[Federal Register Volume 66, Number 131 (Monday, July 9, 2001)]
[Notices]
[Pages 35798-35799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1033]


Draft Guidance for Industry on Information Program on Clinical 
Trials for Serious or Life-Threatening Diseases: Implementation Plan; 
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availability of a draft guidance for industry entitled ``Information 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: 
Implementation Plan.'' The draft guidance discusses procedures for 
submission of protocol information to the Clinical Trials Data Bank 
established under section 113 of the Food and Drug Administration 
Modernization Act (Modernization Act), which required the establishment 
of this data bank and specified what information was to be submitted 
for it. Procedural issues discussed in this guidance document were not 
included in an earlier draft guidance document on the scope of the Data 
Bank, which published in the Federal Register on March 29, 2000 (65 FR 
16620).

DATES: Submit written comments on the draft guidance by September 7, 
2001. 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 (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 Submit written comments on the draft guidance 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Theresa Toigo, Center for Drug 
Evaluation and Research (HF-12), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4460.

SUPPLEMENTARY INFORMATION:

I. Description of Guidance

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Information Program on Clinical Trials for Serious or Life-
Threatening Diseases: Implementation Plan.'' The draft guidance is 
intended to provide recommendations for sponsors of investigational new 
drug applications (INDs) on how to submit information about clinical 
trials for serious or life-threatening diseases to a clinical trials 
data bank developed by the National Library of Medicine (NLM), National 
Institutes of Health (NIH).
    The Modernization Act (Pub. L. 105-115), enacted on November 21, 
1997, amends section 402 of the Public Health Service Act (42 U.S.C. 
282) and directs the Secretary of Health and Human Services (the 
Secretary), acting through the Director, NIH, to establish, maintain, 
and operate a data bank of information on clinical trials for drugs for 
serious or life-threatening diseases and conditions (hereafter referred 
to as the Clinical Trials Data Bank).
    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, to other members of the public, 
and to health care providers and researchers. Specifically, the 
Clinical Trials Data Bank will contain information about both federally 
and privately funded studies of experimental treatments for patients 
with serious or life-threatening diseases conducted under FDA's IND 
regulations (21 CFR part 312).
    The NIH, through NLM and with input from FDA and others, developed 
the Clinical Trials Data Bank and is implementing it in a phased 
approach. The first version of the Clinical Trials Data Bank was made 
available to the public on February 29, 2000, on the Internet at http://clinicaltrials.gov. It included primarily NIH-sponsored trials.
    In the Federal Register of March 29, 2000, FDA published 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

[[Page 35799]]

Bank. It included information on the types of clinical trials for which 
submissions will be required under section 113 of the Modernization 
Act, as well as the types of information to be submitted. The draft 
guidance stated that an implementation plan, addressing procedural 
issues, would be available later. The draft guidance stated that the 
implementation plan would include: (1) Information on how to submit 
protocols to the Clinical Trials Data Bank, (2) information about 
providing 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, (3) discussion 
about issues related to the voluntary submission of information not 
required by section 113 of the Modernization Act (e.g., study results, 
trials for non-serious or non-life-threatening diseases), and (4) a 
timeframe for submitting the information.
    In developing a plan for making publicly available information from 
the Clinical Trials Data Bank, FDA and NIH considered comments 
submitted to Docket Nos. 98D-0293 and 00D-1033, ``Section 113 NIH Data 
Bank--Clinical Trials for Serious Diseases.'' A phased approach was 
used for developing guidance. A first draft guidance (the March 29, 
2000, draft guidance) addressed general information on the scope of the 
data bank. The draft guidance being made available by this notice 
discusses procedures that were not included in the first guidance. This 
draft guidance was developed based on the initial data bank experience 
using NIH-sponsored trials. A final guidance will be developed that 
combines the informational and procedural draft guidances and considers 
comments received on both of the draft guidances.
    Section 113(a) of the Modernization Act requires that sponsors of 
INDs submit to the Clinical Trials Data Bank a description of the 
purpose of each experimental drug, eligibility criteria for 
participation in the trial, the location of clinical trial sites, and a 
point of contact for those wanting to enroll in the trial. The statute 
requires that the information be provided in a form that can be readily 
understood by members of the public. This draft guidance provides 
information on how IND sponsors can fulfill the requirements of section 
113(a) of the Modernization Act by submitting information in the 
following four areas: (1) Descriptive information, (2) recruitment 
information, (3) location and contact information, and (4) 
administrative information. FDA and NIH developed these data elements 
based on the legislative requirements and comments submitted to Docket 
No. 98D-0293. Information will be submitted to the Clinical Trials Data 
Bank through a Web-based Protocol Registration System (PRS). For a 
preview of the PRS system see http://prsinfo.clinicaltrials.gov/.
    This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115; 65 FR 56468, 
September 19, 2000). The draft guidance represents the agency's current 
thinking on submitting information on clinical trials for serious or 
life-threatening diseases to a Clinical Trials Data Bank developed by 
the NLM. 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 Dockets Management Branch 
(address above) written comments on the draft 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 draft 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. The Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 published notice of a 
proposed collection of information, along with the first draft 
guidance, in the Federal Register on March 29, 2000. On November 9, 
2000 (65 FR 67385), FDA published a notice that the proposed collection 
of information was submitted to OMB for review. The report considered 
comments received on the proposed collection of information. On March 
23, 2001 (66 FR 16251), as corrected on April 17, 2001 (66 FR 19788), 
FDA announced OMB's approval of the agency's information collection 
activities for the program (OMB Control No. 0910-0459).

IV. 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: June 27, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-17050 Filed 7-6-01; 8:45 am]
BILLING CODE 4160-01-S