Document ID: FDA-2011-N-0481-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: New Animal Drugs for Investigational Uses
Posted Date: 2015-04-02T04:00Z

[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Pages 17758-17760]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07539]

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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

[[Page 17759]]

the reporting and recordkeeping requirements for ``New Animal Drugs for 
Investigational Uses''.

DATES: Submit either electronic or written comments on the collection 
of information by June 1, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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 
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 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) 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 new animal 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 professions. Respondents to 
this collection of information are the persons who use new animal drugs 
for investigational purposes.
    FDA estimates the burden of this information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
         21 CFR Section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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511.1(b)(4).....................             263            5.30           1,395               1           1,395
511.1(b)(5).....................             263             .26              69               8             552
511.1(b)(6).....................             263             .01               2               1               2
511.1(b)(8)(ii).................             263             .06              15               2              30
511.1(b)(9).....................             263             .06              15               8             120
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    Total.......................  ..............  ..............  ..............  ..............           2,099
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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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                                                     Number of                    Average burden
         21 CFR Section              Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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511.1(a)(3).....................             263            2.07             545               1             545
511.1(b)(3).....................             263            5.30           1,395               1           1,395
511.1(b)(7)(ii).................             263            5.30           1,395             3.5         4,882.5

[[Page 17760]]

 
511.1(b)(8)(i)..................             263            5.30           1,395             3.5         4,882.5
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    Total.......................  ..............  ..............  ..............  ..............          11,705
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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 informal Agency communication with industry. Based on the 
number of sponsors subject to animal drug user fees, FDA estimates that 
there are 263 respondents. We use this estimate consistently throughout 
the table and calculate the ``annual frequency 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: March 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07539 Filed 4-1-15; 8:45 am]
BILLING CODE CODE 4164-01-P