[Federal Register Volume 75, Number 232 (Friday, December 3, 2010)]
[Notices]
[Pages 75481-75482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30335]
-----------------------------------------------------------------------
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 legally marketed unapproved new animal drugs for minor
species.
DATES: Submit either electronic or written comments on the collection
of information by February 1, 2011.
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: Johnny Vilela, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7651, [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.
Index of Legally Marketed Unapproved New Animal Drugs for Minor
Species--21 CFR Part 516 (OMB Control Number 0910-0620)--Extension
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 added three new sections to the FD&C Act (sections
571, 572, and 573 (21 U.S.C. 360ccc, 360ccc-1, and 360ccc-2,
respectively)). The final rule (72 FR 69108, December 6, 2007)
implements section 572 of the FD&C Act, 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 the new subpart C of part 516 (21 CFR part 516, subpart C),
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
[[Page 75482]]
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 of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Number of frequency per Total annual Hours per Total hours
respondents response responses response
----------------------------------------------------------------------------------------------------------------
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 1,200
516.141......................... 20 1 20 16 320
516.143......................... 20 1 20 120 2,400
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
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 4,872
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section Number of frequency per Total annual Hours per Total hours
recordkeepers recordkeeper records recordkeeper
----------------------------------------------------------------------------------------------------------------
516.141......................... 30 2 60 0.5 30
516.165......................... 10 2 20 1 20
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 50
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: November 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30335 Filed 12-2-10; 8:45 am]
BILLING CODE 4160-01-P