Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive, 26532-26534 [2021-10245]
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Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
received an order under section
911(g)(2) of the FD&C Act 1 as an MRTP
and is including information from the
authorized MRTPA by cross-reference.
FDA will post the application
documents, including those crossreferenced from prior submissions
previously authorized and those
contained in any amendments, for
public comment in batches on a rolling
basis as they are redacted in accordance
with applicable laws. In this document,
FDA is announcing the availability of
the first batch of application documents
for public comment. FDA intends to
establish a closing date for the comment
period that is both at least 45 days after
the date this notice publishes and at
least 30 days after the final documents
from the application are made available
for public comment. FDA will announce
the closing date at least 30 days in
advance. FDA believes that this
comment period is appropriate given
the relatively low volume of information
in the MRTPA that has not already been
available for public comment as part of
the previously authorized MRTPAs for
the IQOS system. FDA will notify the
public about the availability of
application documents and comment
period closing date via the Agency’s
web page for the MRTPA (see section II)
and by other means of public
communication, such as by email to
individuals who have signed up to
receive email alerts. FDA does not
intend to issue additional notices in the
Federal Register regarding the
availability of additional application
documents, including amendments, or
the comment period for this MRTPA. To
receive email alerts, visit FDA’s email
subscription service management
website (https://www.fda.gov/about-fda/
contact-fda/get-email-updates), provide
an email address, scroll down to the
‘‘Tobacco’’ heading, select ‘‘Modified
Risk Tobacco Product Application
Update’’, and click ‘‘Submit’’. To
encourage public participation
consistent with section 911(e) of the
FD&C Act, FDA is making the redacted
MRTPA that is the subject of this notice
available electronically (see section II).
II. Electronic Access
Persons with access to the internet
may obtain the application documents
at either https://www.fda.gov/tobaccoproducts/advertising-and-promotion/
philip-morris-products-sa-modified-risk1 The notice of availability for the IQOS MRTPAs
that received a modified risk granted order
appeared in the Federal Register of June 15, 2017
(82 FR 27487), and the docket containing notices
and public comments, FDA–2017–D–3001, is
accessible at: https://www.regulations.gov/docket/
FDA-2017-D-3001/.
VerDate Sep<11>2014
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tobacco-product-mrtp-applications or
https://www.regulations.gov.
Dated: May 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–10177 Filed 5–13–21; 8:45 am]
BILLING CODE 4164–01–P
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.
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).
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by June 14,
2021.
DATES:
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.
ADDRESSES:
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
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
§ 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 (§ 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 (§ 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 (§ 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 (§ 558.6(b)(3)),
along with other information required
under § 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.
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14MYN1
Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices
A distributor of animal feed
containing a VFD drug must notify FDA
prior to the first time it distributes the
VFD feed (§ 558.6(c)(5)). This
notification is required one time per
distributor and must include the
information set forth in § 558.6(c)(5). In
addition, a distributor must notify FDA
within 30 days of any change in
ownership, business name, or business
address (§ 558.6(c)(6)). Additional
reporting burdens for current VFD drug
26533
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
respondents
21 CFR section/activity
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
558.6(c)(5) requires a distributor to notify FDA prior
to the first time it distributes a VFD feed.
558.6(c)(6) requires a distributor to notify FDA within
30 days of any change in ownership, business
name, or business address.
188
1
188
0.117 (7 minutes) ..
22
192
1
192
0.117 (7 minutes) ...
22
Total ......................................................................
........................
........................
........................
................................
44
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 (§ 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 (§ 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 (§ 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
(§ 558.6(c)(8)).
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section/activity
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
558.6(a)(4); required recordkeeping by veterinarians
and producers.
558.6(a)(4), (c)(3), (4), and (8); required recordkeeping by distributors.
13,050
114.9
1,500,000
0.0167 (1 minute) ..
25,050
9,635
545.1
5,252,039
0.0167 (1 minute) ..
87,709
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 § 558.6(b)(3) through (5) on
the VFD. Additional requirements
relating to the VFD are specified at
§ 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 (§ 558.6(c)(8)).
khammond on DSKJM1Z7X2PROD with NOTICES
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section/activity
558.6(b)(3)–(5) and (b)(7)–(9); required disclosures
when a veterinarian issues a VFD.
558.6(c)(8); required disclosure (acknowledgment letter) from one distributor to another.
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19:58 May 13, 2021
Jkt 253001
PO 00000
Frm 00077
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
3,050
246
750,300
0.117 (7 minutes) ..
87,785
1,000
5
5,000
0.117 (7 minutes) ...
585
Fmt 4703
Sfmt 4703
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26534
Federal Register / Vol. 86, No. 92 / Friday, May 14, 2021 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
21 CFR section/activity
Total ......................................................................
khammond on DSKJM1Z7X2PROD with NOTICES
1 There
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
........................
........................
........................
................................
Total hours
88,370
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’’ (§ 558.6(a)(6)). In addition,
the veterinarian must ensure that the
following statement is included on the
VFD (§ 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 (§ 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’’ (§ 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.)
(§ 558.6(b)(6)(ii)).
VerDate Sep<11>2014
19:58 May 13, 2021
Jkt 253001
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’’ (§ 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]
May 4, 2021, concerning a virtual
meeting of the National Clinical Care
Commission. The date of the eleventh
meeting of the Commission has
changed. The original dates for the
eleventh meeting were May 19 and June
1, 2021. The new dates for the two-day
meeting are June 1 and June 22, 2021.
Kara
Elam, Ph.D., MPH, MS, Designated
Federal Officer, National Clinical Care
Commission, U.S. Department of Health
and Human Services, Office on
Women’s Health, 200 Independence
Ave. SW, 7th Floor, Washington, DC
20201, Phone: (240) 435–9438, Email:
Kara.Elam@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Correction
In the Federal Register of May 4,
2021, FR Doc. 2021–09277, page 23731,
in the first column, correct the SUMMARY
caption to read:
The National Clinical Care
Commission (the Commission) will
conduct its eleventh meeting virtually
on June 1 and June 22, 2021. The
Commission is charged to evaluate and
make recommendations to the U.S.
Department of Health and Human
Services (HHS) Secretary and Congress
regarding improvements to the
coordination and leveraging of federal
programs related to diabetes and its
complications.
SUMMARY:
BILLING CODE 4164–01–P
Correction
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In the Federal Register of May 4,
2021, FR Doc. 2021–09277, page 23731,
in the first column, correct the DATES
caption to read:
Eleventh Meeting of the National
Clinical Care Commission; Correction
DATES:
Office on Women’s Health,
Office of the Assistant Secretary for
Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice; correction.
AGENCY:
The Office of the Assistant
Secretary for Health published a
document in the Federal Register of
SUMMARY:
PO 00000
Frm 00078
Fmt 4703
Sfmt 9990
The two-day meeting will take
place June 1 and June 22, 2021 from 1
p.m. to approximately 6 p.m. Eastern
Time (ET).
Dated: May 4, 2021.
Dorothy A. Fink,
Deputy Assistant Secretary for Women’s
Health.
[FR Doc. 2021–10258 Filed 5–13–21; 8:45 am]
BILLING CODE 4150–32–P
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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.
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 44
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/activity Number of records 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), (4), and (8); required 9,635 545.1 5,252,039 0.0167 (1 minute)........................ 87,709
recordkeeping 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
Number of disclosures Total annual
21 CFR section/activity respondents per disclosures Average burden per disclosure Total hours
respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------
[[Page 26534]]
Total.................................... .............. .............. .............. ......................................... 88,370
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
