[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Notices]
[Pages 46818-46819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0554]


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 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 reporting and recordkeeping 
requirements for distribution and use of Veterinary Feed Directive 
(VFD) drugs and animal feeds containing VFD drugs.

DATES: Submit either electronic or written comments on the collection 
of information by October 3, 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: Juanmanuel 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.

Veterinary Feed Directive--21 CFR Part 558 (OMB Control Number 0910-
0363)--Extension

    With the passage of the Animal Drug Availability Act of 1996 (Pub. 
L. 104-250), 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 feeds 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 of 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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558.6(a)(3) through (a)(5)......          15,000              25         375,000             .25          93,750
558.6(d)(1)(i) through                       300               1             300             .25              75
 (d)(1)(iii)....................
558.6(d)(1)(iv).................              20               1              20             .25               5
558.6(d)(2).....................           1,000               5           5,000             .25           1,250
514.1(b)(9).....................               1               1               1            3.00               3
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    Total.......................  ..............  ..............  ..............  ..............          95,083
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 46819]]


                                 Table 2--Estimated Annual Recordkeeping Burden1
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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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558.6(c)(1) through (c)(4)......         112,500              10       1,125,000           .0167          18,788
558.6(e)(1) through (e)(4)......           5,000              75         375,000           .0167           6,263
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    Total.......................  ..............  ..............  ..............  ..............          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: July 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19603 Filed 8-2-11; 8:45 am]
BILLING CODE 4160-01-P