[Federal Register Volume 86, Number 92 (Friday, May 14, 2021)]
[Notices]
[Pages 26532-26534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10245]
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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 (PRA).
DATES: Submit written comments (including recommendations) on the
collection of information by June 14, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 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,
[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
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.
In the Federal Register of December 23, 2020 (85 FR 83968), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
A. Reporting Requirements
Description of Respondents: VFD Feed Distributors and VFD Drug
Sponsors.
[[Page 26533]]
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
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Number of
21 CFR section/activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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558.6(c)(5) requires a distributor to notify 188 1 188 0.117 (7 minutes)........................ 22
FDA prior to the first time it distributes a
VFD feed.
558.6(c)(6) requires a distributor to notify 192 1 192 0.117 (7 minutes)........................ 22
FDA within 30 days of any change in
ownership, business name, or business
address.
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Total.................................... .............. .............. .............. ......................................... 44
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\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 (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
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Number of
21 CFR section/activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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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), (4), and (8); required 9,635 545.1 5,252,039 0.0167 (1 minute)........................ 87,709
recordkeeping by distributors.
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Total.................................... .............. .............. .............. ......................................... 112,759
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\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
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Number of
Number of disclosures Total annual
21 CFR section/activity respondents per disclosures Average burden per disclosure Total hours
respondent
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558.6(b)(3)-(5) and (b)(7)-(9); required 3,050 246 750,300 0.117 (7 minutes)........................ 87,785
disclosures when a veterinarian issues a VFD.
558.6(c)(8); required disclosure 1,000 5 5,000 0.117 (7 minutes)........................ 585
(acknowledgment letter) from one distributor
to another.
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[[Page 26534]]
Total.................................... .............. .............. .............. ......................................... 88,370
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\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.).
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. As a result, the burden for the information
collection has increased 69,148 hours since the last OMB approval.
Since the publication of the 60-day notice, we have adjusted 7
minutes for the average burden per response from 0.125 to 0.117. We
believe this is a better representation for 7 minutes. As a result,
this has slightly changed the burden hours.
Dated: May 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10245 Filed 5-13-21; 8:45 am]
BILLING CODE 4164-01-P