[Federal Register Volume 85, Number 247 (Wednesday, December 23, 2020)]
[Notices]
[Pages 83968-83971]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28353]


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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 or Agency) 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 veterinary feed directive regulation.

DATES: Submit either electronic or written comments on the collection 
of information by February 22, 2021.

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 February 22, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of February 22, 2021. 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:
    <bullet> 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 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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 ``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 between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
    <bullet> 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

[[Page 83969]]

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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
<a href="/cdn-cgi/l/email-protection#85d5d7c4d6f1e4e3e3c5e3e1e4abededf6abe2eaf3"><span class="__cf_email__" data-cfemail="722220332106131414321416135c1a1a015c151d04">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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

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.  558.6(a)(4) and (b)(8) and (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 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 products from 
treated animals will be free of unsafe drug residues.

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 Application) 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     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
558.6(c)(5) requires a                     188               1             188  0.125 (7                      24
 distributor to notify FDA                                                       minutes).
 prior to the first time it
 distributes a VFD feed.
558.6(c)(6) requires a                     192               1             192  0.125 (7                      24
 distributor to notify FDA                                                       minutes).
 within 30 days of any change
 in ownership, business name,
 or business address.
                               ---------------------------------------------------------------------------------
Total.........................  ..............  ..............  ..............  ................              48
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 83970]]

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 (consignor) first obtains a written 
acknowledgment letter from the receiving distributor (consignee) before 
the feed is shipped. 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  0.0167 (1                 25,050
 recordkeeping by                                                                minute).
 veterinarians and producers.
558.6(a)(4), (c)(3), (4), and            9,635           545.1       5,252,038  0.0167 (1                 87,709
 (8); required recordkeeping                                                     minute).
 by distributors.
                               ---------------------------------------------------------------------------------
Total.........................  ..............  ..............  ..............  ................         112,759
----------------------------------------------------------------------------------------------------------------
\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 acknowledgment letter from the 
receiving distributor (consignee) before the feed is shipped (Sec.  
558.6(c)(8)).

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                  Number of
   21 CFR section/activity        Number of    disclosures per   Total annual    Average burden     Total hours
                                 respondents      respondent      disclosures    per disclosure
----------------------------------------------------------------------------------------------------------------
558.6(b)(3)-(5) and (b)(7)-             3,050              246         750,000  0.125 (7                  93,750
 (9); required disclosures                                                       minutes).
 when a veterinarian issues a
 VFD.
558.6(c)(8); required                   1,000                5           5,000  0.125 (7                     625
 disclosure (acknowledgment                                                      minutes).
 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)).

[[Page 83971]]

    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.).
    Based on a review of the information collection since our last 
request for OMB approval, there has been a significant increase in the 
number of VFD distributors due to changes to the VFD regulations that 
were implemented in 2017. Since implementation, the number of approved 
VFD drugs has increased.

    Dated: December 17, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28353 Filed 12-22-20; 8:45 am]
BILLING CODE 4164-01-P


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