[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 27007-27009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12448]


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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 or we) 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 July 
11, 2018.

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 <a href="/cdn-cgi/l/email-protection#96f9ffe4f7c9e5e3f4fbffe5e5fff9f8d6f9fbf4b8f3f9e6b8f1f9e0"><span class="__cf_email__" data-cfemail="c3acaab1a29cb0b6a1aeaab0b0aaacad83acaea1eda6acb3eda4acb5">[email protected]</span></a>. 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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
<a href="/cdn-cgi/l/email-protection#154547544661747373557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="83d3d1c2d0f7e2e5e5c3e5e7e2adebebf0ade4ecf5">[email protected]</span></a>.

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 Food Directive

OMB Control Number 0910-0363--Extension

    Section 504 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
354) establishes a regulatory category for certain new animal drugs 
called veterinary feed directive (VFD) drugs. The VFD regulation is set 
forth at Sec.  558.6 (21 CFR 558.6). VFD drugs are new animal drugs 
intended for use in or on animal feed which are limited to use under 
the professional supervision of a licensed veterinarian in the course 
of the veterinarian's professional practice (Sec.  558.6(b)(6)). An 
animal feed containing a VFD drug or a combination VFD drug may be fed 
to animals only by or upon a lawful VFD issued by a licensed 
veterinarian (Sec.  558.6(a)(1)).
    Veterinarians issue three copies of the VFD: One for their own 
records, one for their client, and one to the client's VFD feed 
distributor (Sec. Sec.  558.6(a)(4) and 558.6(b)(8)-(9)). The VFD 
includes information about the number and species of animals to receive 
feed containing one or more of the VFD drugs (Sec.  558.6(b)(3)), along 
with other information required under Sec.  558.6. All distributors of 
medicated feed containing VFD drugs must notify FDA

[[Page 27008]]

of their intent to distribute such feed and must maintain records of 
the receipt and 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. The VFD regulation is tailored to the 
unique circumstances relating to the distribution and use of animal 
feeds containing a VFD drug.
    We use the information collected to assess compliance with the VFD 
regulation. The required recordkeeping and third party disclosures 
provide assurance that the medicated feeds will be safe and effective 
for their labeled conditions of use and that edible products from 
treated animals will be free of unsafe drug residues.
    We are retaining the estimates used in FDA's analysis of the 
information collection provisions in the final rule entitled 
``Veterinary Feed Directive,'' published in the Federal Register of 
June 3, 2015 (80 FR 31708 at 31728), and approved by OMB.
A. Reporting Requirements
    Description of Respondents: VFD Feed Distributors and VFD Drug 
Sponsors.
    A distributor of animal feed containing a VFD drug must notify FDA 
prior to the first time it distributes the VFD feed (Sec.  
558.6(c)(5)). This notification is required one time per distributor 
and must include the information set forth in Sec.  558.6(c)(5). In 
addition, a distributor must notify FDA within 30 days of any change in 
ownership, business name, or business address (Sec.  558.6(c)(6)). 
Additional reporting burdens for current VFD drug sponsors are approved 
under OMB control numbers 0910-0032 (New Animal Drug Applications) and 
0910-0669 (Abbreviated New Animal Drug Applications).

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           21 CFR section/activity               Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(c)(5) requires a distributor to notify             300               1             300  0.125 (7 minutes).........................            37.5
 FDA prior to the first time it distributes
 a VFD feed.
558.6(c)(6) requires a distributor to notify              20               1              20  0.125 (7 minutes).........................             2.5
 FDA within 30 days of any change in
 ownership, business name, or business
 address.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................              40
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

B. Recordkeeping Requirements
    Description of Respondents: VFD Feed Distributors, Food Animal 
Veterinarians, and Clients (Food Animal Producers).
    As stated previously, veterinarians issue three copies of the VFD: 
One for their own records, one for their client, and one to the 
client's VFD feed distributor. All involved parties (veterinarian, 
distributor, and client) must retain a copy of the VFD for 2 years 
(Sec.  558.6(a)(4)). In addition, VFD feed distributors must also keep 
receipt and distribution records of VFD feeds they manufacture and make 
them available for inspection by FDA for 2 years (Sec.  558.6(c)(3)). 
If a distributor manufactures the VFD feed, the distributor must also 
keep VFD manufacturing records for 1 year in accordance with 21 CFR 
part 225 and such records must be made available for inspection and 
copying by FDA upon request (Sec.  558.6(c)(4)). These record 
requirements are currently approved under OMB control number 0910-0152, 
``Current Good Manufacturing Practice Regulations for Medicated Feed.'' 
Distributors may distribute VFD feeds to another distributor only if 
the originating distributor first obtains a written acknowledgement 
letter. Such letters, like VFDs, are also subject to a 2-year record 
retention requirement (Sec.  558.6(c)(8)).

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           21 CFR section/activity               Number of     responses per   Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(a)(4); required recordkeeping by                13,050           114.9       1,500,000  0.0167 (1 minute).........................          25,050
 veterinarians and producers.
558.6(a)(4), (c)(3), (c)(4), and (c)(8);               1,376           545.1         750,000  0.0167 (1 minute).........................          12,525
 required recordkeeping by distributors.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          37,575
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

C. Third-Party Disclosure Requirements
    Description of Respondents: VFD Drug Sponsors, Food Animal 
Veterinarians, VFD Feed Distributors, and Clients.
    FDA regulation requires that veterinarians include the information 
specified at Sec.  558.6(b)(3) through (5) on the VFD. Additional 
requirements relating to the VFD are specified at Sec.  558.6(b)(7) 
through (9). A distributor may only distribute a VFD feed to another 
distributor for further distribution if the originating distributor 
(consignor) first obtains a written acknowledgement letter from the 
receiving distributor (consignee) before the feed is shipped (Sec.  
558.6(c)(8)).

[[Page 27009]]



                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
           21 CFR section/activity               Number of      disclosures    Total annual          Average burden per disclosure          Total hours
                                                respondents   per respondent    disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(b)(3)-(b)(5) and (b)(7)-(b)(9);                  3,050             246         750,000  0.125 (7 minutes).........................          93,750
 required disclosures when a veterinarian
 issues a VFD.
558.6(c)(8); required disclosure                       1,000               5           5,000  0.125 (7 minutes).........................             625
 (acknowledgement letter) from one
 distributor to another.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................          94,375
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The VFD regulation also contains several labeling provisions that 
are exempt from OMB review and approval under the PRA because they are 
a ``public disclosure of information originally supplied by the Federal 
government to the recipient for the purpose of disclosure to the 
public'' (5 CFR 1320.3(c)(2)) and therefore do not constitute a 
``collection of information'' under the PRA (44 U.S.C. 3501, et seq.). 
All labeling and advertising for VFD drugs, combination VFD drugs, and 
feeds containing VFD drugs or combination VFD drugs must prominently 
and conspicuously display the following cautionary statement: 
``Caution: Federal law restricts medicated feed containing this 
veterinary feed directive (VFD) drug to use by or on the order of a 
licensed veterinarian'' (Sec.  558.6(a)(6)). In addition, the 
veterinarian must ensure that the following statement is included on 
the VFD (Sec.  558.6(b)(3)(xiii)): ``Use of feed containing this 
veterinary feed directive (VFD) drug in a manner other than as directed 
on the labeling (extralabel use) is not permitted.''
    The veterinarian may restrict VFD authorization to only include the 
VFD drug(s) cited on the VFD or such authorization may be expanded to 
allow the use of the cited VFD drug(s) along with one or more over-the-
counter animal drugs in an approved, conditionally approved, or indexed 
combination VFD drug (Sec.  558.6(b)(6)). The veterinarian must affirm 
his or her intent regarding combination VFD drugs by including one of 
the following statements on the VFD:
    1. ``This VFD only authorizes the use of the VFD drug(s) cited in 
this order and is not intended to authorize the use of such drug(s) in 
combination with any other animal drugs'' (Sec.  558.6(b)(6)(i)).
    2. ``This VFD authorizes the use of the VFD drug(s) cited in this 
order in the following FDA-approved, conditionally approved, or indexed 
combination(s) in medicated feed that contains the VFD drug(s) as a 
component.'' (List specific approved, conditionally approved, or 
indexed combination medicated feeds following this statement.) (Sec.  
558.6(b)(6)(ii)).
    3. ``This VFD authorizes the use of the VFD drug(s) cited in this 
order in any FDA-approved, conditionally approved, or indexed 
combination(s) in medicated feed that contains the VFD drug(s) as a 
component'' (Sec.  558.6(b)(6)(iii)).
    These labeling statements are not subject to review by OMB because, 
as stated previously, they are a ``public disclosure of information 
originally supplied by the Federal government to the recipient for the 
purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)) and 
therefore do not constitute a ``collection of information'' under the 
PRA (44 U.S.C. 3501, et seq.).
    The one-time burdens included in FDA's analysis of the June 3, 
2015, final rule (80 FR 31708 at 31729 to 31732) are not included in 
the estimate provided in this notice. FDA's estimate of the annual 
recurring burden for this information collection has not changed since 
the last OMB approval.

    Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12448 Filed 6-8-18; 8:45 am]
 BILLING CODE 4164-01-P


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