Document ID: FDA-2008-N-0341-0005
Agency: fda
Document Type: Rule
Title: Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports: Reporting Information about Authorized Generic Drugs; Withdrawal
Posted Date: 2009-02-10T05:00Z

[Federal Register: February 10, 2009 (Volume 74, Number 26)]
[Rules and Regulations]
[Page 6541]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10fe09-3]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. FDA-2008-N-0341]

Applications for Food and Drug Administration Approval to Market
a New Drug; Postmarketing Reports; Reporting Information About
Authorized Generic Drugs; Withdrawal

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 September 29, 2008 (73 FR 56487), a direct final
rule amending its regulations to require that the holder of a new drug
application (NDA) submit certain information regarding authorized
generic drugs in an annual report to a central office in the agency.
The comment period closed December 15, 2008. FDA is withdrawing the
direct final rule because the agency received significant adverse
comment.

DATES:  The direct final rule published at 73 FR 56487 on September 29,
2008, is withdrawn as of February 10, 2009.

FOR FURTHER INFORMATION CONTACT:  Michelle D.D. Bernstein, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6362, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: FDA published a direct final rule on
September 29, 2008 (73 FR 56487), that was intended to amend its
regulations to require that the holder of an NDA submit certain
information regarding authorized generic drugs in an annual report to a
central office in the agency. In response to the direct final rule, the
agency received significant adverse comments about the proposed
revisions to the rule.
    Under FDA's direct final rules procedures, the receipt of any
significant adverse comment will result in the withdrawal of the direct
final rule. Thus, this direct final rule is being withdrawn, effective
immediately. Comments received by the agency regarding the withdrawn
rule will be considered in developing a final rule using the usual
Administrative Procedure Act notice-and-comment procedures.

    Authority:  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 September 29,
2008 (73 FR 56487), is withdrawn.

    Dated: February 5, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-2746 Filed 2-9-09; 8:45 am]

BILLING CODE 4160-01-S