[Federal Register Volume 67, Number 52 (Monday, March 18, 2002)]
[Notices]
[Pages 12022-12023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6421]


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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