[Federal Register Volume 75, Number 62 (Thursday, April 1, 2010)]
[Rules and Regulations]
[Pages 16345-16346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7286]



Food and Drug Administration

21 CFR Part 10

[Docket No. FDA-1999-N-3539] (formerly Docket No. 1999N-4783)

Administrative Practices and Procedures; Good Guidance Practices; 
Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.


SUMMARY: The Food and Drug Administration (FDA) is amending its 
administrative regulations. This action is being taken to ensure 
accuracy and clarity in agency regulations.

DATES: The rule is effective April 1, 2010.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy (HF-
27), Food and Drug Administration, 5600

[[Page 16346]]

Fishers Lane, Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION: FDA is amending its administrative 
regulations in 21 CFR part 10. We are taking this action to ensure 
accuracy and clarity in the agency's regulations.
    Publication of this document constitutes final action under the 
Administrative Procedure Act (5 U.S.C. 553). FDA has determined that 
notice and public comment are unnecessary because the amendments to the 
regulations provide only technical changes to correct inaccurate 
citations and to update terminology, and are nonsubstantive.

List of Subjects in 21 CFR Part 10

    Administrative practice and procedure, News media.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
10 is amended as follows:


1. The authority citation for 21 CFR part 10 continues to read as 

    Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264.

2. In Sec.  10.90, revise paragraphs (a) and (c) to read as follows:

Sec.  10.90  Food and Drug Administration regulations, recommendations, 
and agreements.

    (a) Regulations. FDA regulations are issued in the Federal Register 
under Sec.  10.40 or Sec.  10.50 and codified in the Code of Federal 
Regulations. Regulations may contain provisions that will be enforced 
as legal requirements, or which are intended only as guidance documents 
and recommendations, or both. The dissemination of draft notices and 
regulations is subject to Sec.  10.80.
* * * * *
    (c) Recommendations. In addition to the guidance documents subject 
to Sec.  10.115, FDA often formulates and disseminates recommendations 
about matters which are authorized by, but do not involve direct 
regulatory action under, the laws administered by the Commissioner, 
e.g., model State and local ordinances, or personnel practices for 
reducing radiation exposure, issued under 42 U.S.C. 243 and 21 U.S.C. 
360ii. These recommendations may, in the discretion of the 
Commissioner, be handled under the procedures established in Sec.  
10.115, except that the recommendations will be included in a separate 
public file of recommendations established by the Division of Dockets 
Management and will be separated from the guidance documents in the 
notice of availability published in the Federal Register, or be 
published in the Federal Register as regulations under paragraph (a) of 
this section.
* * * * *

    Dated: March 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7286 Filed 3-31-10; 8:45 am]