[Federal Register Volume 66, Number 116 (Friday, June 15, 2001)]
[Notices]
[Pages 32626-32628]
From the Federal Register Online via the Government Publishing 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
                                                                                                                                       -----------------
 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
                                                                                             -------------------
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