[Federal Register: October 26, 2000 (Volume 65, Number 208)]
[Notices]
[Page 64226]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc00-79]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm; or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
BILLING CODE 4160-01-F