[Federal Register Volume 59, Number 3 (Wednesday, January 5, 1994)]
[Rules and Regulations]
[Pages 531-536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-98]


[[Page Unknown]]

[Federal Register: January 5, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 20

[Docket No. 92N-0244]

 

Freedom of Information Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its public 
information regulations to reflect changes already adopted by the 
agency as a result of the 1986 amendments to the Freedom of Information 
Act (the FOIA), executive branch directives, and judicial standards 
governing disclosure of agency records under the FOIA. In practice, FDA 
modified its policies and procedures to comply with these changes as 
they became effective. The regulations are being updated to reflect 
these changes. The agency is also adding clarifying language to certain 
of its public information regulations and making technical changes 
necessary to update citations and cross-references.

DATES: Effective January 5, 1994. Written comments by March 7, 1994. As 
provided in Sec. 10.40(e) (21 CFR 10.40(e)), FDA is providing an 
opportunity for public comment on whether the regulations should 
subsequently be modified or revoked.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Gerald H. Deighton, Freedom of 
Information Staff (HFI-30), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-443-6310.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's practice and policy under the FOIA have undergone a number of 
changes as a result of legislation, executive directives, and judicial 
precedents over the past years. FDA modified and updated its practices 
and policies to comply with these changes as they became effective. FDA 
is now formally amending its public information regulations to reflect 
changes that were required by law and which have already been put into 
effect. Specifically, FDA is updating its public information 
regulations to reflect provisions of the Omnibus Budget Reconciliation 
Act of 1990 (Pub. L. 101-508), the Freedom of Information Reform Act of 
1986 (Pub. L. 99-570), Executive Order 12600 (June 23, 1987) 
establishing predisclosure notification procedures, guidelines 
promulgated by the Office of Management and Budget (OMB) (52 FR 10012 
at 10018, March 27, 1987), the revised Department of Health and Human 
Services (DHHS) regulations at 45 CFR part 5, and the widely adopted 
District of Columbia (D.C.) Circuit Court of Appeals opinion in Public 
Citizen Health Research Group v. FDA, 704 F.2d 1280 (D.C. Cir. 1983). 
The agency is also adding language to Secs. 20.53 and 20.85 (21 CFR 
20.53 and 20.83) in order to clarify particular aspects of those 
regulations that have been the subject of some confusion. In addition, 
FDA is making technical revisions to certain public information 
regulations to update citations to cross-references that have changed 
since the last revision of part 20 (21 CFR part 20).

II. Procedural Amendments

A. Investigatory Records Compiled for Law Enforcement Purposes

    The language of Sec. 20.64, regarding records compiled for law 
enforcement purposes, is being changed to conform to the 1986 
amendments to the FOIA, which broadened the FOIA exemption 5 U.S.C. 
552(b)(7) that protects certain law enforcement records from mandatory 
public disclosure.

B. Disclosure to Congress

    Section 20.87 is being revised to reflect the provision of the 
Omnibus Budget Reconciliation Act of 1990 that removed the statutory 
barrier that previously prohibited FDA from disclosing certain trade 
secret information to Congress, (Pub. L. 101-508). Section 4755(c)(2) 
of the Omnibus Budget Reconciliation Act of 1990 amended section 301(j) 
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
331(j)) in order to permit FDA to disclose to Congress certain trade 
secret information that is otherwise prohibited from disclosure except 
to employees of DHHS or to the courts in relevant judicial proceedings. 
Such disclosures to Congress may only be pursuant to a request from the 
Senate, the House of Representatives, any committee or subcommittee 
with jurisdiction over the matter being investigated, or any joint 
committee of Congress or any subcommittee of such joint committee.

C. Trade Secret and Confidential Commercial Information

    Executive Order 12600, issued June 23, 1987, requires Federal 
agencies to establish predisclosure notification procedures in certain 
circumstances before releasing commercial information submitted by 
businesses. FDA has complied with the terms of the Executive Order 
since it became effective, and has followed the procedures adopted by 
DHHS in the regulations published in the Federal Register of November 
25, 1988 (53 FR 47697). To clarify these practices and for the 
convenience of the public, FDA is incorporating DHHS' regulations 
concerning predisclosure notification into FDA's regulations governing 
the disclosure of trade secret and confidential commercial information 
at Sec. 20.61. Accordingly, the standards and procedures promulgated by 
DHHS at 45 CFR 5.65(c), (d), and (e) are being added to FDA's public 
information regulations in Sec. 20.61(d), (e), and (f).
    Section 20.61 also is being amended to reflect the narrow 
definition of ``trade secret'' that was adopted by the D.C. Circuit 
Court of Appeals in Public Citizen Health Research Group v. FDA, 704 
F.2d 1280, 1288 (D.C. Cir. 1983). That definition requires a direct 
relationship between the information being protected and the productive 
process. The definition adopted by the D.C. Circuit in that case has 
become the most widely adopted judicial test for defining trade secret 
information under the FOIA and is already codified in the DHHS FOIA 
regulations at 45 CFR 5.65(a). This amendment to Sec. 20.61 will not 
affect agency practice because FDA has distinguished between trade 
secret and confidential commercial information in accordance with the 
definition in the Public Citizen Health Research Group v. FDA case 
since that case was decided.

D. Fees and Fee Waivers

    Sections 20.42 and 20.43 are being amended to reflect changes 
required by the 1986 amendments to the FOIA concerning fees and fee 
waivers and the OMB guidelines promulgated to implement those changes. 
FDA is adopting the standards and procedures promulgated by DHHS at 45 
CFR 5.41 through 5.45, except that 45 CFR 5.42(g) is excluded from 
Sec. 20.42 because 45 CFR 5.42(g) pertains only to the Social Security 
Administration. In general, the regulations being adopted codify the 
descriptions of categories of requesters, the new fee structure and fee 
limitations, and the revised standards for fee waivers or reductions 
established by the 1986 amendments to the FOIA.
    Section 20.41 is being amended to remove the paragraphs that refer 
to $25 as the amount that triggers a requirement for prepayment of FOIA 
fees. The guidelines promulgated by OMB and the DHHS regulations 
include an advance payment provision for fees that exceed $250. That 
requirement is being included in revised Sec. 20.42.

III. Clarifications

A. Indexing Trade Secrets and Confidential Commercial or Financial 
Information

    A recent report by the General Accounting Office (GAO) criticized 
FDA's regulation concerning Sec. 20.53 Indexing trade secrets and 
confidential or financial information. GAO believed that it would be an 
abrogation of the agency's responsibilities to disclose information in 
those circumstances when a submitter failed to intervene to defend 
against the release of its records. The report hypothesized 
circumstances in which a firm could suffer severe financial loss 
because it could not afford legal representation to defend the 
competitive value of its commercial information.
    Although the regulation has been in effect for almost two decades, 
such a situation has never materialized. The agency continues to 
believe that the burden of defending business related records should be 
borne by the owner and submitter of such information, who is in the 
best position to explain the competitive harm that may result from 
disclosure. A company's unwillingness to take steps to protect the 
information it has submitted to the agency and to index the records at 
issue is ordinarily evidence to FDA that disclosure of the information 
is not likely to cause the submitter substantial competitive harm.
    However, the agency has never and would not at any time abandon its 
responsibilities to protect information that is truly prohibited from 
release. Although the situation has never previously arisen, there may 
be exceptional circumstances that would make it unreasonable for FDA to 
expect a submitter to participate as an intervenor in defending the 
proprietary value of its records. Accordingly, the language of the 
regulation is being amended to clarify that a company's failure to 
intervene to defend the exempt status of its information and to itemize 
and index the disputed records is not treated as an automatic waiver of 
the submitter's interest in protection of the information.

B. Disclosure to Other Federal Agencies

    A 1991 contract report ``FDA Safeguards Against Improper Disclosure 
of Financially Sensitive Information,'' which was undertaken as part of 
the FDA Commissioner's integrity initiative, recommended that FDA 
obtain written pledges of confidentiality when it provides nonpublic 
information to other Federal agencies, such as the Securities Exchange 
Commission (SEC), as part of cooperative law enforcement efforts. FDA's 
regulations governing the disclosure of information to other Federal 
agencies, Sec. 20.85, is intended to require written commitments of 
confidentiality, and staff manual guides and internal agency guidance 
have consistently instructed personnel to obtain such written 
commitments. However, because the 1991 report named above suggested 
some confusion among FDA and other Department and Federal employees, 
FDA is adding the word ``written'' to Sec. 20.85 so that the regulation 
clearly states that such disclosures can only be made pursuant to a 
``written'' agreement.

IV. Technical Changes

    Section 20.100 is being revised to update cross-references that 
have changed because agency regulations have been amended or new 
regulations have been promulgated since the last revision of part 20.
    Because the agency's current practice with respect to disclosure of 
records will not change as a result of any of these amendments, and 
because the amendments set forth in section I. of this document are 
required either by statute, executive branch directives, or judicial 
decisions, FDA finds for good cause under Sec. 10.40(e) that notice and 
public procedure are unnecessary (5 U.S.C. 553(b)(3)(B) and (d)). 
However, under Sec. 10.40(e), FDA is providing an opportunity for 
comment to determine whether the regulations should subsequently be 
modified or revoked.

V. Request for Comments

    Interested persons may, on or before March 7, 1994 submit to the 
Dockets Management Branch (address above) written comments regarding 
this final 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.

VI. 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.

VII. Economic Impact

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act. 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 effects; distributive 
impacts; and equity). The Regulatory Flexibility Act (Pub. L. 96-354) 
requires analyzing options for regulatory relief for small businesses.
    This rule amends the regulations for FDA's practice and policy 
under the FOIA. Because the amendments merely update the regulations to 
reflect procedural changes already adopted by the agency as a result of 
legislation, executive branch directives, or legal precedents, no 
additional impact is anticipated. Accordingly, FDA finds that this 
final rule is not a significant regulatory action as defined by 
Executive Order 12866. In compliance with the Regulatory Flexibility 
Act, the agency certifies that the final rule will not have a 
significant impact on a substantial number of small businesses.

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 the authority delegated to the Commissioner of Food and Drugs, 21 
CFR part 20 is amended as follows:

PART 20--PUBLIC INFORMATION

    1. The authority citation for 21 CFR part 20 continues to read as 
follows:

    Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321-393); secs. 301, 302, 303, 307, 310, 311, 351, 
352, 354-360F, 361, 362, 1701-1706, 2101 of the Public Health 
Service Act (42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 
263b-263n, 264, 265, 300u-300u-5, 300aa-1); 5 U.S.C. 552; 18 U.S.C. 
1905.


Sec. 20.41  [Amended]

    2. Section 20.41 Time limitations is amended by removing paragraphs 
(b)(5), (c), and (d).
    3. Section 20.42 is revised to read as follows:


Sec. 20.42  Fees to be charged.

    (a) Categories of requests. Paragraphs (a)(1) through (3) of this 
section state, for each category of request, the type of fees that the 
Food and Drug Administration will generally charge. However, for each 
of these categories, the fees may be limited, waived, or reduced for 
the reasons given in paragraphs (b) and (c) of this section and in 
Sec. 20.43 or for other reasons.
    (1) Commercial use request. If the request is for a commercial use, 
the Food and Drug Administration will charge for the costs of search, 
review, and duplication.
    (2) Educational and scientific institutions and news media. If the 
request is from an educational institution or a noncommercial 
scientific institution, operated primarily for scholarly or scientific 
research, or a representative of the news media, and the request is not 
for a commercial use, the Food and Drug Administration will charge only 
for the duplication of documents. Also, the Food and Drug 
Administration will not charge the copying costs for the first 100 
pages of duplication.
    (3) Other requests. If the request is not the kind described in 
paragraph (a)(1) or (a)(2) of this section, then the Food and Drug 
Administration will charge only for the search and the duplication. 
Also, the Food and Drug Administration will not charge for the first 2 
hours of search time or for the copying costs of the first 100 pages of 
duplication.
    (b) General provisions. (1) The Food and Drug Administration may 
charge search fees even if the records found are exempt from disclosure 
or if no records are found.
    (2) If, under paragraph (a)(3) of this section, there is no charge 
for the first 2 hours of search time, and those 2 hours are spent on a 
computer search, then the 2 free hours are the first 2 hours of the 
operator's own operation. If the operator spends less than 2 hours on 
the search, the total search fees will be reduced by the average hourly 
rate for the operator's time, multiplied by 2.
    (3) If, under paragraph (a)(2) or (a)(3) of this section, there is 
no charge for the first 100 pages of duplication, then those 100 pages 
are the first 100 pages of photocopies of standard size pages, or the 
first 100 pages of computer printout. If this method to calculate the 
fee reduction cannot be used, then the total duplication fee will be 
reduced by the normal charge for photocopying a standard size page, 
multiplied by 100.
    (4) No charge will be made if the costs of routine collection and 
processing of the fee are likely to equal or exceed the amount of the 
fee.
    (5) If it is determined that a requester (acting either alone or 
together with others) is breaking down a single request into a series 
of requests in order to avoid (or reduce) the fees charged, all these 
requests may be aggregated for purposes of calculating the fees 
charged.
    (6) Interest will be charged on unpaid bills beginning on the 31st 
day following the day the bill was sent. Provisions in 45 CFR part 30, 
the Department of Health and Human Services regulations governing 
claims collection, will be used in assessing interest, administrative 
costs, and penalties, and in taking actions to encourage payment.
    (c) Fee schedule. The Food and Drug Administration charges the 
following fees:
    (1) Manual searching for or reviewing of records. When the search 
or review is performed by employees at grade GS-1 through GS-8, an 
hourly rate based on the salary of a GS-5, step 7, employee; when done 
by a GS-9 through GS-14, an hourly rate based on the salary of a GS-12, 
step 4, employee; and when done by a GS-15 or above, an hourly rate 
based on the salary of a GS-15, step 7, employee. In each case, the 
hourly rate will be computed by taking the current hourly rate for the 
specified grade and step, adding 16 percent of that rate to cover 
benefits, and rounding to the nearest whole dollar. As of January 1, 
1993, these rates were $12, $24, and $43 respectively. When a search 
involves employees at more than one of these levels, the Food and Drug 
Administration will charge the rate appropriate for each.
    (2) Computer searching and printing. The actual cost of operating 
the computer plus charges for the time spent by the operator, at the 
rates given in paragraph (c)(1) of this section.
    (3) Photocopying standard size pages. $0.10 per page. Freedom of 
Information Officers may charge lower fees for particular documents 
where:
    (i) The document has already been printed in large numbers;
    (ii) The program office determines that using existing stock to 
answer this request, and any other anticipated Freedom of Information 
requests, will not interfere with program requirements; and
    (iii) The Freedom of Information Officer determines that the lower 
fee is adequate to recover the prorated share of the original printing 
costs.
    (4) Photocopying odd-size documents (such as punchcards or 
blueprints), or reproducing other records (such as tapes). The actual 
costs of operating the machine, plus the actual cost of the materials 
used, plus charges for the time spent by the operator, at the rates 
given in paragraph (c)(1) of this section.
    (5) Certifying that records are true copies. This service is not 
required by the Freedom of Information Act. If the Food and Drug 
Administration agrees to provide certification, there is a $10 charge 
per certification.
    (6) Sending records by express mail, certified 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, actual costs will be charged.
    (7) Performing any other special service in connection with a 
request to which the Food and Drug Administration has agreed. Actual 
costs of operating any machinery, plus actual cost of any materials 
used, plus charges for the time of the Food and Drug Administration's 
employees, at the rates given in paragraph (c)(1) of this section.
    (d) Procedures for assessing and collecting fees. (1) Agreement to 
pay. The Food and Drug Administration generally assumes that a 
requester is willing to pay the fees charged for services associated 
with the request. The requester may specify a limit on the amount to be 
spent. If it appears that the fees will exceed the limit, the Food and 
Drug Administration will consult the requester to determine whether to 
proceed with the search.
    (2) Advance payment. If a requester has failed to pay previous 
bills in a timely fashion, or if the Food and Drug Administration's 
initial review of the request indicates that the charges will exceed 
$250, the requester will be required to pay past due fees and/or the 
estimated fees, or a deposit, before the search for the requested 
records begins. In such cases, the requester will be notified promptly 
upon receipt of the request, and the administrative time limits 
prescribed in Sec. 20.41 will begin only after there is an agreement 
with the requester over payment of fees, or a decision that fee waiver 
or reduction is appropriate.
    (3) Billing and payment. Ordinarily, the requester will be required 
to pay all fees before the Food and Drug Administration will furnish 
the records. At its discretion, the Food and Drug Administration may 
send the requester a bill along with or following the records. For 
example, the Food and Drug Administration may do this if the requester 
has a history of prompt payment. The Food and Drug Administration may 
also, at its discretion, aggregate the charges for certain time periods 
in order to avoid sending numerous small bills to frequent requesters, 
or to businesses or agents representing requesters. For example, the 
Food and Drug Administration might send a bill to such a requester once 
a month. Fees should be paid in accordance with the instructions 
furnished by the person who responds to the request.
    4. Section 20.43 is revised to read as follows:


Sec. 20.43  Waiver or reduction of fees.

    (a) Standard. The Associate Commissioner for Public Affairs will 
waive or reduce the fees that would otherwise be charged if disclosure 
of the information meets both of the following tests:
    (1) Is in the public interest because it is likely to contribute 
significantly to public understanding of the operations or activities 
of the Government; and
    (2) It is not primarily in the commercial interest of the 
requester. These two tests are explained in paragraphs (b) and (c) of 
this section.
    (b) Public interest. Disclosure of information satisfies the first 
test only if it furthers the specific public interest of being likely 
to contribute significantly to public understanding of Government 
operations or activities, regardless of any other public interest it 
may further. In analyzing this question, the Food and Drug 
Administration will consider the following factors:
    (1) Whether the records to be disclosed pertain to the operations 
or activities of the Federal Government;
    (2) Whether disclosure of the records would reveal any meaningful 
information about Government operations or activities that is not 
already public knowledge;
    (3) Whether disclosure will advance the understanding of the 
general public as distinguished from a narrow segment of interested 
persons. Under this factor, the Food and Drug Administration may 
consider whether the requester is in a position to contribute to public 
understanding. For example, the Food and Drug Administration may 
consider whether the requester has such knowledge or expertise as may 
be necessary to understand the information, and whether the requester's 
intended use of the information would be likely to disseminate the 
information to the public. An unsupported claim to be doing research 
for a book or article does not demonstrate that likelihood, while such 
a claim by a representative of the news media is better evidence; and
    (4) Whether the contribution to public understanding will be a 
significant one, i.e., will the public's understanding of the 
Government's operations be substantially greater as a result of the 
disclosure.
    (c) Not primarily in the requester's commercial interest. If 
disclosure passes the test of furthering the specific public interest 
described in paragraph (b) of this section, the Food and Drug 
Administration will determine whether disclosure also furthers the 
requester's commercial interest and, if so, whether this effect 
outweighs the advancement of that public interest. In applying this 
second test, the Food and Drug Administration will consider the 
following factors:
    (1) Whether disclosure would further a commercial interest of the 
requester, or of someone on whose behalf the requester is acting. 
Commercial interests include interests relating to business, trade, and 
profit. Both profit and nonprofit-making corporations have commercial 
interests, as well as individuals, unions, and other associations. The 
interest of a representative of the news media in using the information 
for news dissemination purposes will not be considered a commercial 
interest.
    (2) If disclosure would further a commercial interest of the 
requester, whether that effect outweighs the advancement of the public 
interest as defined in paragraph (b) of this section.
    (d) Deciding between waiver and reduction. If the disclosure of the 
information requested passes both tests described in paragraphs (b) and 
(c) of this section, the Food and Drug Administration will normally 
waive fees. However, in some cases the Food and Drug Administration may 
decide only to reduce the fees. For example, the Food and Drug 
Administration may do this when disclosure of some but not all of the 
requested records passes the tests.
    (e) Procedure for requesting a waiver or reduction. A requester 
must request a waiver or reduction of fees at the same time as the 
request for records. The requester should explain why a waiver or 
reduction is proper under the factors set forth in paragraphs (a) 
through (d) of this section. Only the Associate Commissioner for Public 
Affairs may make the decision whether to waive or reduce the fees. If 
the Food and Drug Administration does not completely grant the request 
for a waiver or reduction, the denial letter will designate a review 
official. The requester may appeal the denial to that official. The 
appeal letter should address reasons for the Associate Commissioner's 
decision that are set forth in the denial letter.
    5. Section 20.53 is amended by revising the last sentence to read 
as follows:


Sec. 20.53  Indexing trade secrets and confidential commercial or 
financial information.

    * * * If the affected person fails to intervene to defend the 
exempt status of the records and to itemize and index the disputed 
records, the Food and Drug Administration will take this failure into 
consideration in deciding whether that person has waived such exemption 
so as to require the Food and Drug Administration to promptly make the 
records available for public disclosure.
    6. Section 20.61 is amended by revising paragraph (a) and by adding 
new paragraphs (d), (e), and (f) to read as follows:


Sec. 20.61  Trade secrets and commercial or financial information which 
is privileged or confidential.

    (a) A trade secret may consist of any commercially valuable plan, 
formula, process, or device that is used for the making, preparing, 
compounding, or processing of trade commodities and that can be said to 
be the end product of either innovation or substantial effort. There 
must be a direct relationship between the trade secret and the 
productive process.
* * * * *
    (d) A person who submits records to the Government may designate 
part or all of the information in such records as exempt from 
disclosure under exemption 4 of the Freedom of Information Act. The 
person may make this designation either at the time the records are 
submitted to the Government or within a reasonable time thereafter. The 
designation must be in writing. Where a legend is required by a request 
for proposals or request for quotations, pursuant to 48 CFR 352.215-12, 
then that legend is necessary for this purpose. Any such designation 
will expire 10 years after the records were submitted to the 
Government.
    (e) The procedures in this paragraph apply to records on which the 
submitter has designated information as provided in paragraph (d) of 
this section. These procedures also apply to records that were 
submitted to the Food and Drug Administration when the agency has 
substantial reason to believe that information in the records could 
reasonably be considered exempt under exemption 4 of the Freedom of 
Information Act. Certain exceptions to these procedures are set forth 
in paragraph (f) of this section.
    (1) When the Food and Drug Administration receives a request for 
such records and determines that disclosure may be required, the Food 
and Drug Administration will make reasonable efforts to notify the 
submitter about these facts. The notice will include a copy of the 
request, and it will inform the submitter about the procedures and time 
limits for submission and consideration of objections to disclosure. If 
the Food and Drug Administration must notify a large number of 
submitters, notification may be done by posting or publishing a notice 
in a place where the submitters are reasonably likely to become aware 
of it.
    (2) The submitter has 5 working days from receipt of the notice to 
object to disclosure of any part of the records and to state all bases 
for its objections.
    (3) The Food and Drug Administration will give consideration to all 
bases that have been stated in a timely manner by the submitter. If the 
Food and Drug Administration decides to disclose the records, the Food 
and Drug Administration will notify the submitter in writing. This 
notice will briefly explain why the agency did not sustain the 
submitter's objections. The Food and Drug Administration will include 
with the notice a copy of the records about which the submitter 
objected, as the agency proposes to disclose them. The notice will 
state that the Food and Drug Administration intends to disclose the 
records 5 working days after the submitter receives the notice unless a 
U.S. District Court orders the agency not to release them.
    (4) If a requester files suit under the Freedom of Information Act 
to obtain records covered by this paragraph, the Food and Drug 
Administration will promptly notify the submitter.
    (5) Whenever the Food and Drug Administration sends a notice to a 
submitter under paragraph (e)(1) of this section, the Food and Drug 
Administration will notify the requester that the Food and Drug 
Administration is giving the submitter a notice and an opportunity to 
object. Whenever the Food and Drug Administration sends a notice to a 
submitter under paragraph (e)(3) of this section, the Food and Drug 
Administration will notify the requester of this fact.
    (f) The notice requirements in paragraph (e) of this section do not 
apply in the following situations:
    (1) The Food and Drug Administration decided not to disclose the 
records;
    (2) The information has previously been published or made generally 
available;
    (3) Disclosure is required by a regulation issued after notice and 
opportunity for public comment, that specifies narrow categories of 
records that are to be disclosed under the Freedom of Information Act, 
but in this case a submitter may still designate records as described 
in paragraph (d) of this section, and in exceptional cases, the Food 
and Drug Administration may, at its discretion, follow the notice 
procedures in paragraph (e) of this section;
    (4) The information requested has not been designated by the 
submitter as exempt from disclosure when the submitter had an 
opportunity to do so at the time of submission of the information or 
within a reasonable time thereafter, unless the Food and Drug 
Administration has substantial reason to believe that disclosure of the 
information would result in competitive harm; or
    (5) The designation appears to be obviously frivolous, but in this 
case the Food and Drug Administration will still give the submitter the 
written notice required by paragraph (e)(3) of this section (although 
this notice need not explain our decision or include a copy of the 
records), and the Food and Drug Administration will notify the 
requester as described in paragraph (e)(5) of this section.
    7. Section 20.64 is amended by revising the section heading and 
paragraph (a), and by removing the word ``investigatory'' in paragraphs 
(b), (c) introductory text, (d) introductory text, and (e) to read as 
follows:


Sec. 20.64  Records or information compiled for law enforcement 
purposes.

    (a) Records or information compiled for law enforcement purposes 
may be withheld from public disclosure pursuant to the provisions of 
this section to the extent that disclosure of such records or 
information:
    (1) Could reasonably be expected to interfere with enforcement 
proceedings;
    (2) Would deprive a person to a right to a fair trial or an 
impartial adjudication;
    (3) Could reasonably be expected to constitute an unwarranted 
invasion of personal privacy;
    (4) Could reasonably be expected to disclose the identity of a 
confidential source, including a State, local, or foreign agency or 
authority or any private institution which furnished information on a 
confidential basis; and information furnished by a confidential source 
in the case of a record compiled by the Food and Drug Administration or 
any other criminal law enforcement authority in the course of a 
criminal investigation or by an agency conducting a lawful national 
security intelligence investigation;
    (5) Would disclose techniques and procedures for law enforcement 
investigations or prosecutions or would disclose guidelines for law 
enforcement investigations or prosecutions, if such disclosure could 
reasonably be expected to risk circumvention of the law; or
    (6) Could reasonably be expected to endanger the life or physical 
safety of any individual.
* * * * *


Sec. 20.81  [Amended]

    8. Section 20.81 Data and information previously disclosed to the 
public is amended in paragraph (a)(3) by removing the phrase ``part 312 
of this chapter or other''.


Sec. 20.85  [Amended]

    9. Section 20.85 Disclosure to other Federal government departments 
and agencies is amended in the last sentence by removing the words ``an 
agreement'' and adding in their place the words ``a written 
agreement''.
    10. Section 20.87 is amended by revising paragraph (a) to read as 
follows:


Sec. 20.87  Disclosure to Congress.

    (a) All records of the Food and Drug Administration shall be 
disclosed to Congress upon an authorized request.
* * * * *
    11. Section 20.100 is amended by revising paragraphs (c)(7), 
(c)(14), (c)(16), and (c)(17) and by adding new paragraphs (c)(35) 
through (c)(40) to read as follows:


Sec. 20.100  Applicability; cross-reference to other regulations.

* * * * *
    (c) * * *
* * * * *
    (7) Food additive petitions, in Secs. 171.1(h) and 571.1(h) of this 
chapter.
* * * * *
    (14) Investigational new drug notice, in Sec. 312.130 of this 
chapter.
* * * * *
    (16) Master file for a new drug application, in Sec. 312.420 of 
this chapter.
    (17) New drug application file, in Sec. 314.430 of this chapter.
* * * * *
    (35) Premarket approval application, in Sec. 814.9 of this chapter.
    (36) Report of certain adverse experiences with a medical device, 
in Sec. 803.9 of this chapter.
    (37) Disqualification determination of an institutional review 
board, in Sec. 56.122 of this chapter.
    (38) Disqualification determination of a nonclinical laboratory, in 
Sec. 58.213 of this chapter.
    (39) Minutes or records regarding a public advisory committee, in 
Sec. 14.65(c) of this chapter.
    (40) Data submitted regarding persons receiving an implanted 
pacemaker device or lead, in Sec. 805.25 of this chapter.

    Dated: December 23, 1993.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-98 Filed 1-4-94; 8:45 am]
BILLING CODE 4160-01-P