Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Food Defense Strategy Survey, 30941-30942 [2021-12188]
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30941
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
evaluation of surveillance and
prevention activities. The OD2A TA
Center is designed to enhance the
efficiency, coordination, and
effectiveness of TA efforts by
streamlining and centralizing the
provision of overdose surveillance and
prevention TA. TA to OD2A recipients
is divided into four different levels with
multiple modes of TA delivery and
involves a wide range of TA providers
including CDC staff, internal and
external subject matter experts (SMEs),
and program partners, as well as
contract staff.
The evaluation consists of two webbased surveys designed to collect
process and outcome measures about
TA access, utilization, and outcomes
across all 66 OD2A recipient programs.
The Technical Assistance Feedback
Form will be administered to collect
immediate feedback following
individual TA encounters and group
events such as webinars and in-person
trainings. The Annual OD2A TA Survey
will be distributed twice (mid-point and
final) to assess satisfaction with overall
TA provided and the extent to which
TA supports informed implementation
of OD2A strategies. The information
obtained through this evaluation will
allow TA providers to assess OD2A
recipients’ experience and utility of
knowledge and resources gained
through individual TA support, peer-topeer sessions, and other group trainings.
Ultimately, the evaluation data will
inform subsequent rounds of TA and
allow TA providers to make necessary
adjustments to the overall TA strategy
for continuous quality improvement.
This will ensure recipients have the
support necessary to implement
strategies that will improve opioid
surveillance and prevention policies
and practices within their communities.
The total annualized burden estimate
is 222 hours. There is no cost to
respondents other than the time to
participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
OD2A Recipients ............................................
TA Feedback Form ........................................
Annual OD2A Survey .....................................
Email invitation and reminders for OD2A
Survey.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–12208 Filed 6–9–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; National
Agriculture and Food Defense Strategy
Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by July 12,
2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
SUMMARY:
VerDate Sep<11>2014
17:15 Jun 09, 2021
Jkt 253001
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 0910–0855. Also include
the FDA docket number found in
brackets in the heading of this
document.
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.
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2018–N–1129]
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondents
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
National Agriculture and Food Defense
Strategy Survey
OMB Control Number 0910–0855—
Extension
We are seeking OMB approval of the
National Agriculture and Food Defense
Strategy (NAFDS) under section 108 of
the FDA Food and Safety Modernization
Act (FSMA). This is a voluntary survey
of State, local, territorial, and/or tribal
(SLTT) governments intended to gauge
government activities in food and
agriculture defense from intentional
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
671
440
440
Number of
responses per
respondent
2
1
1
Average
burden per
response
(in hours)
5/60
13/60
2/60
contamination and emerging threats.
The collected information will be
included in the mandatory NAFDS
followup Report to Congress. The
authority for us to collect the
information derives from the
Commissioner of Food and Drugs’
authority provided in section
1003(d)(2)(C) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(C)).
Protecting the nation’s food and
agriculture supply against intentional
contamination and other emerging
threats is an important responsibility
shared by SLTT governments as well as
private sector partners. On January 4,
2011, the President signed into law
FSMA. FSMA focuses on ensuring the
safety of the U.S. food supply by
shifting the efforts of Federal regulators
from response to prevention and
recognizes the importance of
strengthening existing collaboration
among all stakeholders to achieve
common public health and security
goals. FSMA identifies some key
priorities for working with partners in
areas such as reliance on Federal, State,
and local agencies for inspections;
improving foodborne illness
surveillance; and leveraging and
enhancing State and local food safety
and defense capacities. Section 108 of
FSMA (NAFDS) requires the
Department of Health and Human
Services (HHS) and the U.S. Department
of Agriculture (USDA), in coordination
E:\FR\FM\10JNN1.SGM
10JNN1
30942
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
with the Department of Homeland
Security (DHS), to work together with
State, local, territorial, and tribal
governments to monitor and measure
progress in food defense.
In 2015, the initial NAFDS Report to
Congress detailed the specific Federal
response to food and agriculture defense
goals, objectives, key initiatives, and
activities that HHS, USDA, DHS, and
other stakeholders planned to
accomplish to meet the objectives
outlined in FSMA. The NAFDS charts a
direction for how Federal Agencies, in
cooperation with SLTT governments
and private sector partners, protect the
nation’s food supply against intentional
contamination. Not later than 4 years
after the initial NAFDS Report to
Congress (2015), and every 4 years
thereafter (i.e., 2019, 2023, 2027, etc.),
HHS, USDA, and DHS are required to
revise and submit an updated report to
the relevant committees of Congress.
FDA is the Agency primarily
responsible for obtaining the
information from Federal and SLTT
partners to complete the NAFDS Report
to Congress. An interagency working
group will conduct the survey and
collect and update the NAFDS as
directed by FSMA, including
developing metrics and measuring
progress for the evaluation process.
The survey of Federal and State
partners will be used to determine what
food defense activities, if any, Federal
and/or SLTT agencies have completed
(or are planning on completing) from
2021 to 2025. Planning for the local,
territorial, and tribal information
collections will commence during this
period of renewal. The survey will
continue to be repeated approximately
every 2 to 4 years, as described in
section 108 of FSMA. The NAFDS
survey is being administered for the
purpose of monitoring progress in food
and agricultural defense by government
agencies.
A purposive sampling strategy is
employed, such that the government
agencies participating in food and
agricultural defense are asked to
respond to the voluntary survey. Food
defense leaders responsible for
conducting food defense activities
during a food emergency for their
jurisdiction are identified and will
receive an emailed invitation to
complete the survey online; they will be
provided with a web link to the survey.
The survey will be conducted
electronically on the FDA.gov web
portal, and results will be analyzed by
the interagency working group.
Description of Respondents:
Respondents to this collection are SLTT
government representatives (survey
respondents) who are food defense
leaders responsible for conducting food
defense activities during a food
emergency for their jurisdictions.
In the Federal Register of January 4,
2021 (86 FR 104), FDA published a 60day notice requesting public comment
on the proposed collection of
information. Although one comment
was received, it was not responsive to
the four collection of information topics
solicited and therefore will not be
discussed in this document.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
SLTT Surveys ......................................................................
500
1
500
0.33
(20 minutes)
1 There
165
are no capital costs or operating and maintenance costs associated with this collection of information.
The FDA Office of Partnerships
reviewed the questionnaire and
provided the estimate of time to
complete the survey. The total burden is
based on our previous experiences
conducting surveys. The burden has
been revised to reflect the total number
of States and possible number of local,
tribal, and territorial entities that may
partake of the survey. Based on a review
of the information collection since our
last request for OMB approval, we have
increased our burden estimate by 149
hours (from 16.17 to 165 hours) and 451
respondents (from 49 to 500
respondents).
khammond on DSKJM1Z7X2PROD with NOTICES
Total hours
Dated: June 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12188 Filed 6–9–21; 8:45 am]
BILLING CODE 4164–01–P
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17:15 Jun 09, 2021
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2019–E–5338; FDA–
2019–E–5346; and FDA–2019–E–5343]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; EVENITY
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for EVENITY 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 a
patent which claims that human
biological product.
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
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 August 9, 2021.
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
December 7, 2021. 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 August 9,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 9, 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.
DATES:
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]]>Agencies
[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30941-30942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12188]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1129]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; National Agriculture
and Food Defense Strategy Survey
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by July 12, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0855. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
National Agriculture and Food Defense Strategy Survey
OMB Control Number 0910-0855--Extension
We are seeking OMB approval of the National Agriculture and Food
Defense Strategy (NAFDS) under section 108 of the FDA Food and Safety
Modernization Act (FSMA). This is a voluntary survey of State, local,
territorial, and/or tribal (SLTT) governments intended to gauge
government activities in food and agriculture defense from intentional
contamination and emerging threats. The collected information will be
included in the mandatory NAFDS followup Report to Congress. The
authority for us to collect the information derives from the
Commissioner of Food and Drugs' authority provided in section
1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
393(d)(2)(C)).
Protecting the nation's food and agriculture supply against
intentional contamination and other emerging threats is an important
responsibility shared by SLTT governments as well as private sector
partners. On January 4, 2011, the President signed into law FSMA. FSMA
focuses on ensuring the safety of the U.S. food supply by shifting the
efforts of Federal regulators from response to prevention and
recognizes the importance of strengthening existing collaboration among
all stakeholders to achieve common public health and security goals.
FSMA identifies some key priorities for working with partners in areas
such as reliance on Federal, State, and local agencies for inspections;
improving foodborne illness surveillance; and leveraging and enhancing
State and local food safety and defense capacities. Section 108 of FSMA
(NAFDS) requires the Department of Health and Human Services (HHS) and
the U.S. Department of Agriculture (USDA), in coordination
[[Page 30942]]
with the Department of Homeland Security (DHS), to work together with
State, local, territorial, and tribal governments to monitor and
measure progress in food defense.
In 2015, the initial NAFDS Report to Congress detailed the specific
Federal response to food and agriculture defense goals, objectives, key
initiatives, and activities that HHS, USDA, DHS, and other stakeholders
planned to accomplish to meet the objectives outlined in FSMA. The
NAFDS charts a direction for how Federal Agencies, in cooperation with
SLTT governments and private sector partners, protect the nation's food
supply against intentional contamination. Not later than 4 years after
the initial NAFDS Report to Congress (2015), and every 4 years
thereafter (i.e., 2019, 2023, 2027, etc.), HHS, USDA, and DHS are
required to revise and submit an updated report to the relevant
committees of Congress.
FDA is the Agency primarily responsible for obtaining the
information from Federal and SLTT partners to complete the NAFDS Report
to Congress. An interagency working group will conduct the survey and
collect and update the NAFDS as directed by FSMA, including developing
metrics and measuring progress for the evaluation process.
The survey of Federal and State partners will be used to determine
what food defense activities, if any, Federal and/or SLTT agencies have
completed (or are planning on completing) from 2021 to 2025. Planning
for the local, territorial, and tribal information collections will
commence during this period of renewal. The survey will continue to be
repeated approximately every 2 to 4 years, as described in section 108
of FSMA. The NAFDS survey is being administered for the purpose of
monitoring progress in food and agricultural defense by government
agencies.
A purposive sampling strategy is employed, such that the government
agencies participating in food and agricultural defense are asked to
respond to the voluntary survey. Food defense leaders responsible for
conducting food defense activities during a food emergency for their
jurisdiction are identified and will receive an emailed invitation to
complete the survey online; they will be provided with a web link to
the survey. The survey will be conducted electronically on the FDA.gov
web portal, and results will be analyzed by the interagency working
group.
Description of Respondents: Respondents to this collection are SLTT
government representatives (survey respondents) who are food defense
leaders responsible for conducting food defense activities during a
food emergency for their jurisdictions.
In the Federal Register of January 4, 2021 (86 FR 104), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited
and therefore will not be discussed in this document.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
SLTT Surveys....................................................... 500 1 500 0.33 165
(20 minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The FDA Office of Partnerships reviewed the questionnaire and
provided the estimate of time to complete the survey. The total burden
is based on our previous experiences conducting surveys. The burden has
been revised to reflect the total number of States and possible number
of local, tribal, and territorial entities that may partake of the
survey. Based on a review of the information collection since our last
request for OMB approval, we have increased our burden estimate by 149
hours (from 16.17 to 165 hours) and 451 respondents (from 49 to 500
respondents).
Dated: June 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12188 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P
