[Federal Register Volume 61, Number 135 (Friday, July 12, 1996)]
[Rules and Regulations]
[Page 36624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17686]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14


 Advisory Committees; Conversion of Ad Hoc Advisory Committee to 
Standing Advisory Committee

AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
standing advisory committees' regulations to add the name and function 
of the Transmissible Spongiform Encephalopathies Advisory Committee 
(formerly Ad Hoc Advisory Committee on Creutzfeldt-Jakob Disease). 
Appearing elsewhere in this issue of the Federal Register is a notice 
announcing the renewal of this advisory committee. A notice requesting 
nominations for membership on this committee will publish at a later 
date. This action is being taken to incorporate this committee into the 
agency's list of standing advisory committees because it will no longer 
be serving in an ad hoc capacity.

EFFECTIVE DATE: July 12, 1996.
FOR FURTHER INFORMATION CONTACT: Donna M. Combs, Committee Management 
Office (HFA-306), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-2765.

SUPPLEMENTARY INFORMATION: FDA is announcing that the name of the Ad 
Hoc Advisory Committee on Creutzfeldt-Jakob Disease has been changed. 
The committee was established on June 21, 1995, to advise the 
Commissioner of Food and Drugs regarding the safety of blood products 
obtained or prepared from one or more donations from a donor who, after 
donation, was diagnosed with Creutzfeldt-Jakob Disease. The committee 
was chartered for the duration of 1 year.
    The Commissioner has now formally determined that there is a 
continuing need for this committee, that the name and function of the 
committee will be changed to more accurately describe the committee, 
and that the committee will no longer be serving in an ad hoc capacity. 
The name ``Transmissible Spongiform Encephalopathies Advisory 
Committee''will more accurately describe the subject area for which the 
committee is responsible. The change is consistent with the expanded 
function of the committee.
    The committee's new function is to review and evaluate available 
scientific data concerning the safety of products which may be at risk 
for transmission of spongiform encephalopathies having an impact on the 
public health as determined by the Commissioner of Food and Drugs. The 
committee will also make recommendations to the Commissioner regarding 
the regulation of such products.
    Management and support services for the committee will continue to 
be provided by FDA's Center For Biologics Evaluation and Research. In 
this document, FDA is formally incorporating this committee into the 
agency's list of standing advisory committees by adding a new paragraph 
in 21 CFR 14.100(b).
    Publication of this final rule constitutes a final action on this 
change under the Administrative Procedure Act. Under 5 U.S.C. 
553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), the agency finds good 
cause to dispense with notice and public procedure and to proceed to an 
immediately effective regulation. Such notice and procedures are 
unnecessary and are not in the public interest, because the final rule 
is merely codifying the new name and expanded function of the advisory 
committee, as well as its status as a standing advisory committee, and 
when effective will reflect the current committee charter.

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 as follows:

PART 14-PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

    1. The authority citation for 21 CFR part 14 continues to read as 
follows:

    Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321-394; 21 U.S.C. 41-50, 141-149, 467f, 679, 821, 
1034; secs. 2, 351, 354, 361 of the Public Health Service Act (42 
U.S.C. 201, 262, 263b, 264); secs. 2-12 of the Fair Packaging and 
Labeling Act (15 U.S.C. 1451-1461); 5 U.S.C. App. 2; 28 U.S.C. 2112.

    2. Section 14.100 is amended by adding new paragraph (b)(6) to read 
as follows:

Sec. 14.100   List of standing advisory committees.

* * * * *
    (b) * * *
    (6) Transmissible Spongiform Encephalopathies Advisory Committee.
    (i) Date established: June 21, 1995.
    (ii) Function: Reviews and evaluates available scientific data 
concerning the safety of products which may be at risk for transmission 
of spongiform encephalopathies having an impact on the public health.
* * * * *

    Dated: July 5, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-17686 Filed 7-11-96; 8:45 am]
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