98-32021. Agency Information Collection Activities; Submission for OMB Review; Comment Request; New Animal Drugs for Investigational Use  

  • [Federal Register Volume 63, Number 231 (Wednesday, December 2, 1998)]
    [Notices]
    [Pages 66548-66549]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-32021]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    [Docket No. 98N-0363]
    
    
    Agency Information Collection Activities; Submission for OMB 
    Review; Comment Request; New Animal Drugs for Investigational Use
    
    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 
    January 4, 1999.
    
    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:  Denver Presley, Office of Information 
    Resources Management (HFA-250), Food and Drug Administration, 5600 
    Fishers Lane, Rockville, MD 20857, 301-827-1472.
    
    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.
    
    New Animal Drugs for Investigational Use ( 21 CFR Part 511) (OMB 
    Control Number 0910-0117)
    
        Under the Federal Food, Drug, and Cosmetic Act (the act), FDA is 
    responsible for the approval of new animal drugs for investigational 
    use. Section 512(j) of the act (21 U.S.C. 360b(j)) requires that a 
    sponsor submit to FDA ``Notice of Claimed Investigational Exemption'' 
    (INAD), prior to shipment of the new animal drug for clinical tests in 
    animals. The regulations implementing statutory requirements for INAD 
    approval have been codified under part 511 (21 CFR part 511). The INAD 
    application must contain, among other things, the following specific 
    information: (1) Identity of the new animal drug, (2) labeling, (3) 
    statement of compliance of any nonclinical laboratory studies with good 
    laboratory practices, and (4) name and address of each clinical 
    investigator and the approximate number of animals to be treated or the 
    amount of new animal drugs to be shipped. Part 511 also requires that 
    records be established and maintained to document the distribution and 
    use of the investigational drug to ensure that its use is safe, that 
    distribution is controlled to prevent potential abuse, and that edible 
    products of treated animals will not be distributed for food without 
    proper authorization from FDA. The agency utilizes these required 
    records under its ``Bio-Research Monitoring Program'' to monitor the 
    validity of the studies and to ensure that proper use of the drug is 
    maintained by the investigator.
        Investigational new animal drugs are sponsored primarily by drug 
    industry firms, academic institutions, and the Government. 
    Investigators may include individuals from these entities as well as 
    research firms and members of the medical profession. Respondents to 
    this collection of information are both sponsors and investigators.
        FDA estimates the burden of this collection of information as 
    follows:
    
                                      Table 1.--Estimated Annual Reporting Burden1
    ----------------------------------------------------------------------------------------------------------------
                                                          Annual
             21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                        Respondents      Response        Responses       Response
    ----------------------------------------------------------------------------------------------------------------
    511.1(b)(4)                           190               6           1,147               8           9,176
    511.1(b)(5)                           190               1.5           287             140          40,180
    511.1(b)(6)                           190                .005           1             250             250
    511.1(b)(8)(ii)                       190                .005           1              20              20
    511.1(b)(9)                           190                .16           30               8             240
    Total Burden Hours                                                                                 49,866
    ----------------------------------------------------------------------------------------------------------------
    \1\ There are no capital costs or operating and maintenance costs associated with this collection of
      information.
    
    
                                    Table 2.--Estimated Annual Recordkeeping Burden1
    ----------------------------------------------------------------------------------------------------------------
                                                          Annual
             21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                       Recordkeepers   Recordkeeping      Records      Recordkeeper
    ----------------------------------------------------------------------------------------------------------------
    511.1(a)(3)                           190               7.5         1,434               9          12,906
    511.1(b)(3)                           190              10           1,912               1           1,912
    511.1(b)(7)(ii)                       190               2             956               3.5         3,346
    511.1(b)(8)(i)                        190               4             956               3.5         3,346
    Total Burden Hours                                                                                 21,510
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    \1\ There are no capital costs or operating and maintenance costs associated with this collection of
      information.
    
        The estimated time required for reporting requirements, record 
    preparation, and maintenance for this collection of information is 
    based on agency communication with industry. Additional information 
    needed to make a final calculation of the total burden hours (i.e., the 
    number of respondents, the number of recordkeepers, the number of INAD 
    applications received, etc.) is derived from agency records.
    
    
    [[Page 66549]]
    
    
        Dated: November 24, 1998.
     William K. Hubbard,
     Associate Commissioner for Policy Coordination.
    [FR Doc. 98-32021 Filed 12-1-98; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
12/02/1998
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
98-32021
Dates:
Submit written comments on the collection of information by January 4, 1999.
Pages:
66548-66549 (2 pages)
Docket Numbers:
Docket No. 98N-0363
PDF File:
98-32021.pdf