Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Veterinary Feed Directive, 27007-27009 [2018-12448]
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27007
Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Child Welfare Information Gateway’s Targeted Survey ..................................
Child Welfare Information Gateway’s Event Survey .......................................
Child Welfare Information Gateway’s Focus Group Guide .............................
Child Welfare Information Gateway’s General Customer Survey: Questions
for Professionals ..........................................................................................
Child Welfare Information Gateway’s General Customer Survey: Questions
for Students ..................................................................................................
Child Welfare Information Gateway’s General Customer Survey: Questions
for Personal Customers ...............................................................................
Market Research Sub-Study: Online Information Habits and Preferences
Survey (for child welfare professionals in state, county, and private agencies) ..............................................................................................................
Market Research Sub-Study: Online Information Habits and Preferences
Survey (for child welfare professionals working with tribes) ........................
Market Research Sub-Study: Online Information Habits and Preferences
Survey (for legal professionals working in child welfare) ............................
Market Research Sub-Study: Online Information Habits and Preferences
Survey (for students planning to enter the child welfare workforce) ...........
Market Research Sub-Study: Focus Groups on Information Habits and Preferences .........................................................................................................
Estimated Total Annual Burden
Hours: 3,026.08 hours.
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attention
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment:
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
daltland on DSKBBV9HB2PROD with NOTICES
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–12468 Filed 6–8–18; 8:45 am]
BILLING CODE 4184–01–P
0.084
0.05
1
223.44
45
50
960
1
0.084
80.64
480
1
0.05
24
960
1
0.05
48
1,800
1
0.5
900
800
1
0.5
400
1,400
1
0.5
700
810
1
0.5
405
100
1
1.5
150
[Docket No. FDA–2010–N–0155]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Veterinary Feed
Directive
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or we) 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.
DATES: Fax written comments on the
collection of information by July 11,
2018.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 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
VerDate Sep<11>2014
19:19 Jun 08, 2018
Jkt 244001
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
Total burden
hours
1
1
1
Food and Drug Administration
ACTION:
Average
burden hours
per response
2,660
900
50
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Number of
responses per
respondent
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
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 Food 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
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 (§ 558.6(b)(3)), along with other
information required under § 558.6. All
distributors of medicated feed
containing VFD drugs must notify FDA
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Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
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 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.
We are retaining the estimates used in
FDA’s analysis of the information
collection provisions in the final rule
entitled ‘‘Veterinary Feed Directive,’’
published in the Federal Register of
June 3, 2015 (80 FR 31708 at 31728),
and approved by OMB.
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 (§ 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
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.
300
1
300
0.125 (7 minutes) ......
37.5
20
1
20
0.125 (7 minutes) ......
2.5
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
(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 first obtains a
written acknowledgement letter. 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
Number of
responses per
recordkeeper
558.6(a)(4); required recordkeeping by veterinarians and producers.
558.6(a)(4), (c)(3), (c)(4), and (c)(8); required recordkeeping by distributors.
13,050
114.9
1,500,000
0.0167 (1 minute) ......
25,050
1,376
545.1
750,000
0.0167 (1 minute) ......
12,525
Total ..................................................................
........................
........................
........................
....................................
37,575
21 CFR section/activity
daltland on DSKBBV9HB2PROD with NOTICES
1 There
Total annual
records
Average
burden per
recordkeeping
Total hours
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
VerDate Sep<11>2014
19:19 Jun 08, 2018
Jkt 244001
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
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
(consignor) first obtains a written
acknowledgement letter from the
receiving distributor (consignee) before
the feed is shipped (§ 558.6(c)(8)).
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Federal Register / Vol. 83, No. 112 / Monday, June 11, 2018 / Notices
27009
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
21 CFR section/activity
Total annual
disclosures
Average
burden per
disclosure
Total hours
558.6(b)(3)–(b)(5) and (b)(7)–(b)(9); required disclosures when a veterinarian issues a VFD.
558.6(c)(8); required disclosure (acknowledgement
letter) from one distributor to another.
3,050
246
750,000
0.125 (7 minutes) ......
93,750
1,000
5
5,000
0.125 (7 minutes) ......
625
Total ..................................................................
........................
........................
........................
....................................
94,375
daltland on DSKBBV9HB2PROD with NOTICES
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’’ (§ 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
VerDate Sep<11>2014
19:19 Jun 08, 2018
Jkt 244001
indexed combination medicated feeds
following this statement.)
(§ 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’’ (§ 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.).
The one-time burdens included in
FDA’s analysis of the June 3, 2015, final
rule (80 FR 31708 at 31729 to 31732) are
not included in the estimate provided in
this notice. FDA’s estimate of the annual
recurring burden for this information
collection has not changed since the last
OMB approval.
Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–12448 Filed 6–8–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1768]
Advisory Committee; Pharmacy
Compounding Advisory Committee,
Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Pharmacy Compounding
Advisory Committee by the
Commissioner of Food and Drugs (the
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Pharmacy
Compounding Advisory Committee for
an additional 2 years beyond the charter
expiration date. The new charter will be
in effect until April 25, 2020.
DATES: Authority for the Pharmacy
Compounding Advisory Committee will
expire on April 25, 2020, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Cindy Chee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001,
PCAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Pharmacy Compounding Advisory
Committee (the Committee). The
committee is a non-discretionary
Federal advisory committee established
to provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to compounding drugs for human
use and, as required, any other product
for which FDA has regulatory
responsibility.
The Committee shall provide advice
on scientific, technical, and medical
issues concerning drug compounding
under sections 503A and 503B of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353a and 353b), and, as
required, any other product for which
FDA has regulatory responsibility, and
make appropriate recommendations to
the Commissioner.
The Committee shall consist of a core
of 12 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
E:\FR\FM\11JNN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 27007-27009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12448]
-----------------------------------------------------------------------
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 or we) 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.
DATES: Fax written comments on the collection of information by July
11, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 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 Food 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. 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 FDA
[[Page 27008]]
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 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.
We are retaining the estimates used in FDA's analysis of the
information collection provisions in the final rule entitled
``Veterinary Feed Directive,'' published in the Federal Register of
June 3, 2015 (80 FR 31708 at 31728), and approved by OMB.
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 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 300 1 300 0.125 (7 minutes)......................... 37.5
FDA prior to the first time it distributes
a VFD feed.
558.6(c)(6) requires a distributor to notify 20 1 20 0.125 (7 minutes)......................... 2.5
FDA 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 (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 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
21 CFR section/activity Number of responses 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), (c)(4), and (c)(8); 1,376 545.1 750,000 0.0167 (1 minute)......................... 12,525
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.
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 acknowledgement letter from the
receiving distributor (consignee) before the feed is shipped (Sec.
558.6(c)(8)).
[[Page 27009]]
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section/activity Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(b)(3)-(b)(5) and (b)(7)-(b)(9); 3,050 246 750,000 0.125 (7 minutes)......................... 93,750
required disclosures when a veterinarian
issues a VFD.
558.6(c)(8); required disclosure 1,000 5 5,000 0.125 (7 minutes)......................... 625
(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.).
The one-time burdens included in FDA's analysis of the June 3,
2015, final rule (80 FR 31708 at 31729 to 31732) are not included in
the estimate provided in this notice. FDA's estimate of the annual
recurring burden for this information collection has not changed since
the last OMB approval.
Dated: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12448 Filed 6-8-18; 8:45 am]
BILLING CODE 4164-01-P
