Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice, 13811-13812 [2017-05105]
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Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
of a possible total of 125 (for the total
determinant score) a suitable choice for
the data sufficiency threshold? Is the
relative weight for each score
appropriate?
7. How should NIOSH consider data
collected on structural analogs or
related chemicals in the banding
scheme?
8. Qualitative and quantitative
technical criteria have been adopted for
some endpoints. Is this approach
adequately justified and suitably
explained in the document? If not, how
should the explanations be refined?
9. If a chemical has two forms (vapor
or particulate) in the workplace, we
have recommended that the most
protective OEB take precedence. Please
comment on the utility and adequacy of
that recommendation.
10. Acute toxicity information may be
presented in an array of different units.
We have attempted to address those
possibilities in the banding criteria for
the acute toxicity endpoint, especially
for inhalation exposures. Is this
information sufficiently clear? Are
suitable rubrics for unit conversions
provided?
11. Does this draft document
adequately describe the occupational
exposure banding process in a way that
supports its use in assigning ranges of
exposure concentrations to protect
worker health in the occupational
setting?
Public Review
The external review of the draft
document has been (1) developed in
accordance with Office of Management
and Budget (OMB) guidelines, (2) is
consistent with NIOSH peer review
practice, and (3) is meant to ensure that
credible and appropriate science is
reflected within the draft document.
Dated: March 10, 2017.
Frank Hearl,
Chief of Staff, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention.
[FR Doc. 2017–05115 Filed 3–14–17; 8:45 am]
Food and Drug Administration
Hazard Analysis and Critical Control
Point (HACCP) Procedures for the Safe
and Sanitary Processing and Importing
of Juice—21 CFR Part 120
[Docket No. FDA–2013–N–1427]
OMB Control Number 0910–0466—
Extension
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Hazard Analysis
and Critical Control Point Procedures
for the Safe and Sanitary Processing
and Importing of Juice
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.
SUMMARY:
Fax written comments on the
collection of information by April 14,
2017.
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 0910–0466. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
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:
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
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FDA’s regulations in part 120 (21 CFR
part 120) mandate the application of
HACCP procedures to the processing of
fruit and vegetable juices. HACCP is a
preventative system of hazard control
designed to help ensure the safety of
foods. The regulations were issued
under FDA’s statutory authority to
regulate food safety under section
402(a)(4) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
342(a)(4)). Under section 402(a)(4) of the
FD&C Act, a food is adulterated if it is
prepared, packed, or held under
insanitary conditions whereby it may
have been contaminated with filth or
rendered injurious to health. The
Agency also has authority under section
361 of the Public Health Service Act (42
U.S.C. 264) to issue and enforce
regulations to prevent the introduction,
transmission, or spread of
communicable diseases from one State,
territory, or possession to another, or
from outside the United States into this
country. Under section 701(a) of the
FD&C Act (21 U.S.C. 371(a)), FDA is
authorized to issue regulations for the
efficient enforcement of that act.
Under HACCP, processors of fruit and
vegetable juices establish and follow a
preplanned sequence of operations and
observations (the HACCP plan) designed
to avoid or eliminate one or more
specific food hazards, and thereby
ensure that their products are safe,
wholesome, and not adulterated; in
compliance with section 402 of the
FD&C Act. Information development
and recordkeeping are essential parts of
any HACCP system. The information
collection requirements are narrowly
tailored to focus on the development of
appropriate controls and document
those aspects of processing that are
critical to food safety.
In the Federal Register of August 30,
2016 (81 FR 59636), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\15MRN1.SGM
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13812
Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
120.6(c) and 120.12(a)(1) and (b)—Require written monitoring and correction records for Sanitation Standard Operating Procedures.
120.7, 120.10(a), and 120.12(a)(2), (b) and (c)—Require written hazard
analysis of food hazards.
120.8(a) and 20.12(a)(3), (b), and (c)—Require written HACCP plan ..........
120.8(b)(7) and 120.12(a)(4)(i) and (b)—Require a recordkeeping system
that documents monitoring of the critical control points and other measurements as prescribed in the HACCP plan.
120.10(c) and 120.12(a)(4)(ii) and (b)—Require that all corrective actions
taken in response to a deviation from a critical limit be documented.
120.11(a)(1)(iv) and (a)(2) and 120.12 (a)(5) and (b)—Require records
showing verification activities associated with the HACCP system.
120.11(b) and 120.12(a)(5) and (b)—Require records showing validation
activities associated with the HACCP system.
120.11(c) and 120.12(a)(5) and (b)—Require documentation of revalidation
of the hazard analysis upon any changes that might affect the original
hazard analysis (applies when a firm does not have a HACCP plan because the original hazard analysis did not reveal hazards likely to occur).
120.14(a)(2), (c), and (d) and 120.12(b)—Require that juice importers have
written procedures to ensure that the juice is processed in accordance
with our regulations in part 120.
Total ........................................................................................................
1 There
Average
burden per
recordkeeping
Total annual
records
Total hours
1,875
365
684,375
0.1 (6 minutes) .....
68,438
2,300
1.1
2,530
20 .........................
50,600
1,560
1,450
1.1
14,600
1716
21,170,000
60 .........................
0.01 (1 minute) .....
102,960
211,700
1,840
12
22,080
0.1 (6 minutes) .....
2,208
1,840
52
95,680
0.1 (6 minutes) .....
9,568
1,840
1
1,840
4 ...........................
7,360
1,840
1
1,840
4 ...........................
7,360
308
1
308
4 ...........................
1,232
........................
........................
........................
...............................
461,426
are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 provides our estimate of the
total annual recordkeeping burden of
our regulations in part 120. We base our
estimate of the average burden per
recordkeeping on our experience with
the application of HACCP principles in
food processing. We base our estimate of
the number of recordkeepers on our
estimate of the total number of juice
manufacturing plants affected by the
regulations (plants identified in our
official establishment inventory plus
very small apple juice and very small
orange juice manufacturers). These
estimates assume that every processor
will prepare sanitary standard operating
procedures and an HACCP plan and
maintain the associated monitoring
records, and that every importer will
require product safety specifications. In
fact, there are likely to be some small
number of juice processors that, based
upon their hazard analysis, determine
that they are not required to have an
HACCP plan under these regulations.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05105 Filed 3–14–17; 8:45 am]
BILLING CODE 4164–01–P
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Number of
records per
recordkeeper
VerDate Sep<11>2014
18:19 Mar 14, 2017
Jkt 241001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0796]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Testing
Communications on Medical Devices
and Radiation-Emitting Products
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 April 14,
2017.
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 0910–0678. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
SUMMARY:
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 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.
Testing Communications on Medical
Devices and Radiation-Emitting
Products—OMB Control Number 0910–
0678—Extension
FDA is authorized by section
1003(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)) to conduct educational
and public information programs
relating to the safety of regulated
medical devices and radiation-emitting
products. FDA must conduct needed
research to ensure that such programs
have the highest likelihood of being
effective. Improving communications
about medical devices and radiation
emitting products will involve many
research methods, including individual
in-depth interviews, mall-intercept
interviews, focus groups, selfadministered surveys, gatekeeper
reviews, and omnibus telephone
surveys.
The information collected will serve
three major purposes. First, as formative
research it will provide critical
knowledge needed about target
audiences to develop messages and
campaigns about medical device and
radiation-emitting product use.
Knowledge of consumer and health care
professional decision making processes
E:\FR\FM\15MRN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13811-13812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05105]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1427]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Hazard Analysis and
Critical Control Point Procedures for the Safe and Sanitary Processing
and Importing of Juice
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 April
14, 2017.
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 0910-0466.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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.
Hazard Analysis and Critical Control Point (HACCP) Procedures for the
Safe and Sanitary Processing and Importing of Juice--21 CFR Part 120
OMB Control Number 0910-0466--Extension
FDA's regulations in part 120 (21 CFR part 120) mandate the
application of HACCP procedures to the processing of fruit and
vegetable juices. HACCP is a preventative system of hazard control
designed to help ensure the safety of foods. The regulations were
issued under FDA's statutory authority to regulate food safety under
section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 342(a)(4)). Under section 402(a)(4) of the FD&C Act, a
food is adulterated if it is prepared, packed, or held under insanitary
conditions whereby it may have been contaminated with filth or rendered
injurious to health. The Agency also has authority under section 361 of
the Public Health Service Act (42 U.S.C. 264) to issue and enforce
regulations to prevent the introduction, transmission, or spread of
communicable diseases from one State, territory, or possession to
another, or from outside the United States into this country. Under
section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to
issue regulations for the efficient enforcement of that act.
Under HACCP, processors of fruit and vegetable juices establish and
follow a preplanned sequence of operations and observations (the HACCP
plan) designed to avoid or eliminate one or more specific food hazards,
and thereby ensure that their products are safe, wholesome, and not
adulterated; in compliance with section 402 of the FD&C Act.
Information development and recordkeeping are essential parts of any
HACCP system. The information collection requirements are narrowly
tailored to focus on the development of appropriate controls and
document those aspects of processing that are critical to food safety.
In the Federal Register of August 30, 2016 (81 FR 59636), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 13812]]
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
120.6(c) and 120.12(a)(1) and (b)--Require 1,875 365 684,375 0.1 (6 minutes)........................ 68,438
written monitoring and correction records for
Sanitation Standard Operating Procedures.
120.7, 120.10(a), and 120.12(a)(2), (b) and 2,300 1.1 2,530 20..................................... 50,600
(c)--Require written hazard analysis of food
hazards.
120.8(a) and 20.12(a)(3), (b), and (c)--Require 1,560 1.1 1716 60..................................... 102,960
written HACCP plan.
120.8(b)(7) and 120.12(a)(4)(i) and (b)-- 1,450 14,600 21,170,000 0.01 (1 minute)........................ 211,700
Require a recordkeeping system that documents
monitoring of the critical control points and
other measurements as prescribed in the HACCP
plan.
120.10(c) and 120.12(a)(4)(ii) and (b)--Require 1,840 12 22,080 0.1 (6 minutes)........................ 2,208
that all corrective actions taken in response
to a deviation from a critical limit be
documented.
120.11(a)(1)(iv) and (a)(2) and 120.12 (a)(5) 1,840 52 95,680 0.1 (6 minutes)........................ 9,568
and (b)--Require records showing verification
activities associated with the HACCP system.
120.11(b) and 120.12(a)(5) and (b)--Require 1,840 1 1,840 4...................................... 7,360
records showing validation activities
associated with the HACCP system.
120.11(c) and 120.12(a)(5) and (b)--Require 1,840 1 1,840 4...................................... 7,360
documentation of revalidation of the hazard
analysis upon any changes that might affect
the original hazard analysis (applies when a
firm does not have a HACCP plan because the
original hazard analysis did not reveal
hazards likely to occur).
120.14(a)(2), (c), and (d) and 120.12(b)-- 308 1 308 4...................................... 1,232
Require that juice importers have written
procedures to ensure that the juice is
processed in accordance with our regulations
in part 120.
--------------------------------------------------------------------------------------------------------
Total...................................... .............. .............. .............. ....................................... 461,426
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 1 provides our estimate of the total annual recordkeeping
burden of our regulations in part 120. We base our estimate of the
average burden per recordkeeping on our experience with the application
of HACCP principles in food processing. We base our estimate of the
number of recordkeepers on our estimate of the total number of juice
manufacturing plants affected by the regulations (plants identified in
our official establishment inventory plus very small apple juice and
very small orange juice manufacturers). These estimates assume that
every processor will prepare sanitary standard operating procedures and
an HACCP plan and maintain the associated monitoring records, and that
every importer will require product safety specifications. In fact,
there are likely to be some small number of juice processors that,
based upon their hazard analysis, determine that they are not required
to have an HACCP plan under these regulations.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05105 Filed 3-14-17; 8:45 am]
BILLING CODE 4164-01-P
