37500 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices 

2Task Force on Sudden Infant Death Syndrome. 

‘‘SIDS and Other Sleep-Related Infant Deaths: 

Updated 2016 Recommendations for a Safe Infant 

Sleeping Environment.’’ Pediatrics, 138, no. 5 

(2016): 1, http://pediatrics.aappublications.org/ 

content/138/5/e20162938. 

3 Ibid., 2–4. 

Subject standard Standard and summary 

Summary—Transportation Standards ................ The proposed transportation standards focus broadly on the applicant having a reliable, legal, 

and safe mode of transportation for a child in foster care to attend appointments, visitation, 

and meetings. We also propose that only adults in the home be permitted to transport children in foster care and only those having a driving record in good standing. We specifically 

avoid proposing standards that could impact a foster parent based on geographic location 

and income. For example, some states require foster parents to have their own vehicle. 

However, applicants in states with a high urban population may not have access to or need 

a vehicle. Rather, they rely upon public transportation. 

Training ............................................................... G. Training: a. Applicants must complete pre-licensing training on the following topics: legal 

rights, roles, responsibilities and expectations of foster parents; agency structure, purpose, 

policies, and services; laws and regulations; the impact of childhood trauma; managing child 

behaviors; first aid (including cardiopulmonary resuscitation (CPR) for the ages of the children in placement) and medication administration; and the importance of maintaining meaningful connections between the child and parents, including regular visitation. Foster parents 

must participate in ongoing training to receive instruction to support their parental roles and 

ensure the parent is up to date with agency requirements. Further, this training may also include child-specific training and/or may address issues relevant to the general population of 

children in foster care. 

Summary—Training ............................................ The proposed training standards include both pre-licensing and ongoing training and include 

mandatory training topics. The purpose of the pre-licensing training standards is to provide 

information to applicants so they can make an informed decision about their commitment to 

foster a child. In addition, the pre-service training is to prepare the applicant to be licensed 

as a foster parent. This includes training on the reasonable and prudent parent standard per 

section 471(a)(24) of the Act. The ongoing training is to ensure the parent receives ongoing 

instruction to support their parental roles and remain up to date on policies, requirements, 

and services. Therefore, there are no mandatory topics, as these depend on agency priorities and specific individual needs. 

Foster Parent Assurances .................................. H. Foster Parent Assurances: Applicants must agree to comply with their roles and responsibilities as discussed with the title IV–E agency once a child is placed in their care. The title 

IV–E agency must require assurances including: 

a. Applicants will not use corporal or degrading punishment 

b. Applicants will not use any illegal substances, abuse alcohol by consuming it in excess 

amounts, or abuse legal prescription and/or nonprescription drugs by consuming them 

in excess amounts or using them contrary to as indicated. 

b. Applicants and their guests will not smoke in the family foster home, in any vehicle 

used to transport the child, or in the presence of the child in foster care. 

c. Applicants will adhere to the title IV–E agency’s reasonable and prudent parent standard per section 472(c)(1)(A)(ii)(I) of the Act. 

Summary—Foster Parent Assurances ............... There are four proposed foster parent assurances are broadly written to apply across title IV– 

E jurisdictions which cover corporal punishment, alcohol and drug use, the reasonable and 

prudent parent standard and smoking. Assurances help potential foster family to have a 

clear understanding of expectations prior to approval as a foster home, cover behaviors 

which cannot be verified as part of the home study and typically are expectations after a 

home is licensed. Title IV–E agencies may wish to develop additional assurances as appropriate to their jurisdiction. 

Dated: July 24, 2018. 

Steven Wagner, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. 2018–16380 Filed 7–31–18; 8:45 am] 

BILLING CODE 4148–25–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0007] 

Outsourcing Facility Fee Rates for 

Fiscal Year 2019 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fiscal year (FY) 2019 rates for the 

establishment and re-inspection fees 

related to entities that compound 

human drugs and elect to register as 

outsourcing facilities under the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act). The FD&C Act authorizes 

FDA to assess and collect an annual 

establishment fee from outsourcing 

facilities, as well as a re-inspection fee 

for each re-inspection of an outsourcing 

facility. This document establishes the 

FY 2019 rates for the small business 

establishment fee ($5,461), the nonsmall business establishment fee 

($18,375), and the re-inspection fee 

($16,382) for outsourcing facilities; 

provides information on how the fees 

for FY 2019 were determined; and 

describes the payment procedures 

outsourcing facilities should follow. 

These fee rates are effective October 1, 

2018, and will remain in effect through 

September 30, 2019. 

FOR FURTHER INFORMATION CONTACT: For 

more information on human drug 

compounding and outsourcing facility 

fees: Visit FDAs website at: https://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

PharmacyCompounding/default.htm. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices 37501 

For questions relating to this notice: 

Melissa Hurley, Office of Financial 

Management, Food and Drug 

Administration, 8455 Colesville Rd., 

COLE–14202J, Silver Spring, MD 

20993–0002, 240–402–4585. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Quality and Security Act 

(DQSA) contains important provisions 

relating to the oversight of 

compounding human drugs. Title I of 

this law, the Compounding Quality Act, 

created a new section 503B in the FD&C 

Act (21 U.S.C. 353b). Under section 

503B of the FD&C Act, a human drug 

compounder can become an 

‘‘outsourcing facility.’’ 

Outsourcing facilities, as defined in 

section 503B(d)(4) of the FD&C Act, are 

facilities that meet all of the conditions 

described in section 503B(a), including 

registering with FDA as an outsourcing 

facility and paying an annual 

establishment fee. If the conditions of 

section 503B are met, a drug 

compounded by or under the direct 

supervision of a licensed pharmacist in 

an outsourcing facility is exempt from 

three sections of the FD&C Act: (1) 

Section 502(f)(1) (21 U.S.C. 352(f)(1)) 

concerning the labeling of drugs with 

adequate directions for use; (2) section 

505 (21 U.S.C. 355) concerning the 

approval of human drug products under 

new drug applications (NDAs) or 

abbreviated new drug applications 

(ANDAs); and (3) section 582 (21 U.S.C. 

360eee–1) concerning drug supply chain 

security requirements. Drugs 

compounded in outsourcing facilities 

are not exempt from the requirements of 

section 501(a)(2)(B) of the FD&C Act (21 

U.S.C. 351(a)(2)(B)) concerning current 

good manufacturing practice 

requirements for drugs. 

Section 744K of the FD&C Act (21 

U.S.C. 379j–62) authorizes FDA to 

assess and collect the following fees 

associated with outsourcing facilities: 

(1) An annual establishment fee from 

each outsourcing facility and (2) a reinspection fee from each outsourcing 

facility subject to a re-inspection (see 

section 744K(a)(1) of the FD&C Act). 

Under statutorily defined conditions, a 

qualified applicant may pay a reduced 

small business establishment fee (see 

section 744K(c)(4) of the FD&C Act). 

FDA announced in the Federal 

Register of November 24, 2014 (79 FR 

69856), the availability of a final 

guidance for industry entitled ‘‘Fees for 

Human Drug Compounding Outsourcing 

Facilities Under Sections 503B and 

744K of the FD&C Act.’’ The guidance 

provides additional information on the 

annual fees for outsourcing facilities 

and adjustments required by law, reinspection fees, how to submit payment, 

the effect of failure to pay fees, and how 

to qualify as a small business to obtain 

a reduction of the annual establishment 

fee. This guidance can be accessed on 

FDA’s website at: https://www.fda.gov/ 

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/ 

UCM391102.pdf. 

II. Fees for FY 2019 

A. Methodology for Calculating FY 2019 

Adjustment Factors 

1. Inflation Adjustment Factor 

Section 744K(c)(2) of the FD&C Act 

specifies the annual inflation 

adjustment for outsourcing facility fees. 

The inflation adjustment has two 

components: One based on FDA’s 

payroll costs and one based on FDA’s 

non-payroll costs for the first 3 of the 4 

previous fiscal years. The payroll 

component of the annual inflation 

adjustment is calculated by taking the 

average change in FDA’s per-full time 

equivalent (FTE) personnel 

compensation and benefits (PC&B) in 

the first 3 of the 4 previous fiscal years 

(see section 744K(c)(2)(A)(ii) of the 

FD&C Act). FDA’s total annual spending 

on PC&B is divided by the total number 

of FTEs per fiscal year to determine the 

average PC&B per FTE. 

Table 1 summarizes the actual cost 

and FTE data for the specified fiscal 

years, and provides the percent change 

from the previous fiscal year and the 

average percent change over the first 3 

of the 4 fiscal years preceding FY 2019. 

The 3-year average is 2.4152 percent. 

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

Total FTE ......................................................................... 15,484 16,381 17,022 ................................

PC&B per FTE ................................................................. $144,168 $147,408 $151,660 ................................

Percent change from previous year ................................ 2.1136% 2.2474% 2.8845% 2.4152% 

Section 744K(c)(2)(A)(ii) of the FD&C 

Act specifies that this 2.4152 percent 

should be multiplied by the proportion 

of PC&B to total costs of an average FDA 

FTE for the same 3 fiscal years. 

TABLE 2—FDA PC&BS AS A PERCENT OF FDA TOTAL COSTS OF AN AVERAGE FTE 

Fiscal year 2015 2016 2017 3-year average 

Total PC&B ...................................................................... $2,232,304,000 $2,414,728,159 $2,581,551,000 ................................

Total Costs ....................................................................... $4,510,565,000 $4,666,236,000 $5,104,580,000 ................................

PC&B Percent .................................................................. 49.4906% 51.7490% 50.5732% 50.6043% 

The payroll adjustment is 2.4152 

percent multiplied by 50.6043 percent, 

or 1.2222 percent. 

Section 744K(c)(2)(A)(iii) of the FD&C 

Act specifies that the portion of the 

inflation adjustment for non-payroll 

costs for FY 2019 is equal to the average 

annual percent change in the Consumer 

Price Index (CPI) for urban consumers 

(U.S. City Average; Not Seasonally 

Adjusted; All items; Annual Index) for 

the first 3 years of the preceding 4 years 

of available data, multiplied by the 

proportion of all non-PC&B costs to total 

costs of an average FDA FTE for the 

same period. 

Table 2 provides the summary data 

for the percent change in the specified 

CPI for U.S. cities. These data are 

published by the Bureau of Labor 

Statistics and can be found on its 

website: https://data.bls.gov/cgi-bin/ 

surveymost?cu. The data can be viewed 

by checking the box marked ‘‘U.S. All 


sradovich on DSK3GMQ082PROD with NOTICES
37502 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices 

items, 1982–84 = 100—CUUR0000SA0’’ 

and then selecting ‘‘Retrieve Data.’’ 

TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN U.S. CITY AVERAGE CPI 

Year 2015 2016 2017 3-year average 

Annual CPI ....................................................................... 237.017 240.007 245.120 ................................

Annual Percent Change .................................................. 0.1187% 1.2615% 2.1304% 1.1702% 

Section 744K(c)(2)(A)(iii) of the FD&C 

Act specifies that this 1.1702 percent 

should be multiplied by the proportion 

of all non-PC&B costs to total costs of an 

average FTE for the same 3 fiscal years. 

The proportion of all non-PC&B costs to 

total costs of an average FDA FTE for 

FYs 2015 to 2017 is 49.3957 percent 

(100 percent ¥ 50.6043 percent = 

49.3957 percent). Therefore, the nonpay adjustment is 1.1702 percent times 

49.3957 percent, or 0.5780 percent. 

The PC&B component (1.2222 

percent) is added to the non-PC&B 

component (0.5780 percent), for a total 

inflation adjustment of 1.8002 percent 

(rounded). Section 744K(c)(2)(A)(i) of 

the FD&C Act specifies that one is 

added to that figure, making the 

inflation adjustment 1.018002. 

Section 744K(c)(2)(B) of the FD&C Act 

provides for this inflation adjustment to 

be compounded after FY 2015. This 

factor for FY 2019 (1.8002 percent) is 

compounded by adding one to it, and 

then multiplying it by one plus the 

inflation adjustment factor for FY 2018 

(7.2835 percent), as published in the 

Federal Register of August 2, 2017 (82 

FR 35962 at 35965). The result of this 

multiplication of the inflation factors for 

the 4 years since FY 2015 (1.018002 × 

1.072835) becomes the inflation 

adjustment for FY 2019. For FY 2019, 

the inflation adjustment is 9.2148 

percent (rounded). We then add one, 

making the FY 2019 inflation 

adjustment factor 1.092148. 

2. Small Business Adjustment Factor 

Section 744K(c)(3) of the FD&C Act 

specifies that in addition to the inflation 

adjustment factor, the establishment fee 

for non-small businesses is to be further 

adjusted for a small business adjustment 

factor. Section 744K(c)(3)(B) of the 

FD&C Act provides that the small 

business adjustment factor is the 

adjustment to the establishment fee for 

non-small businesses that is necessary 

to achieve total fees equaling the 

amount that FDA would have collected 

if no entity qualified for the small 

business exception in section 744K(c)(4) 

of the FD&C Act. Additionally, section 

744K(c)(5)(A) states that in establishing 

the small business adjustment factor for 

a fiscal year, FDA shall provide for the 

crediting of fees from the previous year 

to the next year if FDA overestimated 

the amount of the small business 

adjustment factor for such previous 

fiscal year. 

Therefore, to calculate the small 

business adjustment to the 

establishment fee for non-small 

businesses for FY 2019, FDA must 

estimate: (1) The number of outsourcing 

facilities that will pay the reduced fee 

for small businesses for FY 2019 and (2) 

the total fee revenue it would have 

collected if no entity had qualified for 

the small business exception (i.e., if 

each entity that registers as an 

outsourcing facility for FY 2019 were to 

pay the inflation-adjusted fee amount of 

$16,382). 

With respect to (1), FDA estimates 

that 14 entities will qualify for small 

business exceptions and will pay the 

reduced fee for FY 2019. With respect 

to (2), to estimate the total number of 

entities that will register as outsourcing 

facilities for FY 2019, FDA used data 

submitted by outsourcing facilities 

through the voluntary registration 

process, which began in December 2013. 

Accordingly, FDA estimates that 82 

outsourcing facilities, including 14 

small businesses, will be registered with 

FDA in FY 2019. 

If the projected 82 outsourcing 

facilities paid the full inflation-adjusted 

fee of $16,382, this would result in total 

revenue of $1,343,324 in FY 2019 

($16,382 × 82). However, 14 of the 

entities that are expected to register as 

outsourcing facilities for FY 2019 are 

projected to qualify for the small 

business exception and to pay one-third 

of the full fee ($5,461 × 14), totaling 

$76,454 instead of paying the full fee 

($16,382 × 14), which would total 

$229,348. This would leave a potential 

shortfall of $152,894 ($229,348 ¥ 

$76,454). 

Additionally, section 744K(c)(5)(A) of 

the FD&C Act states that in establishing 

the small business adjustment factor for 

a fiscal year, FDA shall provide for the 

crediting of fees from the previous year 

to the next year if FDA overestimated 

the amount of the small business 

adjustment factor for such previous 

fiscal year. FDA has determined that it 

is appropriate to credit excess fees 

collected from the last completed fiscal 

year, due to the inability to conclusively 

determine the amount of excess fees 

from the fiscal year that is in progress 

at the time this calculation is made. 

This crediting is done by comparing the 

small business adjustment factor for the 

last completed fiscal year, FY 2017 

($1,137), to what would have been the 

small business adjustment factor for FY 

2017 ($892) if FDA had estimated 

perfectly. 

The calculation for what the small 

business adjustment would have been if 

FDA had estimated perfectly begins by 

determining the total target collections 

(15,000 × [inflation adjustment factor] × 

[number of registrants]). For the most 

recent complete fiscal year, FY 2017, 

this was $1,219,449 ($15,837 × 77). The 

actual FY 2017 revenue from the 77 

total registrants (i.e., 71 registrants 

paying FY 2017 non-small business 

establishment fee and six small business 

registrants) paying establishment fees is 

$1,156,101. $1,156,101 is calculated as 

follows: (FY 2017 Non-Small Business 

Establishment Fee adjusted for inflation 

only) × (total number of registrants in 

FY 2017 paying Non-Small Business 

Establishment Fee) + (FY 2017 Small 

Business Establishment Fee) × (total 

number of small business registrants in 

FY 2017 paying Small Business 

Establishment Fee). $15,837 × 71 + 

$5,279 × 6 = $1,156,101. This left a 

shortfall of $63,348 from the estimated 

total target collection amount 

($1,219,449 ¥ $1,156,101). $63,348 

divided by the total number of 

registrants in FY 2017 paying Standard 

Establishment Fee (71) equals $892. 

The difference between the small 

business adjustment factor used in FY 

2017 and the small business adjustment 

factor that would have been used had 

FDA estimated perfectly; is $245 ($1,137 

¥ $892). The $245 (rounded to the 

nearest dollar) is then multiplied by the 

number of actual registrants who paid 

the standard fee for FY 2017 (71), which 

provides us a total excess collection of 

$17,380 in FY 2017. 

Therefore, to calculate the small 

business adjustment factor for FY 2019, 

FDA subtracts $17,380 from the 

projected shortfall of $152,894 for FY 

2019 to arrive at the numerator for the 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices 37503 

1To qualify for a small business reduction of the 

FY 2019 establishment fee, entities had to submit 

their exception requests by April 30, 2018. See 

section 744K(c)(4)(B) of the FD&C Act. The time for 

requesting a small business exception for FY 2019 

has now passed. An entity that wishes to request 

a small business exception for FY 2020 should 

consult section 744K(c)(4) of the FD&C Act and 

section III.D of FDA’s guidance for industry entitled 

‘‘Fees for Human Drug Compounding Outsourcing 

Facilities Under Sections 503B and 744K of the 

FD&C Act,’’ which can be accessed on FDA’s 

website at https://www.fda.gov/downloads/drugs/ 

guidancecomplianceregulatoryinformation/ 

guidances/ucm391102.pdf. 

small business adjustment amount, 

which equals $135,514. This number 

divided by 68 (the number of expected 

non-small businesses for FY 2019) is the 

small business adjustment amount for 

FY 2019, which is $1,993 (rounded to 

the nearest dollar). 

B. FY 2019 Rates for Small Business 

Establishment Fee, Non-Small Business 

Establishment Fee, and Re-Inspection 

Fee 

1. Establishment Fee for Qualified Small 

Businesses 1

The amount of the establishment fee 

for a qualified small business is equal to 

$15,000 multiplied by the inflation 

adjustment factor for that fiscal year, 

divided by three (see section 

744K(c)(4)(A) and (c)(1)(A) of the FD&C 

Act). The inflation adjustment factor for 

FY 2019 is 1.092148. See section II.A.1 

for the methodology used to calculate 

the FY 2019 inflation adjustment factor. 

Therefore, the establishment fee for a 

qualified small business for FY 2019 is 

one third of $16,382, which equals 

$5,461 (rounded to the nearest dollar). 

2. Establishment Fee for Non-Small 

Businesses 

Under section 744K(c) of the FD&C 

Act, the amount of the establishment fee 

for a non-small business is equal to 

$15,000 multiplied by the inflation 

adjustment factor for that fiscal year, 

plus the small business adjustment 

factor for that fiscal year, and plus or 

minus an adjustment factor to account 

for over- or under-collections due to the 

small business adjustment factor in the 

prior year. The inflation adjustment 

factor for FY 2019 is 1.092148. The 

small business adjustment amount for 

FY 2019 is $1,993. See section II.A.2 for 

the methodology used to calculate the 

small business adjustment factor for FY 

2019. Therefore, the establishment fee 

for a non-small business for FY 2019 is 

$15,000 multiplied by 1.092148 plus 

$1,993, which equals $18,375 (rounded 

to the nearest dollar). 

3. Re-Inspection Fee 

Section 744K(c)(1)(B) of the FD&C Act 

provides that the amount of the FY 2019 

re-inspection fee is equal to $15,000, 

multiplied by the inflation adjustment 

factor for that fiscal year. The inflation 

adjustment factor for FY 2019 is 

1.092148. Therefore, the re-inspection 

fee for FY 2019 is $15,000 multiplied by 

1.092148, which equals $16,382 

(rounded to the nearest dollar). There is 

no reduction in this fee for small 

businesses. 

C. Summary of FY 2019 Fee Rates 

TABLE 4—OUTSOURCING FACILITY

FEES

Qualified Small Business Establishment Fee ....................................... $5,461 

Non-Small Business Establishment 

Fee ................................................ 18,375 

Re-inspection Fee ............................ 16,382 

III. Fee Payment Options and 

Procedures 

A. Establishment Fee 

Once an entity submits registration 

information and FDA has determined 

that the information is complete, the 

entity will incur the annual 

establishment fee. FDA will send an 

invoice to the entity, via email to the 

email address indicated in the 

registration file, or via regular mail if 

email is not an option. The invoice will 

contain information regarding the 

obligation incurred, the amount owed, 

and payment procedures. A facility will 

not be registered as an outsourcing 

facility until it has paid the annual 

establishment fee under section 744K of 

the FD&C Act. Accordingly, it is 

important that facilities seeking to 

operate as outsourcing facilities pay all 

fees immediately upon receiving an 

invoice. If an entity does not pay the full 

invoiced amount within 15 calendar 

days after FDA issues the invoice, FDA 

will consider the submission of 

registration information to have been 

withdrawn and adjust the invoice to 

reflect that no fee is due. 

Outsourcing facilities that registered 

in FY 2018 and wish to maintain their 

status as an outsourcing facility in FY 

2019 must register during the annual 

registration period that lasts from 

October 1, 2018, to December 31, 2018. 

Failure to register and complete 

payment by December 31, 2018, will 

result in a loss of status as an 

outsourcing facility on January 1, 2019. 

Entities should submit their registration 

information no later than December 10, 

2018, to allow enough time for review 

of the registration information, 

invoicing, and payment of fees before 

the end of the registration period. 

B. Re-Inspection Fee 

FDA will issue invoices for each reinspection after the conclusion of the reinspection, via email to the email 

address indicated in the registration file 

or via regular mail if email is not an 

option. Invoices must be paid within 30 

days. 

C. Fee Payment Procedures 

1. The preferred payment method is 

online using electronic check 

(Automated Clearing House (ACH) also 

known as eCheck) or credit card 

(Discover, VISA, MasterCard, American 

Express). Secure electronic payments 

can be submitted using the User Fees 

Payment Portal at https://

userfees.fda.gov/pay. (Note: only full 

payments are accepted. No partial 

payments can be made online.) Once 

you search for your invoice, click ‘‘Pay 

Now’’ to be redirected to Pay.gov. 

Electronic payment options are based on 

the balance due. Payment by credit card 

is available for balances less than 

$25,000. If the balance exceeds this 

amount, only the ACH option is 

available. Payments must be made using 

U.S bank accounts as well as U.S. credit 

cards. 

2. If paying with a paper check: 

Checks must be in U.S. currency from 

a U.S. bank and made payable to the 

Food and Drug Administration. 

Payments can be mailed to: Food and 

Drug Administration, P.O. Box 979033, 

St. Louis, MO 63197–9000. If a check is 

sent by a courier that requests a street 

address, the courier can deliver the 

check to: U.S. Bank, Attn: Government 

Lockbox 979033, 1005 Convention 

Plaza, St. Louis, MO 63101. (Note: This 

U.S. Bank address is for courier delivery 

only. If you have any questions 

concerning courier delivery, contact the 

U.S. Bank at 314–418–4013). 

3. When paying by wire transfer, the 

invoice number must be included. 

Without the invoice number the 

payment may not be applied. Regarding 

re-inspection fees, if the payment 

amount is not applied, the invoice 

amount will be referred to collections. 

The originating financial institution 

may charge a wire transfer fee. If the 

financial institution charges a wire 

transfer fee, it is required that the 

outsourcing facility add that amount to 

the payment to ensure that the invoice 

is paid in full. Use the following 

account information when sending a 

wire transfer: New York Federal Reserve 

Bank, U.S. Dept of Treasury, TREAS 

NYC, 33 Liberty St., New York, NY 

10045, Acct. No. 75060099, Routing No. 

021030004, SWIFT: FRNYUS33. If 


sradovich on DSK3GMQ082PROD with NOTICES
37504 Federal Register / Vol. 83, No. 148 / Wednesday, August 1, 2018 / Notices 

needed, FDA’s tax identification 

number is 53–0196965. 

Dated: July 26, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16416 Filed 7–31–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0007] 

Prescription Drug 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 

rates for prescription drug user fees for 

fiscal year (FY) 2019. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act), as 

amended by the Prescription Drug User 

Fee Amendments of 2017 (PDUFA VI), 

authorizes FDA to collect application 

fees for certain applications for the 

review of human drug and biological 

products, and prescription drug 

program fees for certain approved 

products. This notice establishes the fee 

rates for FY 2019. 

FOR FURTHER INFORMATION CONTACT: Lola 

Olajide, Office of Financial 

Management, Food and Drug 

Administration, 8455 Colesville Rd., 

COLE–14541B, Silver Spring, MD 

20993–0002, 240–402–4244. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 735 and 736 of the FD&C Act 

(21 U.S.C. 379g and 379h, respectively) 

establish two different kinds of user 

fees. Fees are assessed as follows: (1) 

Application fees are assessed on certain 

types of applications for the review of 

human drug and biological products; 

and (2) prescription drug program fees 

are assessed on certain approved 

products (section 736(a) of the FD&C 

Act). When specific conditions are met, 

FDA may waive or reduce fees (section 

736(d) of the FD&C Act). 

For FY 2018 through FY 2022, the 

base revenue amounts for the total 

revenues from all PDUFA fees are 

established by PDUFA VI. The base 

revenue amount for FY 2019 is 

$935,903,507. The FY 2019 base 

revenue amount is adjusted for inflation 

and for the resource capacity needs for 

the process for the review of human 

drug applications (the capacity planning 

adjustment). An additional dollar 

amount specified in the statute (see 

section 736(b)(1)(F) of the FD&C Act) is 

then added to provide for additional 

full-time equivalent (FTE) positions to 

support PDUFA VI initiatives. The FY 

2019 revenue amount may be adjusted 

further, if necessary, to provide for 

sufficient operating reserves of 

carryover user fees. Finally, the amount 

is adjusted to provide for additional 

direct costs to fund PDUFA VI 

initiatives. Fee amounts are to be 

established each year so that revenues 

from application fees provide 20 percent 

of the total revenue, and prescription 

drug program fees provide 80 percent of 

the total revenue. 

This document provides fee rates for 

FY 2019 for an application requiring 

clinical data ($2,588,478), for an 

application not requiring clinical data 

($1,294,239), and for the prescription 

drug program fee ($309,915). These fees 

are effective on October 1, 2018, and 

will remain in effect through September 

30, 2019. For applications that are 

submitted on or after October 1, 2018, 

the new fee schedule must be used. 

II. Fee Revenue Amount for FY 2019 

The base revenue amount for FY 2019 

is $935,903,507 prior to adjustments for 

inflation, capacity planning, additional 

FTE, operating reserve, and additional 

direct costs (see section 736(b)(1) of the 

FD&C Act). 

A. FY 2018 Statutory Fee Revenue 

Adjustments for Inflation 

PDUFA VI specifies that the 

$935,903,507 is to be adjusted for 

inflation increases for FY 2019 using 

two separate adjustments—one for 

personnel compensation and benefits 

(PC&B) and one for non-PC&B costs (see 

section 736(c)(1) of the FD&C Act). 

The component of the inflation 

adjustment for payroll costs shall be one 

plus the average annual percent change 

in the cost of all PC&B paid per FTE 

positions at FDA for the first 3 of the 

preceding 4 FYs, multiplied by the 

proportion of PC&B costs to total FDA 

costs of the process for the review of 

human drug applications for the first 3 

of the preceding 4 FYs (see section 

736(c)(1)(A) and (c)(1)(B) of the FD&C 

Act). 

Table 1 summarizes the actual cost 

and FTE data for the specified FYs and 

provides the percent changes from the 

previous FYs and the average percent 

changes over the first three of the four 

FYs preceding FY 2019. The 3-year 

average is 2.4152 percent. 

TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGES

Fiscal year 2015 2016 2017 3-year average 

Total PC&B ...................................... $2,232,304,000 $2,414,728,159 $2,581,551,000 ........................................

Total FTE ......................................... 15,484 16,381 17,022 ........................................

PC&B per FTE ................................. $144,168 $147,408 $151,660 ........................................

Percent Change From Previous 

Year .............................................. 2.1136 2.2474 2.8845 2.4152 

The statute specifies that this 2.4152 

percent be multiplied by the proportion 

of PC&B costs to the total FDA costs of 

the process for the review of human 

drug applications. Table 2 shows the 

PC&B and the total obligations for the 

process for the review of human drug 

applications for the first three of the 

preceding four FYs. 

TABLE 2—PC&B AS A PERCENT OF TOTAL COST OF THE PROCESS FOR THE REVIEW OF HUMAN DRUG APPLICATIONS

Fiscal year 2015 2016 2017 3-year average 

Total PC&B ...................................... $615,483,892 $652,508,273 $711,016,627 ........................................

Total Costs ....................................... $1,127,664,528 $1,157,817,695 $1,206,657,269 ........................................

PC&B Percent .................................. 54.5804 56.3567 58.9245 56.6205 


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