[Federal Register: November 3, 2004 (Volume 69, Number 212)]
[Notices]
[Page 64068-64069]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no04-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0269]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Radioactive Drug
Research Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
December 3, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Radioactive Drug Research Committees--(OMB Control Number 0910-0053)
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
[[Page 64069]]
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 in OMB approval 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 No. of Frequency Total Hours Total
Section Forms Respondents per Annual per Hours
Response Responses Response
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361.1(c FDA 2914 80 1 80 1 80
)(3)
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361.1(c FDA 2915 50 6.8 340 3.5 1,190
)(3)
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361.1(d .......... 50 6.8 340 0.1 34
)(8)
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Total .......... ........... ......... ......... ........ 1,304
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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
21 CFR Forms No. of Frequency per Hours per Total
Section Recordkeepers Recordkeeping Recordkeeper Hours
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361.1(c) ....... 80 1 per qtr= 10 800
(2) 4 per yr
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361.1(d) ....... 50 6.8 0.75 38
(5)
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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
In the Federal Register of July 23, 2004 (69 FR 44037), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Dated: October 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24444 Filed 11-2-04; 8:45 am]
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