[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Rules and Regulations]
[Page 6541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-2746]


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

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.

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

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2008, is withdrawn as of February 10, 2009.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 Thus, this direct final rule is being withdrawn, effective 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 Comments received by the agency regarding the withdrawn 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