[Federal Register: July 23, 2004 (Volume 69, Number 141)]
[Page 44037-44039]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0269]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Radioactive Drugs for Certain Uses Research

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 reporting requirements related 
to radioactive drugs used in research.

DATES: Submit written or electronic comments on the collection of 
information by September 21, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/

[[Page 44038]]

dockets/ecomments. 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 Management 
Programs (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 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 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 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. 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 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 
    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 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 under OMB control number 
    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 
chairpersons who were selected from Radioactive Drug Research 
Committees of different geographical areas and of varying levels of 
activity. 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 

                                 Table 1.--Estimated Annual Reporting Burden\1\
       21 CFR Section             Forms        No. of       Frequency   Total Annual    Hours per    Total Hours
                                             Respondents  per Response    Responses     Response
361.1(c)(3)                     FDA 2914            80             1            80             1            80

[[Page 44039]]

361.1(c)(3)                     FDA 2915            50             6.8         340             3.5        1190
361.1(d)(8)                   ............          50             6.8         340             0.1          34
Total                         ............  ............  ............  ............  ............        1304
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
                                                                                        Annual Frequency per    Hours per Record-
              21 CFR Section                        Forms         No. of Recordkeepers      Recordkeeping            Keeper              Total Hours
361.1(c)(2)                                 ....................          80            1 per qtr = 4 per             10                   800
361.1(d)(5)                                 ....................          50                     6.8                   0.75                 38
Total                                       ....................  ....................  ....................  ....................         838
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: July 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-16824 Filed 7-22-04; 8:45 am]