[Federal Register Volume 66, Number 5 (Monday, January 8, 2001)]
[Proposed Rules]
[Pages 1276-1277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-390]


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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its administrative regulations governing the public disclosure of 
written information for consideration by an advisory committee at an 
advisory committee meeting. This action would amend the regulations to 
state that 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 
proposing this action to reflect current FDA policy in conformance with 
applicable law. This proposed rule is a companion document to the 
direct final rule published elsewhere in this issue of the Federal 
Register.

DATES: Submit written comments on the proposed rule by March 26, 2001. 
If FDA receives no significant adverse comment on the amendment of 
these regulations within the specified comment period, the agency 
intends to publish a document confirming the effective date of the 
final rule in the Federal Register within 30 days after the comment 
period in the direct final rule ends. The direct final rule will be 
effective 30 days after publication of the confirmation notice in the 
Federal Register.

ADDRESSES: Submit written comments 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

    As described more fully in the related direct final rule, 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. FDA finds that this provision for simultaneous disclosure is 
not required by the Federal Advisory Committee Act (5 U.S.C. app. 2) 
and that compliance with this provision would be detrimental to the 
advisory committee process. Therefore, the agency is proposing to amend 
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. Additional Information

    This proposed rule is a companion to the direct final rule 
published in the final rules section of this issue of the Federal 
Register. This companion proposed rule and the direct final rule are 
identical. This companion proposed rule will provide the procedural 
framework to finalize the rule in the event the direct final rule 
receives significant adverse comments and is withdrawn. The comment 
period for this companion proposed rule runs concurrently with the 
comment period of the direct final rule. Any comments received under 
the companion proposed rule will be treated as comments regarding the 
direct final rule.
    If no significant adverse comment is received in response to the 
direct final rule, no further action will be taken related to this 
proposed rule. Instead, FDA will publish a confirmation document within 
30 days after the comment period ends, and FDA intends the direct final 
rule to become effective 30 days after publication of the confirmation 
document. If FDA receives significant adverse comments, the agency will 
withdraw the direct final rule. FDA will proceed to respond to all of 
the comments received regarding the rule and, if appropriate, the rule 
will be finalized under this companion proposed rule using usual 
notice-and-comment procedures.
    For additional information, see the corresponding direct final rule 
published in the final rules section of this issue of the Federal 
Register. FDA will not provide additional opportunity for comment. 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.

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 proposed 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 proposed rule is consistent with the regulatory philosophy and 
principles identified in Executive Order 12866 and in the other two 
statutes. This proposed 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 proposed rule will have on small entities. Because the 
proposed rule will amend 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 proposed rule because the 
proposed rule is not expected to

[[Page 1277]]

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 proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed 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 proposed 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

    FDA tentatively concludes that this proposed rule contains no 
collections of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

VII. Request for Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this proposal by March 26, 
2001. This comment period runs concurrently with the comment period for 
the direct final rule; any comments received will be considered as 
comments regarding the direct 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 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday. In the event the direct final rule is withdrawn, all comments 
received will be considered comments on this proposed rule.

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, it is 
proposed that 21 CFR part 14 be 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. 01-390 Filed 1-5-01; 8:45 am]
BILLING CODE 4160-01-F