
[Federal Register Volume 77, Number 221 (Thursday, November 15, 2012)]
[Notices]
[Pages 68130-68132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27721]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1105]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Voluntary Hazard Analysis and Critical Control Point 
Manuals for Operators and Regulators of Retail and Food Service 
Establishments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 
associated with FDA's technical assistance reference manuals provided 
to State, local, territorial, and tribal jurisdictions, and other 
Federal Agencies to interpret and promote the application of Hazard 
Analysis and Critical Control Point (HACCP) principles to reduce the 
risk of foodborne illness in the operation of retail and food service 
establishments.

DATES: Submit either electronic or written comments on the collection 
of information by January 14, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, domini.bean@fda.hhs.gov.

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

[[Page 68131]]

collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Voluntary Hazard Analysis and Critical Control Point Manuals for 
Operators and Regulators of Retail and Food Service Establishments (OMB 
Control Number 0910-0578)--Extension

    HACCP principles are designed to reduce the occurrence of foodborne 
illness risk factors through preventive controls. FDA has developed two 
technical assistance reference manuals that interpret and promote the 
application of HACCP principles to reduce the risk of foodborne illness 
in the operation of retail and food service establishments.
    The responsibility and authority for regulating retail and food 
service establishments lie primarily with State and local governments. 
Officials in State, local, territorial, and tribal agencies inspect 
these food facilities, license establishments, issue permits, and 
enforce their State or local government's laws and regulations. FDA's 
Retail Food Protection Program provides assistance to the more than 
3,000 State and local government agencies that regulate the retail food 
industry nationally. The primary objective of the Retail Food 
Protection Program is to prevent foodborne illness at the retail level 
of the food industry by directing activities toward promotion of 
effective State and local regulatory programs. FDA provides assistance 
to State, local, territorial, and tribal regulatory jurisdictions 
through multiple means including, but not limited to, training and 
technical assistance. Authority for providing such assistance is 
derived from section 311 of the Public Health Service Act (42 U.S.C. 
243). In addition, FDA's mission under section 903(b)(2)(A) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
393(b)(2)(A)) includes ensuring that foods are safe, wholesome, and 
sanitary, and section 903(b)(4) of the FD&C Act directs FDA to 
cooperate with food retailers, among others, in carrying out this part 
of its mission.
    The first manual, entitled ``Managing Food Safety: A Manual for the 
Voluntary Use of HACCP Principles for Operators of Food Service and 
Retail Establishments'' (Operator's Manual) (available at http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/ManagingFoodSafetyHACCPPrinciples/Operators/default.htm), provides 
operators of retail and food service establishments a roadmap for 
developing a food safety management system based on HACCP principles. 
Food safety management systems allow establishment operators to take a 
proactive role in ensuring that the food served or sold in their 
establishment is safe. Rather than responding to a foodborne illness 
when it occurs, they can prevent it by taking active steps to 
eliminate, prevent, or reduce to an acceptable level food safety 
hazards that may cause someone to become sick or injured.
    The second manual, entitled ``Managing Food Safety: A Regulator's 
Manual for Applying HACCP Principles to Risk-based Retail and Food 
Service Inspections and Evaluating Voluntary Food Safety Management 
Systems'' (Regulator's Manual) (available at http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/ManagingFoodSafetyHACCPPrinciples/Regulators/default.htm), provides State, local, territorial, and tribal 
regulatory authorities with a model for prioritizing inspections using 
a risk-based approach. The Regulator's Manual provides a roadmap for 
evaluating retail and food service establishments based on the 
application of HACCP principles.
    FDA developed the manuals as technical assistance reference 
resources for regulators and operators to help reduce the risk of 
foodborne illness. There is no Federal requirement that retail and food 
service establishments implement food safety management systems based 
on HACCP principles. State, local, territorial, and tribal regulatory 
authorities decide whether to require food safety management systems in 
the operation of retail and food service establishments. Regulators and 
operators will not submit information to FDA based on these manuals.
    Regulators and retail and food service operators use the manuals as 
technical assistance reference resources. The Regulator's Manual 
contains information, recommendations and model documents for State, 
local, territorial, and tribal regulators who wish to develop practices 
for risk-based inspections of retail and food service establishments 
based on the application of HACCP principles. The Operator's Manual 
contains information, recommendations and model documents for operators 
of retail and food service establishments who wish to develop and/or 
validate the practices used in a food safety management system based on 
HACCP principles.
    Description of Respondents: The respondents are State, local, 
territorial, and tribal regulatory jurisdictions and operators of 
retail and food service establishments in the United States. 
Respondents are from both the public sector (State, local, territorial, 
and tribal governments) and the private sector (for-profit businesses).
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                   Annual         Total
           Activity               Number of     frequency per     annual        Hours per record     Total hours
                                recordkeepers   recordkeeping    records
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Reference of Technical                 25,000               1       25,000  0.2 (12 minutes).......        5,000
 Assistance Manuals by
 Operators.
Reference of Technical                  1,500               1        1,500  0.25 (15 minutes)......          375
 Assistance Manuals by
 Regulators.
                              ----------------------------------------------------------------------------------
    Total....................  ..............  ..............  ...........  .......................        5,375
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The number of operator recordkeepers estimated in column 2 of Table 
1 is based on FDA's goal to have 50,000 (\1/2\ of 1 percent) of the 
approximately one million U.S. retail and food service operators 
implement the recommendations outlined in the two manuals, as estimated 
in 2009 (73 FR 77721, at 77722). FDA's estimate of the total number of 
retail and food service establishments is based on numbers obtained 
from the two major trade organizations representing these industries, 
the Food Marketing Institute and the National Restaurant Association. 
Gathering reference material to develop and/or validate food safety 
management system practices is a one-time burden. We assume that those 
50,000 operators have utilized FDA's technical assistance manuals to 
the

[[Page 68132]]

degree that they chose to do so over the past 3 years and over the next 
3 years will only need to reference these manuals on an as-needed 
basis. FDA estimates that, annually, approximately one half of the 
operators, 25,000, will choose to reference FDA's information, 
recommendations or model documents.
    The number of regulator recordkeepers estimated in column 2 of 
Table 1 is based on FDA's estimate that there are approximately 3,000 
State, local, territorial, and tribal regulatory jurisdictions. 
Gathering and reviewing reference material to develop practices for 
risk-based inspections of retail and food service establishments based 
on HACCP principles is a one-time burden. We assume that those 3,000 
regulatory jurisdictions have utilized FDA's technical assistance 
manuals to the degree that they chose to do so over the past 3 years 
and over the next 3 years will only need to reference these manuals on 
an as-needed basis. FDA estimates that, annually, approximately one 
half of the regulatory jurisdictions (1,500) will choose to reference 
FDA's information, recommendations or model documents.
    The hours per record estimated in column 2 of Table 1 are based on 
FDA's experience with similar technical assistance materials offered by 
the Agency. FDA estimates that over the next 3 years regulators and 
operators will only need to reference these manuals on an as needed 
basis. We estimate that it will take an operator with a specific need 
for information approximately 12 minutes (0.2 hour) to gather and 
record the data from the manuals. We estimate that it will take a 
regulator with a specific need for information approximately 15 minutes 
(0.25 hour) to gather and record the data from the manuals.
    The total recordkeeping burden of the technical assistance manuals 
is 5,375 hours, as shown in Table 1.

    Dated: November 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-27721 Filed 11-14-12; 8:45 am]
BILLING CODE 4160-01-P


