Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards, 32839-32842 [2017-14994]
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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of October 4, 2016 (81 FR
68427). The document announced the
withdrawal of approval of 44 new drug
applications and 158 abbreviated new
drug applications (ANDAs) from
multiple applicants, effective November
3, 2016. The document inadvertently
announced withdrawal of approval for
the following two ANDAs: ANDA
074123 for Pindolol Tablets, held by
G&W Laboratories, Inc., 111 Coolidge
St., South Plainfield, NJ 07080; and
ANDA 080828 for Hydrocortisone
Acetate Ophthalmic Ointment USP,
held by Fera Pharmaceuticals LLC, 134
Birch Hill Rd., Locust Valley, NY 11560.
FDA confirms that the approval of
ANDAs 074123 and 080828 is still in
effect.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Florine Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Tuesday, October 4,
2016, appearing on page 68427 in FR
Doc. 2016–23893, the following
corrections are made:
1. On page 68429, in table 1, the entry
for ANDA 074123 is removed.
2. On page 68431, in table 1, the entry
for ANDA 080828 is removed.
Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–15003 Filed 7–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. FDA–2011–N–0017]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Voluntary National
Retail Food Regulatory Program
Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
SUMMARY:
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17:47 Jul 17, 2017
Jkt 241001
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 August 17,
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 0910–0621. Also
include the FDA docket number found
in brackets in the heading of this
document.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726.
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.
FOR FURTHER INFORMATION CONTACT:
Voluntary National Retail Food
Regulatory Program Standards
OMB Control Number 0910–0621—
Extension
The Voluntary National Retail Food
Regulatory Program Standards (the
Program Standards) define nine
essential elements of an effective
regulatory program for retail food
establishments, establish basic quality
control criteria for each element, and
provide a means of recognition for the
State, local, territorial, tribal and
Federal regulatory programs that meet
the Program Standards. The program
elements addressed by the Program
Standards are as follows: (1) Regulatory
foundation; (2) trained regulatory staff;
(3) inspection program based on Hazard
Analysis and Critical Control Point
(HACCP) principles; (4) uniform
inspection program, (5) foodborne
illness and food defense preparedness
and response; (6) compliance and
enforcement; (7) industry and
community relations; (8) program
support and resources; and (9) program
assessment. Each standard includes a
list of records needed to document
conformance with the standard (referred
to in the Program Standards document
as ‘‘quality records’’) and has one or
more corresponding forms and
worksheets to facilitate the collection of
information needed to assess the retail
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32839
food regulatory program against that
standard. The respondents are State,
local, territorial, tribal, and potentially
other Federal regulatory Agencies.
Regulatory Agencies may use existing
available records or may choose to
develop and use alternate forms and
worksheets that capture the same
information.
In the course of their normal
activities, State, local, territorial, tribal,
and Federal regulatory Agencies already
collect and keep on file many of the
records needed as quality records to
document compliance with each of the
Program Standards. Although the detail
and format in which this information is
collected and recorded may vary by
jurisdiction, records that are kept as a
usual and customary part of normal
Agency activities include inspection
records, written quality assurance
procedures, records of quality assurance
checks, staff training certificates and
other training records, a log or database
of food-related illness or injury
complaints, records of investigations
resulting from such complaints, an
inventory of inspection equipment,
records of outside audits, and records of
outreach efforts (e.g., meeting agendas
and minutes, documentation of food
safety education activities). No new
recordkeeping burden is associated with
these existing records, which are
already a part of usual and customary
program recordkeeping activities by
State, local, territorial, tribal and
Federal regulatory Agencies, and which
can serve as quality records under the
Program Standards.
In April 2016, the Conference for
Food Protection (CFP) recommended
that FDA make a change in Program
Standard #4—Uniform Inspection
Program, more specifically to change
Program Standard #4’s Program SelfAssessment and Verification Audit
Form. Once changes have been
incorporated into the 2017 version, it
will be available on FDA’s Web site.
With this change, in order to achieve
conformance to Program Standard #4,
jurisdictions must achieve an overall
inspection program performance rating
for 20 elements as opposed to 10
elements that were previously required.
The previous 10 elements had several
criteria under one program element. The
change to 20 elements allows the
Standard to clearly delineate out each
criterion individually rather than having
several criteria under one program
element. This streamlines and clarifies
the process in meeting the standard. As
a result, the assessment review of each
inspector’s work will now be required
for three joint inspections as opposed to
the previously required two.
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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
State, local, territorial, tribal and
Federal regulatory Agencies that enroll
in the Program Standards and seek
listing in the FDA National Registry are
required to report to FDA on the
completion of the following three
management tasks outlined in the
Program Standards: (1) Conducting a
program self-assessment; (2) conducting
a risk factor study of the regulated
industry; and (3) obtaining an
independent outside audit (verification
audit). The results are reported on forms
formerly known as Forms FDA 3519 and
FDA 3520. Currently FDA is working to
consolidate both Forms FDA 3519 ‘‘FDA
National Registry Report’’ and FDA
3520 ‘‘Permission to Publish in National
Registry’’ into one form thereby
reducing the burden by 50 percent. The
new Form FDA 3958 ‘‘Voluntary
National Retail Food Regulatory
Program Standards FDA National
Registry Report’’ will be provided in the
Program Standards document, and will
also be provided on FDA’s Web site at:
https://www.fda.gov/Food/
GuidanceRegulation/
RetailFoodProtection/
ProgramStandards/default.htm. If a
regulatory Agency follows all the
recordkeeping recommendations in the
individual standards and their sample
worksheets, it will have all the
information needed to complete the
forms.
In the Federal Register of March 20,
2017 (82 FR 14369), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received four
comments, two which duplicated each
other. Therefore, FDA received three
separate comments, two of which were
PRA related and one which was not
PRA-related and will not be addressed
here.
(Comment 1) One commenter noted
that achieving all of the standards under
the existing program lasts only 2 years,
and then a state regulatory program has
to start all over again. The commenter
indicated standards certification should
last for 7 years, and then there would be
more incentive to achieve some or all of
the standards.
(Response 1) The purpose of the
Voluntary National Retail Food
Regulatory Program Standards (Retail
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Jkt 241001
Program Standards) is to establish best
practices for regulatory programs that
license and inspect foodservice and
retail food establishments. Jurisdictions
are encouraged to use the Retail
Program Standards to improve program
management and to implement best
practices that enhance the quality of
public health services provided to
stakeholders. Effective use of the Retail
Program Standards will enable a
jurisdiction to make lasting
programmatic improvements to their
retail food protection program. While
meeting all nine standards is a
significant accomplishment, the true
intent is continual program
improvement across all standards
during varied time frames. There are
general procedures for enrolling in the
Retail Program Standards and
maintaining active participation.
Though timelines may vary depending
on jurisdictional needs and priorities at
any given time, the general
administrative procedure is that within
the first year of enrollment the
jurisdiction will conduct a selfassessment using the criteria in the nine
Retail Program Standards. As part of the
continuous improvement process,
jurisdictions review the self-assessment
to determine program areas that need
improvements and will provide the
greatest health benefit. To maintain
active participation in the Retail
Program Standards and listing on the
National Registry, the participating
jurisdiction must conduct a selfassessment every 60 months. FDA
works in conjunction with the
Conference for Food Protection (CFP) in
a process whereby representatives from
the food industry, government,
academia, consumer and professional
organizations identify and address
emerging problems of food safety in an
open forum and formulate
recommendations biennially to enhance
the Retail Program Standards. These
recommendations are then submitted to
FDA for consideration to be
incorporated into the newest edition of
the FDA Food Code or the Retail
Program Standards. Issues may be
submitted by anyone who has an
interest or concern about food safety.
For an overview of the CFP please go to:
www.foodprotect.org.
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(Comment 2) Another commenter
thanked the FDA for the opportunity to
provide the comments on the proposed
FDA Voluntary Standards. They stated
that it was great to have these standards
for health officials to do their absolute
best for their community, and provided
their comments to FDA on behalf of a
trade quality assurance group.
(Response 2) FDA appreciates the
continued support from the retail food
industry for the Retail Program
Standards. FDA works in conjunction
with the CFP in a process whereby
representatives from consumer and
professional organizations, food
industry, government, and academia
identify and address emerging problems
of food safety in an open forum and
formulate recommendations. These
recommendations are then submitted to
FDA for consideration to be
incorporated into the newest editions of
the FDA Food Code or the Retail
Program Standards. Issues may be
submitted directly to CRP as there is a
clear defined process and template for
issue submittal. For an overview of the
CFP and instructions on how to submit
an issue, use the following link: https://
www.foodprotect.org/about/issuesubmission/.
Recordkeeping
FDA’s recordkeeping burden estimate
includes time required for a State, local,
territorial, tribal, or Federal Agency to
review the instructions in the Program
Standards, compile information from
existing sources, and create any records
recommended in the Program Standards
that are not already kept in the normal
course of the Agency’s usual and
customary activities. Sample worksheets
are provided to assist in this
compilation. In estimating the time
needed for the program self-assessment
(Program Standards 1 through 8, shown
in table 1), FDA considered responses
from four State and three local
jurisdictions that participated in an FDA
Program Standards Pilot study. Table 2
shows the estimated recordkeeping
burden for the completion of the
baseline data collection, and table 3
shows the estimated recordkeeping
burden for the verification audit.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
TABLE 1—SELF-ASSESSMENT
Hours per
record
Standard
Recordkeeping activity
No. 1: Regulatory Foundation .....................................................
No. 7: Industry & Community Relations .....................................
No. 8: Program Support and Resources ....................................
Self-Assessment: Completion of worksheet recording results
of evaluations and comparison on worksheets 1.
Self-Assessment: Completion of CFP Field Training Manual
and Documentation of Successful Completion—Field Training Process; completion of summary worksheet of each employee training records 1 2.
Self-Assessment: Completion of worksheet documentation 1 ...
Self-Assessment: Completion of worksheet documentation of
jurisdiction’s quality assurance procedures 1 2.
Self-Assessment: Completion of worksheet documentation 1 ...
Self-Assessment: Selection and review of 20 to 70 establishment files at 25 minutes per file. Estimate is based on a
mean number of 45. Completion of worksheet 1.
Self-Assessment: Completion of worksheet 1 ............................
Self-Assessment: Selection and review of establishment files 1
Total .....................................................................................
....................................................................................................
No. 2: Trained Regulatory Staff ..................................................
No. 3: HACCP Principles ............................................................
No. 4: Uniform Inspection Program ............................................
No. 5: Foodborne Illness Investigation .......................................
No. 6: Compliance Enforcement .................................................
1 Or
16
19.3
4
19
5
19
2
8
92.3
comparable documentation.
will vary depending on number of regulated food establishments and the number of inspectors employed by the jurisdiction.
2 Estimates
TABLE 2—BASELINE DATA COLLECTION
Hours per
record
Standard
Recordkeeping activity
No. 9: Program Assessment .......................................................
Risk Factor Study and Intervention Strategy 1 ...........................
333
1 Calculation
based on mean sample size of 39 and average FDA inspection time for each establishment type. Estimates will vary depending
on number of regulated food establishments within a jurisdiction and the number of inspectors employed by the jurisdiction.
TABLE 3—VERIFICATION AUDIT
Hours per
record
Activity
Recordkeeping activity
Administrative Procedures ..........................................................
Verification Audit 1 ......................................................................
46.15
1 We
estimate that no more than 50% of time spent to complete self-assessment of all nine standards is spent completing verification audit
worksheets. Time will be considerably less if less than nine standards require verification audits.
TABLE 4—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Recordkeeping for FDA Worksheets 2 .................................
Number of
records per
recordkeeper
500
Total annual
records
1
500
Average
burden per
recordkeeping
(hours)
94.29
Total hours
47,145
1 There
sradovich on DSK3GMQ082PROD with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Or comparable documentation.
FDA bases its estimates of the number
of recordkeepers and the hours per
record on its experience with the
Program Standards over the past 16
years. As of September 30, 2016, 711
jurisdictions were enrolled in the
Program Standards. However, based
upon the level of ongoing support
provided by FDA to enrolled
jurisdictions and the number of forms
submitted annually, FDA estimates that
no more than 500 jurisdictions actively
participate in the Program Standards
during any given year. There are
approximately 3,000 jurisdictions in the
United States and its territories that
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17:47 Jul 17, 2017
Jkt 241001
have retail food regulatory programs.
Enrollment in the Program Standards is
voluntary and, therefore, FDA does not
expect all jurisdictions to participate.
FDA bases its estimate of the hours
per record on the recordkeeping
estimates for the management tasks of
self-assessment, risk factor study, and
verification audit (tables 1, 2, and 3) that
enrolled jurisdictions must perform a
total of 471.45 hours (92.3 + 333 + 46.15
= 471.45). Enrolled jurisdictions must
conduct the work described in tables 1,
2, and 3 over a 5-year period. Therefore
FDA estimates that, annually, 500
recordkeepers will spend 94.29 hours
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(471.45 ÷ 5 = 94.29) performing the
required recordkeeping for a total of
47,145 hours as shown in table 4.
Reporting
Previously, FDA required regulatory
jurisdictions that participate in the
Program Standards to submit two forms
annually: Form FDA 3519, ‘‘FDA
National Registry Report,’’ and Form
FDA 3520, ‘‘Permission to Publish in
National Registry.’’ FDA created a new
consolidated FDA Form 3958 that has
four parts: Part 1 requires the name and
address of the jurisdiction; name and
contact information for the contact
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Federal Register / Vol. 82, No. 136 / Tuesday, July 18, 2017 / Notices
person for this jurisdiction; the
jurisdictions Web site address and if the
jurisdiction is willing to serve as an
auditor for another jurisdiction. Part 2
requires information about enrollment,
whether this jurisdiction is a new
enrollee and the date of enrollment;
indication whether this jurisdiction
would like to be removed from the
jurisdiction listing; indication of
requires permission to publish
information on FDA’s Web site by
checking the appropriate box(es) to
indicate what information FDA may
publish on the Web site.
FDA estimates the reporting burden
for this collection of information as
follows:
updated findings to the self-assessment
or verification audit. Part 3 requires
information about self-assessment
findings and verification audit findings;
dates when self-assessment was
completed; which standards have been
met as determined by the selfassessment; which standards have been
met as verified by a verification audit
including the completion dates. Part 4
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(hours)
Activity
FDA form
Total hours
Submission of ‘‘Voluntary
National Retail Food Regulatory Program Standards FDA National Registry Report’’.
Request for documentation
of successful completion
of staff training.
3,958 ..................................
500
1
500
* 0.1
50
Conference for Food Protection Training Plan and
Log.
500
3
1,500
* 0.1
150
Total .............................
.............................................
........................
........................
........................
........................
200
1 There
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*6
are no capital costs or operating and maintenance costs associated with this collection of information.
minutes
FDA bases its estimates of the number
of respondents and the hours per
response on its experience with the
Program Standards. As explained
previously, FDA estimates that no more
than 500 regulatory jurisdictions will
participate in the Program Standards in
any given year. FDA estimates a total of
6 minutes annually for each enrolled
jurisdiction to complete the form. FDA
bases its estimate on the small number
of data elements on the form and the
ease of availability of the information.
FDA estimates that, annually, 500
regulatory jurisdictions will submit one
Form FDA 3958 for a total of 500 annual
responses. Each submission is estimated
to take 0.1 hour (or 6 minutes) per
response for a total of 50 hours. In
addition, FDA estimates that, annually,
500 regulatory jurisdictions will submit
three requests for documentation of
successful completion of staff training
using the CFP Training Plan and Log for
a total of 1,500 annual responses. Each
submission is estimated to take 0.1 hour
(or 6 minutes) per response for a total
of 150 hours. The total reporting burden
for this information collection is 200
hours.
Thus, the total hourly burden for this
information collection is 47,345 hours
(47,145 recordkeeping hours and 200
reporting hours).
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17:47 Jul 17, 2017
Jkt 241001
Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–14994 Filed 7–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–3585]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Character-SpaceLimited Online Prescription Drug
Communications
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 August 17,
2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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–NEW and
title ‘‘Character-Space-Limited Online
Prescription Drug Communications.’’
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726, 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.
Character Space-Limited Online
Prescription Drug Communications
OMB Control Number 0910—NEW
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 393(d)(2)(C))
authorizes FDA to conduct research
relating to drugs and other FDA
regulated products in carrying out the
provisions of the FD&C Act. Under the
FD&C Act and implementing
E:\FR\FM\18JYN1.SGM
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Agencies
[Federal Register Volume 82, Number 136 (Tuesday, July 18, 2017)]
[Notices]
[Pages 32839-32842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0017]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Voluntary National
Retail Food Regulatory Program Standards
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 August
17, 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 0910-0621.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726.
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.
Voluntary National Retail Food Regulatory Program Standards
OMB Control Number 0910-0621--Extension
The Voluntary National Retail Food Regulatory Program Standards
(the Program Standards) define nine essential elements of an effective
regulatory program for retail food establishments, establish basic
quality control criteria for each element, and provide a means of
recognition for the State, local, territorial, tribal and Federal
regulatory programs that meet the Program Standards. The program
elements addressed by the Program Standards are as follows: (1)
Regulatory foundation; (2) trained regulatory staff; (3) inspection
program based on Hazard Analysis and Critical Control Point (HACCP)
principles; (4) uniform inspection program, (5) foodborne illness and
food defense preparedness and response; (6) compliance and enforcement;
(7) industry and community relations; (8) program support and
resources; and (9) program assessment. Each standard includes a list of
records needed to document conformance with the standard (referred to
in the Program Standards document as ``quality records'') and has one
or more corresponding forms and worksheets to facilitate the collection
of information needed to assess the retail food regulatory program
against that standard. The respondents are State, local, territorial,
tribal, and potentially other Federal regulatory Agencies. Regulatory
Agencies may use existing available records or may choose to develop
and use alternate forms and worksheets that capture the same
information.
In the course of their normal activities, State, local,
territorial, tribal, and Federal regulatory Agencies already collect
and keep on file many of the records needed as quality records to
document compliance with each of the Program Standards. Although the
detail and format in which this information is collected and recorded
may vary by jurisdiction, records that are kept as a usual and
customary part of normal Agency activities include inspection records,
written quality assurance procedures, records of quality assurance
checks, staff training certificates and other training records, a log
or database of food-related illness or injury complaints, records of
investigations resulting from such complaints, an inventory of
inspection equipment, records of outside audits, and records of
outreach efforts (e.g., meeting agendas and minutes, documentation of
food safety education activities). No new recordkeeping burden is
associated with these existing records, which are already a part of
usual and customary program recordkeeping activities by State, local,
territorial, tribal and Federal regulatory Agencies, and which can
serve as quality records under the Program Standards.
In April 2016, the Conference for Food Protection (CFP) recommended
that FDA make a change in Program Standard #4--Uniform Inspection
Program, more specifically to change Program Standard #4's Program
Self-Assessment and Verification Audit Form. Once changes have been
incorporated into the 2017 version, it will be available on FDA's Web
site.
With this change, in order to achieve conformance to Program
Standard #4, jurisdictions must achieve an overall inspection program
performance rating for 20 elements as opposed to 10 elements that were
previously required. The previous 10 elements had several criteria
under one program element. The change to 20 elements allows the
Standard to clearly delineate out each criterion individually rather
than having several criteria under one program element. This
streamlines and clarifies the process in meeting the standard. As a
result, the assessment review of each inspector's work will now be
required for three joint inspections as opposed to the previously
required two.
[[Page 32840]]
State, local, territorial, tribal and Federal regulatory Agencies
that enroll in the Program Standards and seek listing in the FDA
National Registry are required to report to FDA on the completion of
the following three management tasks outlined in the Program Standards:
(1) Conducting a program self-assessment; (2) conducting a risk factor
study of the regulated industry; and (3) obtaining an independent
outside audit (verification audit). The results are reported on forms
formerly known as Forms FDA 3519 and FDA 3520. Currently FDA is working
to consolidate both Forms FDA 3519 ``FDA National Registry Report'' and
FDA 3520 ``Permission to Publish in National Registry'' into one form
thereby reducing the burden by 50 percent. The new Form FDA 3958
``Voluntary National Retail Food Regulatory Program Standards FDA
National Registry Report'' will be provided in the Program Standards
document, and will also be provided on FDA's Web site at: https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandards/default.htm. If a regulatory Agency follows all the
recordkeeping recommendations in the individual standards and their
sample worksheets, it will have all the information needed to complete
the forms.
In the Federal Register of March 20, 2017 (82 FR 14369), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received four comments, two which
duplicated each other. Therefore, FDA received three separate comments,
two of which were PRA related and one which was not PRA-related and
will not be addressed here.
(Comment 1) One commenter noted that achieving all of the standards
under the existing program lasts only 2 years, and then a state
regulatory program has to start all over again. The commenter indicated
standards certification should last for 7 years, and then there would
be more incentive to achieve some or all of the standards.
(Response 1) The purpose of the Voluntary National Retail Food
Regulatory Program Standards (Retail Program Standards) is to establish
best practices for regulatory programs that license and inspect
foodservice and retail food establishments. Jurisdictions are
encouraged to use the Retail Program Standards to improve program
management and to implement best practices that enhance the quality of
public health services provided to stakeholders. Effective use of the
Retail Program Standards will enable a jurisdiction to make lasting
programmatic improvements to their retail food protection program.
While meeting all nine standards is a significant accomplishment, the
true intent is continual program improvement across all standards
during varied time frames. There are general procedures for enrolling
in the Retail Program Standards and maintaining active participation.
Though timelines may vary depending on jurisdictional needs and
priorities at any given time, the general administrative procedure is
that within the first year of enrollment the jurisdiction will conduct
a self-assessment using the criteria in the nine Retail Program
Standards. As part of the continuous improvement process, jurisdictions
review the self-assessment to determine program areas that need
improvements and will provide the greatest health benefit. To maintain
active participation in the Retail Program Standards and listing on the
National Registry, the participating jurisdiction must conduct a self-
assessment every 60 months. FDA works in conjunction with the
Conference for Food Protection (CFP) in a process whereby
representatives from the food industry, government, academia, consumer
and professional organizations identify and address emerging problems
of food safety in an open forum and formulate recommendations
biennially to enhance the Retail Program Standards. These
recommendations are then submitted to FDA for consideration to be
incorporated into the newest edition of the FDA Food Code or the Retail
Program Standards. Issues may be submitted by anyone who has an
interest or concern about food safety. For an overview of the CFP
please go to: www.foodprotect.org.
(Comment 2) Another commenter thanked the FDA for the opportunity
to provide the comments on the proposed FDA Voluntary Standards. They
stated that it was great to have these standards for health officials
to do their absolute best for their community, and provided their
comments to FDA on behalf of a trade quality assurance group.
(Response 2) FDA appreciates the continued support from the retail
food industry for the Retail Program Standards. FDA works in
conjunction with the CFP in a process whereby representatives from
consumer and professional organizations, food industry, government, and
academia identify and address emerging problems of food safety in an
open forum and formulate recommendations. These recommendations are
then submitted to FDA for consideration to be incorporated into the
newest editions of the FDA Food Code or the Retail Program Standards.
Issues may be submitted directly to CRP as there is a clear defined
process and template for issue submittal. For an overview of the CFP
and instructions on how to submit an issue, use the following link:
https://www.foodprotect.org/about/issue-submission/.
Recordkeeping
FDA's recordkeeping burden estimate includes time required for a
State, local, territorial, tribal, or Federal Agency to review the
instructions in the Program Standards, compile information from
existing sources, and create any records recommended in the Program
Standards that are not already kept in the normal course of the
Agency's usual and customary activities. Sample worksheets are provided
to assist in this compilation. In estimating the time needed for the
program self-assessment (Program Standards 1 through 8, shown in table
1), FDA considered responses from four State and three local
jurisdictions that participated in an FDA Program Standards Pilot
study. Table 2 shows the estimated recordkeeping burden for the
completion of the baseline data collection, and table 3 shows the
estimated recordkeeping burden for the verification audit.
FDA estimates the burden of this collection of information as
follows:
[[Page 32841]]
Table 1--Self-Assessment
------------------------------------------------------------------------
Hours per
Standard Recordkeeping activity record
------------------------------------------------------------------------
No. 1: Regulatory Foundation... Self-Assessment: 16
Completion of
worksheet recording
results of evaluations
and comparison on
worksheets \1\.
No. 2: Trained Regulatory Staff Self-Assessment: 19.3
Completion of CFP
Field Training Manual
and Documentation of
Successful Completion--
Field Training
Process; completion of
summary worksheet of
each employee training
records 1 2.
No. 3: HACCP Principles........ Self-Assessment: 4
Completion of
worksheet
documentation \1\.
No. 4: Uniform Inspection Self-Assessment: 19
Program. Completion of
worksheet
documentation of
jurisdiction's quality
assurance procedures 1
2.
No. 5: Foodborne Illness Self-Assessment: 5
Investigation. Completion of
worksheet
documentation \1\.
No. 6: Compliance Enforcement.. Self-Assessment: 19
Selection and review
of 20 to 70
establishment files at
25 minutes per file.
Estimate is based on a
mean number of 45.
Completion of
worksheet \1\.
No. 7: Industry & Community Self-Assessment: 2
Relations. Completion of
worksheet \1\.
No. 8: Program Support and Self-Assessment: 8
Resources. Selection and review
of establishment files
\1\.
----------------------------------------
Total...................... ....................... 92.3
------------------------------------------------------------------------
\1\ Or comparable documentation.
\2\ Estimates will vary depending on number of regulated food
establishments and the number of inspectors employed by the
jurisdiction.
Table 2--Baseline Data Collection
------------------------------------------------------------------------
Hours per
Standard Recordkeeping activity record
------------------------------------------------------------------------
No. 9: Program Assessment...... Risk Factor Study and 333
Intervention Strategy
\1\.
------------------------------------------------------------------------
\1\ Calculation based on mean sample size of 39 and average FDA
inspection time for each establishment type. Estimates will vary
depending on number of regulated food establishments within a
jurisdiction and the number of inspectors employed by the
jurisdiction.
Table 3--Verification Audit
------------------------------------------------------------------------
Hours per
Activity Recordkeeping activity record
------------------------------------------------------------------------
Administrative Procedures...... Verification Audit \1\. 46.15
------------------------------------------------------------------------
\1\ We estimate that no more than 50% of time spent to complete self-
assessment of all nine standards is spent completing verification
audit worksheets. Time will be considerably less if less than nine
standards require verification audits.
Table 4--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
Activity recordkeepers records per records recordkeeping Total hours
recordkeeper (hours)
----------------------------------------------------------------------------------------------------------------
Recordkeeping for FDA Worksheets 500 1 500 94.29 47,145
\2\............................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Or comparable documentation.
FDA bases its estimates of the number of recordkeepers and the
hours per record on its experience with the Program Standards over the
past 16 years. As of September 30, 2016, 711 jurisdictions were
enrolled in the Program Standards. However, based upon the level of
ongoing support provided by FDA to enrolled jurisdictions and the
number of forms submitted annually, FDA estimates that no more than 500
jurisdictions actively participate in the Program Standards during any
given year. There are approximately 3,000 jurisdictions in the United
States and its territories that have retail food regulatory programs.
Enrollment in the Program Standards is voluntary and, therefore, FDA
does not expect all jurisdictions to participate.
FDA bases its estimate of the hours per record on the recordkeeping
estimates for the management tasks of self-assessment, risk factor
study, and verification audit (tables 1, 2, and 3) that enrolled
jurisdictions must perform a total of 471.45 hours (92.3 + 333 + 46.15
= 471.45). Enrolled jurisdictions must conduct the work described in
tables 1, 2, and 3 over a 5-year period. Therefore FDA estimates that,
annually, 500 recordkeepers will spend 94.29 hours (471.45 / 5 = 94.29)
performing the required recordkeeping for a total of 47,145 hours as
shown in table 4.
Reporting
Previously, FDA required regulatory jurisdictions that participate
in the Program Standards to submit two forms annually: Form FDA 3519,
``FDA National Registry Report,'' and Form FDA 3520, ``Permission to
Publish in National Registry.'' FDA created a new consolidated FDA Form
3958 that has four parts: Part 1 requires the name and address of the
jurisdiction; name and contact information for the contact
[[Page 32842]]
person for this jurisdiction; the jurisdictions Web site address and if
the jurisdiction is willing to serve as an auditor for another
jurisdiction. Part 2 requires information about enrollment, whether
this jurisdiction is a new enrollee and the date of enrollment;
indication whether this jurisdiction would like to be removed from the
jurisdiction listing; indication of updated findings to the self-
assessment or verification audit. Part 3 requires information about
self-assessment findings and verification audit findings; dates when
self-assessment was completed; which standards have been met as
determined by the self-assessment; which standards have been met as
verified by a verification audit including the completion dates. Part 4
requires permission to publish information on FDA's Web site by
checking the appropriate box(es) to indicate what information FDA may
publish on the Web site.
FDA estimates the reporting burden for this collection of
information as follows:
Table 5--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity FDA form Number of responses per Total annual per response Total hours
respondents respondent responses (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of ``Voluntary National Retail 3,958....................... 500 1 500 * 0.1 50
Food Regulatory Program Standards FDA
National Registry Report''.
Request for documentation of successful Conference for Food 500 3 1,500 * 0.1 150
completion of staff training. Protection Training Plan
and Log.
-------------------------------------------------------------------------------
Total................................. ............................ .............. .............. .............. .............. 200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\*\ 6 minutes
FDA bases its estimates of the number of respondents and the hours
per response on its experience with the Program Standards. As explained
previously, FDA estimates that no more than 500 regulatory
jurisdictions will participate in the Program Standards in any given
year. FDA estimates a total of 6 minutes annually for each enrolled
jurisdiction to complete the form. FDA bases its estimate on the small
number of data elements on the form and the ease of availability of the
information. FDA estimates that, annually, 500 regulatory jurisdictions
will submit one Form FDA 3958 for a total of 500 annual responses. Each
submission is estimated to take 0.1 hour (or 6 minutes) per response
for a total of 50 hours. In addition, FDA estimates that, annually, 500
regulatory jurisdictions will submit three requests for documentation
of successful completion of staff training using the CFP Training Plan
and Log for a total of 1,500 annual responses. Each submission is
estimated to take 0.1 hour (or 6 minutes) per response for a total of
150 hours. The total reporting burden for this information collection
is 200 hours.
Thus, the total hourly burden for this information collection is
47,345 hours (47,145 recordkeeping hours and 200 reporting hours).
Dated: July 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14994 Filed 7-17-17; 8:45 am]
BILLING CODE 4164-01-P