[Federal Register Volume 80, Number 63 (Thursday, April 2, 2015)]
[Notices]
[Pages 17758-17760]
From the Federal Register Online via the Government Publishing 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, [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
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