[Federal Register Volume 65, Number 168 (Tuesday, August 29, 2000)]
[Rules and Regulations]
[Page 52302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21895]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 56

[Docket No. 98N-0144]


Biological Products Regulated Under Section 351 of the Public 
Health Service Act; Implementation of Biologics License; Elimination of 
Establishment License and Product License; 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 correct inadvertent errors. This action is 
necessary to ensure the accuracy and consistency of the regulations.

DATES: This rule is effective August 29, 2000.

FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, 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 errors have 
inadvertently become incorporated into the agency's regulations for 
biologics. In the Federal Register of October 20, 1999 (64 FR 56441), a 
final rule incorrectly revised Sec. 56.102 (21 CFR 56.102) in paragraph 
(b)(11) instead of correctly revising paragraph (b)(10). Section 56.102 
(b)(10) and (b)(11) were affected by this inadvertent error. This 
document corrects those errors.

List of Subjects in 21 CFR Part 56

    Human research subjects, Reporting and recordkeeping requirements, 
Safety.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Public Health Service Act, and authority delegated to the Commissioner 
of Food and Drugs, 21 CFR part 56 is amended as follows:

PART 56--INSTITUTIONAL REVIEW BOARDS

    1. The authority citation for 21 CFR part 56 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 346, 346a, 348, 351, 352, 353, 355, 
360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 
263b-263n.
    2. Section 56.102 is amended by revising paragraphs (b)(10) and 
(b)(11) to read as follows:


Sec. 56.102  Definitions.

* * * * *
    (b) * * *
    (10) An application for a biologics license, described in part 601 
of this chapter.
    (11) Data and information regarding a biological product submitted 
as part of the procedures for determining that licensed biological 
products are safe and effective and not misbranded, as described in 
part 601 of this chapter.
* * * * *

    Dated: August 4, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-21895 Filed 8-28-00; 8:45 am]
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