[Federal Register Volume 79, Number 247 (Wednesday, December 24, 2014)]
[Notices]
[Pages 77498-77500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30157]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
23, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0363. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

    With the passage of the Animal Drug Availability Act of 1996 
(Public Law 104-250), 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

[[Page 77499]]

relating to the distribution of medicated feeds. All distributors of 
medicated feed containing VFD drugs must notify FDA of their intent to 
distribute such feed, and records must be maintained of the 
distribution and feeding (under the professional supervision of a 
licensed veterinarian) 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).
    In the Federal Register of September 25, 2014 (79 FR 57558), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received but it did not 
respond to any of the four collection of information topics solicited 
in the notice and therefore is not discussed in this document. At the 
same time, since publication of the 60-day notice, the burden for this 
information collection has been revised to reflect an update in the 
number of veterinarians, producers, and distributors, as well as 
updated cost burden information.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
        21 CFR section             Number of     responses per   Total annual    Average  burden    Total hours
                                  respondents     respondent       responses      per  response
----------------------------------------------------------------------------------------------------------------
558.6(d)(1)(i) through                     300               1             300  .25 (15 minutes)              75
 (d)(1)(iii): A distributor
 must notify FDA prior to the
 first time it distributes a
 VFD drug.
558.6(d)(1)(iv): A distributor              20               1              20  .25 (15 minutes)               5
 must notify FDA within 30
 days of any change in
 ownership, business name, or
 business address.
514.1(b)(9): Sponsor submits 3               1               1               1  3...............               3
 copies of VFD with new drug
 application.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................              83
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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\
----------------------------------------------------------------------------------------------------------------
                                                   Number of                     Average  burden
        21 CFR section             Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
558.6(c)(1) through (c)(4):             13,050           114.9       1,500,000  .0167 (1 minute)          25,050
 Filing of VFD copies by
 veterinarians and producers
 \2\.
558.6(e)(1) through (e)(4):              1,376           545.1         750,000  .0167 (1 minute)          12,525
 Filing of VFD copies by
 distributors only \3\.
                               ---------------------------------------------------------------------------------
    Total.....................          14,426  ..............       2,250,000  ................          37,575
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The same recordkeeping requirement for distributors is listed in two separate sections of the codified;
  therefore, we have listed distributors separately (in reference to 558.6(e)(1) through (e)(4)) in order to
  avoid double counting their recordkeeping requirement.
\3\ Distributors may receive an acknowledgement letter in lieu of a VFD when consigning VFD feed to another
  distributor (please see table 3.). Such letters, like VFDs, are also subject to a 2-year record retention
  requirement. Thus, the recordkeeping burden for acknowledgement letters is included as a subset of the VFD
  recordkeeping burden.


                              Table 3--Estimated Annual Third-Party Disclosure \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
                                   Number of      disclosures    Total annual    Average  burden
        21 CFR section            respondents         per         disclosures    per  disclosure    Total hours
                                                  respondent
----------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5):              3,050             246         750,000  0.125 (7                  93,750
 Veterinarian issues VFD.                                                        minutes).
558.6(d)(2): Acknowledgement         \2\ 1,000               5           5,000  0.125 (7                     625
 letter generation \2\.                                                          minutes).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          94,375
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ 1,000 VFD distributors (of the 1,376 total distributors) multiplied by 5 disclosures per distributor equals
  5,000 annual acknowledgement letters, multiplied by 0.125 hours equals 625 hours annually.

    The estimate of time required for record preparation and 
maintenance is based on Agency communication with industry and Agency 
records and experience.


[[Page 77500]]


    Dated: December 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30157 Filed 12-23-14; 8:45 am]
BILLING CODE 4164-01-P