[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