[Federal Register: July 23, 2004 (Volume 69, Number 141)]
[Notices]
[Page 44037-44039]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy04-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0269]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Radioactive Drugs for Certain Uses Research
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 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 September 21, 2004.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/
[[Page 44038]]
dockets/ecomments. Submit written comments on the collection of
information to the Division of Dockets Management (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 Management
Programs (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 set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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 Drugs for Certain Research Uses--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. Section 361.1 (21 CFR 361.1) sets forth
specific regulations regarding the establishment and composition of
Radioactive Drug Research Committees and their role in approving and
monitoring basic research studies utilizing radiopharmaceuticals. No
basic research 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.
Section 361.1(c)(2) requires 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, using FDA Form 2914, and a
summary of 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 Sec. 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 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 (IND) under 21 CFR 312.1, and the
associated information collections are covered under OMB control number
0910-0014.
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,
investigators, and participants in the studies.
The source of the burden estimates was a phone survey of three
chairpersons who were selected from Radioactive Drug Research
Committees of different geographical areas and of varying levels of
activity. 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\1\
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Annual
21 CFR Section Forms No. of Frequency Total Annual Hours per Total Hours
Respondents per Response Responses Response
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361.1(c)(3) FDA 2914 80 1 80 1 80
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[[Page 44039]]
361.1(c)(3) FDA 2915 50 6.8 340 3.5 1190
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361.1(d)(8) ............ 50 6.8 340 0.1 34
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Total ............ ............ ............ ............ ............ 1304
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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Annual Frequency per Hours per Record-
21 CFR Section Forms No. of Recordkeepers Recordkeeping Keeper Total Hours
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361.1(c)(2) .................... 80 1 per qtr = 4 per 10 800
year
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361.1(d)(5) .................... 50 6.8 0.75 38
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Total .................... .................... .................... .................... 838
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-16824 Filed 7-22-04; 8:45 am]
BILLING CODE 4160-01-S