[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]



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.


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, 
    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 
    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:


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]

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]