[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]


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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.

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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 [email protected]. 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: 
http://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\
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                                                                                  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\
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                                                                                             Number of                    Average burden
                 Activity                             FDA form               Number of     responses per   Total annual    per response     Total hours
                                                                            respondents     respondent       responses        (hours)
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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
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\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