[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Pages 19094-19096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07708]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0597]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Index of Legally Marketed Unapproved New Animal Drugs
for Minor Species; Extension
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 burden hours associated
with indexing of legal marketed unapproved new animal drugs for minor
species.
DATES: Submit either electronic or written comments on the collection
of information by June 6, 2014.
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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, [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
[[Page 19095]]
(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.
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
21 CFR Part 516 (OMB Control Number 0910-0620)--Extension
Description: The Minor Use and Minor Species Animal Health Act of
2004 (MUMS Act) amended the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) to authorize FDA to establish new regulatory procedures
intended to make more medications legally available to veterinarians
and animal owners for the treatment of minor animal species (species
other than cattle, horses, swine, chickens, turkeys, dogs, and cats),
as well as uncommon diseases in major animal species.
The MUMS Act created three new sections to the FD&C Act (sections
571, 572, and 573), and this final rule implements section 572, which
provides for an index of legally marketed unapproved new animal drugs
for minor species. Participation in any part of the MUMS program is
optional so the associated paperwork only applies to those who choose
to participate. The final rule specifies, among other things, the
criteria and procedures for requesting eligibility for indexing and for
requesting addition to the index as well as the annual reporting
requirements for index holders.
Under subpart C of part 516, Sec. 516.119 provides requirements
for naming a permanent resident U.S. agent by foreign drug companies,
and Sec. 516.121 provides for informational meetings with FDA. Section
516.123 provides requirements for requesting informal conferences
regarding Agency administrative actions and Sec. 516.125 provides for
investigational use of new animal drugs intended for indexing.
Provisions for requesting a determination of eligibility for indexing
can be found under Sec. 516.129 and provisions for subsequent requests
for addition to the index can be found under Sec. 516.145. A
description of the written report required in Sec. 516.145 can be
found under Sec. 516.143. Under Sec. 516.141 are provisions for drug
companies to nominate a qualified expert panel as well as the panel's
recordkeeping requirements. This section also calls for the submission
of a written conflict of interest statement to FDA by each proposed
panel member. Index holders are able to modify their index listing
under Sec. 516.161 or change drug ownership under Sec. 516.163.
Requirements for records and reports are under Sec. 516.165.
Description of Respondents: Pharmaceutical companies that sponsor
new animal drugs. FDA estimates the burden for this collection of
information as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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516.119......................... 2 1 2 1 2
516.121......................... 30 2 60 4 240
516.123......................... 3 1 3 8 24
516.125......................... 2 3 6 20 120
516.129......................... 30 2 60 20 1200
516.141......................... 20 1 20 16 320
516.143......................... 20 1 20 120 2400
516.145......................... 20 1 20 20 400
516.161......................... 1 1 1 4 4
516.163......................... 1 1 1 2 2
516.165......................... 10 2 20 8 160
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Total....................... .............. .............. .............. .............. 4,872
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\1\ There is no capital or operating and maintenance cost associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average
21 CFR section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
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516.141........................ 30 2 60 \2\ 0.5 30
516.165........................ 10 2 20 1 20
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Total...................... .............. .............. .............. .............. 50
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\1\ There is no capital or operating and maintenance cost associated with this collection of information.
\2\ 30 minutes.
[[Page 19096]]
Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07708 Filed 4-4-14; 8:45 am]
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