[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Notices]
[Pages 2456-2459]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00676]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency or we) is 
announcing an opportunity for public comment on the proposed collection 
of certain information by the Agency. Under the Paperwork Reduction Act 
of 1995 (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 the information collection 
provisions of our veterinary feed directive (VFD) regulation.

DATES: Submit either electronic or written comments on the collection 
of information by March 19, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of March 19, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to

[[Page 2457]]

the docket unchanged. Because your comment will be made public, you are 
solely responsible for ensuring that your comment does not include any 
confidential information that you or a third party may not wish to be 
posted, such as medical information, your or anyone else's Social 
Security number, or confidential business information, such as a 
manufacturing process. Please note that if you include your name, 
contact information, or other information that identifies you in the 
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0155 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Veterinary Feed Directive.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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 558.6

OMB Control Number 0910-0363--Extension

    Section 504 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 354) establishes a regulatory category for certain new 
animal drugs called VFD drugs. Our 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.  558.3 (21 CFR 
558.3(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 us 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 will 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

[[Page 2458]]

products from treated animals will be free of unsafe drug residues.
    We estimate the burden of this collection of information as 
follows. We base our estimates on our analysis of the information 
collection provisions of the final rule entitled ``Veterinary Feed 
Directive,'' published in the Federal Register of June 3, 2015 (80 FR 
31708 at 31728) (the June 3, 2015, final rule).

A. Reporting Requirements

    Description of Respondents: VFD Feed Distributors, VFD Drug 
Sponsors.
    A distributor of animal feed containing a VFD drug must notify us 
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 us 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).
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
   21 CFR section, activity        Number of    responses  per   Total annual    Average burden     Total hours
                                  respondents      respondent      responses      per response
----------------------------------------------------------------------------------------------------------------
558.6(c)(5); requires a                    300               1             300  .125 (7 minutes)            37.5
 distributor to notify us
 prior to the first time it
 distributes a VFD feed.
558.6(c)(6); requires a                     20               1              20  .125 (7 minutes)             2.5
 distributor to notify us
 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 (the veterinarian, 
the distributor, and the 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 us 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 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                     Average burden
   21 CFR section, activity        Number of      records per    Total annual          per          Total hours
                                 recordkeepers   recordkeeper       records       recordkeeping
----------------------------------------------------------------------------------------------------------------
558.6(a)(4); required                   13,050           114.9       1,500,000  .0167 (1 minute)          25,050
 recordkeeping by
 veterinarians and producers.
558.6(a)(4), (c)(3)-(4), and             1,376           545.1         750,000  .0167 (1 minute)          12,525
 (c)(8); 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.
    Our 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 2459]]



                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
                                   Number of      disclosures    Total annual    Average burden
   21 CFR section, activity       respondents         per         disclosures    per disclosure     Total hours
                                                  respondent
----------------------------------------------------------------------------------------------------------------
558.6(b)(3)-(5) and (b)(7)-              3,050             246         750,000  .125 (7 minutes)          93,750
 (9); required disclosures
 when a veterinarian issues a
 VFD.
558.6(c)(8); required                    1,000               5           5,000  .125 (7 minutes)             625
 disclosure (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.). Our estimate of the annual burden for 
this information collection has not changed since the last OMB 
approval, which was associated with the June 3, 2015, final rule. 
However, the one-time burdens that we included in our analysis of the 
June 3, 2015, final rule (80 FR 31708 at 31729 to 31732) are not 
included in our current estimate.

    Dated: January 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00676 Filed 1-16-18; 8:45 am]
 BILLING CODE 4164-01-P