[Federal Register Volume 72, Number 61 (Friday, March 30, 2007)]
[Rules and Regulations]
[Page 15043]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5895]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 310

[Docket No. 2007N-0099]


New Drugs Exempted From Prescription-Dispensing Requirements; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: Amendments to the Federal Food, Drug, and Cosmetic Act (the 
act) necessitate several changes to the citations used in Food and Drug 
Administration (FDA) regulations regarding the prescription-exemption 
procedure and the list of new drugs that are exempted from the 
prescription-dispensing requirements. These changes are editorial, 
pertaining only to citations, and do not constitute a change in FDA 
regulation.

DATES: This rule is effective March 30, 2007.

FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5496, Silver Spring, MD 20993, 301-796-
2090.

SUPPLEMENTARY INFORMATION: Section 126 of the Food and Drug 
Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) 
amended section 503(b)(1) of the act (21 U.S.C. 353(b)(1)). 
Specifically, the previous paragraph (b)(1)(A) of the act was stricken 
from the act and paragraphs (b)(1)(B) and (b)(1)(C) were redesignated 
as paragraphs (b)(1)(A) and (b)(1)(B), respectively. This amendment to 
the act necessitates that FDA revise the corresponding citations in its 
regulations. FDA is making this change in 21 CFR part 310 (Sec. Sec.  
310.200 and 310.201). These changes are editorial, pertaining only to 
citations, and do not constitute a change in FDA regulation.
    Publication of this document constitutes final action on this 
change under the Administrative Procedure Act (5 U.S.C. 553). Notice 
and public procedures are unnecessary because FDA is merely 
implementing a change in citation to a section of the act as a result 
of amendment of the act.

List of Subjects in 21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical 
devices, 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 part 
310 is amended as follows:

PART 310--NEW DRUGS

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1. The authority citation for 21 CFR part 310 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 
360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 
263b-263n.


Sec.  310.200  [Amended]

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2. In Sec.  310.200(a), (b), and (e) remove ``503(b)(1)(C)'' wherever 
it appears and add in its place ``503(b)(1)(B)''.


Sec.  310.201  [Amended]

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3. In Sec.  310.201(a) remove ``503(b)(1)(C)'' and add in its place 
``503(b)(1)(B)''.

    Dated: March 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5895 Filed 3-29-07; 8:45 am]
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