
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Notices]
[Pages 35956-35957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15320]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 
23, 2015.

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: 202-395-7285, or emailed to oira_submission@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: 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: 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 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. 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 Bioresearch 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.
    In the Federal Register of April 2, 2015 (80 FR 17758), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of

[[Page 35957]]

information. Two comments were received but neither responded to any of 
the four information collection topics solicited and are therefore not 
addressed by the Agency.
    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      Number of records    Total annual      Average burden
                       21 CFR section                          recordkeepers    per  recordkeeper       records      per recordkeeping     Total hours
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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
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: June 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15320 Filed 6-22-15; 8:45 am]
 BILLING CODE 4164-01-P


