[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16, 1998, is withdrawn on September 23, 1998.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withdrawn.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]
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