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