Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sanitary Transportation of Human and Animal Food, 25816-25817 [2019-11532]
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25816
Federal Register / Vol. 84, No. 107 / Tuesday, June 4, 2019 / Notices
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2013–N–0013]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Sanitary
Transportation of Human and Animal
Food
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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:
Food and Drug Administration
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 5,
2019.
SUMMARY:
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 0910–0773. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
Sanitary Transportation of Human and
Animal Food—21 CFR 1.900
OMB Control Number 0910–0773—
Extension
This information collection supports
FDA regulations regarding the sanitary
transportation of human and animal
food. The regulations are intended to
focus on preventing food safety
problems throughout the food chain and
were issued under the Sanitary Food
Transportation Act of 2005 (2005
SFTA), and the FDA Food Safety
Modernization Act, enacted in 2011.
The 2005 SFTA amended the Federal
Food, Drug, and Cosmetic Act (FD&C
Act), in part, by creating section 416 (21
U.S.C. 350e), which directs us to issue
regulations to require shippers, carriers
by motor vehicle or rail vehicle,
receivers, and other persons engaged in
the transportation of food to use
prescribed sanitary transportation
practices to ensure that food is not
transported under conditions that may
render the food adulterated. Section 416
also directs that we prescribe
appropriate human and animal food
transportation practice requirements
relating to: (1) Sanitation; (2) packaging,
isolation, and other protective measures;
(3) limitations on the use of vehicles; (4)
information to be disclosed to carriers
and to manufacturers; and (5)
recordkeeping.
In addition, the 2005 SFTA created
section 402(i) of the FD&C Act (21
U.S.C. 342(i)), which provides that food
that is transported or offered for
transport by a shipper, carrier by motor
vehicle or rail vehicle, receiver, or any
other person engaged in the
transportation of food under conditions
that are not in compliance with the
regulations issued under section 416 is
adulterated and section 301(hh) of the
FD&C Act (21 U.S.C. 331(hh)), which
prohibits the failure by a shipper, carrier
by motor vehicle or rail vehicle,
receiver, or any other person engaged in
the transportation of food to comply
with the regulations issued under
section 416.
The 2005 SFTA also amended section
703 of the FD&C Act (21 U.S.C. 373) by
providing that a shipper, carrier by
motor vehicle or rail vehicle, receiver,
or other person subject to section 416
shall, on request of an officer or
employee designated by FDA, permit
the officer or employee, at reasonable
times, to have access to and to copy all
records that are required to be kept
under the regulations issued under
section 416.
Accordingly, we issued regulations in
21 CFR 1.900 that establish
requirements for the sanitary
transportation of human and animal
food. The regulations include certain
recordkeeping requirements, procedures
and information collection for
respondents who wish to request a
waiver for any requirement, as well as
third-party disclosures regarding
sanitary specifications.
In the Federal Register of February
20, 2019 (84 FR 5087), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section; activity
1.912; Record retention ...............................................
khammond on DSKBBV9HB2PROD with NOTICES
1 There
Number of
records per
recordkeeper
1,502,032
1
Total annual
records
1,502,032
Average
burden per
recordkeeping
0.083 (5 minutes) ..
Total hours
124,669
are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate an annual recordkeeping
burden of 124,669 hours, consistent
with the estimate found in the Final
Regulatory Impact Analysis for the 2016
final rule and used to establish the
VerDate Sep<11>2014
17:16 Jun 03, 2019
Jkt 247001
information collection. This assumes
1,502,032 workers will spend an average
of 5 minutes on activities related to the
record retention requirements under 21
CFR 1.912. We expect these activities
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
will likely include documenting
procedures and training, as well as
sanitary transportation operations and
specification requirements.
E:\FR\FM\04JNN1.SGM
04JNN1
25817
Federal Register / Vol. 84, No. 107 / Tuesday, June 4, 2019 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
1.914; Waiver petitions ........................................................
2
1
2
24
48
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate one waiver petition from
each of two firms will be submitted and
respondents will spend 24 hours to
prepare and submit the petition to FDA.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section; activity
1.908; Disclosure of sanitary specifications; operating
temperature conditions.
1 There
226
Average
burden per
disclosure
Total annual
disclosures
1
226
0.5833 (∼35 mins.)
Total hours
132
are no capital costs or operating and maintenance costs associated with this collection of information.
Finally, we estimate an annual thirdparty disclosure burden of 132 hours,
consistent with the currently approved
burden estimate for this collection of
information. We assume each of 226
firms will spend an average of 35
minutes, annually, disclosing written
records as required under 21 CFR 1.908.
Cumulatively, we have reduced our
burden estimate for the information
collection. We made this adjustment to
reflect the removal of one-time burden
associated with implementation of the
new regulatory requirements. Because
these provisions have since become
effective, the one-time estimates
previously included have been
removed.
Dated: May 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11532 Filed 6–3–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation for Written Comments on
an Updated Health Literacy Definition
for Healthy People 2030
Office of Disease Prevention
and Health Promotion, Office of the
Assistant Secretary for Health, Office of
the Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
khammond on DSKBBV9HB2PROD with NOTICES
Number of
disclosures
per
respondent
The Department of Health and
Human Services (HHS) provides notice
of a request for comments about the
proposed update to the definition of
health literacy. The Secretary’s
Advisory Committee on National Health
SUMMARY:
VerDate Sep<11>2014
17:16 Jun 03, 2019
Jkt 247001
Promotion and Disease Prevention
Objectives for Healthy People 2030 used
the following working definition:
‘‘Health literacy occurs when a society
provides accurate health information
and services that people can easily find,
understand, and use to inform their
decisions and actions.’’
DATES: Written comments must be
submitted by August 5, 2019.
ADDRESSES: Written comments will be
accepted via email at
Definehealthliteracy@HHS.gov.
FOR FURTHER INFORMATION CONTACT:
Stephanie Santana, Public Health
Analyst, U.S. Department of Health and
Human Services, Office of the Assistant
Secretary for Health, Office of Disease
Prevention and Health Promotion, 1101
Wootton Parkway, Rockville, MD 20852.
240–453–8265 Email:
Definehealthliteracy@HHS.gov.
SUPPLEMENTARY INFORMATION: Healthy
People and health literacy. Healthy
People provides science-based, 10-year
national objectives for improving the
health of all Americans. Health literacy
objectives have been tracked in Healthy
People 2010 and 2020 and will also be
included in Healthy People 2030.
Health literacy is one of the Healthy
People 2030 framework’s foundational
principles (‘‘Achieving health and wellbeing requires eliminating health
disparities, achieving health equity, and
attaining health literacy’’) and one of its
overarching goals (‘‘Eliminate health
disparities, achieve health equity, and
attain health literacy to improve the
health and well-being of all’’).
Current Healthy People health literacy
definition. The following definition of
health literacy has been used in Healthy
People 2010 and Healthy People 2020:
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
‘‘Health literacy is the degree to which
individuals have the capacity to obtain,
process, and understand basic health
information needed to make appropriate
health decisions.’’
This definition of health literacy has
had a tremendous impact on the field,
influencing health literacy measurement
and improvement efforts around the
world.
The Secretary’s Advisory Committee
on National Health Promotion and
Disease Prevention Objectives used this
working definition of health literacy for
2030: ‘‘Health literacy occurs when a
society provides accurate health
information and services that people
can easily find, understand, and use to
inform their decisions and actions.’’
This working definition reflects the
evolution of the concept of health
literacy toward a consensus that health
literacy is affected not only by an
individual’s capacities, but also by the
accessibility, clarity, and actionability of
health information and health services.
Submission Instructions. Comments
should:
1. Address the strengths and/or
weaknesses of the recommended
definition,
2. Be brief and concise; Limit 250
words
3. Make specific editing suggestions,
and
4. Cite articles that support suggested
changes (if any).
Reference Material
Healthy People 2030 Framework. Available
at https://www.healthypeople.gov/2020/
About-Healthy-People/DevelopmentHealthy-People-2030/Framework.
Pleasant, A., R.E. Rudd, C. O’Leary, M.K.
Paasche-Orlow, M.P. Allen, W.
Alvarado-Little, L. Myers, K. Parson, and
E:\FR\FM\04JNN1.SGM
04JNN1
]]>Agencies
[Federal Register Volume 84, Number 107 (Tuesday, June 4, 2019)]
[Notices]
[Pages 25816-25817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11532]
[[Page 25816]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0013]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Sanitary
Transportation of Human and Animal Food
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 5,
2019.
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 0910-0773.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[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.
Sanitary Transportation of Human and Animal Food--21 CFR 1.900
OMB Control Number 0910-0773--Extension
This information collection supports FDA regulations regarding the
sanitary transportation of human and animal food. The regulations are
intended to focus on preventing food safety problems throughout the
food chain and were issued under the Sanitary Food Transportation Act
of 2005 (2005 SFTA), and the FDA Food Safety Modernization Act, enacted
in 2011. The 2005 SFTA amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act), in part, by creating section 416 (21 U.S.C. 350e), which
directs us to issue regulations to require shippers, carriers by motor
vehicle or rail vehicle, receivers, and other persons engaged in the
transportation of food to use prescribed sanitary transportation
practices to ensure that food is not transported under conditions that
may render the food adulterated. Section 416 also directs that we
prescribe appropriate human and animal food transportation practice
requirements relating to: (1) Sanitation; (2) packaging, isolation, and
other protective measures; (3) limitations on the use of vehicles; (4)
information to be disclosed to carriers and to manufacturers; and (5)
recordkeeping.
In addition, the 2005 SFTA created section 402(i) of the FD&C Act
(21 U.S.C. 342(i)), which provides that food that is transported or
offered for transport by a shipper, carrier by motor vehicle or rail
vehicle, receiver, or any other person engaged in the transportation of
food under conditions that are not in compliance with the regulations
issued under section 416 is adulterated and section 301(hh) of the FD&C
Act (21 U.S.C. 331(hh)), which prohibits the failure by a shipper,
carrier by motor vehicle or rail vehicle, receiver, or any other person
engaged in the transportation of food to comply with the regulations
issued under section 416.
The 2005 SFTA also amended section 703 of the FD&C Act (21 U.S.C.
373) by providing that a shipper, carrier by motor vehicle or rail
vehicle, receiver, or other person subject to section 416 shall, on
request of an officer or employee designated by FDA, permit the officer
or employee, at reasonable times, to have access to and to copy all
records that are required to be kept under the regulations issued under
section 416.
Accordingly, we issued regulations in 21 CFR 1.900 that establish
requirements for the sanitary transportation of human and animal food.
The regulations include certain recordkeeping requirements, procedures
and information collection for respondents who wish to request a waiver
for any requirement, as well as third-party disclosures regarding
sanitary specifications.
In the Federal Register of February 20, 2019 (84 FR 5087), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.912; Record retention...................... 1,502,032 1 1,502,032 0.083 (5 minutes)........................ 124,669
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate an annual recordkeeping burden of 124,669 hours,
consistent with the estimate found in the Final Regulatory Impact
Analysis for the 2016 final rule and used to establish the information
collection. This assumes 1,502,032 workers will spend an average of 5
minutes on activities related to the record retention requirements
under 21 CFR 1.912. We expect these activities will likely include
documenting procedures and training, as well as sanitary transportation
operations and specification requirements.
[[Page 25817]]
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.914; Waiver petitions............................................ 2 1 2 24 48
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We estimate one waiver petition from each of two firms will be
submitted and respondents will spend 24 hours to prepare and submit the
petition to FDA.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.908; Disclosure of sanitary specifications; 226 1 226 0.5833 (~35 mins.)....................... 132
operating temperature conditions.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Finally, we estimate an annual third-party disclosure burden of 132
hours, consistent with the currently approved burden estimate for this
collection of information. We assume each of 226 firms will spend an
average of 35 minutes, annually, disclosing written records as required
under 21 CFR 1.908.
Cumulatively, we have reduced our burden estimate for the
information collection. We made this adjustment to reflect the removal
of one-time burden associated with implementation of the new regulatory
requirements. Because these provisions have since become effective, the
one-time estimates previously included have been removed.
Dated: May 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11532 Filed 6-3-19; 8:45 am]
BILLING CODE 4164-01-P
