[Federal Register: December 11, 2007 (Volume 72, Number 237)]
[Notices]
[Page 70329-70330]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de07-50]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0337]
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 January
10, 2008.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments
should be identified with the OMB control number 0910-0053. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4816.
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)--
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
scientific 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 for safety or efficacy. 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
[[Page 70330]]
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 or
effectiveness of the drug in humans for such purposes (i.e., to carry
out a clinical trial for safety or efficacy). These studies require
filing of an investigational new drug application (IND) under 21 CFR
part 312, and the associated information collections are covered in 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 and that human subject safety is assured. If
these studies were not reviewed, human subjects could be subjected to
inappropriate radiation or pharmacologic risks.
Respondents to this information collection are the chairperson(s)
of each individual Radioactive Drug Research Committee, investigators,
and participants in the studies.
The burden estimates are based on FDA's experience with these
reporting and recordkeeping requirements over the past few years and
the number of submissions received by FDA under the regulations.
In the Federal Register of September 21, 2007 (72 FR 54044), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Forms Respondents per Response Responses Response Total Hours
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361.1(c)(3) and (c)(4) FDA 2914 80 1 80 1 80
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361.1(c)(3) FDA 2915 50 6.8 340 3.5 1,190
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361.1(d)(8) ................. 50 6.8 340 0.1 34
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Total Reporting ................. ................. ................. ................. ................. 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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No. of Annual Frequency
21 CFR Section Recordkeepers per Recordkeeping Hours per Record Total Hours
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361.1(c)(2) 80 4 10 800
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361.1(d)(5) 50 6.8 .75 38
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Total Recordkeeping ................. ................. ................. 838
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: December 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-23977 Filed 12-10-07; 8:45 am]
BILLING CODE 4160-01-S