Document ID: FDA-2011-N-0481-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; New Animal Drugs
for Investigational Uses
Posted Date: 2011-09-23T04:00Z

[Federal Register Volume 76, Number 185 (Friday, September 23, 2011)]
[Notices]
[Pages 59139-59141]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24433]

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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.

[[Page 59140]]

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 October 
24, 2011.

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 e-mailed 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: Juanmanuel Vilela, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-7651, 
juanmanuel.vilela@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 (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) 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 profession. Respondents to 
this collection of information are the persons who use new animal drugs 
for purposes of an investigation.
    In the Federal Register of June 28, 2011 (76 FR 37814), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 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 \1\
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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           1,238               1           1,238
511.1(b)(7)(ii).................             206            6.01           1,238             3.5           4,333
511.1(b)(8)(i)..................             206            6.01           1,238             3.5           4,333
                                 -------------------------------------------------------------------------------
    Total Burden Hours..........  ..............  ..............  ..............  ..............          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

[[Page 59141]]

subject to animal drug user fees, FDA estimates that there are 206 
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 record keepers, the number of 
NCIEs received, etc.) is derived from agency records.

    Dated: September 19, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2011-24433 Filed 9-22-11; 8:45 am]
BILLING CODE 4160-01-P