36594 Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 

priorities, standards, budget requests, 

and assistance policies. ORR regulations 

require that State Refugee Resettlement 

and Wilson-Fish agencies, and local and 

Tribal governments complete Form 

ORR–6 in order to participate in the 

above-mentioned programs. 

Respondents: State governments, 

Replacement Designees, and Wilson/ 

Fish Alternative Projects. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total burden 

hours 

ORR–6 Performance Report ........................................................................... 59 2 15 1,770 

Estimated Total Annual Burden 

Hours: 1,770. 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 330 C Street SW, 

Washington, DC 20201. Attention 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. Email address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Email: OIRA_

SUBMISSION@OMB.EOP.GOV, Attn: 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2018–15987 Filed 7–27–18; 8:45 am] 

BILLING CODE 4184–45–P 

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 oira_

submission@omb.eop.gov. 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, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

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/CrossContamination. 

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). 


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Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 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 


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36596 Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 

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 × 2 

facility types × 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. 


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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

Activity Number of 

respondents 

Number of 

responses 

per 

respondent 

Total 

annual 

responses 

Number 

of nonrespondents 

Number of 

responses 

per nonrespondent 

Total 

annual nonresponses 

Average burden 

per response Total hours 

2021–2022 Data Collection (Fast Food 

Restaurants)—Completion of Sections 

1 and 3.

400 1 400 .................... .................... .................... 1.36 ................... 544 

2021–2022 Data Collection (Full Service 

Restaurants)—Completion of Sections 

1 and 3.

400 1 400 .................... .................... .................... 1.73 ................... 692 

2021–2022 Data Collection-Completion of 

Section 2—All Facility Types.

800 1 800 .................... .................... .................... 0.5 (30 minutes) 400 

2021–2022 Data Collection-Entry Refusals—All Facility Types..................... .................... .................... 16 1 16 0.08 (5 minutes) 1.28 

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/7993/201704

06023019/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/Foodborne

IllnessRiskFactorReduction/ 

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/ 


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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.archiveit.org/7993/20170406022950/https://

www.fda.gov/Food/GuidanceRegulation/ 

RetailFoodProtection/FoodborneIllness

RiskFactorReduction/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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0007] 

Medical Device User Fee Rates for 

Fiscal Year 2019 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fee rates and payment procedures for 

medical device user fees for fiscal year 

(FY) 2019. The Federal Food, Drug, and 

Cosmetic Act (FD&C Act), as amended 

by the Medical Device User Fee 

Amendments of 2017 (MDUFA IV), 

authorizes FDA to collect user fees for 

certain medical device submissions and 

annual fees both for certain periodic 

reports and for establishments subject to 

registration. This notice establishes the 

fee rates for FY 2019, which apply from 

October 1, 2018, through September 30, 

2019. To avoid delay in the review of 

your application, you should pay the 

application fee before or at the time you 

submit your application to FDA. The fee 

you must pay is the fee that is in effect 

on the later of the date that your 

application is received by FDA or the 

date your fee payment is recognized by 

the U.S. Treasury. If you want to pay a 

reduced small business fee, you must 

qualify as a small business before 

making your submission to FDA; if you 

do not qualify as a small business before 

making your submission to FDA, you 

will have to pay the higher standard fee. 

Please note that the establishment 

registration fee is not eligible for a 

reduced small business fee. As a result, 

if the establishment registration fee is 

the only medical device user fee that 

you will pay in FY 2019, you should not 

submit a Small Business Certification 

Request. This document provides 

information on how the fees for FY 2019 

were determined, the payment 

procedures you should follow, and how 

you may qualify for reduced small 

business fees. 

FOR FURTHER INFORMATION CONTACT:

For information on Medical Device 

User Fees: Visit FDA’s website at: 

https://www.fda.gov/ForIndustry/ 

UserFees/MedicalDeviceUserFee/ 

ucm20081521.htm. 

For questions relating to the MDUFA 

Small Business Program, please visit 

CDRH’s website: https://www.fda.gov/ 

medicaldevices/deviceregulation

andguidance/howtomarketyourdevice/ 

premarketsubmissions/ucm577696.htm. 

For questions relating to this notice: 

David Haas, Office of Financial 

Management, Food and Drug 

Administration, 8455 Colesville Rd. 

(COLE–14202I), Silver Spring, MD 

20993–0002, 240–402–9845. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 738 of the FD&C Act (21 

U.S.C. 379j) establishes fees for certain 

medical device applications, 

submissions, supplements, notices, and 

requests (for simplicity, this document 

refers to these collectively as 

‘‘submissions’’ or ‘‘applications’’); for 

periodic reporting on class III devices; 

and for the registration of certain 

establishments. Under statutorily 

defined conditions, a qualified 

applicant may receive a fee waiver or 

may pay a lower small business fee (see 

21 U.S.C. 379j(d) and (e)). 

Under the FD&C Act, the fee rate for 

each type of submission is set at a 

specified percentage of the standard fee 

for a premarket application (a premarket 

application is a premarket approval 

application (PMA), a product 

development protocol (PDP), or a 

biologics license application (BLA)). 

The FD&C Act specifies the base fee for 

a premarket application for each year 

from FY 2018 through FY 2022; the base 

fee for a premarket application received 

by FDA during FY 2019 is $300,000. 

From this starting point, this document 

establishes FY 2019 fee rates for certain 

types of submissions, and for periodic 

reporting, by applying criteria specified 

in the FD&C Act. 

The FD&C Act specifies the base fee 

for establishment registration for each 

year from FY 2018 through FY 2022; the 

base fee for an establishment 

registration in FY 2019 is $4,548. There 

is no reduction in the registration fee for 

small businesses. Each establishment 

that is registered (or is required to 

register) with the Secretary of Health 

and Human Services under section 510 

of the FD&C Act (21 U.S.C. 360) because 

such establishment is engaged in the 

manufacture, preparation, propagation, 

compounding, or processing of a device 

is required to pay the annual fee for 

establishment registration. 

II. Revenue Amount for FY 2019 

The total revenue amount for FY 2019 

is $190,654,875, as set forth in the 

statute prior to the inflation adjustment 

(see 21 U.S.C. 379j(b)(3)). MDUFA 

directs FDA to use the yearly total 

revenue amount as a starting point to set 

the standard fee rates for each fee type. 

The fee calculations for FY 2019 are 

described in this document. 

Inflation Adjustment 

MDUFA specifies that the 

$190,654,875 is to be adjusted for 

inflation increases for FY 2019 using 

two separate adjustments—one for 

payroll costs and one for non-payroll 

costs (see 21 U.S.C. 379j(c)(2)). The base 

inflation adjustment for FY 2019 is the 

sum of one plus these two separate 

adjustments, and is compounded as 

specified in the statute (see 21 U.S.C. 

379j(c)(2)(C) and 379j(c)(2)(B)). 

The component of the inflation 

adjustment for payroll costs is the 

average annual percent change in the 

cost of all personnel compensation and 

benefits (PC&B) paid per full-time 

equivalent position (FTE) at FDA for the 

first 3 of the 4 preceding FYs, 

multiplied by 0.60, or 60 percent (see 21 

U.S.C. 379j(c)(2)(C)). 

Table 1 summarizes the actual cost 

and FTE data for the specified FYs, and 

provides the percent change from the 

previous FY and the average percent 

change over the first 3 of the 4 FYs 

preceding FY 2019. The 3-year average 

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 ..........................


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