[Federal Register: March 18, 2002 (Volume 67, Number 52)]
[Notices]
[Page 12022-12023]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18mr02-81]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1033]
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 guidance for industry entitled ``Information Program
on Clinical Trials for Serious or Life-Threatening Diseases and
Conditions.'' The document provides guidance for industry on procedures
for submitting protocol information to the Clinical Trials Data Bank
established by section 113 of the Food and Drug Administration
Modernization Act of 1997 (Modernization Act). Section 113 of the
Modernization Act creates a public resource for information on studies
of drugs for serious or life-threatening diseases and conditions
conducted under FDA's investigational new drug (IND) regulations.
DATES: Submit written or electronic comments at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research (CDER), 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, 301-827-3844, FAX 888-CBER-
FAX. Send one self-addressed adhesive label to assist that office in
processing your requests. Submit written comments on the guidance to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments tohttp://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY
INFORMATION section for electronicaccess to the guidance document.
FOR FURTHER INFORMATION CONTACT: Theresa Toigo, Office of Special
Health Issues, Office of the Commissioner (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 guidance for industry
entitled ``Information Program on Clinical Trials for Serious or Life-
Threatening Diseases and Conditions.'' The agency has finalized the
guidance after considering comments received on two draft guidance
documents. In the Federal Register of March 29, 2000 (65 FR 16620), FDA
published the notice of availability of a draft guidance entitled
``Information Program on Clinical Trials for Serious or Life-
Threatening Diseases: Establishment of a Data Bank.'' The March 29,
2000, draft guidance provided recommendations for industry on the
submission of protocol information to the clinical trials data bank. It
included information on the types of clinical trials for which
submissions are required under section 113 of the Modernization Act (42
U.S.C. 282) and on the content of those submissions.
Notice of the availability of the second draft guidance entitled
``Information Program on Clinical Trials for Serious or Life-
Threatening Diseases: Implementation Plan,'' was published on July 9,
2001 (66 FR 35798). It addressed procedural issues, including how to
submit required and voluntary protocol information to the Clinical
Trials Data Bank through a Web-based Protocol Registration System (PRS)
available at http://prsinfo.clinicaltrials.gov/.
This guidance, which is a combination of the informational and
procedural draft guidances, was finalized after consideration of
comments received on both draft guidances. The comments received
addressed the following topics: (1) Scope of data requirements, (2)
international trial sites, (3) voluntary information, (4) compliance,
(5) timeframes, (6) procedural issues (e.g. contact names and
intermediaries), and (7) burden estimate. Revisions made in the
guidance are intended to clarify issues raised in the comments and to
make the document clearer.
We note that Senate 1789, ``Best Pharmaceuticals for Children Act''
(Public Law 107-109), which was signed by the President on January 4,
2002, provides for 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 protocol use of the investigational drug,
particularly in children. The agency intends to issue a revised
guidance in the future to address this provision.
Along with the first draft guidance, FDA published a notice in the
Federal Register of March 29, 2000, announcing a proposed collection of
information. On November 9, 2000 (65 FR 67385), FDA published a notice
stating that the proposed collection of information was submitted to
the Office of Management and Budget (OMB) for review. The report
considered comments received on the proposed collection of information.
On March 23, 2001 (66 FR 16251), FDA announced OMB's approval of the
agency's information collection activities for the program (OMB Control
No. 0910-0459). This approval expires March 31, 2004. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.
[[Page 12023]]
This level 1 final guidance is being issued in accordance with
FDA's good guidance practices regulation (21 CFR 10.115). The guidance
represents the agency's current thinking on compliance with section 113
of Modernization Act, i.e., submitting information on clinical trials
for serious or life-threatening diseases and conditions to a Clinical
Trials Data Bank developed by the National Library of Medicine,
National Institutes of Health. 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, at any time, submit to the Dockets
Management Branch (address above) written or electronic comments on the
guidance. Two copies of any comments are to be submitted, 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
guidance and received comments are available for public examination in
the Dockets Management Branch 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
either http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/
cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: March 1, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-6421 Filed 3-15-02; 8:45 am]
BILLING CODE 4160-01-S