[Federal Register Volume 63, Number 184 (Wednesday, September 23, 1998)]
[Rules and Regulations]
[Page 50757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25363]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 10
[Docket No. 98N-0361]
Administrative Practices and Procedures; Internal Agency Review
of Decisions
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA) published in the
Federal Register of June 16, 1998 (63 FR 32733), a direct final rule to
implement the new Dispute Resolution provision of the Federal Food,
Drug, and Cosmetic Act, as amended by the Food and Drug Administration
Modernization Act of 1997 (FDAMA). The comment period closed on August
31, 1998. FDA is withdrawing the direct final rule because the agency
received significant adverse comment.
EFFECTIVE DATE: The direct final rule published at 63 FR 32733, June
16, 1998, is withdrawn on September 23, 1998.
FOR FURTHER INFORMATION CONTACT: Suzanne M. O'Shea, Office of the Chief
Mediator and Ombudsman (HF-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-3390.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, the
direct final rule published on June 16, 1998, at 63 FR 32733 is
withdrawn.
Dated: September 16, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-25363 Filed 9-22-98; 8:45 am]
BILLING CODE 4160-01-F
