Investigational New Drug Applications and Abbreviated New Drug Applications; Technical Amendment, 13880 [2011-5946]
Download as PDF
<![CDATA[
13880
Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Rules and Regulations
List of Subjects in 19 CFR Part 12
Cultural property, Customs duties and
inspection, Imports, Prohibited
merchandise.
Amendment to CBP Regulations
For the reasons set forth above, part
12 of Title 19 of the Code of Federal
Regulations (19 CFR part 12), is
amended as set forth below:
PART 12—SPECIAL CLASSES OF
MERCHANDISE
1. The general authority citation for
part 12 and the specific authority
citation for § 12.104g continue to read as
follows:
■
Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202
(General Note 3(i), Harmonized Tariff
Schedule of the United States (HTSUS)),
1624;
*
*
*
*
*
Sections 12.104 through 12.104i also
issued under 19 U.S.C. 2612;
*
*
*
§ 12.104g
*
*
[Amended]
2. In § 12.104g, paragraph (a), the table
is amended in the entry for Colombia by
adding, after the reference to ‘‘CBP Dec.
06–09’’, the words ‘‘extended by CBP
Dec. 11–06’’.
■
action is being taken to ensure accuracy
and clarity in the Agency’s regulations.
DATES: This rule is effective March 15,
2011.
FOR FURTHER INFORMATION CONTACT:
Olivia A. Pritzlaff, Center for Drug
Evaluation and Research, Food and
Drug Administration, Bldg. 51, Rm.
6308, 10903 New Hampshire Ave.,
Silver Spring, MD 20993–0002, 301–
796–3506.
SUPPLEMENTARY INFORMATION: FDA is
amending its regulation in 21 CFR
312.83 to correct an inaccurate crossreference to other sections of the IND
regulations. FDA is amending its
regulation in 21 CFR 314.94 to correct
an inaccurate cross-reference to a
section of the FD&C Act.
Publication of this document
constitutes final action on these changes
under the Administrative Procedure Act
(5 U.S.C. 553). FDA has determined that
notice and public comment are
unnecessary because this amendment to
the regulations provides only technical
changes to correct inaccurate crossreferences to the IND regulations and
the FD&C Act.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 356, 356a, 356b, 356c, 371, 374,
379e.
List of Subjects
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
PART 312—INVESTIGATIONAL NEW
DRUG APPLICATION
[Docket No. FDA–2011–N–0130]
Investigational New Drug Applications
and Abbreviated New Drug
Applications; Technical Amendment
Food and Drug Administration,
HHS.
erowe on DSK5CLS3C1PROD with RULES
1. The authority citation for 21 CFR
part 312 continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360bbb, 371; 42 U.S.C. 262.
§ 312.83
Final rule; technical
amendment.
ACTION:
[Amended]
2. Section 312.83 is amended by
removing ‘‘312.34 and 312.35’’ and by
adding in its place ‘‘312.305 and
312.320’’.
■
The Food and Drug
Administration (FDA) is amending its
investigational new drug application
(IND) regulations and abbreviated new
drug application regulations to correct
inaccurate cross-references to the IND
regulations and the Federal Food, Drug,
and Cosmetic Act (the FD&C Act). This
Jkt 223001
BILLING CODE 4160–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 301
[TD 9516]
RIN 1545–BG73
Disclosure of Return Information in
Connection With Written Contracts
Among the IRS, Whistleblowers, and
Legal Representatives of
Whistleblowers
SUMMARY:
21 CFR Parts 312 and 314
13:15 Mar 14, 2011
[FR Doc. 2011–5946 Filed 3–14–11; 8:45 am]
21 CFR Part 312
Administrative practice and
procedure, Confidential business
information, Drugs, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 312
and 314 are amended as follows:
BILLING CODE 9111–14–P
VerDate Mar<15>2010
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations and removal of
temporary regulations.
21 CFR Part 314
[FR Doc. 2011–5879 Filed 3–14–11; 8:45 am]
SUMMARY:
[Amended]
4. Section 314.94 is amended in
paragraph (a)(8)(iv) by removing
‘‘505(j)(4)(D)’’ and by adding in its place
‘‘505(j)(5)(F)’’.
■
Drugs, Exports, Imports,
Investigations, Labeling, Medical
research, Reporting and recordkeeping
requirements, Safety.
Alan Bersin,
Commissioner, U.S. Customs and Border
Protection.
Approved: March 9, 2011.
Timothy E. Skud,
Deputy Assistant Secretary of the Treasury.
AGENCY:
§ 314.94
PART 314—APPLICATIONS FOR FDA
APPROVAL TO MARKET A NEW DRUG
3. The authority citation for 21 CFR
part 314 continues to read as follows:
■
PO 00000
Frm 00002
Fmt 4700
Sfmt 4700
This document contains final
regulations relating to the disclosure of
return information by an officer or
employee of the Treasury Department,
to a whistleblower and, if applicable,
the legal representative of the
whistleblower, to the extent necessary
in connection with a written contract
among the IRS, the whistleblower and,
if applicable, the legal representative of
the whistleblower, for services relating
to the detection of violations of the
internal revenue laws or related statutes.
The final regulations will affect officers
and employees of the Treasury
Department who disclose return
information to whistleblowers or their
legal representatives in connection with
written contracts among the IRS,
whistleblowers and, if applicable, their
legal representatives, for services
relating to the detection of violations of
the internal revenue laws or related
statutes. The final regulations will also
affect any whistleblower or legal
representative of a whistleblower who
receives return information in
connection with a written contract
among the IRS, the whistleblower and,
if applicable, the legal representative of
the whistleblower, for services relating
to the detection of violations of the
internal revenue laws or related statutes.
E:\FR\FM\15MRR1.SGM
15MRR1
]]>Agencies
[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Rules and Regulations]
[Page 13880]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-5946]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 312 and 314
[Docket No. FDA-2011-N-0130]
Investigational New Drug Applications and Abbreviated New Drug
Applications; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its
investigational new drug application (IND) regulations and abbreviated
new drug application regulations to correct inaccurate cross-references
to the IND regulations and the Federal Food, Drug, and Cosmetic Act
(the FD&C Act). This action is being taken to ensure accuracy and
clarity in the Agency's regulations.
DATES: This rule is effective March 15, 2011.
FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, Center for Drug
Evaluation and Research, Food and Drug Administration, Bldg. 51, Rm.
6308, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
3506.
SUPPLEMENTARY INFORMATION: FDA is amending its regulation in 21 CFR
312.83 to correct an inaccurate cross-reference to other sections of
the IND regulations. FDA is amending its regulation in 21 CFR 314.94 to
correct an inaccurate cross-reference to a section of the FD&C Act.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has
determined that notice and public comment are unnecessary because this
amendment to the regulations provides only technical changes to correct
inaccurate cross-references to the IND regulations and the FD&C Act.
List of Subjects
21 CFR Part 312
Drugs, Exports, Imports, Investigations, Labeling, Medical
research, Reporting and recordkeeping requirements, Safety.
21 CFR Part 314
Administrative practice and procedure, Confidential business
information, Drugs, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
312 and 314 are amended as follows:
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION
0
1. The authority citation for 21 CFR part 312 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371;
42 U.S.C. 262.
Sec. 312.83 [Amended]
0
2. Section 312.83 is amended by removing ``312.34 and 312.35'' and by
adding in its place ``312.305 and 312.320''.
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
0
3. The authority citation for 21 CFR part 314 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 356a,
356b, 356c, 371, 374, 379e.
Sec. 314.94 [Amended]
0
4. Section 314.94 is amended in paragraph (a)(8)(iv) by removing
``505(j)(4)(D)'' and by adding in its place ``505(j)(5)(F)''.
Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5946 Filed 3-14-11; 8:45 am]
BILLING CODE 4160-01-P
