[Federal Register: November 3, 2004 (Volume 69, Number 212)]
[Page 64068-64069]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0269]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Radioactive Drug 
Research Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 3, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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: 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 Committees--(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 
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

[[Page 64069]]

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 
    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 
    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 in OMB approval 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                 No. of    Frequency    Total      Hours    Total
Section     Forms    Respondents     per       Annual      per     Hours
                                   Response  Responses  Response
361.1(c  FDA 2914    80           1          80         1         80
361.1(c  FDA 2915    50           6.8        340        3.5       1,190
361.1(d  ..........  50           6.8        340        0.1       34
Total    ..........  ...........  .........  .........  ........  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\
 21 CFR    Forms       No. of       Frequency per    Hours per     Total
 Section            Recordkeepers   Recordkeeping   Recordkeeper   Hours
361.1(c)  .......  80              1 per qtr=      10             800
 (2)                               4 per yr
361.1(d)  .......  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

    In the Federal Register of July 23, 2004 (69 FR 44037), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

    Dated: October 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24444 Filed 11-2-04; 8:45 am]