[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