[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Notices]
[Pages 13284-13286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06135]


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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 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 U.S. Department of

[[Page 13285]]

Health and Human Services (HHS), the U.S. Department of Agriculture 
(USDA), and the U.S. 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 that 
is required by April 2019. The proposed survey will be used to 
determine what food defense activities, if any, State Agencies have 
completed to date.

DATES: Submit either electronic or written comments on the collection 
of information by May 29, 2018.

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 May 29, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of May 29, 2018. 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:
     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.
     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.gpo.gov/fdsys/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.

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: Under the PRA (44 U.S.C. 3501-3520), 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 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--New

    We are seeking OMB approval of the NAFDS under 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

[[Page 13286]]

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. 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 the USDA, in 
coordination with the 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.
    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: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06135 Filed 3-27-18; 8:45 am]
 BILLING CODE 4164-01-P


