Change of Address; Abbreviated New Drug Applications; Technical Amendment, 37295 [2010-15711]
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Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Rules and Regulations
MPN II, Rockville, MD 20855, 240–276–
8675.
signed August 27, 2009, and effective
September 15, 2009 is amended as
follows:
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*
*
*
ANM WA, ES Kelso, WA [Modified]
Southwest Washington Regional Airport, WA
(Lat. 46°07′05″ N., long. 122°53′54″ W.)
*
*
*
*
*
That airspace extending upward from 700
feet above the surface within a 6.4-mile
radius of the Southwest Washington Regional
Airport, and 2.4 miles each side of the 290°
bearing of the airport extending 9.1 miles
west, and 4.3 miles each side of the 337°
bearing of the airport extending 22.2 miles
northwest, and 5.8 miles west and 3 miles
east of the 012° bearing of the airport
extending 18.2 miles north of the airport.
Issued in Seattle, Washington, on June 14,
2010.
Kevin Nolan,
Acting Manager, Operations Support Group,
Western Service Center.
[FR Doc. 2010–15436 Filed 6–28–10; 8:45 am]
BILLING CODE 4910–13–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Change of Address; Abbreviated New
Drug Applications; Technical
Amendment
Food and Drug Administration,
HHS.
wwoods2 on DSK1DXX6B1PROD with RULES
ACTION: Final rule; technical
amendment.
SUMMARY: The Food and Drug
Administration (FDA) is amending its
regulations to update the address for
applicants to submit abbreviated new
drug applications (ANDAs) and ANDA
amendments, supplements, and
resubmissions. FDA is also updating the
address for ANDA applicants to submit
investigational new drug applications
(INDs) for in vivo bioavailability and
bioequivalence studies in humans that
are intended to support ANDAs. This
action is being taken to ensure accuracy
and clarity in the agency’s regulations.
DATES: This rule is effective August 1,
2010.
FOR FURTHER INFORMATION CONTACT:
Martin Shimer, Center for Drug
Evaluation and Research, Food and
Drug Administration, 7500 Standish Pl.,
15:06 Jun 28, 2010
■
21 CFR Part 312
[Docket No. FDA–2010–N–0010]
VerDate Mar<15>2010
FDA is
amending 21 CFR 314.440(a)(2) to
update the address for applicants to
submit ANDAs and ANDA
amendments, supplements, and
resubmissions. FDA is also amending 21
CFR 312.140(a)(1) to update the address
for ANDA applicants to submit INDs for
in vivo bioavailability and
bioequivalence studies that are intended
to support ANDAs. The new address for
all these submissions is Office of
Generic Drugs (HFD–600), Center for
Drug Evaluation and Research, Food
and Drug Administration, Metro Park
North VII, 7620 Standish Pl., Rockville,
MD 20855. This action is being taken to
ensure accuracy and clarity in the
agency’s regulations.
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 update an address for the
submission of ANDAs; ANDA
amendments, supplements, and
resubmissions; and INDs related to
ANDAs.
List of Subjects
21 CFR Parts 312 and 314
AGENCY:
PART 314—APPLICATIONS FOR FDA
APPROVAL TO MARKET A NEW DRUG
SUPPLEMENTARY INFORMATION:
Paragraph 6005 Class E airspace areas
extending upward from 700 feet or more
above the surface of the earth.
*
Jkt 220001
37295
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
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.
§ 312.140
[Amended]
2. Section 312.140 is amended in
paragraph (a)(1) by removing ‘‘II, 7500’’
and adding in its place ‘‘VII, 7620’’.
■
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
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.
§ 314.440
[Amended]
4. Section 314.440 is amended in the
first sentence of paragraph (a)(2) by
removing ‘‘II, 7500 Standish Place., rm.
150’’ and adding in its place ‘‘VII, 7620
Standish Pl.’’.
■
Dated: June 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–15711 Filed 6–28–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–305F]
RIN 1117–AB16
Control of Immediate Precursor Used
in the Illicit Manufacture of Fentanyl as
a Schedule II Controlled Substance
AGENCY: Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final Rule.
SUMMARY: The Drug Enforcement
Administration (DEA) is designating the
precursor chemical, 4-anilino-Nphenethyl-4-piperidine (ANPP) as an
immediate precursor for the schedule II
controlled substance fentanyl under the
definition set forth in 21 U.S.C. 802(23).
Furthermore, DEA is finalizing the
control of ANPP as a schedule II
substance under the Controlled
Substances Act (CSA), pursuant to the
authority in 21 U.S.C. 811(e), which
states that an immediate precursor may
be placed in the same schedule as the
controlled substance it produces,
without regard to the procedures
required by 21 U.S.C. 811(a) and (b) and
without regard to the findings required
by 21 U.S.C. 811(a) and 812(b).
ANPP is the immediate chemical
intermediary in the synthesis process
currently used by clandestine laboratory
operators for the illicit manufacture of
the schedule II controlled substance
fentanyl. In 2005 and 2006, the
distribution of illicitly manufactured
fentanyl caused an unprecedented
outbreak of hundreds of fentanyl-related
E:\FR\FM\29JNR1.SGM
29JNR1
]]>Agencies
[Federal Register Volume 75, Number 124 (Tuesday, June 29, 2010)]
[Rules and Regulations]
[Page 37295]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-15711]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 312 and 314
[Docket No. FDA-2010-N-0010]
Change of Address; 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
regulations to update the address for applicants to submit abbreviated
new drug applications (ANDAs) and ANDA amendments, supplements, and
resubmissions. FDA is also updating the address for ANDA applicants to
submit investigational new drug applications (INDs) for in vivo
bioavailability and bioequivalence studies in humans that are intended
to support ANDAs. This action is being taken to ensure accuracy and
clarity in the agency's regulations.
DATES: This rule is effective August 1, 2010.
FOR FURTHER INFORMATION CONTACT: Martin Shimer, Center for Drug
Evaluation and Research, Food and Drug Administration, 7500 Standish
Pl., MPN II, Rockville, MD 20855, 240-276-8675.
SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR 314.440(a)(2) to
update the address for applicants to submit ANDAs and ANDA amendments,
supplements, and resubmissions. FDA is also amending 21 CFR
312.140(a)(1) to update the address for ANDA applicants to submit INDs
for in vivo bioavailability and bioequivalence studies that are
intended to support ANDAs. The new address for all these submissions is
Office of Generic Drugs (HFD-600), Center for Drug Evaluation and
Research, Food and Drug Administration, Metro Park North VII, 7620
Standish Pl., Rockville, MD 20855. This action is being taken to ensure
accuracy and clarity in the agency's regulations.
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 update
an address for the submission of ANDAs; ANDA amendments, supplements,
and resubmissions; and INDs related to ANDAs.
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.
0
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. 312.140 [Amended]
0
2. Section 312.140 is amended in paragraph (a)(1) by removing ``II,
7500'' and adding in its place ``VII, 7620''.
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. 314.440 [Amended]
0
4. Section 314.440 is amended in the first sentence of paragraph (a)(2)
by removing ``II, 7500 Standish Place., rm. 150'' and adding in its
place ``VII, 7620 Standish Pl.''.
Dated: June 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-15711 Filed 6-28-10; 8:45 am]
BILLING CODE 4160-01-S
