[Federal Register Volume 64, Number 213 (Thursday, November 4, 1999)]
[Proposed Rules]
[Pages 60143-60149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28857]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 20

[Docket No. 99N-2637]


Public Information Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its public information regulations to comply with the requirements of 
the Electronic Freedom of Information Act 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: Written comments by February 2, 2000.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Betty B. Dorsey, Freedom of 
Information Staff (HFI-35), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-6567.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 2, 1996, the President signed into law the EFOIA (Public 
Law 104-231). 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 a 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 and the establishment of ``electronic reading rooms,'' as well as 
provisions requiring agencies to inform requesters about the amount of 
information not being released to them. FDA is proposing to amend its 
Public Information Regulations (part 20 (21 CFR part 20)) to implement 
EFOIA and

[[Page 60144]]

to clarify and update certain provisions unrelated to EFOIA.

II. Proposed New and Revised Provisions

A. Proposed Changes to FDA's Public Information Regulations to 
Implement EFOIA

    The proposed rule would make the following changes to FDA's Public 
Information Regulations to implement EFOIA:
1. Definitions
    New definitions will be added for the following terms:
    a. ``Record''--section 3 of EFOIA amends 5 U.S.C. 552(f) to define 
``record'' for purposes of FOIA as including any information that would 
be an agency record subject to the requirements of 5 U.S.C. 552 (FOIA) 
when maintained by an agency in any format, including an electronic 
format. Section 20.20 will be revised to incorporate this definition.
    b. ``Search''--section 5 of EFOIA amends 5 U.S.C. 552(a)(3) to 
clarify that when an FOIA request is received, an agency should not 
only search for hard copies, but should also make reasonable efforts to 
search for records in their electronic form or format, except when such 
efforts would significantly interfere with the operation of the 
agency's automated information systems. This provision will be 
implemented at Sec. 20.34.
2. Information Provided When the Agency Makes a Denial or Partial 
Disclosure
    The amendments (5 U.S.C. 552(a)(6)(F)), require agencies to make a 
reasonable effort to estimate the volume of any records that are denied 
either in whole or in part, and to provide the estimate to the 
requester, unless providing such an estimate would harm an interest 
protected by an FOIA exemption. FDA will provide an estimate of the 
volume of records denied if the volume is not otherwise indicated 
through deletions on records disclosed in part. Such estimates will be 
provided in terms of number of pages or some other reasonable measure. 
FDA will implement this new requirement at Sec. 20.49(c).
    Additionally, EFOIA amends 5 U.S.C. 552(b) by adding the 
requirement that when an agency withholds only a portion of a record, 
the agency shall indicate the amount of information deleted on the 
released portion of the record to the extent possible, except where 
doing so would harm an interest protected by an FOIA exemption. If 
technically feasible, FDA will indicate the amount of information 
deleted at the place in the record where the deletion is made.
    The purpose of this deletion specification requirement is to make 
it readily apparent to a requester that a deletion has been made. When 
possible, the extent of the deletion will ordinarily be indicated 
through the use of some self-evident means. For example, a deletion may 
be shown by physically obscuring or removing the nondisclosable 
information by covering the text or figure with opaque marker or dark 
colored editing tape, cutting out a portion of a microfiche, or by 
describing in writing the extent of the deletion (e.g., ``pages 3 
through 7 are not disclosable''). In those cases in which a record is 
provided on disk, tape, or in some other electronic form, deletions may 
also be indicated by using special characters or other indicators. This 
requirement will be implemented at Sec. 20.22(b).
3. Electronic Reading Room Information and Indexes
    Section 4 of EFOIA amends 5 U.S.C. 552(a)(2) which requires 
agencies to make available for public inspection and copying certain 
information, such as final agency opinions and orders, certain 
statements of policy and interpretations, and administrative staff 
manuals and instructions that affect a member of the public. EFOIA (5 
U.S.C. 552(a)(2)(D)) adds a new category of records that agencies must 
make available in their public reading rooms. This new category 
consists of copies of records which have been released to any person 
under FOIA and which, because of their subject matter, the agency 
determines have become or are likely to become the subject of 
subsequent requests for substantially the same records. (Examples of 
such records at FDA might include warning letters and product approval 
packages.) EFOIA further requires agencies to make available for public 
inspection and copying a general index of frequently requested records. 
In addition, EFOIA requires agencies to make available by ``computer 
telecommunications'' (or by other electronic means, if computer 
telecommunications means have not been established) all reading room 
records that were created on or after November 1, 1996, as well as the 
general index of frequently requested records. FDA will implement these 
EFOIA requirements at Secs. 20.26(a)(4) and 20.120. In addition, at its 
discretion, the agency may also make available other records and 
information that EFOIA does not require to be made available on the 
agency's website but which may be useful to the public. FDA's 
electronic FOI reading room can be accessed on the Internet through the 
World Wide Web at http://www.fda.gov.
4. Form or Format of FDA's Response
    Section 5 of EFOIA amends 5 U.S.C. 552(a)(3) by adding the 
requirement for agencies making records available under FOIA to do so 
``in the form or format requested by the person if the record is 
readily reproducible by the agency'' in the requested form or format. 
``Form'' refers to the medium in which the record will be provided, 
such as paper, microfiche, floppy diskette, CD-ROM, or tape. ``Format'' 
refers to the particular manner of storing or presenting a record 
within a given medium, such as a particular computer program used to 
generate the record. Examples would include word processing, 
spreadsheet, data base or graphics programs and the specific software 
used.
    When converting a record from one form or format to another, the 
agency will not be required to make special efforts to ensure that the 
physical appearance of the record is preserved. This means that in some 
cases, such as when the document contains tables, the appearance of the 
converted record may vary from the original. If the agency is unable to 
accommodate a particular request, the requester may be given an 
opportunity to choose from available alternative forms or formats. If 
the requester does not express a preference for an alternative form or 
format, the agency may choose the form or format in which the records 
will be provided.
    FDA's FOIA operations are decentralized and each component office 
is responsible for responding to FOIA requests for the materials 
maintained by that office. These component offices 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 agency component responding 
to an FOIA request may not have the means to provide records in all 
requested forms and formats. Agency components are not required to 
purchase special equipment or software to accommodate a request for a 
particular form or format, and are not required to send records to 
another component to accommodate an FOIA request. The agency 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. FDA will implement EFOIA's form and format requirement 
at Sec. 20.33.

[[Page 60145]]

5. Search for Records
    Section 5 of EFOIA amends 5 U.S.C. 552(a)(3) to clarify that when 
an FOIA request is received, an agency should not only search for hard 
copies, but should also 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. Under Sec. 20.34, the agency makes clear that 
searches for records include and extend to records maintained in an 
electronic form or format. FDA has included such records in its 
searches under FOIA for many years, so this provision simply clarifies 
and formalizes existing practice. The agency will not search for 
electronic records when to do so would significantly interfere with the 
operation of the agency's automated information systems. Decisions 
about when there is significant interference will be made on a case-by-
case basis.
6. Time Limits for Responding to Requests
    EFOIA amends 5 U.S.C. 552(a)(6)(A)(i) by increasing the time to 
respond to an FOIA request from 10 to 20 working days. Section 20.41(b) 
will be revised to reflect this change.
7. Unusual Circumstances
    FOIA (5 U.S.C. 552(a)(6)(B)), permits agencies to extend the 
initial time limit for responding in ``unusual circumstances.'' FOIA 
specifies various reasons for such an extension. These reasons include 
the need to search for and collect records from field facilities or 
other components that are separate from the office processing the 
request; the need to search for, collect, and appropriately examine a 
voluminous amount of separate and distinct records which are demanded 
in a single request; and the need for consultation among two or more 
components of FDA, or with another Federal agency having a substantial 
interest in the determination of the request. In unusual circumstances, 
the agency may extend the time for informing a requester, by written 
notice, of the agency's determination of the extent to which the agency 
will comply with or deny an FOIA request for an additional period 
beyond the normal 20 days. The agency may extend the time for a 
response by up to an additional 10 days by providing a written notice 
to the requester. If the agency is unable to comply within the 
additional 10 days, the agency may further extend the time for a 
response by notifying the requester and providing the requester an 
opportunity to limit the scope of the request so that it can be 
processed in a shorter time, and/or an opportunity to agree to an 
alternative timeframe for processing the request. In the event there is 
a legal dispute concerning a request, section 6(c)(iii) of EFOIA 
requires the court to take into account a requester's failure to modify 
the request or arrange for an alternative timeframe when determining 
whether ``exceptional circumstances'' exist. When exceptional 
circumstances exist, the court may allow the agency additional time to 
complete its processing of the request. FDA will implement this 
provision at Sec. 20.41(b)(3).
8. Aggregation of Certain Requests
    Section 7 of EFOIA provides at 5 U.S.C. 552(a)(6)(B)(iv) that 
agencies may issue regulations allowing for the aggregation of certain 
FOIA requests by the same requester or by a group of requesters acting 
together, if the agency reasonably believes that such requests actually 
constitute a single request, which would otherwise satisfy the unusual 
circumstances that could justify an extension of the response time. FDA 
has decided to issue such a regulation and will do so at Sec. 20.42.
9. Multitrack Processing
    Section 7 of EFOIA (5 U.S.C. 552(a)(6)(D)(i)) authorizes agencies 
that experience difficulties in meeting FOIA's time limits to issue 
regulations providing for multitrack processing of FOIA requests rather 
than processing them on a first-in, first-out basis. 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 
purpose of multitrack processing is to promote faster and more 
efficient processing of FOIA requests.
    As amended, FDA regulations would permit, but not require, each FDA 
component to establish a multitrack processing system for responding to 
FOIA requests. Because FDA has a decentralized system for processing 
FOIA requests, the agency will allow each of its component offices to 
make its own decision on whether to use a multitrack processing system 
or single track processing system. The nature and volume of FOIA 
requests received and the types of records maintained can differ 
greatly from one FDA component to another. If a component does choose 
multitrack processing, that component may determine how many tracks to 
establish and the specific criteria for assigning requests to each 
track. Requests assigned to a given track generally will be processed 
on a first-in, first-out basis within that track. Although requests 
assigned to a faster track will ordinarily have a faster response time 
than requests assigned to other tracks, the agency will exercise due 
diligence in processing all requests, regardless of track. The 
requester may be provided an opportunity to limit the scope of the 
request in order to qualify for a faster processing track. If a 
component chooses not to establish multitrack processing, it ordinarily 
will use a first-in, first-out single track processing system. This 
provision will be implemented at Sec. 20.43.
    10. Expedited Processing
    Section 8 of EFOIA (5 U.S.C. 552(a)(6)(E)) requires agencies to 
issue regulations 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 
amendments define ``compelling need'' in two ways. One way is where 
``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.'' The other way is ``with respect to 
a request made by a person primarily engaged in disseminating 
information, [there is an] urgency to inform the public concerning 
actual or alleged Federal Government activity.'' If a requester 
demonstrates a compelling need, FDA will process the request out of 
turn and give it expedited treatment. Granting a request for expedited 
processing does not constitute a promise to meet any particular 
deadline for responding. Rather, requests that qualify for expedited 
processing will be processed ``as soon as practicable.''
    Where records are required to avoid an imminent threat to the life 
or physical safety of an individual, the request for expedited 
processing must be made by the individual whose life or safety is 
threatened, or by an authorized representative of that individual. 
Where records are required due to an urgency to inform the public 
concerning actual or alleged Federal Government activity, the requester 
must be primarily engaged in disseminating information to the general 
public and not merely to a narrow interest group. General circulation 
newspapers and magazines, and radio and television stations are 
examples of media that are primarily engaged in disseminating 
information to the general public. In addition, the requested records 
should pertain to a matter of current exigency to the public and must 
have a value that will be lost if not obtained and disseminated

[[Page 60146]]

quickly. A routine publication or broadcast deadline alone shall not 
constitute urgency.
    Requests for expedited processing must be accompanied by 
appropriate documentation, including the requester's certification that 
the information provided in the request is true and correct to best of 
the requester's knowledge and belief. A requester who knowingly 
provides false information in support of a request for expedited 
processing will be subject to criminal penalties under 18 U.S.C. 1001, 
the False Reports to the Government Act.
    Within 10 days of receipt by FDA's Freedom of Information Staff 
(FOI Staff) of a request for expedited processing and all documentation 
needed to make a decision on the request, the agency will determine 
whether to provide expedited processing. The agency will exercise its 
discretion with fairness and diligence in making a determination about 
whether to provide expedited processing, giving appropriate 
consideration to limited resources available to FDA for fulfilling FOIA 
requests. If the agency denies a request for expedited processing, it 
will process the request for records with other nonexpedited requests. 
A requester may appeal FDA's decision to deny expedited processing by 
writing to the official identified in the denial letter. This new 
requirement will be implemented at Secs. 20.41(c) and 20.44.

B. Proposed Changes to FDA's Public Information Regulations Unrelated 
to EFOIA

    The proposed rule would make the following changes to FDA's public 
information regulations unrelated to EFOIA:
1. Filing a Request for Records
    Section 20.40(a) is being revised to clarify the agency's existing 
practice of accepting requests submitted to the FOI Staff via facsimile 
as well as via mail.
2. Revocation of Presubmission Review
    The agency proposes to revise Sec. 20.44 concerning presubmission 
review. This provision allows any person who is considering submission 
of data or information voluntarily to FDA to request a presubmission 
review of records involved to determine whether FDA will or will not 
make part or all of the records available for public disclosure upon 
request if they are submitted. The FOIA does not require this 
provision, and the agency has found that presubmission review has not 
met the underlying policy objective of encouraging the submission to 
the agency of information bearing on important public health and safety 
concerns. The provision has fallen into disuse and only rarely has been 
invoked in the past several years. In addition, the validity of this 
provision has been questioned by a Federal District Court in the case 
Teich v. Food and Drug Admin., 751 F. Supp. 243 (D.D.C. 1990).
3. Fees to be Charged
    Section 20.45 (formerly Sec. 20.42) is being revised to reflect the 
fact that FDA's fee schedule is in accordance with the fee schedule of 
the Department of Health and Human Services (DHHS). Section 20.45(c)(6) 
of the proposed rule would require a requester who wishes to use a 
courier service for delivery of the agency's response to a request to 
directly pay, or be directly charged by, the courier service.
4. Records Available in FDA's Public Reading Rooms
    Section 20.120 provides the locations and hours of operation of the 
agency's public reading rooms and outlines the types of records that 
are available there. This provision essentially summarizes existing 
agency practice for the convenience of the public.
5. Denial of a Request for Records and Waiver or Reduction of Fees
    Sections 20.46 and 20.49 (formerly Secs. 20.43 and 20.47) are being 
revised to indicate that the Associate Commissioner for Public Affairs 
may delegate his or her authority to deny a request for FDA records or 
to waive or reduce FOIA fees. FDA is proposing this change to increase 
the efficiency of its FOIA operations and to make its regulations 
consistent with DHHS' FOIA regulations at 45 CFR part 5. Section 
20.49(c) is also being revised in accordance with current DHHS 
procedures to indicate that appeals of FDA denials are to be sent to 
the Deputy Assistant Secretary for Public Affairs (Media), DHHS.

III. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(8) 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 (21 CFR 25.23(a)).

IV. Economic Impact and Regulatory Flexibility Act

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, under the Regulatory Flexibility Act (5 U.S.C. 601-612), 
and under 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). Unless an agency 
certifies that a rule will not have a significant economic impact on a 
substantial number of small entities, the Regulatory Flexibility Act 
requires an analysis of regulatory options that would minimize any 
significant impact of a rule on small entities. The Unfunded Mandates 
Reform Act requires that agencies prepare an assessment of anticipated 
costs and benefits before proposing any rule that may result in an 
annual expenditure by State, local, and tribal governments, in the 
aggregate, or by the private sector, of $100 million (adjusted annually 
for inflation).
    The agency believes that this proposed rule is consistent with the 
regulatory philosophy and principles identified in the Executive Order. 
In this proposal, the agency is amending its FOIA regulations to 
reflect the statutory changes made by the EFOIA. The amendments allow 
greater flexibility to the requesters of information by providing 
electronic access to information and provide the agency with greater 
flexibility in providing the requested information through the use of 
electronic dissemination. The agency is required to make certain 
records available over the Internet to enable greater public access to 
this information. The agency is also permitted to adopt multitrack 
processing systems as a means of decreasing the overall processing time 
for requests. FDA is updating its record searching and retrieval fees 
in accordance with the most recent Federal pay increase. Despite the 
insignificant cost increase for those requesting information, the 
public will receive the benefits of greater flexibility in making 
requests, increased access to public information, and in certain cases, 
a faster agency response.
    This rule is not a significant regulatory action as defined by the 
Executive Order, and is not subject to review under the Executive 
Order. This rule does not impose any mandates on State, local, or 
tribal governments, nor is it a significant regulatory action under the 
Unfunded Mandates Reform Act. Furthermore, the agency certifies that 
this rule will not have a significant economic impact on a substantial 
number of small entities. Therefore,

[[Page 60147]]

under the Regulatory Flexibility Act, no further regulatory flexibility 
analysis is required.

V. Paperwork Reduction Act

     The agency has determined that this rule does not impose any 
reporting or recordkeeping requirements under the Paperwork Reduction 
Act of 1995.

VI. Request for Comments

    Interested persons may, on or before February 2, 2000, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposed rule. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 20

    Confidential business information, Courts, Freedom of information, 
Government employees.
    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, it is 
proposed that 21 CFR part 20 be amended as follows:

PART 20--PUBLIC INFORMATION

    1. 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, 242l, 242n, 
243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.

    2. 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.
    3. Section 20.22 is amended by redesignating the existing paragraph 
as paragraph (a) and by adding new 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.
    4. Section 20.26 is amended by adding new paragraph (a)(4) and by 
revising paragraph (b) to read as follows:


Sec. 20.26  Indexes of certain records.

    (a) * * *
    (4) 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.
    (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 located in 
rm. 12A-30 at the same address.
    5. Subpart B is amended by adding Secs. 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.
    6. 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, 5600 Fishers 
Lane, rm. 12A-16, 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.
* * * * *
    7. Section 20.41 is amended by revising the introductory text of 
paragraph (b) and paragraph (b)(3), and by adding new 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 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

[[Page 60148]]

distinct records which are demanded in a single request; or
    (C) There is a 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).
    8. Sections 20.45 through 20.53 are redesignated as Secs. 20.47 
through 20.55; Secs. 20.42 and 20.43 are redesignated as Secs. 20.45 
and 20.46; new Secs. 20.42 and 20.43 are added; and newly redesignated 
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 Associate 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.
    9. Newly redesignated Sec. 20.45 is amended 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 not permit the requester to directly pay or be directly charged 
for the service.
 * * * * *
    10. 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 Associate 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:
* * * * *

[[Page 60149]]

    11. 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 Associate 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.
* * * * *
    12. 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, 5600 Fishers Lane, rm. 12A-16, 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.
* * * * *
    13. 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 at 5600 Fishers Lane, rm. 12A-30, Rockville, MD 20857; the 
phone number is 301-827-6500. The Dockets Management Branch's public 
reading room is located at 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852; 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 as it believes will be 
useful to the public.

    Dated: September 17, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-28857 Filed 11-3-99; 8:45 am]
BILLING CODE 4160-01-F