Agency Information Collection Activities; Proposed Collection; Comment Request; National Agriculture and Food Defense Strategy Survey
| Published date | 04 January 2021 |
| Citation | 86 FR 104 |
| Record Number | 2020-29082 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 86 Issue 1 (Monday, January 4, 2021)
[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:
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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,
[email protected].
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
