[Federal Register: October 2, 2006 (Volume 71, Number 190)]
[Notices]
[Page 57972-57973]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02oc06-73]
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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