43244 Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Annual 

frequency 

per response 

Total annual 

responses 

Hours per 

response Total hours 

Focus Group Interviews ....................................................... 8,800 1 8,800 1.75 15,400 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: September 8, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–19492 Filed 9–13–17; 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 2018 

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) 2018. The Federal Food, 

Drug, and Cosmetic Act (the 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 2018. 

FOR FURTHER INFORMATION CONTACT: 

Robert J. Marcarelli, Office of Financial 

Management, Food and Drug 

Administration, 8455 Colesville Rd., 

COLE–14202F, Silver Spring, MD 

20993–0002, 301–796–7223. 

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 on the following: 

(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 2018 is 

$878,590,000. The FY 2018 base 

revenue amount is to be 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 2018 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 2018 for an application requiring 

clinical data ($2,421,495), for an 

application not requiring clinical data 

($1,210,748), and for the prescription 

drug program fee ($304,162). These fees 

are effective on October 1, 2017, and 

will remain in effect through September 

30, 2018. For applications that are 

submitted on or after October 1, 2017, 

the new fee schedule must be used. 

II. Fee Revenue Amount for FY 2018 

The base revenue amount for FY 2018 

is $878,590,000 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 

$878,590,000 is to be adjusted for 

inflation increases for FY 2018 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 three of the 

preceding four 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 

three of the preceding four 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 2018. The 3-year 

average is 2.2354 percent. 

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

Fiscal year 2014 2015 2016 3-year 

average 

Total PC&B .............................................................................. $2,054,937,000 $2,232,304,000 $2,414,728,159 

Total FTE ................................................................................. 14,555 15,484 16,381 

PC&B per FTE ......................................................................... $141,184 $144,168 $147,408 

Percent Change From Previous Year ..................................... 2.3451 2.1136 2.2474 2.2354 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 43245 

The statute specifies that this 2.2354 

percent should 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 

three FYs. 

TABLE 2—PC&B AS A PERCENT OF FEE REVENUES SPENT ON THE PROCESS FOR THE REVIEW OF HUMAN DRUG

APPLICATIONS

Fiscal year 2014 2015 2016 3-year 

average 

Total PC&B .............................................................................. $585,260,720 $615,483,892 $652,508,273 

Total Costs ............................................................................... $1,077,263,695 $1,127,664,528 $1,157,817,695 

PC&B Percent .......................................................................... 54.3285 54.5804 56.3567 55.0885 

The payroll adjustment is 2.2354 

percent from table 1 multiplied by 

55.0885 percent (or 1.2314 percent). 

The statute specifies that the portion 

of the inflation adjustment for nonpayroll costs is the average annual 

percent change that occurred in the 

Consumer Price Index (CPI) for urban 

consumers (Washington-Baltimore, DCMD-VA-WV; 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 

costs other than PC&B costs to total 

costs of the process for the review of 

human drug applications for the first 

three years of the preceding four FYs 

(see section 736(c)(1)(B) of the FD&C 

Act). Table 3 provides the summary data 

for the percent changes in the specified 

CPI for the Washington-Baltimore area. 

The data are published by the Bureau of 

Labor Statistics and can be found on its 

Web site at: http://data.bls.gov/cgi-bin/ 

surveymost?cu. The data can be viewed 

by checking the box marked 

‘‘Washington-Baltimore All Items, 

November 1996=100—CUURA311SA0’’ 

and then selecting ‘‘Retrieve Data’’. 

TABLE 3—ANNUAL AND THREE-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-BALTIMORE AREA

Fiscal year 2014 2015 2016 3-year 

average 

Annual CPI ....................................................................................................... 154.847 155.353 157.180 

Annual Percent Change .................................................................................. 1.5390 0.3268 1.1760 1.0139 

The statute specifies that this 1.0139 

percent should be multiplied by the 

proportion of all costs other than PC&B 

to total costs of the process for the 

review of human drug applications 

obligated. Since 55.0885 percent was 

obligated for PC&B (as shown in table 

2), 44.9115 percent is the portion of 

costs other than PC&B (100 percent 

minus 55.0885 percent equals 44.9115 

percent). The non-payroll adjustment is 

1.0139 percent times 44.9115 percent, or 

0.4554 percent. 

Next, we add the payroll adjustment 

(1.2314 percent) to the non-payroll 

adjustment (0.4554 percent), for a total 

inflation adjustment of 1.6868 percent 

(rounded) for FY 2018. 

We then multiply the base revenue 

amount for FY 2018 ($878,590,000) by 

1.016868, yielding an inflation-adjusted 

amount of $893,410,056. 

B. FY 2018 Statutory Fee Revenue 

Adjustments for Capacity Planning 

The statute specifies that after 

$878,590,000 has been adjusted for 

inflation, the inflation-adjusted amount 

shall be further adjusted to reflect 

changes in the resource capacity needs 

for the process of human drug 

application reviews (see section 

736(c)(2) of the FD&C Act). The statute 

prescribes an interim capacity planning 

adjustment be utilized until a new 

methodology can be developed through 

a process involving an independent 

evaluation as well as obtaining public 

comment. The interim capacity 

planning adjustment is applied to FY 

2018 fee setting. 

To determine the FY 2018 capacity 

planning adjustment, FDA calculated 

the average number of each of the five 

elements specified in the capacity 

planning adjustment provision: (1) 

Human drug applications (new drug 

applications (NDAs)/biologics license 

applications (BLAs)); (2) active 

commercial investigational new drug 

applications (INDs) (IND applications 

that have at least one submission during 

the previous 12 months); (3) efficacy 

supplements; (4) manufacturing 

supplements; and (5) formal meetings, 

type A, B, B(EoP), C, and written 

responses only (WRO) issued in lieu of 

such formal meetings, over the 3-year 

period that ended on June 30, 2016, and 

the average number of each of these 

elements over the most recent 3-year 

period that ended June 30, 2017. 

The calculations are summarized in 

table 4. The 3-year averages for each 

element are provided in column 1 (‘‘3- 

Year Average Ending 2016’’) and 

column 2 (‘‘3-Year Average Ending 

2017’’). Column 3 reflects the percent 

change from column 1 to column 2. 

Column 4 shows the weighting factor for 

each element. The weighting factor 

methodology has been updated for 

PDUFA VI. The previous methodology 

relied on the relative value of the 

standard costs for the elements included 

in the adjuster, and summed to 100 

percent. The weighting factor now is the 

time invested in activities related to the 

element expressed as a percentage of 

total time invested in PDUFA activities, 

and will adjust only the costs attributed 

to the elements included in the model 

(hence the weighting factor does not 

now sum to 100 percent). Column 5 is 

the weighted percent change in each 

element. This is calculated by 

multiplying the weighting factor in each 

line in column 4 by the percent change 

in column 3. The values in column 5 are 

summed, reflecting an adjustment of 

2.5090 percent (rounded). 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
43246 Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 

1The PDUFA VI commitment letter can be 

viewed at https://www.fda.gov/downloads/ 

forindustry/userfees/prescriptiondruguserfee/ 

ucm511438.pdf. 

TABLE 4—CAPACITY PLANNING ADJUSTER (INTERIM METHODOLOGY) CALCULATION FOR FY 2018 

Element 

Column 1 Column 2 Column 3 Column 4 Column 5 

3-year 

average 

ending 2016 

3-year 

average 

ending 2017 

Percent 

change 

(column 1 

to column 2) 

Weighting 

factor 

(percent) 

Weighted 

percent 

change 

NDAs/BLAs .......................................................................... 147.3333 153.0000 3.8462 18.0915 0.6958 

Active Commercial INDs ...................................................... 7,598.0000 7,846.6667 3.2728 23.3890 0.7655 

Efficacy Supplements .......................................................... 196.3333 212.3333 8.1494 4.1848 0.3410 

Manufacturing Supplements ................................................ 2,368.0000 2,482.6667 4.8423 4.3690 0.2116 

Meetings Scheduled and WROs ......................................... 2,720.6667 2,940.0000 8.0617 6.1417 0.4951 

FY 2018 Capacity Planning Adjuster ........................... ........................ ........................ ........................ ........................ 2.5090 

Table 5 shows the calculation of the 

inflation and capacity planning adjusted 

amount for FY 2018. The FY 2018 base 

revenue amount, $878,590,000, shown 

on line 1 is multiplied by the inflation 

adjustment factor of 1.016868, resulting 

in the inflation-adjusted amount of 

$893,410,056 shown on line 3. That 

amount is then multiplied by one plus 

the capacity planning adjustment of 

2.5090 percent, resulting in the inflation 

and capacity planning adjusted amount 

of $915,825,714 shown on line 5. 

TABLE 5—PDUFA INFLATION AND CAPACITY PLANNING ADJUSTED AMOUNT FOR FY 2018, SUMMARY CALCULATION

FY 2018 Revenue Amount ...................................................................................................................................... $878,590,000 Line 1 

Inflation Adjustment Factor for FY 2018 (1 plus 1.6868 percent) ........................................................................... 1.016868 Line 2 

Inflation Adjusted Amount ........................................................................................................................................ $893,410,056 Line 3 

Capacity Planning Adjustment Factor for FY 2018 (1 plus 2.5090 percent) .......................................................... 1.025090 Line 4 

Inflation and Capacity Planning Adjusted Amount .................................................................................................. $915,825,714 Line 5 

The capacity planning adjustment 

adds $22,415,658 to the fee revenue 

amount for FY 2018. This increase is 

driven by the fact that the counts of 

elements for 2017 (year ending June 30) 

are at or near the highest levels since the 

first incorporation of the workload 

adjuster in 2003. The NDA/BLA count 

in 2017 is equal to the highest annual 

number recorded since the advent of the 

workload adjuster methodology in 2003. 

Active commercial INDs, efficacy 

supplements, and meetings/WROs are 

higher in 2017 than in any previous year 

recorded in the workload adjuster (note: 

Meetings/WROs are only counted back 

to 2014 while the other elements are 

counted back to 2003). The 

manufacturing supplement count is 

approximately 2 percent below the 

highest number recorded in the history 

of the workload adjuster. Comparing 

2017 to 2014, the first year included in 

the average in column 1 in the 

adjustment, NDA/BLAs are 12 percent 

higher, active commercial INDs are 10 

percent higher, efficacy supplements are 

25 percent higher, manufacturing 

supplements are 15 percent higher, and 

meetings scheduled and WROs are 27 

percent higher. This significant and 

across the board increase in submission 

activity is the driver of the $22,415,658 

upward adjustment to the fee revenue 

amount. 

Per the commitments made in PDUFA 

VI, this increase in the revenue amount 

will be allocated and used by 

organizational review components 

engaged in direct review work to 

enhance resources and expand staff 

capacity and capability (see II.A.4 on 

p.37 of the PDUFA VI commitment 

letter).1

C. FY 2018 Statutory Fee Revenue 

Adjustments for Additional Dollar 

Amounts 

PDUFA VI provides an additional 

dollar amount for each of the next five 

fiscal years for additional FTE to 

support PDUFA VI enhancements 

outlined in the PDUFA VI commitment 

letter. The amount for FY 2018 is 

$20,077,793 (see section 736(b)(1)(F) of 

the FD&C Act). Adding this amount to 

the inflation and capacity planning 

adjusted revenue amount, $915,825,714, 

equals $935,904,000 (rounded to the 

nearest thousand dollars). 

D. FY 2018 Statutory Fee Revenue 

Adjustments for Operating Reserve 

PDUFA VI provides for an operating 

reserve adjustment to allow FDA to 

increase the fee revenue and fees for any 

given fiscal year during PDUFA VI to 

maintain up to 14 weeks of operating 

reserve of carryover user fees. If the 

carryover balance exceeds 14 weeks of 

operating reserves, FDA is required to 

decrease fees to provide for not more 

than 14 weeks of operating reserves of 

carryover user fees. 

To determine the 14-week operating 

reserve amount, the FY 2018 annual 

base revenue adjusted for inflation and 

capacity planning, $915,825,714, is 

divided by 52, and then multiplied by 

14. The 14-week operating reserve 

amount for FY 2018 is $246,568,461. 

To determine the end of year 

operating reserve amount, the Agency 

must assess actual operating reserve at 

the end of the third quarter of FY 2017, 

and forecast collections and obligations 

in the fourth quarter of FY 2017. The 

estimated end of year FY 2017 operating 

reserve is $279,856,044. 

Because the estimated end of year FY 

2017 PDUFA operating reserve exceeds 

the 14-week operating reserve for FY 

2018, FDA will reduce the FY 2018 

PDUFA fee revenue of $935,903,507 by 

$33,287,582, resulting in an adjusted fee 

revenue of $902,615,925. 

E. FY 2018 Statutory Fee Revenue 

Adjustments for Additional Direct Cost 

PDUFA VI specifies that $8,730,000 

be added in addition to the operating 

reserve adjustment to account for 

additional direct costs in FY 2018. This 

additional direct cost adjustment will be 

adjusted for inflation each year 

beginning in FY 2019. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 43247 

The final FY 2018 PDUFA fee revenue 

is $911,346,000 (rounded to the nearest 

thousand dollars). 

III. Application Fee Calculations 

A. Application Fee Revenues and 

Application Fees 

Application fees will be set to 

generate 20 percent of the total revenue 

amount, or $182,269,200 in FY 2018. 

B. Estimate of the Number of Fee-Paying 

Applications and Setting the 

Application Fees 

FDA will estimate the total number of 

fee-paying full application equivalents 

(FAEs) it expects to receive during the 

next FY by averaging the number of feepaying FAEs received in the three most 

recently completed FYs. Prior year FAE 

totals are updated annually to reflect 

refunds and waivers processed after the 

close of the FY. 

In estimating the number of feepaying FAEs, a full application 

requiring clinical data counts as one 

FAE. An application not requiring 

clinical data counts as one-half of an 

FAE. An application that is withdrawn 

before filing, or refused for filing, counts 

as one-fourth of an FAE if the applicant 

initially paid a full application fee, or 

one-eighth of an FAE if the applicant 

initially paid one-half of the full 

application fee amount. Prior to PDUFA 

VI, the FAE amount also included 

supplements; supplements have been 

removed from the FAE calculation as 

the supplement fee has been 

discontinued in PDUFA VI. 

As table 6 shows, the average number 

of fee-paying FAEs received annually in 

the most recent 3-year period is 

75.271347 FAEs. FDA will set fees for 

FY 2018 based on this estimate as the 

number of full application equivalents 

that will pay fees. 

TABLE 6—FEE-PAYING FAES

FY 2014 2015 2016 3-year 

average 

Fee-Paying FAEs ............................................................................................. 73.375000 81.955603 70.483437 75.271347 

Note: Prior year FAE totals are updated annually to reflect refunds and waivers processed after the close of the FY. 

The FY 2018 application fee is 

estimated by dividing the average 

number of full applications that paid 

fees over the latest 3 years, 75.271347, 

into the fee revenue amount to be 

derived from application fees in FY 

2018, $182,269,200. The result is a fee 

of $2,421,495 per full application 

requiring clinical data, and $1,210,748 

per application not requiring clinical 

data. 

IV. Fee Calculations for Prescription 

Drug Program Fees 

PDUFA VI renamed the product fee 

the ‘‘prescription drug program fee’’; in 

addition, PDUFA VI introduced a 

limitation that an applicant will not be 

assessed more than five program fees for 

a fiscal year for prescription drug 

products identified in a single approved 

NDA or BLA (see section 736(a)(2)(C)). 

The program fee was also modified so 

that applicants are assessed a program 

fee only for prescription drug products 

identified in a human drug application 

approved as of October 1 of such fiscal 

year. 

FDA estimates 2,461 program fees 

will be invoiced in FY 2018 before 

factoring in waivers, refunds, and 

exemptions. FDA approximates that 

there will be 27 waivers and refunds 

granted. In addition, FDA approximates 

that another 37 program fees will be 

exempted in FY 2018 based on the 

orphan drug exemption in section 

736(k) of the FD&C Act. FDA estimates 

2,397 program fees in FY 2018, after 

allowing for an estimated 64 waivers 

and reductions, including the orphan 

drug exemptions. The FY 2018 

prescription drug program fee rate is 

calculated by dividing the adjusted total 

revenue from program fees 

($729,076,800) by the estimated 2,397 

program fees, for a FY 2018 program fee 

of $304,162. 

V. Fee Schedule for FY 2018 

The fee rates for FY 2018 are 

displayed in table 7: 

TABLE 7—FEE SCHEDULE FOR FY 

2018 

Fee category Fee rates 

for FY 2018 

Application: 

Requiring clinical data ....... $2,421,495 

Not requiring clinical data 1,210,748 

Program ................................ 304,162 

VI. Fee Payment Options and 

Procedures 

A. Application Fees 

The appropriate application fee 

established in the new fee schedule 

must be paid for any application subject 

to fees under PDUFA that is received on 

or after October 1, 2017. Payment must 

be made in U.S. currency by electronic 

check, check, bank draft, wire transfer, 

or U.S. postal money order payable to 

the order of the Food and Drug 

Administration. 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, select ‘‘Pay 

Now’’ to be redirected to Pay.gov. 

Payment by credit card is available for 

balances that are 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. 

FDA has partnered with the U.S. 

Department of the Treasury to use 

Pay.gov, a web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA Web site after the 

user fee ID number is generated. 

Please include the user fee 

identification (ID) number on your 

check, bank draft, or postal money 

order. Mail your payment to: Food and 

Drug Administration, P.O. Box 979107, 

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

bank draft, or money order is to be sent 

by a courier that requests a street 

address, the courier should deliver your 

payment to: U.S. Bank, Attention: 

Government Lockbox 979107, 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. 

This telephone number is only for 

questions about courier delivery). Please 

make sure that the FDA post office box 

number (P.O. Box 979107) is written on 

the check, bank draft, or postal money 

order. 

If paying by wire transfer, please 

reference your unique user fee ID 

number when completing your transfer. 

The originating financial institution 

may charge a wire transfer fee. Please 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
43248 Federal Register / Vol. 82, No. 177 / Thursday, September 14, 2017 / Notices 

ask your financial institution about the 

fee and add it to your payment to ensure 

that your fee is fully paid. The account 

information for wire transfers is as 

follows: U.S. Department of the 

Treasury, TREAS NYC, 33 Liberty St., 

New York, NY 10045, Acct. No.: 

75060099, Routing No.: 021030004, 

SWIFT: FRNYUS33, Beneficiary: FDA, 

8455 Colesville Rd., 14th Floor, Silver 

Spring, MD 20993–0002. If needed, 

FDA’s tax identification number is 53– 

0196965. 

B. Prescription Drug Program Fees 

FDA plans to issue invoices and 

payment instructions for FY 2018 

program fees under the new fee 

schedule in September 2017. Payment 

will be due on October 1, 2017. FDA 

plans to issue invoices in December 

2017 for FY 2018 program fees that 

qualify for fee assessments after the 

initial 2017 billing. 

Dated: September 8, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–19494 Filed 9–13–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

Waiver of Compliance With Navigation 

Laws; Hurricanes Harvey and Irma 

AGENCY: Office of the Secretary, 

Department of Homeland Security. 

ACTION: Notice. 

Hurricane Harvey striking the U.S. 

Gulf Coast has resulted in severe 

disruptions in both the midstream and 

downstream sectors of the oil supply 

system. Some refineries and pipeline 

networks are shut-in or running at 

reduced rates. In addition, conditions 

exist for a potential imminent shortage 

of energy supply in areas predicted to be 

affected by Hurricane Irma. In light of 

the impact on the affected region’s 

energy needs, the Department of Energy 

(DOE) has recommended that the 

Department of Homeland Security 

waive the requirements of the Jones Act 

in the interest of national defense to 

facilitate the transportation of the 

necessary volume of petroleum products 

for a 7-day period. Furthermore, the 

Department of Defense (DoD) has 

requested a 7-day waiver of the Jones 

Act in the interest of national defense, 

commencing immediately. 

The Jones Act, 46 United States Code 

(U.S.C.) 55102, states ‘‘a vessel may not 

provide any part of the transportation of 

merchandise by water, or by land and 

water, between points in the United 

States to which the coastwise laws 

apply, either directly or via a foreign 

port’’ unless the vessel was built in and 

documented under the laws of the 

United States and is wholly owned by 

persons who are citizens of the United 

States. Such a vessel, after obtaining a 

coastwise endorsement from the U.S. 

Coast Guard, is ‘‘coastwise-qualified.’’ 

The coastwise laws generally apply to 

points in the territorial sea, which is 

defined as the belt, three nautical miles 

wide, seaward of the territorial sea 

baseline, and to points located in 

internal waters, landward of the 

territorial sea baseline. 

The navigation laws, including the 

coastwise laws, can be waived under the 

authority provided by 46 U.S.C. 501. 

The statute provides in relevant part, 

‘‘On request of the Secretary of Defense, 

the head of an agency responsible for 

the administration of the navigation or 

vessel-inspection laws shall waive 

compliance with those laws to the 

extent the Secretary considers necessary 

in the interest of national defense.’’ 46 

U.S.C. 501(a). 

For the reasons stated above, and in 

light of the request from the Department 

of Defense and the concurrence of the 

Department of Energy, I am exercising 

my authority to waive the Jones Act for 

a 7-day period, commencing 

immediately, to facilitate movement of 

refined petroleum products, including 

gasoline, diesel, and jet fuel—to be 

shipped from New York, Pennsylvania, 

Texas, and Louisiana to South Carolina, 

Georgia, Florida, and Puerto Rico. This 

waiver applies to covered merchandise 

laded on board a vessel within the 7 day 

period of the waiver. 

Executed this 8th day of September, 2017. 

Elaine C. Duke, 

Acting Secretary of Homeland Security. 

[FR Doc. 2017–19523 Filed 9–13–17; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

[OMB Control Number 1615–0131] 

Agency Information Collection 

Activities; Revision of a Currently 

Approved Collection: USCIS Electronic 

Payment Processing 

AGENCY: U.S. Citizenship and 

Immigration Services, Department of 

Homeland Security. 

ACTION: 60-Day notice. 

SUMMARY: The Department of Homeland 

Security (DHS), U.S. Citizenship and 

Immigration (USCIS) invites the general 

public and other Federal agencies to 

comment upon this proposed revision of 

a currently approved collection of 

information. In accordance with the 

Paperwork Reduction Act (PRA) of 

1995, the information collection notice 

is published in the Federal Register to 

obtain comments regarding the nature of 

the information collection, the 

categories of respondents, the estimated 

burden (i.e. the time, effort, and 

resources used by the respondents to 

respond), the estimated cost to the 

respondent, and the actual information 

collection instruments. 

DATES: Comments are encouraged and 

will be accepted for 60 days until 

November 13, 2017. 

ADDRESSES: All submissions received 

must include the OMB Control Number 

1615–0131 in the body of the letter, the 

agency name and Docket ID USCIS– 

2014–0005. To avoid duplicate 

submissions, please use only one of the 

following methods to submit comments: 

(1) Online. Submit comments via the 

Federal eRulemaking Portal Web site at 

http://www.regulations.gov under eDocket ID number USCIS–2014–0005; 

(2) Mail. Submit written comments to 

DHS, USCIS, Office of Policy and 

Strategy, Chief, Regulatory Coordination 

Division, 20 Massachusetts Avenue 

NW., Washington, DC 20529–2140. 

FOR FURTHER INFORMATION CONTACT: 

USCIS, Office of Policy and Strategy, 

Regulatory Coordination Division, 

Samantha Deshommes, Chief, 20 

Massachusetts Avenue NW., 

Washington, DC 20529–2140, telephone 

number 202–272–8377 (This is not a 

toll-free number. Comments are not 

accepted via telephone message). Please 

note contact information provided here 

is solely for questions regarding this 

notice. It is not for individual case 

status inquiries. Applicants seeking 

information about the status of their 

individual cases can check Case Status 

Online, available at the USCIS Web site 

at http://www.uscis.gov, or call the 

USCIS National Customer Service 

Center at 800–375–5283 (TTY 800–767– 

1833). 

SUPPLEMENTARY INFORMATION: 

Comments 

You may access the information 

collection instrument with instructions, 

or additional information by visiting the 

Federal eRulemaking Portal site at: 

http://www.regulations.gov and enter 

USCIS–2014–0005 in the search box. 

Regardless of the method used for 

submitting comments or material, all 


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