83 FR 36594 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 146 (July 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 146 (July 30, 2018)
| Page Range | 36594-36598 | |
| FR Document | 2018-16189 |
[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)] [Notices] [Pages 36594-36598] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16189] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0547] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types 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 29, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0744. 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, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types OMB Control Number 0910-0744--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) 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 to 2014 FDA initiated a new study in full service and fast food restaurants. This study will span 10 years with a data collection currently being conducted in 2017 to 2018 and another data collection planned for 2021 to 2022 (the subject of this information collection request extension). [[Page 36595]] Table 1--Description of the Facility Types Included in the Survey ------------------------------------------------------------------------ Facility type Description ------------------------------------------------------------------------ Full Service Restaurants..... A restaurant where customers place their order at their table, are served their meal at the table, receive the service of the wait staff, and pay at the end of the meal. Fast Food Restaurants........ A restaurant that is not a full service restaurant. This includes restaurants commonly referred to as quick service restaurants and fast casual restaurants. ------------------------------------------------------------------------ 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 (FD&C 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 least and most often occurring foodborne illness risk factors and food safety behaviors/practices in retail and foodservice facility types during each data collection period; Track improvement and/or regression trends in the occurrence of foodborne illness risk factors during the 10-year study period; 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 control of foodborne illness risk factors; and Determine the extent to which food safety management systems and the presence of a certified food protection manager impact 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 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 restaurant 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 [[Page 36596]] 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 system 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 has collaborated with the Food Protection and Defense Institute to develop a web-based platform in FoodSHIELD to collect, store, and analyze data for the Retail Risk Factor Study. This platform is accessible to State, local, territorial, and tribal regulatory jurisdictions to collect data relevant to their own risk factor studies. For the 2015 to 2016 data collection, FDA piloted the use of hand-held technology for capturing the data onsite during the data collection visits. The tablets that were made available for the data collections were part of a broader Agency initiative focused on internal uses of hand-held technology. The tablets provided for the data collection presented several technical and logistical challenges and increased the time burden associated with the data collection as compared to the manual entry of data collections. FDA continues to assess the feasibility for fully incorporating use of hand-held technology in subsequent data collections during the 10-year study period. 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 directly enter information in the database via a web browser. The burden for the 2021 to 2022 data collection is as follows. For each data collection, the respondents will include: (1) The person in charge of the selected facility (whether it be a fast food or full service restaurant) 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 two restaurant facility types. Therefore, the total number of responses will be 1,600 (400 data collections x 2 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 person in charge to accompany the data collector during the site visit and answer the data collector's 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. In the Federal Register of February 7, 2018 (83 FR 5433), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received two comments. (Comment 1) We received comments related to FDA's authority for collaboration with State and local governments regarding food safety at the retail level. (Response 1) The statutory basis for FDA conducting this survey is the PHS Act, which requires that FDA provide assistance to State and local governments relative to the prevention and suppression of communicable diseases. 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 FD&C 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. (Comment 2) The Academy of Nutrition and Dietetics (the Academy) commented that they support the proposed information collection for the survey on the occurrence of foodborne illness risk factors in various settings. The Academy provided comments pertaining to the following general areas of the study: a. Question as to whether 90 minutes is adequate for surveying larger facilities. b. Request FDA evaluate the impact of conducting surveys during non-peak hours of operation. c. Suggest that the use of gloves is not adequately addressed in the survey. d. Recommend adding a food allergy component. e. Encourage continued efforts to simplify and standardize expiration dates. Related to foodservice operations at the retail level, the Academy provided the following comments: a. Suggest that FDA consider conducting the survey by using local inspectors who already inspect facilities for other purposes. b. Suggest that educational efforts should be culturally guided, provided in multiple languages, and include photos or illustrations to facilitate remediation. c. FDA consider modifying the survey to account for new foods and new means of conveying food. (Response 2) FDA thanks the submitter for their comments and appreciates their support. Regarding general areas of the study, FDA provides the following responses: a. The current 10-year study estimates 90 minutes as the average time needed to adequately collect necessary information, taking into account both small and large facilities. This average time is consistent with the amount of time burden estimated for the previous data collection periods and provides a sufficient timeframe to observe food safety practices and procedures that are the focus of the study. b. Based on the methodology of the study, the information collection is performed during hours of operation of the randomly selected facility. Data collections are scheduled at times that provide the best opportunity to observe food preparation activities. [[Page 36597]] c. Information collection related to handwashing and no bare hand contact with ready to eat foods, which may include use of gloves, is based on assessment of observations against the most current addition of the FDA Model Food Code. Provisions of the FDA Food Code identify when handwashing and no bare hand contact with ready to eat food are required during food preparation and service. The current FDA Food Code does not recognize the use of hand antiseptics in lieu of handwashing during food preparation and service. d. The study is collecting information regarding the knowledge of the person in charge related to food allergens and training of food service employees on allergy awareness as it relates to their assigned duties in their facility. e. The scope of this data collection focuses on foodborne illness risk factors and does not include assessment of expiration dates of manufactured foods as part of this research assessment. Related to foodservice operations at the retail level, FDA provides the following responses: a. This type of research requires a standardized design and methodology to ensure that the occurrences of the foodborne illness risk factors are uniformly assessed. Retail Food Specialists are standardized by Center for Food Safety and Applied Nutrition and have a strong working knowledge of retail food industry. State and local regulators are encouraged to accompany the data collectors during the data collection. b. The research from this study facilitates the development of culturally guided, multi-language education outreach materials that can be shared with regulatory and industry partners. c. The study design accounts for a variety of food conveyances in the retail food setting. The study includes four major segments of the retail and foodservice industries that account for over a million varied and diverse types of operations in the United States: Restaurants Healthcare Facilities Schools (K-12) Retail Food Stores To calculate the estimate of the hours per response, FDA will use the average data collection duration for the same facility types during the 2013 to 2014 data collection. FDA estimates that it will take the persons in charge of full service restaurants and fast food restaurants 104 minutes (1.73 hours) and 82 minutes (1.36 hours), respectively, to accompany the data collectors while they complete Sections 1 and 3 of the form. In comparison, for the 2013 to 2014 data collection, the burden estimate was 106 minutes (1.76 hours) in full service restaurants and 73 minutes (1.21 hours) in fast food restaurants. 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. This burden estimate is unchanged from the last data collection. Hence, the total burden estimate for a data collection in a full service restaurant, including the responses of both the program director and the person in charge, is 134 minutes (104 + 30) (2.23 hours). The total burden estimate for a data collection in a fast food restaurant, including the responses of both the program director and the person in charge, is 112 minutes (82 + 30) (1.86 hours). Based on the number of entry refusals from the 2013 to 2014 baseline data collection, we estimate a refusal rate of 2 percent for the data collections within restaurant 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. FDA estimates the burden of this collection of information as follows: Table 2--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of Number of responses Total Number of responses Total Average burden per Activity respondents per annual non- per non- annual non- response Total hours respondent responses respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- 2021-2022 Data Collection (Fast 400 1 400 ........... ........... ........... 1.36.................... 544 Food Restaurants)--Completion of Sections 1 and 3. 2021-2022 Data Collection (Full 400 1 400 ........... ........... ........... 1.73.................... 692 Service Restaurants)--Completion of Sections 1 and 3. 2021-2022 Data Collection- 800 1 800 ........... ........... ........... 0.5 (30 minutes)........ 400 Completion of Section 2--All Facility Types. 2021-2022 Data Collection-Entry ........... ........... ........... 16 1 16 0.08 (5 minutes)........ 1.28 Refusals--All Facility Types. -------------------------------------------------------------------------------------------------------------------- Total Hours.................... ........... ........... ........... ........... ........... ........... ........................ 1,637.28 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1.\ There are no capital costs or operating and maintenance costs associated with this collection of information. The burden for this information collection has not changed since the last OMB approval. II. References The following references are on display in the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday, they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. ``Report of the FDA Retail Food Program Database of Foodborne Illness Risk Factors'' (2000). Available at: https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/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: https://wayback.archive-it.org/7993/20170406023011/https://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: https:// wayback.archive-it.org/7993/20170406023004/https://www.fda.gov/Food/ GuidanceRegulation/RetailFoodProtection/ [[Page 36598]] FoodborneIllnessRiskFactorReduction/ucm224321.htm. 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: https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm. 5. ``FDA Food Code.'' Available at: https://www.fda.gov/FoodCode. Dated: July 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-16189 Filed 7-27-18; 8:45 am] BILLING CODE 4164-01-P
![36594 Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices
priorities, standards, budget requests, Tribal governments complete Form Respondents: State governments,
and assistance policies. ORR regulations ORR–6 in order to participate in the Replacement Designees, and Wilson/
require that State Refugee Resettlement above-mentioned programs. Fish Alternative Projects.
and Wilson-Fish agencies, and local and
ANNUAL BURDEN ESTIMATES
Average
Number of
Number of burden Total burden
Instrument responses per
respondents hours per hours
respondent response
ORR–6 Performance Report ........................................................................... 59 2 15 1,770
Estimated Total Annual Burden ACTION: Notice. preparation practices, and employee
Hours: 1,770. behaviors most commonly reported to
Copies of the proposed collection may SUMMARY: The Food and Drug the Centers for Disease Control and
be obtained by writing to the Administration (FDA) is announcing Prevention as contributing factors to
Administration for Children and that a proposed collection of
foodborne illness outbreaks at the retail
Families, Office of Planning, Research information has been submitted to the
level. Specifically, data was collected by
and Evaluation, 330 C Street SW, Office of Management and Budget
FDA Specialists in retail and
Washington, DC 20201. Attention (OMB) for review and clearance under
the Paperwork Reduction Act of 1995. foodservice establishments at 5-year
Reports Clearance Officer. All requests
intervals (1998, 2003, and 2008) to
should be identified by the title of the DATES: Fax written comments on the
observe and document trends in the
information collection. Email address: collection of information by August 29,
infocollection@acf.hhs.gov. occurrence of the following foodborne
2018.
OMB Comment: OMB is required to illness risk factors:
ADDRESSES: To ensure that comments on
make a decision concerning the the information collection are received, • Food from Unsafe Sources,
collection of information between 30 OMB recommends that written • Poor Personal Hygiene,
and 60 days after publication of this comments be faxed to the Office of
document in the Federal Register. • Inadequate Cooking,
Information and Regulatory Affairs,
Therefore, a comment is best assured of OMB, Attn: FDA Desk Officer, Fax: 202– • Improper Holding/Time and
having its full effect if OMB receives it 395–7285, or emailed to oira_ Temperature, and
within 30 days of publication. Written submission@omb.eop.gov. All • Contaminated Equipment/Cross-
comments and recommendations for the comments should be identified with the Contamination.
proposed information collection should OMB control number 0910–0744. Also
be sent directly to the following: Office FDA developed reports summarizing
include the FDA docket number found the findings for each of the three data
of Management and Budget, Paperwork in brackets in the heading of this
Reduction Project, Email: OIRA_ collection periods (1998, 2003, and
document.
SUBMISSION@OMB.EOP.GOV, Attn: 2008) (Refs. 1 to 3). Data from all three
Desk Officer for the Administration for FOR FURTHER INFORMATION CONTACT: Ila data collection periods were analyzed to
Children and Families. S. Mizrachi, Office of Operations, Food detect trends in improvement or
and Drug Administration, Three White regression over time and to determine
Robert Sargis, Flint North, 10A–12M, 11601
Reports Clearance Officer.
whether progress had been made toward
Landsdown St., North Bethesda, MD the goal of reducing the occurrence of
[FR Doc. 2018–15987 Filed 7–27–18; 8:45 am] 20852, 301–796–7726, PRAStaff@ foodborne illness risk factors in selected
BILLING CODE 4184–45–P fda.hhs.gov. retail and foodservice facility types (Ref.
SUPPLEMENTARY INFORMATION: In 4).
DEPARTMENT OF HEALTH AND compliance with 44 U.S.C. 3507, FDA Using this 10-year survey as a
HUMAN SERVICES has submitted the following proposed
foundation, in 2013 to 2014 FDA
collection of information to OMB for
initiated a new study in full service and
Food and Drug Administration review and clearance.
fast food restaurants. This study will
[Docket No. FDA–2012–N–0547] Survey on the Occurrence of Foodborne span 10 years with a data collection
Illness Risk Factors in Selected Retail currently being conducted in 2017 to
Agency Information Collection and Foodservice Facility Types 2018 and another data collection
Activities; Submission for Office of planned for 2021 to 2022 (the subject of
Management and Budget Review; OMB Control Number 0910–0744—
Extension this information collection request
Comment Request; Survey on the extension).
Occurrence of Foodborne Illness Risk I. Background
Factors in Selected Retail and
From 1998 to 2008, FDA’s National
Foodservice Facility Types
daltland on DSKBBV9HB2PROD with NOTICES
Retail Food Team conducted a study to
AGENCY: Food and Drug Administration, measure trends in the occurrence of
HHS. foodborne illness risk factors,
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FoodborneIllnessRiskFactorReduction/ making your submission to FDA, you by FDA during FY 2019 is $300,000.
ucm224321.htm. will have to pay the higher standard fee. From this starting point, this document
4. FDA National Retail Food Team. ‘‘FDA Please note that the establishment establishes FY 2019 fee rates for certain
Trend Analysis Report on the registration fee is not eligible for a types of submissions, and for periodic
Occurrence of Foodborne Illness Risk
Factors in Selected Institutional
reduced small business fee. As a result, reporting, by applying criteria specified
Foodservice, Restaurant, and Retail Food if the establishment registration fee is in the FD&C Act.
Store Facility Types (1998–2008).’’ the only medical device user fee that The FD&C Act specifies the base fee
Available at: https://wayback.archive- you will pay in FY 2019, you should not for establishment registration for each
it.org/7993/20170406022950/https:// submit a Small Business Certification year from FY 2018 through FY 2022; the
www.fda.gov/Food/GuidanceRegulation/ Request. This document provides base fee for an establishment
RetailFoodProtection/FoodborneIllness information on how the fees for FY 2019 registration in FY 2019 is $4,548. There
RiskFactorReduction/ucm223293.htm. were determined, the payment is no reduction in the registration fee for
5. ‘‘FDA Food Code.’’ Available at: https:// procedures you should follow, and how
www.fda.gov/FoodCode.
small businesses. Each establishment
you may qualify for reduced small that is registered (or is required to
Dated: July 24, 2018. business fees. register) with the Secretary of Health
Leslie Kux, FOR FURTHER INFORMATION CONTACT: and Human Services under section 510
Associate Commissioner for Policy. For information on Medical Device of the FD&C Act (21 U.S.C. 360) because
[FR Doc. 2018–16189 Filed 7–27–18; 8:45 am]
User Fees: Visit FDA’s website at: such establishment is engaged in the
https://www.fda.gov/ForIndustry/ manufacture, preparation, propagation,
BILLING CODE 4164–01–P
UserFees/MedicalDeviceUserFee/ compounding, or processing of a device
ucm20081521.htm. is required to pay the annual fee for
DEPARTMENT OF HEALTH AND For questions relating to the MDUFA establishment registration.
HUMAN SERVICES Small Business Program, please visit
II. Revenue Amount for FY 2019
CDRH’s website: https://www.fda.gov/
Food and Drug Administration medicaldevices/deviceregulation The total revenue amount for FY 2019
andguidance/howtomarketyourdevice/ is $190,654,875, as set forth in the
[Docket No. FDA–2017–N–0007] premarketsubmissions/ucm577696.htm. statute prior to the inflation adjustment
For questions relating to this notice: (see 21 U.S.C. 379j(b)(3)). MDUFA
Medical Device User Fee Rates for
David Haas, Office of Financial directs FDA to use the yearly total
Fiscal Year 2019
Management, Food and Drug revenue amount as a starting point to set
AGENCY: Food and Drug Administration, Administration, 8455 Colesville Rd. the standard fee rates for each fee type.
HHS. (COLE–14202I), Silver Spring, MD The fee calculations for FY 2019 are
ACTION: Notice. 20993–0002, 240–402–9845. described in this document.
SUPPLEMENTARY INFORMATION: Inflation Adjustment
SUMMARY: The Food and Drug
Administration (FDA) is announcing the I. Background MDUFA specifies that the
fee rates and payment procedures for Section 738 of the FD&C Act (21 $190,654,875 is to be adjusted for
medical device user fees for fiscal year U.S.C. 379j) establishes fees for certain inflation increases for FY 2019 using
(FY) 2019. The Federal Food, Drug, and medical device applications, two separate adjustments—one for
Cosmetic Act (FD&C Act), as amended submissions, supplements, notices, and payroll costs and one for non-payroll
by the Medical Device User Fee requests (for simplicity, this document costs (see 21 U.S.C. 379j(c)(2)). The base
Amendments of 2017 (MDUFA IV), refers to these collectively as inflation adjustment for FY 2019 is the
authorizes FDA to collect user fees for ‘‘submissions’’ or ‘‘applications’’); for sum of one plus these two separate
certain medical device submissions and periodic reporting on class III devices; adjustments, and is compounded as
annual fees both for certain periodic and for the registration of certain specified in the statute (see 21 U.S.C.
reports and for establishments subject to establishments. Under statutorily 379j(c)(2)(C) and 379j(c)(2)(B)).
registration. This notice establishes the defined conditions, a qualified The component of the inflation
fee rates for FY 2019, which apply from applicant may receive a fee waiver or adjustment for payroll costs is the
October 1, 2018, through September 30, may pay a lower small business fee (see average annual percent change in the
2019. To avoid delay in the review of 21 U.S.C. 379j(d) and (e)). cost of all personnel compensation and
your application, you should pay the Under the FD&C Act, the fee rate for benefits (PC&B) paid per full-time
application fee before or at the time you each type of submission is set at a equivalent position (FTE) at FDA for the
submit your application to FDA. The fee specified percentage of the standard fee first 3 of the 4 preceding FYs,
you must pay is the fee that is in effect for a premarket application (a premarket multiplied by 0.60, or 60 percent (see 21
on the later of the date that your application is a premarket approval U.S.C. 379j(c)(2)(C)).
application is received by FDA or the application (PMA), a product Table 1 summarizes the actual cost
date your fee payment is recognized by development protocol (PDP), or a and FTE data for the specified FYs, and
the U.S. Treasury. If you want to pay a biologics license application (BLA)). provides the percent change from the
reduced small business fee, you must The FD&C Act specifies the base fee for previous FY and the average percent
qualify as a small business before a premarket application for each year change over the first 3 of the 4 FYs
making your submission to FDA; if you from FY 2018 through FY 2022; the base preceding FY 2019. The 3-year average
daltland on DSKBBV9HB2PROD with NOTICES
do not qualify as a small business before fee for a premarket application received is 2.4152 percent (rounded).
TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
Fiscal year 2015 2016 2017 3-Year average
Total PC&B .............................................................................................. $2,232,304,000 $2,414,728,159 $2,581,551,000 ..........................
VerDate Sep<11>2014 20:33 Jul 27, 2018 Jkt 244001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\30JYN1.SGM 30JYN1](https://thefederalregister.org/doc/83_FR_36740/page/5.svg)
Document Created: 2018-07-28 01:44:08
Document Modified: 2018-07-28 01:44:08
| 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 | Fax written comments on the collection of information by August 29, 2018. | |
| Contact | Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected] | |
| FR Citation | 83 FR 36594 |
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