[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]
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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.
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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.
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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
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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).
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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