Return to Title 21, Code of Federal Regulations Cosmetic
Products Contents
Code of Federal Regulations
Title 21, Volume 1, Parts 1 to 99
Revised as of April 1, 1996
From the U.S. Government Printing Office via GPO Access
CITE: 21CFR20
Page 184-213
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 20--PUBLIC INFORMATION
Subpart A--Official Testimony and Information
Sec.
20.1 Testimony by Food and Drug Administration employees.
20.2 Production of records by Food and Drug Administration employees.
20.3 Certification and authentication of Food and Drug Administration
records.
Subpart B--General Policy
20.20 Policy on disclosure of Food and Drug Administration records.
20.21 Uniform access to records.
20.22 Partial disclosure of records.
20.23 Request for existing records.
20.24 Preparation of new records.
20.25 Retroactive application of regulations.
20.26 Indexes of certain records.
20.27 Submission of records marked as confidential.
20.28 Food and Drug Administration determinations of confidentiality.
20.29 Prohibition on withdrawal of records from Food and Drug
Administration files.
20.30 Food and Drug Administration Freedom of Information Staff.
20.31 Retention schedule of requests for Food and Drug Administration
records.
20.32 Disclosure of Food and Drug Administration employee names.
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Subpart C--Procedures and Fees
20.40 Filing a request for records.
20.41 Time limitations.
20.42 Fees to be charged.
20.43 Waiver or reduction of fees.
20.44 Presubmission review of request for confidentiality of
voluntarily submitted data or information.
20.45 Situations in which confidentiality is uncertain.
20.46 Judicial review of proposed disclosure.
20.47 Denial of a request for records.
20.48 Nonspecific and overly burdensome requests.
20.49 Referral to primary source of records.
20.50 Availability of records at National Technical Information
Service.
20.51 Use of private contractor for copying.
20.52 Request for review without copying.
20.53 Indexing trade secrets and confidential commercial or financial
information.
Subpart D--Exemptions
20.60 Applicability of exemptions.
20.61 Trade secrets and commercial or financial information which is
privileged or confidential.
20.62 Inter- or intra-agency memoranda or letters.
20.63 Personnel, medical, and similar files, disclosure of which
constitutes a clearly unwarranted invasion of personal
privacy.
20.64 Records or information compiled for law enforcement purposes.
Subpart E--Limitations on Exemptions
20.80 Applicability of limitations on exemptions.
20.81 Data and information previously disclosed to the public.
20.82 Discretionary disclosure by the Commissioner.
20.83 Disclosure required by court order.
20.84 Disclosure to consultants, advisory committees, State and local
government officials commissioned pursuant to 21 U.S.C.
372(a), and other special government employees.
20.85 Disclosure to other Federal government departments and agencies.
20.86 Disclosure in administrative or court proceedings.
20.87 Disclosure to Congress.
20.88 Communications with State and local government officials.
20.89 Communications with foreign government officials.
20.90 Disclosure to contractors.
20.91 Use of data or information for administrative or court
enforcement action.
Subpart F--Availability of Specific Categories of Records
20.100 Applicability; cross-reference to other regulations.
20.101 Administrative enforcement records.
20.102 Court enforcement records.
20.103 Correspondence.
20.104 Summaries of oral discussions.
20.105 Testing and research conducted by or with funds provided by the
Food and Drug Administration.
20.106 Studies and reports prepared by or with funds provided by the
Food and Drug Administration.
20.107 Food and Drug Administration manuals.
20.108 Agreements between the Food and Drug Administration and other
departments, agencies, and organizations.
20.109 Data and information obtained by contract.
20.110 Data and information about Food and Drug Administration
employees.
20.111 Data and information submitted voluntarily to the Food and Drug
Administration.
20.112 Voluntary drug experience reports submitted by physicians and
hospitals.
20.113 Voluntary product defect reports.
20.114 Data and information submitted pursuant to cooperative quality
assurance agreements.
20.115 Product codes for manufacturing or sales dates.
20.116 Drug and device listing information.
20.117 New drug information.
20.118 Advisory committee records.
20.119 Lists of names and addresses.
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; 19 U.S.C. 2531-
2582; 21 U.S.C. 1401-1403.
Source: 42 FR 15616, Mar. 22, 1977, unless otherwise noted.
Subpart A--Official Testimony and Information
Sec. 20.1 Testimony by Food and Drug Administration employees.
(a) No officer or employee of the Food and Drug Administration or of
any other office or establishment in the Department of Health and Human
Services, except as authorized by the Commissioner of Food and Drugs
pursuant to this section or in the discharge of his official duties
under the
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laws administered by the Food and Drug Administration, shall give any
testimony before any tribunal pertaining to any function of the Food and
Drug Administration or with respect to any information acquired in the
discharge of his official duties.
(b) Whenever a subpoena, in appropriate form, has been lawfully
served upon an officer or employee of the Food and Drug Administration
commanding the giving of any testimony, such officer or employee shall,
unless otherwise authorized by the Commissioner, appear in response
thereto and respectfully decline to testify on the grounds that it is
prohibited by this section.
(c) A person who desires testimony from any employee may make
written request therefor, verified by oath, directed to the Commissioner
setting forth his interest in the matter sought to be disclosed and
designating the use to which such testimony will be put in the event of
compliance with such request: Provided, That a written request therefor
made by a health, food, or drug officer, prosecuting attorney, or member
of the judiciary of any State, Territory, or political subdivision
thereof, acting in his official capacity, need not be verified by oath.
If it is determined by the Commissioner, or any other officer or
employee of the Food and Drug Administration whom he may designate to
act on his behalf for the purpose, that such testimony will be in the
public interest and will promote the objectives of the act and the
agency, the request may be granted. Where a request for testimony is
granted, one or more employees of the Food and Drug Administration may
be designated to appear, in response to a subpoena, and testify with
respect thereto.
Sec. 20.2 Production of records by Food and Drug Administration
employees.
(a) Any request for records of the Food and Drug Administration,
whether it be by letter or by a subpena duces tecum or by any other
writing, shall be handled pursuant to the procedures established in
subpart B of this part, and shall comply with the rules governing public
disclosure established in subparts C, D, E, and F of this part and in
other regulations cross-referenced in Sec. 20.100(c).
(b) Whenever a subpoena duces tecum, in appropriate form, has been
lawfully served upon an officer or employee of the Food and Drug
Administration commanding the production of any record, such officer or
employee shall appear in response thereto, respectfully decline to
produce the record on the ground that it is prohibited by this section,
and state that the production of the record(s) involved will be handled
by the procedures established in this part.
Sec. 20.3 Certification and authentication of Food and Drug
Administration records.
(a) Upon request, the Food and Drug Administration will certify the
authenticity of copies of records that are requested to be disclosed
pursuant to this part or will authenticate copies of records previously
disclosed.
(b) A request for certified copies of records or for authentication
of records shall be sent in writing to the Freedom of Information Staff
(HFI-35), Food and Drug Administration, Room 12A-16, 5600 Fishers Lane,
Rockville, MD 20857.
42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981
Subpart B--General Policy
Sec. 20.20 Policy on disclosure of Food and Drug Administration
records.
(a) The Food and Drug Administration will make the fullest possible
disclosure of records to the public, consistent with the rights of
individuals to privacy, the property rights of persons in trade secrets
and confidential commercial or financial information, and the need for
the agency to promote frank internal policy deliberations and to pursue
its regulatory activities without disruption.
(b) Except where specifically exempt pursuant to the provisions of
this part, all Food and Drug Administration records shall be made
available for public disclosure.
(c) Except as provided in paragraph (d) of this section, all
nonexempt records shall be made available for
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public disclosure upon request regardless whether any justification or
need for such records have been shown.
(d) Under Sec. 21.71 of this chapter, a statement of the purposes to
which the record requested is to be put, and a certification that the
record will be so used, may be requested when:
(1) The requested record is contained in a Privacy Act Record System
as defined in Sec. 21.3(c) of this chapter;
(2) The requester is a person other than the individual who is the
subject of the record that is so retrieved or a person acting on his
behalf; and
(3) The disclosure is one that is discretionary, i.e., not required
under this part.
Sec. 20.21 Uniform access to records.
Any record of the Food and Drug Administration that is disclosed in
an authorized manner to any member of the public is available for
disclosure to all members of the public, except that:
(a) Data and information subject to the exemptions established in
Sec. 20.61 for trade secrets and confidential commercial or financial
information, and in Sec. 20.63 for personal privacy, shall be disclosed
only to the persons for the protection of whom these exemptions exist.
(b) The limited disclosure of records permitted in Sec. 7.87(c) of
this chapter for section 305 hearing records, in Sec. 20.80(b) regarding
certain limitations on exemptions, in Sec. 20.103(b) for certain
correspondence, and in Sec. 20.104(b) for certain summaries of oral
discussions, shall be subject to the special rules stated therein.
(c) Disclosure of a record about an individual, as defined in
Sec. 21.3(a) of this chapter, that is retrieved by the individual's name
or other personal identifier and is contained in a Privacy Act Record
System, as defined in Sec. 21.3(c) of this chapter, shall be subject to
the special requirements of part 21 of this chapter. Disclosure of such
a record to an individual who is the subject of the record does not
invoke the rule established in this section that such records shall be
made available for disclosure to all members of the public.
42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9037, Mar. 3, 1989
Sec. 20.22 Partial disclosure of records.
If a record contains both disclosable and nondisclosable
information, the nondisclosable information will be deleted and the
remaining record will be disclosed unless the two are so inextricably
intertwined that it is not feasible to separate them or release of the
disclosable information would compromise or impinge upon the
nondisclosable portion of the record.
Sec. 20.23 Request for existing records.
(a) Any written request to the Food and Drug Administration for
existing records not prepared for routine distribution to the public
shall be deemed to be a request for records pursuant to the Freedom of
Information Act, whether or not the Freedom of Information Act is
mentioned in the request, and shall be governed by the provisions of
this part.
(b) Records or documents prepared by the Food and Drug
Administration for routine public distribution, e.g., pamphlets,
speeches, and educational materials, shall be furnished free of charge
upon request as long as the supply lasts. The provisions of this part
shall not be applicable to such requests except when the supply of such
material is exhausted and it is necessary to reproduce individual copies
upon specific request.
(c) All existing Food and Drug Administration records are subject to
routine destruction according to standard record retention schedules.
Sec. 20.24 Preparation of new records.
(a) The Freedom of Information Act and the provisions of this part
apply only to existing records that are reasonably described in a
request filed with the Food and Drug Administration pursuant to the
procedures established in subpart C of this part.
(b) The Commissioner may, in his discretion, prepare new records in
order to respond adequately to a request for information when he
concludes that it is in the public interest and promotes the objectives
of the act and the agency.
Page 188
Sec. 20.25 Retroactive application of regulations.
The provisions of this part apply to all records in Food and Drug
Administration files.
Sec. 20.26 Indexes of certain records.
(a) Indexes shall be maintained, and revised at least quarterly, for
the following Food and Drug Administration records:
(1) Final orders published in the Federal Register with respect to
every denial or withdrawal of approval of a new drug application or a
new animal drug application for which a public hearing has been
requested.
(2) Statements of policy and interpretation adopted by the agency
and still in force and not published in the Federal Register.
(3) Administrative staff manuals and instructions to staff that
affect a member of the public.
(b) A copy of each such index is available at cost from the Freedom
of Information Staff (HFI-35), Food and Drug Administration, Room 12A-
16, 5600 Fishers Lane, Rockville, MD 20857.
42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981
Sec. 20.27 Submission of records marked as confidential.
Marking records submitted to the Food and Drug Administration as
confidential, or with any other similar term, raises no obligation by
the Food and Drug Administration to regard such records as confidential,
to return them to the person who has submitted them, to review them
pursuant to the procedures established in Sec. 20.44, to withhold them
from disclosure to the public, or to advise the person submitting them
when a request for their public disclosure is received or when they are
in fact disclosed.
Sec. 20.28 Food and Drug Administration determinations of
confidentiality.
A determination that data or information submitted to the Food and
Drug Administration will be held in confidence and will not be available
for public disclosure shall be made only in the form of a regulation
published or cross-referenced in this part or by a written determination
pursuant to the procedure established in Sec. 20.44.
Sec. 20.29 Prohibition on withdrawal of records from Food and Drug
Administration files.
Except pursuant to the procedure established in Sec. 20.44 for
presubmission review of records, no person may withdraw records
submitted to the Food and Drug Administration. All Food and Drug
Administration records shall be retained by the agency until disposed of
pursuant to routine record disposal procedures.
Sec. 20.30 Food and Drug Administration Freedom of Information Staff.
(a) The Office responsible for agency compliance with the Freedom of
Information Act and this part is:
Freedom of Information Staff (HFI-35), Food and Drug Administration,
Room 12A-16, 5600 Fishers Lane, Rockville, MD 20857.
(b) All requests for agency records shall be sent in writing to this
office.
42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981
Sec. 20.31 Retention schedule of requests for Food and Drug
Administration records.
(a) Unless unusual circumstances dictate otherwise, the Food and
Drug Administration shall maintain and dispose of files of requests and
reponses furnished thereto within the time limits authorized by GSA
General Records Schedule 14, FPMR 101-11-4, January 10, 1977, as
follows:
(1) Files created by the receipt of and response to freedom of
information requests, except denials and/or appeals, may be destroyed 2
years from date of final response.
(2) Files created by a freedom of information request which was
wholly or partially denied may be destroyed 5 years after the denial
letter was issued.
(3) Files created by a freedom of information request which was
wholly or partially denied and which denial was subsequently appealed to
the Department of Health and Human Services may be destroyed 4 years
after final determination by FDA or 3 years after final adjudication by
courts, whichever is later.
Page 189
(b) This destruction schedule will automatically be revised whenever
the time limits pertaining to these records are revised by the GSA
General Records Schedule.
47 FR 24277, June 4, 1982
Sec. 20.32 Disclosure of Food and Drug Administration employee names.
The names of Food and Drug Administration employees will not be
deleted from disclosable records except where such deletion is necessary
to prevent disclosure of an informant or danger to the life or physical
safety of the employee or under other extraordinary circumstances.
Subpart C--Procedures and Fees
Sec. 20.40 Filing a request for records.
(a) All requests for Food and Drug Administration records shall be
filed in writing by mailing the request or delivering it to the Freedom
of Information Staff (HFI-35), Food and Drug Administration, Room 12A-
16, 5600 Fishers Lane, Rockville, MD 20857.
(b) A request for Food and Drug Administration records shall
reasonably describe the records being sought, in a way that they can be
identified and located. A request should include all pertinent details
that will help identify the records sought.
(1) If the description is insufficient to locate the records
requested, the Food and Drug Administration will so notify the person
making the request and indicate the additional information needed to
identify the records requested.
(2) Every reasonable effort shall be made by the Food and Drug
Administration to assist in the identification and location of the
records sought.
(c) Upon receipt of a request for records, the Freedom of
Information Staff shall enter it in a public log. The log shall state
the date received, the name of the person making the request, the nature
of the record requested, the action taken on the request, the date of
determination letter sent pursuant to Sec. 20.41(b), and the date(s) any
records are subsequently furnished.
(d) A request by an individual, as defined in Sec. 21.3(a) of this
chapter, for a record about himself shall be subject to:
(1) The special requirements of part 21 of this chapter (the privacy
regulations), and not to the provisions of this subpart, if the record
requested is retrieved by the individual's name or other personal
identifier and is contained in a Privacy Act Record System, as defined
in Sec. 21.3(c) of this chapter.
(2) The provisions of this subpart if the record requested is not
retrieved by the individual's name or other personal identifier, whether
or not the record is contained in a Privacy Act Record System.
42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981
Sec. 20.41 Time limitations.
(a) All time limitations prescribed pursuant to this section shall
begin as of the time at which a request for records is logged in by the
Freedom of Information Staff pursuant to Sec. 20.40(c). An oral request
for records shall not begin any time requirement. A written request for
records sent elsewhere within the agency shall not begin any time
requirement until it is redirected to the Freedom of Information Staff
and is logged in there in accordance with Sec. 20.40(c).
(b) Within 10 working days (excepting Saturdays, Sundays, and legal
public holidays) after a request for records is logged in at the Freedom
of Information Staff, a letter shall be sent to the persons making the
request determining whether, or to the extent which, the agency will
comply with the request, and, if any records are denied, the reasons
therefor.
(1) If all of the records requested have been located and a final
determination has been made with respect to disclosure of all of the
records requested, the letter shall so state.
(2) If all of the records have not been located or a final
determination has not yet been made with respect to disclosure of all of
the records requested, e.g., because it is necessary to consult the
person affected pursuant to Sec. 20.45, the letter shall state the
extent to which the records involved shall be disclosed pursuant to the
rules established in this part.
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(3) In the following unusual circumstances, the time for sending
this letter may be extended for up to an additional 10 working days by
written notice to the person making the request setting forth the
reasons for such extension and the time within which a determination is
expected to be dispatched:
(i) The need to search for and collect the requested records from
field facilities or other establishments that are separate from the
Freedom of Information Staff.
(ii) The need to search for, collect, and appropriately examine a
voluminous amount of separate and distinct records which are demanded in
a single request.
(iii) The 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
therein.
(4) If any record is denied, the letter shall state the right of the
person requesting such records to appeal any adverse determination to
the Assistant Secretary for Health, Department of Health and Human
Services, in accordance with the provisions of 45 CFR 5.34.
42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8456, Jan. 27, 1981; 55
FR 1405, Jan. 16, 1990; 59 FR 533, Jan. 5, 1994
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.
Page 191
(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
Page 192
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.
59 FR 533, Jan. 5, 1994
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
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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.
59 FR 534, Jan. 5, 1994
Sec. 20.44 Presubmission review of request for confidentiality of
voluntarily submitted data or information.
(a) Any person who is considering submission of data or information
voluntarily to the Food and Drug Administration may forward to the
Director of the Center involved, or to the Associate Commissioner for
Regulatory Affairs, a request for presubmission review of the records
involved to determine whether the Food and Drug Administration will or
will not make part or all of them available for public disclosure upon
request if they are submitted. Any such request shall state why the data
or information involved fall within an exemption from public disclosure
set out in subpart D of this part and shall enclose the records
involved.
(b) Pending a determination upon such request, the records involved
shall be held confidentially and separately by the Food and Drug
Administration and shall not be received as part of Food and Drug
Administration files.
(c) Pursuant to such a request, the Food and Drug Administration
shall make a determination whether part or all of the records involved
will be made available for public disclosure upon request if they are
submitted. A determination of confidentiality will be made only if it is
concluded that the data or information involved fall within an exemption
from public disclosure set out in subpart D of this part and are
relevant to and important for agency activity.
(d) After a determination is made pursuant to this section, the Food
and Drug Administration shall receive as part of its files the records
for which a request for confidentiality has been granted and shall so
mark or designate those records. The person requesting the presubmission
review shall have the option of submitting or withdrawing the records
for which a request for confidentiality has been denied. No copy or
summary of records withdrawn pursuant to this section, or any
correspondence or memoranda or records relating thereto, shall be
retained in Food and Drug Administration files.
(e) A determination of confidentiality pursuant to this section is
subject to the limitations established in subpart E of this part except
that the data or information involved shall not be subject to
discretionary release pursuant to Sec. 20.82. Such a determination of
confidentiality by the Food and Drug Administration means that the Food
and Drug Administration will not make the data or information involved
available for public disclosure unless ordered to do so by a court.
(f) A determination based upon a presubmission review pursuant to
this section shall be made in writing and shall be signed only by the
Associate Commissioner for Public Affairs.
(g) Data and information that may be required to be submitted to the
Food and Drug Administration but that are submitted voluntarily instead
are not subject to the provisions of this section and will be handled as
if they had been required to be submitted.
(h) No request under this section shall be accepted if the status of
the records involved is already determined by Sec. 20.111 or by any
other regulation
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published or cross-referenced in this part.
42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 50
FR 8995, Mar. 6, 1985
Sec. 20.45 Situations in which confidentiality is uncertain.
In situations where the confidentiality of data or information is
uncertain and there is a request for public disclosure, the Food and
Drug Administration will consult with the person who has submitted or
divulged the data or information or who would be affected by disclosure
before determining whether or not such data or information is available
for public disclosure.
Sec. 20.46 Judicial review of proposed disclosure.
Where the Food and Drug Administration consults with a person who
will be affected by a proposed disclosure of data or information
contained in Food and Drug Administration records pursuant to
Sec. 20.45, and rejects the person's request that part or all of the
records not be made available for public disclosure, the decision
constitutes final agency action that is subject to judicial review
pursuant to 5 U.S.C. chapter 7. The person affected will be permitted 5
days after receipt of notification of such decision within which to
institute suit in a United States District Court to enjoin release of
the records involved. If suit is brought, the Food and Drug
Administration will not disclose the records involved until the matter
and all related appeals have been concluded.
Sec. 20.47 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.
(b) The name and title or position of each person who participated
in the denial of a request for records shall be set forth in the letter
denying the request. This requirement may be met by attaching a list of
such individuals to the letter.
(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 Assistant Secretary for Health, Department of Health
and Human Services, pursuant to the provisions of 45 CFR 5.34.
(d) Minor deletions of nondisclosable data and information from
disclosable records shall not be deemed to be a denial of a request for
records.
42 FR 15616, Mar. 22, 1977, as amended at 46 FR 8457, Jan. 27, 1981; 55
FR 1405, Jan. 16, 1990
Sec. 20.48 Nonspecific and overly burdensome requests.
The Food and Drug Administration will make every reasonable effort
to comply fully with all requests for disclosure of nonexempt records.
Nonspecific requests or requests for a large number of documents that
require the deployment of a substantial amount of agency man-hours to
search for and compile will be processed taking into account the staff-
hours required, the tasks from which these resources must be diverted,
the impact that this diversion will have upon the agency's consumer
protection activities, and the public policy reasons justifying the
requests. A decision on the processing of such a request for information
shall be made after balancing the public benefit to be gained by the
disclosure against the public loss that will result from diverting
agency personnel from their other responsibilities. In any situation in
which it is determined that a request for voluminous records would
unduly burden and interfere with the operations of the Food and Drug
Administration, the person making the request will be asked to be more
specific and to narrow the request, and to agree on an orderly procedure
for the production of the requested records, in order to satisfy the
request without disproportionate adverse effects on agency operations.
Sec. 20.49 Referral to primary source of records.
Upon receipt of a request for a record or document which is
contained in Food and Drug Administration files but which is available
elsewhere at a lower cost, the person requesting the record or document
shall be referred to the primary source of the record or document.
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Sec. 20.50 Availability of records at National Technical Information
Service.
The Food and Drug Administration is furnishing a number of records
to the National Technical Information Service (NTIS), 5285 Port Royal
Rd., Springfield, VA 22162, which reproduces and distributes such
information to the public at cost. A single copy of each such record
shall be available for public review at the Food and Drug
Administration. All persons requesting copies of such records shall be
answered by referring the person requesting the records to NTIS.
42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989
Sec. 20.51 Use of private contractor for copying.
The Food and Drug Administration may furnish requested records to a
private contractor for copying after deletion of all nondisclosable data
and information. Under these circumstances, the Food and Drug
Administration will charge the person requesting the records for all of
the fees involved pursuant to Sec. 20.42.
Sec. 20.52 Request for review without copying.
(a) A person requesting disclosure of records shall be permitted an
opportunity to review them without the necessity for copying them where
the records involved contain only disclosable data and information.
Under these circumstances, the Food and Drug Administration will charge
only for the costs of searching for the records.
(b) Where a request is made for review of records without copying,
and the records involved contain both disclosable and nondisclosable
information, the records containing nondisclosable information shall
first be copied with the nondisclosable information blocked out and the
Food and Drug Administration will charge for the costs of searching and
copying.
Sec. 20.53 Indexing trade secrets and confidential commercial or
financial information.
Whenever the Food and Drug Administration denies a request for a
record or portion thereof on the grounds that the record or portion
thereof is exempt from public disclosure as trade secret or confidential
commercial or financial data and information under Sec. 20.61, and the
person requesting the record subsequently contests the denial in the
courts, the Food and Drug Administration will so inform the person
affected, i.e., the person who submitted the record, and will require
that such person intervene to defend the exempt status of the record. If
a court requires the Food and Drug Administration to itemize and index
such records, the Food and Drug Administration will so inform the person
affected and will require that such person undertake the itemization and
indexing of the records. 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.
42 FR 15616, Mar. 22, 1977, as amended at 59 FR 535, Jan. 5, 1994
Subpart D--Exemptions
Sec. 20.60 Applicability of exemptions.
(a) The exemptions established in this subpart shall apply to all
Food and Drug Administration records, except as provided in subpart E of
this part. Accordingly, a record that is ordinarily available for public
disclosure in accordance with the provisions in subpart F of this part
or of another regulation cross-referenced in Sec. 20.100(c) is not
available for such disclosure to the extent that it falls within an
exemption contained in this subpart, except as provided by the
limitations on exemptions specified in subpart E of this part. For
example, correspondence that is ordinarily disclosable under Sec. 20.103
is not disclosable to the extent that it contains trade secrets exempt
from disclosure under Sec. 20.61 and is not subject to discretionary
release under Sec. 20.82.
(b) Where application of one or more exemptions results in a record
being disclosable in part and nondisclosable in part, the rule
established
Page 196
in Sec. 20.22 shall apply.
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.
(b) Commercial or financial information that is privileged or
confidential means valuable data or information which is used in one's
business and is of a type customarily held in strict confidence or
regarded as privileged and not disclosed to any member of the public by
the person to whom it belongs.
(c) Data and information submitted or divulged to the Food and Drug
Administration which fall within the definitions of a trade secret or
confidential commercial or financial information are not available for
public disclosure.
(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
Page 197
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.
42 FR 15616, Mar. 22, 1977, as amended at 59 FR 535, Jan. 5, 1994
Sec. 20.62 Inter- or intra-agency memoranda or letters.
All communications within the Executive Branch of the Federal
government which are in written form or which are subsequently reduced
to writing may be withheld from public disclosure except that factual
information which is reasonably segregable in accordance with the rule
established in Sec. 20.22 is available for public disclosure.
Sec. 20.63 Personnel, medical, and similar files, disclosure of which
constitutes a clearly unwarranted invasion of personal
privacy.
(a) The names or other information which would identify patients or
research subjects in any medical or similar report, test, study, or
other research project shall be deleted before the record is made
available for public disclosure.
(b) The names and other information which would identify patients or
research subjects should be deleted from any record before it is
submitted to the Food and Drug Administration. If the Food and Drug
Administration subsequently needs the names of such individuals, a
separate request will be made.
(c) Requests for deletion of business or product names prior to
disclosure of any record to the public shall not be granted on the
ground of privacy, but such deletion may be justified under another
exemption established in this subpart, e.g., the exemption for trade
secrets and confidential commercial or financial information under
Sec. 20.61.
(d) Names of individuals conducting investigations, studies, or
tests on products or ingredients shall not be deleted prior to
disclosure of any record to the public unless extraordinary
circumstances are shown.
(e) A request for all records relating to a specific individual will
be denied as a clearly unwarranted invasion of personal privacy unless
accompanied by the written consent of the individual named.
(f) The names and any information that would identify the voluntary
reporter or any other person associated with an adverse event involving
a human drug, biologic, or medical device product shall not be disclosed
by the Food and Drug Administration or by a manufacturer in possession
of such reports in response to a request, demand, or order. Information
that would identify the voluntary reporter or persons identified in the
report includes, but is not limited to, the name,
Page 198
address, institution, or any other information that would lead to the
identities of the reporter or persons identified in a report. This
provision does not affect disclosure of the identities of reporters
required by a Federal statute or regulation to make adverse event
reports. Disclosure of the identities of such reporters is governed by
the applicable Federal statutes and regulations.
(1) Exceptions. (i) Identities may be disclosed if both the
voluntary reporter and the person identified in an adverse event report
or that person's legal representative consent in writing to disclosure,
but neither FDA nor any manufacturer in possession of such reports shall
be required to seek consent for disclosure from the voluntary reporter
or the person identified in the adverse event report or that person's
legal representative; or
(ii) Identities of the voluntary reporter and the person who
experienced the reported adverse event may be disclosed pursuant to a
court order in the course of medical malpractice litigation involving
both parties; or (iii) The report, excluding the identities of any other
individuals, shall be disclosed to the person who is the subject of the
report upon request.
(2) Preemption. No State or local governing entity shall establish
or continue in effect any law, rule, regulation, or other requirement
that permits or requires disclosure of the identities of the voluntary
reporter or other person identified in an adverse event report except as
provided in this section.
42 FR 15616, Mar. 22, 1977, as amended at 60 FR 16968, Apr. 3, 1995
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.
(b) Records include all records relating to regulatory enforcement
action, including both administrative and court action, which have not
been disclosed to any member of the public, including any person who is
the subject of the investigation.
(c) Any record which is disclosed to any person, including any
person who is the subject of a Food and Drug Administration
investigation, and any data or information received from any person who
is the subject of a Food and Drug Administration investigation relating
to such investigation, is available for public disclosure at that time
in accordance with the rule established in Sec. 20.21, except that:
(1) Disclosure of such records shall be subject to the other
exemptions established in this subpart and to the limitations on
exemptions established in subpart E of this part.
(2) The record of a section 305 hearing shall be available for
public disclosure only in accordance with the provisions of Sec. 7.87 of
this chapter.
(d) Records for law enforcement purposes shall be subject to the
following rules:
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(1) No such record is available for public disclosure prior to the
consideration of regulatory enforcement action based upon that record's
being closed, except as provided in Sec. 20.82. The Commissioner will
exercise his discretion to disclose records relating to possible
criminal prosecution pursuant to Sec. 20.82 prior to consideration of
criminal prosecution being closed only very rarely and only under
circumstances that demonstrate a compelling public interest.
