[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]
-----------------------------------------------------------------------
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 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:
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.
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 ``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.
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,
[email protected].
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