Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, 46499-46500 [2018-19911]
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Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
must send a letter stating that interest to
FDA by October 15, 2018, (see sections
I and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by October 15,
2018.
ADDRESSES: All statements of interest
from small business tobacco
manufacturing industry organizations
interested in participating in the
selection process of nonvoting industry
representative nominations should be
sent to Caryn Cohen (see FOR FURTHER
INFORMATION CONTACT). All nominations
for nonvoting industry representatives
may be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal at:
https://www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at: https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Caryn Cohen, Office of Science, Center
for Tobacco Products, Food and Drug
Administration, Center for Tobacco
Products Document Control Center,
10903 New Hampshire Ave., Bldg. 71,
Rm. G335, Silver Spring, MD 20993–
0002, 1–877–287–1373 (choose Option
5), TPSAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative to represent the
interests of the small business tobacco
manufacturing industry to the following
advisory committee:
I. Tobacco Products Scientific Advisory
Committee
The Tobacco Products Scientific
Advisory Committee (the Committee)
advises the Commissioner of Food and
Drugs (the Commissioner) or designee in
discharging responsibilities related to
the regulation of tobacco products. The
Committee reviews and evaluates safety,
dependence, and health issues relating
to tobacco products and provides
appropriate advice, information, and
recommendations to the Commissioner.
The Committee includes three
nonvoting members who represent
industry interests. These members
include one representative of the
interests of the tobacco manufacturing
industry; one representative of the
interests of tobacco growers; and one
representative of the interests of the
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19:20 Sep 12, 2018
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small business tobacco manufacturing
industry, which may be filled on a
rotating, sequential basis by
representatives of different small
business tobacco manufacturers based
on areas of expertise relevant to the
topics being considered by the Advisory
Committee.
With this notice, nominations are
sought for a pool of individuals, with
varying areas of expertise, to represent
the interests of the small business
tobacco manufacturing industry on a
rotating, sequential basis.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women, and men, members of all racial
and ethnic groups and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
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46499
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19922 Filed 9–12–18; 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; Submission for Office of
Management and Budget Review;
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) 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 October 15,
2018.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0751. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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:
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46500
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
Current Good Manufacturing Practice,
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
information collection, we retain the
currently approved figures as shown in
the tables below.
In the Federal Register of June 1, 2018
(83 FR 25466), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
One comment was received stating that
our estimate of burden associated with
creating a food safety plan was too low
and suggested a much higher figure. We
appreciate this comment. However,
because the annual burden is based on
an industry average and because we
continue to evaluate this relatively new
collection, we are not adjusting our
current estimate. At the same time, we
continue to invite comment so that we
might better refine our estimates for all
elements of the collection.
Our estimate of the burden for the
information collection is as follows:
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
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
117.201(e); qualified facility .................................................................................
1 There
Number of
responses
per
respondent
Number of
respondents
21 CFR section
37,134
Total annual
responses
0.5
18,567
Average
burden per response
Total hours
0.5 (30 minutes) .............
9,284
are no capital costs or operating and maintenance costs associated with this collection of information.
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
16,285
8,143
16,285
8,143
3,677
16,285
46,685
1
1
730
2
244
6
10
1
46,685
16,285
5,944,390
32,570
1,986,892
22,062
162,850
46,685
110 ..................................
0.25 (15 minutes) ...........
0.05 (3 minutes) .............
1 ......................................
0.05 (3 minutes) .............
0.25 (15 minutes) ...........
4 ......................................
0.25 (15 minutes) ...........
5,135,350
4,071
297,220
32,570
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 .................................................
daltland on DSKBBV9HB2PROD with NOTICES
1 There
Number of
disclosures
per
respondent
37,134
Total annual
disclosures
1
37,134
Average
burden per
disclosure
Total hours
0.25 (15
minutes)
are no capital costs or operating and maintenance costs associated with this collection of information.
As stated previously, we retain the
currently approved burden for the
information collection. 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).
VerDate Sep<11>2014
19:20 Sep 12, 2018
Jkt 244001
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.
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Dated: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–19911 Filed 9–12–18; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46499-46500]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19911]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0920]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 October
15, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0751.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
[[Page 46500]]
Current Good Manufacturing Practice, 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 in the tables below.
In the Federal Register of June 1, 2018 (83 FR 25466), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received stating that our
estimate of burden associated with creating a food safety plan was too
low and suggested a much higher figure. We appreciate this comment.
However, because the annual burden is based on an industry average and
because we continue to evaluate this relatively new collection, we are
not adjusting our current estimate. At the same time, we continue to
invite comment so that we might better refine our estimates for all
elements of the collection.
Our estimate of the burden for the information collection is as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total
21 CFR section respondents per annual Average burden per response Total hours
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.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total
21 CFR section Number of records per annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.126(c) and 117.170(d); food safety plan and 46,685 1 46,685 110.......................................... 5,135,350
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 corrections 16,285 2 32,570 1............................................ 32,570
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
Number of disclosures Total Average
21 CFR section respondents per annual burden per Total hours
respondent disclosures disclosure
----------------------------------------------------------------------------------------------------------------
117.201(e); disclosure of food manufacturing 37,134 1 37,134 0.25 (15 9,284
facility address.............................. minutes)
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
As stated previously, we retain the currently approved burden for
the information collection. 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: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19911 Filed 9-12-18; 8:45 am]
BILLING CODE 4164-01-P
