Agency Information Collection Activities; Proposed Collection; Comment Request; National Agriculture and Food Defense Strategy Survey, 13284-13286 [2018-06135]
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Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
Docket; Request for Comments.’’
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.’’ FDA
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/201523389.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: Jay
R. Fajiculay, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, Fax:
301–847–8533, email: GIDAC@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
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Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
FDA’s website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The committees will discuss
new drug application (NDA) 209904 for
stannsoporfin injection, for
intramuscular use, submitted by
InfaCare Pharmaceutical Corporation,
proposed for the treatment of neonates
greater than or equal to 35 weeks of
gestational age with indicators of
hemolysis who are at risk of developing
severe hyperbilirubinemia.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. All electronic
and written submissions submitted to
the Docket (see ADDRESSES) on or before
April 19, 2018, will be provided to the
committees. Oral presentations from the
public will be scheduled between
approximately 1:15 p.m. and 2:15 p.m.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before April 11, 2018. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
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notify interested persons regarding their
request to speak by April 12, 2018.
Persons attending FDA’s advisory
committee meetings are advised that
FDA is not responsible for providing
access to electrical outlets.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require special accommodations
due to a disability, please contact Jay R.
Fajiculay (see FOR FURTHER INFORMATION
CONTACT) at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06168 Filed 3–27–18; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
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Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
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.
daltland on DSKBBV9HB2PROD with NOTICES
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
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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/201523389.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
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13285
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, PRAStaff@
fda.hhs.gov.
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
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Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
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
Number of
respondents
Activity
State Survey ............................................................
1 There
49
Total annual
responses
1
49
Average burden per
response
0.33 (20 minutes) ......
Total hours
16.17
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
Food and Drug Administration
DATES:
[Docket No. FDA–2016–D–1267]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Compounded Drug
Products That Are Essentially Copies
of an Approved Drug Product Under
Section 503B of the Federal Food,
Drug, and Cosmetic Act
AGENCY:
daltland on DSKBBV9HB2PROD with NOTICES
Number of
responses per
respondent
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
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Fax written comments on the
collection of information by April 27,
2018.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Guidance for Industry on
Compounded Drug Products That Are
Essentially Copies of an Approved Drug
Product Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
ADDRESSES:
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
