency management. (3) In unusual situations requiring an immediate review in the public inter est. (4) As required by delegations of au thority. (d) Internal agency review of a deci sion must be based on the information in the administrative file. If an inter ested person presents new information not in the file, the matter will be re turned to the appropriate lower level in the agency for reevaluation based on the new information. [44 FR 22323, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 63 FR 63982, Nov. 18, 1998] § 10.80 Dissemination of draft Federal Register notices and regulations. (a) A representative of FDA may dis cuss orally or in writing with an inter ested person ideas and recommenda tions for notices or regulations. FDA welcomes assistance in developing ideas for, and in gathering the informa tion to support, notices and regula tions. (b) Notices and proposed regulations. (1) Once it is determined that a notice or proposed regulation will be prepared, the general concepts may be discussed by a representative of FDA with an in terested person. Details of a draft of a notice or proposed regulation may be discussed with a person outside the ex ecutive branch only with the specific permission of the Commissioner. The permission must be in writing and filed with the Division of Dockets Manage ment. (2) A draft of a notice or proposed regulation or its preamble, or a portion of either, may be furnished to an inter ested person outside the executive branch only if it is made available to all interested persons by a notice pub lished in the FEDERAL REGISTER. A draft of a notice or proposed regulation made available in this manner may, without the prior permission of the Commissioner, be discussed with an in terested person to clarify and resolve questions raised and concerns ex pressed about the draft. (c) After publication of a notice or proposed regulation in the FEDERAL REGISTER, and before preparation of a draft of the final notice or regulation, a representative of FDA may discuss the proposal with an interested person as provided in paragraph (b)(2) of this section. (d) Final notices and regulations. (1) Details of a draft of a final notice or regulation may be discussed with an interested person outside the executive branch only with the specific permis sion of the Commissioner. The permis sion must be in writing and filed with the Division of Dockets Management. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00166 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 157 Food and Drug Administration, HHS § 10.85 (2) A draft of a final notice or regula tion or its preamble, or any portion of either, may be furnished to an inter ested person outside the executive branch only if it is made available to all interested persons by a notice pub lished in the FEDERAL REGISTER, except as otherwise provided in paragraphs (g) and (j) of this section. A draft of a final notice or regulation made available to an interested person in this manner may, without the prior permission of the Commissioner, be discussed as pro vided in paragraph (b)(2) of this sec tion. (i) The final notice or regulation and its preamble will be prepared solely on the basis of the administrative record. (ii) If additional technical informa tion from a person outside the execu tive branch is necessary to draft the final notice or regulation or its pre amble, it will be requested by FDA in general terms and furnished directly to the Division of Dockets Management to be included as part of the adminis trative record. (iii) If direct discussion by FDA of a draft of a final notice or regulation or its preamble is required with a person outside the executive branch, appro priate protective procedures will be un dertaken to make certain that a full and impartial administrative record is established. Such procedures may in clude either: (a) The scheduling of an open public meeting under § 10.65(b) at which inter ested persons may participate in re view of and comment on the draft doc ument; or (b) The preparation of a tentative final regulation or tentative revised final regulation under § 10.40(f)(6), on which interested persons will be given an additional period of time for oral and written comment. (e) After a final regulation is pub lished, an FDA representative may dis cuss any aspect of it with an interested person. (f) In addition to the requirements of this section, the provisions of § 10.55 apply to the promulgation of a regula tion subject to § 10.50 and part 12. (g) A draft of a final food additive color additive, or new animal drug reg ulation may be furnished to the peti tioner for comment on the technical accuracy of the regulation. Every meeting with a petitioner relating to the draft will be recorded in a written memorandum, and all memoranda and correspondence will be filed with the Division of Dockets Management as part of the administrative record of the regulation under the provisions of § 10.65. (h) In accordance with 42 U.S.C 263f, the Commissioner shall consult with interested persons and with the Tech nical Electronic Product Radiation Safety Standards Committee (TEPRSSC) before prescribing any per formance standard for an electronic product. Accordingly, the Commis sioner shall publish in the FEDERAL REGISTER an announcement when a proposed or final performance stand ard, including any amendment, is being considered for an electronic product, and any draft of any proposed or final standard will be furnished to an inter ested person upon request and may be discussed in detail. (i) The provisions of § 10.65 apply to meetings and correspondence relating to draft notices and regulations. (j) The provisions of this section re stricting discussion and disclosure of draft notices and regulations do not apply to situations covered by §§ 20.83 through 20.89. [44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 FR 398, Jan. 5, 1999] § 10.85 Advisory opinions. (a) An interested person may request an advisory opinion from the Commis sioner on a matter of general applica bility. (1) The request will be granted when ever feasible. (2) The request may be denied if: (i) The request contains incomplete information on which to base an in formed advisory opinion; (ii) The Commissioner concludes that an advisory opinion cannot reasonably be given on the matter involved; (iii) The matter is adequately cov ered by a prior advisory opinion or a regulation; (iv) The request covers a particular product or ingredient or label and does not raise a policy issue of broad appli cability; or VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00167 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 158 21 CFR Ch. I (4–1–16 Edition) § 10.85 (v) The Commissioner otherwise con cludes that an advisory opinion would not be in the public interest. (b) A request for an advisory opinion is to be submitted in accordance with § 10.20, is subject to the provisions of § 10.30 (c) through (l), and must be in the following form: (Date) llllllllllllllllllll Division of Dockets Management, Food and Drug Administration, Department of Health and Human Services, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. REQUEST FOR ADVISORY OPINION The undersigned submits this request for an advisory opinion of the Commissioner of Food and Drugs with respect to lll (the general nature of the matter involved). A. Issues involved. (A concise statement of the issues and questions on which an opinion is requested.) B. Statement of facts and law. (A full statement of all facts and legal points relevant to the request.) The undersigned certifies that, to the best of his/her knowledge and belief, this request includes all data, information, and views rel evant to the matter, whether favorable or unfavorable to the position of the under signed, which is the subject of the request. (Signature) lllllllllllllllll (Person making request) llllllllll (Mailing address) llllllllllllll (Telephone number) lllllllllllll (c) The Commissioner may respond to an oral or written request to the agen cy as a request for an advisory opinion, in which case the request will be filed with the Division of Dockets Manage ment and be subject to this section. (d) A statement of policy or interpre tation made in the following docu ments, unless subsequently repudiated by the agency or overruled by a court, will constitute an advisory opinion: (1) Any portion of a FEDERAL REG ISTER notice other than the text of a proposed or final regulation, e.g., a no tice to manufacturers or a preamble to a proposed or final regulation. (2) Trade Correspondence (T.C. Nos. 1–431 and 1A–8A) issued by FDA be tween 1938 and 1946. (3) Compliance policy guides issued by FDA beginning in 1968 and codified in the Compliance Policy Guides man ual. (4) Other documents specifically identified as advisory opinions, e.g., ad visory opinions on the performance standard for diagnostic X-ray systems, issued before July 1, 1975, and filed in a permanent public file for prior advi sory opinions maintained by the Divi sion of Freedom of Information (ELEM–1029)’’ and adding in its place ‘‘(the Freedom of Information Staff’s address is available on the agency’s web site at http://www.fda.gov.) (e) An advisory opinion represents the formal position of FDA on a matter and except as provided in paragraph (f) of this section, obligates the agency to follow it until it is amended or re voked. The Commissioner may not rec ommend legal action against a person or product with respect to an action taken in conformity with an advisory opinion which has not been amended or revoked. (f) In unusual situations involving an immediate and significant danger to health, the Commissioner may take ap propriate civil enforcement action con trary to an advisory opinion before amending or revoking the opinion. This action may be taken only with the ap proval of the Commissioner, who may not delegate this function. Appropriate amendment or revocation of the advi sory opinion involved will be expedited. (g) An advisory opinion may be amended or revoked at any time after it has been issued. Notice of amend ment or revocation will be given in the same manner as notice of the advisory opinion was originally given or in the FEDERAL REGISTER, and will be placed on public display as part of the file on the matter in the office of the Division of Dockets Management. The Division of Dockets Management shall maintain a separate chronological index of all advisory opinions filed. The index will specify the date of the request for the advisory opinion, the date of the opin ion, and identification of the appro priate file. (h) Action undertaken or completed in conformity with an advisory opinion which has subsequently been amended or revoked is acceptable to FDA unless the Commissioner determines that sub stantial public interest considerations preclude continued acceptance. When ever possible, an amended or revoked advisory opinion will state when action previously undertaken or completed VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00168 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 159 Food and Drug Administration, HHS § 10.95 does not remain acceptable, and any transition period that may be applica ble. (i) An interested person may submit written comments on an advisory opin ion or modified advisory opinion. Four copies of any comments are to be sent to the Division of Dockets Manage ment for inclusion in the public file on the advisory opinion. Individuals may submit only one copy. Comments will be considered in determining whether further modification of an advisory opinion is warranted. (j) An advisory opinion may be used in administrative or court proceedings to illustrate acceptable and unaccept able procedures or standards, but not as a legal requirement. (k) A statement made or advice pro vided by an FDA employee constitutes an advisory opinion only if it is issued in writing under this section. A state ment or advice given by an FDA em ployee orally, or given in writing but not under this section or § 10.90, is an informal communication that rep resents the best judgment of that em ployee at that time but does not con stitute an advisory opinion, does not necessarily represent the formal posi tion of FDA, and does not bind or oth erwise obligate or commit the agency to the views expressed. [44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 59 FR 14364, Mar. 28, 1994; 65 FR 56477, Sept. 19, 2000; 76 FR 31469, June 1, 2011; 79 FR 68114, Nov. 14, 2014] § 10.90 Food and Drug Administration regulations, recommendations, and agreements. (a) Regulations. FDA regulations are issued in the FEDERAL REGISTER under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be en forced as legal requirements, or which are intended only as guidance docu ments and recommendations, or both. The dissemination of draft notices and regulations is subject to § 10.80. (b) [Reserved] (c) Recommendations. In addition to the guidance documents subject to § 10.115, FDA often formulates and dis seminates recommendations about matters which are authorized by, but do not involve direct regulatory action under, the laws administered by the Commissioner, e.g., model State and local ordinances, or personnel practices for reducing radiation exposure, issued under 42 U.S.C. 243 and 21 U.S.C. 360ii. These recommendations may, in the discretion of the Commissioner, be handled under the procedures estab lished in § 10.115, except that the rec ommendations will be included in a separate public file of recommenda tions established by the Division of Dockets Management and will be sepa rated from the guidance documents in the notice of availability published in the FEDERAL REGISTER, or be published in the FEDERAL REGISTER as regula tions under paragraph (a) of this sec tion. (d) Agreements. Formal agreements, memoranda of understanding, or other similar written documents executed by FDA and another person will be in cluded in the public file on agreements established by the Division of Freedom of Information (ELEM–1029)’’ and add ing in its place ‘‘(the Freedom of Infor mation Staff’s address is available on the agency’s web site at http:// www.fda.gov) under § 20.108. A docu ment not included in the public file is deemed to be rescinded and has no force or effect whatever. [44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 65 FR 56477, Sept. 19, 2000; 75 FR 16346, Apr. 1, 2010; 79 FR 68114, Nov. 14, 2014] § 10.95 Participation in outside stand ard-setting activities. (a) General. This section applies to participation by FDA employees in standard-setting activities outside the agency. Standard-setting activities in clude matters such as the development of performance characteristics, testing methodology, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient speci fications, labeling, or other technical or policy criteria. FDA encourages em ployee participation in outside stand ard-setting activities that are in the public interest. (b) Standard-setting activities by other Federal Government agencies. (1) An FDA employee may participate in these ac tivities after approval of the activity VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00169 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 160 21 CFR Ch. I (4–1–16 Edition) § 10.95 under procedures specified in the cur rent agency Staff Manual Guide. (2) Approval forms and all pertinent background information describing the activity will be included in the public file on standard-setting activities es tablished by the Division of Freedom of Information (ELEM–1029)’’ and adding in its place ‘‘(the Freedom of Informa tion Staff’s address is available on the agency’s web site at http:// www.fda.gov). (3) If a member of the public is in vited by FDA to present views to, or to accompany, the FDA employee at a meeting, the invitations will be ex tended to a representative sampling of the public, including consumer groups, industry associations, professional so cieties, and academic institutions. (4) An FDA employee appointed as the liaison representative to an activ ity shall refer all requests for informa tion about or participation in the ac tivity to the group or organization re sponsible for the activity. (c) Standard-setting activities by State and local government agencies and by United Nations organizations and other international organizations and foreign governments pursuant to treaty. (1) An FDA employee may participate in these activities after approval of the activity under procedures specified in the current agency Staff Manual Guide. (2) Approval forms and all pertinent background information describing the activity will be included in the public file on standard-setting activities es tablished by the Division of Freedom of Information (ELEM–1029)’’ and adding in its place ‘‘(the Freedom of Informa tion Staff’s address is available on the agency’s web site at http:// www.fda.gov). (3) The availability for public disclo sure of records relating to the activity will be governed by part 20. (4) If a member of the public is in vited by FDA to present views to, or to accompany, the FDA employee at a meeting, the invitation will be ex tended to a representative sampling of the public, including consumer groups, industry associations, professional so cieties, and academic institutions. (5) An FDA employee appointed as the liaison representative to an activ ity shall refer all requests for informa tion about or participation in the ac tivity to the group or organization re sponsible for the activity. (d) Standard-setting activities by pri vate groups and organizations. (1) An FDA employee may engage in these ac tivities after approval of the activity under procedures specified in the cur rent agency Staff Manual Guide. A re quest for official participation must be made by the group or organization in writing, must describe the scope of the activity, and must demonstrate that the minimum standards set out in paragraph (d)(5) of this section are met. Except as provided in paragraph (d)(7) of this section, a request that is grant ed will be the subject of a letter from the Commissioner or the center direc tor to the organization stating— (i) Whether participation by the indi vidual will be as a voting or nonvoting liaison representative; (ii) That participation by the indi vidual does not connote FDA agree ment with, or endorsement of, any de cisions reached; and (iii) That participation by the indi vidual precludes service as the deciding official on the standard involved if it should later come before FDA. The de ciding official is the person who signs a document ruling upon the standard. (2) The letter requesting official FDA participation, the approval form, and the Commissioner’s or center director’s letter, together with all pertinent background information describing the activities involved, will be included in the public file on standard-setting ac tivities established by the Division of Freedom of Information (ELEM–1029)’’ and adding in its place ‘‘(the Freedom of Information Staff’s address is avail able on the agency’s web site at http:// www.fda.gov). (3) The availability for public disclo sure of records relating to the activi ties will be governed by part 20. (4) An FDA employee appointed as the liaison representative to an activ ity shall refer all requests for informa tion about or participation in the ac tivity to the group or organization re sponsible for the activity. (5) The following minimum standards apply to an outside private standard VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00170 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 161 Food and Drug Administration, HHS § 10.95 setting activity in which FDA employ ees participate: (i) The activity will be based upon consideration of sound scientific and technological information, will permit revision on the basis of new informa tion, and will be designed to protect the public against unsafe, ineffective, or deceptive products or practices. (ii) The activity and resulting stand ards will not be designed for the eco nomic benefit of any company, group, or organization, will not be used for such antitrust violations as fixing prices or hindering competition, and will not involve establishment of cer tification or specific approval of indi vidual products or services. (iii) The group or organization re sponsible for the standard-setting ac tivity must have a procedure by which an interested person will have an op portunity to provide information and views on the activity and standards in volved, without the payment of fees, and the information and views will be considered. How this is accomplished, including whether the presentation will be in person or in writing, will be decided by the group or organization responsible for the activity. (6) Membership of an FDA employee in an organization that also conducts a standard-setting activity does not in voke the provisions of this section un less the employee participates in the standard-setting activity. Participa tion in a standard-setting activity is subject to this section. (7) The Commissioner may determine in writing that, because direct involve ment by FDA in a particular standard setting activity is in the public inter est and will promote the objectives of the act and the agency, the participa tion is exempt from the requirements of paragraph (d)(1) (ii) and/or (iii) of this section. This determination will be included in the public file on standard setting activities established by the Di vision of Freedom of Information (ELEM–1029)’’ and adding in its place ‘‘(the Freedom of Information Staff’s address is available on the agency’s web site at http://www.fda.gov) and in any relevant administrative file. The activity may include the establishment and validation of analytical methods for regulatory use, drafting uniform laws and regulations, and the develop ment of recommendations concerning public health and preventive medicine practices by national and international organizations. (8) Because of the close daily co operation between FDA and the asso ciations of State and local government officials listed below in this paragraph, and the large number of agency em ployees who are members of or work with these associations, participation in the activities of these associations is exempt from paragraphs (d)(1) through (7) of this section, except that a list of the committees and other groups of these associations will be included in the public file on standard-setting ac tivities established by the Division of Freedom of Information (ELEM–1029)’’ and adding in its place ‘‘(the Freedom of Information Staff’s address is avail able on the agency’s web site at http:// www.fda.gov). (i) American Association of Food Hy giene Veterinarians (AAFHV). (ii) American Public Health Associa tion (APHA). (iii) Association of American Feed Control Officials, Inc. (AAFCO). (iv) Association of Food and Drug Of ficials (AFDO). (v) AOAC INTERNATIONAL (AOAC). (vi) Association of State and Terri torial Health Officials (ASTHO). (vii) Conference for Food Protection (CFP). (viii) Conference of State Health and Environmental Managers (COSHEM). (ix) Conference of Radiation Control Program Directors (CRCPD). (x) International Association of Milk, Food, and Environmental Sanitation, Inc. (IAMFES). (xi) Interstate Shellfish Sanitation Conference (ISSC). (xii) National Association of Boards of Pharmacy (NABP). (xiii) National Association of Depart ments of Agriculture (NADA). (xiv) National Conference on Inter state Milk Shipments (NCIMS). (xv) National Conference of Local En vironmental Health Administrators (NCLEHA). (xvi) National Conference on Weights and Measures (NCWW). (xvii) National Environmental Health Association (NEHA). VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00171 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 162 21 CFR Ch. I (4–1–16 Edition) § 10.100 (xviii) National Society of Profes sional Sanitarians (NSPS). [44 FR 22323, Apr. 13, 1979, as amended at 46 FR 8455, Jan. 27, 1981; 52 FR 35064, Sept. 17, 1987; 54 FR 9035, Mar. 3, 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005; 76 FR 31469, June 1, 2011; 79 FR 68114, Nov. 14, 2014] § 10.100 Public calendar. (a) Public calendar. A public calendar will be prepared and made publicly available by FDA each week showing, to the extent feasible, significant events of the previous week, including significant meetings with persons out side the executive branch, that involve the representatives of FDA designated under paragraph (c) of this section. (1) Public calendar entries will in clude: (i) Significant meetings with mem bers of the judiciary, representatives of Congress, or staffs of congressional committees when the meeting relates to a pending court case, administrative hearing, or other regulatory action or decision; (ii) Significant meetings, con ferences, seminars, and speeches; and (iii) Social events sponsored by the regulated industry. (2) The public calendar will not in clude reports of meetings that would prejudice law enforcement activities (e.g., a meeting with an informant) or invade privacy (e.g., a meeting with a candidate for possible employment at FDA), meetings with members of the press, or meetings with onsite contrac tors. (b) Calendar entries. The calendar will specify for each entry the date, per son(s), and subject matter involved. If a large number of persons are in at tendance, the name of each individual need not be specified. When more than one FDA representative is in attend ance, the most senior agency official will report the meeting on the public calendar. (c) Affected persons. The following FDA representatives are subject to the requirements of this section: (1) Commissioner of Food and Drugs. (2) Senior Associate Commissioners. (3) Deputy Commissioners. (4) Associate Commissioner for Regu latory Affairs. (5) Center Directors. (6) Chief Counsel for the Food and Drug Administration. (d) Public display. The public calendar will be placed on public display at the following locations: (1) Division of Dockets Management. (2) Office of the Associate Commis sioner for Public Affairs. (3) The FDA home page, to the extent feasible. [66 FR 6468, Jan. 22, 2001] § 10.105 Representation by an organi zation. (a) An organization may represent its members by filing petitions, com ments, and objections, and otherwise participating in an administrative pro ceeding subject to this part. (b) A petition, comment, objection, or other representation by an organiza tion will not abridge the right of a member to take individual action of a similar type, in the member’s own name. (c) It is requested that each organiza tion participating in FDA administra tive proceedings file annually with the Division of Dockets Management a cur rent list of all of the members of the organization. (d) The filing by an organization of an objection or request for hearing under §§ 12.20 through 12.22 does not provide a member a legal right with re spect to the objection or request for hearing that the member may individ ually exercise. A member of an organi zation wishing to file an objection or request for hearing must do so individ ually. (e) In a court proceeding in which an organization participates, the Commis sioner will take appropriate legal measures to have the case brought or considered as a class action or other wise as binding upon all members of the organization except those specifi cally excluded by name. Regardless of whether the case is brought or consid ered as a class action or as otherwise binding upon all members of the orga nization except those specifically ex cluded by name, the Commissioner will take the position in any subsequent suit involving the same issues and a member of the organization that the VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00172 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 163 Food and Drug Administration, HHS § 10.115 issues are precluded from further liti gation by the member under the doc trines of collateral estoppel or res judi cata. § 10.110 Settlement proposals. At any time in the course of a pro ceeding subject to this part, a person may propose settlement of the issues involved. A participant in a proceeding will have an opportunity to consider a proposed settlement. Unaccepted pro posals of settlement and related mat ters, e.g., proposed stipulations not agreed to, will not be admissible in evi dence in an FDA administrative pro ceeding. FDA will oppose the admission in evidence of settlement information in a court proceeding or in another ad ministrative proceeding. § 10.115 Good guidance practices. (a) What are good guidance practices? Good guidance practices (GGP’s) are FDA’s policies and procedures for de veloping, issuing, and using guidance documents. (b) What is a guidance document? (1) Guidance documents are documents prepared for FDA staff, applicants/ sponsors, and the public that describe the agency’s interpretation of or policy on a regulatory issue. (2) Guidance documents include, but are not limited to, documents that re late to: The design, production, label ing, promotion, manufacturing, and testing of regulated products; the proc essing, content, and evaluation or ap proval of submissions; and inspection and enforcement policies. (3) Guidance documents do not in clude: Documents relating to internal FDA procedures, agency reports, gen eral information documents provided to consumers or health professionals, speeches, journal articles and edi torials, media interviews, press mate rials, warning letters, memoranda of understanding, or other communica tions directed to individual persons or firms. (c) What other terms have a special meaning? (1) ‘‘Level 1 guidance docu ments’’ include guidance documents that: (i) Set forth initial interpretations of statutory or regulatory requirements; (ii) Set forth changes in interpreta tion or policy that are of more than a minor nature; (iii) Include complex scientific issues; or (iv) Cover highly controversial issues. (2) ‘‘Level 2 guidance documents’’ are guidance documents that set forth ex isting practices or minor changes in in terpretation or policy. Level 2 guidance documents include all guidance docu ments that are not classified as Level 1. (3) ‘‘You’’ refers to all affected par ties outside of FDA. (d) Are you or FDA required to follow a guidance document? (1) No. Guidance documents do not establish legally en forceable rights or responsibilities. They do not legally bind the public or FDA. (2) You may choose to use an ap proach other than the one set forth in a guidance document. However, your alternative approach must comply with the relevant statutes and regulations. FDA is willing to discuss an alter native approach with you to ensure that it complies with the relevant stat utes and regulations. (3) Although guidance documents do not legally bind FDA, they represent the agency’s current thinking. There fore, FDA employees may depart from guidance documents only with appro priate justification and supervisory concurrence. (e) Can FDA use means other than a guidance document to communicate new agency policy or a new regulatory ap proach to a broad public audience? The agency may not use documents or other means of communication that are excluded from the definition of guidance document to informally com municate new or different regulatory expectations to a broad public audience for the first time. These GGP’s must be followed whenever regulatory expecta tions that are not readily apparent from the statute or regulations are first communicated to a broad public audience. (f) How can you participate in the de velopment and issuance of guidance docu ments? (1) You can provide input on VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00173 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 164 21 CFR Ch. I (4–1–16 Edition) § 10.115 guidance documents that FDA is devel oping under the procedures described in paragraph (g) of this section. (2) You can suggest areas for guid ance document development. Your sug gestions should address why a guidance document is necessary. (3) You can submit drafts of proposed guidance documents for FDA to con sider. When you do so, you should mark the document ‘‘Guidance Docu ment Submission’’ and submit it to Di vision of Dockets Management (HFA– 305), 5630 Fishers Lane, rm. 1061, Rock ville, MD 20852. (4) You can, at any time, suggest that FDA revise or withdraw an already ex isting guidance document. Your sug gestion should address why the guid ance document should be revised or withdrawn and, if applicable, how it should be revised. (5) Once a year, FDA will publish, both in the FEDERAL REGISTER and on the Internet, a list of possible topics for future guidance document develop ment or revision during the next year. You can comment on this list (e.g., by suggesting alternatives or making rec ommendations on the topics that FDA is considering). (6) To participate in the development and issuance of guidance documents through one of the mechanisms de scribed in paragraphs (f)(1), (f)(2), or (f)(4) of this section, you should con tact the center or office that is respon sible for the regulatory activity cov ered by the guidance document. (7) If FDA agrees to draft or revise a guidance document, under a suggestion made under paragraphs (f)(1), (f)(2), (f)(3) or (f)(4) of this section, you can participate in the development of that guidance document under the proce dures described in paragraph (g) of this section. (g) What are FDA’s procedures for de veloping and issuing guidance documents? (1) FDA’s procedures for the develop ment and issuance of Level 1 guidance documents are as follows: (i) Before FDA prepares a draft of a Level 1 guidance document, FDA can seek or accept early input from indi viduals or groups outside the agency. For example, FDA can do this by par ticipating in or holding public meet ings and workshops. (ii) After FDA prepares a draft of a Level 1 guidance document, FDA will: (A) Publish a notice in the FEDERAL REGISTER announcing that the draft guidance document is available; (B) Post the draft guidance document on the Internet and make it available in hard copy; and (C) Invite your comment on the draft guidance document. Paragraph (h) of this section tells you how to submit your comments. (iii) After FDA prepares a draft of a Level 1 guidance document, FDA also can: (A) Hold public meetings or work shops; or (B) Present the draft guidance docu ment to an advisory committee for re view. (iv) After providing an opportunity for public comment on a Level 1 guid ance document, FDA will: (A) Review any comments received and prepare the final version of the guidance document that incorporates suggested changes, when appropriate; (B) Publish a notice in the FEDERAL REGISTER announcing that the guid ance document is available; (C) Post the guidance document on the Internet and make it available in hard copy; and (D) Implement the guidance docu ment. (v) After providing an opportunity for comment, FDA may decide that it should issue another draft of the guid ance document. In this case, FDA will follow the steps in paragraphs (g)(1)(ii), (g)(1)(iii), and (g)(1)(iv) of this section. (2) FDA will not seek your comment before it implements a Level 1 guid ance document if the agency deter mines that prior public participation is not feasible or appropriate. (3) FDA will use the following proce dures for developing and issuing Level 1 guidance documents under the cir cumstances described in paragraph (g)(2) of this section: (i) After FDA prepares a guidance document, FDA will: (A) Publish a notice in the FEDERAL REGISTER announcing that the guid ance document is available; (B) Post the guidance document on the Internet and make it available in hard copy; VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00174 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 165 Food and Drug Administration, HHS § 10.115 (C) Immediately implement the guid ance document; and (D) Invite your comment when it issues or publishes the guidance docu ment. Paragraph (h) of this section tells you how to submit your com ments. (ii) If FDA receives comments on the guidance document, FDA will review those comments and revise the guid ance document when appropriate. (4) FDA will use the following proce dures for developing and issuing Level 2 guidance documents: (i) After it prepares a guidance docu ment, FDA will: (A) Post the guidance document on the Internet and make it available in hard copy; (B) Immediately implement the guid ance document, unless FDA indicates otherwise when the document is made available; and (C) Invite your comment on the Level 2 guidance document. Paragraph (h) of this section tells you how to submit your comments. (ii) If FDA receives comments on the guidance document, FDA will review those comments and revise the docu ment when appropriate. If a version is revised, the new version will be placed on the Internet. (5) You can comment on any guid ance document at any time. Paragraph (h) of this section tells you how to sub mit your comments. FDA will revise guidance documents in response to your comments when appropriate. (h) How should you submit comments on a guidance document? (1) If you choose to submit comments on any guidance document under paragraph (g) of this section, you must send them to the Division of Dockets Management (HFA–305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. (2) Comments should identify the docket number on the guidance docu ment, if such a docket number exists. For documents without a docket num ber, the title of the guidance document should be included. (3) Comments will be available to the public in accordance with FDA’s regu lations on submission of documents to the Division of Dockets Management specified in § 10.20(j). (i) What standard elements must FDA include in a guidance document? (1) A guidance document must: (i) Include the term ‘‘guidance,’’ (ii) Identify the center(s) or office(s) issuing the document, (iii) Identify the activity to which and the people to whom the document applies, (iv) Prominently display a statement of the document’s nonbinding effect, (v) Include the date of issuance, (vi) Note if it is a revision to a pre viously issued guidance and identify the document that it replaces, and (vii) Contain the word ‘‘draft’’ if the document is a draft guidance. (2) Guidance documents must not in clude mandatory language such as ‘‘shall,’’ ‘‘must,’’ ‘‘required,’’ or ‘‘re quirement,’’ unless FDA is using these words to describe a statutory or regu latory requirement. (3) When issuing draft guidance docu ments that are the product of inter national negotiations (e.g., guidances resulting from the International Con ference on Harmonisation), FDA need not apply paragraphs (i)(1) and (i)(2) of this section. However, any final guid ance document issued according to this provision must contain the elements in paragraphs (i)(1) and (i)(2) of this sec tion. (j) Who, within FDA, can approve issuance of guidance documents? Each center and office must have written procedures for the approval of guidance documents. Those procedures must en sure that issuance of all documents is approved by appropriate senior FDA of ficials. (k) How will FDA review and revise ex isting guidance documents? (1) The agen cy will periodically review existing guidance documents to determine whether they need to be changed or withdrawn. (2) When significant changes are made to the statute or regulations, the agency will review and, if appropriate, revise guidance documents relating to that changed statute or regulation. (3) As discussed in paragraph (f)(3) of this section, you may at any time sug gest that FDA revise a guidance docu ment. (l) How will FDA ensure that FDA staff are following GGP’s? (1) All current and VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00175 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 166 21 CFR Ch. I (4–1–16 Edition) § 10.200 new FDA employees involved in the de velopment, issuance, or application of guidance documents will be trained re garding the agency’s GGP’s. (2) FDA centers and offices will mon itor the development and issuance of guidance documents to ensure that GGP’s are being followed. (m) How can you get copies of FDA’s guidance documents? FDA will make copies available in hard copy and, as feasible, through the Internet. (n) How will FDA keep you informed of the guidance documents that are avail able? (1) FDA will maintain on the Internet a current list of all guidance documents. New documents will be added to this list within 30 days of issuance. (2) Once a year, FDA will publish in the FEDERAL REGISTER its comprehen sive list of guidance documents. The comprehensive list will identify docu ments that have been added to the list or withdrawn from the list since the previous comprehensive list. (3) FDA’s guidance document lists will include the name of the guidance document, issuance and revision dates, and information on how to obtain cop ies of the document. (o) What can you do if you believe that someone at FDA is not following these GGP’s? If you believe that someone at FDA did not follow the procedures in this section or that someone at FDA treated a guidance document as a bind ing requirement, you should contact that person’s supervisor in the center or office that issued the guidance docu ment. If the issue cannot be resolved, you should contact the next highest su pervisor. You can also contact the cen ter or office ombudsman for assistance in resolving the issue. If you are unable to resolve the issue at the center or of fice level or if you feel that you are not making progress by going through the chain of command, you may ask the Office of the Chief Mediator and Om budsman to become involved. [65 FR 56477, Sept. 19, 2000] Subpart C—Electronic Media Cov erage of Public Administrative Proceedings; Guideline on Policy and Procedures SOURCE: 49 FR 14726, Apr. 13, 1984, unless otherwise noted. § 10.200 Scope. This guideline describes FDA’s policy and procedures applicable to electronic media coverage of agency public ad ministrative proceedings. It is a guide line intended to clarify and explain FDA’s policy on the presence and oper ation of electronic recording equip ment at such proceedings and to assure uniform and consistent application of practices and procedures throughout the agency. § 10.203 Definitions. (a) Public administrative proceeding as used in this guideline means any FDA proceeding which the public has a right to attend. This includes a formal evi dentiary public hearing as set forth in part 12, a public hearing before a Pub lic Board of Inquiry as set forth in part 13, a public hearing before a Public Ad visory Committee as set forth in part 14, a public hearing before the Commis sioner as set forth in part 15, a regu latory hearing before FDA as set forth in part 16, consumer exchange meet ings, and Commissioner’s public meet ings with health professionals. (b) Advance notice as used in this guideline means written or telephone notification to FDA’s Office of Public Affairs (Press Relations Staff) of intent to electronically record an agency pub lic administrative proceeding. (c) Electronic recording as used in this guideline means any visual or audio re cording made by videotape recording equipment or moving film camera, and/ or other electronic recording equip ment. [49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989] § 10.204 General. (a) FDA has for many years willingly committed itself to a policy of open ness. In many instances FDA has sought to make the open portions of VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00176 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 167 Food and Drug Administration, HHS § 10.204 agency public administrative pro ceedings more accessible to public par ticipation. Similarly, FDA has sought, wherever possible, to allow full written media access to its proceedings, so that members of the press would have the opportunity to provide first-hand re ports. However, because electronic media coverage presents certain dif ficulties that are easier to resolve with advance notice to the agency and all participants, FDA believes that codi fication of its policy will facilitate and further increase media access to its public administrative proceedings. The agency intends to refer to this guide line when notices of hearing, or indi vidual advisory committee meetings, are published in the FEDERAL REG ISTER. Thus, all parties to a proceeding will be on notice that the proceeding may be recorded electronically and any person interested in videotaping or otherwise recording the proceeding will be notified that there are established procedures to be followed. (b) The designated presiding officer of a public administrative proceeding retains the existing discretionary au thority set forth in specific regulations pertaining to each type of administra tive proceeding to regulate the conduct of the proceeding over which he or she presides. The responsibilities of the presiding officer, established elsewhere in parts 10 through 16, include an obli gation to be concerned with the timely conduct of a hearing, the limited avail ability of certain witnesses, and reduc ing disruptions to the proceeding which may occur. Each proceeding varies, and the presiding officer cannot anticipate all that might occur. Discretionary au thority to regulate conduct at a pro ceeding has traditionally been granted to presiding officers to enable them to fulfill their responsibility to maintain a fair and orderly hearing conducted in an expeditious manner. (c) This guideline provides the pre siding officer with a degree of flexi bility in that it sets forth the agency’s policy as well as the procedures that presiding officers should ordinarily fol low, but from which they may depart in particular situations if necessary, subject to the presumption of openness of public proceedings to electronic media coverage. The presiding officer’s discretion to establish additional pro cedures or to limit electronic coverage is to be exercised only in the unusual circumstances defined in this guide line. Even though a presiding officer may establish additional procedures or limits as may be required in a par ticular situation, he or she will be guided by the policy expressed in this guideline in establishing these condi tions. The presiding officer may also be less restrictive, taking into account such factors as the duration of a hear ing and the design of the room. (d) If a portion or all of a proceeding is closed to the public because material is to be discussed that is not disclosable to the public under applica ble laws, the proceeding also will be closed to electronic media coverage. (e) The agency requests advance no tice of intent to record a proceeding electronically to facilitate the orderly conduct of the proceeding. Knowledge of anticipated media coverage will allow the presiding officer to make any special arrangements required by the circumstances of the proceeding. The agency believes that this guideline es tablishes sufficiently specific criteria to promote uniformity. (f) The agency would like to allow all interested media representatives to videotape a proceeding in which they have an interest. However, should space limitations preclude a multitude of cameras, the presiding officer may require pool sharing. In such a case, pool sharing arrangements of the re sulting videotape should be made be tween those allowed to film and those who were excluded. Arrangements for who is designated to present the pool and a method of distributing the re sulting film or tape may be determined by the established networks’ pooling system. However, the agency has a strong commitment to ensuring that media representatives other than the major networks also be able to obtain a copy of the tape at cost. FDA is con cerned that if the network pool rep resentative wishes to record only a short portion of a proceeding, but an excluded party wishes to record the en tire proceeding, confusion will result. The agency expects the interested media representatives to negotiate a suitable agreement among themselves VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00177 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 168 21 CFR Ch. I (4–1–16 Edition) § 10.205 before commencement of the pro ceeding. For example, the network pool representatives might agree to record a portion of the proceeding up to a break in the proceeding, at which time, while the network representative is dis assembling equipment, another media representative might set up to con tinue recording. If an agreement can not be reached before the proceeding, the agency will use the time of receipt of any advance notice to determine the representation for each category of media, e.g., one network reporter, one independent reporter. The agency rec ommends that parties intending to vid eotape provide as much advance notice as possible, so that the agency may best respond to the needs of the elec tronic media. (g) To ensure the timely conduct of agency hearings and to prevent disrup tions, equipment is to be stationary during a proceeding and should be set up and taken down when the pro ceeding is not in progress. As noted previously, the presiding officer may, at his or her discretion, be less restric tive if appropriate. (h) The agency recognizes that elec tronic media representatives may de sire only short footage of a proceeding, a facsimile of the proceeding, and/or interview opportunities and may be un necessarily restricted by requirements for setting up before a proceeding and then waiting until a break in the pro ceeding before being permitted to take down their equipment. To accommo date this possibility, FDA’s Press Rela tions Staff will attempt to make ar rangements to respond to such needs by, for example, requesting that the presiding officer provide a break short ly after commencement of the pro ceeding to permit take down of equip ment. (i) The agency is making a full com mitment to allowing, whenever pos sible, electronic coverage of its public administrative proceedings subject to the limited restrictions established in this guideline. § 10.205 Electronic media coverage of public administrative proceedings. (a) A person may record electroni cally any open public administrative proceeding, subject to the procedures specified in this guideline. The proce dures include a presumption that agen cy public proceedings are open to the electronic media. Whenever possible, FDA will permit all interested persons access to record agency public adminis trative proceedings. Restrictions other than those listed in § 10.206 will be im posed only under exceptional cir cumstances. (b) A videotape recording of an FDA public administrative proceeding is not an official record of the proceeding. The only official record is the written transcript of the proceeding, which is taken by the official reporter. § 10.206 Procedures for electronic media coverage of agency public administrative proceedings. (a) To facilitate the agency’s re sponse to media needs, a person intend ing to videotape an FDA public admin istrative proceeding should, whenever possible, provide advance notice to the Press Relations Staff (HFI–20), Office of Public Affairs, Food and Drug Adminis tration, 5600 Fishers Lane, Rockville, MD 20857, in writing or by telephone (telephone 301–443–4177), at least 48 hours in advance of the proceeding. The Press Relations Staff will inform the presiding officer that the pro ceeding will be attended by representa tives of the electronic media, and as certain whether any special provisions in addition to those set forth in this subpart are required by the presiding officer. If so, the Press Relations Staff will function as a liaison between the presiding officer and the person intend ing to record the proceeding in facili tating any procedures in addition to those outlined in this subpart. The pre siding officer will not deny access for failure to provide a 48-hour advance no tice. Any advance notice may describe the intended length of recording if known, the amount and type of equip ment to be used, and any special needs such as interviews. (b) Cameras should be completely set up before a proceeding is scheduled to begin or during a break in the pro ceeding and should remain standing in the area designated for electronic media equipment. Cameras may be taken down only during breaks or after the hearing is over. Roving cameras VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00178 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 169 Food and Drug Administration, HHS § 10.206 will not be permitted during the pro ceeding. Any artificial lighting should be unobtrusive. Microphones, like cam eras, should be in place before the start of a proceeding and may be taken down as indicated in this paragraph. (c) When space in the hearing room is limited, the presiding officer may re strict the number of cameras or the equipment present. Should such a re striction become necessary, the pool arrangements are the responsibility of the participating media. The agency encourages the network pool to make copies of the tape, film, or other prod uct available at cost to nonpool par ticipants. However, if this is not pos sible, the agency may need to use the time of receipt of any advance notice to determine the representation for each category, e.g., one network re porter, one independent reporter, etc. (d) Off the record portions of a pro ceeding may not be videotaped. (e) Before or during the proceeding, the presiding officer may establish other conditions specific to the pro ceeding for which the request is being made. These conditions may be more or less restrictive than those stated in this guideline, except that the pre siding officer shall observe the agen cy’s presumption of openness of its public proceedings to the electronic media. Only a substantial and clear threat to the agency’s interests in order, fairness, and timeliness author izes the presiding officer to impose ad ditional restrictions. This threat must outweigh the public interest in elec tronic media coverage of agency pro ceedings. Additional restrictions shall be narrowly drawn to the particular circumstances. The following factors are listed to assist presiding officers in determining whether the agency’s in terest is sufficiently compelling to call for the unusual step of imposing addi tional restrictions. Generally this step is justified when one of the following factors is met: (1) Electronic recording would result in a substantial likelihood of disrup tion that clearly cannot be contained by the procedures established in para graphs (a) through (d) of this section. (2) Electronic recording would result in a substantial likelihood of preju dicial impact on the fairness of the pro ceeding or the substantive discussion in a proceeding. (3) There is a substantial likelihood that a witness’ ability to testify may be impaired due to unique personal cir cumstances such as the age or psycho logical state of the witness or the par ticularly personal or private nature of the witness’ testimony, if the witness’ testimony were electronically re corded. (f) Before the proceeding, the Press Relations Staff will, upon request, pro vide written copies of any additional conditions imposed by the presiding of ficer (as described in paragraph (e) of this section) to requesting members of the media. Any appeals should be made in accordance with paragraph (h) of this section. (g) The presiding officer retains au thority to restrict or discontinue videotaping or other recording of a pro ceeding, or parts of a proceeding, should such a decision become nec essary. The presiding officer’s responsi bility to conduct the hearing includes the right and duty to remove a source of substantial disruption. In exercising his or her authority, the presiding offi cer shall observe the presumption that agency public proceedings are open to the electronic media. The presiding of ficer shall exercise his or her discretion to restrict or discontinue electronic coverage of a public proceeding, or por tions of a public proceeding, only if he or she determines that the agency’s in terest in the fair and orderly adminis trative process is substantially threat ened. A clear and substantial threat to the integrity of agency proceedings must clearly outweigh the public inter est in electronic media coverage of the proceedings before additional restric tions are imposed on the electronic media during the course of the pro ceedings. The factors noted in para graph (e) of this section indicate the kind of substantial threat to the agen cy interests that may require imposing additional restrictions during the course of the proceedings. If additional requirements are established during the hearing, the presiding officer shall notify immediately the Deputy Com missioner of Food and Drugs of that fact by telephone and submit a written explanation of the circumstances that VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00179 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B 170 21 CFR Ch. I (4–1–16 Edition) Pt. 11 necessitated such an action within 24 hours or sooner if requested by the Deputy Commissioner. In the absence or unavailability of the Deputy Com missioner, the presiding officer shall notify the Associate Commissioner for Regulatory Affairs. (h) A decision by a presiding officer, made either before the proceeding or during the course of a proceeding, to establish requirements in addition to the minimum standards set forth in this guideline may be appealed by any adversely affected person who intends to record the proceeding electronically. Appeals may be made in writing or by phone to the Deputy Commissioner or, in his or her absence, to the Associate Commissioner for Regulatory Affairs. The filing of an appeal, whether before or during a proceeding, does not re quire the presiding officer to interrupt the proceeding. However, the Deputy Commissioner or, in his or her absence, the Associate Commissioner for Regu latory Affairs will resolve an appeal as expeditiously as possible so as to pre serve, to the extent possible, the re porters’ opportunity to record the pro ceedings. [49 FR 14726, Apr. 13, 1984, as amended at 54 FR 9035, Mar. 3, 1989] PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Subpart A—General Provisions Sec. 11.1 Scope. 11.2 Implementation. 11.3 Definitions. Subpart B—Electronic Records 11.10 Controls for closed systems. 11.30 Controls for open systems. 11.50 Signature manifestations. 11.70 Signature/record linking. Subpart C—Electronic Signatures 11.100 General requirements. 11.200 Electronic signature components and controls. 11.300 Controls for identification codes/pass words. AUTHORITY: 21 U.S.C. 321–393; 42 U.S.C. 262. SOURCE: 62 FR 13464, Mar. 20, 1997, unless otherwise noted. Subpart A—General Provisions § 11.1 Scope. (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. (b) This part applies to records in electronic form that are created, modi fied, maintained, archived, retrieved, or transmitted, under any records re quirements set forth in agency regula tions. This part also applies to elec tronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means. (c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic sig natures to be equivalent to full hand written signatures, initials, and other general signings as required by agency regulations, unless specifically ex cepted by regulation(s) effective on or after August 20, 1997. (d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with § 11.2, unless paper records are spe cifically required. (e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily avail able for, and subject to, FDA inspec tion. (f) This part does not apply to records required to be established or maintained by §§ 1.326 through 1.368 of this chapter. Records that satisfy the requirements of part 1, subpart J of this chapter, but that also are required under other applicable statutory provi sions or regulations, remain subject to this part. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00180 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp ow el l o n D S K 54 D X V N 1O F R w ith $ $ JO B