[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30740-30741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14051]


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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: Fax written comments on the collection of information by July 
30, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to <a href="/cdn-cgi/l/email-protection#e08f899281bf9395828d899393898f8ea08f8d82ce858f90ce878f96"><span class="__cf_email__" data-cfemail="ea8583988bb5999f8887839999838584aa858788c48f859ac48d859c">[email protected]</span></a>. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``National Agriculture and Food Defense Strategy Survey.'' 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="441416051730252222042220256a2c2c376a232b32">[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-NEW

    We are seeking OMB approval of the National Agriculture and Food 
Defense Strategy (NAFDS) under the FDA Food Safety Modernization Act 
(FSMA), section 108. This is a voluntary survey of State 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 2019 NAFDS followup 
Report to Congress. The authority for FDA 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 Federal, State, local, tribal, and territorial 
governments as well as private sector partners. On January 4, 2011, the 
President signed FSMA.

[[Page 30741]]

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 U.S. Department of Health and Human Services (HHS) 
and the U.S. Department of Agriculture (USDA), in coordination 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 the Federal Agencies, in cooperation 
with State, local, territorial, and tribal 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, 2017, 
etc.), HHS, USDA, and DHS are required to revise and submit an updated 
report to the relevant committees of Congress.
    HHS/FDA is primarily responsible for obtaining the information from 
Federal and State, local, territorial, and tribal 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 proposed survey of Federal and State partners will be used to 
determine what food defense activities, if any, Federal and/or State 
Agencies have completed (or are planning) from 2015 to 2019. Planning 
for the local, territorial, and tribal information collections will 
commence after the collection and reporting of Federal and State Agency 
level data.
    This survey will be repeated approximately every 2 to 4 years, as 
described in section 108 of FSMA (NAFDS), for the purpose of monitoring 
progress in food and agricultural defense by government agencies.
    A purposive sampling strategy will be employed, such that the 
government agencies participating in food and agricultural defense 
cooperative agreements with FDA (22 State Agencies) and USDA (27 State 
Agencies) will be asked to respond to the voluntary survey. Food 
defense leaders responsible for conducting food defense activities 
during a food emergency for their jurisdiction will be 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.
    In the Federal Register of March 28, 2018 (83 FR 13284), we 
published a notice inviting 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.
    FDA estimates 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 per response          Total hours
                                             respondents       respondent         responses
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State Survey............................                49                 1                49  0.33 (20 minutes).....................             16.17
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The total burden for this collection of information, therefore, is 
16.17 hours.
    The FDA Office of Partnerships reviewed the questionnaire and 
provided the amount of time to complete the survey. The total burden is 
based on our previous experiences conducting surveys.

    Dated: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14051 Filed 6-28-18; 8:45 am]
 BILLING CODE 4164-01-P


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