[Federal Register Volume 81, Number 111 (Thursday, June 9, 2016)]
[Rules and Regulations]
[Page 37153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13705]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 14
[Docket No. FDA-2016-N-0001]
Advisory Committee; Transmissible Spongiform Encephalopathies
Advisory Committee; Termination
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
termination of the Transmissible Spongiform Encephalopathies Advisory
Committee. This document removes the Transmissible Spongiform
Encephalopathies Advisory Committee from the Agency's list of standing
advisory committees.
DATES: This rule is effective June 9, 2016.
FOR FURTHER INFORMATION CONTACT: Bryan Emery, Division of Scientific
Advisors and Consultants, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993-0002, 240-
402-8054, FAX: 301-595-1307, or [email protected].
SUPPLEMENTARY INFORMATION: The Transmissible Spongiform
Encephalopathies Advisory Committee (the Committee) was established on
June 9, 1995 (60 FR 31311, June 14, 1995; 21 CFR 14.100 erroneously
lists the date of establishment as June 21, 1995). The Committee
reviews and evaluates available scientific data concerning the safety
of products that may be a risk for transmission of spongiform
encephalopathies having an impact on the public health as determined by
the Commissioner of Food and Drugs. The Committee makes recommendations
to the Commissioner regarding the regulation of such products. In
recent years, the number of issues requiring Committee advice has
declined, and the Committee has met very infrequently. Therefore, the
effort and expense of maintaining this advisory committee is no longer
justified. Any relevant Transmissible Spongiform Encephalopathy issues
in the future could be addressed by the Agency's other advisory
committees, such as the Agency's Blood Products Advisory Committee,
with additional augmentation of expertise by appropriate subject matter
experts serving as temporary members on the committee.
The Committee is no longer needed and will be terminated on June 9,
2016.
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 comment
procedures and to proceed to an immediate effective date on this rule.
Notice and public comment and a delayed effective date are unnecessary
and are not in the public interest as this final rule merely removes
the name of the Transmissible Spongiform Encephalopathies Advisory
Committee from the list of standing advisory committees in 21 CFR
14.100.
Therefore, the Agency is amending 21 CFR 14.100(b) as set forth in
the regulatory text of this document.
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
0
1. The authority citation for part 14 continues 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; Pub. L. 107-109; Pub. L. 108-155.
Sec. 14.100 [Amended]
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2. In Sec. 14.100, redesignate paragraph (b)(5) as (b)(4) and remove
paragraph (b)(6).
Dated: June 6, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-13705 Filed 6-8-16; 8:45 am]
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