[Federal Register: January 27, 2004 (Volume 69, Number 17)]
[Notices]
[Page 3923-3925]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ja04-72]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0014]
Draft Guidance for Industry on Information Program on Clinical
Trials for Serious or Life-Threatening Diseases and Conditions;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Information
Program on Clinical Trials for Serious or Life-Threatening Diseases and
Conditions.'' FDA is revising its March 2002 guidance
[[Page 3924]]
for industry of the same title to include guidance for sponsors who
will be submitting information required by the Best Pharmaceuticals for
Children Act (BPCA). The BPCA amended the Public Health Service Act
(PHS Act) to require that additional information be included in the
Clinical Trials Data Bank established as required by the Food and Drug
Administration Modernization Act of 1997 (Modernization Act). This
draft guidance explains how to provide that information.
DATES: Submit written or electronic comments on the draft guidance by
March 29, 2004. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857 or to the Office of Communication, Training,
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation
and Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. The draft guidance may also be obtained by
mail by calling the CBER Voice Information System at 1-800-835-4709 or
301-827-1800. Send one self-addressed adhesive label to assist that
office in processing your requests. Submit written comments on the
draft guidance to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Theresa Toigo, Office of Special
Health Issues (HF-12), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-4460.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Information Program on Clinical Trials for Serious or Life-
Threatening Diseases and Conditions'' to assist sponsors who will be
submitting information to the Clinical Trials Data Bank established by
section 113 of the Modernization Act (42 U.S.C. 282). This draft
guidance revises the guidance of the same title issued in March 2002
(67 FR 12022, March 18, 2002) to include assistance on submitting
information required by the BPCA (Public Law 107-109). This draft
guidance updates the March 2002 guidance.
The BPCA amends section 402(j)(3)(A) of the PHS Act (42 U.S.C.
282(j)(3)(A)) to require that additional information be included in the
Clinical Trials Data Bank established as required under section 113 of
the Modernization Act. Additional information to be submitted includes
a description of whether, and through what procedure, the manufacturer
or sponsor of an investigation of a new drug will respond to requests
for a protocol exception, with appropriate safeguards, for single-
patient and expanded access use of the investigational drug,
particularly in children.
Section 113 of the Modernization Act, enacted November 21, 1997,
directs the Secretary of Health and Human Services (the Secretary),
acting through the Director of the National Institutes of Health (NIH),
to establish, maintain, and operate a data bank of information on
clinical trials for drugs to treat serious or life-threatening diseases
and conditions. The Clinical Trials Data Bank is intended to be a
central resource, providing current information on clinical trials to
individuals with serious or life-threatening diseases or conditions, to
other members of the public, and to health care providers and
researchers.
Specifically, section 113 of the Modernization Act requires that
the Clinical Trials Data Bank contain the following information: (1)
Information about Federally and privately funded clinical trials for
experimental treatments (drug and biological products) for patients
with serious or life-threatening diseases or conditions, (2) a
description of the purpose of each experimental drug, (3) patient
eligibility criteria, (4) a description of the location of clinical
trial sites, and (5) a point of contact for patients wanting to enroll
in the trial. Section 113 of the Modernization Act also requires that
information provided through the Clinical Trials Data Bank be in a form
that can be readily understood by the public (42 U.S.C. 282(j)(3)(A)).
The BPCA, signed by the President on January 4, 2002, requires that the
Clinical Trials Data Bank contain additional information including a
description of whether, and through what procedure, the manufacturer or
sponsor of an IND will respond to requests for protocol exception, with
appropriate safeguards, for single-patient and expanded access use of
the investigational drug, particularly in children.
The NIH, through its National Library of Medicine (NLM) and with
input from FDA and others, developed the Clinical Trials Data Bank. The
first version of the Clinical Trials Data Bank was made available to
the public on February 29, 2000, on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://clinicaltrials.gov.
At that time, the data bank included primarily NIH-
sponsored trials.
Shortly thereafter, FDA made available two draft guidances. The
first draft guidance provided recommendations for industry on the
submission of protocol information to the Clinical Trials Data Bank. It
included information about the types of clinical trials for which
submissions are required under section 113 of the Modernization Act as
well as information about the content of those submissions. The second
draft guidance addressed procedural issues, including how to submit
required and voluntary protocol information to the Clinical Trials Data
Bank. It also discussed issues related to submitting certification to
the Secretary that disclosure of information for a particular protocol
would substantially interfere with the timely enrollment of subjects in
the clinical investigation. The second draft guidance also proposed a
timeframe for submitting the information. The March 2002 guidance
combined the two draft guidances into a single guidance (available at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/4856fnl.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/gdlns/clintrial
.htm).
This draft guidance updates the March 2002 guidance to include
information on how to comply with new statutory requirements contained
in the BPCA, for submitting details about single-patient use and
expanded access use contained in the BPCA. This draft guidance also
includes several minor updates to the information in it and to the
format. Additional updates on procedural issues not related to the BPCA
will be discussed in future revisions to the guidance.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the
information program on clinical trials for serious or life-threatening
diseases and conditions. It does not create or confer any rights for or
on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic
[[Page 3925]]
comments on the draft guidance. Submit two copies of mailed comments,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. The draft guidance and received comments are available
for public examination in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.
ts/default.htm.
Dated: January 20, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-1591 Filed 1-26-04; 8:45 am]
BILLING CODE 4160-01-S