[Federal Register Volume 71, Number 190 (Monday, October 2, 2006)]
[Notices]
[Pages 57972-57973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16225]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0211]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 1, 2006.

[[Page 57973]]


ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Management Programs (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry on 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 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(i)(3)(C)), 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 investigational new drug (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 
the FDA contact listed in the clinical hold letter who is responsible 
for the IND. The guidance requests more than an original and 2 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.


    In the Federal Register of May 25, 2006 (71 FR 30142), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

    Dated: September 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-16225 Filed 9-29-06; 8:45 am]
BILLING CODE 4160-01-S