81 FR 37153 - Advisory Committee; Transmissible Spongiform Encephalopathies Advisory Committee; Termination
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 111 (June 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 111 (June 9, 2016)
| Page Range | 37153-37153 | |
| FR Document | 2016-13705 |
[Federal Register Volume 81, Number 111 (Thursday, June 9, 2016)] [Rules and Regulations] [Page 37153] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-13705] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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] 0 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] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 111 / Thursday, June 9, 2016 / Rules and Regulations 37153
§ 416.926a [Amended] Transmissible Spongiform DEPARTMENT OF THE INTERIOR
■ 4. Amend § 416.926a by removing Encephalopathy issues in the future
paragraph (m)(1) and redesignating could be addressed by the Agency’s Office of Natural Resources Revenue
paragraphs (m)(2) through (6) as (m)(1) other advisory committees, such as the
through (5). Agency’s Blood Products Advisory 30 CFR Part 1241
[FR Doc. 2016–13275 Filed 6–8–16; 8:45 am] Committee, with additional [Docket No. ONRR–2016–0002; DS63644000
BILLING CODE 4191–02–P
augmentation of expertise by DR2PS0000.CH7000167D0102R2]
appropriate subject matter experts
serving as temporary members on the RIN 1012–AA17
DEPARTMENT OF HEALTH AND committee.
Civil Monetary Penalties Inflation
HUMAN SERVICES The Committee is no longer needed Adjustment
and will be terminated on June 9, 2016.
Food and Drug Administration AGENCY: Office of the Secretary, Office
Under 5 U.S.C. 553(b)(3)(B) and (d) of Natural Resources Revenue, Interior.
and 21 CFR 10.40 (d) and (e), the
21 CFR Part 14 ACTION: Interim final rule.
Agency finds good cause to dispense
[Docket No. FDA–2016–N–0001] with notice and public comment SUMMARY: The Office of Natural
procedures and to proceed to an Resources Revenue (ONRR) publishes
Advisory Committee; Transmissible immediate effective date on this rule. this interim final rule to adjust the
Spongiform Encephalopathies Notice and public comment and a amount of our civil monetary penalties
Advisory Committee; Termination delayed effective date are unnecessary (CMPs) for inflation with an initial
AGENCY: Food and Drug Administration, and are not in the public interest as this ‘‘catch-up’’ adjustment under the
HHS. final rule merely removes the name of Federal Civil Penalties Inflation
ACTION: Final rule. the Transmissible Spongiform Adjustment Act Improvements Act of
Encephalopathies Advisory Committee 2015 and Office of Management and
SUMMARY: The Food and Drug from the list of standing advisory Budget (OMB) guidance.
Administration (FDA) is announcing the committees in 21 CFR 14.100. DATES: This rule is effective July 11,
termination of the Transmissible 2016. Comments will be accepted until
Therefore, the Agency is amending 21
Spongiform Encephalopathies Advisory August 8, 2016.
CFR 14.100(b) as set forth in the
Committee. This document removes the ADDRESSES: You may submit comments
Transmissible Spongiform regulatory text of this document.
to ONRR by one of the following three
Encephalopathies Advisory Committee List of Subjects in 21 CFR Part 14 methods. (Please reference the
from the Agency’s list of standing Regulation Identifier Number (RIN)
advisory committees. Administrative practice and
1012–AA17 in your comments.). See
DATES: This rule is effective June 9, procedure, Advisory committees, Color
also Public Availability of Comments
2016. additives, Drugs, Radiation protection.
under Procedural Requirements.
FOR FURTHER INFORMATION CONTACT: Therefore, under the Federal Food, 1. Electronically, go to
Bryan Emery, Division of Scientific Drug, and Cosmetic Act and under www.regulations.gov. In the entry titled
Advisors and Consultants, Food and authority delegated to the Commissioner ‘‘Enter Keyword or ID,’’ enter ‘‘ONRR–
Drug Administration, 10903 New of Food and Drugs, 21 CFR part 14 is 2016–0002,’’ and then click ‘‘Search.’’
Hampshire Ave., Bldg. 71, Rm. 6132, amended as follows: Follow the instructions to submit public
Silver Spring, MD 20993–0002, 240– comments. ONRR will post all
402–8054, FAX: 301–595–1307, or PART 14—PUBLIC HEARING BEFORE comments.
bryan.emery@fda.hhs.gov. A PUBLIC ADVISORY COMMITTEE 2. Mail comments to Luis Aguilar,
SUPPLEMENTARY INFORMATION: The
Regulatory Specialist, ONRR, P.O. Box
Transmissible Spongiform ■ 1. The authority citation for part 14 25165, MS 64400B, Denver, Colorado
Encephalopathies Advisory Committee continues to read as follows: 80225.
(the Committee) was established on June 3. Hand-carry comments, or use an
Authority: 5 U.S.C. App. 2; 15 U.S.C. overnight courier service to the Office of
9, 1995 (60 FR 31311, June 14, 1995; 21 1451–1461, 21 U.S.C. 41–50, 141–149, 321–
CFR 14.100 erroneously lists the date of Natural Resources Revenue, Building
394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 53, Entrance E–20, Denver Federal
establishment as June 21, 1995). The U.S.C. 201, 262, 263b, 264; Pub. L. 107–109;
Committee reviews and evaluates Center, West 6th Ave. and Kipling St.,
Pub. L. 108–155. Denver, Colorado 80225.
available scientific data concerning the
safety of products that may be a risk for § 14.100 [Amended] FOR FURTHER INFORMATION CONTACT: For
transmission of spongiform comments or questions on procedural
encephalopathies having an impact on ■ 2. In § 14.100, redesignate paragraph issues, contact Luis Aguilar, Regulatory
the public health as determined by the (b)(5) as (b)(4) and remove paragraph Specialist, by telephone at (303) 231–
Commissioner of Food and Drugs. The (b)(6). 3418 or email to luis.aguilar@onrr.gov.
Committee makes recommendations to Dated: June 6, 2016. For questions on technical issues,
the Commissioner regarding the Jill Hartzler Warner,
contact Geary Keeton, Chief of
regulation of such products. In recent Enforcement, by telephone at (303) 231–
rmajette on DSK2TPTVN1PROD with RULES
Associate Commissioner for Special Medical 3096 or email to geary.keeton@onrr.gov.
years, the number of issues requiring Programs.
Committee advice has declined, and the SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–13705 Filed 6–8–16; 8:45 am]
Committee has met very infrequently. I. Background
BILLING CODE 4164–01–P
Therefore, the effort and expense of II. Method of Calculation
maintaining this advisory committee is III. Summary of Final Rule
no longer justified. Any relevant IV. Procedural Requirements
VerDate Sep<11>2014 14:17 Jun 08, 2016 Jkt 238001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\09JNR1.SGM 09JNR1](https://thefederalregister.org/doc/81_FR_37264/page/1.svg)
Document Created: 2018-02-08 07:33:54
Document Modified: 2018-02-08 07:33:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective June 9, 2016. | |
| 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] | |
| FR Citation | 81 FR 37153 | |
| CFR Associated | Administrative Practice and Procedure; Advisory Committees; Color Additives; Drugs and Radiation Protection |
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