[Federal Register: March 30, 2007 (Volume 72, Number 61)]
[Rules and Regulations]
[Page 15043]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr07-4]
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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]
BILLING CODE 4160-01-S