Administrative Practices and Procedures; Internal Agency Review of Decisions

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16, 1998, is withdrawn on September 23, 1998.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withdrawn.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