[Federal Register Volume 68, Number 91 (Monday, May 12, 2003)]
[Rules and Regulations]
[Pages 25283-25288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 10, 14, 20, 314, and 720

[Docket No. 99N-2637]


Public Information Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: 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.

DATES: This rule is effective July 28, 2003.

FOR FURTHER INFORMATION CONTACT: Betty Dorsey, Freedom of Information 
Staff (HFI-30), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-6567.

SUPPLEMENTARY INFORMATION:

I. Introduction

    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 Sec.  20.44 for the 
reasons outlined in the proposed rule.

II. Discussion of Comments on the Proposed Rule

    FDA received one comment on the proposed rule from a pharmaceutical 
research and development organization.

A. Section 20.33--Form or Format of Response

    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.

[[Page 25284]]

B. Section 20.34--Search for Records

    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.

C. Section 20.40--Filing a Request for Records

    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.

D. Section 20.44--Expedited Processing

    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.

III. Environmental Impact

    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.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

V. Analysis of Impacts

    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.

VI. Paperwork Reduction Act of 1995

    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.

List of Subjects

21 CFR Part 10

    Administrative practice and procedure, News media.

21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

21 CFR Part 20

    Confidential business information, Courts, Freedom of information, 
Government employees.

21 CFR Part 314

    Administrative practice and procedure, Confidential business 
information, Drugs, Reporting and recordkeeping requirements.

21 CFR Part 720

    Confidential business information, Cosmetics.

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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:

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

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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.

[[Page 25285]]

Sec.  10.20  [Amended]

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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 ``Sec.  20.46'' and by adding in its place 
``Sec.  20.48''.

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

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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.


Sec.  14.61  [Amended]

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4. Section 14.61 Transcripts of advisory committee meetings is amended 
in paragraph (d) by removing ``Sec.  20.42'' and by adding in its place 
``Sec.  20.45'' and by removing ``Sec.  20.51'' and by adding in its 
place ``Sec.  20.53''.

PART 20--PUBLIC INFORMATION

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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.


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6. Section 20.20 is amended by adding paragraph (e) to read as follows:


Sec.  20.20  Policy on disclosure of Food and Drug Administration 
records.

* * * * *
    (e) ``Record'' and any other term used in this section in reference 
to information includes any information that would be an agency record 
subject to the requirements of this part when maintained by the agency 
in any format, including an electronic format.

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7. Section 20.22 is amended by redesignating the existing paragraph as 
paragraph (a) and by adding paragraph (b) to read as follows:


Sec.  20.22  Partial disclosure of records.

    (a) * * *
    (b)(1) Whenever information is deleted from a record that contains 
both disclosable and nondisclosable information, the amount of 
information deleted shall be indicated on the portion of the record 
that is made available, unless including that indication would harm an 
interest protected by an exemption under the Freedom of Information 
Act.
    (2) When technically feasible, the amount of information deleted 
shall be indicated at the place in the record where the deletion is 
made.

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8. Section 20.26 is amended by adding paragraph (a)(4) and by revising 
paragraph (b) to read as follows:


Sec.  20.26  Indexes of certain records.

    (a) * * *
    (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 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.


Sec.  20.27  [Amended]

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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 Sec.  20.44,''


Sec.  20.28  [Amended]

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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 Sec.  20.44''.


Sec.  20.29  [Amended]

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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 Sec.  20.44 for presubmission 
review of records, no'' from the first sentence and by adding in its 
place the word ``No''.

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12. Subpart B is amended by adding Sec. Sec.  20.33 and 20.34 to read 
as follows:


Sec.  20.33  Form or format of response.

    (a) The Food and Drug Administration shall make reasonable efforts 
to provide a record in any requested form or format if the record is 
readily reproducible 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 agency may notify the 
requester of alternative forms and formats that are available. If the 
requester does not express a preference for an alternative in response 
to such notification, the agency may provide its response in the form 
and format of the agency's choice.


Sec.  20.34  Search for records.

    (a) In responding to a request for records, the Food and Drug 
Administration shall make reasonable efforts to search for records kept 
in electronic form or format, except when such efforts would 
significantly interfere with the operation of the agency's automated 
information systems.
    (b) The term ``search'' means to review, manually or by automated 
means, agency records for the purpose of locating those records that 
are responsive to the request.

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13. Section 20.40 is amended by revising paragraph (a) to read as 
follows:


Sec.  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.
* * * * *

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14. Section 20.41 is amended by revising the introductory text of 
paragraph (b) and paragraph (b)(3), in paragraph (b)(2) by removing 
``Sec.  20.45'' and by adding in its place ``Sec.  20.47'', and by 
adding paragraph (c) to read as follows:


Sec.  20.41  Time limitations.

* * * * *
    (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.
    (A) The agency may provide for an extension of up to 10 working 
days by providing written notice to the requester setting out the 
reasons for the extension and the date by which a determination 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 requester setting out the 
reasons for the extension. The notice also will give the requester an 
opportunity to limit the

[[Page 25286]]

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, collect, and appropriately 
examine a voluminous amount of separate and distinct records that are 
demanded in a single request; or
    (C) There is need for consultation, which shall be conducted with 
all practicable speed, with another agency having a substantial 
interest in the determination of the request, or among two or more 
components of the Food and Drug Administration having substantial 
subject-matter interest in the determination.
* * * * *
    (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 Sec.  
20.44(b).

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15. Sections 20.45 through 20.53 are redesignated as Sec. Sec.  20.47 
through 20.55, Sec. Sec.  20.42 and 20.43 are redesignated as 
Sec. Sec.  20.45 and 20.46, new Sec. Sec.  20.42 and 20.43 are added, 
and Sec.  20.44 is revised, to read as follows:


Sec.  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 Sec.  
20.41(b)(3)(ii)(B). FDA may extend the time for processing aggregated 
requests in accordance with the unusual circumstances provisions of 
Sec.  20.41.


Sec.  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 Sec.  20.44.
    (b) If multitrack processing is not adopted by a particular agency 
component, 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 determine how many 
tracks to establish and the specific criteria for assigning requests to 
each track. Multiple tracks may be established for requests based on 
the amount of work and/or time required 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 requester may be provided an opportunity to limit the scope of the 
request in order to qualify for faster processing.


Sec.  20.44  Expedited processing.

    (a) The Food and Drug Administration will provide expedited 
processing of a request for records when the requester demonstrates a 
compelling need, or in other cases as determined by the agency. A 
compelling need exists when:
    (1) A failure to obtain requested records on an expedited basis 
could reasonably be expected to pose an imminent threat to the life or 
physical safety of an individual; or
    (2) With respect to a request made by a person primarily engaged in 
disseminating information, there is a demonstrated 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 section must be made by the specific individual who is subject 
to an imminent threat, or by a family member, medical or health care 
professional, or other authorized representative of the individual, and 
must demonstrate a reasonable basis for concluding that failure to 
obtain the requested records on an expedited basis could reasonably be 
expected to pose a specific and identifiable imminent threat to the 
life or safety of the individual.
    (c) A request for expedited processing made under paragraph (a)(2) 
of this section must demonstrate that:
    (1) The requester is primarily engaged in disseminating information 
to the general public and not merely to a narrow interest group;
    (2) There is an urgent need for the requested 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 qualify as an urgent need, nor does a request 
for historical information; and
    (3) The request for records specifically concerns identifiable 
operations or activities of the Federal Government.
    (d) All requests for expedited processing shall be filed in writing 
as provided by Sec.  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.
    (f) If the agency grants a request for expedited processing, the 
agency shall process the request as soon as practicable.
    (g) If the agency denies a request for expedited processing, the 
agency shall process the request with other nonexpedited requests.
    (h) If the agency denies a request for expedited processing, the 
requester may appeal the agency's decision by writing to the official 
identified in the denial letter.

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16. Newly redesignated Sec.  20.45 is amended in paragraph (a) 
introductory text by removing ``Sec.  20.43'' and by adding in its 
place ``Sec.  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:


Sec.  20.45  Fees to be charged.

* * * * *
    (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.
* * * * *
    (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

[[Page 25287]]

not permit the requester to directly pay or be directly charged for the 
service.
* * * * *

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17. Newly redesignated Sec.  20.46 is amended by revising the 
introductory text of paragraph (a) to read as follows:


Sec.  20.46  Waiver or reduction of fees.

    (a) Standard. The Assistant Commissioner for Public Affairs (or 
delegatee) will waive or reduce the fees that would otherwise be 
charged if disclosure of the information meets both of the following 
tests:
* * * * *


Sec.  20.48  [Amended]

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18. Newly redesignated Sec.  20.48 Judicial review of proposed 
disclosure is amended by removing ``Sec.  20.45'' and by adding in its 
place ``Sec.  20.47''.

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19. Newly redesignated Sec.  20.49 is amended by revising paragraphs 
(a) and (c) to read as follows:


Sec.  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).
* * * * *
    (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 agency 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 provided in terms of 
the approximate number of pages or some other reasonable measure. This 
estimate will not be provided if the volume of records denied is 
otherwise indicated through deletions on records disclosed in part.
* * * * *


Sec.  20.53  [Amended]

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20. Newly redesignated Sec.  20.53 is amended by removing ``Sec.  
20.42'' and by adding in its place ``Sec.  20.45''.


Sec.  20.81  [Amended]

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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).


Sec.  20.83  [Amended]

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22. Section 20.83Disclosure 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 Sec.  
20.44''.

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23. Section 20.107 is amended by revising paragraph (a) to read as 
follows:


Sec.  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.
* * * * *


Sec.  20.111  [Amended]

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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 Sec.  20.44'' and in paragraph (c)(4) by removing the 
last sentence.

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25. Section 20.120 is added to subpart F to read as follows:


Sec.  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:
    (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 member 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 subsequent requests for substantially the same records;
    (4) Indexes of records maintained in the Freedom of Information 
Staff's Public Reading Room; and
    (5) Such other records and information as the agency determines are 
appropriate for inclusion in the public reading room.
    (c) The following records are available in the Dockets Management 
Branch's Public Reading Room:
    (1) Final opinions, including concurring and dissenting opinions, 
as well as orders, made in the adjudication of cases;
    (2) Statements of policy and interpretation adopted by the agency 
that are still in force and not published in the Federal Register;
    (3) Indexes of records maintained in the Dockets Management 
Branch's Public Reading Room; and
    (4) Such other records and information as the agency determines are 
appropriate 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 November 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 available through the 
Internet such additional records and information it believes will be 
useful to the public.

PART 314--APPLICATION FOR FDA APPROVAL TO MARKET A NEW DRUG

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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.


Sec.  314.65  [Amended]

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27. Section 314.65Withdrawal by the applicant of an unapproved 
application is amended by removing ``Sec.  20.42'' and by adding in its 
place ``Sec.  20.45''.


Sec.  314.72  [Amended]

0
28. Section 314.72 Change in ownership of an applicationis amended in 
paragraph (a)(2)(iii) by removing ``Sec.  20.42'' and by adding in its 
place ``Sec.  20.45''.

PART 720--VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT 
COMPOSITION STATEMENTS

0
29. The authority citation for 21 CFR part 720 continues to read as 
follows:


[[Page 25288]]


    Authority: 21 U.S.C. 321, 331, 361, 362, 371, 374.


Sec.  720.8  [Amended]

0
30. Section 720.8 Confidentiality of statements is amended by removing 
from the second sentence of paragraph (a) the phrase ``and in Sec.  
20.44 of this chapter''.

    Dated: May 3, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-11647 Filed 5-9-03; 8:45 am]
BILLING CODE 4160-01-S