[Federal Register Volume 63, Number 71 (Tuesday, April 14, 1998)]
[Notices]
[Pages 18203-18204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9705]



[[Page 18203]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0532]


Agency Information Collection Activities; Submission for OMB 
Review; Radioactive Drug Research Committees; Comment Request

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 (the PRA).

DATES: Submit written comments on the collection of information by May 
14, 1998.

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: 
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 section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

Radioactive Drug For Certain Research Uses--21 CFR 361.1--(OMB 
Control Number 0910-0053--Reinstatement)

    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 research studies utilizing radiopharmaceuticals. No 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 carry out a clinical trial. The types 
of basic research permitted are specified in the regulation, and 
includes 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, and for each study conducted 
during the preceeding 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 to be confirmed are present.
    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 (the) 
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 
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. If these studies were not reviewed, human 
subjects could be subjected to inappropriate radiation and/or safety 
risks.
    Respondents to this information collection are 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 
committee chairpersons who were selected from different geographical 
areas and of varying levels of Radioactive Drug Research Committee 
membership and activities. These chairpersons were asked for their 
assessment of time expended, cost, and views on completing the 
necessary reporting forms.
    In the Federal Register of January 9, 1998 (63 FR 1484), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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                                                      Annual                                                    
  21 CFR Section      Form No.        No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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361.1(c)(3)        FDA 2914           100               1.0           100               1.0           100       
361.1(c)(3)        FDA 2915            62               3.5           217               3.75          814       
361.1(d)(5)                            62               3.5           217               0.1            22       
361.1(d)(8)                            62               3.5           217               0               0       
Totals                                                                                                936       
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  


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                                Table 2.--Estimated Annual Recordkeeping Burden1                                
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                                           No. of         Annual Frequency per       Hours per                  
   21 CFR Section        Form No.       Recordkeepers        Recordkeeping         Recordkeeper     Total Hours 
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361.1(c)(2)          FDA 2914 and          100         1 per qtr = 4 per yr            10           1,000       
                      2915                                                                                      
Total                                                                                               1,000       
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  


    Dated: April 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-9705 Filed 4-13-98; 8:45 am]
BILLING CODE 4160-01-F