[Federal Register: November 18, 2008 (Volume 73, Number 223)]
[Rules and Regulations]               
[Page 68332-68333]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no08-11]                         

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


21 CFR Part 601


[Docket No. FDA-2006-N-0364] (formerly Docket No. 2006N-0466)

 
Exceptions or Alternatives to Labeling Requirements for Products 
Held by the Strategic National Stockpile; Technical Amendment


AGENCY: Food and Drug Administration, HHS.


ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------


SUMMARY: The Food and Drug Administration (FDA) is amending the 
biologics regulations to reincorporate a regulation that was 
inadvertently removed. This action is being taken to correct the 
regulations.


DATES: This rule is effective November 18, 2008.


FOR FURTHER INFORMATION CONTACT: Tiffany J. Brown, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.


SUPPLEMENTARY INFORMATION: FDA has discovered that an error appeared in 
the agency's codified regulations for part 601 (21 CFR part 601). In 
the Federal Register of December 28, 2007 (72 FR 73589), FDA published 
an interim final rule that inadvertently revised Sec.  
601.12(f)(3)(i)(D) (21 CFR 601.12(f)(3)(i)(D)) instead of adding a new 
paragraph, Sec.  601.12(f)(3)(i)(E). Accordingly, Sec.  
601.12(f)(3)(i)(D), which was added in the Federal Register of January 
24, 2006 (71 FR 3922), is being reincorporated into the regulations to 
replace current Sec.  601.12(f)(3)(i)(D); current Sec.  
601.12(f)(3)(i)(D) is being redesignated as Sec.  601.12(f)(3)(i)(E). 
This document corrects the errors described previously. 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 this amendment is nonsubstantive.


[[Page 68333]]


List of Subjects in 21 CFR Part 601


    Administrative practice and procedure, Biologics, Confidential 
business information.


0
Therefore, under the Federal Food, Drug, and Cosmetic Act and the 
Public Health Service Act, and under authority delegated to the 
Commissioner of Food and Drugs, 21 CFR part 601 is amended as follows:

PART 601--LICENSING

0
1. The authority citation for 21 CFR part 601 continues to read as 
follows:


    Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 
355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 
216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 
(21 U.S.C. 355 note).

0


2. In Sec.  601.12, redesignate paragraph (f)(3)(i)(D) as paragraph 
(f)(3)(i)(E) and add new paragraph (f)(3)(i)(D) to read as follows:


Sec.  601.12  Changes to an approved application.

* * * * *
    (f) * * *
    (3)(i) * * *
    (D) A change to the information required in Sec.  201.57(a) of this 
chapter as follows:
    (1) Removal of a listed section(s) specified in Sec.  201.57(a)(5) 
of this chapter; and
    (2) Changes to the most recent revision date of the labeling as 
specified in Sec.  201.57(a)(15) of this chapter.
* * * * *

    Dated: November 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.


[FR Doc. E8-27254 Filed 11-17-08; 8:45 am]


BILLING CODE 4160-01-S