Source: https://www.federalregister.gov/documents/2003/05/12/03-11647/public-information-regulations
Timestamp: 2018-04-22 19:07:20
Document Index: 41727361

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Federal Register :: Public Information Regulations
Public Information Regulations
A Rule by the Food and Drug Administration on 05/12/2003
This rule is effective July 28, 2003.
68 FR 25283
25283-25288 (6 pages)
21 CFR 720
Docket No. 99N-2637
03-11647
II. Discussion of Comments on the Proposed Rule
A. Section 20.33—Form or Format of Response
B. Section 20.34—Search for Records
C. Section 20.40—Filing a Request for Records
D. Section 20.44—Expedited Processing
21 CFR Part 10
21 CFR Part 14
21 CFR Part 20
21 CFR Part 720
PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
PART 314—APPLICATION FOR FDA APPROVAL TO MARKET A NEW DRUG
PART 720—VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS
https://www.federalregister.gov/d/03-11647 https://www.federalregister.gov/d/03-11647
The Food and Drug Administration (FDA) is issuing final regulations to comply with the requirements of the Electronic Freedom of Information Amendments of 1996 (EFOIA). EFOIA is designed to broaden public access to Government documents by making them more accessible in electronic form and by streamlining the process by which agencies generally disclose information.
Betty Dorsey, Freedom of Information Staff (HFI-30), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-6567.
In the Federal Register of November 4, 1999 (64 FR 60143), FDA published a proposed rule that would amend its public information regulations in part 20 (21 CFR part 20) to comply with the requirements of the EFOIA and to clarify and update certain provisions unrelated to EFOIA. EFOIA authorizes, and in some instances requires, agencies to issue regulations implementing certain of its provisions, including provisions regarding the aggregation of Freedom of Information Act (FOIA) requests, the expedited processing of FOIA requests, and the establishment of separate queues for the processing of FOIA requests. In addition, EFOIA amends the time limits for responding to an FOIA request from 10 to 20 working days, the process by which an agency may extend the time for responding to an FOIA request, and the requirements for reporting on FOIA activities. EFOIA also includes provisions regarding the availability of records in electronic form, the establishment of “electronic reading rooms,” and provisions requiring agencies to inform requesters about the amount of information not being released to them.
In addition to the changes in the proposed rule, this document also reflects technical changes caused by the redesignation of several provisions and by the revocation of existing § 20.44 for the reasons outlined in the proposed rule.
FDA received one comment on the proposed rule from a pharmaceutical research and development organization.
The proposal would revise the agency's regulation by adding a requirement to provide records in any requested form or format if the record is readily reproducible by the agency in the requested form or format. FDA offices responsible for responding to FOIA requests shall make reasonable efforts to maintain their records in forms or formats that are readily reproducible for FOIA purposes. Because of the wide range of possible forms and formats, a specific office responding to a FOIA request may not have means to respond to requests in all requested forms and formats. In its proposal, the agency noted that it is striving toward a common records filing structure that will enhance the agency's ability to respond to requests for records in a particular form or format.
The comment asked whether FDA has requested input from its constituents with regard to a common record filing structure, and, if not, recommended that FDA do so.
FDA has not requested input from its constituents on this matter, but will take this comment into consideration as the agency continues to develop a common records filing structure. However, until such a structure is in place, FDA will respond to requests for records in specified forms or formats based on its existing technological and resource capabilities.
Start Printed Page 25284
The proposal stated that in responding to a request for records, the agency shall make reasonable efforts to search for records kept in their electronic form or format, except when such efforts would significantly interfere with the operation of the agency's automated information systems.
The comment recommended that the agency provide an example of the kind of requests FDA believes would significantly interfere with the operation of the agency's automated information systems.
It is not readily possible for FDA to provide examples of situations that would significantly interfere with the operation of the agency's automated information systems. Because FDA has a decentralized system for processing FOIA requests, what constitutes significant interference may depend on the technical capabilities and resources of the particular office processing a request. Thus, the agency will be making these decisions on a case by case basis.
As stated in the proposal, FDA will accept FOI requests via facsimile as well as via mail.
The comment requested that FDA also add e-mail as an acceptable means of filing a FOIA request in light of the common use of e-mail in today's business world. The agency is exploring the possibility of accepting electronic FOI requests, and at some future time may amend its regulations to permit the filing of electronic requests.
The proposal implements section 8 of EFOIA, which requires agencies to provide for expedited processing of FOIA requests in cases where the person requesting the records demonstrates a “compelling need” and in other cases as determined by the agency.
The comment expressed concern that the scope of individuals or entities that can demonstrate “compelling need” is too narrow. In particular, the comment stated that the rule should be restructured so that pharmaceutical and other healthcare companies would also be in a position to obtain expedited processing when there is an urgency to inform the public about FDA regulatory activity, such as product recalls.
The definition of “compelling need” is set forth in the EFOIA statute (5 U.S.C. 552(a)(6)(E)) itself and cannot be changed by agency rulemaking. However, because EFOIA also permits agencies to grant expedited processing in other cases as determined by the agency, in those instances where the requester does not meet the statutory definition of “compelling need” but demonstrates a need for expedited processing, the agency has the discretion to grant such requests.
The agency has determined under 21 CFR 25.30(h) and (i) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive order. In addition, the final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the final rule provides for greater flexibility in making requests, increased access to public information, and in certain cases, a faster agency response, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required.
Section 202 of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits before issuing any rule that may result in expenditure in any 1 year by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million, adjusted annually for inflation. As noted above, we find that this final rule would not have an effect of this magnitude on the economy.
The final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and the Freedom of Information Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 10, 14, 20, 314, and 720 are amended as follows:
1. The authority citation for 21 CFR part 10 continues to read as follows:
Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112, 42 U.S.C. 201, 262, 263b, 264.
Start Printed Page 25285
§ 10.20
2. Section 10.20 Submission of documents to Dockets Management Branch; computation of time; availability for public disclosure is amended in paragraph (c)(6) by removing the last sentence and in paragraph (j)(2)(ii) by removing “§ 20.46” and by adding in its place “§ 20.48”.
3. The authority citation for 21 CFR part 14 continues to read as follows:
Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461; 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.
§ 14.61
4. Section 14.61 Transcripts of advisory committee meetings is amended in paragraph (d) by removing “§ 20.42” and by adding in its place “§ 20.45” and by removing “§ 20.51” and by adding in its place “§ 20.53”.
5. The authority citation for 21 CFR part 20 continues to read as follows:
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, 2421, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.
6. Section 20.20 is amended by adding paragraph (e) to read as follows:
§ 20.20
Policy on disclosure of Food and Drug Administration records.
7. Section 20.22 is amended by redesignating the existing paragraph as paragraph (a) and by adding paragraph (b) to read as follows:
§ 20.22
Partial disclosure of records.
8. Section 20.26 is amended by adding paragraph (a)(4) and by revising paragraph (b) to read as follows:
§ 20.26
Indexes of certain records.
(b) Each such index will be made available through the Internet at http://www.fda.gov. A printed copy of each index is available by writing to the Freedom of Information Staff (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, or by visiting the Freedom of Information Public Reading Room in rm. 12A-30 at the same address.
§ 20.27
9. Section 20.27 Submission of records marked as confidential is amended by removing the phrase “to review them pursuant to the procedures established in § 20.44,”
§ 20.28
10. Section 20.28 Food and Drug Administration determinations of confidentiality is amended by removing the phrase “or by a written determination pursuant to the procedure established in § 20.44”.
§ 20.29
11. Section 20.29 Prohibition on withdrawal of records from Food and Drug Administration files is amended by removing the phrase “Except pursuant to the procedures established in § 20.44 for presubmission review of records, no” from the first sentence and by adding in its place the word “No”.
12. Subpart B is amended by adding §§ 20.33 and 20.34 to read as follows:
§ 20.33
Form or format of response.
§ 20.34
13. Section 20.40 is amended by revising paragraph (a) to read as follows:
§ 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 (HFI-35), Food and Drug Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, or by faxing it to 301-443-1726. All requests must contain the postal address and telephone number of the requester and the name of the person responsible for payment of any fees that may be charged.
14. Section 20.41 is amended by revising the introductory text of paragraph (b) and paragraph (b)(3), in paragraph (b)(2) by removing “§ 20.45” and by adding in its place “§ 20.47”, and by adding paragraph (c) to read as follows:
§ 20.41
(b) Within 20 working days (excluding Saturdays, Sundays, and legal public holidays) after a request for records is logged in at the Freedom of Information Staff, 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.
(3) (i) In unusual circumstances, the agency may extend the time for sending the letter for an additional period.
(B) The agency may provide for an extension of more than 10 working days by providing written notice to the requester setting out the reasons for the extension. The notice also will give the requester an opportunity to limit the Start Printed Page 25286scope 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.
(c) The Food and Drug Administration shall provide a determination of whether to provide expedited processing within 10 calendar days of receipt by the Freedom of Information Staff of the request and the required documentation of compelling need in accordance with § 20.44(b).
15. Sections 20.45 through 20.53 are redesignated as §§ 20.47 through 20.55, §§ 20.42 and 20.43 are redesignated as §§ 20.45 and 20.46, new §§ 20.42 and 20.43 are added, and § 20.44 is revised, to read as follows:
§ 20.42
Aggregation of certain requests.
The Food and Drug Administration may aggregate certain requests by the same requester, or by a group of requesters acting in concert, if the requests 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 aggregated requests in accordance with the unusual circumstances provisions of § 20.41.
§ 20.43
Multitrack processing.
(a) Each Food and Drug Administration component is responsible for determining whether to use a multitrack system to process requests for records maintained by that component. A multitrack system provides two or more tracks for processing requests, based on the amount of work and/or time required for a request to be processed. The availability of multitrack processing does not affect expedited processing in accordance with § 20.44.
§ 20.44
Expedited processing.
(d) All requests for expedited processing shall be filed in writing as provided 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 section and a certification that the information provided in the request is true and correct to the best of the requester's knowledge and belief. Any statements 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 determine whether to grant a request for expedited processing within 10 days of receipt by the Freedom of Information Staff of all information required to make a decision.
16. Newly redesignated § 20.45 is amended in paragraph (a) introductory text by removing “§ 20.43” and by adding in its place “§ 20.46”, by revising the introductory text of paragraph (c), by removing the third sentence in paragraph (c)(1), and by revising paragraph (c)(6) to read as follows:
§ 20.45
Fees to be charged.
(6) Sending records by express mail or other special methods. This service is not required by the Freedom of Information Act. If the Food and Drug Administration agrees to provide this service, the requester will be required to directly pay, or be directly charged by, the courier. The agency will not agree to any special delivery method that does Start Printed Page 25287not permit the requester to directly pay or be directly charged for the service.
17. Newly redesignated § 20.46 is amended by revising the introductory text of paragraph (a) to read as follows:
§ 20.46
Waiver or reduction of fees.
§ 20.48
18. Newly redesignated § 20.48 Judicial review of proposed disclosure is amended by removing “§ 20.45” and by adding in its place “§ 20.47”.
19. Newly redesignated § 20.49 is amended by revising paragraphs (a) and (c) to read as follows:
§ 20.49
Denial of a request for records.
§ 20.53
20. Newly redesignated § 20.53 is amended by removing “§ 20.42” and by adding in its place “§ 20.45”.
§ 20.81
21. Section 20.81 Data and information previously disclosed to the public is amended by removing paragraph (b) and by redesignating paragraph (c) as new paragraph (b).
§ 20.83
22. Section 20.83 Disclosure required by court order is amended in paragraph (a) by removing “either” and by removing the phrase “or by a written determination pursuant to the procedure established in § 20.44”.
23. Section 20.107 is amended by revising paragraph (a) to read as follows:
§ 20.107
Food and Drug Administration manuals.
(a) Food and Drug Administration administrative staff manuals and instructions that affect a member of the public are available for public disclosure. An index of all such manuals is available by writing to the Freedom of Information Staff (HFI-35), Food and Drug Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, or by visiting the Freedom of Information Public Reading Room, located in rm. 12A-30 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.
§ 20.111
24. Section 20.111 Data and information submitted voluntarily to the Food and Drug Administration is amended in paragraph (b) by removing the phrase “or by a written determination pursuant to the procedure established in § 20.44” and in paragraph (c)(4) by removing the last sentence.
25. Section 20.120 is added to subpart F to read as follows:
§ 20.120
Records available in Food and Drug Administration Public Reading Rooms.
(a) The Food and Drug Administration operates two public reading rooms. The Freedom of Information Staff's Public Reading Room is located in rm. 12A-30, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857, the phone number is 301-827-6500. The Dockets Management Branch's Public Reading Room is located in rm. 1061, 5630 Fishers Lane, Rockville, MD 20857; the phone number is 301-827-6860. Both public reading rooms are open from 9 a.m. to 4 p.m., Monday through Friday, excluding legal public holidays.
(b) The following records are available at the Freedom of Information Staff's Public Reading Room:
(4) Indexes of records maintained in the Freedom of Information Staff's Public Reading Room; and
(c) The following records are available in the Dockets Management Branch's Public Reading Room:
(3) Indexes of records maintained in the Dockets Management Branch's Public Reading Room; and
26. The authority citation for 21 CFR part 314 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 355a, 356, 356a, 356b, 356c, 371, 374, 379e.
§ 314.65
27. Section 314.65 Withdrawal by the applicant of an unapproved application is amended by removing “§ 20.42” and by adding in its place “§ 20.45”.
§ 314.72
28. Section 314.72 Change in ownership of an application is amended in paragraph (a)(2)(iii) by removing “§ 20.42” and by adding in its place “§ 20.45”.
29. The authority citation for 21 CFR part 720 continues to read as follows:
Start Printed Page 25288 Authority: 21 U.S.C. 321, 331, 361, 362, 371, 374.
§ 720.8
30. Section 720.8 Confidentiality of statements is amended by removing from the second sentence of paragraph (a) the phrase “and in § 20.44 of this chapter”.
Dated: May 3, 2003.
[FR Doc. 03-11647 Filed 5-9-03; 8:45 am]