Reports and guidance documents; availability, etc.: Submitting and reviewing complete responses to clinical holds; industry guidance,

[Federal Register: May 14, 1998 (Volume 63, Number 93)]

[Notices]

[Page 26809-26810]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr14my98-70]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0282]

Guidance for Industry on Submitting and Reviewing Complete Responses to Clinical Holds; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Submitting and Reviewing Complete Responses to Clinical Holds.'' This guidance describes how to submit a complete response if an investigational new drug application is placed on clinical hold.

DATES: Written comments may be submitted on this guidance document by August 12, 1998. General comments on agency guidance documents are welcome at any time.

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 addresses that follow.

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, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-0373.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a guidance for industry entitled ``Submitting and Reviewing Complete Responses to Clinical Holds.'' Section 117 of the Food and Drug Administration Modernization Act of 1997 (Modernization Act), signed into law by President Clinton on November 21, 1997, provides that a written request that a clinical hold be removed shall receive a decision in writing, specifying the reasons for that decision, within 30 days after receipt of such request. In addition, the agency committed to user fee performance goals incorporating the same response time. This guidance describes how sponsors should submit responses to clinical holds so that they may be identified as complete responses and the agency can track the time to response.

This guidance document 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 for industry is 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 submitting complete responses to clinical holds. 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.

The guidance and comments received in the Dockets Management Branch (address above) are available for public examination between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 26810]]

Dated: May 8, 1998. William B. Schultz, Deputy Commissioner for Policy.

[FR Doc. 98-12831Filed5-13-98; 8:45 am]

BILLING CODE 4160-01-F