Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Feed Directive, 83968-83971 [2020-28353]
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Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices
Methodological Research for the
Medicare Current Beneficiary Survey
(MCBS); Use: The current generic
clearance for MCBS Questionnaire
Testing and Methodological Research
encompasses development and testing
of MCBS questionnaires,
instrumentation, and data collection
protocols, as well as a mechanism for
conducting methodological
experiments. The current clearance
includes conducting field tests and
experiments, including split ballot
experiments, within the MCBS
production environment, and
conducting usability tests. The purpose
of this OMB clearance package is to
revise the current clearance to expand
the methods to allow for field tests
outside of MCBS production Field tests
conducted within production do not
incur any additional burden on
respondents whereas tests conducted
outside production must account for
additional respondent burden. The
MCBS is a continuous, multipurpose
survey of a nationally representative
sample of aged, disabled, and
institutionalized Medicare beneficiaries.
The MCBS, which is sponsored by the
Centers for Medicare & Medicaid
Services (CMS), is the only
comprehensive source of information on
the health status, health care use and
expenditures, health insurance
coverage, and socioeconomic and
demographic characteristics of the
entire spectrum of Medicare
beneficiaries. The core of the MCBS is
a series of interviews with a stratified
random sample of the Medicare
population, including aged and disabled
enrollees, residing in the community or
in institutions. Questions are asked
about enrollees’ patterns of health care
use, charges, insurance coverage, and
payments over time. Respondents are
asked about their sources of health care
coverage and payment, their
demographic characteristics, their
health and work history, and their
family living circumstances. In addition
to collecting information through the
core questionnaire, the MCBS collects
information on special topics. Form
Number: CMS–10549 (OMB control
number: 0938–1275); Frequency:
Occasionally; Affected Public:
Individuals or Households; Number of
Respondents: 11,655; Total Annual
Responses: 11,655; Total Annual Hours:
3,947. (For policy questions regarding
this collection, contact William Long at
410–786–7927.)
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Dated: December 17, 2020.
William N. Parham III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–28224 Filed 12–22–20; 8:45 am]
BILLING CODE 4120–01–P
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
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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
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Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices
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-201509-18/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, PRAStaff@fda.hhs.gov.
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
§ 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
83969
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.
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 Application) and 0910–
0669 (Abbreviated New Animal Drug
Applications).
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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Number of
responses per
respondent
Number of
respondents
21 CFR section/activity
Total annual
responses
Average burden per response
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
0.125 (7 minutes) .............................
24
192
1
192
0.125 (7 minutes) .............................
24
Total ..................................................
........................
........................
........................
...........................................................
48
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices
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
5,252,038
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.
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)).
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
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section/activity
Total annual
disclosures
Average burden per disclosure
Total hours
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.
3,050
246
750,000
0.125 (7 minutes) ............................
93,750
1,000
5
5,000
0.125 (7 minutes) ............................
625
Total .................................................
........................
..........................
........................
..........................................................
94,375
1 There
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Number of
disclosures per
respondent
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
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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
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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)).
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Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices
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)).
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.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0386]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Orphan Drugs
AGENCY:
Food and Drug Administration,
HHS.
jbell on DSKJLSW7X2PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA, Agency, 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: Submit written comments
(including recommendations) on the
collection of information by January 22,
2021.
VerDate Sep<11>2014
21:21 Dec 22, 2020
Jkt 253001
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 0910–0167. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
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, 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.
Orphan Drugs
OMB Control Number 0910–0167—
Revision
This information collection supports
FDA regulations implementing sections
525, 526, 527, and 528 of the Federal
Food, Drug and Cosmetic Act (FD&C
Act) (21 U.S.C. 360aa, 360bb, 360cc, and
360dd), as well as related guidance.
Sections 525, 526, 527, and 528 of the
FD&C Act pertain to the development of
drugs for rare diseases or conditions,
including biological products and
antibiotics, otherwise known or referred
to as ‘‘Orphan Drugs.’’ Specifically,
section 525 of the FD&C Act requires
written recommendations on studies
required for approval of a marketing
application for a drug for a rare disease
or condition. The information collection
in 21 CFR 316.10, 316.12, and 316.14 is
approved under OMB control numbers
0910–0001 and 0910–0014. Section 526
of the FD&C Act provides for
designation of drugs as orphan drugs
when certain conditions are met, section
527 provides conditions under which a
sponsor of an approved orphan drug
enjoys exclusive FDA marketing
approval for that drug for the orphan
indication for a period of 7 years, and,
finally, section 528 is intended to
encourage sponsors to make
investigational orphan drugs available
for treatment of persons in need on an
open protocol basis before the drug has
been approved for general marketing.
Open protocols may permit patients
who are not part of the formal clinical
investigation to obtain treatment where
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83971
adequate supplies exist and no
alternative effective therapy is available.
We have issued regulations in part
316 (21 CFR part 316) to implement the
Orphan Drug provisions of the FD&C
Act and to set forth procedures and
requirements related to requesting
recommendations for investigations of
drugs for rare diseases or conditions,
requesting designation of a drug for a
rare disease or condition, or requesting
exclusive approval for a drug for a rare
disease or condition. To assist
respondents and to be consistent with
§ 316.50, our Office of Orphan Products
Development (OOPD) maintains and
makes publicly available guidance
documents that apply to the Orphan
Drug provisions of the FD&C Act and
regulations in part 316. The list is
maintained on the internet and
guidance documents are issued in
accordance with our Good Guidance
Practice regulations in 21 CFR 10.115,
which provide for public comment at
any time.
Accordingly, we are revising the
information collection to include
Agency guidance. The document
entitled ‘‘Meetings with the Office of
Orphan Products Development:
Guidance for Industry, Researchers,
Patient Groups, and Food and Drug
Administration Staff’’ provides
recommendations to industry,
researchers, patient groups, and other
stakeholders interested in requesting a
meeting, including a teleconference,
with OOPD on issues related to orphan
drug designation requests, humanitarian
use device designation requests, rare
pediatric disease designation requests,
funding opportunities through the
Orphan Products Grants Program and
the Pediatric Device Consortia Grants
Program, and orphan product patientrelated topics of concern. It is also
intended to assist OOPD staff in
addressing such meeting requests. This
guidance describes procedures for
requesting, preparing, scheduling,
conducting, and documenting such
meetings and discusses background
information we recommend be included
in such requests. Information collection
attendant to recommendations in the
guidance are currently approved under
OMB control number 0910–0787;
however, for efficiency of Agency
operations, we are consolidating it into
this related information collection. The
guidance is available at https://
www.fda.gov/media/92815/download.
The FDA Orphan Drug Designation
Request Form (Form FDA 4035) is
intended to benefit sponsors who desire
to seek orphan designation of drugs
intended for rare diseases or conditions
from only FDA. The form is a simplified
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]]>Agencies
[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
