[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
