[Federal Register Volume 68, Number 76 (Monday, April 21, 2003)]
[Notices]
[Pages 19545-19546]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9664]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0142]


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.

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

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 ``Guidance for Industry on 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 June 20, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
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 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 set forth in this document.
    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 on Submitting and Reviewing Complete Responses to 
Clinical Holds

    Section 117 of the Food and Drug Administration Modernization Act 
(Public Law 105-115), signed into law by President Clinton 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. 505(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

[[Page 19546]]

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.
    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 
the FDA contact person 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 years 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 each 
response to CDER.
    Based on data concerning the number of complete responses to 
clinical holds received by the Center for Biologics Evaluation and 
Research (CBER) in fiscal years 2001 and 2002, CBER estimates that 
approximately 123 responses are submitted annually from approximately 
78 applicants, and that it takes approximately 284 hours to prepare and 
submit each response to CBER.

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


    Dated: April 14, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-9664 Filed 4-18-03; 8:45 am]
BILLING CODE 4160-01-S