[Federal Register Volume 65, Number 208 (Thursday, October 26, 2000)]
[Notices]
[Page 64226]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27454]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0282]


Revised Guidance for Industry on Submitting and Reviewing 
Complete Responses to Clinical Holds; 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 revised 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 (IND) application is placed on clinical hold. The revised guidance 
reflects amendments to FDA's clinical hold regulations, includes the 
definition of a commercial IND, and discusses the agency's policy on 
resolving clinical trial issues that are not related to the imposition 
of a clinical hold.

DATES: 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 (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Linda S. Carter (HFD-101), Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-6578; or Robert A. Yetter 
(HFM-10), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
0373.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
revised 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. Section 117(3)(c) of the 
Modernization Act is codified in the Federal Food, Drug, and Cosmetic 
Act at section 505(i)(3)(c) (21 U.S.C. 355(i)(3)(c)). In addition, the 
agency committed to user fee performance goals incorporating the same 
response time. In the Federal Register of December 14, 1998 (63 FR 
68676), FDA amended its clinical hold regulations in Sec. 312.42(e) (21 
CFR 312.42(e)) to include this 30-day response requirement. 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.
    In the Federal Register of May 14, 1998 (63 FR 26809), FDA 
published a notice announcing the availability of the original guidance 
and soliciting comments. Two comments on the guidance were submitted to 
the docket. After considering the comments, FDA is issuing a revised 
guidance.
    The revised guidance: (1) Reflects amendments to FDA's clinical 
hold regulations, stating that FDA will respond in writing within 30-
calendar days of receipt of a sponsor's request to release a clinical 
hold and complete response to the issue(s) that led to the clinical 
hold (Sec. 312.42(e)); (2) includes the definition of a commercial IND 
and clarifies that the Prescription Drug User Fee Act goals apply only 
to commercial IND's, although the 30-calendar day response applies to 
all IND clinical hold complete responses; and (3) states that clinical 
trial issues that are not related to the imposition of a clinical hold 
may be discussed in the letter placing the trial on clinical hold, but 
will be clearly marked as nonhold issues and that a sponsor's response 
to such nonhold issues should be addressed in a separate amendment to 
the IND.
    The collection of information contained in the revised guidance has 
been approved by the Office of Management and Budget under OMB control 
number 0910-0445.
    This revised guidance document supersedes the original guidance. 
This Level 1 guidance document is being issued consistent with FDA's 
good guidance practices (65 FR 56468, September 19, 2000). The revised 
guidance represents the agency's current thinking on the submission of 
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 and regulations.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the guidance at any time. 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: October 13, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-27454 Filed 10-25-00; 8:45 am]
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