Notice2021-12188
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Food Defense Strategy Survey
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 10, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 110 (Thursday, June 10, 2021)</title>
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[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30941-30942]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-12188]
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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.
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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#c696948795b2a7a0a086a0a2a7e8aeaeb5e8a1a9b0"><span class="__cf_email__" data-cfemail="81d1d3c0d2f5e0e7e7c1e7e5e0afe9e9f2afe6eef7">[email protected]</span></a>.
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 <a href="http://FDA.gov">FDA.gov</a>
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\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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SLTT Surveys....................................................... 500 1 500 0.33 165
(20 minutes)
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\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
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