[Federal Register Volume 67, Number 9 (Monday, January 14, 2002)]
[Notices]
[Page 1772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-855]



[[Page 1772]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0437]


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.

DATES: Submit written comments on the collection of information by 
February 13, 2002.

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., Washington, DC 20503, Attn: Stuart 
Shapiro, 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 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 No. 0910-0017)--Extension

    FDA has the responsibility under the Federal Food, Drug, and 
Cosmetic Act (the act) for approval of new animal drugs. Section 512(j) 
of the act (21 U.S.C. 360b(j)) authorizes FDA to issue regulations 
relating to the investigational use of new animal drugs. The 
regulations setting forth the conditions for investigational use of new 
animal drugs have been codified at part 511 (21 CFR part 511). A 
sponsor must submit to FDA a notice of claimed investigational 
exemption (INAD) before shipping the new animal drug for clinical tests 
in animals. The INAD 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, (4) name and address of each 
clinical investigator, (5) the approximate number of animals to be 
treated or amount of new animal drug(s) to be shipped, and (6) 
information regarding the use of edible tissues from investigational 
animals. The regulations in part 511 also require that records be 
established and maintained to document the distribution and use of the 
investigational drug to assure that its use is safe, and that 
distribution is controlled to prevent potential abuse. The agency 
utilizes these required records under its Bio-Research Monitoring 
Program to monitor the validity of the studies submitted to FDA to 
support new animal drug approval and to assure that proper use of the 
drug is maintained by the investigator.
    Investigational new animal drugs are used 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 the persons who use new animal drugs 
investigationally.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
   21 CFR                          Annual Frequency      Total Annual
   Section    No. of Respondents     per Response          Responses      Hours per Response      Total Hours
----------------------------------------------------------------------------------------------------------------
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)(        190                    .005               1                  20                  20
 ii)
511.1(b)(9)         190                    .16               30                   8                 240
                                                                                             -------------------
Total                                                                                            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 Burden\1\
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                                                            No. of         Annual Frequency      Total Annual          Hours per
                   21 CFR Section                        Recordkeepers     per Recordkeeping        Records          Recordkeeper         Total Hours
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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                                                                                                                                    21,510
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimate of the 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.

    Dated: January 7, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-855 Filed 1-11-02; 8:45 am]
BILLING CODE 4160-01-S