[Federal Register Volume 63, Number 6 (Friday, January 9, 1998)]
[Notices]
[Pages 1484-1486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-590]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0532]
Agency Information Collection Activities: Proposed Collection;
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 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 comments on the collection of information by
March 10, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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 below.
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.
[[Page 1485]]
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 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
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 the 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
the 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
0190-0014.
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
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 \1\
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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......................... 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
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Totals.............................. ................................. .............. .............. .............. ............ 936
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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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Number of Hours per
21 CFR section Form recordkeepers Annual frequency per recordkeeping recordkeeper Total hours
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361.1(c)(2)..................... FDA 2914 and 2915............... 100 1 per qtr=4 per yr.................. 10 1,000
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Total..................... ................................ ................ .................................... ............... 1,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 1486]]
Dated: January 2, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-590 Filed 1-8-98; 8:45 am]
BILLING CODE 4160-01-M
