Regulatory hearing before the Food and Drug Administration (21 CFR 16.1-16.120)

226 21 CFR Ch. I (4–1–16 Edition) § 15.30 writing to the Division of Dockets Management, under § 10.20. The record of the hearing will remain open for 15 days after the hearing is held for any additional written submissions, unless the notice of the hearing specifies oth erwise or the presiding officer rules otherwise. § 15.30 Conduct of a public hearing be fore the Commissioner. (a) The Commissioner or a designee may preside at the hearing, except where a regulation provides that the Commissioner will preside personally. The presiding officer may be accom panied by other FDA employees or other Federal Government employees designated by the Commissioner, who may serve as a panel in conducting the hearing. (b) The hearing will be transcribed. (c) Persons may use their alloted time in whatever way they wish, con sistent with a reasonable and orderly hearing. A person may be accompanied by any number of additional persons, and may present any written informa tion or views for inclusion in the record of the hearing, subject to the re quirements of § 15.25. The presiding offi cer may allot additional time to any person when the officer concludes that it is in the public interest, but may not reduce the time allotted for any person without the consent of the person. (d) If a person is not present at the time specified for the presentation, the persons following will appear in order, with adjustments for those appearing at their scheduled time. An attempt will be made to hear any person who is late at the conclusion of the hearing. Other interested persons attending the hearing who did not request an oppor tunity to make an oral presentation will be given an opportunity to make an oral presentation at the conclusion of the hearing, in the discretion of the presiding officer, to the extent that time permits. (e) The presiding officer and any other persons serving on a panel may question any person during or at the conclusion of the presentation. No other person attending the hearing may question a person making a pres entation. The presiding officer may, as a matter of discretion, permit ques tions to be submitted to the presiding officer or panel for response by them or by persons attending the hearing. (f) The hearing is informal in nature, and the rules of evidence do not apply. No motions or objections relating to the admissibility of information and views may be made or considered, but other participants may comment upon or rebut all such information and views. No participant may interrupt the presentation of another participant at any hearing for any reason. (g) The hearing may end early only if all persons scheduled for a later presen tation have already appeared or it is past the time specified in the hearing schedule, under § 15.21(e), by which par ticipants must be present. (h) The Commissioner or the pre siding officer may, under § 10.19, sus pend, modify, or waive any provision of this part. Subpart C—Records of a Public Hearing Before the Commissioner § 15.40 Administrative record. (a) The administrative record of a public hearing before the Commis sioner consists of the following: (1) All relevant FEDERAL REGISTER notices, including any documents to which they refer. (2) All written submissions under § 15.25. (3) The transcript of the oral hearing. (b) The record of the administrative proceeding will be closed at the time specified in § 15.25. § 15.45 Examination of administrative record. Section 10.20(j) governs the avail ability for public examination and copying of each document in the ad ministrative record of the hearing PART 16—REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION Subpart A—General Provisions Sec. 16.1 Scope. 16.5 Inapplicability and limited applica bility. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00236 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 227 Food and Drug Administration, HHS § 16.1 Subpart B—Initiation of Proceedings 16.22 Initiation of regulatory hearing. 16.24 Regulatory hearing required by the act or a regulation. 16.26 Denial of hearing and summary deci sion. Subpart C—Commissioner and Presiding Officer 16.40 Commissioner. 16.42 Presiding officer. 16.44 Communication to presiding officer and Commissioner. Subpart D—Procedures for Regulatory Hearing 16.60 Hearing procedure. 16.62 Right to counsel. Subpart E—Administrative Record and Decision 16.80 Administrative record of a regulatory hearing. 16.85 Examination of administrative record. 16.95 Administrative decision and record for decision. Subpart F—Reconsideration and Stay 16.119 Reconsideration and stay of action. Subpart G—Judicial Review 16.120 Judicial review. AUTHORITY: 15 U.S.C. 1451–1461; 21 U.S.C. 141–149, 321–394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. SOURCE: 44 FR 22367, Apr. 13, 1979, unless otherwise noted. Subpart A—General Provisions § 16.1 Scope. The procedures in this part apply when: (a) The Commissioner is considering any regulatory action, including a re fusal to act, and concludes, as a matter of discretion, on the Commissioner’s initiative or at the suggestion of any person, to offer an opportunity for a regulatory hearing to obtain additional information before making a decision or taking action. (b) The act or a regulation provides a person with an opportunity for a hear ing on a regulatory action, including proposed action, and the act or a regu lation either specifically provides an opportunity for a regulatory hearing under this part or provides an oppor tunity for a hearing for which no pro cedures are specified by regulation. Listed below are the statutory and reg ulatory provisions under which regu latory hearings are available: (1) Statutory provisions: Section 304(g) of the act relating to the ad ministrative detention of devices and drugs (see §§ 800.55(g) and 1.980(g) of this chapter). Section 304(h) of the act relating to the ad ministrative detention of food for human or animal consumption (see part 1, subpart k of this chapter). Section 419(c)(2)(D) of the Federal Food, Drug, and Cosmetic Act relating to the modification or revocation of a variance from the requirements of section 419 (see part 112, subpart P of this chapter). Section 515(e)(1) of the act relating to the proposed withdrawal of approval of a de vice premarket approval application. Section 515(e)(3) of the act relating to the temporary suspension of approval of a pre market approval application. Section 515(f)(6) of the act relating to a pro posed order revoking a device product de velopment protocol or declaring a protocol not completed. Section 515(f)(7) of the act relating to revoca tion of a notice of completion of a product development protocol. Section 516 of the act relating to a proposed banned device regulations (see § 895.21(d) of this chapter). Section 518(b) of the act relating to a deter mination that a device is subject to a re pair, replacement, or refund order or that a correction plan, or revised correction plan, submitted by a manufacturer, im porter, or distributor is inadequate. Section 518(e) of the act relating to a cease distribution and notification order or man datory recall order concerning a medical device for human use. Section 520(f)(2)(D) of the act relating to ex emptions or variances from device current good manufacturing practice requirements (see § 820.1(d)). Section 520(g)(4) and (g)(5) of the act relating to disapproval and withdrawal of approval of an application from an investigational device exemption (see §§ 812.19(c), 812.30(c), 813.30(d), and 813.35(c) of this chapter). Section 903(a)(8)(B)(ii) of the Federal Food, Drug, and Cosmetic Act relating to the misbranding of tobacco products. Section 906(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act relating to the es tablishment of good manufacturing prac tice requirements for tobacco products. Section 910(d)(1) of the Federal Food, Drug, and Cosmetic Act relating to the with drawal of an order allowing a new tobacco VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00237 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 228 21 CFR Ch. I (4–1–16 Edition) § 16.1 product to be introduced or delivered for introduction into interstate commerce. Section 911(j) of the Federal Food, Drug, and Cosmetic Act relating to the withdrawal of an order allowing a modified risk tobacco product to be introduced or delivered for introduction into interstate commerce. (2) Regulatory provisions: §§ 1.634 and 1.664, relating to revocation of recognition of an accreditation body and withdrawal of accreditation of third-party certification bodies that conduct food safe ty audits of eligible entities in the food im port supply chain and issue food and facil ity certifications. § 56.121(a), relating to disqualifying an insti tutional review board or an institution. § 58.204(b), relating to disqualifying a testing facility. § 71.37(a), relating to use of food containing a color additive. § 80.31(b), relating to refusal to certify a batch of a color additive. § 80.34(b), relating to suspension of certifi cation service for a color additive. § 99.401(c), relating to a due diligence deter mination concerning the conduct of studies necessary for a supplemental application for a new use of a drug or device. §§ 112.201 through 112.213, (see part 112, sub part R of this chapter), relating to with drawal of a qualified exemption. §§ 117.251 through 117.287 (part 117, subpart E of this chapter), relating to withdrawal of a qualified facility exemption. § 130.17(1), relating to a temporary permit to vary from a food standard. § 170.17(b), relating to use of food containing an investigational food additive. § 202.1(j)(5), relating to approval of prescrip tion drug advertisements. § 312.70, relating to whether an investigator is eligible to receive test articles under part 312 of this chapter and eligible to con duct any clinical investigation that sup ports an application for a research or mar keting permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco prod ucts. § 312.70(d) and 312.44, relating to termination of an IND for a sponsor. § 312.160(b), relating to termination of an IND for tests in vitro and in laboratory re search animals for a sponsor. §§ 507.60 through 507.85 (part 507, subpart D of this chapter) relating to withdrawal of a qualified facility exemption. § 511.1(b)(5), relating to use of food containing an investigational new animal drug. § 511.1(c)(1), relating to whether an investi gator is eligible to receive test articles under part 511 of this chapter and eligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco prod ucts. § 511.1(c) (4) and (d), relating to termination of an INAD for a sponsor. § 812.119, relating to whether an investigator is eligible to receive test articles under part 812 of this chapter and eligible to con duct any clinical investigation that sup ports an application for a research or mar keting permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco prod ucts. § 814.46(c) relating to withdrawal of approval of a device premarket approval applica tion. § 822.7(a)(3), relating to an order to conduct postmarket surveillance of a medical de vice under section 522 of the act. § 830.130, relating to suspension or revocation of the accreditation of an issuing agency. § 900.7, relating to approval, reapproval, or withdrawal of approval of mammography accreditation bodies or rejection of a pro posed fee for accreditation. § 900.14, relating to suspension or revocation of a mammography certificate. § 900.25, relating to approval or withdrawal of approval of certification agencies. § 1003.11(a)(3), relating to the failure of an electronic product to comply with an ap plicable standard or to a defect in an elec tronic product. § 1003.31(d), relating to denial of an exemp tion from notification requirements for an electronic product which fails to comply with an applicable standard or has a de fect. § 1004.6, relating to plan for repurchase, re pair, or replacement of an electronic prod uct. § 1107.1(d), relating to rescission of an exemp tion from the requirement of dem onstrating substantial equivalence for a tobacco product. § 1210.30, relating to denial, suspension, or revocation of a permit under the Federal Import Milk Act. § 1270.43(e), relating to the retention, recall, and destruction of human tissue. § 1271.440(e) relating to the retention, recall, and destruction of human cells, tissues, and cellular and tissue-based products (HCT/Ps), and/or the cessation of manufac turing HCT/Ps. [44 FR 22367, Apr. 13, 1979] VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00238 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 229 Food and Drug Administration, HHS § 16.22 EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 16.1, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. § 16.5 Inapplicability and limited ap plicability. (a) This part does not apply to the following: (1) Informal presentation of views be fore reporting a criminal violation under section 305 of the act and section 5 of the Federal Import Milk Act and § 1210.31. (2) A hearing on a refusal of admis sion of a food, drug, device, or cosmetic under section 801(a) of the act and § 1.94, or of an electronic product under section 360(a) of the Public Health Service Act and § 1005.20. (3) Factory inspections, recalls (ex cept mandatory recalls of medical de vices intended for human use), regu latory letters, and similar compliance activities related to law enforcement. (4) A hearing on an order for re labeling, diversion, or destruction of shell eggs under section 361 of the Pub lic Health Service Act (42 U.S.C. 264) and §§ 101.17(h) and 115.50 of this chap ter. (5) A hearing on an order for diver sion or destruction of shell eggs under section 361 of the Public Health Service Act (42 U.S.C. 264), and § 118.12 of this chapter. (b) If a regulation provides a person with an opportunity for hearing and specifies some procedures for the hear ing but not a comprehensive set of pro cedures, the procedures in this part apply to the extent that they are sup plementary and not in conflict with the other procedures specified for the hearing. Thus, the procedures in sub part A of part 108 relating to emer gency permit control are supplemented by the nonconflicting procedures in this part, e.g., the right to counsel, public notice of the hearing, reconsid eration and stay, and judicial review. [44 FR 22367, Apr. 13, 1979, as amended at 57 FR 58403, Dec. 10, 1992; 65 FR 76110, Dec. 5, 2000; 74 FR 33095, July 9, 2009] Subpart B—Initiation of Proceedings § 16.22 Initiation of regulatory hear ing. (a) A regulatory hearing is initiated by a notice of opportunity for hearing from FDA. The notice will— (1) Be sent by mail, telegram, telex, personal delivery, or any other mode of written communication; (2) Specify the facts and the action that are the subject of the opportunity for a hearing; (3) State that the notice of oppor tunity for hearing and the hearing are governed by this part; and (4) State the time within which a hearing may be requested, and state the name, address, and telephone num ber of the FDA employee to whom any request for hearing is to be addressed. (5) Refer to FDA’s guideline on elec tronic media coverage of its adminis trative proceedings (21 CFR part 10, subpart C). (b) A person offered an opportunity for a hearing has the amount of time specified in the notice, which may not be less than 3 working days after re ceipt of the notice, within which to re quest a hearing. The request may be filed by mail, telegram, telex, personal delivery, or any other mode of written communication, addressed to the des ignated FDA employee. If no response is filed within that time, the offer is deemed to have been refused and no hearing will be held. (c) If a hearing is requested, the Com missioner will designate a presiding of ficer, and the hearing will take place at a time and location agreed upon by the party requesting the hearing, the FDA, and the presiding officer or, if agree ment cannot be reached, at a reason able time and location designated by the presiding officer. (d) A notice of opportunity for hear ing under this section will not operate to delay or stay any administrative ac tion, including enforcement action by the agency unless the Commissioner, as a matter of discretion, determines that delay or a stay is in the public in terest. [44 FR 22367, Apr. 13, 1979, as amended at 49 FR 32173, Aug. 13, 1984] VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00239 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 230 21 CFR Ch. I (4–1–16 Edition) § 16.24 § 16.24 Regulatory hearing required by the act or a regulation. (a) A regulatory hearing required by the act or a regulation under § 16.1(b) will be initiated in the same manner as other regulatory hearings subject to the additional procedures in this sec tion. (b) [Reserved] (c) The notice will state whether any action concerning the matter that is the subject of the opportunity for hear ing is or is not being taken pending the hearing under paragraph (d) of this sec tion. (d) The Commissioner may take such action pending a hearing under this section as the Commissioner concludes is necessary to protect the public health, except where expressly prohib ited by statute or regulation. A hear ing to consider action already taken, and not stayed by the Commissioner, will be conducted on an expedited basis. (e) The hearing may not be required to be held at a time less than 2 working days after receipt of the request for hearing. (f) Before the hearing, FDA will give to the party requesting the hearing reasonable notice of the matters to be considered at the hearing, including a comprehensive statement of the basis for the decision or action taken or pro posed that is the subject of the hearing and a general summary of the informa tion that will be presented by FDA at the hearing in support of the decision or action. This information may be given orally or in writing, in the dis cretion of FDA. (g) FDA and the party requesting the hearing will, if feasible, at least 1 day before the hearing provide to each other written notice of any published articles or written information to be presented at or relied on at the hear ing. A copy will also be provided in ad vance if the other participant could not reasonably be expected to have or be able to obtain a copy. If written notice or a copy is not provided, the presiding officer may, if time permits, allow the party who did not receive the notice or copy additional time after the close of the hearing to make a submission con cerning the article or information. [44 FR 22367, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982; 54 FR 9037, Mar. 3, 1989] § 16.26 Denial of hearing and summary decision. (a) A request for a hearing may be de nied, in whole or in part, if the Com missioner or the FDA official to whom authority is delegated to make the final decision on the matter deter mines that no genuine and substantial issue of fact has been raised by the ma terial submitted. If the Commissioner or his or her delegate determines that a hearing is not justified, written no tice of the determination will be given to the parties explaining the reason for denial. (b) After a hearing commences, the presiding officer may issue a summary decision on any issue in the hearing if the presiding officer determines from the material submitted in connection with the hearing, or from matters offi cially noticed, that there is no genuine and substantial issue of fact respecting that issue. For the purpose of this paragraph, a hearing commences upon the receipt by FDA of a request for hearing submitted under § 16.22(b). (c) The Commissioner or his or her delegate may review any summary de cision of the presiding officer issued under paragraph (b) of this section at the request of a party or on the Com missioner’s or his or her delegate’s own initiative. [53 FR 4615, Feb. 17, 1988, as amended at 69 FR 17290, Apr. 2, 2004] Subpart C—Commissioner and Presiding Officer § 16.40 Commissioner. Whenever the Commissioner has del egated authority on a matter for which a regulatory hearing is available under this part, the functions of the Commis sioner under this part may be per formed by any of the officials to whom the authority has been delegated, e.g., a center director. [69 FR 17290, Apr. 2, 2004] VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00240 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 231 Food and Drug Administration, HHS § 16.60 § 16.42 Presiding officer. (a) An FDA employee to whom the Commissioner delegates such author ity, or any other agency employee des ignated by an employee to whom such authority is delegated, or, consistent with 5 CFR 930.209(b) or (c), an adminis trative law judge to whom such author ity is delegated, may serve as the pre siding officer and conduct a regulatory hearing under this part. (b) In a regulatory hearing required by the act or a regulation, the pre siding officer is to be free from bias or prejudice and may not have partici pated in the investigation or action that is the subject of the hearing or be subordinate to a person, other than the Commissioner, who has participated in such investigation or action. (c)(1) The Commissioner or the dele gate under § 16.40 is not precluded by this section from prior participation in the investigation or action that is the subject of the hearing. If there has been prior participation, the Commis sioner or the delegate should, if fea sible, designate a presiding officer for the hearing who is not a subordinate. Thus, if the Commissioner’s authority to make a final decision has been dele gated to a center director, the pre siding officer may be an official in an other center or the office of the Com missioner. The exercise of general su pervisory responsibility, or the des ignation of the presiding officer, does not constitute prior participation in the investigation or action that is the subject of the hearing so as to preclude the Commissioner or delegate from designating a subordinate as the pre siding officer. (2) The party requesting a hearing may make a written request to have the Commissioner or the delegate under § 16.40 be the presiding officer, notwithstanding paragraph (c)(1) of this section. If accepted, as a matter of discretion, by the Commissioner or the delegate, the request is binding upon the party making the request. (3) A different presiding officer may be substituted for the one originally designated under § 16.22 without notice to the parties. [44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989; 67 FR 53306, Aug. 15, 2002] § 16.44 Communication to presiding of ficer and Commissioner. (a) Regulatory hearings are not sub ject to the separation of functions rules in § 10.55. (b) Those persons who are directly in volved in the investigation or presen tation of the position of FDA or any party at a regulatory hearing that is required by the act or a regulation should avoid any off-the-record com munication on the matter to the pre siding officer or the Commissioner or their advisors if the communication is inconsistent with the requirement of § 16.95(b)(1) that the administrative record be the exclusive record for deci sion. If any communication of this type occurs, it is to be reduced to writing and made part of the record, and the other party provided an opportunity to respond. (c) A copy of any letter or memo randum of meeting between a partici pant in the hearing and the presiding officer or the Commissioner, e.g., a re sponse by the presiding officer to a re quest for a change in the time of the hearing, is to be sent to all partici pants by the person writing the letter or the memorandum. Subpart D—Procedures for Regulatory Hearing § 16.60 Hearing procedure. (a) A regulatory hearing is public, ex cept when the Commissioner deter mines that all or part of a hearing should be closed to prevent a clearly unwarranted invasion of personal pri vacy; to prevent the disclosure of a trade secret or confidential commer cial or financial information that is not available for public disclosure under § 20.61; or to protect investiga tory records complied for law enforce ment purposes that are not available for public disclosure under § 20.64. (1) The Commissioner may determine that a regulatory hearing is closed ei ther on the Commissioner’s initiative or on a request by the party asking for a regulatory hearing, in the request for the hearing. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00241 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 232 21 CFR Ch. I (4–1–16 Edition) § 16.62 (2) If the hearing is a private hearing, no persons other than the party re questing the hearing, counsel and wit nesses, and an employee or consultant or other person subject to a commer cial arrangement as defined in § 20.81(a) and FDA representatives with a direct professional interest in the subject matter of the proceeding are entitled to attend. (b) A regulatory hearing will be con ducted by a presiding officer. Employ ees of FDA will first give a full and complete statement of the action which is the subject of the hearing, to gether with the information and rea sons supporting it, and may present any oral or written information rel evant to the hearing. The party re questing the hearing may then present any oral or written information rel evant to the hearing. All parties may confront and conduct reasonable cross examination of any person (except for the presiding officer and counsel for the parties) who makes any statement on the matter at the hearing. (c) The hearing is informal in nature, and the rules of evidence do not apply. No motions or objections relating to the admissibility of information and views will be made or considered, but any other party may comment upon or rebut all such data, information, and views. (d) The presiding officer may order the hearing to be transcribed. The party requesting the hearing may have the hearing transcribed, at the party’s expense, in which case a copy of the transcript is to be furnished to FDA. Any transcript of the hearing will be included with the presiding officer’s re port of the hearing. (e) The presiding officer shall prepare a written report of the hearing. All written material presented at the hear ing will be attached to the report. Whenever time permits, the parties to the hearing will be given the oppor tunity to review and comment on the presiding officer’s report of the hear ing. (f) The presiding officer shall include as part of the report of the hearing a finding on the credibility of witnesses (other than expert witnesses) whenever credibility is a material issue, and shall include a recommended decision, with a statement of reasons, unless the Commissioner directs otherwise. (g) The presiding officer has the power to take such actions and make such rulings as are necessary or appro priate to maintain order and to con duct a fair, expeditious, and impartial hearing, and to enforce the require ments of this part concerning the con duct of hearings. The presiding officer may direct that the hearing be con ducted in any suitable manner per mitted by law and these regulations. (h) The Commissioner or the pre siding officer has the power under § 10.19 to suspend, modify, or waive any provision of this part. [44 FR 22367, Apr. 13, 1979, as amended at 66 FR 6469, Jan. 22, 2001; 66 FR 12850, Mar. 1, 2001] § 16.62 Right to counsel. Any party to a hearing under this part has the right at all times to be ad vised and accompanied by counsel. Subpart E—Administrative Record and Decision § 16.80 Administrative record of a reg ulatory hearing. (a) The administrative record of the regulatory hearing consists of the fol lowing: (1) The notice of opportunity for hearing and the response. (2) All written information and views submitted to the presiding officer at the hearing or after if specifically per mitted by the presiding officer. (3) Any transcript of the hearing. (4) The presiding officer’s report of the hearing and comments on the re port under § 16.60(e). (5) All letters and memoranda of meetings or communications between participants and the presiding officer or the Commissioner referred to in § 16.44(c). (b) The record of the regulatory hear ing is closed to the submission of infor mation and views, at the close of the hearing, unless the presiding officer specifically permits additional time for a further submission. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00242 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 233 Food and Drug Administration, HHS § 17.1 § 16.85 Examination of administrative record. Part 20 governs the availability for public disclosure of each document that is a part of the administrative record of a regulatory hearing. § 16.95 Administrative decision and record for decision. (a) With respect to a regulatory hear ing at the Commissioner’s initiative under § 16.1(a), the Commissioner shall consider the administrative record of the hearing specified in § 16.80(a) to gether with all other relevant informa tion and views available to FDA in de termining whether regulatory action should be taken and, if so, in what form. (b) With respect to a regulatory hear ing required by the act or a regulation under § 16.1(b)— (1) The administrative record of the hearing specified in § 16.80(a) con stitutes the exclusive record for deci sion; (2) On the basis of the administrative record of the hearing, the Commis sioner shall issue a written decision stating the reasons for the Commis sioner’s administrative action and the basis in the record; and (3) For purposes of judicial review under § 10.45, the record of the adminis trative proceeding consists of the record of the hearing and the Commis sioner’s decision. Subpart F—Reconsideration and Stay § 16.119 Reconsideration and stay of action. After any final administrative action that is the subject of a hearing under this part, any party may petition the Commissioner for reconsideration of any part or all of the decision or action under § 10.33 or may petition for a stay of the decision or action under § 10.35. [44 FR 22367, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989] Subpart G—Judicial Review § 16.120 Judicial review. Section 10.45 governs the availability of judicial review concerning any regu latory action which is the subject of a hearing under this part PART 17—CIVIL MONEY PENALTIES HEARINGS Sec. 17.1 Scope. 17.2 Maximum penalty amounts. 17.3 Definitions. 17.5 Complaint. 17.7 Service of complaint. 17.9 Answer. 17.11 Default upon failure to file an answer. 17.13 Notice of hearing. 17.15 Parties to the hearing. 17.17 Summary decisions. 17.18 Interlocutory appeal from ruling of presiding officer. 17.19 Authority of the presiding officer. 17.20 Ex parte contacts. 17.21 Prehearing conferences. 17.23 Discovery. 17.25 Exchange of witness lists, witness statements, and exhibits. 17.27 Hearing subpoenas. 17.28 Protective order. 17.29 Fees. 17.30 Computation of time. 17.31 Form, filing, and service of papers. 17.32 Motions. 17.33 The hearing and burden of proof. 17.34 Determining the amount of penalties and assessments. 17.35 Sanctions. 17.37 Witnesses. 17.39 Evidence. 17.41 The administrative record. 17.43 Posthearing briefs. 17.45 Initial decision. 17.47 Appeals. 17.48 Harmless error. 17.51 Judicial review. 17.54 Deposit in the Treasury of the United States. AUTHORITY: 21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c, 360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa–28; 5 U.S.C. 554, 555, 556, 557. SOURCE: 60 FR 38626, July 27, 1995, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 17 appear at 68 FR 24879, May 9, 2003. § 17.1 Scope. This part sets forth practices and procedures for hearings concerning the administrative imposition of civil money penalties by FDA. Listed below are the statutory provisions that au thorize civil money penalties that are governed by these procedures. (a) Section 303(b)(2) and (b)(3) of the Federal Food, Drug, and Cosmetic Act VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00243 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B