[Federal Register: June 10, 2005 (Volume 70, Number 111)]
[Notices]
[Page 33907-33908]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jn05-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0210]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Veterinary Feed Directive
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 renewal of an existing collection of information, and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on reporting and recordkeeping requirements for
distribution and use of Veterinary Feed Directive (VFD) drugs and
animal feeds containing VFD drugs.
DATES: Submit written or electronic comments on the collection of
information by August 9, 2005.
ADDRESSES: Submit electronic comments on the collection of information
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
rm. 4B-41, Rockville, MD 20857, 301-827-1472.
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 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 a proposed
collection of information as 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
[[Page 33908]]
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.
Veterinary Feed Directive (OMB Control Number 0910-0363)--Extension
With the passage of Animal Drug Availability Act (ADAA), the
Congress enacted legislation establishing a new class of restricted
feed use drugs, VFD drugs, which may be distributed without involving
State pharmacy laws. Although controls on the distribution and use of
VFD drugs are similar to those for prescription drugs regulated under
section 503(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
353(f)), the implementing VFD regulation (21 CFR 558.6), is tailored to
the unique circumstances relating to the distribution of medicated
feeds. The content of the VFD is spelled out in the regulation. All
distributors of medicated feed containing VFD drugs must notify FDA of
their intent to distribute, and records must be maintained of the
distribution of all medicated feed containing VFD drugs. The VFD
regulation ensures the protection of public health while enabling
animal producers to obtain and use needed drugs as efficiently and
cost-effectively as possible.
FDA estimates the burden for this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per Total Annual Hours per
21 CFR Section No. of Respondents Response Responses Response Total Hours
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558.6(a)(3) 15,000 25 375,000 0.25 93,750
through
(a)(5)
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558.6(d)(1)(i) 500 1 500 0.25 125
through
(d)(1)(iii)
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558.6(d)(1)(iv 20 1 20 0.25 5
)
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558.6(d)(2) 1,000 5 5,000 0.25 1,250
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514.1(b)(9) 1 1 1 3.00 3
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Total Hours 16,521 .................... .................... .............. 95,133
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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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Annual Frequency per Total Annual Hours per
21 CFR Section No. of Recordkeepers Recordkeeper Records Record Total Hours
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558.6(c)(1) through 112,500 10 1,125,000 .0167 18,788
(c)(4)
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558.6(e)(1) through 5,000 75 375,000 .0167 6,263
(e)(4)
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Total Hours .................... .................... .............. .............. 25,051
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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 times required for record preparation and
maintenance is based on agency communication with industry and agency
records and experience.
Dated: June 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11581 Filed 6-9-05; 8:45 am]
BILLING CODE 4160-01-S