Public Information Regulations

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

nformation 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

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

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'')

rdinarily 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, 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

quired 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.

ftware 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.

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

ing 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

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

em 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

is

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

ic 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

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

y 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)

t 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

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

diture 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,

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

ule will not have a significant economic impact on a substantial

number of small entities. Therefore,

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.

* * * * *

r 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.

n 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.

ency 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.

* * * * *

) 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

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.

* * * * *

ent 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.

eed 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.

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.

* * * * *

y 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:

* * * * *

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).

* * * * *

erwise be

charged if disclosure of the information meets both of the following

tests:

* * * * *

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:

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.

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