Food and Drug Administration, HHS.
Final rule; technical amendment.
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.
This rule is effective March 30, 2007.Start Further Info
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.End Further Info End Preamble Start Supplemental 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 (§§ 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.Start List of Subjects
List of Subjects in 21 CFR Part 310
- Administrative practice and procedure
- Medical devices
- Reporting and recordkeeping requirements
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs,End Amendment Part Start Part
PART 310—NEW DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In § 310.200(a), (b), and (e) remove “503(b)(1)(C)” wherever it appears and add in its place “503(b)(1)(B)”.End Amendment Part
3. In § 310.201(a) remove “503(b)(1)(C)” and add in its place “503(b)(1)(B)”.End Amendment Part Start Signature
Dated: March 22, 2007.
Assistant Commissioner for Policy.
[FR Doc. E7-5895 Filed 3-29-07; 8:45 am]
BILLING CODE 4160-01-S