Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping, 62178-62181 [2021-24433]
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62178
Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
9857 et seq.); regulations at 45 CFR
98.70 and 98.71.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–24398 Filed 11–8–21; 8:45 am]
BILLING CODE 4184–81–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Success Sequence Qualitative
Interviews (New Collection)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Office of Planning,
Research, and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS),
proposes interview data collection
activities for the Success Sequence
Interviews study.
DATES: Comments due within 60 days of
publication. In compliance with the
SUMMARY:
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
ADDRESSES: You can obtain copies of the
proposed collection of information and
submit comments by emailing
OPREinfocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
SUPPLEMENTARY INFORMATION:
Description: OPRE/ACF/HHS
proposes qualitative data collection as
part of the Success Sequence Interviews
study. The goal of this project is to
understand complex decisions and
circumstances of youth transitions to
adulthood and explore the complexities
around achieving the success sequence
milestones of high school graduation,
full-time employment, getting married,
and having children. The data collected
from the interviews will help ACF and
the broader research field understand
adults’ perspectives and experiences
related to the milestones, and will
provide ACF’s Family and Youth
Services Bureau’s Sexual Risk
Avoidance Education grant program
with greater insight into the program
content and strategies related to the
success sequence milestones and their
ordering that could best resonate with
youth. To support these efforts, we seek
approval from the Office of Management
and Budget to collect qualitative
interview data from adults ages 30–35,
recruiting from online research panels
with participants across all U.S. regions.
We propose the following data
collection instruments:
(1) Success Sequence Screener: The
screener will be administered by
telephone. Information collected
through the screener will be used to
screen interview respondents into the
study based on respondent
demographics, household income,
geographic location, and life milestones.
(2) Success Sequence Interview
Protocol: We will administer an
asynchronous interview with adults
ages 30–35. Information collected
through the interview protocol includes
respondent life history focused on
education, employment and work
experience, family life, and financial
status.
Respondents: A total of 225 interview
respondents will be recruited from
existing large national online panels of
research participants.
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Total number
of responses
per respondent
675
225
1
1
jspears on DSK121TN23PROD with NOTICES1
(1) Success Sequence Screener ...................................................................
(2) Success Sequence Interview Protocol ....................................................
Estimated Total Annual Burden
Hours: 225.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Sec. 510. [42 U.S.C. 710].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–24397 Filed 11–8–21; 8:45 am]
BILLING CODE 4184–83–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3353]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Antimicrobial
Animal Drug Distribution Reports and
Recordkeeping
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
SUMMARY:
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Avg. burden
per response
(in hours)
.083
.75
Total/annual
burden
(in hours)
56
169
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 the information
collection provisions of our reporting
and recordkeeping requirements for
antimicrobial animal drug sales and
distribution.
Submit either electronic or
written comments on the collection of
information by January 10, 2022.
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 January 10,
DATES:
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Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 10, 2022.
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.
jspears on DSK121TN23PROD with NOTICES1
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–
2018–N–3353 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Antimicrobial Animal Drug Distribution
Reports and Recordkeeping.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
VerDate Sep<11>2014
17:00 Nov 08, 2021
Jkt 256001
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
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: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, 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
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62179
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.
Antimicrobial Animal Drug
Distribution Reports and
Recordkeeping—21 CFR 514.87
OMB Control Number 0910–0659—
Extension
Sponsors of approved or conditionally
approved applications for new animal
drugs containing an antimicrobial active
ingredient are required by section 512 of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360b) to
submit to FDA an annual report on the
amount of each such ingredient in the
drug that is sold or distributed for use
in food-producing animals. Sponsors are
also required to maintain distribution
records for their animal drug products,
including separate information for each
month of the calendar year, under
section 512(l)(3) of the FD&C Act. These
provisions were enacted to assist FDA
in our continuing analysis of the
interactions (including drug resistance),
efficacy, and safety of antimicrobials
approved for use in both humans and
food-producing animals for the purpose
of mitigating the public health risk
associated with antimicrobial resistance.
Section 514.87 of our regulations (21
CFR 514.87) codifies the reporting
requirements established in the FD&C
Act. Sponsors submit antimicrobial
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Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
animal drug sales and distribution
reports to us on Form FDA 3744. Each
report must specify: (1) The amount of
each antimicrobial active ingredient by
container size, strength, and dosage
form; (2) quantities distributed
domestically and quantities exported;
and (3) a listing of the target animals,
indications, and production classes that
are specified on the approved label of
the product. The report must cover the
period of the preceding calendar year
and include separate information for
each month of the calendar year. Each
report must also provide a speciesspecific estimate of the percentage of
each product that was sold or
distributed domestically in the reporting
year for use in cattle, swine, chickens,
or turkeys for such species that appear
on the approved label.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
FDA form
514.87(a)–(e)—Annual Reports for Sponsors With Active Applications—Paper
Submission ...........................................
514.87(a)–(e)—Annual Reports for Sponsors With Active Applications—Electronic Submission .................................
514.87(a)–(e)—Annual Reports for Sponsors With Inactive Applications—Paper
Submission ...........................................
514.87(a)–(e)—Annual Reports for Sponsors With Inactive Applications—Electronic Submission .................................
Total ..................................................
1 There
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
3744
4
1.5
6
62
372
3744
16
9.1
146
52
7,592
3744
5
3
15
2
30
3744
16
12.6
201
2
402
........................
........................
........................
........................
........................
8,396
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the average
burden per response on our recent
experience with the existing
antimicrobial animal drug distribution
reports program. We base our estimate
of the number of affected respondents
reported in tables 1 and 2 and the
average number of responses per
respondent in table 1 on a review of our
records of sponsors with active and
inactive applications. We estimate that
20 sponsors will have active
applications, and we assume that 75
percent of the respondents will report
electronically, while the other 25
percent will report on paper. We
estimate that 4 sponsors with active
applications will spend 62 hours
annually to assemble the necessary
information, prepare, and submit an
annual antimicrobial animal drug sales
and distribution report on paper and 16
sponsors with active applications will
spend 52 hours annually to assemble
the necessary information, prepare, and
electronically submit an annual
antimicrobial animal drug sales and
distribution report. We estimate that 21
sponsors will have inactive
applications, and we assume that 93
percent of these respondents will report
electronically, while the other 7 percent
will report on paper. We estimate that
sponsors with inactive applications will
spend 2 hours to prepare their annual
antimicrobial animal drug sales and
distribution reports, whether
electronically or on paper.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
respondents
Number of
records per
respondent
Total annual
records
Average
burden per
recordkeeping
Total hours
Recordkeeping required by section 512(l)(3) of the FD&C
Act ....................................................................................
21
1
21
2
42
jspears on DSK121TN23PROD with NOTICES1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Animal drug manufacturers are
already required to maintain
distribution records for their animal
drug products to comply with FDA’s
current good manufacturing regulations
for periodic drug reports under
§ 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)),
approved under OMB control number
0910–0284. Section 512(l)(3) of the
FD&C Act differs from § 514.80(b)(4)(i)
in that it requires that records include
separate information for each month of
the calendar year. In addition, under 21
CFR 211.196 (approved under OMB
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control number 0910–0139),
manufacturers currently are required to
maintain distribution records that
include dosage form, and date drug is
distributed. Based on these
requirements, FDA believes that
manufacturers already keep detailed
records of the dates when antimicrobial
drugs are distributed for marketing and
recall purposes from which monthly
reports can be prepared as part of usual
and customary business practices.
However, FDA estimates an additional
recordkeeping burden of 42 hours for
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further compliance with section
512(l)(3) of the FD&C Act, as detailed in
table 2.
We have adjusted our burden
estimate, which has resulted in a
decrease to the currently approved
burden. We attribute this to respondents
who reported by paper in previous years
and are now reporting electronically.
We also note a decrease in
recordkeeping respondents. We attribute
this to the mergers of sponsors over the
years.
E:\FR\FM\09NON1.SGM
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Federal Register / Vol. 86, No. 214 / Tuesday, November 9, 2021 / Notices
Dated: November 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–24433 Filed 11–8–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–E–2232 and FDA–
2020–E–2204]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; DOJOLVI
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for DOJOLVI and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of
patents which claim that human drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by January 10, 2022.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
May 9, 2022. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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 January 10,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 10, 2022.
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.
jspears on DSK121TN23PROD with NOTICES1
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014
17:00 Nov 08, 2021
Jkt 256001
• 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 Nos. FDA–
2020–E–2232 and FDA–2020–E–2204
for ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; DOJOLVI.’’ 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
PO 00000
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62181
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
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 § 10.20 (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:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug or biologic product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: a testing phase and
an approval phase. For human drug
products, the testing phase begins when
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]]>Agencies
[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Notices]
[Pages 62178-62181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24433]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3353]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Antimicrobial Animal Drug Distribution Reports and
Recordkeeping
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 the information collection
provisions of our reporting and recordkeeping requirements for
antimicrobial animal drug sales and distribution.
DATES: Submit either electronic or written comments on the collection
of information by January 10, 2022.
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 January 10,
[[Page 62179]]
2022. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of January 10,
2022. 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-2018-N-3353 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Antimicrobial Animal Drug
Distribution Reports and Recordkeeping.'' 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 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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[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.
Antimicrobial Animal Drug Distribution Reports and Recordkeeping--21
CFR 514.87
OMB Control Number 0910-0659--Extension
Sponsors of approved or conditionally approved applications for new
animal drugs containing an antimicrobial active ingredient are required
by section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360b) to submit to FDA an annual report on the amount of
each such ingredient in the drug that is sold or distributed for use in
food-producing animals. Sponsors are also required to maintain
distribution records for their animal drug products, including separate
information for each month of the calendar year, under section
512(l)(3) of the FD&C Act. These provisions were enacted to assist FDA
in our continuing analysis of the interactions (including drug
resistance), efficacy, and safety of antimicrobials approved for use in
both humans and food-producing animals for the purpose of mitigating
the public health risk associated with antimicrobial resistance.
Section 514.87 of our regulations (21 CFR 514.87) codifies the
reporting requirements established in the FD&C Act. Sponsors submit
antimicrobial
[[Page 62180]]
animal drug sales and distribution reports to us on Form FDA 3744. Each
report must specify: (1) The amount of each antimicrobial active
ingredient by container size, strength, and dosage form; (2) quantities
distributed domestically and quantities exported; and (3) a listing of
the target animals, indications, and production classes that are
specified on the approved label of the product. The report must cover
the period of the preceding calendar year and include separate
information for each month of the calendar year. Each report must also
provide a species-specific estimate of the percentage of each product
that was sold or distributed domestically in the reporting year for use
in cattle, swine, chickens, or turkeys for such species that appear on
the approved label.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section FDA form Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
514.87(a)-(e)--Annual Reports for Sponsors With Active 3744 4 1.5 6 62 372
Applications--Paper Submission.........................
514.87(a)-(e)--Annual Reports for Sponsors With Active 3744 16 9.1 146 52 7,592
Applications--Electronic Submission....................
514.87(a)-(e)--Annual Reports for Sponsors With Inactive 3744 5 3 15 2 30
Applications--Paper Submission.........................
514.87(a)-(e)--Annual Reports for Sponsors With Inactive 3744 16 12.6 201 2 402
Applications--Electronic Submission....................
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. .............. 8,396
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the average burden per response on our
recent experience with the existing antimicrobial animal drug
distribution reports program. We base our estimate of the number of
affected respondents reported in tables 1 and 2 and the average number
of responses per respondent in table 1 on a review of our records of
sponsors with active and inactive applications. We estimate that 20
sponsors will have active applications, and we assume that 75 percent
of the respondents will report electronically, while the other 25
percent will report on paper. We estimate that 4 sponsors with active
applications will spend 62 hours annually to assemble the necessary
information, prepare, and submit an annual antimicrobial animal drug
sales and distribution report on paper and 16 sponsors with active
applications will spend 52 hours annually to assemble the necessary
information, prepare, and electronically submit an annual antimicrobial
animal drug sales and distribution report. We estimate that 21 sponsors
will have inactive applications, and we assume that 93 percent of these
respondents will report electronically, while the other 7 percent will
report on paper. We estimate that sponsors with inactive applications
will spend 2 hours to prepare their annual antimicrobial animal drug
sales and distribution reports, whether electronically or on paper.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
respondents respondent records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping required by section 512(l)(3) of the FD&C Act........ 21 1 21 2 42
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Animal drug manufacturers are already required to maintain
distribution records for their animal drug products to comply with
FDA's current good manufacturing regulations for periodic drug reports
under Sec. 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)), approved under
OMB control number 0910-0284. Section 512(l)(3) of the FD&C Act differs
from Sec. 514.80(b)(4)(i) in that it requires that records include
separate information for each month of the calendar year. In addition,
under 21 CFR 211.196 (approved under OMB control number 0910-0139),
manufacturers currently are required to maintain distribution records
that include dosage form, and date drug is distributed. Based on these
requirements, FDA believes that manufacturers already keep detailed
records of the dates when antimicrobial drugs are distributed for
marketing and recall purposes from which monthly reports can be
prepared as part of usual and customary business practices. However,
FDA estimates an additional recordkeeping burden of 42 hours for
further compliance with section 512(l)(3) of the FD&C Act, as detailed
in table 2.
We have adjusted our burden estimate, which has resulted in a
decrease to the currently approved burden. We attribute this to
respondents who reported by paper in previous years and are now
reporting electronically. We also note a decrease in recordkeeping
respondents. We attribute this to the mergers of sponsors over the
years.
[[Page 62181]]
Dated: November 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-24433 Filed 11-8-21; 8:45 am]
BILLING CODE 4164-01-P
