[Federal Register Volume 65, Number 129 (Wednesday, July 5, 2000)]
[Notices]
[Pages 41473-41474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16813]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1224]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Guidance for Industry: Submitting and 
Reviewing Complete Responses to Clinical Holds

AGENCY: Food and Drug Administration, HHS.

[[Page 41474]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
August 4, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

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: 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: 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.
    Section 505(i)(3)(C) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(i)(3)(C)) requires that 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 investigational 
new drug application (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, i.e., three 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 Burden1
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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          approx. 1           48             284          13,632
CBER                                  110          approx. 1          134             284          38,056
Total                                                                                             51,688
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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 April 13, 2000 (65 FR 19911), the agency 
requested comments on the proposed collections of information. No 
significant comments were received.

    Dated: June 27, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-16813 Filed 7-3-00; 8:45 am]
BILLING CODE 4160-01-F