This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
Food and Drug Administration, HHS.
Final rule; technical amendment.
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.
This rule is effective August 29, 2000.Start Further Info
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.End Further Info End Preamble Start Supplemental 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 § 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.Start List of Subjects
List of Subjects in 21 CFR Part 56
- Human research subjects
- Reporting and recordkeeping requirements
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:Start Part
PART 56—INSTITUTIONAL REVIEW BOARDS
1. The authority citation for 21 CFR part 56 continues to read as follows:
(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]
BILLING CODE 4160-01-F