[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
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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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
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                Table 2.--Estimated Annual Recordkeeping Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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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