[Federal Register Volume 66, Number 5 (Monday, January 8, 2001)]
[Rules and Regulations]
[Pages 1257-1259]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-389]


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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.

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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.

SUPPLEMENTARY INFORMATION:

I. Discussion

A. Background

    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

[[Page 1258]]

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 
regulations.

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 
and Research.
    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 
process.
    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 
this rule.
    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

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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 
rule.
    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.

V. Federalism

    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 
follows:

    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 
follows:


Sec. 14.75  Examination of administrative record and other advisory 
committee records.

    (a) * * *
    (1) The written information for consideration by the committee at 
any meeting: Whenever practicable, before or at the time of the 
meeting.
* * * * *

    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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