[Federal Register Volume 63, Number 93 (Thursday, May 14, 1998)]
[Notices]
[Pages 26808-26809]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12830]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0284]


Guidance for Industry on Classifying Resubmissions in Response to 
Action Letters; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Classifying 
Resubmissions in Response to Action Letters.'' This guidance explains 
how the agency will classify resubmissions of new drug applications 
(NDA's) and license applications (LA's) and specifies the agency's 
response timeframes. The guidance also recommends procedures for making 
resubmissions.
DATES: Written comments may be submitted on the guidance by August 12, 
1998. General comments on the agency guidance documents are welcome at 
any time.

[[Page 26809]]

ADDRESSES: Copies of this guidance for industry are available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm, or http://
www.fda.gov/cber/guidelines.htm. Submit written comments on this 
guidance to the Dockets Management Branch (HFD-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. After the comment period, comments may 
be submitted to one of the centers at the address below.

FOR FURTHER INFORMATION CONTACT: 
    Murray M. Lumpkin, Center for Drug Evaluation and Research (HFD-
002), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-5400, or
    Robert A. Yetter, Center for Biologics Evaluation and Research 
(HFM-10), 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-0373.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``Classifying Resubmissions in Response 
to Action Letters.'' In the Prescription Drug User Fee Act of 1992 
(PDUFA), FDA committed to certain user fee performance goals, including 
the goal of responding to an applicant's resubmission of an original 
NDA or LA in 6 months or less. In her letter to Congress regarding the 
reauthorization of PDUFA in November 1997 as part of the Food and Drug 
Administration Modernization Act of 1997 (Modernization Act), the 
Secretary of Health and Human Services committed FDA to recognizing two 
classes of resubmissions: Class 1 and Class 2. This guidance describes 
the classification of resubmissions as Class 1 or Class 2 based on the 
information submitted by the applicant in response to the action 
letter. In addition, the guidance specifies the percentages of 
resubmissions in each class that will be reviewed and acted upon within 
a certain time period from the date the resubmission is received by 
FDA, based on the fiscal year in which the resubmission is received.
    This guidance is being implemented immediately without prior public 
comment because the guidance is needed to implement the Modernization 
Act. However, the agency wishes to solicit comment from the public and 
is providing a 90-day comment period and establishing a docket for the 
receipt of comments.
    This guidance is issued as a Level 1 guidance consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). It represents 
the agency's current thinking on classifying resubmissions in response 
to action letters. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute, regulations, or both.
    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 8, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-12830 Filed 5-13-98; 8:45 am]
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