FDA Regulations; Technical Amendment; Correction, 54314 [E8-21966]

Download as PDF 54314 Federal Register / Vol. 73, No. 183 / Friday, September 19, 2008 / Rules and Regulations Arms Regulations (ITAR) to clarify that certain anti-tumor drugs are not within the definition of ‘‘chemical agents.’’ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Effective Date: This rule is effective September 19, 2008. DATES: 21 CFR Parts 16, 610, 640, 812, 814, 822, and 860 [Docket No. FDA–2008–N–0423] FDA Regulations; Technical Amendment; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Interested parties may submit comments at any time by any of the following methods: • E-mail: DDTCResponseTeam@state.gov with an appropriate subject line. • Mail: Department of State, Directorate of Defense Trade Controls, Office of Defense Trade Controls Policy, ATTN: Regulatory Change, 12th Floor, SA–1, Washington, DC 20522–0112. • Fax: 202–261–8199. Persons with access to the Internet may also view this notice by going to the regulations.gov Web site at: https:// www.regulations.gov/index.cfm. ADDRESSES: Final rule; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Monday, August 25, 2008 (73 FR 49941). The final rule made technical amendments to several FDA regulations. The document was published with two inaccurate citations in the first paragraph of the Background Section under Supplementary Information. This document corrects that error. DATES: September 19, 2008. FOR FURTHER INFORMATION CONTACT: ´ Denise Sanchez, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: In FR Doc. E8–19654, appearing on page 49941 in the Federal Register of Monday, August 25, 2008 (73 FR 49941), the following correction is made: On page 49941, in the first paragraph of the Background section under Supplementary Information, ‘‘21 CFR 610.51’’ is corrected to read as ‘‘21 CFR 610.53’’ and ‘‘21 CFR 640.53’’ is corrected to read as ‘‘21 CFR 640.51’’. Dated: September 15, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–21966 Filed 9–18–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF STATE Lisa Wenger, Office of Defense Trade Controls Policy, Department of State; Telephone 202–663–2171 or FAX 202– 261–8199; e-mail: DDTCResponseTeam@state.gov. ATTN: Regulatory Change. FOR FURTHER INFORMATION CONTACT: In this regulatory change, we clarify that certain anti-tumor drugs are not considered defense articles under this subchapter; however, the know-how for production of nitrogen mustards or their salts is specifically retained on the U.S. Munitions List. SUPPLEMENTARY INFORMATION: Regulatory Analysis and Notices Administrative Procedure Act This amendment involves a foreign affairs function of the United States and, therefore, is not subject to the procedures contained in 5 U.S.C. 553 and 554. [Public Notice: 6364] yshivers on PROD1PC62 with RULES Amendment to the International Traffic in Arms Regulations: U.S. Munitions List Interpretation Department of State. ACTION: Final rule. AGENCY: SUMMARY: The Department of State is amending the International Traffic in VerDate Aug<31>2005 15:21 Sep 18, 2008 Jkt 214001 Executive Orders 12372 and 13132 This amendment will not 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. Therefore, in accordance with Executive Order 13132, it is determined that this amendment does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. Executive Order 12372, regarding intergovernmental consultation on Federal programs and activities, does not apply to this amendment. Executive Order 12866 This amendment is exempt from review under Executive Order 12866, but has been reviewed internally by the Department of State to ensure consistency with the purposes thereof. Paperwork Reduction Act This rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35. List of Subjects in 22 CFR Part 121 Arms and munitions, Exports, U.S. Munitions List. ■ Accordingly, for the reasons set forth above, Title 22, Chapter I, Subchapter M, part 121 is amended as follows: PART 121—THE UNITED STATES MUNITIONS LIST Regulatory Flexibility Act ■ Because this final rule is exempt from notice and comment rulemaking under 5 U.S.C. 553, it is exempt from the provisions of section 603 and 604 of the Regulatory Flexibility Act (5 U.S.C. 603 and 604). Authority: Secs. 2, 38, and 71, Pub.L. 90– 629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); E.O. 11958, 42 FR 4311; 3 CFR, 1977 Comp. p. 79; 22 U.S.C. 2658; Pub.L. 105–261, 112 Stat. 1920. Unfunded Mandates Act of 1995 22 CFR Part 121 Small Business Regulatory Enforcement Fairness Act of 1996 This amendment has been found not to be a major rule within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996. This amendment does not involve a mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 1. The authority citation for part 121 continues to read as follows: 2. In § 121.1, paragraph (c) Category XIV is amended by adding NOTE 5 to read as follows: ■ § 121.1 General. The United States Munitions List. * * * (c) * * * * * * * * * * Category XIV—Toxicological Agents, Including Chemical Agents, Biological Agents, and Associated Equipment * E:\FR\FM\19SER1.SGM * * 19SER1 * *

Agencies

[Federal Register Volume 73, Number 183 (Friday, September 19, 2008)]
[Rules and Regulations]
[Page 54314]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21966]



[[Page 54314]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16, 610, 640, 812, 814, 822, and 860

[Docket No. FDA-2008-N-0423]


FDA Regulations; Technical Amendment; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of Monday, August 25, 2008 
(73 FR 49941). The final rule made technical amendments to several FDA 
regulations. The document was published with two inaccurate citations 
in the first paragraph of the Background Section under Supplementary 
Information. This document corrects that error.

DATES:  September 19, 2008.

FOR FURTHER INFORMATION CONTACT: Denise S[aacute]nchez, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: In FR Doc. E8-19654, appearing on page 49941 
in the Federal Register of Monday, August 25, 2008 (73 FR 49941), the 
following correction is made:
    On page 49941, in the first paragraph of the Background section 
under Supplementary Information, ``21 CFR 610.51'' is corrected to read 
as ``21 CFR 610.53'' and ``21 CFR 640.53'' is corrected to read as ``21 
CFR 640.51''.

    Dated: September 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21966 Filed 9-18-08; 8:45 am]
BILLING CODE 4160-01-S
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