Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Food Defense Strategy Survey, 30740-30741 [2018-14051]
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30740
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
disclosures
per respondent
Number of
respondents
21 CFR section; activity
Total annual
disclosures
Average burden
per disclosure
Total hours
Guidance document entitled ‘‘Labeling of
Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug Administration’’.
12
1
12
1 ................................
12
Total ..................................................
............................
............................
............................
....................................
186
sradovich on DSK3GMQ082PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. Our
estimate of the number of respondents
is based on the number of regulatory
submissions to TTB for beers that do not
meet the definition of a ‘‘malt beverage’’
under the FAA Act. Based on its records
of submissions received from
manufacturers of such products, TTB
estimates the annual number of
respondents to be 12 and the annual
number of disclosures to be 24. Thus,
we adopt TTB’s estimate of 12 annual
respondents, and an annual number of
disclosures per respondent of 2 in table
1.
Our estimates of the average burden
per disclosure for each collection
provision are based on our experience
with food labeling under the Agency’s
jurisdiction. The estimated average
burden per disclosure for §§ 101.3,
101.4, 101.5, 101.9, 101.22, and 101.105
in table 1 are equal to, and based upon,
the estimated average burden per
disclosure approved by OMB in OMB
control number 0910–0381. We further
estimate that the labeling burden of
section 403(w)(1) of the FD&C Act,
which specifies requirements for the
declaration of food allergens, will be 1
hour based upon the similarity of the
requirements to that of § 101.4. Finally,
FDA estimates that a respondent will
spend 1 hour reading the guidance.
Thus, we estimate that 12 respondents
will each label 2 products annually, for
a total of 24 labels. We estimate that the
manufacturers will spend 7.25 hours
(0.5 hours + 1 hour + 0.25 hour + 4
hours + 0.5 hour + 1 hour = 7.25 hours)
on each label to comply with our
labeling regulations and the
requirements of section 403(w)(1) of the
FD&C Act, for a total of 174 hours (24
labels × 7.25 hours = 174 hours). In
addition, 12 respondents will each
spend 1 hour reading the guidance
document, for a total of 12 hours. Thus,
we estimate the total hour burden of the
proposed collection of information to be
VerDate Sep<11>2014
17:58 Jun 28, 2018
Jkt 244001
186 hours (174 hours + 12 hours = 186
hours).
The guidance also refers to previously
approved collections of information
found in our regulations. The
collections of information in §§ 101.3,
101.4, 101.5, 101.9, 101.22, and 101.105
have been approved under OMB control
number 0910–0381. Allergen labeling of
these beers under section 403(w)(1) of
the FD&C Act, which was added by the
Food Allergen Labeling and Consumer
Protection Act of 2004, has been
approved under OMB control number
0910–0792.
Dated: June 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14056 Filed 6–28–18; 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; 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.
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,
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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.
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.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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.
E:\FR\FM\29JNN1.SGM
29JNN1
30741
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
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
State Survey ............................................
1 There
Number of
responses per
respondent
Number of
respondents
Activity
49
Total annual
responses
1
49
Total hours
0.33 (20 minutes) ......
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: June 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–14051 Filed 6–28–18; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0025]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Animal Food
Labeling; Declaration of Certifiable
Color Additives
AGENCY:
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
sradovich on DSK3GMQ082PROD with NOTICES
Average burden per
response
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
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
VerDate Sep<11>2014
17:58 Jun 28, 2018
Jkt 244001
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Fax written comments on the
collection of information by July 30,
2018.
DATES:
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 0910–0721.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
E:\FR\FM\29JNN1.SGM
29JNN1
]]>Agencies
[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30740-30741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 [email protected]. 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,
[email protected].
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
