[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]


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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 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\
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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]
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