[Federal Register Volume 76, Number 124 (Tuesday, June 28, 2011)]
[Notices]
[Pages 37814-37815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-16090]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0481]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; New Animal Drugs for Investigational Uses

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 
Uses.''

DATES: Submit electronic or written comments on the collection of 
information by August 29, 2011.

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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
[email protected].

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 Uses--21 CFR Part 511 (OMB Control 
Number 0910-0117--Extension)

    FDA has the authority under the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) to approve new animal drugs. Section 512(j) of the 
FD&C 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). If the 
new animal drug is only for tests in vitro or in laboratory research 
animals, the person distributing the new animal drug must maintain 
records showing the name and post office address of the expert or 
expert organization to whom it is shipped and the date, quantity, and 
batch or code mark of each shipment and delivery for a period of 2 
years after such shipment or delivery. Before 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) 
Identity of the new animal drug, (2) labeling, (3) statement of 
compliance of any non-clinical 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)

[[Page 37815]]

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 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 professional. Respondents to 
this collection of information are the persons who use new animal drugs 
investigationally.

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
           21 CFR Part               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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511.1(b)(4).....................             206            6.01           1,238               1           1,238
511.1(b)(5).....................             206             .34              70               8             560
511.1(b)(6).....................             206             .01               2               1               2
511.1(b)(8) (ii)................             206             .07              15               2              30
511.1(b)(9).....................             206             .07              15               8             120
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    Total.......................  ..............  ..............  ..............  ..............           1,950
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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
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                                                     Number of                        Average
           21 CFR Part               Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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511.1(a)(3).....................             206            2.30             473               1             473
511.1(b)(3).....................             206            6.01            1238               1           1,238
511.1(b)(7)(ii).................             206            6.01            1238             3.5           4,333
511.1(b)(8)(i)..................             206            6.01            1238             3.5           4,333
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    Total.......................  ..............  ..............  ..............  ..............          10,377
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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. Based on the number of 
sponsors subject to animal drug user fees, FDA estimates that there are 
206 respondents. We use this estimate consistently throughout the table 
and calculate the ``No. of Responses per Respondent'' by dividing the 
total annual responses by number of respondents. 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 NCIEs 
received, etc.) is derived from Agency records.

    Dated: June 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-16090 Filed 6-27-11; 8:45 am]
BILLING CODE 4160-01-P