[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57558-57559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0155]


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 electronic or written comments on the collection of 
information by November 24, 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, 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.

Veterinary Feed Directive--21 CFR 558; OMB Control Number 0910-0363--
Extension

    With the passage of the Animal Drug Availability Act, 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) was tailored to 
the unique circumstances relating to the distribution of medicated 
feeds. 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.
    On December 12, 2013, FDA published a proposed rule in the Federal 
Register (78 FR 75515) intended to improve the efficiency of FDA's VFD 
program. The provisions included in the proposed rule were based on 
stakeholder input received in response to solicitations for public 
comment, including an advance notice of proposed rulemaking on March 
29, 2010 (75 FR 15387), and draft text of proposed amendments to the 
current VFD regulations on April 13, 2012 (77 FR 22247).
    While FDA intends to finalize the VFD rulemaking in 2015, the 
current

[[Page 57559]]

information collection request supporting the program expires on 
December 31, 2014. At this time, the burden for this information 
collection remains unchanged.
    FDA estimates the burden of this collection of information 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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558.6(a)(3) through (a)(5)...............................             15,000                 25            375,000  0.25 (15 minutes)             93,750
558.6(d)(1)(i) through (d)(1)(iii).......................                300                  1                300  0.25 (15 minutes)                 75
558.6(d)(1)(iv)..........................................                 20                  1                 20  0.25 (15 minutes)                  5
558.6(d)(2)..............................................              1,000                  5               5000  0.25 (15 minutes)              1,250
514.1(b)(9)..............................................                  1                  1                  1               3.00                  3
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total................................................  .................  .................  .................  .................             95,083
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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      Number of records     Total annual      Average burden
                      21 CFR Section                         recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
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558.6(c)(1) through (c)(4)...............................            112,500                 10          1,125,000  0.0167 (1 minute)             18,788
558.6(e)(1) through (e)(4)...............................              5,000                 75            375,000  0.0167 (1 minute)              6,263
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    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 time required for record preparation and 
maintenance is based on Agency communication with industry and Agency 
records and experience.

    Dated: September 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22808 Filed 9-24-14; 8:45 am]
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