[Federal Register Volume 65, Number 72 (Thursday, April 13, 2000)]
[Notices]
[Pages 19910-19912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-9128]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1224]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Guidance for Industry: Submitting and Reviewing
Complete Responses to Clinical Holds
AGENCY: Food and Drug Administration, HHS.
[[Page 19911]]
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on the collection of information contained in
a guidance for industry entitled ``Submitting and Reviewing Complete
Responses to Clinical Holds.'' The guidance describes how to submit a
complete response if an investigational new drug (IND) application is
placed on clinical hold by FDA.
DATES: Submit written comments on the collection of information by June
12, 2000.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information
Resources Management (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information listed below.
With respect to the following collection of information, FDA
invites comments on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Guidance for Industry: ``Submitting and Reviewing Complete
Responses to Clinical Holds''
On November 21, 1997, the President signed into law the Food and
Drug Administration Modernization Act (the Modernization Act) (Public
Law 105-115). Section 117 of the Modernization Act provides that a
written request to FDA from the applicant of an investigation 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. A clinical hold is an order issued by FDA to the
applicant to delay a proposed clinical investigation or to suspend an
ongoing investigation for a drug or biologic. An applicant may respond
to a clinical hold.
Under section 505(i)(3)(C) of the Federal Food, Drug, and Cosmetic
Act, any written request to FDA from the sponsor of an investigation
that a clinical hold be removed must receive a decision, in writing and
specifying the reasons, within 30 days after receipt of the request.
The request must include sufficient information to support the removal
of the clinical hold.
In the Federal Register of May 14, 1998 (63 FR 26809), FDA
published a notice of availability of a guidance that described how
applicants should submit responses to clinical holds so that they may
be identified as complete responses and the agency can track the time
to respond. FDA is now issuing a revised guidance.
The revised guidance states that FDA will respond in writing within
30-calendar days of receipt of a sponsor's request to release a
clinical hold and a complete response to the issue(s) that led to the
clinical hold. An applicant's complete response to an IND clinical hold
is a response in which all clinical hold issues identified in the
clinical hold letter have been addressed.
The guidance requests that applicants type in large, bold letters
at the top of the cover letter of the complete response ``Clinical Hold
Complete Response'' to expedite review of the response. The guidance
also requests that applicants submit the complete response letter in
triplicate to the IND, and that they fax a copy of the cover letter to
FDA's contact listed in the clinical hold letter who is responsible for
the IND. The guidance requests more than an original and two copies of
the cover letter in order to ensure that the submission is received and
handled in a timely manner.
Based on data concerning the number of complete responses to
clinical holds received by the Center for Drug Evaluation and Research
(CDER) from July 1, 1998, to June 30, 1999, CDER estimates that
approximately 48 responses are submitted annually from approximately 43
applicants, and that it takes approximately 284 hours to prepare and
submit to CDER each response.
Based on data concerning the number of complete responses to
clinical holds received by the Center for Biologics Evaluation and
Research (CBER) in fiscal year 1999, CBER estimates that approximately
134 responses are submitted annually from approximately 110 applicants,
and that it takes approximately 284 hours to prepare and submit to CBER
each response.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden \1\
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No. of
Complete Responses to Clinical No. of Responses per Total Annual Hours per Total Hours
Holds Respondents Respondent Responses Response
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CDER 43 1 48 284 13,632
CBER 110 1 134 284 38,056
Total 51,688
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\1\ There are no capital cost or operating and maintenance costs associated with this collection of information.
[[Page 19912]]
Dated: April 7, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-9128 Filed 4-12-00; 8:45 am]
BILLING CODE 4160-01-F