[Federal Register Volume 75, Number 124 (Tuesday, June 29, 2010)]
[Rules and Regulations]
[Page 37295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15711]
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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.
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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.
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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
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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]
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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
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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]
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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]
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