[Federal Register Volume 71, Number 101 (Thursday, May 25, 2006)]
[Notices]
[Pages 30142-30143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7983]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0211]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on Submitting and Reviewing 
Complete Responses to Clinical Holds

AGENCY: Food and Drug Administration, HHS.

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, 
including each proposed extension of an existing 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 or electronic comments on the collection of 
information by July 24, 2006.

ADDRESSES: Submit electronic comments on the collection to: http://www.fda.gov/dockets/ecomments. Submit written comments on the 
collection of information to the Division of Dockets Management (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 Nelson, Office of Management 
Programs (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, including 
each proposed extension of an existing 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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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 (OMB Control Number 0910-0445)--Extension

    Section 117 of the Food and Drug Administration Modernization Act 
(Public Law 105-115), signed into law by the President on November 21, 
1997, 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

[[Page 30143]]

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 (21 U.S.C. 355), 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 issued a revised guidance in October 2000 which 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 ``Clinical Hold Complete 
Response'' in large, bold letters at the top of the cover letter of the 
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) in 2004 and 2005, CDER estimates that approximately 88 responses 
are submitted annually from approximately 67 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 2004 and 2005, CBER estimates that approximately 92 
responses are submitted annually from approximately 60 applicants, and 
that it takes approximately 284 hours to prepare and submit to CBER 
each response.

                                                      Table 1--Estimated Annual Reporting Burden\1\
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  Complete Responses to Clinical                               No. of Responses Per
               Holds                    No. of Respondents          Respondent        Total Annual Responses   Hours Per Response        Total Hours
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CDER                                                       67                   .76                       88                   284                24,992
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CBER                                                       60                  1.53                       92                   284                26,128
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Total                                                                                                                                             51,120
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: May 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7983 Filed 5-24-06; 8:45 am]
BILLING CODE 4160-01-S