[Federal Register Volume 63, Number 71 (Tuesday, April 14, 1998)]
[Notices]
[Pages 18203-18204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9705]
[[Page 18203]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0532]
Agency Information Collection Activities; Submission for OMB
Review; Radioactive Drug Research Committees; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by May
14, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
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: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
Radioactive Drug For Certain Research Uses--21 CFR 361.1--(OMB
Control Number 0910-0053--Reinstatement)
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 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 carry out a clinical trial. The types
of basic research permitted are specified in the regulation, and
includes 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, and for each study conducted
during the preceeding 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 to be confirmed are present.
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 (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 (IND) under 21 CFR 312.1 and
the associated information collections are covered in OMB Approval
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 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
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.
In the Federal Register of January 9, 1998 (63 FR 1484), the agency
requested comments on the proposed collection of information. No
comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
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Annual
21 CFR Section Form No. No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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361.1(c)(3) FDA 2914 100 1.0 100 1.0 100
361.1(c)(3) FDA 2915 62 3.5 217 3.75 814
361.1(d)(5) 62 3.5 217 0.1 22
361.1(d)(8) 62 3.5 217 0 0
Totals 936
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 18204]]
Table 2.--Estimated Annual Recordkeeping Burden1
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No. of Annual Frequency per Hours per
21 CFR Section Form No. Recordkeepers Recordkeeping Recordkeeper Total Hours
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361.1(c)(2) FDA 2914 and 100 1 per qtr = 4 per yr 10 1,000
2915
Total 1,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: April 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-9705 Filed 4-13-98; 8:45 am]
BILLING CODE 4160-01-F
