[Federal Register: January 8, 2001 (Volume 66, Number 5)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. 00N-1634]
Public Hearing Before a Public Advisory Committee; Examination of
Administrative Record and Other Advisory Committee Records
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending its
administrative regulations governing the public disclosure of written
information for consideration by an advisory committee at an advisory
committee meeting. This action amends the regulations to state that the
written information for consideration by an advisory committee at a
committee meeting is available for public disclosure, whenever
practicable, before or at the time of the meeting. FDA is taking this
action to reflect current FDA policy in conformance with applicable
law. Elsewhere in this issue of the Federal Register, FDA is publishing
a companion proposed rule, under FDA's usual procedure for notice-and-
comment rulemaking, to provide a procedural framework to finalize the
rule in the event the agency receives any significant adverse comments
and withdraws this direct final rule.
DATES: This rule is effective May 23, 2001. Submit written comments by
March 26, 2001. If no timely significant adverse comments are received,
the agency will publish a document in the Federal Register before April
23, 2001, confirming the effective date of the direct final rule. The
agency intends to make the direct final rule effective 30 days after
publication of the confirmation notice in the Federal Register. If
timely significant adverse comments are received, the agency will
publish a document of significant adverse comments in the Federal
Register and withdraw this direct final rule before April 23, 2001.
ADDRESSES: Submit written comments on the direct final rule to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Andrea C. Masciale, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
Advisory committees provide independent advice and recommendations
to FDA on scientific and technical matters related to products
regulated by the agency. To assist committee members in preparing to
discuss the issues that will be raised at a committee meeting, the
agency and, in certain circumstances, affected members of the regulated
industry prepare written background materials
for committee members. Generally, advisory committee members are
provided these materials soon after they are completed, often weeks
before a committee meeting.
FDA's advisory committees are established under the Federal
Advisory Committee Act (5 U.S.C. app. 2) (the FACA). FDA's procedures
for the administration of advisory committees are set forth in part 14
(21 CFR part 14). Section 14.75(a)(1) states that, unless it is
otherwise exempt from disclosure, written information for consideration
by the committee at the meeting should be available for public
disclosure at the same time it is made available to the committee. As
described below, FDA finds this provision for simultaneous disclosure
unnecessary and detrimental to the advisory committee process.
Therefore, FDA is amending this provision in its administrative
B. Rationale for the Rule
As interpreted by case law, the FACA requires that, whenever
practicable and subject to any applicable exemption of the Freedom of
Information Act (the FOIA) (5 U.S.C. 552), information prepared for or
provided to an advisory committee be made publicly available before or
at the time of the advisory committee meeting at which the information
is used and discussed (see, e.g., Food Chemical News v. Department of
Health and Human Services, 980 F.2d 1468 (D.C. Cir. 1992)). Therefore,
FDA's provision for disclosing information to the public at the same
time the information is provided to the advisory committee
(Sec. 14.75(a)(1)) goes beyond the requirements of the FACA. The agency
is not obligated under the FACA to provide the materials to the public
at the same time they are provided to the advisory committee.
Under Sec. 14.75(b)(1), the public disclosure provision of
Sec. 14.75(a)(1) is subject to FDA's regulations in part 20 (21 CFR
part 20). The regulations in part 20 describe the agency's policies and
procedures for disclosing information to the public under the FOIA.
Information that generally may be released to the public, including
information described in Sec. 14.75(a)(1), may not be released if it
falls within one or more of the exemptions described in part 20.
Written materials provided to an advisory committee for consideration
at a committee meeting often include information that is not made
publicly available because the information is subject to one or more of
the following exemptions: (1) Trade secrets and commercial or financial
information that is privileged or confidential (Sec. 20.61); (2) inter-
or intra-agency memoranda or letters (Sec. 20.62); and (3) personnel,
medical, and similar files, the disclosure of which constitutes a
clearly unwarranted invasion of personal privacy (Sec. 20.63).
If written materials contain some information that is disclosable
and some information that is not subject to disclosure, the agency can
make the materials available to the public after deleting the
nondisclosable information (Sec. 20.22). The process of reviewing the
advisory committee materials, determining which information is exempt
from disclosure, and redacting the documents to remove the
nondisclosable information requires a significant amount of time. For
example, in the Federal Register of December 22, 1999 (64 FR 71794),
FDA announced the availability of a draft guidance document entitled
``Disclosing Information Provided to Advisory Committees in Connection
With Open Advisory Committee Meetings Related to the Testing or
Approval of New Drugs and Convened by the Center for Drug Evaluation
and Research, Beginning on January 1, 2000.'' In the draft guidance
document, the agency described a 4-week process of reviewing and
redacting an advisory committee package submitted by a sponsor of a new
drug application and a 3-week process of reviewing and redacting an
advisory committee package generated by the Center for Drug Evaluation
Materials that are otherwise exempt from disclosure under
Secs. 20.61, 20.62, and 20.63, however, may be disclosed to advisory
committee members who are special government employees for use in
connection with their work on an advisory committee (Sec. 20.84).
Therefore, the materials provided to advisory committee members need
not go through the extensive and time-consuming review and redaction
Advisory committees provide meaningful advice to FDA on technical
and scientific matters related to the development and evaluation of
FDA-regulated products. The value of the advice provided by FDA
advisory committees depends, in large part, on the ability of advisory
committee members to evaluate diverse, complex, and sometimes
contentious scientific issues during the course of a committee meeting.
It is crucial that the agency provide advisory committee members
background information as soon as practicable after the materials are
generated so the members can adequately prepare for the meeting.
Because Sec. 14.75(a)(1) provides for the public availability of these
materials at the same time as the materials are provided to an advisory
committee, and because the advisory committee materials often need to
be redacted before being made publicly available, complying with
Sec. 14.75(a)(1) would require the agency to wait until the materials
are redacted before sending the information to the advisory committees.
This, in turn, would result in less time for the committee members to
review the materials prior to the committee meeting. This delay would
be detrimental to the advisory committee process. Furthermore,
simultaneous availability of briefing materials to the advisory
committee and to the public is not required under the FACA.
Therefore, the agency is amending Sec. 14.75(a)(1) to state that
the written information for consideration by an advisory committee at
any meeting is available for public disclosure whenever practicable,
before or at the time of the meeting.
II. Direct Final Rulemaking
FDA has determined that the subject of this rulemaking is suitable
for a direct final rule. This direct final rule revises
Sec. 14.75(a)(1) to reflect current agency policy in conformance with
applicable law. The actions taken should be noncontroversial, and the
agency does not anticipate receiving any significant adverse comment on
If FDA does not receive significant adverse comment by March 26,
2001, the agency will publish a document in the Federal Register before
April 23, 2001, confirming the effective date of the direct final rule.
The agency intends to make the direct final rule effective 30 days
after publication of the confirmation document in the Federal Register.
A significant adverse comment is one that explains why the rule would
be inappropriate, including challenges to the rule's underlying premise
or approach, or would be ineffective or unacceptable without a change.
A comment recommending a rule change in addition to this rule will not
be considered a significant adverse comment unless the comment states
why this rule would be ineffective without the additional change. If
timely significant adverse comments are received, the agency will
publish a notice of significant adverse comment in the Federal Register
withdrawing this direct final rule before April 23, 2001.
Elsewhere in this issue of the Federal Register, FDA is publishing
a companion proposed rule, identical to the direct final rule, that
provides a procedural framework within which the
rule may be finalized in the event the direct final rule is withdrawn
because of significant adverse comment. The comment period for the
direct final rule runs concurrently with that of the companion proposed
rule. Any comments received under the companion proposed rule will be
treated as comments regarding the direct final rule. Likewise,
significant adverse comments submitted to the direct final rule will be
considered as comments to the companion proposed rule and the agency
will consider such comments in developing a final rule. FDA will not
provide additional opportunity for comment on the companion proposed
If a significant adverse comment applies to part of this rule and
that part may be severed from the remainder of the rule, FDA may adopt
as final those parts of the rule that are not the subject of a
significant adverse comment. A full description of FDA's policy on
direct final rule procedures may be found in a guidance document
published in the Federal Register of November 21, 1997 (62 FR 62466).
III. Environmental Impact
The agency has determined under 21 CFR 25.30(h) 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.
IV. Analysis of Impacts
FDA has examined the impacts of this direct final rule under
Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et
seq.). Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety,
and other advantages; distributive impacts; and equity). The agency
believes that this rule is consistent with the regulatory philosophy
and principles identified in Executive Order 12866 and in the other two
statutes. This rule is not a significant regulatory action as defined
by the Executive order.
Under the Regulatory Flexibility Act, if a rule has a significant
impact on a substantial number of small entities, an agency must
analyze regulatory options that would minimize any significant impact
of the rule on small entities. The agency has considered the effect
that this rule will have on small entities. Because the rule amends
only internal agency procedures, the agency certifies that the rule
will not have a significant economic impact on a substantial number of
small entities. Therefore, under the Regulatory Flexibility Act, no
further analysis is required.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4) requires that agencies prepare a written statement of
anticipated costs and benefits before proposing any rule that may
result in an expenditure by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100 million in any one
year (adjusted annually for inflation). FDA is not required to prepare
a statement of the costs and benefits of this rule because the rule is
not expected to result in any 1-year expenditure that would exceed $100
million adjusted for inflation. The current inflation-adjusted
statutory threshold is $110 million.
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the final
rule does not contain policies that have substantial direct effects on
the States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the final rule does not contain policies that have federalism
implications as defined in the order and, consequently, a federalism
summary impact statement is not required.
VI. Paperwork Reduction Act of 1995
This direct final rule does not require information collections
and, thus, is not subject to review by the Office of Management and
Budget under the Paperwork Reduction Act of 1995.
VII. Request for Comments
Interested persons may submit to the Dockets Management Branch
(address above) written comments regarding this rule by March 26, 2001.
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 Dockets Management Branch between 9 a.m.
and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 14
Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
14 is amended to read as follows:
PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
1. The authority citation for 21 CFR part 14 is revised to read as
Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461; 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42
U.S.C. 201, 262, 263b, 264.
2. Section 14.75 is amended by revising paragraph (a)(1) to read as
Sec. 14.75 Examination of administrative record and other advisory
(a) * * *
(1) The written information for consideration by the committee at
any meeting: Whenever practicable, before or at the time of the
* * * * *
Dated: December 29, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-389 Filed 1-5-01; 8:45 am]
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