Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, 25466-25468 [2018-11801]
Download as PDF
<![CDATA[
25466
Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices
3600, Elaine.Lippmann@fda.hhs.gov; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
daltland on DSKBBV9HB2PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Waivers of the Single, Shared System
REMS Requirement.’’ This guidance
describes how the Agency intends to
consider granting a waiver of the
requirement in section 505–1(i) of the
FD&C Act (21 U.S.C. 355–1(i)) that the
applicant for an ANDA and its RLD use
a SSS for a required REMS with ETASU.
Section 505–l(i)(l)(B) of the FD&C Act
requires that a holder of an ANDA
under section 505(j) use a ‘‘single,
shared system’’ with the RLD for any
ETASU, unless FDA waives this
requirement. The statute permits a
waiver of the SSS requirement if FDA
finds that (1) ‘‘the burden of creating a
[SSS] outweighs the benefit of a single,
system, taking into consideration the
impact on health care providers,
patients, the applicant for the [ANDA],
and the holder of the reference drug
product,’’ or (2) an aspect of the ETASU
for the applicable listed drug is claimed
by an unexpired patent or trade secret
and the ANDA applicant certifies that it
sought a license for use of the aspect,
but was unable to obtain one. If a waiver
of the SSS requirement is granted, the
ANDA may use ‘‘a different, comparable
aspect of the [ETASU],’’ instead of
participating in a SSS with the RLD.
This guidance is intended to explain
the factors FDA will consider in
evaluating a request for waiver of the
SSS requirement and provide
recommendations to ANDA applicants
regarding the submission and content of
waiver requests. The guidance also
addresses FDA’s interpretation of what
constitutes a different, comparable
aspect of the ETASU as described in
section 505–1(i)(1)(B).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Waivers of the Single, Shared
System REMS Requirement.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
VerDate Sep<11>2014
17:06 May 31, 2018
Jkt 244001
II. Paperwork Reduction Act of 1995
This draft guidance refers to
collections of information that are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501–3520). The
preparation and submission of waiver
requests (as described in 21 CFR 314.90
for new drug application applicants and
314.99(b) for ANDA applicants) has
been approved under OMB control
number 0910–0001. In accordance with
the PRA, before publication of the final
guidance document, FDA intends to
solicit public comment and obtain OMB
approval for any information collections
recommended in this guidance that are
new or that would represent material
modifications to previously approved
collections of information found in FDA
regulations.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.regulations.gov.
Dated: May 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–11784 Filed 5–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0920]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Human 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,
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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
current good manufacturing practice,
hazard analysis, and risk-based
preventive controls for human food.
DATES: Submit either electronic or
written comments on the collection of
information by July 31, 2018.
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 July 31, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 31, 2018. 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.
E:\FR\FM\01JNN1.SGM
01JNN1
Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices
• 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–
2011–N–0920 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Current
Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals.’’
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/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.
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
SUPPLEMENTARY INFORMATION:
25467
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.
Current Good Manufacturing Practice
and Hazard Analysis, and Risk-Based
Preventive Controls for Human Food—
21 CFR Part 117
OMB Control Number 0910–0751—
Extension
This information collection supports
FDA regulations. As amended by the
FDA Food Safety Modernization Act
(FSMA) (Pub. L. 111–353), the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) enables the Agency to better protect
the public health by helping to ensure
the safety and security of the food
supply. It enables FDA to focus more on
preventing food safety problems rather
than relying primarily on reacting to
problems after they occur. FSMA
recognizes the important role industry
plays in ensuring the safety of the food
supply, including the adoption of
modern systems of preventive controls
in food production. Specifically, section
418 of the FD&C Act (21 U.S.C. 350g)
sets forth requirements for hazard
analysis and risk-based preventive
controls for facilities that produce food
for human consumption. To implement
these provisions, regulations were
codified under 21 CFR part 117—
Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based
Preventive Controls for Human Food.
The regulations establish requirements
for a written food safety plan; hazard
analysis preventive controls;
monitoring; corrective actions and
corrections; verification; supply-chain
program; recall plan; and associated
records, and became effective November
16, 2015. Currently, we continue to
evaluate burden associated with the
information collection requirements;
however, for purposes of extending the
information collection we retain the
currently approved figures as shown
below.
Our estimate of the burden for the
information collection is as follows:
daltland on DSKBBV9HB2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
117.201(e); qualified facility .......................................
1 There
Number of
responses per
respondent
37,134
0.5
Average
burden per
response
Total annual
responses
18,567
0.5 (30 minutes) ....
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
17:06 May 31, 2018
Jkt 244001
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
E:\FR\FM\01JNN1.SGM
01JNN1
Total hours
9,284
25468
Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
117.126(c) and 117.170(d); food safety plan and reanalysis.
117.136; assurance records .......................................
117.145(c); monitoring records ..................................
117.150(d); corrective actions and corrections
records.
117.155(b); verification records ..................................
117.160; validation records ........................................
117.475(c)(7)-(9); supplier records ............................
117.180(d); training records for preventive controls
qualified individual.
46,685
1
46,685
110 ........................
5,135,350
16,285
8,143
16,285
1
730
2
16,285
5,944,390
32,570
0.25 (15 minutes) ..
0.05 (3 minutes) ....
1 ............................
4,071
297,220
32,570
8,143
3,677
16,285
46,685
244
6
10
1
1,986,892
22,062
162,850
46,685
0.05 (3 minutes) ....
0.25 (15 minutes) ..
4 ............................
0.25 (15 minutes) ..
99,345
5,515
651,400
11,671
Total ....................................................................
........................
..........................
........................
...............................
6,237,142
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
117.201(e); disclosure of food manufacturing facility
address.
1 There
Dated: May 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–11801 Filed 5–31–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2018–D–1041]
daltland on DSKBBV9HB2PROD with NOTICES
1
Development of a Shared System Risk
Evaluation and Mitigation Strategy;
Draft Guidance for Industry;
Availability
Food and Drug Administration,
HHS.
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
VerDate Sep<11>2014
17:06 May 31, 2018
Jkt 244001
announcing the availability of a draft
guidance for industry entitled
‘‘Development of a Shared System
REMS.’’ This draft guidance provides
recommendations on the development
of a shared system risk evaluation and
mitigation strategy (REMS) for multiple
prescription drug (including biological)
products. This guidance describes some
of the possible benefits of a shared
system REMS, and provides general
principles and recommendations to
assist industry with the development of
these programs.
DATES: Submit either electronic or
written comments on the draft guidance
by July 31, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Food and Drug Administration
ACTION:
37,134
Average
burden per
disclosure
Total annual
disclosures
37,134
0.25 (15 minutes) ..
Total hours
9,284
are no capital costs or operating and maintenance costs associated with this collection of information.
These figures are based on our
regulatory impact analysis in support of
the final rule on preventive controls for
human food, which published in the
Federal Register of September 17, 2015
(80 FR 55908). Using Agency data, we
estimated the number of food facilities
that we believe are subject to the
regulations. We base our estimate of the
time necessary for the individual
reporting, recordkeeping, and thirdparty disclosure activities on our
experience with similar information
collections.
AGENCY:
Number of
disclosures
per respondent
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,
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
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–
2018–D–1041 for ‘‘Development of a
Shared System REMS; Draft Guidance
for Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
E:\FR\FM\01JNN1.SGM
01JNN1
]]>Agencies
[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Notices]
[Pages 25466-25468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11801]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0920]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice, Hazard Analysis,
and Risk-Based Preventive Controls for Human 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 current good manufacturing practice, hazard analysis,
and risk-based preventive controls for human food.
DATES: Submit either electronic or written comments on the collection
of information by July 31, 2018.
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 July 31, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 31, 2018. 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.
[[Page 25467]]
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-2011-N-0920 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food
for Animals.'' 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,
[email protected].
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 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.
Current Good Manufacturing Practice and Hazard Analysis, and Risk-Based
Preventive Controls for Human Food--21 CFR Part 117
OMB Control Number 0910-0751--Extension
This information collection supports FDA regulations. As amended by
the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), the
Federal Food, Drug, and Cosmetic Act (FD&C Act) enables the Agency to
better protect the public health by helping to ensure the safety and
security of the food supply. It enables FDA to focus more on preventing
food safety problems rather than relying primarily on reacting to
problems after they occur. FSMA recognizes the important role industry
plays in ensuring the safety of the food supply, including the adoption
of modern systems of preventive controls in food production.
Specifically, section 418 of the FD&C Act (21 U.S.C. 350g) sets forth
requirements for hazard analysis and risk-based preventive controls for
facilities that produce food for human consumption. To implement these
provisions, regulations were codified under 21 CFR part 117--Current
Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food. The regulations establish requirements for a
written food safety plan; hazard analysis preventive controls;
monitoring; corrective actions and corrections; verification; supply-
chain program; recall plan; and associated records, and became
effective November 16, 2015. Currently, we continue to evaluate burden
associated with the information collection requirements; however, for
purposes of extending the information collection we retain the
currently approved figures as shown below.
Our estimate of the burden for the information collection is as
follows:
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.201(e); qualified facility............... 37,134 0.5 18,567 0.5 (30 minutes)........................ 9,284
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 25468]]
Table 2--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
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.126(c) and 117.170(d); food safety plan 46,685 1 46,685 110..................................... 5,135,350
and reanalysis.
117.136; assurance records................... 16,285 1 16,285 0.25 (15 minutes)....................... 4,071
117.145(c); monitoring records............... 8,143 730 5,944,390 0.05 (3 minutes)........................ 297,220
117.150(d); corrective actions and 16,285 2 32,570 1....................................... 32,570
corrections records.
117.155(b); verification records............. 8,143 244 1,986,892 0.05 (3 minutes)........................ 99,345
117.160; validation records.................. 3,677 6 22,062 0.25 (15 minutes)....................... 5,515
117.475(c)(7)-(9); supplier records.......... 16,285 10 162,850 4....................................... 651,400
117.180(d); training records for preventive 46,685 1 46,685 0.25 (15 minutes)....................... 11,671
controls qualified individual.
----------------------------------------------------------------------------------------------------------
Total.................................... .............. ............... .............. ........................................ 6,237,142
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3--Estimated Annual Third-Party Disclosure Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.201(e); disclosure of food manufacturing 37,134 1 37,134 0.25 (15 minutes)....................... 9,284
facility address.
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
These figures are based on our regulatory impact analysis in
support of the final rule on preventive controls for human food, which
published in the Federal Register of September 17, 2015 (80 FR 55908).
Using Agency data, we estimated the number of food facilities that we
believe are subject to the regulations. We base our estimate of the
time necessary for the individual reporting, recordkeeping, and third-
party disclosure activities on our experience with similar information
collections.
Dated: May 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11801 Filed 5-31-18; 8:45 am]
BILLING CODE 4164-01-P
