
[Federal Register: June 27, 2008 (Volume 73, Number 125)]
[Notices]               
[Page 36533-36534]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27jn08-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0172]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget 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 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 July 
28, 2008.

ADDRESSES:  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: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0117. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of the 
Chief Information Officer (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 (OMB Control Number 0910-
0117)--Extension

    FDA has authority under the Federal Food, Drug, and Cosmetic Act 
(the act) to approve new animal drugs. Section 512(j) of the act (21 
U.S.C.360b(j)), authorized FDA to issue regulations for the 
investigational use of new animal drugs. The regulations which set 
forth conditions for investigational use of new animal drugs are 
codified under part 511 (21 CFR part 511). If a new animal drug is only 
for tests in vitro, or testing in laboratory research animals, the 
person distributing the new animal drug must maintain records showing: 
(1) The name and post office address of the expert or expert 
organization to whom the drug is shipped; and (2) the date, quantity, 
batch or code mark for each shipment for a period of 2 years after such 
shipment or delivery. Prior to shipping a new animal drug for clinical 
investigations in animals, a sponsor must submit to FDA a Notice of 
Claimed Investigational Exemption (NCIE). The NCIE must contain, among 
other things, the following specific information: (1) The identity of 
the new animal drug, (2) labeling, (3) a statement of compliance of any 
non-clinical laboratory studies with good laboratory practices, (4) the 
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. Part 511 also requires 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 the 
distribution is controlled to prevent potential abuse. The agency uses 
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 the 
pharmaceutical industry, academic institutions, and the government. 
Investigators may include individuals from these entities as well as 
research firms and members of the medical professional. Respondents to 
this collection of information are investigators who use new animal 
drugs for investigational purposes.
    In the Federal Register of April 8, 2008 (73 FR 19073), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                      No. of         Annual Frequency       Total Annual        Hours per
21 CFR Section     Respondents         per Response          Responses           Response         Total Hours
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511.1(b)(4)                   134                  7.66               1027                  8              8,216
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511.1(b)(5)                   134                   .19                 25                140              3,500
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511.1(b)(6)                   134                   .01                  2                  1                  2
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511.1(b)(8)                   134                   .11                 15                 20                300
 (ii)
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511.1(b)(9)                   134                  6.7                  20                  8                160
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Total                                                                                                     12,178
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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)                   134                  2.96                400                9                3,600
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511.1(b)(3)                   134                  7.66              1,027                1                1,027
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[[Page 36534]]


511.1(b)(7)(ii                134                  7.46              1,000                3.5              3,500
 )
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511.1(b)(8)(i)                134                  7.46              1,000                3.5              3,500
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Total                                                                                                     11,627
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimates for reporting requirements, record 
preparation, and maintenance for this collection of information are 
based on agency communication with industry. Based on the number of 
sponsors subject to animal drug user fees, FDA estimates that there are 
134 respondents. We use this estimate consistently throughout the table 
and calculated the ``annual frequency per respondent'' by dividing the 
total annual responses by number of respondents. Additional information 
needed to make final calculations of the total burden hours i.e., the 
number of respondents, the number of record keepers, the number of 
NCIEs received, etc., was derived from agency records.

    Dated: June 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14653 Filed 6-26-08; 8:45 am]

BILLING CODE 4160-01-S
