[Federal Register Volume 66, Number 4 (Friday, January 5, 2001)]
[Notices]
[Pages 1137-1138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-262]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1682]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Radioactive Drug Research Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish a notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reporting requirements related 
to radioactive drugs used in research.

DATES: Submit written or electronic comments on the collection of 
information by March 6, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: Under 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, including each proposed extension of an existing 
collection of information, before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information listed set forth in this 
document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Radioactive Drug Research Committee--21 CFR 361.1 (OMB Control 
Number 0910-0053)--Extension

    Under sections 201, 505, and 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to 
issue regulations governing the use of radioactive drugs for basic 
informational research. The regulations in Sec. 361.1 (21 CFR 361.1) 
set forth specific regulations regarding the establishment and 
composition of the Radioactive Drug Research Committees and their role 
in approving and monitoring research studies utilizing 
radiopharmaceuticals. No study involving any administration of a 
radioactive drug to research subjects is permitted without the 
authorization of an FDA-approved Radioactive Drug Research Committee 
(Sec. 361.1(d)(7)). The type of research that may be undertaken with a 
radiopharmaceutical drug must be intended to obtain basic information 
and not to carry out a clinical trial. The types of basic research 
permitted are specified in the regulation, and include studies of 
metabolism, human physiology, pathophysiology, or biochemistry.
    The regulations in Sec. 361.1(c)(2) require that each Radioactive 
Drug Research Committee shall select a chairman, who shall sign all 
applications, minutes, and reports of the committee. Each committee 
shall meet at least once each quarter in which research activity has 
been authorized or conducted. Minutes shall be kept and shall include 
the numerical results of votes on protocols involving use in human 
subjects. Under Sec. 361.1(c)(3), each Radioactive Drug Research 
Committee shall submit an annual report to FDA. The annual report shall 
include the names and qualifications of the members of, and of any 
consultants used by, the Radioactive Drug Research Committee, and for 
each study conducted during the proceeding year, using FDA Form 2915.
    Under Sec. 361.1(d)(5), each investigator shall obtain the proper 
consent required under the regulations. Each female research subject of 
childbearing potential must state in writing that she is not pregnant, 
or on the basis of a pregnancy test be confirmed as not pregnant.
    Under section 361.1(d)(8), the investigator shall immediately 
report to the Radioactive Drug Research Committee all adverse effects 
associated with use of the drug, and the committee shall then report to 
FDA all adverse reactions probably attributed to the use of the 
radioactive drug.
    Section 361.1(f) sets forth labeling requirements for radioactive 
drugs. These requirements are not in the reporting burden estimate 
because they are information supplied by the Federal Government to the 
recipient for the purposes of disclosure to the public (5 CFR 
1320.3(c)(2)). Types of research studies not permitted under this 
regulation are also specified, and include those ``intended for (the) 
immediate therapeutic, diagnostic, or similar purposes or to determine 
the safety and effectiveness of the drug in humans for such purposes 
(i.e., to carry out a clinical trial).'' These studies require filing 
of an investigational new drug application under 21 CFR 312.1 and the 
associated information collections are covered under OMB Control No. 
0190-0014, which expires December 31, 2002.
    The primary purpose of this collection of information is to 
determine if the research studies are being conducted in accordance 
with required regulations. If these studies were not reviewed, human 
subjects could be subjected to inappropriate radiation and/or safety 
risks. Respondents to this information collection are the 
chairperson(s) of each individual Radioactive Drug Research Committee,

[[Page 1138]]

investigators, and participants in the studies.
    The source of the burden estimates was a phone survey of three 
committee chairpersons who were selected from different geographical 
areas and of varying levels of Radioactive Drug Research Committee 
membership and activities. These chairpersons were asked for their 
assessment of time expended, cost, and views on completing the 
necessary reporting forms.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1.--Estimated Annual Reporting Burden
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                                                                                 Annual
            21 CFR Section                     Form              No. of       Frequency per   Total Annual      Hours per            Total Hours
                                                               Respondents      Response        Responses       Response
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361.1(c)(3)                              FDA 2914                 96               1.0            96               1                     96
361.1(c)(3)                              FDA 2915                 63               5             315               3.5                1,103
361.1(d)(5)                                                       63               5             315               0.1                   31
361.1(d)(8)                                                       63               5             315               0                      0
Total                                                                                                                                 1,230
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                                 Table 2.--Estimated Annual Recordkeeping Burden
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                                         Annual
  21 CFR Section          Form        Frequency per      Total Annual Records        Hours per      Total Hours
                                      Recordkeeping                                Recordkeeper
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361.1(c)(2)         FDA 2914 and          96          1 per quarter                    10             960
                     2915                                4 per year
Total                                                                                                 960
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    Dated: December 27, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-262 Filed 1-4-01; 8:45 am]
BILLING CODE 4160-01-F