Agency Information Collection Activities; Proposed Collection; Comment Request; Sanitary Transportation of Human and Animal Food, 5087-5089 [2019-02751]
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Federal Register / Vol. 84, No. 34 / Wednesday, February 20, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0013]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Sanitary
Transportation of Human and Animal
Food
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,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection requirements associated with
the sanitary transportation of human
and animal food.
DATES: Submit either electronic or
written comments on the collection of
information by March 22, 2019.
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 April 22,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 22, 2019. 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.
SUMMARY:
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
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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–
2013–N–0013 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Sanitary
Transportation of Human and Animal
Food.’’ 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
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5087
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:
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, 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,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
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Federal Register / Vol. 84, No. 34 / Wednesday, February 20, 2019 / Notices
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.
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, as well as procedures for
respondents who wish to request a
waiver for any requirement.
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 ...............................................
1 There
Number of
records per
recordkeeper
1,502,032
Average
burden per
recordkeeping
Total annual
records
1
1,502,032
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 our 2016
Final Regulatory Impact Analysis 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.
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
21 CFR section; activity
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
1.908; Disclosure of sanitary specifications; operating temperature conditions ...........................................................
226
1
226
* 0.5833
132
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
* ∼35 mins.
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Federal Register / Vol. 84, No. 34 / Wednesday, February 20, 2019 / Notices
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: February 13, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02751 Filed 2–19–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel; Training and Career
Development Special Emphasis Panel.
Date: March 19, 2019.
Time: 11:00 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Elizabeth Webber, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS/NIH/DHHS, NSC, 6001 Executive
Blvd., Suite 3208, MSC 9529, Bethesda, MD
20892–9529, (301) 496–1917, Webbere@
nih.gov.
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(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: February 13, 2019.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–02774 Filed 2–19–19; 8:45 am]
BILLING CODE 4140–01–P
5089
Activities, National Institute of Mental
Health, NIH, Neuroscience Center/Room
6150/MSC 9606, 6001 Executive Boulevard,
Bethesda, MD 20892–9606, 301–443–2742,
nick.gaiano@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: February 13, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–02773 Filed 2–19–19; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institute of Mental Health;
Notice of Closed Meetings
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Silvio O. Conte Center (P50) Review.
Date: March 28, 2019.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center Building (NSC), 6001
Executive Boulevard, Rockville, MD 20852
(Virtual Meeting).
Contact Person: Nicholas Gaiano, Ph.D.,
Review Branch Chief, Division of Extramural
Activities, National Institute of Mental
Health, NIH, Neuroscience Center/Room
6150/MSC 9606, 6001 Executive Boulevard,
Bethesda, MD 20892–9606, 301–443–2742,
nick.gaiano@nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
BRAIN Initiative: Ruth L. Kirschstein NRSA
Individual Postdoctoral Fellowship (F32)
Review.
Date: April 3, 2019.
Time: 10:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center Building (NSC), 6001
Executive Boulevard, Rockville, MD 20852
(Virtual Meeting).
Contact Person: Nicholas Gaiano, Ph.D.,
Review Branch Chief, Division of Extramural
PO 00000
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Office of The Director, National
Institutes of Health; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Advisory Committee to
the Director, National Institutes of
Health.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Advisory Committee
to the Director, National Institutes of Health.
Date: March 22, 2019.
Time: 1:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 1, One Center Drive, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Gretchen Wood, Staff
Assistant, National Institutes of Health,
Office of the Director, One Center Drive,
Building 1, Room 126, Bethesda, MD 20892,
301–496–4272, Woodgs@od.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
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]]>Agencies
[Federal Register Volume 84, Number 34 (Wednesday, February 20, 2019)]
[Notices]
[Pages 5087-5089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02751]
[[Page 5087]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0013]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Sanitary Transportation of Human and Animal Food
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, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection requirements
associated with the sanitary transportation of human and animal food.
DATES: Submit either electronic or written comments on the collection
of information by March 22, 2019.
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 April 22, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 22, 2019. 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-2013-N-0013 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Sanitary Transportation of Human
and Animal Food.'' 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: 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,
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, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the
[[Page 5088]]
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.
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,
as well as procedures for respondents who wish to request a waiver for
any requirement.
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 our 2016 Final Regulatory Impact
Analysis 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.
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 per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.908; Disclosure of sanitary specifications; operating temperature 226 1 226 * 0.5833 132
conditions........................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
* ~35 mins.
[[Page 5089]]
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: February 13, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02751 Filed 2-19-19; 8:45 am]
BILLING CODE 4164-01-P
