Public information (21 CFR 20.1-20.120)

250 21 CFR Ch. I (4–1–16 Edition) § 19.55 shall appear personally before the Food and Drug Administration or other fed eral agency or court as agent or attor ney for any person other than the United States in connection with any proceeding or matter in which the United States is a party or has a direct and substantial interest and which was under his official responsibility at any time within one year preceding termi nation of such responsibility. The term official responsibility means the direct administrative or operating authority, whether intermediate or final, and ei ther exercisable alone or with others, and either personally or through subor dinates, to approve, disapprove, or oth erwise direct government action. § 19.55 Permanent disqualification of former employees. No former Food and Drug Adminis tration employee, including a special government employee, shall knowingly act as agent or attorney for anyone other than United States in connection with any judicial or other proceeding, application, request for a ruling or other determination, contract, claim, controversy, charge, accusation, or other particular matter involving a specific party or parties in which the United States is a party or has a direct and substantial interest and in which he participated personally and substan tially through decision, approval, dis approval, recommendation, rendering of advice, investigation, or otherwise as a Food and Drug Administration employee. PART 20—PUBLIC INFORMATION Subpart A—Official Testimony and Information Sec. 20.1 Testimony by Food and Drug Adminis tration employees. 20.2 Production of records by Food and Drug Administration employees. 20.3 Certification and authentication of Food and Drug Administration records. Subpart B—General Policy 20.20 Policy on disclosure of Food and Drug Administration records. 20.21 Uniform access to records. 20.22 Partial disclosure of records. 20.23 Request for existing records. 20.24 Preparation of new records. 20.25 Retroactive application of regulations. 20.26 Indexes of certain records. 20.27 Submission of records marked as con fidential. 20.28 Food and Drug Administration deter minations of confidentiality. 20.29 Prohibition on withdrawal of records from Food and Drug Administration files. 20.30 Food and Drug Administration Free dom of Information Staff. 20.31 Retention schedule of requests for Food and Drug Administration records. 20.32 Disclosure of Food and Drug Adminis tration employee names. 20.33 Form or format of response. 20.34 Search for records. Subpart C—Procedures and Fees 20.40 Filing a request for records. 20.41 Time limitations. 20.42 Aggregation of certain requests. 20.43 Multitrack processing. 20.44 Expedited processing. 20.45 Fees to be charged. 20.46 Waiver or reduction of fees. 20.47 Situations in which confidentiality is uncertain. 20.48 Judicial review of proposed disclosure. 20.49 Denial of a request for records. 20.50 Nonspecific and overly burdensome re quests. 20.51 Referral to primary source of records. 20.52 Availability of records at National Technical Information Service. 20.53 Use of private contractor for copying. 20.54 Request for review without copying. 20.55 Indexing trade secrets and confidential commercial or financial information. Subpart D—Exemptions 20.60 Applicability of exemptions. 20.61 Trade secrets and commercial or fi nancial information which is privileged or confidential. 20.62 Inter- or intra-agency memoranda or letters. 20.63 Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal pri vacy. 20.64 Records or information compiled for law enforcement purposes. 20.65 National defense and foreign policy. 20.66 Internal personnel rules and practices. 20.67 Records exempted by other statutes. Subpart E—Limitations on Exemptions 20.80 Applicability of limitations on exemp tions. 20.81 Data and information previously dis closed to the public. 20.82 Discretionary disclosure by the Com missioner. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00260 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 251 Food and Drug Administration, HHS § 20.1 20.83 Disclosure required by court order. 20.84 Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special govern ment employees. 20.85 Disclosure to other Federal govern ment departments and agencies. 20.86 Disclosure in administrative or court proceedings. 20.87 Disclosure to Congress. 20.88 Communications with State and local government officials. 20.89 Communications with foreign govern ment officials. 20.90 Disclosure to contractors. 20.91 Use of data or information for admin istrative or court enforcement action. Subpart F—Availability of Specific Categories of Records 20.100 Applicability; cross-reference to other regulations. 20.101 Administrative enforcement records. 20.102 Court enforcement records. 20.103 Correspondence. 20.104 Summaries of oral discussions. 20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration. 20.106 Studies and reports prepared by or with funds provided by the Food and Drug Administration. 20.107 Food and Drug Administration manu als. 20.108 Agreements between the Food and Drug Administration and other depart ments, agencies, and organizations. 20.109 Data and information obtained by contract. 20.110 Data and information about Food and Drug Administration employees. 20.111 Data and information submitted vol untarily to the Food and Drug Adminis tration. 20.112 Voluntary drug experience reports submitted by physicians and hospitals. 20.113 Voluntary product defect reports. 20.114 Data and information submitted pur suant to cooperative quality assurance agreements. 20.115 Product codes for manufacturing or sales dates. 20.116 Drug and device listing information. 20.117 New drug information. 20.118 Advisory committee records. 20.119 Lists of names and addresses. 20.120 Records available in Food and Drug Administration Public Reading Rooms. AUTHORITY: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531–2582; 21 U.S.C. 321–393, 1401–1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b–263n, 264, 265, 300u–300u–5, 300aa–1. SOURCE: 42 FR 15616, Mar. 22, 1977, unless otherwise noted. Subpart A—Official Testimony and Information § 20.1 Testimony by Food and Drug Administration employees. (a) No officer or employee of the Food and Drug Administration or of any other office or establishment in the Department of Health and Human Services, except as authorized by the Commissioner of Food and Drugs pur suant to this section or in the dis charge of his official duties under the laws administered by the Food and Drug Administration, shall give any testimony before any tribunal per taining to any function of the Food and Drug Administration or with respect to any information acquired in the dis charge of his official duties. (b) Whenever a subpoena, in appro priate form, has been lawfully served upon an officer or employee of the Food and Drug Administration com manding the giving of any testimony, such officer or employee shall, unless otherwise authorized by the Commis sioner, appear in response thereto and respectfully decline to testify on the grounds that it is prohibited by this section. (c) A person who desires testimony from any employee may make written request therefor, verified by oath, di rected to the Commissioner setting forth his interest in the matter sought to be disclosed and designating the use to which such testimony will be put in the event of compliance with such re quest: Provided, That a written request therefor made by a health, food, or drug officer, prosecuting attorney, or member of the judiciary of any State, Territory, or political subdivision thereof, acting in his official capacity, need not be verified by oath. If it is de termined by the Commissioner, or any other officer or employee of the Food and Drug Administration whom he may designate to act on his behalf for the purpose, that such testimony will be in the public interest and will pro mote the objectives of the act and the agency, the request may be granted. Where a request for testimony is grant ed, one or more employees of the Food and Drug Administration may be des ignated to appear, in response to a sub poena, and testify with respect thereto. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00261 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 252 21 CFR Ch. I (4–1–16 Edition) § 20.2 § 20.2 Production of records by Food and Drug Administration employ ees. (a) Any request for records of the Food and Drug Administration, wheth er it be by letter or by a subpena duces tecum or by any other writing, shall be handled pursuant to the procedures es tablished in subpart B of this part, and shall comply with the rules governing public disclosure established in sub parts C, D, E, and F of this part and in other regulations cross-referenced in § 20.100(c). (b) Whenever a subpoena duces tecum, in appropriate form, has been lawfully served upon an officer or em ployee of the Food and Drug Adminis tration commanding the production of any record, such officer or employee shall appear in response thereto, re spectfully decline to produce the record on the ground that it is prohib ited by this section, and state that the production of the record(s) involved will be handled by the procedures es tablished in this part. § 20.3 Certification and authentication of Food and Drug Administration records. (a) Upon request, the Food and Drug administration will certify the authen ticity of copies of records that are re quested to be disclosed pursuant to this part or will authenticate copies of records previously disclosed. (b) A request for certified copies of records or for authentication of records shall be sent in writing to the Division of Freedom of Information at the ad dress located on the agency’s web site at http://www.fda.gov. [42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 76 FR 31469, June 1, 2011; 79 FR 68114, Nov. 14, 2014] Subpart B—General Policy § 20.20 Policy on disclosure of Food and Drug Administration records. (a) The Food and Drug Administra tion will make the fullest possible dis closure of records to the public, con sistent with the rights of individuals to privacy, the property rights of persons in trade secrets and confidential com mercial or financial information, and the need for the agency to promote frank internal policy deliberations and to pursue its regulatory activities without disruption. (b) Except where specifically exempt pursuant to the provisions of this part, all Food and Drug Administration records shall be made available for public disclosure. (c) Except as provided in paragraph (d) of this section, all nonexempt records shall be made available for public disclosure upon request regard less whether any justification or need for such records have been shown. (d) Under § 21.71 of this chapter, a statement of the purposes to which the record requested is to be put, and a cer tification that the record will be so used, may be requested when: (1) The requested record is contained in a Privacy Act Record System as de fined in § 21.3(c) of this chapter; (2) The requester is a person other than the individual who is the subject of the record that is so retrieved or a person acting on his behalf; and (3) The disclosure is one that is dis cretionary, i.e., not required under this part. (e) ‘‘Record’’ and any other term used in this section in reference to informa tion includes any information that would be an agency record subject to the requirements of this part when maintained by the agency in any for mat, including an electronic format. [42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003] § 20.21 Uniform access to records. Any record of the Food and Drug Ad ministration that is disclosed in an au thorized manner to any member of the public is available for disclosure to all members of the public, except that: (a) Data and information subject to the exemptions established in § 20.61 for trade secrets and confidential commer cial or financial information, and in § 20.63 for personal privacy, shall be dis closed only to the persons for the pro tection of whom these exemptions exist. (b) The limited disclosure of records permitted in § 7.87(c) of this chapter for section 305 hearing records, in § 20.80(b) VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00262 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 253 Food and Drug Administration, HHS § 20.26 regarding certain limitations on ex emptions, in § 20.103(b) for certain cor respondence, and in § 20.104(b) for cer tain summaries of oral discussions, shall be subject to the special rules stated therein. (c) Disclosure of a record about an in dividual, as defined in § 21.3(a) of this chapter, that is retrieved by the indi vidual’s name or other personal identi fier and is contained in a Privacy Act Record System, as defined in § 21.3(c) of this chapter, shall be subject to the special requirements of part 21 of this chapter. Disclosure of such a record to an individual who is the subject of the record does not invoke the rule estab lished in this section that such records shall be made available for disclosure to all members of the public. [42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9037, Mar. 3, 1989] § 20.22 Partial disclosure of records. (a) If a record contains both disclosable and nondisclosable informa tion, the nondisclosable information will be deleted and the remaining record will be disclosed unless the two are so inextricably intertwined that it is not feasible to separate them or re lease of the disclosable information would compromise or impinge upon the nondisclosable portion of the record. (b)(1) Whenever information is de leted from a record that contains both disclosable and nondisclosable informa tion, the amount of information de leted shall be indicated on the portion of the record that is made available, unless including that indication would harm an interest protected by an ex emption under the Freedom of Infor mation Act. (2) When technically feasible, the amount of information deleted shall be indicated at the place in the record where the deletion is made. [42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003] § 20.23 Request for existing records. (a) Any written request to the Food and Drug Administration for existing records not prepared for routine dis tribution to the public shall be deemed to be a request for records pursuant to the Freedom of Information Act, whether or not the Freedom of Infor mation Act is mentioned in the re quest, and shall be governed by the provisions of this part. (b) Records or documents prepared by the Food and Drug Administration for routine public distribution, e.g., pam phlets, speeches, and educational mate rials, shall be furnished free of charge upon request as long as the supply lasts. The provisions of this part shall not be applicable to such requests ex cept when the supply of such material is exhausted and it is necessary to re produce individual copies upon specific request. (c) All existing Food and Drug Ad ministration records are subject to routine destruction according to stand ard record retention schedules. § 20.24 Preparation of new records. (a) The Freedom of Information Act and the provisions of this part apply only to existing records that are rea sonably described in a request filed with the Food and Drug Administra tion pursuant to the procedures estab lished in subpart C of this part. (b) The Commissioner may, in his discretion, prepare new records in order to respond adequately to a re quest for information when he con cludes that it is in the public interest and promotes the objectives of the act and the agency. § 20.25 Retroactive application of regu lations. The provisions of this part apply to all records in Food and Drug Adminis tration files. § 20.26 Indexes of certain records. (a) Indexes shall be maintained, and revised at least quarterly, for the fol lowing Food and Drug Administration records: (1) Final orders published in the FEDERAL REGISTER with respect to every denial or withdrawal of approval of a new drug application or a new ani mal drug application for which a public hearing has been requested. (2) Statements of policy and interpre tation adopted by the agency and still in force and not published in the FED ERAL REGISTER. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00263 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 254 21 CFR Ch. I (4–1–16 Edition) § 20.27 (3) Administrative staff manuals and instructions to staff that affect a mem ber of the public. (4) Records that have been released to any person in response to a Freedom of Information request and that the agency has determined have become, or are likely to become, the subject of subsequent requests for substantially the same records. (b) Each such index will be made available by accessing the agency’s web site at http://www.fda.gov. A printed copy of each index is available by writ ing or visiting the Freedom of Informa tion Staff’s address on the agency’s web site at http://www.fda.gov. [42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 68 FR 25285, May 12, 2003; 76 FR 31469, June 1, 2011; 79 FR 68114, Nov. 14, 2014] § 20.27 Submission of records marked as confidential. Marking records submitted to the Food and Drug Administration as con fidential, or with any other similar term, raises no obligation by the Food and Drug Administration to regard such records as confidential, to return them to the person who has submitted them, to withhold them from disclo sure to the public, or to advise the per son submitting them when a request for their public disclosure is received or when they are in fact disclosed. [42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003] § 20.28 Food and Drug Administration determinations of confidentiality. A determination that data or infor mation submitted to the Food and Drug Administration will be held in confidence and will not be available for public disclosure shall be made only in the form of a regulation published or cross-referenced in this part. [42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003] § 20.29 Prohibition on withdrawal of records from Food and Drug Ad ministration files. No person may withdraw records sub mitted to the Food and Drug Adminis tration. All Food and Drug Administra tion records shall be retained by the agency until disposed of pursuant to routine record disposal procedures. [42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25285, May 12, 2003] § 20.30 Food and Drug Administration Division of Freedom of Information. (a) The office responsible for Agency compliance with the Freedom of Infor mation Act and this part is the Divi sion of Freedom of Informationat the address located on the agency’s web site at http://www.fda.gov. (b) All requests for Agency records shall be sent in writing to this office. [76 FR 31469, June 1, 2011, as amended at 79 FR 68114, Nov. 14, 2014] § 20.31 Retention schedule of requests for Food and Drug Administration records. (a) Unless unusual circumstances dic tate otherwise, the Food and Drug Ad ministration shall maintain and dis pose of files of requests and reponses furnished thereto within the time lim its authorized by GSA General Records Schedule 14, FPMR 101–11–4, January 10, 1977, as follows: (1) Files created by the receipt of and response to freedom of information re quests, except denials and/or appeals, may be destroyed 2 years from date of final response. (2) Files created by a freedom of in formation request which was wholly or partially denied may be destroyed 5 years after the denial letter was issued. (3) Files created by a freedom of in formation request which was wholly or partially denied and which denial was subsequently appealed to the Depart ment of Health and Human Services may be destroyed 4 years after final de termination by FDA or 3 years after final adjudication by courts, whichever is later. (b) This destruction schedule will automatically be revised whenever the time limits pertaining to these records are revised by the GSA General Records Schedule. [47 FR 24277, June 4, 1982] § 20.32 Disclosure of Food and Drug Administration employee names. The names of Food and Drug Admin istration employees will not be deleted VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00264 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 255 Food and Drug Administration, HHS § 20.41 from disclosable records except where such deletion is necessary to prevent disclosure of an informant or danger to the life or physical safety of the em ployee or under other extraordinary circumstances. § 20.33 Form or format of response. (a) The Food and Drug Administra tion shall make reasonable efforts to provide a record in any requested form or format if the record is readily repro ducible by the agency in that form or format. (b) If the agency determines that a record is not readily reproducible in the requested form or format, the agen cy may notify the requester of alter native forms and formats that are available. If the requester does not ex press a preference for an alternative in response to such notification, the agen cy may provide its response in the form and format of the agency’s choice. [68 FR 25285, May 12, 2003] § 20.34 Search for records. (a) In responding to a request for records, the Food and Drug Adminis tration shall make reasonable efforts to search for records kept in electronic form or format, except when such ef forts would significantly interfere with the operation of the agency’s auto mated information systems. (b) The term ‘‘search’’ means to re view, manually or by automated means, agency records for the purpose of locating those records that are re sponsive to the request. [68 FR 25285, May 12, 2003] Subpart C—Procedures and Fees § 20.40 Filing a request for records. (a) All requests for Food and Drug Administration records shall be made in writing by mailing or delivering the request to the Freedom of Information Staff at the address on the agency’s web site at http://www.fda.gov or by faxing it to the fax number listed on the agency’s web site at http:// www.fda.gov. All requests must contain the postal address and telephone num ber of the requester and the name of the person responsible for payment of any fees that may be charged. (b) A request for Food and Drug Ad ministration records shall reasonably describe the records being sought, in a way that they can be identified and lo cated. A request should include all per tinent details that will help identify the records sought. (1) If the description is insufficient to locate the records requested, the Food and Drug Administration will so notify the person making the request and in dicate the additional information need ed to identify the records requested. (2) Every reasonable effort shall be made by the Food and Drug Adminis tration to assist in the identification and location of the records sought. (c) Upon receipt of a request for records, the Division of Freedom of In formation shall enter it in a public log. The log shall state the date received, the name of the person making the re quest, the nature of the record re quested, the action taken on the re quest, the date of determination letter sent pursuant to § 20.41(b), and the date(s) any records are subsequently furnished. (d) A request by an individual, as de fined in § 21.3(a) of this chapter, for a record about himself shall be subject to: (1) The special requirements of part 21 of this chapter (the privacy regula tions), and not to the provisions of this subpart, if the record requested is re trieved by the individual’s name or other personal identifier and is con tained in a Privacy Act Record Sys tem, as defined in § 21.3(c) of this chap ter. (2) The provisions of this subpart if the record requested is not retrieved by the individual’s name or other personal identifier, whether or not the record is contained in a Privacy Act Record Sys tem. [42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 68 FR 25285, May 12, 2003; 76 FR 31469, June 1, 2011; 79 FR 68114, Nov. 14, 2014] § 20.41 Time limitations. (a) All time limitations prescribed pursuant to this section shall begin as of the time at which a request for records is logged in by the Division of Freedom of Information pursuant to § 20.40(c). An oral request for records VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00265 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 256 21 CFR Ch. I (4–1–16 Edition) § 20.42 shall not begin any time requirement. A written request for records sent else where within the agency shall not begin any time requirement until it is redirected to the Division of Freedom of Information and is logged in there in accordance with § 20.40(c). (b) Within 20 working days (excluding Saturdays, Sundays, and legal public holidays) after a request for records is logged in at the Division of Freedom of Information, the agency shall send a letter to the requester providing the agency’s determination as to whether, or the extent to which, the agency will comply with the request, and, if any records are denied, the reasons for the denial. (1) If all of the records requested have been located and a final determination has been made with respect to disclo sure of all of the records requested, the letter shall so state. (2) If all of the records have not been located or a final determination has not yet been made with respect to dis closure of all of the records requested, e.g., because it is necessary to consult the person affected pursuant to § 20.47, the letter shall state the extent to which the records involved shall be dis closed pursuant to the rules estab lished in this part. (3)(i) In unusual circumstances, the agency may extend the time for send ing the letter for an additional period. (A) The agency may provide for an extension of up to 10 working days by providing written notice to the re quester setting out the reasons for the extension and the date by which a de termination is expected to be sent. (B) The agency may provide for an extension of more than 10 working days by providing written notice to the re quester setting out the reasons for the extension. The notice also will give the requester an opportunity to limit the scope of the request so that it may be processed in a shorter time and/or an opportunity to agree on a timeframe longer than the 10 extra working days for processing the request. (ii) Unusual circumstances may exist under any of the following conditions: (A) There is a need to search for and collect the requested records from field facilities or other components that are separate from the agency component responsible for processing the request; (B) There is a need to search for, col lect, and appropriately examine a volu minous amount of separate and dis tinct records that are demanded in a single request; or (C) There is need for consultation, which shall be conducted with all prac ticable speed, with another agency hav ing a substantial interest in the deter mination of the request, or among two or more components of the Food and Drug Administration having substan tial subject-matter interest in the de termination. (4) If any record is denied, the letter shall state the right of the person re questing such records to appeal any ad verse determination to the Assistant Secretary for Health, Department of Health and Human Services, in accord ance with the provisions of 45 CFR 5.34. (c) The Food and Drug Administra tion shall provide a determination of whether to provide expedited proc essing within 10 calendar days of re ceipt by the Division of Freedom of In formation of the request and the re quired documentation of compelling need in accordance with § 20.44(b). [42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 55 FR 1405, Jan. 16, 1990; 59 FR 533, Jan. 5, 1994; 68 FR 25285, May 12, 2003; 76 FR 31469, June 1, 2011] § 20.42 Aggregation of certain re quests. The Food and Drug Administration may aggregate certain requests by the same requester, or by a group of re questers acting in concert, if the re quests involve clearly related matters and the agency reasonably believes that such requests actually constitute a single request which would otherwise satisfy the unusual circumstances specified in § 20.41(b)(3)(ii)(B). FDA may extend the time for processing aggre gated requests in accordance with the unusual circumstances provisions of § 20.41. [68 FR 25286, May 12, 2003] § 20.43 Multitrack processing. (a) Each Food and Drug Administra tion component is responsible for de termining whether to use a multitrack system to process requests for records VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00266 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 257 Food and Drug Administration, HHS § 20.44 maintained by that component. A mul titrack system provides two or more tracks for processing requests, based on the amount of work and/or time re quired for a request to be processed. The availability of multitrack proc essing does not affect expedited proc essing in accordance with § 20.44. (b) If multitrack processing is not adopted by a particular agency compo nent, that component will process all requests in a single track, ordinarily on a first-in, first-out basis. (c) If a multitrack processing system is established by a particular agency component, that component may deter mine how many tracks to establish and the specific criteria for assigning re quests to each track. Multiple tracks may be established for requests based on the amount of work and/or time re quired for a request to be processed. (d) Requests assigned to a given track will ordinarily be processed on a first-in, first-out basis within that track. (e) If a request does not qualify for the fastest processing track, the re quester may be provided an oppor tunity to limit the scope of the request in order to qualify for faster proc essing. [68 FR 25286, May 12, 2003] § 20.44 Expedited processing. (a) The Food and Drug Administra tion will provide expedited processing of a request for records when the re quester demonstrates a compelling need, or in other cases as determined by the agency. A compelling need ex ists when: (1) A failure to obtain requested records on an expedited basis could rea sonably be expected to pose an immi nent threat to the life or physical safe ty of an individual; or (2) With respect to a request made by a person primarily engaged in dissemi nating information, there is a dem onstrated urgency to inform the public concerning actual or alleged Federal Government activity. (b) A request for expedited processing made under paragraph (a)(1) of this sec tion must be made by the specific indi vidual who is subject to an imminent threat, or by a family member, medical or health care professional, or other authorized representative of the indi vidual, and must demonstrate a reason able basis for concluding that failure to obtain the requested records on an ex pedited basis could reasonably be ex pected to pose a specific and identifi able imminent threat to the life or safety of the individual. (c) A request for expedited processing made under paragraph (a)(2) of this sec tion must demonstrate that: (1) The requester is primarily en gaged in disseminating information to the general public and not merely to a narrow interest group; (2) There is an urgent need for the re quested information and that it has a particular value that will be lost if not obtained and disseminated quickly; however, a news media publication or broadcast deadline alone does not qual ify as an urgent need, nor does a re quest for historical information; and (3) The request for records specifi cally concerns identifiable operations or activities of the Federal Govern ment. (d) All requests for expedited proc essing shall be filed in writing as pro vided by § 20.40. Each such request shall include information that demonstrates a reasonable basis for concluding that a compelling need exists within the meaning of paragraph (a) of this sec tion and a certification that the infor mation provided in the request is true and correct to the best of the request er’s knowledge and belief. Any state ments made in support of a request for expedited processing are subject to the False Reports to the Government Act (18 U.S.C. 1001). (e) The Assistant Commissioner for Public Affairs (or delegatee) will deter mine whether to grant a request for ex pedited processing within 10 days of re ceipt by the Division of Freedom of In formation of all information required to make a decision. (f) If the agency grants a request for expedited processing, the agency shall process the request as soon as prac ticable. (g) If the agency denies a request for expedited processing, the agency shall process the request with other non expedited requests. (h) If the agency denies a request for expedited processing, the requester VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00267 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 258 21 CFR Ch. I (4–1–16 Edition) § 20.45 may appeal the agency’s decision by writing to the official identified in the denial letter. [68 FR 25286, May 12, 2003, as amended at 76 FR 31469, June 1, 2011] § 20.45 Fees to be charged. (a) Categories of requests. Paragraphs (a) (1) through (3) of this section state, for each category of request, the type of fees that the Food and Drug Admin istration will generally charge. How ever, for each of these categories, the fees may be limited, waived, or reduced for the reasons given in paragraphs (b) and (c) of this section and in § 20.46 or for other reasons. (1) Commercial use request. If the re quest is for a commercial use, the Food and Drug Administration will charge for the costs of search, review, and du plication. (2) Educational and scientific institu tions and news media. If the request is from an educational institution or a noncommercial scientific institution, operated primarily for scholarly or sci entific research, or a representative of the news media, and the request is not for a commercial use, the Food and Drug Administration will charge only for the duplication of documents. Also, the Food and Drug Administration will not charge the copying costs for the first 100 pages of duplication. (3) Other requests. If the request is not the kind described in paragraph (a)(1) or (a)(2) of this section, then the Food and Drug Administration will charge only for the search and the duplication. Also, the Food and Drug Administra tion will not charge for the first 2 hours of search time or for the copying costs of the first 100 pages of duplica tion. (b) General provisions. (1) The Food and Drug Administration may charge search fees even if the records found are exempt from disclosure or if no records are found. (2) If, under paragraph (a)(3) of this section, there is no charge for the first 2 hours of search time, and those 2 hours are spent on a computer search, then the 2 free hours are the first 2 hours of the operator’s own operation. If the operator spends less than 2 hours on the search, the total search fees will be reduced by the average hourly rate for the operator’s time, multiplied by 2. (3) If, under paragraph (a)(2) or (a)(3) of this section, there is no charge for the first 100 pages of duplication, then those 100 pages are the first 100 pages of photocopies of standard size pages, or the first 100 pages of computer print out. If this method to calculate the fee reduction cannot be used, then the total duplication fee will be reduced by the normal charge for photocopying a standard size page, multiplied by 100. (4) No charge will be made if the costs of routine collection and proc essing of the fee are likely to equal or exceed the amount of the fee. (5) If it is determined that a re quester (acting either alone or together with others) is breaking down a single request into a series of requests in order to avoid (or reduce) the fees charged, all these requests may be ag gregated for purposes of calculating the fees charged. (6) Interest will be charged on unpaid bills beginning on the 31st day fol lowing the day the bill was sent. Provi sions in 45 CFR part 30, the Depart ment of Health and Human Services regulations governing claims collec tion, will be used in assessing interest, administrative costs, and penalties, and in taking actions to encourage payment. (c) Fee schedule. The Food and Drug Administration charges the following fees in accordance with the regulations of the Department of Health and Human Services at 45 CFR part 5. (1) Manual searching for or reviewing of records. When the search or review is performed by employees at grade GS–1 through GS–8, an hourly rate based on the salary of a GS–5, step 7, employee; when done by a GS–9 through GS–14, an hourly rate based on the salary of a GS–12, step 4, employee; and when done by a GS–15 or above, an hourly rate based on the salary of a GS–15, step 7, employee. In each case, the hourly rate will be computed by taking the current hourly rate for the specified grade and step, adding 16 percent of that rate to cover benefits, and rounding to the nearest whole dollar. When a search in volves employees at more than one of VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00268 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 259 Food and Drug Administration, HHS § 20.46 these levels, the Food and Drug Admin istration will charge the rate appro priate for each. (2) Computer searching and printing. The actual cost of operating the com puter plus charges for the time spent by the operator, at the rates given in paragraph (c)(1) of this section. (3) Photocopying standard size pages. $0.10 per page. Freedom of Information Officers may charge lower fees for par ticular documents where: (i) The document has already been printed in large numbers; (ii) The program office determines that using existing stock to answer this request, and any other anticipated Freedom of Information requests, will not interfere with program require ments; and (iii) The Freedom of Information Of ficer determines that the lower fee is adequate to recover the prorated share of the original printing costs. (4) Photocopying odd-size documents (such as punchcards or blueprints), or re producing other records (such as tapes). The actual costs of operating the ma chine, plus the actual cost of the mate rials used, plus charges for the time spent by the operator, at the rates given in paragraph (c)(1) of this sec tion. (5) Certifying that records are true cop ies. This service is not required by the Freedom of Information Act. If the Food and Drug Administration agrees to provide certification, there is a $10 charge per certification. (6) Sending records by express mail or other special methods. This service is not required by the Freedom of Informa tion Act. If the Food and Drug Admin istration agrees to provide this service, the requester will be required to di rectly pay, or be directly charged by, the courier. The agency will not agree to any special delivery method that does not permit the requester to di rectly pay or be directly charged for the service. (7) Performing any other special service in connection with a request to which the Food and Drug Administration has agreed. Actual costs of operating any machinery, plus actual cost of any ma terials used, plus charges for the time of the Food and Drug Administration’s employees, at the rates given in para graph (c)(1) of this section. (d) Procedures for assessing and col lecting fees—(1) Agreement to pay. The Food and Drug Administration gen erally assumes that a requester is will ing to pay the fees charged for services associated with the request. The re quester may specify a limit on the amount to be spent. If it appears that the fees will exceed the limit, the Food and Drug Administration will consult the requester to determine whether to proceed with the search. (2) Advance payment. If a requester has failed to pay previous bills in a timely fashion, or if the Food and Drug Administration’s initial review of the request indicates that the charges will exceed $250, the requester will be re quired to pay past due fees and/or the estimated fees, or a deposit, before the search for the requested records begins. In such cases, the requester will be no tified promptly upon receipt of the re quest, and the administrative time limits prescribed in § 20.41 will begin only after there is an agreement with the requester over payment of fees, or a decision that fee waiver or reduction is appropriate. (3) Billing and payment. Ordinarily, the requester will be required to pay all fees before the Food and Drug Ad ministration will furnish the records. At its discretion, the Food and Drug Administration may send the requester a bill along with or following the records. For example, the Food and Drug Administration may do this if the requester has a history of prompt pay ment. The Food and Drug Administra tion may also, at its discretion, aggre gate the charges for certain time peri ods in order to avoid sending numerous small bills to frequent requesters, or to businesses or agents representing re questers. For example, the Food and Drug Administration might send a bill to such a requester once a month. Fees should be paid in accordance with the instructions furnished by the person who responds to the request. [59 FR 533, Jan. 5, 1994. Redesignated and amended at 68 FR 25286, May 12, 2003] § 20.46 Waiver or reduction of fees. (a) Standard. The Assistant Commis sioner for Public Affairs (or delegatee) VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00269 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 260 21 CFR Ch. I (4–1–16 Edition) § 20.46 will waive or reduce the fees that would otherwise be charged if disclo sure of the information meets both of the following tests: (1) Is in the public interest because it is likely to contribute significantly to public understanding of the operations or activities of the Government; and (2) It is not primarily in the commer cial interest of the requester. These two tests are explained in paragraphs (b) and (c) of this section. (b) Public interest. Disclosure of infor mation satisfies the first test only if it furthers the specific public interest of being likely to contribute significantly to public understanding of Government operations or activities, regardless of any other public interest it may fur ther. In analyzing this question, the Food and Drug Administration will consider the following factors: (1) Whether the records to be dis closed pertain to the operations or ac tivities of the Federal Government; (2) Whether disclosure of the records would reveal any meaningful informa tion about Government operations or activities that is not already public knowledge; (3) Whether disclosure will advance the understanding of the general public as distinguished from a narrow seg ment of interested persons. Under this factor, the Food and Drug Administra tion may consider whether the re quester is in a position to contribute to public understanding. For example, the Food and Drug Administration may consider whether the requester has such knowledge or expertise as may be necessary to understand the informa tion, and whether the requester’s in tended use of the information would be likely to disseminate the information to the public. An unsupported claim to be doing research for a book or article does not demonstrate that likelihood, while such a claim by a representative of the news media is better evidence; and (4) Whether the contribution to pub lic understanding will be a significant one, i.e., will the public’s under standing of the Government’s oper ations be substantially greater as a re sult of the disclosure. (c) Not primarily in the requester’s com mercial interest. If disclosure passes the test of furthering the specific public in terest described in paragraph (b) of this section, the Food and Drug Adminis tration will determine whether disclo sure also furthers the requester’s com mercial interest and, if so, whether this effect outweighs the advancement of that public interest. In applying this second test, the Food and Drug Admin istration will consider the following factors: (1) Whether disclosure would further a commercial interest of the requester, or of someone on whose behalf the re quester is acting. Commercial interests include interests relating to business, trade, and profit. Both profit and non profit-making corporations have com mercial interests, as well as individ uals, unions, and other associations. The interest of a representative of the news media in using the information for news dissemination purposes will not be considered a commercial inter est. (2) If disclosure would further a com mercial interest of the requester, whether that effect outweighs the ad vancement of the public interest as de fined in paragraph (b) of this section. (d) Deciding between waiver and reduc tion. If the disclosure of the informa tion requested passes both tests de scribed in paragraphs (b) and (c) of this section, the Food and Drug Adminis tration will normally waive fees. How ever, in some cases the Food and Drug Administration may decide only to re duce the fees. For example, the Food and Drug Administration may do this when disclosure of some but not all of the requested records passes the tests. (e) Procedure for requesting a waiver or reduction. A requester must request a waiver or reduction of fees at the same time as the request for records. The re quester should explain why a waiver or reduction is proper under the factors set forth in paragraphs (a) through (d) of this section. Only the Associate Commissioner for Public Affairs may make the decision whether to waive or reduce the fees. If the Food and Drug Administration does not completely grant the request for a waiver or reduc tion, the denial letter will designate a review official. The requester may ap peal the denial to that official. The ap peal letter should address reasons for VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00270 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 261 Food and Drug Administration, HHS § 20.50 the Associate Commissioner’s decision that are set forth in the denial letter. [59 FR 534, Jan. 5, 1994. Redesignated and amended at 68 FR 25286, 25287, May 12, 2003] § 20.47 Situations in which confiden tiality is uncertain. In situations where the confiden tiality of data or information is uncer tain and there is a request for public disclosure, the Food and Drug Adminis tration will consult with the person who has submitted or divulged the data or information or who would be af fected by disclosure before determining whether or not such data or informa tion is available for public disclosure. [42 FR 15616, Mar. 22, 1977. Redesignated at 68 FR 25286, May 12, 2003] § 20.48 Judicial review of proposed disclosure. Where the Food and Drug Adminis tration consults with a person who will be affected by a proposed disclosure of data or information contained in Food and Drug Administration records pur suant to § 20.47, and rejects the person’s request that part or all of the records not be made available for public disclo sure, the decision constitutes final agency action that is subject to judi cial review pursuant to 5 U.S.C. chap ter 7. The person affected will be per mitted 5 days after receipt of notifica tion of such decision within which to institute suit in a United States Dis trict Court to enjoin release of the records involved. If suit is brought, the Food and Drug Administration will not disclose the records involved until the matter and all related appeals have been concluded. [42 FR 15616, Mar. 22, 1977. Redesignated and amended at 68 FR 25286, 25287, May 12, 2003] § 20.49 Denial of a request for records. (a) A denial of a request for records, in whole or in part, shall be signed by the Assistant Commissioner for Public Affairs (or delegatee). (b) The name and title or position of each person who participated in the de nial of a request for records shall be set forth in the letter denying the request. This requirement may be met by at taching a list of such individuals to the letter. (c) A letter denying a request for records, in whole or in part, shall state the reasons for the denial and shall state that an appeal may be made to the Deputy Assistant Secretary for Public Affairs (Media), Department of Health and Human Services. The agen cy will also make a reasonable effort to include in the letter an estimate of the volume of the records denied, unless providing such an estimate would harm an interest protected by an exemption under the Freedom of Information Act. This estimate will ordinarily be pro vided in terms of the approximate number of pages or some other reason able measure. This estimate will not be provided if the volume of records de nied is otherwise indicated through de letions on records disclosed in part. (d) Minor deletions of nondisclosable data and information from disclosable records shall not be deemed to be a de nial of a request for records. [42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 55 FR 1405, Jan. 16, 1990. Redesignated and amended at 68 FR 25286, 25287, May 12, 2003] § 20.50 Nonspecific and overly burden some requests. The Food and Drug Administration will make every reasonable effort to comply fully with all requests for dis closure of nonexempt records. Nonspe cific requests or requests for a large number of documents that require the deployment of a substantial amount of agency man-hours to search for and compile will be processed taking into account the staff-hours required, the tasks from which these resources must be diverted, the impact that this diver sion will have upon the agency’s con sumer protection activities, and the public policy reasons justifying the re quests. A decision on the processing of such a request for information shall be made after balancing the public benefit to be gained by the disclosure against the public loss that will result from di verting agency personnel from their other responsibilities. In any situation in which it is determined that a re quest for voluminous records would un duly burden and interfere with the op erations of the Food and Drug Admin istration, the person making the re quest will be asked to be more specific VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00271 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 262 21 CFR Ch. I (4–1–16 Edition) § 20.51 and to narrow the request, and to agree on an orderly procedure for the produc tion of the requested records, in order to satisfy the request without dis proportionate adverse effects on agen cy operations. [42 FR 15616, Mar. 22, 1977. Redesignated at 68 FR 25286, May 12, 2003] § 20.51 Referral to primary source of records. Upon receipt of a request for a record or document which is contained in Food and Drug Administration files but which is available elsewhere at a lower cost, the person requesting the record or document shall be referred to the primary source of the record or document. [42 FR 15616, Mar. 22, 1977. Redesignated at 68 FR 25286, May 12, 2003] § 20.52 Availability of records at Na tional Technical Information Serv ice. The Food and Drug Administration is furnishing a number of records to the National Technical Information Serv ice (NTIS), 5285 Port Royal Rd., Spring field, VA 22162, which reproduces and distributes such information to the public at cost. A single copy of each such record shall be available for pub lic review at the Food and Drug Ad ministration. All persons requesting copies of such records shall be an swered by referring the person request ing the records to NTIS. [42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989. Redesignated at 68 FR 25286, May 12, 2003] § 20.53 Use of private contractor for copying. The Food and Drug Administration may furnish requested records to a pri vate contractor for copying after dele tion of all nondisclosable data and in formation. Under these circumstances, the Food and Drug Administration will charge the person requesting the records for all of the fees involved pur suant to § 20.45. [42 FR 15616, Mar. 22, 1977. Redesignated and amended at 68 FR 25286, 25287, May 12, 2003] § 20.54 Request for review without copying. (a) A person requesting disclosure of records shall be permitted an oppor tunity to review them without the ne cessity for copying them where the records involved contain only disclosable data and information. Under these circumstances, the Food and Drug Administration will charge only for the costs of searching for the records. (b) Where a request is made for re view of records without copying, and the records involved contain both disclosable and nondisclosable informa tion, the records containing nondisclosable information shall first be copied with the nondisclosable in formation blocked out and the Food and Drug Administration will charge for the costs of searching and copying. [42 FR 15616, Mar. 22, 1977. Redesignated at 68 FR 25286, May 12, 2003] § 20.55 Indexing trade secrets and con fidential commercial or financial in formation. Whenever the Food and Drug Admin istration denies a request for a record or portion thereof on the grounds that the record or portion thereof is exempt from public disclosure as trade secret or confidential commercial or financial data and information under § 20.61, and the person requesting the record subse quently contests the denial in the courts, the Food and Drug Administra tion will so inform the person affected, i.e., the person who submitted the record, and will require that such per son intervene to defend the exempt sta tus of the record. If a court requires the Food and Drug Administration to itemize and index such records, the Food and Drug Administration will so inform the person affected and will re quire that such person undertake the itemization and indexing of the records. If the affected person fails to intervene to defend the exempt status of the records and to itemize and index the disputed records, the Food and Drug Administration will take this failure into consideration in deciding whether that person has waived such exemption so as to require the Food and Drug Administration to promptly VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00272 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 263 Food and Drug Administration, HHS § 20.61 make the records available for public disclosure. [42 FR 15616, Mar. 22, 1977, as amended at 59 FR 535, Jan. 5, 1994. Redesignated at 68 FR 25286, May 12, 2003] Subpart D—Exemptions § 20.60 Applicability of exemptions. (a) The exemptions established in this subpart shall apply to all Food and Drug Administration records, except as provided in subpart E of this part. Ac cordingly, a record that is ordinarily available for public disclosure in ac cordance with the provisions in subpart F of this part or of another regulation cross-referenced in § 20.100(c) is not available for such disclosure to the ex tent that it falls within an exemption contained in this subpart, except as provided by the limitations on exemp tions specified in subpart E of this part. For example, correspondence that is ordinarily disclosable under § 20.103 is not disclosable to the extent that it contains trade secrets exempt from dis closure under § 20.61 and is not subject to discretionary release under § 20.82. (b) Where application of one or more exemptions results in a record being disclosable in part and nondisclosable in part, the rule established in § 20.22 shall apply. § 20.61 Trade secrets and commercial or financial information which is privileged or confidential. (a) A trade secret may consist of any commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial ef fort. There must be a direct relation ship between the trade secret and the productive process. (b) Commercial or financial informa tion that is privileged or confidential means valuable data or information which is used in one’s business and is of a type customarily held in strict con fidence or regarded as privileged and not disclosed to any member of the public by the person to whom it be longs. (c) Data and information submitted or divulged to the Food and Drug Ad ministration which fall within the defi nitions of a trade secret or confidential commercial or financial information are not available for public disclosure. (d) A person who submits records to the Government may designate part or all of the information in such records as exempt from disclosure under ex emption 4 of the Freedom of Informa tion Act. The person may make this designation either at the time the records are submitted to the Govern ment or within a reasonable time thereafter. The designation must be in writing. Where a legend is required by a request for proposals or request for quotations, pursuant to 48 CFR 352.215– 12, then that legend is necessary for this purpose. Any such designation will expire 10 years after the records were submitted to the Government. (e) The procedures in this paragraph apply to records on which the sub mitter has designated information as provided in paragraph (d) of this sec tion. These procedures also apply to records that were submitted to the Food and Drug Administration when the agency has substantial reason to believe that information in the records could reasonably be considered exempt under exemption 4 of the Freedom of Information Act. Certain exceptions to these procedures are set forth in para graph (f) of this section. (1) When the Food and Drug Adminis tration receives a request for such records and determines that disclosure may be required, the Food and Drug Administration will make reasonable efforts to notify the submitter about these facts. The notice will include a copy of the request, and it will inform the submitter about the procedures and time limits for submission and consid eration of objections to disclosure. If the Food and Drug Administration must notify a large number of submit ters, notification may be done by post ing or publishing a notice in a place where the submitters are reasonably likely to become aware of it. (2) The submitter has 5 working days from receipt of the notice to object to disclosure of any part of the records and to state all bases for its objections. (3) The Food and Drug Administra tion will give consideration to all bases VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00273 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 264 21 CFR Ch. I (4–1–16 Edition) § 20.62 that have been stated in a timely man ner by the submitter. If the Food and Drug Administration decides to dis close the records, the Food and Drug Administration will notify the sub mitter in writing. This notice will briefly explain why the agency did not sustain the submitter’s objections. The Food and Drug Administration will in clude with the notice a copy of the records about which the submitter ob jected, as the agency proposes to dis close them. The notice will state that the Food and Drug Administration in tends to disclose the records 5 working days after the submitter receives the notice unless a U.S. District Court or ders the agency not to release them. (4) If a requester files suit under the Freedom of Information Act to obtain records covered by this paragraph, the Food and Drug Administration will promptly notify the submitter. (5) Whenever the Food and Drug Ad ministration sends a notice to a sub mitter under paragraph (e)(1) of this section, the Food and Drug Adminis tration will notify the requester that the Food and Drug Administration is giving the submitter a notice and an opportunity to object. Whenever the Food and Drug Administration sends a notice to a submitter under paragraph (e)(3) of this section, the Food and Drug Administration will notify the re quester of this fact. (f) The notice requirements in para graph (e) of this section do not apply in the following situations: (1) The Food and Drug Administra tion decided not to disclose the records; (2) The information has previously been published or made generally available; (3) Disclosure is required by a regula tion issued after notice and oppor tunity for public comment, that speci fies narrow categories of records that are to be disclosed under the Freedom of Information Act, but in this case a submitter may still designate records as described in paragraph (d) of this section, and in exceptional cases, the Food and Drug Administration may, at its discretion, follow the notice proce dures in paragraph (e) of this section; (4) The information requested has not been designated by the submitter as ex empt from disclosure when the sub mitter had an opportunity to do so at the time of submission of the informa tion or within a reasonable time there after, unless the Food and Drug Admin istration has substantial reason to be lieve that disclosure of the information would result in competitive harm; or (5) The designation appears to be ob viously frivolous, but in this case the Food and Drug Administration will still give the submitter the written no tice required by paragraph (e)(3) of this section (although this notice need not explain our decision or include a copy of the records), and the Food and Drug Administration will notify the re quester as described in paragraph (e)(5) of this section. [42 FR 15616, Mar. 22, 1977, as amended at 59 FR 535, Jan. 5, 1994] § 20.62 Inter- or intra-agency memo randa or letters. All communications within the Exec utive Branch of the Federal govern ment which are in written form or which are subsequently reduced to writing may be withheld from public disclosure except that factual informa tion which is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure. § 20.63 Personnel, medical, and similar files, disclosure of which con stitutes a clearly unwarranted inva sion of personal privacy. (a) The names or other information which would identify patients or re search subjects in any medical or simi lar report, test, study, or other re search project shall be deleted before the record is made available for public disclosure. (b) The names and other information which would identify patients or re search subjects should be deleted from any record before it is submitted to the Food and Drug Administration. If the Food and Drug Administration subse quently needs the names of such indi viduals, a separate request will be made. (c) Requests for deletion of business or product names prior to disclosure of any record to the public shall not be granted on the ground of privacy, but such deletion may be justified under VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00274 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 265 Food and Drug Administration, HHS § 20.64 another exemption established in this subpart, e.g., the exemption for trade secrets and confidential commercial or financial information under § 20.61. (d) Names of individuals conducting investigations, studies, or tests on products or ingredients shall not be de leted prior to disclosure of any record to the public unless extraordinary cir cumstances are shown. (e) A request for all records relating to a specific individual will be denied as a clearly unwarranted invasion of personal privacy unless accompanied by the written consent of the indi vidual named. (f) The names and any information that would identify the voluntary re porter or any other person associated with an adverse event involving a human drug, biologic, or medical de vice product shall not be disclosed by the Food and Drug Administration or by a manufacturer in possession of such reports in response to a request, demand, or order. Information that would identify the voluntary reporter or persons identified in the report in cludes, but is not limited to, the name, address, institution, or any other infor mation that would lead to the identi ties of the reporter or persons identi fied in a report. This provision does not affect disclosure of the identities of re porters required by a Federal statute or regulation to make adverse event re ports. Disclosure of the identities of such reporters is governed by the appli cable Federal statutes and regulations. (1) Exceptions. (i) Identities may be disclosed if both the voluntary reporter and the person identified in an adverse event report or that person’s legal rep resentative consent in writing to dis closure, but neither FDA nor any man ufacturer in possession of such reports shall be required to seek consent for disclosure from the voluntary reporter or the person identified in the adverse event report or that person’s legal rep resentative; or (ii) Identities of the voluntary re porter and the person who experienced the reported adverse event may be dis closed pursuant to a court order in the course of medical malpractice litiga tion involving both parties; or (iii) The report, excluding the identities of any other individuals, shall be disclosed to the person who is the subject of the re port upon request. (2) Preemption. No State or local gov erning entity shall establish or con tinue in effect any law, rule, regula tion, or other requirement that per mits or requires disclosure of the iden tities of the voluntary reporter or other person identified in an adverse event report except as provided in this section. [42 FR 15616, Mar. 22, 1977, as amended at 60 FR 16968, Apr. 3, 1995] § 20.64 Records or information com piled for law enforcement purposes. (a) Records or information compiled for law enforcement purposes may be withheld from public disclosure pursu ant to the provisions of this section to the extent that disclosure of such records or information: (1) Could reasonably be expected to interfere with enforcement pro ceedings; (2) Would deprive a person to a right to a fair trial or an impartial adjudica tion; (3) Could reasonably be expected to constitute an unwarranted invasion of personal privacy; (4) Could reasonably be expected to disclose the identity of a confidential source, including a State, local, or for eign agency or authority or any pri vate institution which furnished infor mation on a confidential basis; and in formation furnished by a confidential source in the case of a record compiled by the Food and Drug Administration or any other criminal law enforcement authority in the course of a criminal investigation or by an agency con ducting a lawful national security in telligence investigation; (5) Would disclose techniques and procedures for law enforcement inves tigations or prosecutions or would dis close guidelines for law enforcement investigations or prosecutions, if such disclosure could reasonably be ex pected to risk circumvention of the law; or (6) Could reasonably be expected to endanger the life or physical safety of any individual. (b) Records include all records relat ing to regulatory enforcement action, including both administrative and VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00275 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 266 21 CFR Ch. I (4–1–16 Edition) § 20.65 court action, which have not been dis closed to any member of the public, in cluding any person who is the subject of the investigation. (c) Any record which is disclosed to any person, including any person who is the subject of a Food and Drug Ad ministration investigation, and any data or information received from any person who is the subject of a Food and Drug Administration investigation re lating to such investigation, is avail able for public disclosure at that time in accordance with the rule established in § 20.21, except that: (1) Disclosure of such records shall be subject to the other exemptions estab lished in this subpart and to the limi tations on exemptions established in subpart E of this part. (2) The record of a section 305 hearing shall be available for public disclosure only in accordance with the provisions of § 7.87 of this chapter. (d) Records for law enforcement pur poses shall be subject to the following rules: (1) No such record is available for public disclosure prior to the consider ation of regulatory enforcement action based upon that record’s being closed, except as provided in § 20.82. The Com missioner will exercise his discretion to disclose records relating to possible criminal prosecution pursuant to § 20.82 prior to consideration of criminal pros ecution being closed only very rarely and only under circumstances that demonstrate a compelling public inter est. (2) After the consideration of regu latory enforcement action is closed, such records shall be made available for public disclosure except to the ex tent that other exemptions from dis closure in this subpart are applicable. No statements of witnesses obtained through promises of confidentiality are available for public disclosure. (3) The consideration of regulatory enforcement action based upon a par ticular record shall be deemed to be closed within the meaning of this sec tion: (i) If it relates to administrative ac tion, when a final decision has been made not to take such action or such action has been taken and the matter has been concluded. (ii) If it relates to court action, when a final decision has been made not to recommend such action to a United States attorney based upon that record, or a recommendation has been finally refused by a United States at torney, or court action has been insti tuted and the matter and all related appeals have been concluded, or the statute of limitations runs. (iii) If it relates to both administra tive and court action, when the events described in both paragraph (d)(3) (i) and (ii) of this section have occurred. (4) Prior to disclosure of any record specifically reflecting consideration of possible criminal prosecution of any individual, all names and other infor mation that would identify an indi vidual who was considered for criminal prosecution but who was not pros ecuted shall be deleted unless the Com missioner concludes that there is a compelling public interest in the dis closure of such names. (e) Names and other information that would identify a Food and Drug Admin istration employee shall be deleted from records prior to public disclosure only pursuant to § 20.32. [42 FR 15616, Mar. 22, 1977, as amended at 59 FR 536, Jan. 5, 1994] § 20.65 National defense and foreign policy. (a) Records or information may be withheld from public disclosure if they are: (1) Specifically authorized under cri teria established by an Executive order to be kept secret in the interest of na tional defense or foreign policy; and (2) In fact properly classified under such Executive order. (b) [Reserved] [70 FR 41958, July 21, 2005] § 20.66 Internal personnel rules and practices. Records or information may be with held from public disclosure if they are related solely to the internal personnel rules and practices of the Food and Drug Administration (FDA). Under this exemption, FDA may withhold records or information about routine internal agency practices and procedures. Under this exemption, the agency may also VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00276 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 267 Food and Drug Administration, HHS § 20.81 withhold internal records whose re lease would help some persons cir cumvent the law. [70 FR 41958, July 21, 2005] § 20.67 Records exempted by other statutes. Records or information may be with held from public disclosure if a statute specifically allows the Food and Drug Administration (FDA) to withhold them. FDA may use another statute to justify withholding records and infor mation only if it absolutely prohibits disclosure, sets forth criteria to guide our decision on releasing material, or identifies particular types of matters to be withheld. [70 FR 41958, July 21, 2005] Subpart E—Limitations on Exemptions § 20.80 Applicability of limitations on exemptions. (a) The limitations on exemptions es tablished in this subpart shall apply to all Food and Drug Administration records, except as specifically provided herein. Accordingly, a record that is ordinarily exempt from public disclo sure in accordance with the provisions in subpart D of this part is available for such disclosure to the extent that it falls within a limitation on the exemp tion contained in this subpart. For ex ample, an investigatory record that is ordinarily exempt from disclosure under § 20.64 is disclosable to Congress in accordance with the provisions of § 20.87. (b) Disclosure of a record to any member of the public pursuant to the provisions in § 20.81, data and informa tion previously disclosed to the public, in § 20.82, discretionary disclosure by the Commissioner, and in § 20.83, disclo sure pursuant to a court order, shall in volve the rule established in § 20.21 that the record shall be made available for disclosure to all members of the public who request it. Disclosure of a record only to the limited categories of per sons and under the conditions specified in § 20.84, special government employ ees, in § 20.85, other Federal govern ment departments and agencies, in § 20.86, in camera disclosure in adminis trative or court proceedings, in § 20.87(b), Congress, in § 20.88, State and local government officials, in § 20.89, foreign government officials, and in § 20.90, contractors, which does not re sult in disclosure of the record to any member of the public in an authorized manner, shall not invoke the rule es tablished in § 20.21. (c) Disclosure to government employ ees and special government employees of records exempt from public disclo sure shall subject those persons to the same restrictions with respect to the disclosure of such records as any Food and Drug Administration employee. (d) In the case of a record in a Pri vacy Act Record System, as defined in § 21.3(c) of this chapter: (1) The availability to an individual, as defined in § 21.3(a), of a record about himself that is retrieved by the indi vidual’s name or other personal identi fier and is contained in a Privacy Act Record System shall be subject to the special requirements of part 21 of this chapter (the privacy regulations) and shall not be subject to the exemptions in subpart D of this part except that where the system is exempt and the re quested record is not available under § 21.61 of this chapter, the provisions of this part shall apply. (2) The availability of a record about an individual to persons other than the individual who is the subject of the record shall be subject to the special requirements of part 21, subpart G, of this chapter (restrictions on disclosure in the privacy regulations), and shall not be subject to the limitations on ex emptions in this subpart except as pro vided in part 21, subpart G, of this chapter. § 20.81 Data and information pre viously disclosed to the public. (a) Any Food and Drug Administra tion record that is otherwise exempt from public disclosure pursuant to sub part D of this part is available for pub lic disclosure to the extent that it con tains data or information that have previously been disclosed in a lawful manner to any member of the public, other than an employee or consultant or pursuant to other commerical ar rangements with appropriate safe guards for secrecy. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00277 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 268 21 CFR Ch. I (4–1–16 Edition) § 20.82 (1) For purposes of this section, an individual shall be deemed to be a con sultant only if disclosure of the infor mation was necessary in order to per form that specific consulting service and the purpose of the disclosure was solely to obtain that service. The num ber of consultants who have received such information shall have been lim ited to the number reasonably needed to perform that particular consulting service. (2) For purposes of this section, other commercial arrangements shall include licenses, contracts, and similar legal relationships between business associ ates. (3) For purposes of this section, data and information disclosed to clinical investigators or members of institu tional review committees, whether re quired by regulations of the Food and Drug Administration, or made volun tarily, if accompanied by appropriate safeguards to assure secrecy and other wise in accordance with this section, are not deemed to have been previously disclosed to any member of the public within the meaning of paragraph (a) of this section. (b) Any statement relating to prior public disclosure is subject to the False Reports to the Government Act, 18 U.S.C. 1001. [42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 59 FR 536, Jan. 5, 1994; 68 FR 25287, May 12, 2003] § 20.82 Discretionary disclosure by the Commissioner. (a) Except as provided in paragraph (b) of this section, the Commissioner may, in his discretion, disclose part or all of any Food and Drug Administra tion record that is otherwise exempt from disclosure pursuant to subpart D of this part. The Commissioner shall exercise his discretion to disclose such records whenever he determines that such disclosure is in the public inter est, will promote the objectives of the act and the agency, and is consistent with the rights of individuals to pri vacy, the property rights of persons in trade secrets, and the need for the agency to promote frank internal pol icy deliberations and to pursue its reg ulatory activities without disruption. (b) The Commissioner shall not make available for public disclosure any record that is: (1) Exempt from public disclosure pursuant to § 20.61. (2) Exempt from public disclosure pursuant to § 20.63. (3) Prohibited from public disclosure under statute. (4) Contained in a Privacy Act Record System where disclosure would constitute a clearly unwarranted inva sion of personal privacy or is otherwise in violation of 5 U.S.C. 552a(b), as ap plied in part 21, subpart G, of this chap ter (restrictions on disclosure in the privacy regulations). (c) Discretionary disclosure of a record pursuant to this section shall invoke the requirement that the record shall be disclosed to any person who re quests it pursuant to § 20.21, but shall not set a precedent for discretionary disclosure of any similar or related record and shall not obligate the Com missioner to exercise his discretion to disclose any other record that is ex empt from disclosure. [42 FR 15616, Mar. 22, 1977, as amended at 70 FR 41958, July 21, 2005] § 20.83 Disclosure required by court order. (a) Records of the Food and Drug Ad ministration which the Commissioner has determined are not available for public disclosure, in the form of a regu lation published or cross-referenced in this part, shall nevertheless be made available for public disclosure in com pliance with a final court order requir ing such disclosure. (b) Where the Food and Drug Admin istration record ordered disclosed under paragraph (a) of this section is a record about an individual that is not available for public disclosure under § 20.63, the Food and Drug Administra tion shall attempt to notify the indi vidual who is the subject of the record of the disclosure, by sending a notice to the individual’s last known address. (c) Paragraph (b) of this section shall not apply where the name or other per sonal identifying information is de leted prior to disclosure. [42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25287, May 12, 2003] VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00278 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 269 Food and Drug Administration, HHS § 20.88 § 20.84 Disclosure to consultants, advi sory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employ ees. Data and information otherwise ex empt from public disclosure may be disclosed to Food and Drug Adminis tration consultants, advisory commit tees, State and local government offi cials commissioned pursuant to 21 U.S.C. 372(a), and other special govern ment employees for use only in their work with the Food and Drug Adminis tration. Such persons are thereafter subject to the same restrictions with respect to the disclosure of such data and information as any other Food and Drug Administration employee. § 20.85 Disclosure to other Federal government departments and agen cies. Any Food and Drug Administration record otherwise exempt from public disclosure may be disclosed to other Federal government departments and agencies, except that trade secrets and confidential commercial or financial information prohibited from disclosure by 21 U.S.C. 331(j), 21 U.S.C. 360(j)(c), 42 U.S.C. 263g(d) and 42 U.S.C. 263i(e) may be released only as provided by those sections. Any disclosure under this sec tion shall be pursuant to a written agreement that the record shall not be further disclosed by the other depart ment or agency except with the writ ten permission of the Food and Drug Administration. [47 FR 10804, Mar. 12, 1982, as amended at 59 FR 536, Jan. 5, 1994] § 20.86 Disclosure in administrative or court proceedings. Data and information otherwise ex empt from public disclosure may be re vealed in Food and Drug Administra tion administrative proceedings pursu ant to parts 10, 12, 13, 14, 15, 17, and 19 of this chapter or court proceedings, where data or information are rel evant. The Food and Drug Administra tion will take appropriate measures, or request that appropriate measures be taken, to reduce disclosure to the min imum necessary under the cir cumstances. [42 FR 15616, Mar. 22, 1977, as amended at 60 FR 38633, July 27, 1995] § 20.87 Disclosure to Congress. (a) All records of the Food and Drug Administration shall be disclosed to Congress upon an authorized request. (b) An authorized request for Food and Drug Administration records by Congress shall be made by the chair man of a committee or subcommittee of Congress acting pursuant to com mittee business. (c) An individual member of Congress who requests a record for his own use or on behalf of any constituent shall be subject to the same rules in this part that apply to any other member of the public. [42 FR 15616, Mar. 22, 1977, as amended at 59 FR 536, Jan. 5, 1994] § 20.88 Communications with State and local government officials. (a) A State or local government offi cial commissioned by the Food and Drug Administration pursuant to 21 U.S.C. 372(a) shall have the same status with respect to disclosure of Food and Drug Administration records as any special government employee. (b) Communications with State and local government officials with respect to law enforcement activities under taken pursuant to a contract between the Food and Drug Administration and such officials shall be subject to the rules for public disclosure established in § 20.64. (c) Communications with State and local government officials who are not commissioned pursuant to 21 U.S.C. 372(a) or under a contract to perform law enforcement activities shall have the same status as communications with any member of the public, except that: (1) Investigatory records compiled for law enforcement purposes by State and local government officials who perform counterpart functions to the Food and Drug Administration at the State and local level, and trade secrets and con fidential commercial or financial infor mation obtained by such officials, which are voluntarily disclosed to the VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00279 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 270 21 CFR Ch. I (4–1–16 Edition) § 20.88 Food and Drug Administration as part of cooperative law enforcement and regulatory efforts, shall be exempt from public disclosure to the same ex tent to which the records would be so exempt pursuant to §§ 20.61 and 20.64, as if they had been prepared by or sub mitted directly to Food and Drug Ad ministration employees, except that investigatory records shall be exempt from disclosure for a longer period of time if the State or local government officials so require as a condition of their furnishing the information to the Food and Drug Administration. (2) Disclosure of investigatory records compiled for law enforcement purposes by the Food and Drug Admin istration to State and local govern ment officials who perform counterpart functions to the Food and Drug Administratrion at the State and local level as part of cooperative law en forcement efforts does not invoke the rule established in § 20.21 that such records shall be made available for dis closure to all members of the public. (d)(1) The Commissioner of Food and Drugs, or any other officer or employee of the Food and Drug Administration whom the Commissioner may designate to act on his or her behalf for the pur pose, may authorize the disclosure of confidential commercial information submitted to the Food and Drug Ad ministration, or incorporated into agency-prepared records, to State gov ernment officials as part of cooperative law enforcement or regulatory efforts, provided that: (i) The State government agency has provided both a written statement es tablishing its authority to protect con fidential commercial information from public disclosure and a written com mitment not to disclose any such infor mation provided without the written permission of the sponsor or written confirmation by the Food and Drug Ad ministration that the information no longer has confidential status; and (ii) The Commissioner of Food and Drugs or the Commissioner’s designee makes one or more of the following de terminations: (A) The sponsor of the product appli cation has provided written authoriza tion for the disclosure; (B) Disclosure would be in the inter est of public health by reason of the State government’s possessing infor mation concerning the safety, effec tiveness, or quality of a product or in formation concerning an investigation, or by reason of the State government being able to exercise its regulatory authority more expeditiously than the Food and Drug Administration; or (C) The disclosure is to a State gov ernment scientist visiting the Food and Drug Administration on the agen cy’s premises as part of a joint review or long-term cooperative training ef fort authorized under section 708 of the Federal Food, Drug, and Cosmetic Act (the act), the review is in the interest of public health, the Food and Drug Administration retains physical con trol over the information, the Food and Drug Administration requires the vis iting State government scientist to sign a written commitment to protect the confidentiality of the information, and the visiting State government sci entist provides a written assurance that he or she has no financial interest in the regulated industry of the type that would preclude participation in the review of the matter if the indi vidual were subject to the conflict of interest rules applicable to the Food and Drug Administration advisory committee members under § 14.80(b)(1) of this chapter. Subject to all the fore going conditions, a visiting State gov ernment scientist may have access to trade secret information, entitled to protection under section 301(j) of the act, in those cases where such disclo sures would be a necessary part of the joint review or training. (2) Except as provided under para graph (d)(1)(ii)(C) of this section, this provision does not authorize the disclo sure to State government officials of trade secret information concerning manufacturing methods and processes prohibited from disclosure by section 301(j) of the act, unless pursuant to an express written authorization provided by the submitter of the information. (3) Any disclosure under this section of information submitted to the Food and Drug Administration or incor porated into agency-prepared records does not invoke the rule established in VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00280 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 271 Food and Drug Administration, HHS § 20.89 § 20.21 that such records shall be made available to all members of the public. (e)(1) The Senior Associate Commis sioner for Policy, Planning, and Legis lation, or the Deputy Commissioner for International and Constituent Rela tions, or any other officer or employee of the Food and Drug Administration whom the Senior Associate Commis sioner for Policy, Planning, and Legis lation or the Deputy Commissioner for International and Constituent Rela tions may designate to act on their be half for the purpose, may authorize the disclosure to, or receipt from, an offi cial of a State government agency of nonpublic, predecisional documents concerning the Food and Drug Admin istration’s or the other government agency’s regulations or other regu latory requirements, or other non public information relevant to either agency’s activities, as part of efforts to improve Federal-State uniformity, co operative regulatory activities, or im plementation of Federal-State agree ments, provided that: (i) The State government agency has the authority to protect such non public documents from public disclo sure and will not disclose any such doc uments provided without the written confirmation by the Food and Drug Ad ministration that the documents no longer have nonpublic status; and (ii) The Senior Associate Commis sioner for Policy, Planning, and Legis lation or the Deputy Commissioner for International and Constituent Rela tions or their designee makes the de termination that the exchange is rea sonably necessary to improve Federal State uniformity, cooperative regu latory activities, or implementation of Federal-State agreements. (2) Any exchange under this section of nonpublic documents does not in voke the rule established at § 20.21 that such records shall be made available to all members of the public. (3) For purposes of this paragraph, the term official of a State government agency includes, but is not limited to, an agent contracted by the State gov ernment, and an employee of an orga nization of State officials having re sponsibility to facilitate harmoni zation of State standards and require ments in FDA’s areas of responsibility. For such officials, the statement and commitment required by paragraph (e)(1)(i) of this section shall be provided by both the organization and the indi vidual. [42 FR 15616, Mar. 22, 1977, as amended at 60 FR 63381, Dec. 8, 1995; 65 FR 11887, Mar. 7, 2000] § 20.89 Communications with foreign government officials. Communications with foreign gov ernment officials shall have the same status as communications with any member of the public, except that: (a) Investigatory records compiled for law enforcement purposes by for eign government officials who perform counterpart functions to the Food and Drug Administration in a foreign coun try, and trade secrets and confidential commercial or financial information obtained by such officials, which are voluntarily disclosed to the Food and Drug Administration as part of cooper ative law enforcement and regulatory efforts, shall be exempt from public disclosure to the same extent to which the records would be so exempt pursu ant to §§ 20.61 and 20.64, as if they had been prepared by or submitted directly to Food and Drug Administration em ployees, except that investigatory records shall be exempt from disclosure for a longer period of time if the for eign government officials so require as a condition of their furnishing the in formation to the Food and Drug Ad ministration. (b) Disclosure of investigatory records compiled for law enforcement purposes by the Food and Drug Admin istration to foreign government offi cials who perform counterpart func tions to the Food and Drug Adminis tration in a foreign country as part of cooperative law enforcement efforts does not invoke the rule established in § 20.21 that such records shall be made available for disclosure to all members of the public. (c)(1) The Commissioner of Food and Drugs, or any other officer or employee of the Food and Drug Administration whom the Commissioner may designate to act on his or her behalf for the pur pose, may authorize the disclosure of confidential commercial information VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00281 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 272 21 CFR Ch. I (4–1–16 Edition) § 20.89 submitted to the Food and Drug Ad ministration, or incorporated into agency-prepared records, to foreign government officials who perform counterpart functions to the Food and Drug Administration as part of cooper ative law enforcement or regulatory ef forts, provided that: (i) The foreign government agency has provided both a written statement establishing its authority to protect confidential commercial information from public disclosure and a written commitment not to disclose any such information provided without the writ ten permission of the sponsor or writ ten confirmation by the Food and Drug Administration that the information no longer has confidential status; and (ii) The Commissioner of Food and Drugs or the Commissioner’s designee makes one or more of the following de terminations: (A) The sponsor of the product appli cation has provided written authoriza tion for the disclosure; (B) Disclosure would be in the inter est of public health by reason of the foreign government’s possessing infor mation concerning the safety, efficacy, or quality of a product or information concerning an investigation; or (C) The disclosure is to a foreign sci entist visiting the Food and Drug Ad ministration on the agency’s premises as part of a joint review or long-term cooperative training effort authorized under section 708 of the act, the review is in the interest of public health, the Food and Drug Administration retains physical control over the information, the Food and Drug Administration re quires the visiting foreign scientist to sign a written commitment to protect the confidentiality of the information, and the scientist provides a written as surance that he or she has no financial interest in the regulated industry of the type that would preclude participa tion in the review of the matter if the individual were subject to the conflict of interest rules applicable to the Food and Drug Administration advisory committee members under § 14.80(b)(1) of this chapter. Subject to all of the foregoing conditions, visiting foreign scientists may have access to trade se cret information, entitled to protec tion under section 301(j) of the Federal Food, Drug, and Cosmetic Act (the act), in those cases where such disclo sures would be a necessary part of the joint review or training. (2) Except as provided under para graph (c)(1)(ii)(C) of this section, this provision does not authorize the disclo sure to foreign government officials of other countries of trade secret infor mation concerning manufacturing methods and processes prohibited from disclosure by section 301(j) of the act, unless pursuant to an express written authorization provided by the sub mitter of the information. (3) Any disclosure under this section of information submitted to the Food and Drug Administration or incor porated into agency-prepared records does not invoke the rule established in § 20.21 that such records shall be made available to all members of the public. (d)(1) The Senior Associate Commis sioner for Policy, Planning, and Legis lation, or the Deputy Commissioner for International and Constituent Rela tions, or any other officer or employee of the Food and Drug Administration whom the Senior Associate Commis sioner for Policy, Planning, and Legis lation or the Deputy Commissioner for International and Constituent Rela tions may designate to act on their be half for the purpose, may authorize the disclosure to, or receipt from, an offi cial of a foreign government agency of nonpublic, predecisional documents concerning the Food and Drug Admin istration’s or the other government agency’s regulations or other regu latory requirements, or other non public information relevant to either agency’s activities, as part of coopera tive efforts to facilitate global harmo nization of regulatory requirements, cooperative regulatory activities, or implementation of international agree ments, provided that: (i) The foreign government agency has the authority to protect such non public documents from public disclo sure and will not disclose any such doc uments provided without the written confirmation by the Food and Drug Ad ministration that the documents no longer have nonpublic status; and (ii) The Senior Associate Commis sioner for Policy, Planning, and Legis lation or the Deputy Commissioner for VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00282 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 273 Food and Drug Administration, HHS § 20.100 International and Constituent Rela tions or their designee makes the de termination that the exchange is rea sonably necessary to facilitate global harmonization of regulatory require ments, cooperative regulatory activi ties, or implementation of inter national agreements. (2) Any exchange under this section of nonpublic documents does not in voke the rule established in § 20.21 that such records shall be made available to all members of the public. (e) For purposes of this section, the term ‘‘official of a foreign government agency’’ includes, but is not limited to, employees (whether temporary or per manent) of and agents contracted by the foreign government, or by an inter national organization established by law, treaty, or other governmental ac tion and having responsibility to facili tate global or regional harmonization of standards and requirements in FDA’s areas of responsibility or to pro mote and coordinate public health ef forts. For such officials, the statement and commitment required by para graph (c)(1)(i) of this section shall be provided on behalf of both the organi zation and the individual. [42 FR 15616, Mar. 22, 1977, as amended at 58 FR 61603, Nov. 19, 1993; 60 FR 63382, Dec. 8, 1995; 65 FR 11888, Mar. 7, 2000] § 20.90 Disclosure to contractors. (a) Data and information otherwise exempt from public disclosure may be disclosed to contractors with the Food and Drug Administration and their em ployees for use only in their work for the Food and Drug Administration. Contractors and their employees are thereafter subject to the same legal re strictions and penalties with respect to the disclosure of such data and infor mation as Food and Drug Administra tion employees. (b) A written agreement between the Food and Drug Administration and any contractor shall be entered into before data and information otherwise exempt from public disclosure may be disclosed to the contractor. The contractor shall agree to establish and follow security precautions considered by the Food and Drug Administration to be necessary to ensure proper and confidential han dling of the data and information. The written agreement shall include, where appropriate, provisions establishing: (1) Restrictions on access to the data and information by the contractor, its employees, or other persons; (2) Physical storage requirements; (3) Requirements for the handling and accountability of the data and in formation by the contractor and its employees; (4) Limitations on reproduction, transmission, and disclosure of the data and information; (5) A requirement of advance ap proval by the Food and Drug Adminis tration of the use by the contractor of subcontractors, vendors, or suppliers; (6) Procedures to be followed when the contractor employs time-shared computer operations; (7) Methods of destroying source doc uments or related waste material; and (8) The period during which the con tractor may retain such data and infor mation. § 20.91 Use of data or information for administrative or court enforce ment action. Nothing in this part or this chapter shall prevent the Food and Drug Ad ministration from using any data or in formation, whether obtained volun tarily or involuntarily and whether or not it is available for public disclosure, as the basis for taking any administra tive or court enforcement action with in its jurisdiction. Data and informa tion otherwise exempt from public dis closure are nevertheless available for public disclosure to the extent nec essary to effectuate such action, e.g., the brand name, code designation, and distribution information are released when a product is recalled. Subpart F—Availability of Specific Categories of Records § 20.100 Applicability; cross-reference to other regulations. (a) The provisions set forth in this subpart or cross-referenced in para graph (c) of this section state the way in which specific categories of Food and Drug Administration records are handled upon a request for public dis closure. The exemptions established in VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00283 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 274 21 CFR Ch. I (4–1–16 Edition) § 20.100 subpart D of this part and the limita tions on exemptions established in sub part E of this part shall be applicable to all Food and Drug Administration records, as provided in §§ 20.60 and 20.80. Accordingly, a record that is ordinarily available for public disclosure in ac cordance with this part or under other regulations is not available for such disclosure to the extent that it falls within an exemption contained in sub part D of this part except as provided by the limitations on exemptions spec ified in subpart E of this part. (b) The Commissioner, on his own initiative or on the petition of any in terested person, may amend this sub part or promulgate and cross-reference additional regulations to state the sta tus of additional categories of docu ments to settle pending questions or to reflect court decisions. (c) In addition to the provisions of this part, rules on the availability of the following specific categories of Food and Drug Administration records are established by regulations in this chapter: (1) Section 305 hearing records, in § 7.87(c) of this chapter. (2) Flavor ingredient records and notes, in § 101.22(i)(4)(iv) of this chap ter. (3) Environmental assessments; find ing of no significant impact, in § 25.51 of this chapter, or draft and final envi ronmental impact statements, in § 25.52 of this chapter. (4) Color additive petitions, in § 71.15 of this chapter. (5) Food standard temporary permits, in § 130.17(k) of this chapter. (6) Information on thermal proc essing of low-acid foods packaged in hermetically sealed containers, in § 108.35(l) of this chapter. (7) Food additive petitions, in §§ 171.1(h) and 571.1(h) of this chapter. (8) Action levels for natural and un avoidable defects in food for human use, in § 110.110(e) of this chapter. (9) Drug establishment registrations and drug listings, in § 207.37 of this chapter. (10) Investigational new animal drug notices, in § 514.12 of this chapter. (11) New animal drug application files, in § 514.11 of this chapter. (12) Investigational new animal drug notice and a new animal drug applica tion file for an antibiotic drug, in § 514.10 of this chapter. (13) Methadone patient records, in § 291.505(g) of this chapter. (14) Investigational new drug notice, in § 312.130 of this chapter. (15) Labeling for and lists of approved new drug applications, in § 314.430 of this chapter. (16) Master file for a new drug appli cation, in § 312.420 of this chapter. (17) New drug application file, in § 314.430 of this chapter. (18) Data and information submitted for in vitro diagnostic products, in § 809.4 of this chapter. (19) Data and information submitted for OTC drug review, in § 330.10(a)(2) of this chapter. (20) Investigational new drug notice for an antibiotic drug, in § 431.70 of this chapter. (21) Antibiotic drug file, in § 314.430 of this chapter. (22) Data and information submitted for biologics review, in § 601.25(b)(2) of this chapter. (23) Investigational new drug notice for a biological product, in § 601.50 of this chapter. (24) Applications for biologics li censes for biological products, in § 601.51 of this chapter. (25) Cosmetic establishment registra tions, in § 710.7 of this chapter. (26) Cosmetic product ingredient and cosmetic raw material composition statements, § 720.8 of this chapter. (27) Cosmetic product experience re ports, in § 730.7 of this chapter. (28) Device premarket notification submissions, in § 807.95 of this chapter. (29) Electronic product information, in §§ 1002.4 and 1002.42 of this chapter. (30) Data and information submitted to the Commissioner or to classifica tion panels in connection with the clas sification or reclassification of devices intended for human use, in § 860.5 of this chapter. (31) Data and information submitted in offers to develop a proposed perform ance standard for medical devices, in § 861.26 of this chapter. (32) Investigational device exemp tions in § 812.38 of this chapter. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00284 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 275 Food and Drug Administration, HHS § 20.102 (33) Health claims petitions, in § 101.70 of this chapter. (34) Premarket approval application, in § 814.9 of this chapter. (35) Report of certain adverse experi ences with a medical device, in § 803.9 of this chapter. (36) Disqualification determination of an institutional review board, in § 56.122 of this chapter. (37) Disqualification determination of a nonclinical laboratory, in § 58.213 of this chapter. (38) Minutes or records regarding a public advisory committee, in § 14.65(c) of this chapter. (39) Data submitted regarding per sons receiving an implanted pacemaker device or lead, in § 805.25 of this chap ter. (40) Humanitarian device exemption application, in § 814.122 of this chapter. (41) Premarket notifications for food contact substances, in § 170.102 of this chapter. (42) Registration of food facilities, in § 1.243 of this chapter. (43) Minor-use or minor-species (MUMS) drug designations, in § 516.52 of this chapter. (44) Minor-species drug index listings, in § 516.171 of this chapter. (45) Postmarket notifications of a permanent discontinuance or an inter ruption in manufacturing of certain drugs or biological products, in §§ 310.306, 314.81(b)(3)(iii), and 600.82 of this chapter. [42 FR 15616, Mar. 22, 1977, as amended at 42 FR 19989, Apr. 15, 1977; 42 FR 42526, Aug. 28, 1977; 42 FR 58889, Nov. 11, 1977; 43 FR 32993, July 28, 1978; 51 FR 22475, June 19, 1986; 54 FR 9038, Mar. 3, 1989; 58 FR 2533, Jan. 6, 1993; 59 FR 536, Jan. 5, 1994; 61 FR 33244, June 26, 1996; 62 FR 40592, July 29, 1997; 64 FR 56448, Oct. 20, 1999; 67 FR 13717, Mar. 26, 2002; 67 FR 35729, May 21, 2002; 68 FR 58965, Oct. 10, 2003; 72 FR 41017, July 26, 2007; 72 FR 69118, Dec. 6, 2007; 80 FR 38938, July 8, 2015] § 20.101 Administrative enforcement records. (a) All Food and Drug Administra tion records relating to administrative enforcement action disclosed to any member of the public, including the person who is the subject of such ac tion, are available for public disclosure at the time such disclosure is first made. Such records include correspond ence with companies following factory inspection, recall or detention re quests, notice of refusal of admission of an imported product, regulatory let ters, information letters, Forms FD–483 and FD–2275 furnished to companies after factory inspection, and similar records. (b) To the extent that any of such records fall within the exemption for investigatory records established in § 20.64, the Commissioner determines that they are subject to discretionary release pursuant to § 20.82. (c) Records relating to administra tive enforcement action that are not disclosed to any member of the public constitute investigatory records that are subject to the rules for disclosure established in § 20.64. For example, an establishment inspection report is an investigatory record and thus subject to § 20.64 except insofar as the Commis sioner exercises his discretion to re lease it pursuant to § 20.82. § 20.102 Court enforcement records. (a) All records and documents filed in the courts are available for public dis closure unless the court orders other wise. The Food and Drug Administra tion will make available for public dis closure such records or documents if the agency can determine that it has an accurate copy of the actual record or document filed in the court. If the Food and Drug Administration cannot determine whether it has an accurate copy of such a record or document, the person requesting a copy shall be re ferred to the court involved. (b) After a recommendation for court action has been finally refused by a United States attorney, the cor respondence with the United States at torney and the Department of Justice with respect to that recommendation, including the pleadings recommended for filing with the court, is available for public disclosure. Prior to disclo sure of any record specifically reflect ing consideration of possible criminal prosecution of any individual, all names and other information that would identify an individual who was considered for criminal prosecution but who was not prosecuted shall be de leted unless the Commissioner con cludes that there is a compelling public VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00285 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 276 21 CFR Ch. I (4–1–16 Edition) § 20.103 interest in the disclosure of such names. § 20.103 Correspondence. (a) All correspondence to and from members of the public, members of Congress, organization or company of ficials, or other persons, except mem bers of the Executive Branch of the Federal Government and special gov ernment employees, is available for public disclosure. (b) Any such correspondence is avail able for public disclosure at the time that it is sent or received by the Food and Drug Administration unless a dif ferent time for such disclosure is speci fied in other rules established or cross referenced in this part, e.g., cor respondence relating to an IND notice or an NDA in § 314.430 of this chapter. [42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989] § 20.104 Summaries of oral discussions. (a) All written summaries of oral dis cussions, whether in person or by tele phone, with members of the public, members of Congress, organization or company officials, or other persons, ex cept members of the Executive Branch of the Federal government or special government employees, are available for public disclosure. (b) Any such summary is available for public disclosure at the time that it is prepared by the Food and Drug Ad ministration unless a different time for such disclosure is specified in other rules established or cross-referenced in this part, e.g., summaries of oral dis cussions relating to a food additive pe tition in § 171.1(h)(3) of this chapter. (c) If more than one summary of an oral discussion exists in a Food and Drug Administration file, all such sum maries shall be disclosed in response to any request for such summary. § 20.105 Testing and research con ducted by or with funds provided by the Food and Drug Administra tion. (a) Any list that may be prepared by the Food and Drug Administration of testing and research being conducted by or with funds provided by the Food and Drug Administration is available for public disclosure. (b) Any contract relating to agency testing and research, and any progress report relating thereto, is available for public disclosure. (c) The results of all testing or re search conducted by or with funds pro vided by the Food and Drug Adminis tration, such as toxicological testing, compliance assays, methodology stud ies, and product testing, are available for public disclosure when the final re port is complete and accepted by the responsible Food and Drug Administra tion official, after deletion of any in formation that would reveal confiden tial investigative techniques and pro cedures, e.g., the use of ‘‘markers’’ to document adulteration of a product. If such results are disclosed in an author ized manner to any member of the pub lic before the final report is available, they are immediately available for public disclosure to any member of the public who requests them. (d) Access to all raw data, slides, worksheets, and other similar working materials shall be provided at the same time that the final report is disclosed. § 20.106 Studies and reports prepared by or with funds provided by the Food and Drug Administration. (a) The following types of reports and studies prepared by or with funds pro vided by the Food and Drug Adminis tration are available for public disclo sure upon their acceptance by the re sponsible agency official: (1) Quarterly and annual reports of the agency. (2) External investigations or review of agency needs and performance. (3) Surveys, compilations, and sum maries of data and information. (4) Consumer surveys. (5) Compliance surveys. (6) Compliance programs, except that names of specific firms, the location of specific activities, and details about sampling numbers or sizes shall be de leted until implementation of the pro gram is completed. (7) Work plans prepared by Food and Drug Administration centers, field of fices, and other components, except that names of specific firms, the loca tion of specific activities, and details about sampling numbers or sizes shall VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00286 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 277 Food and Drug Administration, HHS § 20.109 be deleted until implementation of the plan is completed. (b) The following types of reports and studies prepared by or with funds pro vided by the Food and Drug Adminis tration are not available for public dis closure: (1) Internal audits of agency needs and performance. (2) Records relating to the internal planning and budget process. (3) Legislative proposals or com ments prior to submission to Congress. [42 FR 15616, Mar. 22, 1977, as amended at 50 FR 8995, Mar. 6, 1985] § 20.107 Food and Drug Administration manuals. (a) Food and Drug Administration administrative staff manuals and in structions that affect a member of the public are available for public disclo sure. An index of all such manuals is available by writing to the Division of Freedom of Informationat the address located on the agency’s web site at http://www.fda.gov.; or by visiting the Division of Freedom of Information Public Reading Room, located in rm. 1050, at the same address. The index and all manuals created by the agency on or after November 1, 1996, will be made available through the Internet at http://www.fda.gov. (b) Manuals relating solely to inter nal personnel rules and practices are not available for public disclosure ex cept to the extent that the Commis sioner determines that they should be disclosed pursuant to § 20.82. (c) All Food and Drug Administration action levels which are used to deter mine when the agency will take regu latory action against a violative prod uct, limits of sensitivity and varia bility of analytical methods which are used in determining whether a product violates the law, and direct reference levels above which Food and Drug Ad ministration field offices may request legal action directly to the office of the General Counsel, are available for pub lic disclosure. [42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981; 68 FR 25287, May 12, 2003; 76 FR 31469, June 1, 2011; 79 FR 68115, Nov. 14, 2014] § 20.108 Agreements between the Food and Drug Administration and other departments, agencies, and organi zations. (a) All written agreements and un derstandings signed by the Food and Drug Administration and other depart ments, agencies, and organizations are available for public disclosure. (b) All written agreements and memoranda of understanding between FDA and any entity, including, but not limited to other departments, Agen cies, and organizations will be made available through the Food and Drug Administration Web site at http:// www.fda.gov once finalized. (c) Agreements and understandings signed by officials of FDA with respect to activities of the Office of Criminal Investigations are exempt from the re quirements set forth in paragraph (b) of this section. Although such agree ments and understandings will not be made available through the FDA Web site, these agreements will be available for disclosure in response to a request from the public after deletion of infor mation that would disclose confiden tial investigative techniques or proce dures, or information that would dis close guidelines for law enforcement investigations if such disclosure could reasonably be expected to risk cir cumvention of the law. [42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 58 FR 48794, 48796, Sept. 20, 1993; 76 FR 31470, June 1, 2011; 77 FR 50591, Aug. 22, 2012] § 20.109 Data and information ob tained by contract. (a) All data and information obtained by the Food and Drug Administration by contract, including all progress re ports pursuant to a contract, are avail able for public disclosure when accept ed by the responsible agency official except to the extent that they remain subject to an exemption established in subpart D of this part, e.g., they relate to law enforcement matters as pro vided in § 20.88(b). (b) Upon the awarding of a contract by the Food and Drug Administration, the technical proposal submitted by the successful offeror will be available for public disclosure. All cost proposals VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00287 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 278 21 CFR Ch. I (4–1–16 Edition) § 20.110 and the technical proposals of unsuc cessful offerors submitted in response to a request for proposals are exempt from disclosure as confidential com mercial or financial information pursu ant to § 20.61. § 20.110 Data and information about Food and Drug Administration em ployees. (a) The name, title, grade, position description, salary, work address, and work telephone number for every Food and Drug Administration employee are available for public disclosure. The home address and home telephone number of any such employee are not available for public disclosure. (b) Statistics on the prior employ ment experience of present agency em ployees, and subsequent employment of past agency employees, are available for public disclosure. § 20.111 Data and information sub mitted voluntarily to the Food and Drug Administration. (a) The provisions of this section shall apply only to data and informa tion submitted voluntarily to the Food and Drug Administration, whether in the course of a factory inspection or at any other time, and not as a part of any petition, application, master file, or other required submission or request for action. Data and information that may be required to be submitted to the Food and Drug Administration but that are submitted voluntarily instead are not subject to the provisions of this section and will be handled as if they had been required to be submitted. (b) A determination that data or in formation submitted voluntarily will be held in confidence and will not be available for public disclosure shall be made only in the form of a regulation published or cross-referenced in this part. (c) The following data and informa tion submitted voluntarily to the Food and Drug Administration are available for public disclosure unless extraor dinary circumstances are shown: (1) All safety, effectiveness, and functionality data and information for a marketed ingredient or product, ex cept as provided in § 330.10(a)(2) of this chapter for OTC drugs. (2) A protocol for a test or study, un less it is shown to fall within the ex emption established in § 20.61 for trade secrets and confidential commercial or financial information. (3) Adverse reaction reports, product experience reports, consumer com plaints, and other similar data and in formation shall be disclosed as follows: (i) If submitted by a consumer or user of the product, the record is avail able for public disclosure after deletion of names and other information that would identify the person submitting the information. (ii) If submitted by the manufacturer of the product, the record is available for public disclosure after deletion of: (a) Names and any information that would identify the person using the product. (b) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution. (c) Names and any other information that would identify the manufacturer or the brand designation of the prod uct, but not the type of product or its ingredients. (iii) If submitted by a third party, such as a physician or hospital or other institution, the record is available for public disclosure after deletion of: (a) Names and any information that would identify the person using the product. (b) Names and any information that would identify any third party involved with the report, such as a physician or hospital or other institution. (iv) If obtained through a Food and Drug Administration investigation, the record shall have the same status as the initial report which led to the in vestigation, i.e., it shall be disclosed in accordance with paragraph (c)(3)(i) through (iii) of this section. (v) Any compilation of data, informa tion, and reports prepared in a way that does not reveal data or informa tion which is not available for public disclosure under this section is avail able for public disclosure. (vi) If a person requests a copy of any such record relating to a specific indi vidual or a specific incident, such re quest will be denied unless accom panied by the written consent to such VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00288 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 279 Food and Drug Administration, HHS § 20.114 disclosure of the person who submitted the report to the Food and Drug Ad ministration and the individual who is the subject of the report. The record will be disclosed to the individual who is the subject of the report upon re quest. (4) A list of all ingredients contained in a food or cosmetic, whether or not it is in descending order of predominance, or a list of all active ingredients and any inactive ingredients previously disclosed to the public as defined in § 20.81 contained in a drug, or a list of all ingredients or components in a de vice. (5) An assay method or other analyt ical method, unless it serves no regu latory or compliance purpose and is shown to fall within the exemption es tablished in § 20.61. (d) The following data and informa tion submitted voluntarily to the Food and Drug Administration are not avail able for public disclosure unless they have been previously disclosed to the public as defined in § 20.81 or they re late to a product or ingredient that has been abandoned and they no longer rep resent a trade secret or confidential commercial or financial information as defined in § 20.61: (1) All safety, effectiveness, and functionality data and information for a developmental ingredient or product that has not previously been disclosed to the public as defined in § 20.81. (2) Manufacturing methods or proc esses, including quality control proce dures. (3) Production, sales, distribution, and similar data and information, ex cept that any compilation of such data and information aggregated and pre pared in a way that does not reveal data or information which is not avail able for public disclosure under this provision is available for public disclo sure. (4) Quantitative or semiquantitative formulas. (e) For purposes of this regulation, safety, effectiveness, and functionality data include all studies and tests of an ingredient or a product on animals and humans and all studies and tests on the ingredient or product for identity, sta bility, purity, potency, bioavailability, performance, and usefulness. [42 FR 15616, Mar. 22, 1977, as amended at 68 FR 25287, May 12, 2003] § 20.112 Voluntary drug experience re ports submitted by physicians and hospitals. (a) A voluntary drug experience re port to the Food and Drug Administra tion on FDA Form 3500 shall be han dled in accordance with the rules es tablished in § 20.111(c)(3)(iii). (b) If a person requests a copy of any such record relating to a specific indi vidual or a specific incident, such re quest will be denied unless accom panied by the written consent to such disclosure of the person who submitted the report to the Food and Drug Ad ministration and the individual who is the subject of the report. [42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 62 FR 52249, Oct. 7, 1997] § 20.113 Voluntary product defect re ports. Voluntary reports of defects in prod ucts subject to the jurisdiction of the Food and Drug Administration are available for public disclosure: (a) If the report is submitted by the manufacturer, after deletion of data and information falling within the ex emptions established in § 20.61 for trade secrets and confidential commercial or financial information and in § 20.63 for personal privacy. (b) If the report is submitted by any person other than the manufacturer, after deletion of names and other infor mation that would identify the person submitting the report and any data or information falling within the exemp tion established in § 20.63 for personal privacy. § 20.114 Data and information sub mitted pursuant to cooperative quality assurance agreements. Data and information submitted to the Food and Drug Administration pur suant to a cooperative quality assur ance agreement shall be handled in ac cordance with the rules established in § 20.111. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00289 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 280 21 CFR Ch. I (4–1–16 Edition) § 20.115 § 20.115 Product codes for manufac turing or sales dates. Data or information in Food and Drug Administration files which pro vide a means for deciphering or decod ing a manufacturing date or sales date or use date contained on the label or in labeling or otherwise used in connec tion with a product subject to the ju risdiction of the Food and Drug Admin istration are available for public dis closure. § 20.116 Drug and device listing infor mation. Information submitted to the Food and Drug Administration pursuant to section 510 (a)–(j) of the act shall be subject only to the special disclosure provisions established in §§ 207.37 and 807.37 of this chapter. [42 FR 42526, Aug. 23, 1977] § 20.117 New drug information. (a) The following computer printouts are available for public inspection in the Food and Drug Administration’s Freedom of Information Public Room: (1) A numerical listing of all new drug applications and abbreviated new drug applications approved since 1938, showing the NDA number, the trade name, the applicant, the approval date, and, where applicable, the date the ap proval was withdrawn and the date the Food and Drug Administration was no tified that marketing of the product was discontinued. (2) A numerical listing of all new drug applications and abbreviated new drug applications approved since 1938 which are still approved, showing the same information as is specified in paragraph (a)(1) of this section except that it does not show a withdrawal date. (3) A listing of new drug applications, abbreviated new drug applications, which were approved since 1938 and which are still approved, covering mar keted prescription drug products ex cept prescription drug products covered by applications deemed approved under the Drug Amendments of 1962 and not yet determined to be effective in the Drug Efficacy Study Implementation program. The listing includes the name of the active ingredient, the type of dosage form, the route of administra tion, the trade name of the product, the name of the application holder, and the strength or potency of the product. The listing also includes, for each ac tive ingredient in a particular dosage form for which there is more than one approved application, an evaluation of the therapeutic equivalence of the drug products covered by such applications. (b) Other computer printouts con taining IND and NDA information are available to the extent that they do not reveal data or information prohib ited from disclosure under §§ 20.61, 312.130, and 314.430 of this chapter. [42 FR 15616, Mar. 22, 1977, as amended at 45 FR 72608, Oct. 31, 1980; 46 FR 8457, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989; 64 FR 399, Jan. 5, 1999] § 20.118 Advisory committee records. All advisory committee records shall be handled in accordance with the rules established in parts 10, 12, 13, 14, 15, 16, and 19 of this chapter. § 20.119 Lists of names and addresses. Names and addresses of individuals in Food and Drug Administration records shall not be sold or rented. Names and addresses shall not be disclosed if dis closure is prohibited as a clearly un warranted invasion of personal privacy, e.g., lists of names and home addresses of Food and Drug Administration em ployees, which shall not be disclosed under § 20.110. § 20.120 Records available in Food and Drug Administration Public Read ing Rooms. (a) The Freedom of Information Staff and the Division of Dockets Manage ment Public Reading Room are located at the same address. Both are located in rm. 1061, 5630 Fishers Lane, Rock ville, MD 20852. The telephone number for the Division of Docket Management is 301–827–6860; the telephone number for the Freedom of Information Staff’s Public Reading Room is located at the address on the agency’s web site at http://www.fda.gov. Both public reading rooms are open from 9 a.m. to 4 p.m., Monday through Friday, excluding legal public holidays. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00290 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 281 Food and Drug Administration, HHS Pt. 21 (b) The following records are avail able at the Division of Freedom of In formation Public Reading Room: (1) A guide for making requests for records or information from the Food and Drug Administration; (2) Administrative staff manuals and instructions to staff that affect a mem ber of the public; (3) Food and Drug Administration records which have been released to any person in response to a Freedom of Information request and which the agency has determined have become or are likely to become the subject of sub sequent requests for substantially the same records; (4) Indexes of records maintained in the Division of Freedom of Information Public Reading Room; and (5) Such other records and informa tion as the agency determines are ap propriate for inclusion in the public reading room. (c) The following records are avail able in the Division of Dockets Man agement’s Public Reading Room: (1) Final opinions, including concur ring and dissenting opinions, as well as orders, made in the adjudication of cases; (2) Statements of policy and interpre tation adopted by the agency that are still in force and not published in the FEDERAL REGISTER; (3) Indexes of records maintained in the Division of Dockets Management’s Public Reading Room; and (4) Such other records and informa tion as the agency determines are ap propriate for inclusion in the public reading room. (d) The agency will make reading room records created by the Food and Drug Administration on or after No vember 1, 1996, available electronically through the Internet at the agency’s World Wide Web site which can be found at http://www.fda.gov. At the agency’s discretion, the Food and Drug Administration may also make avail able through the Internet such addi tional records and information it be lieves will be useful to the public. [68 FR 25287, May 12, 2003; 68 FR 65392, Nov. 20, 2003, as amended at 76 FR 31470, June 1, 2011; 79 FR 68115, Nov. 14, 2014] PART 21—PROTECTION OF PRIVACY Subpart A—General Provisions Sec. 21.1 Scope. 21.3 Definitions. 21.10 Policy concerning records about indi viduals. Subpart B—Food and Drug Administration Privacy Act Record Systems 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record Systems. 21.21 Changes in systems and new systems. Subpart C—Requirements for Specific Categories of Records 21.30 Records of contractors. 21.31 Records stored by the National Ar chives and Records Administration. 21.32 Personnel records. 21.33 Medical records. Subpart D—Procedures for Notification of and Access to Records in Privacy Act Record Systems 21.40 Procedures for submitting requests for notification and access. 21.41 Processing of requests. 21.42 Responses to requests. 21.43 Access to requested records. 21.44 Verification of identity. 21.45 Fees. Subpart E—Procedures for Requests for Amendment of Records 21.50 Procedures for submitting requests for amendment of records. 21.51 Responses to requests for amendment of records. 21.52 Administrative appeals of refusals to amend records. 21.53 Notation and disclosure of disputed records. 21.54 Amended or disputed records received from other agencies. Subpart F—Exemptions 21.60 Policy. 21.61 Exempt systems. 21.65 Access to records in exempt systems. Subpart G—Disclosure of Records in Pri vacy Act Record Systems to Persons Other Than the Subject Individual 21.70 Disclosure and intra-agency use of records in Privacy Act Record Systems; no accounting required. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00291 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