[Federal Register Volume 86, Number 1 (Monday, January 4, 2021)]
[Notices]
[Pages 104-106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29082]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1129]


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) 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 requirements for 
a voluntary survey for the Department of Health and Human Services 
(HHS), the U.S. Department of Agriculture (USDA), and the Department of 
Homeland Security (DHS), which will inform the FDA Food Safety 
Modernization Act (FSMA), National Agriculture and Food Defense 
Strategy (NAFDS) Report to Congress. The proposed survey will be used 
to determine what food defense activities, if any, State, local, 
territorial, and/or tribal (SLTT) agencies have completed to date. The 
information will be compared to the initial baseline data collected by 
State(s) in 2018.

DATES: Submit either electronic or written comments on the collection 
of information by March 5, 2021.

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 March 5, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 5, 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.

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 105]]

     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-1129 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; National Agriculture and Food 
Defense Strategy Survey.'' 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, 
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 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.

National Agriculture and Food Defense Strategy Survey

OMB Control Number 0910-0855--Extension

    We are seeking OMB approval of the NAFDS under section 108 of FSMA. 
This is a voluntary survey of 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 HHS and USDA, in coordination with DHS, to work 
together with State, local,

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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.
    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 per response         Total hours
                                           respondents         respondent         responses
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SLTT Surveys..........................               500                  1                500   0.33 (20 minutes)...................               165
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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: December 29, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-29082 Filed 12-31-20; 8:45 am]
BILLING CODE 4164-01-P


