83 FR 30740 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Food Defense Strategy Survey

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

Page Range		30740-30741
FR Document		2018-14051

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.

Federal Register, Volume 83 Issue 126 (Friday, June 29, 2018)

[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30740-30741]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-14051]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 oira_submission@omb.eop.gov. 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,
PRAStaff@fda.hhs.gov.

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
State Survey............................ 49 1 49 0.33 (20 minutes)..................... 16.17
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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

30740 Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
Number of Total annual Average burden
21 CFR section; activity disclosures Total hours
respondents disclosures per disclosure
per respondent

Guidance document entitled ‘‘Labeling of 12 1 12 1 ................................ 12
Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug Ad-
ministration’’.

Total .................................................. ............................ ............................ ............................ .................................... 186
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information 186 hours (174 hours + 12 hours = 186 OMB, Attn: FDA Desk Officer, Fax: 202–
collection since our last request for hours). 395–7285, or emailed to oira_
OMB approval, we have made no The guidance also refers to previously submission@omb.eop.gov. All
adjustments to our burden estimate. Our approved collections of information comments should be identified with the
estimate of the number of respondents found in our regulations. The OMB control number 0910–NEW and
is based on the number of regulatory collections of information in §§ 101.3, title ‘‘National Agriculture and Food
submissions to TTB for beers that do not 101.4, 101.5, 101.9, 101.22, and 101.105 Defense Strategy Survey.’’ Also include
meet the definition of a ‘‘malt beverage’’ have been approved under OMB control the FDA docket number found in
under the FAA Act. Based on its records number 0910–0381. Allergen labeling of brackets in the heading of this
of submissions received from these beers under section 403(w)(1) of document.
manufacturers of such products, TTB the FD&C Act, which was added by the
FOR FURTHER INFORMATION CONTACT: Ila
estimates the annual number of Food Allergen Labeling and Consumer
S. Mizrachi, Office of Operations, Food
respondents to be 12 and the annual Protection Act of 2004, has been
and Drug Administration, Three White
number of disclosures to be 24. Thus, approved under OMB control number
Flint North, 10A–12M, 11601
we adopt TTB’s estimate of 12 annual 0910–0792.
Landsdown St., North Bethesda, MD
respondents, and an annual number of Dated: June 22, 2018. 20852, 301–796–7726, PRAStaff@
disclosures per respondent of 2 in table Leslie Kux, fda.hhs.gov.
1. Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: In
Our estimates of the average burden [FR Doc. 2018–14056 Filed 6–28–18; 8:45 am] compliance with 44 U.S.C. 3507, FDA
per disclosure for each collection BILLING CODE 4164–01–P has submitted the following proposed
provision are based on our experience collection of information to OMB for
with food labeling under the Agency’s review and clearance.
jurisdiction. The estimated average DEPARTMENT OF HEALTH AND
burden per disclosure for §§ 101.3, HUMAN SERVICES National Agriculture and Food Defense
101.4, 101.5, 101.9, 101.22, and 101.105 Strategy Survey
in table 1 are equal to, and based upon, Food and Drug Administration
OMB Control Number—0910–NEW
the estimated average burden per [Docket No. FDA–2018–N–1129]
disclosure approved by OMB in OMB We are seeking OMB approval of the
control number 0910–0381. We further Agency Information Collection National Agriculture and Food Defense
Activities; Submission for Office of Strategy (NAFDS) under the FDA Food
estimate that the labeling burden of
Management and Budget Review; Safety Modernization Act (FSMA),
section 403(w)(1) of the FD&C Act,
Comment Request; National section 108. This is a voluntary survey
which specifies requirements for the
Agriculture and Food Defense Strategy of State governments intended to gauge
declaration of food allergens, will be 1
Survey government activities in food and
hour based upon the similarity of the
agriculture defense from intentional
requirements to that of § 101.4. Finally, AGENCY: Food and Drug Administration, contamination and emerging threats.
FDA estimates that a respondent will HHS. The collected information will be
spend 1 hour reading the guidance. ACTION: Notice. included in the mandatory 2019 NAFDS
Thus, we estimate that 12 respondents followup Report to Congress. The
will each label 2 products annually, for SUMMARY: The Food and Drug authority for FDA to collect the
a total of 24 labels. We estimate that the Administration (FDA) is announcing information derives from the
manufacturers will spend 7.25 hours that a proposed collection of Commissioner of Food and Drugs’
(0.5 hours + 1 hour + 0.25 hour + 4 information has been submitted to the authority provided in section
hours + 0.5 hour + 1 hour = 7.25 hours) Office of Management and Budget 1003(d)(2)(c) of the Federal Food, Drug,
on each label to comply with our (OMB) for review and clearance under and Cosmetic Act (21 U.S.C.
labeling regulations and the the Paperwork Reduction Act of 1995. 393(d)(2)(c)).
requirements of section 403(w)(1) of the DATES: Fax written comments on the Protecting the nation’s food and
sradovich on DSK3GMQ082PROD with NOTICES

FD&C Act, for a total of 174 hours (24 collection of information by July 30, agriculture supply against intentional
labels × 7.25 hours = 174 hours). In 2018. contamination and other emerging
addition, 12 respondents will each ADDRESSES: To ensure that comments on threats is an important responsibility
spend 1 hour reading the guidance the information collection are received, shared by Federal, State, local, tribal,
document, for a total of 12 hours. Thus, OMB recommends that written and territorial governments as well as
we estimate the total hour burden of the comments be faxed to the Office of private sector partners. On January 4,
proposed collection of information to be Information and Regulatory Affairs, 2011, the President signed FSMA.

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Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices 30741

FSMA focuses on ensuring the safety of in cooperation with State, local, (NAFDS), for the purpose of monitoring
the U.S. food supply by shifting the territorial, and tribal governments and progress in food and agricultural
efforts of Federal regulators from private sector partners, protect the defense by government agencies.
response to prevention and recognizes nation’s food supply against intentional A purposive sampling strategy will be
the importance of strengthening existing contamination. Not later than 4 years employed, such that the government
collaboration among all stakeholders to after the initial NAFDS Report to agencies participating in food and
achieve common public health and Congress (2015), and every 4 years agricultural defense cooperative
security goals. FSMA identifies some thereafter (i.e., 2019, 2023, 2017, etc.), agreements with FDA (22 State
key priorities for working with partners HHS, USDA, and DHS are required to Agencies) and USDA (27 State
in areas such as reliance on Federal, revise and submit an updated report to Agencies) will be asked to respond to
State, and local agencies for inspections; the relevant committees of Congress. the voluntary survey. Food defense
improving foodborne illness HHS/FDA is primarily responsible for leaders responsible for conducting food
surveillance; and leveraging and obtaining the information from Federal defense activities during a food
enhancing State and local food safety and State, local, territorial, and tribal emergency for their jurisdiction will be
and defense capacities. Section 108 of partners to complete the NAFDS Report identified and will receive an emailed
FSMA (NAFDS) requires the U.S. to Congress. An interagency working invitation to complete the survey
Department of Health and Human group will conduct the survey and online; they will be provided with a
Services (HHS) and the U.S. Department collect and update the NAFDS as web link to the survey. The survey will
of Agriculture (USDA), in coordination directed by FSMA, including be conducted electronically on the
with the Department of Homeland developing metrics and measuring FDA.gov web portal, and results will be
Security (DHS), to work together with progress for the evaluation process. analyzed by the interagency working
The proposed survey of Federal and
State, local, territorial, and tribal group.
State partners will be used to determine
governments to monitor and measure In the Federal Register of March 28,
what food defense activities, if any,
progress in food defense. 2018 (83 FR 13284), we published a
Federal and/or State Agencies have
In 2015, the initial NAFDS Report to completed (or are planning) from 2015 notice inviting public comment on the
Congress detailed the specific Federal to 2019. Planning for the local, proposed collection of information.
response to food and agriculture defense territorial, and tribal information Although one comment was received, it
goals, objectives, key initiatives, and collections will commence after the was not responsive to the four collection
activities that HHS, USDA, DHS, and collection and reporting of Federal and of information topics solicited and
other stakeholders planned to State Agency level data. therefore will not be discussed in this
accomplish to meet the objectives This survey will be repeated document.
outlined in FSMA. The NAFDS charts a approximately every 2 to 4 years, as FDA estimates the burden of this
direction for how the Federal Agencies, described in section 108 of FSMA collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Activity responses per Total hours
respondents responses response
respondent

State Survey ............................................ 49 1 49 0.33 (20 minutes) ...... 16.17
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The total burden for this collection of DEPARTMENT OF HEALTH AND DATES: Fax written comments on the
information, therefore, is 16.17 hours. HUMAN SERVICES collection of information by July 30,
The FDA Office of Partnerships 2018.
Food and Drug Administration
reviewed the questionnaire and ADDRESSES: To ensure that comments on
provided the amount of time to the information collection are received,
complete the survey. The total burden is [Docket No. FDA–2009–N–0025]
OMB recommends that written
based on our previous experiences Agency Information Collection comments be faxed to the Office of
conducting surveys. Activities; Submission for Office of Information and Regulatory Affairs,
Dated: June 26, 2018. Management and Budget Review; OMB, Attn: FDA Desk Officer, Fax: 202–
Comment Request; Animal Food 395–7285, or emailed to oira_
Leslie Kux,
Labeling; Declaration of Certifiable submission@omb.eop.gov. All
Associate Commissioner for Policy. comments should be identified with the
Color Additives
[FR Doc. 2018–14051 Filed 6–28–18; 8:45 am] OMB control number 0910–0721.
BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT:
HHS. Amber Sanford, Office of Operations,
ACTION: Notice. Food and Drug Administration, Three
sradovich on DSK3GMQ082PROD with NOTICES

White Flint North, 10A–12M, 11601
SUMMARY: The Food and Drug Landsdown St., North Bethesda, MD
Administration (FDA) is announcing 20852, 301–796–8867, PRAStaff@
that a proposed collection of fda.hhs.gov.
information has been submitted to the
Office of Management and Budget SUPPLEMENTARY INFORMATION: In
(OMB) for review and clearance under compliance with 44 U.S.C. 3507, FDA
the Paperwork Reduction Act of 1995. has submitted the following proposed

VerDate Sep<11>2014 17:58 Jun 28, 2018 Jkt 244001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1

Document Created: 2018-06-29 01:12:59
Document Modified: 2018-06-29 01:12:59

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by July 30, 2018.
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]
FR Citation		83 FR 30740

83 FR 30740 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Food Defense Strategy Survey

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 126 (June 29, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration