[Federal Register Volume 68, Number 141 (Wednesday, July 23, 2003)]
[Notices]
[Pages 43532-43533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18691]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0142]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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: Fax written comments on the collection of information by August 
22, 2003.

ADDRESSES: The Office of Management and Budget (OMB) is still 
experiencing significant delays in the regular mail, including first 
class and express mail, and messenger deliveries are not being 
accepted. 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: Fumie Yokota, Desk 
Officer for FDA, FAX: 202-395-6974.

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--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, 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. After considering the comment received on that guidance, 
FDA issued a revised guidance in October 2000. In the Federal Register 
of April 21, 2003 (68 FR 19545), FDA published a notice requesting 
comment on this information collection. No comments were received 
pertaining to the information collection.
    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 ``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 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 fiscal year 2001 and 2002, CDER estimates that approximately 
41 responses are submitted annually from approximately 29 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 2001 and 2002, CBER estimates that 
approximately 123 responses are submitted annually from approximately 
78 applicants, and that it takes approximately 284 hours to

[[Page 43533]]

prepare and submit to CBER each response.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of Responses Per                                   Hours Per
 Complete Responses to Clinical Holds   Number of Respondents          Respondent            Total Annual Responses         Response        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER                                                    29             approximately 1                          41                284      11,644
CBER                                                    78                           1.58                      123                284      34,932
Total                                   .....................  ..........................  ..........................  .................   46,576
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital cost or operating and maintenance costs associated with this collection of information.


    Dated: July 17, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-18691 Filed 7-22-03; 8:45 am]
BILLING CODE 4160-01-S