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

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.

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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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