[Federal Register Volume 62, Number 158 (Friday, August 15, 1997)]
[Rules and Regulations]
[Page 43639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21649]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314


New Drug Applications and Abbreviated New Drug Applications; 
Editorial Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its new 
drug application (NDA) and abbreviated new drug application (ANDA) 
regulations to reflect a reorganization in the Center for Drug 
Evaluation and Research (CDER). This action will improve the accuracy 
of the regulations.

EFFECTIVE DATE: August 15, 1997.

FOR FURTHER INFORMATION CONTACT:
Olivia A. Vieira, Center for Drug Evaluation and Research (HFD-7), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
594-2041.

SUPPLEMENTARY INFORMATION: FDA is amending its NDA and ANDA regulations 
to reflect a reorganization in CDER. The name of the former Division of 
Regulatory Affairs (HFD-360) has been changed to the Regulatory Policy 
Staff (HFD-7). Furthermore, the division is no longer part of the 
Office of Compliance and now reports to the Associate Director for 
Policy (HFD-5). The regulations are being amended in 21 CFR 314.110 
(a)(3) and (b), 314.120(a)(3), and 314.440(a)(3) to reflect this 
change.
    Publication of this document constitutes final action on these 
changes under the Administrative Procedures Act (5 U.S.C. 553). Because 
the amendments are wholly editorial and nonsubstantive in nature, FDA 
finds that notice and public procedure are unnecessary.

List of Subjects in 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 part 
314 is amended as follows:

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG OR AN 
ANTIBIOTIC DRUG

    1. The authority citation for 21 CFR part 314 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 701, 
704, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 
331, 351, 352, 353, 355, 356, 357, 371, 374, 379e).


Sec. 314.110  [Amended]

    2. Section 314.110 Approvable letter to the applicant is amended in 
paragraphs (a)(3) and (b) by removing the phrase ``Division of 
Regulatory Affairs (HFD-360)'' and adding in its place the phrase 
``Associate Director for Policy (HFD-5)''.


Sec. 314.120  [Amended]

    3. Section 314.120 Not approvable letter to the applicant is 
amended in paragraph (a)(3) by removing the phrase ``Division of 
Regulatory Affairs (HFD-360)'' and adding in its place the phrase 
``Associate Director for Policy (HFD-5)''.


Sec. 314.440  [Amended]

    4. Section 314.440 Addresses for applications and abbreviated 
applications is amended in paragraph (a)(3) by removing the phrase 
``Division of Regulatory Affairs (HFD-360)'' and adding in its place 
the phrase ``Associate Director for Policy (HFD-5)''.

    Dated: August 8, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-21649 Filed 8-14-97; 8:45 am]
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