81 FR 64168 - Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 181 (September 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 181 (September 19, 2016)
| Page Range | 64168-64171 | |
| FR Document | 2016-22438 |
[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)] [Notices] [Pages 64168-64171] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22438] [[Page 64168]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-N-2033] Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- 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 a survey entitled ``Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types (2015- 2025).'' DATES: Submit either electronic or written comments on the collection of information by November 18, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2014-N-2033 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. [[Page 64169]] Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types (2015-2025)--OMB Control Number 0910-0799--Extension I. Background From 1998 to 2008, FDA's National Retail Food Team conducted a study to measure trends in the occurrence of foodborne illness risk factors, preparation practices, and employee behaviors most commonly reported to the Centers for Disease Control and Prevention as contributing factors to foodborne illness outbreaks at the retail level. Specifically, data was collected by FDA Specialists in retail and foodservice establishments at 5-year intervals (1998, 2003, and 2008) in order to observe and document trends in the occurrence of the following foodborne illness risk factors: Food from Unsafe Sources, Poor Personal Hygiene, Inadequate Cooking, Improper Holding/Time and Temperature, and Contaminated Equipment/Cross-Contamination. FDA developed reports summarizing the findings for each of the three data collection periods (1998, 2003, and 2008) (Refs. 1 to 3). Data from all three data collection periods were analyzed to detect trends in improvement or regression over time and to determine whether progress had been made toward the goal of reducing the occurrence of foodborne illness risk factors in selected retail and foodservice facility types (Ref. 4). Using this 10-year survey as a foundation, in 2013-2014, FDA initiated a new study in full service and fast food restaurants. This study will span 10 years with additional data collections planned for 2017-2018 and 2021-2022. FDA is currently collecting data in select institutional foodservice, schools, and retail food store facility types in 2015- 2016. This proposed study will also span 10 years with additional data collections planned for 2019-2020 and 2023-2024. The current data collection in selected institutional foodservice, schools, and retail food store facilities was initiated on October 1, 2016, with a target date for completion by December 31, 2016. FDA is requesting a 90 day extension to complete this data collection by March 31, 2017. The extension is being requested to ensure that the number of facilities included in the study provide a sufficient sample size to conduct statistically significant analysis. Table 1--Description of the Facility Types Included in the Survey ------------------------------------------------------------------------ Facility type Description ------------------------------------------------------------------------ Health Care Facilities............ Hospitals and long-term care facilities foodservice operations that prepare meals for highly susceptible populations as defined as follows: Hospitals--A foodservice operation that provides for the nutritional needs of inpatients by preparing meals and transporting them to the patient's room and/or serving meals in a cafeteria setting (meals in the cafeteria may also be served to hospital staff and visitors). Long-term care facilities--A foodservice operation that prepares meals for the residents in a group care living setting such as nursing homes and assisted living facilities. Note: For the purposes of this study, health care facilities that do not prepare or serve food to a highly susceptible population, such as mental health care facilities, are not included in this facility type category. Schools (K-12).................... Foodservice operations that have the primary function of preparing and serving meals for students in one or more grade levels from kindergarten through grade 12. A school foodservice may be part of a public or private institution. Retail Food Stores................ Supermarkets and grocery stores that have a deli department/operation as described as follows: Deli department/ operation--Areas in a retail food store where foods, such as luncheon meats and cheeses, are sliced for the customers and where sandwiches and salads are prepared on-site or received from a commissary in bulk containers, portioned, and displayed. Parts of deli operations may include: Salad bars, pizza stations, and other food bars managed by the deli department manager. Areas where other foods are cooked or prepared and offered for sale as ready-to-eat and are managed by the deli department manager. Data will also be collected in the following areas of a supermarket or grocery store, if present: Meat and seafood department/operation--Areas in a retail food store where raw animal food products, such as beef, pork, poultry, or seafood, are cut, prepared, stored, or displayed for sale to the consumer. Produce department/ operation--Areas in a retail food store where produce is cut, prepared, stored, or displayed for sale to the consumer. A produce operation may include salad bars or juice stations that are managed by the produce manager. ------------------------------------------------------------------------ The purpose of the study is to: Assist FDA with developing retail food safety initiatives and policies focused on the control of foodborne illness risk factors; Identify retail food safety work plan priorities and allocate resources to enhance retail food safety nationwide; Track changes in the occurrence of foodborne illness risk factors in retail and foodservice establishments over time; and Inform recommendations to the retail and foodservice industry and State, local, tribal, and territorial regulatory professionals on reducing the occurrence of foodborne illness risk factors. The statutory basis for FDA conducting this study is derived from the Public Health Service Act (PHS Act) (42 U.S.C. 243, section 311(a)). Responsibility for carrying out the provisions of the PHS Act relative to food protection was transferred to the Commissioner of Food and Drugs in 1968 (21 CFR 5.10(a)(2) and (4)). Additionally, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the Economy Act (31 U.S.C. 1535) require FDA to provide assistance to other Federal, State, and local government bodies. The objectives of the study are to: Identify the foodborne illness risk factors that are in most need of priority attention during each data collection period; Track trends in the occurrence of foodborne illness risk factors over time; Examine potential correlations between operational characteristics of food establishments and the control of foodborne illness risk factors; Examine potential correlations between elements within regulatory retail food protection programs and the [[Page 64170]] control of foodborne illness risk factors; and Evaluate the impact of industry food safety management systems in controlling the occurrence of foodborne illness risk factors. The methodology to be used for this information collection is described as follows. To obtain a sufficient number of observations to conduct statistically significant analysis, FDA will conduct approximately 400 data collections in each facility type. This sample size has been calculated to provide for sufficient observations to be 95 percent confident that the compliance percentage is within 5 percent of the true compliance percentage. A geographical information system database containing a listing of businesses throughout the United States provides the establishment inventory for the data collections. FDA samples establishments from the inventory based on the descriptions in table 1. FDA does not intend to sample operations that handle only prepackaged food items or conduct low-risk food preparation activities. The ``FDA Food Code'' contains a grouping of establishments by risk, based on the type of food preparation that is normally conducted within the operation (Ref. 5). The intent is to sample establishments that fall under risk categories 2 through 4. FDA has approximately 25 Regional Retail Food Specialists (Specialists) who serve as the data collectors for the 10-year study. The Specialists are geographically dispersed throughout the United States and possess technical expertise in retail food safety and a solid understanding of the operations within each of the facility types to be surveyed. The Specialists are also standardized by FDA's Center for Food Safety and Applied Nutrition personnel in the application and interpretation of the FDA Food Code (Ref. 5). Sampling zones have been established that are equal to the 150-mile radius around a Specialist's home location. The sample is selected randomly from among all eligible establishments located within these sampling zones. The Specialists are generally located in major metropolitan areas (i.e., population centers) across the contiguous United States. Population centers usually contain a large concentration of the establishments FDA intends to sample. Sampling from the 150-mile radius sampling zones around the Specialists' home locations provides three advantages to the study: 1. It provides a cross-section of urban and rural areas from which to sample the eligible establishments. 2. It represents a mix of small, medium, and large regulatory entities having jurisdiction over the eligible establishments. 3. It reduces overnight travel and therefore reduces travel costs incurred by the Agency to collect data. The sample for each data collection period is evenly distributed among Specialists. Given that participation in the study by industry is voluntary and the status of any given randomly selected establishment is subject to change, substitute establishments have been selected for each Specialist for cases where the institutional foodservice, school, or retail food facility is misclassified, closed, or otherwise unavailable, unable, or unwilling to participate. Prior to conducting the data collection, Specialists contact the State or local jurisdiction that has regulatory responsibility for conducting retail food inspections for the selected establishment. The Specialist verifies with the jurisdiction that the facility has been properly classified for the purposes of the study and is still in operation. The Specialist ascertains whether the selected facility is under legal notice from the State or local regulatory authority. If the selected facility is under legal notice, the Specialist will not conduct a data collection, and a substitute establishment will be used. An invitation is extended to the State or local regulatory authority to accompany the Specialist on the data collection visit. A standard form is used by the Specialists during each data collection. The form is divided into three sections: Section 1-- ''Establishment Information''; Section 2--''Regulatory Authority Information''; and Section 3--''Foodborne Illness Risk Factor and Food Safety Management System Assessment''. The information in Section 1-- ''Establishment Information'' of the form is obtained during an interview with the establishment owner or person in charge by the Specialist and includes a standard set of questions. The information in Section 2--''Regulatory Authority Information'' is obtained during an interview with the program director of the State or local jurisdiction that has regulatory responsibility for conducting inspections for the selected establishment. Section 3 includes three parts: Part A for tabulating the Specialists' observations of the food employees' behaviors and practices in limiting contamination, proliferation, and survival of food safety hazards; Part B for assessing the food safety management being implemented by the facility; and Part C for assessing the frequency and extent of food employee hand washing. The information in Part A is collected from the Specialists' direct observations of food employee behaviors and practices. Infrequent, nonstandard questions may be asked by the Specialists if clarification is needed on the food safety procedure or practice being observed. The information in Part B is collected by making direct observations and asking followup questions of facility management to obtain information on the extent to which the food establishment has developed and implemented food safety management systems. The information in Part C is collected by making direct observations of food employee hand washing. No questions are asked in the completion of Section 3, Part C of the form. FDA collects the following information associated with the establishment's identity: Establishment name, street address, city, state, zip code, county, industry segment, and facility type. The establishment identifying information is collected to ensure the data collections are not duplicative. Other information related to the nature of the operation, such as seating capacity and number of employees per shift, is also collected. Data will be consolidated and reported in a manner that does not reveal the identity of any establishment included in the study. FDA is working with the National Center for Food Protection and Defense to develop a Web-based platform in FoodSHIELD to collect, store, and analyze data for the Retail Risk Factor Study. Once developed, this platform will be accessible to State, local, territorial, and tribal regulatory jurisdictions to collect data relevant to their own risk factor studies. FDA is currently transitioning from the manual entry of data to the use of hand-held technology. Contingent upon the completion of the Web-based platform, FDA intends to pilot test the use of hand-held technology during its 2015-2016 risk factor study data collection in institutional foodservice, school, and retail food store facility types, with the goal to have it fully implemented by the next data collection in restaurant facility types that will occur in 2017-2018. When a data collector is assigned a specific establishment, he or she conducts the data collection and enters the information into the Web-based data platform. The interface will support the manual entering of data, as well as the ability to upload a fillable PDF. [[Page 64171]] The burden for this collection of information is as follows. For each data collection, the respondents includes: (1) The person in charge of the selected facility type (whether it be a health care facility, school, or supermarket/grocery store); and (2) the program director (or designated individual) of the respective regulatory authority. To provide the sufficient number of observations needed to conduct a statistically significant analysis of the data, FDA has determined that 400 data collections will be required in each of the three facility types. Therefore, the total number of responses will be 2,400 (400 data collections x 3 facility types x 2 respondents per data collection). The burden associated with the completion of Sections 1 and 3 of the form is specific to the persons in charge of the selected facilities. It includes the time it will take the persons in charge to accompany the data collectors during the site visit and answer the data collectors' questions. The burden related to the completion of Section 2 of the form is specific to the program directors (or designated individuals) of the respective regulatory authorities. It includes the time it will take to answer the data collectors' questions and is the same regardless of the facility type. To calculate the estimate of the hours per response, FDA uses the average data collection duration for similar facility types during FDA's 2008 Risk Factor Study (Ref. 3) plus an extra 30 minutes (0.5 hours) for the information collection related to Section 3, Part B of the form. FDA estimates that it will take the persons in charge of health care facility types, schools, and retail food stores 150 minutes (2.5 hours), 120 minutes (2 hours), and 180 minutes (3 hours), respectively, to accompany the data collectors while they complete Sections 1 and 3 of the form. FDA estimates that it will take the program director (or designated individual) of the respective regulatory authority 30 minutes (0.5 hours) to answer the questions related to Section 2 of the form. The total burden estimate for a data collection, including both the program director's and the person in charge's responses, in health care facility types is 180 minutes (150+30)(3 hours), in schools is 150 minutes (120+30)(2.5 hours), and in retail food stores is 210 minutes (180+30)(3.5 hours). Based on the number of entry refusals from the 2013-2014 Risk Factor Study in the restaurant facility types, we estimate a refusal rate of 2 percent in the institutional foodservice and retail food store facility types. The estimate of the time per non-respondent is 5 minutes (0.08 hours) for the person in charge to listen to the purpose of the visit and provide a verbal refusal of entry. Table 2--Estimated Annual Reporting Burden \1\ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Number of Number of Activity Number of responses per Total annual Number of non- responses per Total annual Average burden per response Total respondents respondent responses respondents non-respondent non-responses hours ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ 2015-2016 Data Collection (Health Care 400 1 400 .............. .............. .............. 2.5................................. 1,000 Facilities)--Completion of Sections 1 and 3. 2015-2016 Data Collection (Schools)-- 400 1 400 .............. .............. .............. 2................................... 800 Completion of Sections 1 and 3. 2015-2016 Data Collection (Retail Food 400 1 400 .............. .............. .............. 3................................... 1,200 Stores)--Completion of Sections 1 and 3. 2015-2016 Data Collection-Completion of 1,200 1 1,200 .............. .............. .............. 0.5................................. 600 Section 2--All Facility Types. 2017-2018 Data Collection-Entry Refusals--All .............. .............. .............. 24 1 24 0.08 (5 minutes).................... 1.92 Facility Types. ------------------------------------------------------------------------------------------------------------------------------------------------- Total Hours............................... .............. .............. .............. .............. .............. .............. .................................... 3,601.92 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. II. References The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. ``Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors (2000).'' Available at: http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/ucm123546.pdf. 2. ``FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2004).'' Available at: http://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf. 3. ``FDA Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (2009).'' Available at: http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224682.pdf. 4. FDA National Retail Food Team. ``FDA Trend Analysis Report on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice, Restaurant, and Retail Food Store Facility Types (1998-2008).'' Available at: http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/UCM224152.pdf. 5. ``FDA Food Code.'' Available at: http://www.fda.gov/FoodCode. Dated: September 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22438 Filed 9-16-16; 8:45 am] BILLING CODE 4164-01-P
![64168 Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices
DEPARTMENT OF HEALTH AND do not wish to be made available to the information about FDA’s posting of
HUMAN SERVICES public, submit the comment as a comments to public dockets, see 80 FR
written/paper submission and in the 56469, September 18, 2015, or access
Food and Drug Administration manner detailed (see ‘‘Written/Paper the information at: http://www.fda.gov/
[Docket No. FDA–2014–N–2033] Submissions’’ and ‘‘Instructions’’). regulatoryinformation/dockets/
Written/Paper Submissions default.htm.
Agency Information Collection Docket: For access to the docket to
Activities; Proposed Collection; Submit written/paper submissions as read background documents or the
Comment Request; Survey on the follows: electronic and written/paper comments
Occurrence of Foodborne Illness Risk • Mail/Hand delivery/Courier (for
received, go to http://
Factors in Selected Institutional written/paper submissions): Division of
www.regulations.gov and insert the
Foodservice and Retail Food Stores Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers docket number, found in brackets in the
Facility Types heading of this document, into the
Lane, Rm. 1061, Rockville, MD 20852.
AGENCY: Food and Drug Administration, • For written/paper comments ‘‘Search’’ box and follow the prompts
HHS. submitted to the Division of Dockets and/or go to the Division of Dockets
Management, FDA will post your Management, 5630 Fishers Lane, Rm.
ACTION: Notice.
comment, as well as any attachments, 1061, Rockville, MD 20852.
SUMMARY: The Food and Drug except for information submitted, FOR FURTHER INFORMATION CONTACT: FDA
Administration (FDA) is announcing an marked and identified, as confidential, PRA Staff, Office of Operations, Food
opportunity for public comment on the if submitted as detailed in and Drug Administration, Three White
proposed collection of certain ‘‘Instructions.’’ Flint North, 10A63, 11601 Landsdown
information by the Agency. Under the Instructions: All submissions received St., North Bethesda, MD 20852,
Paperwork Reduction Act of 1995 (the must include the Docket No. FDA– PRAStaff@fda.hhs.gov.
PRA), Federal Agencies are required to 2014–N–2033 for ‘‘Agency Information
publish notice in the Federal Register Collection Activities; Proposed SUPPLEMENTARY INFORMATION: Under the
concerning each proposed collection of Collection; Comment Request; Survey PRA (44 U.S.C. 3501–3520), Federal
information, including each proposed on the Occurrence of Foodborne Illness Agencies must obtain approval from the
extension of an existing collection of Risk Factors in Selected Institutional Office of Management and Budget
information, and to allow 60 days for Foodservice and Retail Food Stores (OMB) for each collection of
public comment in response to the Facility Types.’’ Received comments information they conduct or sponsor.
notice. This notice solicits comments on will be placed in the docket and, except ‘‘Collection of information’’ is defined
a survey entitled ‘‘Survey on the for those submitted as ‘‘Confidential in 44 U.S.C. 3502(3) and 5 CFR
Occurrence of Foodborne Illness Risk Submissions,’’ publicly viewable at 1320.3(c) and includes Agency requests
Factors in Selected Institutional http://www.regulations.gov or at the or requirements that members of the
Foodservice and Retail Food Stores Division of Dockets Management public submit reports, keep records, or
Facility Types (2015–2025).’’ between 9 a.m. and 4 p.m., Monday provide information to a third party.
DATES: Submit either electronic or through Friday. Section 3506(c)(2)(A) of the PRA (44
written comments on the collection of • Confidential Submissions—To U.S.C. 3506(c)(2)(A)) requires Federal
information by November 18, 2016. submit a comment with confidential Agencies to provide a 60-day notice in
information that you do not wish to be the Federal Register concerning each
ADDRESSES: You may submit comments
made publicly available, submit your proposed collection of information,
as follows: including each proposed extension of an
comments only as a written/paper
Electronic Submissions submission. You should submit two existing collection of information,
Submit electronic comments in the copies total. One copy will include the before submitting the collection to OMB
following way: information you claim to be confidential for approval. To comply with this
• Federal eRulemaking Portal: http:// with a heading or cover note that states requirement, FDA is publishing notice
www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS of the proposed collection of
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The information set forth in this document.
Comments submitted electronically, Agency will review this copy, including With respect to the following
including attachments, to http:// the claimed confidential information, in collection of information, FDA invites
www.regulations.gov will be posted to its consideration of comments. The comments on these topics: (1) Whether
the docket unchanged. Because your second copy, which will have the the proposed collection of information
comment will be made public, you are claimed confidential information is necessary for the proper performance
solely responsible for ensuring that your redacted/blacked out, will be available of FDA’s functions, including whether
comment does not include any for public viewing and posted on http:// the information will have practical
confidential information that you or a www.regulations.gov. Submit both utility; (2) the accuracy of FDA’s
third party may not wish to be posted, copies to the Division of Dockets estimate of the burden of the proposed
such as medical information, your or Management. If you do not wish your collection of information, including the
anyone else’s Social Security number, or name and contact information to be validity of the methodology and
confidential business information, such made publicly available, you can assumptions used; (3) ways to enhance
as a manufacturing process. Please note provide this information on the cover the quality, utility, and clarity of the
mstockstill on DSK3G9T082PROD with NOTICES
that if you include your name, contact sheet and not in the body of your information to be collected; and (4)
information, or other information that comments and you must identify this ways to minimize the burden of the
identifies you in the body of your information as ‘‘confidential.’’ Any collection of information on
comments, that information will be information marked as ‘‘confidential’’ respondents, including through the use
posted on http://www.regulations.gov. will not be disclosed except in of automated collection techniques,
• If you want to submit a comment accordance with 21 CFR 10.20 and other when appropriate, and other forms of
with confidential information that you applicable disclosure law. For more information technology.
VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1](https://thefederalregister.org/doc/81_FR_64349/page/1.svg)
![Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices 64171
The burden for this collection of the site visit and answer the data estimates that it will take the program
information is as follows. For each data collectors’ questions. The burden director (or designated individual) of
collection, the respondents includes: (1) related to the completion of Section 2 of the respective regulatory authority 30
The person in charge of the selected the form is specific to the program minutes (0.5 hours) to answer the
facility type (whether it be a health care directors (or designated individuals) of questions related to Section 2 of the
facility, school, or supermarket/grocery the respective regulatory authorities. It form. The total burden estimate for a
store); and (2) the program director (or includes the time it will take to answer data collection, including both the
designated individual) of the respective the data collectors’ questions and is the program director’s and the person in
regulatory authority. To provide the same regardless of the facility type. charge’s responses, in health care
sufficient number of observations To calculate the estimate of the hours facility types is 180 minutes (150+30)(3
needed to conduct a statistically per response, FDA uses the average data hours), in schools is 150 minutes
significant analysis of the data, FDA has collection duration for similar facility (120+30)(2.5 hours), and in retail food
determined that 400 data collections types during FDA’s 2008 Risk Factor stores is 210 minutes (180+30)(3.5
will be required in each of the three Study (Ref. 3) plus an extra 30 minutes hours).
facility types. Therefore, the total (0.5 hours) for the information Based on the number of entry refusals
number of responses will be 2,400 (400 collection related to Section 3, Part B of from the 2013–2014 Risk Factor Study
data collections × 3 facility types × 2 the form. FDA estimates that it will take in the restaurant facility types, we
respondents per data collection). the persons in charge of health care estimate a refusal rate of 2 percent in the
The burden associated with the facility types, schools, and retail food institutional foodservice and retail food
completion of Sections 1 and 3 of the stores 150 minutes (2.5 hours), 120 store facility types. The estimate of the
form is specific to the persons in charge minutes (2 hours), and 180 minutes (3 time per non-respondent is 5 minutes
of the selected facilities. It includes the hours), respectively, to accompany the (0.08 hours) for the person in charge to
time it will take the persons in charge data collectors while they complete listen to the purpose of the visit and
to accompany the data collectors during Sections 1 and 3 of the form. FDA provide a verbal refusal of entry.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Number of
Number of Total annual responses per Total annual Average burden per
Activity responses per non-respond- Total hours
respondents responses non-respond- non-responses response
respondent ents ent
2015–2016 Data Collection (Health Care Facili- 400 1 400 ........................ ........................ ........................ 2.5 .......................... 1,000
ties)—Completion of Sections 1 and 3.
2015–2016 Data Collection (Schools)—Completion 400 1 400 ........................ ........................ ........................ 2 ............................. 800
of Sections 1 and 3.
2015–2016 Data Collection (Retail Food Stores)— 400 1 400 ........................ ........................ ........................ 3 ............................. 1,200
Completion of Sections 1 and 3.
2015–2016 Data Collection-Completion of Section 1,200 1 1,200 ........................ ........................ ........................ 0.5 .......................... 600
2—All Facility Types.
2017–2018 Data Collection-Entry Refusals—All Fa- ........................ ........................ ........................ 24 1 24 0.08 (5 minutes) ..... 1.92
cility Types.
Total Hours .......................................................... ........................ ........................ ........................ ........................ ........................ ........................ ................................ 3,601.92
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
II. References Reduction/UCM423850.pdf. DEPARTMENT OF HEALTH AND
3. ‘‘FDA Report on the Occurrence of HUMAN SERVICES
The following references are on Foodborne Illness Risk Factors in
display in the Division of Dockets Selected Institutional Foodservice, Food and Drug Administration
Management (see ADDRESSES) and are Restaurant, and Retail Food Store
available for viewing by interested Facility Types (2009).’’ Available at: [Docket No. FDA–2015–N–3326]
persons between 9 a.m. and 4 p.m., http://www.fda.gov/downloads/Food/
FoodSafety/RetailFoodProtection/Food Biosimilar User Fee Act; Public
Monday through Friday, and are
borneIllnessandRiskFactorReduction/ Meeting
available electronically at http://
RetailFoodRiskFactorStudies/
www.regulations.gov. FDA has verified UCM224682.pdf. AGENCY: Food and Drug Administration,
the Web site addresses, as of the date 4. FDA National Retail Food Team. ‘‘FDA HHS.
this document publishes in the Federal Trend Analysis Report on the ACTION: Notice of public meeting;
Register, but Web sites are subject to Occurrence of Foodborne Illness Risk request for comments.
change over time. Factors in Selected Institutional
1. ‘‘Report of the FDA Retail Food Program Foodservice, Restaurant, and Retail Food SUMMARY: The Food and Drug
Database of Foodborne Illness Risk Store Facility Types (1998–2008).’’ Administration (FDA or Agency) is
Factors (2000).’’ Available at: http:// Available at: http://www.fda.gov/ announcing a public meeting to discuss
www.fda.gov/downloads/Food/Food downloads/Food/FoodSafety/RetailFood proposed recommendations for the
Safety/RetailFoodProtection/Foodborne Protection/FoodborneIllnessandRisk reauthorization of the Biosimilar User
IllnessandRiskFactorReduction/Retail FactorReduction/RetailFoodRiskFactor
Fee Act (BsUFA) for fiscal years (FYs)
FoodRiskFactorStudies/ucm123546.pdf. Studies/UCM224152.pdf.
2018 through 2022. BsUFA authorizes
mstockstill on DSK3G9T082PROD with NOTICES
2. ‘‘FDA Report on the Occurrence of 5. ‘‘FDA Food Code.’’ Available at: http://
www.fda.gov/FoodCode. FDA to collect fees and use them for the
Foodborne Illness Risk Factors in process for the review of biosimilar
Selected Institutional Foodservice, Dated: September 13, 2016.
Restaurant, and Retail Food Store
biological product applications. The
Leslie Kux, current legislative authority for BsUFA
Facility Types (2004).’’ Available at:
Associate Commissioner for Policy. expires in September 2017. At that time,
http://www.fda.gov/downloads/Food/
GuidanceRegulation/RetailFood [FR Doc. 2016–22438 Filed 9–16–16; 8:45 am] new legislation will be required for FDA
Protection/FoodborneIllnessRiskFactor BILLING CODE 4164–01–P to continue collecting biosimilar
VerDate Sep<11>2014 21:47 Sep 16, 2016 Jkt 238001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1](https://thefederalregister.org/doc/81_FR_64349/page/4.svg)
Document Created: 2016-09-17 02:29:46
Document Modified: 2016-09-17 02:29:46
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by November 18, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 64168 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR