[Federal Register: July 9, 2001 (Volume 66, Number 131)]
[Notices]
[Page 35798-35799]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy01-63]
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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Draft Guidance for Industry on Information Program on Clinical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availability of a draft guidance for industry entitled ``Information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 The draft guidance discusses procedures for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included in an earlier draft guidance document on the scope of the Data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DATES: Submit written comments on the draft guidance by September 7,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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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 Submit written comments on the draft guidance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INFORMATION section for electronic access to the draft guidance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