[Federal Register Volume 73, Number 68 (Tuesday, April 8, 2008)]
[Notices]
[Pages 19073-19074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-7255]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the reporting and 
recordkeeping requirements for ``New Animal Drugs for Investigational 
Use.''

DATES: Submit written or electronic comments on the collection of 
information by June 9, 2008.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

New Animal Drugs for Investigational Use--21 CFR Part 511 (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

[[Page 19074]]

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 for 
this collection of information are investigators who use new animal 
drugs for investigational purposes.
    FDA estimates the burden for this collection of information as 
follows:

                                  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              1,027                  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)(ii)                  134                .11                 15                 20                300
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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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                                       Annual Frequency
  21 CFR Section         No. of              per            Total Annual    Hours per  Record     Total Hours
                     Recordkeepers      Recordkeeping         Records
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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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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 and agency records. Based 
on the number of sponsors subject to animal drug user fees, FDA 
estimates there are 134 respondents. This estimate is used consistently 
throughout the burden tables and for example, the ``annual frequency 
per respondent'' was calculated by dividing the total annual responses 
by the number of respondents. Additional information needed to make 
final calculations for the total burden estimates in tables 1 and 2 of 
this document, i.e., the hours per response, the hours per record, the 
number of NCIEs received, etc., was derived from agency records.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only.

    Dated: March 31, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7255 Filed 4-7-08; 8:45 am]
BILLING CODE 4160-01-S