[Federal Register Volume 66, Number 116 (Friday, June 15, 2001)]
[Notices]
[Pages 32626-32628]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 01-15079]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1682]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Radioactive Drug Research Committee Report on
Research Use of Radioactive Drugs Membership Summary and Study Summary
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 (PRA).
DATES: Submit written comments on the collection of information by July
16, 2001.
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:
Wendy Taylor, 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 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Radioactive Drug Research Committee Report on Research Use of
Radioactive Drugs Membership Summary and Study Summary (OMB Control No.
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 certain
research uses. The regulations in Sec. 361.1 (21 CFR 361.1) establish
the conditions under which radioactive drugs are generally recognized
as safe and effective for certain research purposes.
The regulations in Sec. 361.1 set forth specific requirements for
the establishment and composition of Radioactive Drug Research
Committees (RDRCs) and their role in approving and monitoring the use
of radioactive drugs in certain types of research. These radioactive
drugs may not be given to human subjects without the authorization of
an FDA-approved RDRC (Sec. 361.1(d)(7)). The types of studies
authorized under Sec. 361.1 are those intended to obtain basic
information on the metabolism of a radioactively labeled drug or
regarding human physiology, pathophysiology, or biochemistry. Research
intended for immediate therapeutic, diagnostic, or similar purposes or
to determine the safety and effectiveness of a radioactive drug in
humans (i.e., to carry out a clinical trial) may not be conducted under
an RDRC. Research for such purposes requires the submission of an
investigational new drug application under 21 CFR part 312.
Section 361.1 requires the RDRCs to perform various activities
involving the collection of information and reporting to FDA that are
subject to the PRA. Under Sec. 361.1(c)(2), each RDRC must do the
following: (1) Select a chairman who must sign all applications,
minutes, and reports of the committee; (2) meet at
[[Page 32627]]
least once each quarter in which research is authorized or performed;
and (3) keep minutes and include the numerical results of votes on
protocols involving use in human subjects. Under Sec. 361.1(c)(3), each
RDRC must submit an annual report to FDA that includes the names and
qualifications of the members of, and of any consultants used by, the
RDRC. It must also include, for each study conducted during the
preceding year, a summary of information using Form FDA 2915. Under
Sec. 361.1(d)(5), each investigator must obtain the proper informed
consent required under the regulations. Each female research subject of
childbearing potential must state in writing that she is not pregnant
or be confirmed as not pregnant on the basis of a pregnancy test before
participating in any study. Under Sec. 361.1(d)(8), each investigator
must immediately report to the RDRC all adverse effects associated with
use of the radioactive drug in the research study, and the RDRC must
report to FDA all adverse reactions probably attributable to such use.
Section 361.1(f) specifies labeling requirements for radioactive
drugs for these research uses. 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)).
The primary purpose of this collection of information is to
determine if these research studies involving radioactive drugs are
being conducted in accordance with regulations. If these studies were
not reviewed, human subjects might be subjected to inappropriate
radiation and/or other safety risks. Individuals responsible for the
collection of this information are the chairpersons of each RDRC, and
investigators in the studies.
The estimate of the paperwork burden was based on a survey of three
different RDRC chairpersons. The three RDRCs reflect different
geographical areas and varying levels of RDRC membership and
activities. The chairpersons provided their assessments of time
expended, cost, and ease of 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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No. of Annual Frequency Total Annual Hours per
21 CFR Section Form Respondents per Response Responses Response Total Hours
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361.1(c)(3) FDA 2914 96 1.0 96 1 96
361.1(c)(3) FDA 2915 63 5 315 3.5 1,103
361.1(d)(5) ........................... 63 5 315 0.1 31
361.1(d)(8) 63 5 315 0 0
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Total 1,230
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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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21 CFR Annual Frequency Total Annual Hours per
Section Form per Recordkeeping Records Recordkeeper Total Hours
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361.1(c)(2) FDA 2914 and 96 1 per quarter 4 per 10 960
2915 year
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Total 960
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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 January 5, 2001 (66 FR 1137), the agency
requested comments on the continued collections of RDRC annual report
information, using Form FDA 2914 and Form FDA 2915, which expire on
October 31, 2001. These forms cannot be used after this date unless
they have a valid OMB control number.
The agency received two written responses to the proposed continued
collections of information; they contained a total of six comments. The
comments received and respective responses are listed below:
1. The comment maintained that FDA has never had any actual
statutory authority over radioactive drugs used for basic research and
the extensive paperwork requirements for Sec. 361.1 should be
completely removed.
This comment involves substantive changes to the regulations and is
beyond the scope of the January 5, 2001, notice. In the Federal
Register of November 30, 2000 (65 FR 73799), FDA announced, as part of
the semiannual regulatory agenda, that it intends to publish a proposed
rule to revise Sec. 361.1 to update FDA's regulations on the use of
radioactive drugs for basic research to reflect technological changes
in the field of radiopharmaceuticals and to clarify and correct certain
provisions. It would be more appropriate to submit this comment in
response to the proposed rule once FDA publishes it.
2. The comment maintained that the term ``radiation dose commitment
to whole body'' is unclear and that reporting the ``absorbed dose to
whole body'' on Form FDA 2915 is inappropriate. The comment stated that
more appropriate calculations of body dose involve the summation of
individual organ doses multiplied by organ weighting factors (e.g.,
effective dose equivalent or effective dose).
This comment is beyond the scope of the January 5, 2001, notice and
would more appropriately be submitted as a comment on the proposed rule
that FDA intends to publish.
3. The comment maintained that the instructions and table headings
on Form FDA 2915 require absorbed doses to be in units of ``mR'' though
this is a unit of exposure rather than absorbed dose. The comment
suggests that the unit of rad or gray should be used.
FDA intends to change Form FDA 2915 to require the total radiation
doses and dose commitments, expressed in the unit of rem
(Sec. 361.1(b)).
4. The comment maintained that the reporting requirements for
gender and age of each human subject over 18 years of age are
unnecessary and should be deleted.
This comment is beyond the scope of the January 5, 2001, notice and
would more appropriately be submitted as a comment on the proposed rule
that FDA intends to publish.
[[Page 32628]]
5. The comment recommends that absorbed doses for individual
subjects who are also representative subjects, or absorbed doses for
individual subjects that are less than those estimated for a
representative subject, be eliminated from the annual reporting
requirements.
This comment is beyond the scope of the January 5, 2001, notice and
would more appropriately be submitted as a comment on the proposed rule
that FDA intends to publish.
6. The comment maintains that the estimated annual reporting burden
stated in table 1 of the January 5, 2001, notice underestimates the
time required for completion of Form FDA 2915 as it currently exists.
The respondent estimates that the time expended to complete an annual
summary on Form FDA 2915 is approximately 10 hours, rather than the 3.5
hours stated.
FDA appreciates the comment but believes that 3.5 hours is a
reasonable estimate of the average time it takes to complete the form.
However, FDA recognizes that the paperwork burden may vary from
committee to committee. FDA's survey of RDRC chairpersons attempted to
reflect differences in RDRC membership and scope of activities. Based
on this comment, FDA may further examine and evaluate the role,
functions, and activities of RDRC and its related paperwork burden in
the future.
Dated: June 8, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-15079 Filed 6-14-01; 8:45 am]
BILLING CODE 4160-01-S