[Federal Register Volume 72, Number 183 (Friday, September 21, 2007)]
[Notices]
[Pages 54044-54045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18646]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0337]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Radioactive Drug Research Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 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 the information collection 
contained in regulations governing the use of radioactive drugs for 
basic informational research.

DATES: Submit written or electronic comments on the collection of 
information by November 20, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments or http://www.regulations.gov. 
Submit written comments on the collection of information to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 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 the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 1061, Rockville, MD 20857, 301-827-4816.

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 set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

Radioactive Drug Research Committees-- 21 CFR 361.1 (OMB Control Number 
0910-0053)

    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

[[Page 54045]]

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 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 no. 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         No. of Responses       Total Annual        Hours per
           21 CFR Section                  Forms           Respondents        per Respondent         Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
361.1(c)(3) and (c)(4)                        FDA 2914                 80                     1                 80                  1                 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
361.1(c)(3)                                   FDA 2915                 50                   6.8                340                3.5              1,190
--------------------------------------------------------------------------------------------------------------------------------------------------------
361.1(d)(8)                          .................                 50                   6.8                340                0.1                 34
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Reporting                                                                                                                                    1,304
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                         No. of       Annual Frequency  of
          21 CFR Section             Recordkeepers        Recordkeeping     Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
361.1(c)(2)                                       80                     4                 10                800
----------------------------------------------------------------------------------------------------------------
361.1(d)(5)                                       50                   6.8                .75                 38
----------------------------------------------------------------------------------------------------------------
Total Recordkeeping                                                                                          838
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: September 14, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18646 Filed 9-20-07; 8:45 am]
BILLING CODE 4160-01-S