[Federal Register Volume 60, Number 40 (Wednesday, March 1, 1995)]
[Rules and Regulations]
[Pages 11026-11027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-5058]



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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 450

[Docket No. 94N-0302]


Antibiotic Drugs; Bleomycin Sulfate; Stay of Regulation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; stay of regulation.

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

SUMMARY: The Food and Drug Administration (FDA) is staying a regulation 
that established standards for an antibiotic drug, bleomycin sulfate 
bulk drug substance. This action is being taken in response to a 
petition for stay of action.

EFFECTIVE DATE: November 9, 1994.

FOR FURTHER INFORMATION CONTACT: Tamar S. Nordenberg, Center for Drug 
Evaluation and Research (HFD-366), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 4, 1994 
(59 FR 50484), FDA published, as a final rule to become effective on 
November 3, 1994, a new antibiotic regulation setting forth standards 
for a bleomycin sulfate bulk drug substance (21 CFR 450.10). This new 
regulation differed from the monograph standards for sterile bleomycin 
sulfate bulk drug, set forth in 21 CFR 450.10a, in two respects: The 
new regulation did not require sterility at the bulk stage, and the new 
regulation [[Page 11027]] did not require testing for pyrogens at the 
bulk stage.
    Bristol-Myers Squibb Co., the manufacturer of the innovator 
product, filed a petition for stay of action pursuant to 21 CFR 10.35, 
objecting to FDA's decision to promulgate the new regulation without 
notice and a prior opportunity for public comment. On November 9, 1994, 
FDA agreed to stay the effective date of the monograph for bleomycin 
sulfate bulk drug substance in order to reconsider the manner in which 
the agency promulgated the new monograph. A copy of FDA's letter 
notifying Bristol-Myers Squibb Co. of the stay is on file in the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
450 is amended as follows:

List of Subjects in 21 CFR Part 450

    Antibiotics.

PART 450--ANTITUMOR ANTIBIOTIC DRUGS

    1. The authority citation for 21 CFR part 450 continues to read as 
follows:

    Authority: Sec. 507 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 357).

Sec. 450.10  [Stayed]

    2. Section 450.10 Bleomycin sulfate is stayed effective November 9, 
1994.

    Dated: February 15, 1995.
Murray M. Lumpkin,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 95-5058 Filed 2-28-95; 8:45 am]
BILLING CODE 4160-01-F