Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Proposed Rules 52217 

(e) Reason 

This AD was prompted by mandatory 

continuing airworthiness information (MCAI) 

originated by an aviation authority of another 

country to identify and correct an unsafe 

condition on an aviation product. The MCAI 

describes the unsafe condition as humidity in 

the horizontal stabilizer on airplanes subject 

to severe environmental conditions. We are 

issuing this AD to detect and correct 

corrosion of the horizontal stabilizer (HS) 

spar, which could lead to result in buckling 

and permanent HS distortion, possibly 

resulting in reduced control. 

(f) Actions and Compliance 

Unless already done, do the actions in 

paragraphs (f)(1) through (f)(5) of this AD: 

(1) Within 13 months after the effective 

date of this AD and repetitively thereafter at 

intervals not to exceed 72 months, do a 

special detailed inspection of the HS spar 

following the instructions of DAHER– 

SOCATA TB Aircraft Mandatory Service 

Bulletin SB 10–152, Amendment 1, dated 

April 2015. 

(2) If no discrepancy is detected during any 

inspections required by paragraph (f)(1) of 

this AD, protect the HS spar following the 

instructions of DAHER–SOCATA TB Aircraft 

Mandatory Service Bulletin SB 10–152, 

Amendment 1, dated April 2015. 

(3) If any discrepancy is detected during 

any inspection required by paragraph (f)(1) of 

this AD, before further flight, do the 

applicable corrective action(s) following the 

instructions of DAHER–SOCATA TB Aircraft 

Mandatory Service Bulletin SB 10–152, 

Amendment 1, dated April 2015. 

(4) Accomplishment of protection or 

corrective actions on an airplane as required 

by paragraph (f)(2) or (f)(3) of this AD, as 

applicable, does not constitute terminating 

action for the repetitive inspections as 

required by paragraph (f)(1) of this AD for 

that airplane. 

(5) Inspections and corrective actions on an 

airplane, done before the effective date of this 

AD following the instructions of DAHER– 

SOCATA TB Aircraft Recommended Service 

Bulletin SB 10–152, dated May 2013, are 

acceptable to comply with the requirements 

of this AD for that airplane. After the 

effective date of this AD, repetitive 

inspections and applicable corrective actions, 

as required by this AD, must be done as 

required by paragraph (f)(1) of this AD 

following the instructions of DAHER– 

SOCATA TB Aircraft Mandatory Service 

Bulletin SB 10–152, Amendment 1, dated 

April 2015. 

(g) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, Standards Office, 

FAA, has the authority to approve AMOCs 

for this AD, if requested using the procedures 

found in 14 CFR 39.19. Send information to 

ATTN: Albert Mercado, Aerospace Engineer, 

FAA, Small Airplane Directorate, 901 Locust, 

Room 301, Kansas City, Missouri 64106; 

telephone: (816) 329–4119; fax: (816) 329– 

4090; email: albert.mercado@faa.gov. Before 

using any approved AMOC on any airplane 

to which the AMOC applies, notify your 

appropriate principal inspector (PI) in the 

FAA Flight Standards District Office (FSDO), 

or lacking a PI, your local FSDO. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(h) Related Information 

Refer to MCAI European Aviation Safety 

Agency (EASA) AD No. 2015–0130, dated 

July 7, 2015; and DAHER–SOCATA TB 

Aircraft Recommended Service Bulletin SB 

10–152, dated May 2013, for related 

information. You may examine the MCAI on 

the Internet at http://www.regulations.gov by 

searching for and locating Docket No. FAA– 

2015–3642. For service information related to 

this AD, contact SOCATA, Direction des 

Services, 65921 Tarbes Cedex 9, France; 

telephone: 33 (0)5 62.41.73.00; fax: 33 (0)5 

62.41.76.54; or SOCATA North America, 

North Perry Airport, 7501 S Airport Rd., 

Pembroke Pines, Florida 33023, telephone: 

(954) 893–1400; fax: (954) 964–4141; 

Internet: http://www.socata.com. You may 

review this referenced service information at 

the FAA, Small Airplane Directorate, 901 

Locust, Kansas City, Missouri 64106. For 

information on the availability of this 

material at the FAA, call (816) 329–4148. 

Issued in Kansas City, Missouri, on August 

20, 2015. 

Earl Lawrence, 

Manager, Small Airplane Directorate, Aircraft 

Certification Service. 

[FR Doc. 2015–21283 Filed 8–27–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 187 

[Docket No.: FAA–2015–3597; Notice No. 

15–06] 

RIN 2120–AK53 

Update of Overflight Fee Rates 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: This proposed rule would 

update existing overflight fee rates using 

more current FAA cost accounting and 

air traffic activity data. Overflight fees 

are charges for aircraft flights that transit 

U.S.-controlled airspace, but neither 

land in nor depart from the United 

States. Overflight fee rates were last 

updated in 2011. As a result, the FAA 

is not recovering the full cost of the 

services it provides. The FAA proposes 

to increase the rates for Enroute and 

Oceanic overflights based on fiscal year 

2013 cost and air traffic activity data. 

The FAA proposes to phase in this rate 

increase over three years in equal 

percentage terms. This is a less 

burdensome approach than the 

alternative of phasing in the new rates 

in equal absolute terms, and is the same 

methodology used in the previous 

rulemaking. Finally, the FAA proposes 

several organizational and clarifying 

revisions to the overflight fee 

requirements. 

DATES: Send comments on or before 

October 27, 2015. 

ADDRESSES: Send comments identified 

by docket number FAA–2015–3597 

using any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov and follow 

the online instructions for sending your 

comments electronically. 

• Mail: Send comments to Docket 

Operations, M–30; U.S. Department of 

Transportation (DOT), 1200 New Jersey 

Avenue SE., Room W12–140, West 

Building Ground Floor, Washington, DC 

20590–0001. 

• Hand Delivery or Courier: Take 

comments to Docket Operations in 

Room W12–140 of the West Building 

Ground Floor at 1200 New Jersey 

Avenue SE., Washington, DC, between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. 

• Fax: Fax comments to Docket 

Operations at 202–493–2251. 

Privacy: In accordance with 5 U.S.C. 

553(c), DOT solicits comments from the 

public to better inform its rulemaking 

process. DOT posts these comments, 

without edit, including any personal 

information the commenter provides, to 

www.regulations.gov, as described in 

the system of records notice (DOT/ALL– 

14 FDMS), which can be reviewed at 

www.dot.gov/privacy. 

Docket: Background documents or 

comments received may be read at 

http://www.regulations.gov at any time. 

Follow the online instructions for 

accessing the docket or go to the Docket 

Operations in Room W12–140 of the 

West Building Ground Floor at 1200 

New Jersey Avenue SE., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: For 

technical questions concerning this 

action, contact Aleksandra Damsz, 

Financial Analyst, Office of Financial 

Analysis, AFA–400, Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 20591; 

telephone (202) 267–8055; email 

aleksandra.damsz@faa.gov. 


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52218 Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Proposed Rules 

1 ICAO’s Policies on Charges for Airports and Air 

Navigation Services, Document 9082, at 15–06 

(2009). 

2Pub. L. 104–264, 110 Stat. 3213 (Oct. 9, 1996). 

The statutory authority has been updated several 

times, most recently with section 122 of the FAA 

Modernization and Reform Act of 2012. Pub. L. 

112–95, 126 Stat. 19 (Feb. 14, 2012). 

3 66 FR 43680 (Aug. 20, 2001). A full discussion 

of the history of overflight fees can be found in the 

Update of August 2001 Overflight Fees final rule. 

See 76 FR 43112, 43112–43114 (Jul. 20, 2011). 

4TFMS was formerly known as the Enhanced 

Traffic Management System (ETMS). 

5 76 FR 43112 (Jul. 20, 2011). 

6A copy of the ‘‘Recommendation of the Industry 

Members of the 2013/2014 FAA Aviation 

Rulemaking Committee on Overflight Fees’’ is 

available in the docket for this rulemaking. 

For legal questions concerning this 

action, contact Jonathan Cross, Office of 

the Chief Counsel, Federal Aviation 

Administration, 800 Independence 

Avenue SW., Washington, DC 20591; 

telephone (202) 267–7173; email 

jonathan.cross@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Authority for This Rulemaking 

The FAA’s authority to issue rules 

establishing fees is found in Title 49 of 

the United States Code. Subtitle I, 

Section 106 describes the authority of 

the FAA Administrator. Subtitle VII, 

Aviation Programs, describes in more 

detail the scope of the agency’s 

authority. 

This rulemaking is promulgated 

under the authority described in 

Chapter 453, Section 45301 et seq. 

Under that Chapter, the FAA is charged 

with prescribing regulations for the 

collection of fees for air traffic control 

and related services provided to aircraft, 

other than military and civilian aircraft 

of the United States Government or a 

foreign government, that transit U.S.- 

controlled airspace, but neither take off 

from nor land in the United States 

(‘‘overflights’’). This rulemaking is 

within the scope of that authority. 

I. Executive Summary 

The FAA proposes to increase the 

rates for Enroute and Oceanic 

overflights over a 3-year period to bring 

cost recovery from Fiscal Year (FY) 2008 

recovery to FY 2013 recovery. The 

following table shows the proposed 

increases. 

TABLE 1—PROPOSED RATE INCREASES FOR ENROUTE AND OCEANIC OVERFLIGHTS

Revision date 

Enroute rate 

(per 100 

nautical miles) 

Oceanic rate 

(per 100 

nautical miles) 

Current Rate ............................................................................................................................................................ $56.86 $21.63 

October 1, 2015 ....................................................................................................................................................... 58.45 23.15 

October 1, 2016 ....................................................................................................................................................... 60.07 24.77 

October 1, 2017 ....................................................................................................................................................... 61.75 26.51 

The International Civil Aviation 

Organization (ICAO) recommends that 

the ‘‘cost to be shared is the full cost of 

providing the air navigation services’’ 

and that the ‘‘approach toward the 

recovery of full costs should be a 

gradual progression.’’ 1 The FAA 

requests comments on whether it should 

expedite the rate of increase to achieve 

full cost recovery before 2017. 

The FAA also proposes several 

organizational and content revisions to 

part 187 to clarify the overflight fees 

requirements. 

Summary of Costs and Benefits of the 

Proposed Rule 

The higher overflight rates based on 

FY 2013 unit costs would allow the 

FAA to move closer to full cost recovery 

of air traffic control services already 

being provided to operators. The present 

value of the projected fee increases 

through FY 2018—when the full 

increase in rates would have taken 

place—would be $9,560,692 for foreign 

operators and $141,888 for domestic 

operators. The updated fees would 

provide greater incentives for foreign 

and domestic operators to economize on 

U.S. air traffic control facilities and 

U.S.-controlled airspace, thus increasing 

the efficient allocation of resources. 

II. Background 

History of Overflight Fees 

The FAA’s overflight fees were 

initially authorized in section 273 of the 

Federal Aviation Reauthorization Act of 

1996.2 After a series of legal challenges 

and refinements, overflight fees were 

implemented in their current form in 

2001.3 Since that time the fee rates have 

been based on cost data from the FAA’s 

Cost Accounting System (CAS) and air 

traffic data from the FAA’s Traffic Flow 

Management System (TFMS 4). They 

were last updated in 2011.5 The 2011 

final rule updated the existing rates by 

using cost and activity data for FY 2008. 

Because the rates had not been updated 

for 9 years, and the total Enroute and 

Oceanic rate increases were significant, 

the FAA decided to phase in the 

increases. The 2011 final rule phased in 

the increases over a 4-year period, with 

rate increases occurring on October 1 of 

2011, 2012, 2013, and 2014. Thus, on 

October 1, 2014, the FAA was 

recovering the amounts that would have 

produced full cost recovery in FY 2008. 

Aviation Rulemaking Committee 

The FAA established and chartered an 

Overflight Fees Aviation Rulemaking 

Committee (ARC) consisting of foreign 

air carriers (and trade associations of 

those carriers) that are subject to the 

FAA’s overflight fees. The ARC was 

chartered on May 1, 2013, with the task 

to provide the FAA a report detailing 

recommendations for tasks moving 

forward with the overflight fees update 

process. 

The ARC met with the FAA on June 

12, 2013, and on January 23, 2014. On 

February 14, 2014, the ARC submitted 

several recommendations on future 

overflight rate updates.6

The ARC recommended that the FAA 

increase overflight rates annually from 

FY 2016 (beginning October 1, 2015) 

through FY 2018 (beginning October 1, 

2017) at the compounded annual growth 

rate (CAGR) of FY 2008 through FY 

2013 FAA costs, calculated separately 

for the Enroute and Oceanic rates. 

Calculations from CAS show this would 

result in an annual increase of 1.72% for 

Enroute fees, and an annual increase of 

3.76% for Oceanic fees. In other words, 

the ARC proposed that the FAA phase 

in the rate increases using equal annual 

percentage increases as done in the 2011 

final rule. The final proposed fees are 

listed in the table below: 


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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Proposed Rules 52219 

7See 76 FR 43112, 43114–43116 (Jul. 20, 2011). 

8A copy of the ‘‘Costing Methodology Report 

Fiscal Year 2013’’ is available in the docket for this 

rulemaking. 

9A copy of the ‘‘Description of U.S.-Controlled 

Airspace’’ is available in the docket for this 

rulemaking. 

TABLE 2—ARC PROPOSED RATE INCREASES FOR ENROUTE AND OCEANIC OVERFLIGHTS

Revision date 

ARC-Proposed 

enroute rate 

(per 100 

nautical miles) 

ARC-Proposed 

oceanic rate 

(per 100 

nautical miles) 

Current Rate ............................................................................................................................................................ $56.86 $21.63 

October 1, 2015 ....................................................................................................................................................... 57.77 22.40 

October 1, 2016 ....................................................................................................................................................... 58.75 23.23 

October 1, 2017 ....................................................................................................................................................... 59.75 24.09 

The ARC stated that while it does not 

challenge the use of CAS as a basis for 

setting the fee, it does not endorse the 

current methodology as a whole and 

recommends that the cost base exclude 

certain elements of the FAA’s overhead 

and other non-overflight related costs. 

Similar recommendations were 

proffered in comments leading to the 

2011 final rule.7 In consideration of this 

ARC recommendation, the FAA has 

reviewed its costing methodology and 

determined that the best approach is to 

update the methodology to exclude 

Enroute Guam and San Juan costs from 

total FAA costs since these combined 

control facilities may handle a mix of 

general and commercial aviation traffic. 

Enroute costs for Honolulu were already 

excluded and are handled similarly to 

Guam and San Juan. With this 

approach, Enroute costs for Guam, San 

Juan and Honolulu, which are similar 

facility types, are being treated in the 

same manner. Additionally, to be 

consistent with the treatment of costs 

for these facilities, flight miles for 

Honolulu and Guam are being excluded 

from Enroute and Oceanic miles 

respectively in estimating the fees. With 

this change, the treatment of miles for 

Honolulu, Guam and San Juan are in 

line with the treatment of costs and are 

consistent with FAA air traffic boundary 

definitions. The FAA’s costs used for 

this fee calculation are total costs 

because the services provided benefit all 

system users, including overflight users. 

As stated in 2011, any costs related to 

low activity airports and airfields where 

traffic is controlled by Enroute 

controllers are de minimus. Finally, the 

allocation of overhead is consistent with 

the currently implemented methodology 

and with generally accepted accounting 

principles. 

The ARC industry members 

recommended that the FAA include all 

traffic receiving services from the FAA 

ATO personnel in Enroute and Oceanic 

Air Route Traffic Control Centers 

(ARTCCs) in the determination of the 

flight miles that are used in the rate 

calculation. The ARC contended that 

currently only filed flight plans (IFR/

VFR) are used in the fee calculation 

while a significant portion of the traffic 

consists of the unfiled VFR traffic using 

flight following or being actively 

separated from IFR. 

For this rulemaking, the ARC 

recommendation is consistent with the 

FAA’s approach to determine the total 

miles used to calculate the overflight fee 

rate. VFR aircraft, which use flightfollowing services without filing a flight 

plan, are assigned discrete beacon codes 

and included as part of the total miles 

used to determine the fee rates. 

The ARC industry members also 

recommended that the FAA continue to 

engage in meaningful financial 

discussions with its stakeholders and 

provide full transparency on its cost 

development through CAS. The 

industry members recommended that 

the FAA provide the industry (including 

the non-ARC members) on an annual 

basis with year-to-year comparisons of 

costs and traffic, and that any major 

changes in allocations between cost 

centers are accompanied by the high 

level summary justifying the changes. 

The industry members also asked that a 

new ARC be convened in three years to 

analyze the costs and air traffic activity 

data and determine the need for a future 

change of rates for FY 2019 and beyond 

based on the updated cost and traffic 

data. 

The FAA generally supports 

continued engagement with industry 

members. The FAA will consider 

reconvening an ARC for future rate 

updates and will continue to provide 

cost and activity data through the 

rulemaking process. 

Finally, the ARC industry members 

recommended that the FAA set a target 

on its cost development that remains 

below inflation and takes into 

consideration the expected development 

of traffic. 

The FAA believes forecasting based 

on projected traffic is more appropriate 

than using arbitrary cost targets. Each 

year the FAA publishes a 10-year 

Aerospace Forecast that includes 

anticipated levels of activity. FAA 

hiring and capital investments are based 

on forecasted levels of traffic activity. 

III. Discussion of the Proposed Rule 

The FAA proposes to update 

overflight fee rates based on final CAS 

data and TFMS data for FY 2013, which 

are the most recent cost and air traffic 

activity data available. This update uses 

the same general methodology, 

calculation, and data sources as those 

used for the last update in 2011.8 The 

general methodology had been 

recommended by the ARC and adopted 

by the FAA for the 2011 final rule. The 

FAA continues to believe it is a 

reasonable methodology and has 

updated this methodology based on an 

ARC recommendation to exclude costs 

and miles for combined control facilities 

that may handle a mix of general and 

commercial aviation traffic. 

Separate overflight rates have been 

established, and are currently in effect, 

for flights that transit U.S.-controlled 

airspace in each of two operational 

environments (Enroute and Oceanic 

airspace) without taking off from or 

landing in the United States.9 The 

updated Enroute rate would be derived 

by dividing the total costs incurred in 

the Enroute environment in FY 2013 by 

the number of nautical miles flown in 

U.S.-controlled Enroute airspace in FY 

2013. Similarly, the Oceanic rate would 

be derived by dividing the total Oceanic 

costs for FY 2013 by the total number 

of Oceanic miles flown in FY 2013. 

These calculations would each produce 

a per-mile cost that would be levied as 

a rate per 100 nautical miles flown. The 

rates calculated (based on FY 2013 data) 

for Enroute and Oceanic overflights are 

$61.75 and $26.51, respectively. The 

step-by-step derivation of these rates, 

using CAS and TFMS numbers for FY 


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10A copy of the ‘‘Overflight Fee Rate 

Development Report’’ is available in the docket for 

this rulemaking. 

11 54 FR 777 (Dec. 27, 1988). 

2013, is shown in the ‘‘Overflight Fee 

Rate Development Report.’’ 10

As in the 2011 update, the FAA 

proposes to phase in the rate increases. 

This approach is consistent with ICAO’s 

principle of gradualism. The FAA 

proposes a 3-year phase-in for this fee 

increase. The FAA intends the first 

increase would occur beginning on 

October 1, 2015, and proceed according 

to the following schedule: 

TABLE 3—PROPOSED RATE INCREASES FOR ENROUTE AND OCEANIC OVERFLIGHTS

Revision date 

Enroute rate 

(per 100 

nautical miles) 

Oceanic rate 

(per 100 

nautical miles) 

Current Rate ............................................................................................................................................................ $56.86 $21.63 

October 1, 2015 ....................................................................................................................................................... 58.45 23.15 

October 1, 2016 ....................................................................................................................................................... 60.07 24.77 

October 1, 2017 ....................................................................................................................................................... 61.75 26.51 

The FAA has considered the ARC 

recommendation. While the FAA 

believes the ARC’s approach is not 

unreasonable, the FAA has decided to 

not move forward with the ARC 

recommendation since the methodology 

to increase rates based on the CAGR 

between FY 2008 through FY 2013 

allows only a partial recovery of the FY 

2013 costs that the FAA is authorized to 

recover. Using that methodology, the 

FAA would have recovered slightly less 

than 60% for Enroute and 50% for 

Oceanic of the total increase between 

FY 2015 rates (based on FY 2008 costs) 

and rates using FY 2013 data. The FAA 

is instead moving forward with the 

same basic approach that was used in 

the FY 2011 final rule, which would 

recover the FY 2013 cost basis 

beginning in FY 2018. 

The FAA also proposes organizational 

changes to part 187 to clarify the 

overflight fee requirements. The FAA 

proposal replaces current Appendix B of 

part 187 with new §§ 187.3 

(Definitions), 187.51 (Applicability of 

overflight fees), 187.53 (Calculation of 

overflight fees), and 187.55 (Overflight 

fees billing and payment procedures). 

Except as discussed in the following 

paragraphs, the FAA proposes no 

changes to the substance of current 

requirements. 

In § 187.1, the FAA proposes to 

remove the duplicate reference to 

Appendix A, remove the reference to 

Appendix B because Appendix B is 

being removed, and add a reference to 

Appendix C that inadvertently had not 

been added when Appendix C 

(computation of fees for production 

certification-related services performed 

outside the United States) was added. 

The FAA proposes a new § 187.3 to 

contain definitions relevant to part 187. 

The terms overflight, overflight through 

Enroute airspace, overflight through 

Oceanic airspace, and U.S.-controlled 

airspace had been defined in Appendix 

B. The FAA proposes to revise the 

definition for U.S.-controlled airspace to 

be more consistent with the definition 

under international treaties, ICAO 

standards and guidance, customary law, 

and Presidential Proclamation Number 

5928.11 Finally, the FAA proposes to 

define great circle distance consistent 

with the FAA’s method used for 

calculating overflight fees. 

In new § 187.51, the FAA proposes a 

new paragraph (d) to address fees for 

flights through U.S.-controlled airspace 

covered by an FAA agreement or other 

binding arrangement. The FAA 

periodically enters into agreements with 

foreign States, regional groups of States, 

or foreign air navigation services 

providers to set the terms for the FAA’s 

management or control of foreign 

airspace among other air navigation 

services provided by the FAA. 

Generally, these agreements include 

specific terms for how the FAA recovers 

costs for the services it provides. This 

paragraph would avoid a potential 

conflict between such an agreement or 

arrangement and FAA regulations as 

well as ensure that overflight fee 

regulations apply uniform conditions 

and are non-discriminatory as required 

under the Chicago Convention. The 

FAA also proposes to remove the 

exception from overflight fees for 

Canada-to-Canada flights because those 

flights would continue to be addressed 

under proposed paragraph (d). 

In new § 187.53, the FAA proposes to 

retain the formula for calculating 

overflight fees from existing Appendix B 

but also proposes to clarify the 

explanation of calculating that fee. The 

total fee for a particular flight would be 

the sum of the Enroute and Oceanic 

fees. The Enroute and Oceanic fees 

would be calculated by multiplying the 

Enroute or Oceanic rate (per 100 

nautical miles), respectively, by the 

number of miles flown through each 

segment of Enroute or Oceanic airspace, 

respectively. Miles flown through each 

segment of airspace would be 

calculated, using great circle distance 

(GCD), from the point of entry into U.S.- 

controlled airspace to the point of exit 

from U.S.-controlled airspace. As under 

the current rule, the FAA would use the 

best available flight data to calculate the 

entry and exit points. The FAA is 

considering removing the formula 

because it is redundant and has created 

confusion. The FAA requests comments 

on whether the formula still is necessary 

in light of the narrative explanation. 

The proposed billing and payment 

procedures in new § 187.55 are 

unchanged from those in existing 

Appendix B. 

IV. Regulatory Notices and Analyses 

Changes to Federal regulations must 

undergo several economic analyses. 

First, Executive Order 12866 and 

Executive Order 13563 direct that each 

Federal agency shall propose or adopt a 

regulation only upon a reasoned 

determination that the benefits of the 

intended regulation justify its costs. 

Second, the Regulatory Flexibility Act 

of 1980 (Pub. L. 96–354) requires 

agencies to analyze the economic 

impact of regulatory changes on small 

entities. Third, the Trade Agreements 

Act (Pub. L. 96–39) prohibits agencies 

from setting standards that create 

unnecessary obstacles to the foreign 

commerce of the United States. In 

developing U.S. standards, the Trade 

Act requires agencies to consider 

international standards and, where 

appropriate, that they be the basis of 

U.S. standards. Fourth, the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4) requires agencies to prepare a 

written assessment of the costs, benefits, 

and other effects of proposed or final 

rules that include a Federal mandate 


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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Proposed Rules 52221 

12Office of Management and Budget, Circular A– 

94, ‘‘Guidelines and Discount Rates for Benefit-Cost 

Analysis of Federal Programs,’’ October 29, 1992, p. 

8. 

likely to result in the expenditure by 

State, local, or tribal governments, in the 

aggregate, or by the private sector, of 

$100 million or more annually (adjusted 

for inflation with base year of 1995). 

This portion of the preamble 

summarizes the FAA’s analysis of the 

economic impacts of this proposed rule. 

A. Regulatory Evaluation 

Department of Transportation Order 

DOT 2100.5 prescribes policies and 

procedures for simplification, analysis, 

and review of regulations. If the 

expected cost impact is so minimal that 

a proposed or final rule does not 

warrant a full evaluation, this order 

permits that a statement to that effect 

and the basis for it be included in the 

preamble if a full regulatory evaluation 

of the costs and benefits is not prepared. 

Such a determination has been made for 

this proposed rule. The reasoning for 

this determination follows. 

This proposed rule would institute a 

3-year phase-in of rate increases for 

Oceanic and Enroute overflights, with 

rates per 100 nautical miles increasing 

in FY 2016–2018 to $23.15, $24.77, and 

$26.51 for Oceanic flights, and to 

$58.45, $60.07, and $61.75 for Enroute 

flights. The final FY 2018 rate of $26.51 

for Oceanic services is derived from the 

FAA’s FY 2013 total cost of providing 

these services divided by the total 

nautical miles flown by operators 

(overflights and non-overflights) in 

Oceanic airspace. An analogous 

calculation is made to obtain the FY 

2018 rate of $61.75 for Enroute services. 

These higher rates based on FY 2013 

unit costs would allow the FAA to move 

closer to full cost recovery of air traffic 

control services already being provided 

to operators. 

Tables 4 and 5 show estimates of the 

increase in overflight fees for domestic 

operators and foreign operators for FY 

2016, FY 2017, and FY 2018, using FY 

2013 overflight mileage totals assuming 

no annual growth. As the tables show, 

the present value of the projected fee 

increases through FY 2018—when the 

full increase in rates would have taken 

place—would be $141,888 for domestic 

operators and $9,560,692 for foreign 

operators. The updated fee rates would 

provide greater incentives for foreign 

and domestic operators to economize on 

U.S. air traffic control facilities and 

U.S.-controlled airspace, thus increasing 

the efficient allocation of resources. 

TABLE 4—DOMESTIC OPERATORS—OVERFLIGHT FEES

Domestic operators FY 2015 FY 2016 FY 2017 FY 2018 

Oceanic Fees (per 100 nm) ............................................................................ $21.63 $23.15 $24.77 $26.51 

Oceanic Billings w/o Proposed Rule ............................................................... 528,616 528,616 528,616 528,616 

Oceanic Billings w/Proposed Rule .................................................................. 528,616 565,707 605,400 647,878 

Increase in Oceanic Billings ............................................................................ 0 37,091 76,784 119,262

Enroute Fees (per 100 nm) ............................................................................. $56.86 $58.45 $60.07 $61.75 

Enroute Billings w/o Proposed Rule ................................................................ 634,376 634,376 634,376 634,376 

Enroute Billings w/o Proposed Rule ................................................................ 634,376 652,064 670,245 688,933 

Increase in Enroute Billings ............................................................................. 0 17,688 35,869 54,557

Increase in Overflight Billings .......................................................................... 0 54,779 112,653 173,819 

PV Increase in Overflight Billings .................................................................... 0 $51,195 $98,395 $141,888 

TABLE 5—FOREIGN OPERATORS—OVERFLIGHT FEES

Foreign operators FY 2015 FY 2016 FY 2017 FY 2018 

Oceanic Fees (per 100 nm) ............................................................................ $21.63 $23.15 $24.77 $26.51 

Oceanic Billings w/o Proposed Rule ............................................................... 28,072,427 28,072,427 28,072,427 28,072,427 

Oceanic Billings w/Proposed Rule .................................................................. 28,072,427 30,042,152 32,150,083 34,405,920 

Increase in Oceanic Billings ............................................................................ 0 1,969,724 4,077,656 6,333,493 

Enroute Fees (per 100 nm) ............................................................................. $56.86 $58.45 $60.07 $61.75 

Enroute Billings w/o Proposed Rule ................................................................ 62,543,288 62,543,288 62,543,288 62,543,288 

Enroute Billings w/Proposed Rule ................................................................... 62,543,288 64,287,136 66,079,607 67,922,055 

Increase in Enroute Billings ............................................................................. 0 1,743,848 3,536,318 5,378,767 

Increase in Overflight Billings .......................................................................... 0 3,713,572 7,613,974 11,712,259 

PV Increase in Overflight Billings .................................................................... 0 $3,470,628 $6,650,340 $9,560,692 

Notes: 1. Rates for overflights are per 100 nautical miles. 2. Fees are in U.S. dollars. 3. Values are discounted back to FY 2015 at a 7% discount rate.12

B. Regulatory Flexibility Determination 

The Regulatory Flexibility Act of 1980 

(Pub. L. 96–354) (RFA) establishes ‘‘as a 

principle of regulatory issuance that 

agencies shall endeavor, consistent with 

the objectives of the rule and of 

applicable statutes, to fit regulatory and 

informational requirements to the scale 

of the businesses, organizations, and 

governmental jurisdictions subject to 

regulation. To achieve this principle, 

agencies are required to solicit and 

consider flexible regulatory proposals 

and to explain the rationale for their 

actions to assure that such proposals are 

given serious consideration.’’ The RFA 

covers a wide range of small entities, 

including small businesses, not-forprofit organizations, and small 

governmental jurisdictions. 

Agencies must perform a review to 

determine whether a rule will have a 

significant economic impact on a 

substantial number of small entities. If 

the agency determines that it will, the 

agency must prepare a regulatory 

flexibility analysis as described in the 

RFA. 

However, if an agency determines that 

a rule will not result in a significant 

economic impact on a substantial 

number of small entities, section 605(b) 

of the RFA provides that the head of the 

agency may so certify and a regulatory 

flexibility analysis is not required. The 

certification must include a statement 

providing the factual basis for this 

determination, and the reasoning should 

be clear. 


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For FY 2013 there were 469 domestic 

operators who overflew U.S.-controlled 

airspace, many of whom appear to be 

small entities. As Table 4 shows, 

however, after the phase-in of fee 

increases has been completed, in FY 

2018, overflight billings to domestic 

operators would have increased by just 

$173,819. Dividing this figure by the 

number of FY 2013 domestic 

overflights, 4762, the FAA estimates 

that the average increase in overflight 

billings would be $36.50 per operation. 

Accordingly, the proposed rule would 

not have a significant economic impact 

on a substantial number of small 

entities. 

Therefore, as provided in section 

605(b), the head of the FAA certifies 

that this rulemaking will not have a 

significant economic impact on a 

substantial number of small entities. 

The FAA solicits comments regarding 

this determination. 

C. International Trade Impact 

Assessment 

The Trade Agreements Act of 1979 

(Pub. L. 96–39), as amended by the 

Uruguay Round Agreements Act (Pub. 

L. 103–465), prohibits Federal agencies 

from establishing standards or engaging 

in related activities that create 

unnecessary obstacles to the foreign 

commerce of the United States. 

Pursuant to these Acts, the 

establishment of standards is not 

considered an unnecessary obstacle to 

the foreign commerce of the United 

States, so long as the standard has a 

legitimate domestic objective, such as 

the protection of safety, and does not 

operate in a manner that excludes 

imports that meet this objective. The 

statute also requires consideration of 

international standards and, where 

appropriate, that they be the basis for 

U.S. standards. ICAO standards allow 

providers of navigation services to 

require users of these services to pay 

their share of the related costs. The FAA 

has determined that this proposed rule 

primarily affects foreign commercial 

operators. The proposal to recover costs 

of providing air navigation services is 

consistent with ICAO standards and 

international practice. Foreign operators 

would be charged a fee only if they use 

U.S.-controlled airspace without taking 

off or landing in the U.S., and U.S. 

operators would be charged in the same 

manner. Accordingly, the FAA does not 

believe this proposal would create an 

unnecessary obstacle to the foreign 

commerce of the United States. 

D. Unfunded Mandates Assessment 

Title II of the Unfunded Mandates 

Reform Act of 1995 (Pub. L. 104–4) 

requires each Federal agency to prepare 

a written statement assessing the effects 

of any Federal mandate in a proposed or 

final agency rule that may result in an 

expenditure of $100 million or more (in 

1995 dollars) in any one year by State, 

local, and tribal governments, in the 

aggregate, or by the private sector; such 

a mandate is deemed to be a ‘‘significant 

regulatory action.’’ The FAA currently 

uses an inflation-adjusted value of 

$151.0 million in lieu of $100 million. 

This proposed rule does not contain 

such a mandate; therefore, the 

requirements of Title II of the Act do not 

apply. 

E. Paperwork Reduction Act 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3507(d)) requires that the 

FAA consider the impact of paperwork 

and other information collection 

burdens imposed on the public. The 

FAA has determined that there is no 

new requirement for information 

collection associated with this rule. The 

information used to track overflights 

(including the information collection 

necessary to implement this rule) can be 

accessed from flight plans filed with the 

FAA. The collection of information from 

the Domestic and International Flight 

Plans is approved under OMB 

information collection 2120–0026. 

F. International Compatibility and 

Cooperation 

In keeping with U.S. obligations 

under the Convention on International 

Civil Aviation, it is FAA policy to 

conform to ICAO Standards and 

Recommended Practices to the 

maximum extent practicable. The FAA 

has reviewed the corresponding ICAO 

Standards and Recommended Practices 

and has identified no differences with 

these proposed regulations. 

The ICAO guidance document on 

aviation fees and charges, ICAO 

Document 9082 (Ninth Edition—2012), 

ICAO’s Policies on Charges for Airports 

and Air Navigation Services, 

recommends consultations before 

imposing fees. In addition, Article 12 of 

the Air Transport Agreement between 

the United States of America and the 

European Union and its Member States 

(April 30, 2007, as amended June 24, 

2010) encourages consultation. 

By convening an ARC, presenting 

updated cost and traffic data to the ARC, 

and considering the ARC’s 

recommendation, the FAA consulted 

with system users prior to proposing 

this overflight fee update. Additionally, 

the FAA invites comments on this 

proposal, which permits participation 

by all interested parties in the 

rulemaking process. 

G. Environmental Analysis 

FAA Order 1050.1E identifies FAA 

actions that are categorically excluded 

from preparation of an environmental 

assessment or environmental impact 

statement under the National 

Environmental Policy Act in the 

absence of extraordinary circumstances. 

The FAA has determined this 

rulemaking action qualifies for the 

categorical exclusion identified in 

paragraph 312f and involves no 

extraordinary circumstances. 

V. Executive Order Determinations 

A. Executive Order 13132, Federalism 

The FAA has analyzed this proposed 

rule under the principles and criteria of 

Executive Order 13132, Federalism. The 

agency has determined that this action 

would not have a substantial direct 

effect on the States, or the relationship 

between the Federal Government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government, and, 

therefore, would not have Federalism 

implications. 

B. Executive Order 13211, Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use 

The FAA analyzed this proposed rule 

under Executive Order 13211, Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Distribution, or Use (May 18, 2001). The 

agency has determined that it would not 

be a ‘‘significant energy action’’ under 

the executive order and would not be 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. 

C. Executive Order 13609, Promoting 

International Regulatory Cooperation 

Executive Order 13609, Promoting 

International Regulatory Cooperation, 

(77 FR 26413, May 4, 2012) promotes 

international regulatory cooperation to 

meet shared challenges involving 

health, safety, labor, security, 

environmental, and other issues and to 

reduce, eliminate, or prevent 

unnecessary differences in regulatory 

requirements. The FAA has analyzed 

this action under the policies and 

agency responsibilities of Executive 

Order 13609, and has determined that 

this action would have no effect on 

international regulatory cooperation. 

VI. Additional Information 

A. Comments Invited 

The FAA invites interested persons to 

participate in this rulemaking by 

submitting written comments, data, or 

views. The agency also invites 


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Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Proposed Rules 52223 

comments relating to the economic, 

environmental, energy, or federalism 

impacts that might result from adopting 

the proposals in this document. The 

most helpful comments reference a 

specific portion of the proposal, explain 

the reason for any recommended 

change, and include supporting data. To 

ensure the docket does not contain 

duplicate comments, commenters 

should send only one copy of written 

comments, or if comments are filed 

electronically, commenters should 

submit only one time. 

The FAA will file in the docket all 

comments it receives, as well as a report 

summarizing each substantive public 

contact with FAA personnel concerning 

this proposed rulemaking. Before acting 

on this proposal, the FAA will consider 

all comments it receives on or before the 

closing date for comments. The FAA 

will consider comments filed after the 

comment period has closed if it is 

possible to do so without incurring 

expense or delay. The agency may 

change this proposal in light of the 

comments it receives. 

Proprietary or Confidential Business 

Information: Commenters should not 

file proprietary or confidential business 

information in the docket. Such 

information must be sent or delivered 

directly to the person identified in the 

FOR FURTHER INFORMATION CONTACT

section of this document, and marked as 

proprietary or confidential. If submitting 

information on a disk or CD ROM, mark 

the outside of the disk or CD ROM, and 

identify electronically within the disk or 

CD ROM the specific information that is 

proprietary or confidential. 

Under 14 CFR 11.35(b), if the FAA is 

aware of proprietary information filed 

with a comment, the agency does not 

place it in the docket. It is held in a 

separate file to which the public does 

not have access, and the FAA places a 

note in the docket that it has received 

it. If the FAA receives a request to 

examine or copy this information, it 

treats it as any other request under the 

Freedom of Information Act (5 U.S.C. 

552). The FAA processes such a request 

under Department of Transportation 

procedures found in 49 CFR part 7. 

B. Availability of Rulemaking 

Documents 

An electronic copy of rulemaking 

documents may be obtained from the 

Internet by— 

1. Searching the Federal eRulemaking 

Portal (http://www.regulations.gov); 

2. Visiting the FAA’s Regulations and 

Policies Web page at http://

www.faa.gov/regulations_policies or 

3. Accessing the Government Printing 

Office’s Web page at http://

www.gpo.gov/fdsys/. 

Copies may also be obtained by 

sending a request to the Federal 

Aviation Administration, Office of 

Rulemaking, ARM–1, 800 Independence 

Avenue SW., Washington, DC 20591, or 

by calling (202) 267–9677. Commenters 

must identify the docket or notice 

number of this rulemaking. 

All documents the FAA considered in 

developing this proposed rule, 

including economic analyses and 

technical reports, may be accessed from 

the Internet through the Federal 

eRulemaking Portal referenced above. 

List of Subjects in 14 CFR Part 187 

Administrative practice and 

procedure, Air transportation. 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend chapter I of title 14, 

Code of Federal Regulations as follows: 

PART 187—FEES 

■ 1. Revise the authority citation for part 

187 to read as follows: 

Authority: 31 U.S.C. 9701; 49 U.S.C. 

106(f), 106(g), 106(l)(6), 40104–40105, 40109, 

40113–40114, 44702, 45301. 

■ 2. Revise § 187.1 to read as follows: 

§ 187.1 Scope. 

This part prescribes fees only for FAA 

services for which fees are not 

prescribed in other parts of this chapter 

or in 49 CFR part 7. The fees for services 

furnished in connection with making 

information available to the public are 

prescribed exclusively in 49 CFR part 7. 

Appendix A to this part prescribes the 

methodology for computation of fees for 

certification services performed outside 

the United States. Appendix C to this 

part prescribes the methodology for 

computation of fees for production 

certification-related services performed 

outside the United States. 

■ 3. Add § 187.3 to read as follows: 

§ 187.3 Definitions. 

For the purpose of this part: 

Great circle distance means the 

shortest distance between two points on 

the surface of the Earth. 

Overflight means a flight through 

U.S.-controlled airspace that does not 

include a landing in or takeoff from the 

United States. 

Overflight through Enroute airspace 

means an overflight through U.S.- 

controlled airspace where primarily 

radar-based air traffic services are 

provided. 

Overflight through Oceanic airspace 

means an overflight through U.S.- 

controlled airspace where primarily 

procedural air traffic services are 

provided. 

U.S.-controlled airspace means all 

airspace over the territory of the United 

States, extending 12 nautical miles from 

the coastline of U.S. territory; any 

airspace delegated to the United States 

for U.S. control by other countries or 

under a regional air navigation 

agreement; or any international 

airspace, or airspace of undetermined 

sovereignty, for which the United States 

has accepted responsibility for 

providing air traffic control services. 

■ 4. Add §§ 187.51, 187.53, and 187.55 

to read as follows: 

§ 187.51 Applicability of overflight fees. 

(a) Except as provided in paragraphs 

(c) or (d) of this section, any person who 

conducts an overflight through either 

Enroute or Oceanic airspace must pay a 

fee as calculated in section 187.53. 

(b) Services. Persons covered by 

paragraph (a) of this section must pay a 

fee for the FAA’s rendering or providing 

of certain services, including but not 

limited to the following: 

(1) Air traffic management. 

(2) Communications. 

(3) Navigation. 

(4) Radar surveillance, including 

separation services. 

(5) Flight information services. 

(6) Procedural control. 

(7) Emergency services and training. 

(c) The FAA does not assess a fee for 

any military or civilian overflight 

operated by the United States 

Government or by any foreign 

government. 

(d) Fees for overflights through U.S.- 

controlled airspace covered by a written 

FAA agreement or other binding 

arrangement are charged according to 

the terms of that agreement or 

arrangement unless the terms are silent 

on fees. 

§ 187.53 Calculation of overflight fees. 

(a) The FAA assesses a total fee that 

is the sum of the Enroute and Oceanic 

calculated fees. 

(1) Enroute fee. The Enroute fee is 

calculated by multiplying the Enroute 

rate in paragraph (c) of this section by 

the total number of nautical miles flown 

through each segment of Enroute 

airspace divided by 100 (because the 

Enroute rate is expressed per 100 

nautical miles). 

(2) Oceanic fee. The Oceanic fee is 

calculated by multiplying the Oceanic 

rate in paragraph (c) of this section by 

the total number of nautical miles flown 

through each segment of Oceanic 


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52224 Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Proposed Rules 

airspace divided by 100 (because the 

Oceanic rate is expressed per 100 

nautical miles). 

(b) Distance flown through each 

segment of Enroute or Oceanic airspace 

is based on the great circle distance 

(GCD) from the point of entry into U.S.- 

controlled airspace to the point of exit 

from U.S.-controlled airspace based on 

FAA flight data. Where actual entry and 

exit points are not available, the FAA 

will use the best available flight data to 

calculate the entry and exit points. 

(c) The rate for each 100 nautical 

miles flown through Enroute or Oceanic 

airspace is: 

Time period Enroute rate Oceanic rate 

Through September 30, 2015 ................................................................................................................................. 56.86 21.63 

October 1, 2015 through September 30, 2016 ....................................................................................................... 58.45 23.15 

October 1, 2016 through September 30, 2017 ....................................................................................................... 60.07 24.77 

October 1, 2017 and beyond ................................................................................................................................... 61.75 26.51 

(d) The formula for the total overflight 

fee is: 

Rij = E*DEij/100 + O*DOij/100 

Where: 

Rij = the total fee charged to aircraft flying 

between entry point i and exit point j. 

DEij = total distance flown through each 

segment of Enroute airspace between 

entry point i and exit point j. 

DOij = total distance flown through each 

segment of Oceanic airspace between 

entry point i and exit point j. 

E and O = the Enroute and Oceanic rates, 

respectively, set forth in paragraph (c) of 

this section. 

(e) The FAA will review the rates 

described in this section at least once 

every 2 years and will adjust them to 

reflect the current costs and volume of 

the services provided. 

§ 187.55 Overflight fees billing and 

payment procedures. 

(a) The FAA will send an invoice to 

each user when fees are owed to the 

FAA. If the FAA cannot identify the 

user, then an invoice will be sent to the 

registered owner. Users will be billed at 

the address of record in the country 

where the aircraft is registered, unless a 

billing address is otherwise provided. 

(b) The FAA will send an invoice if 

the monthly (based on Universal 

Coordinated Time) fees equal or exceed 

$250. 

(c) Payment must be made by one of 

the methods described in § 187.15(d). 

Appendix B to Part 187—[Removed and 

Reserved] 

■ 5. Remove and reserve Appendix B to 

Part 187. 

Issued under authority provided by 49 

U.S.C. 106(f) and 45302, in Washington, DC, 

on August 24, 2015. 

David Rickard, 

Director, Office of Financial Analysis. 

[FR Doc. 2015–21293 Filed 8–27–15; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 299 

[Docket No. FDA–2015–N–0648] 

RIN 0910–AH25 

Designation of Official Names and 

Proper Names for Certain Biological 

Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing a 

regulation to designate official names 

and proper names for certain biological 

products. These products are filgrastimsndz (Biologics License Application 

(BLA) 125553), filgrastim (BLA 103353), 

tbo-filgrastim (BLA 125294), 

pegfilgrastim (BLA 125031), epoetin alfa 

(BLA 103234), and infliximab (BLA 

103772). The official names and proper 

names of these products would include 

distinguishing suffixes composed of 

four lowercase letters and would be 

designated as filgrastim-bflm (BLA 

125553), filgrastim-jcwp (BLA 103353), 

filgrastim-vkzt (BLA 125294), 

pegfilgrastim-ljfd (BLA 125031), epoetin 

alfa-cgkn (BLA 103234), and infliximabhjmt (BLA 103772). Although FDA is 

continuing to consider the appropriate 

naming convention for biological 

products, including how such a 

convention would be applied 

retrospectively to currently licensed 

products, FDA is proposing to take 

action with respect to these six products 

because of the need to encourage 

routine usage of designated suffixes in 

ordering, prescribing, dispensing, 

recordkeeping, and pharmacovigilance 

practices for the biological products 

subject to this rulemaking, and to avoid 

inaccurate perceptions of the safety and 

effectiveness of biological products 

based on their licensure pathway. 

DATES: Submit either electronic or 

written comments on the proposed rule 

by November 12, 2015. See section IV of 

this document for the proposed effective 

date of any final rule that may publish 

based on this proposal. 

ADDRESSES: You may submit comments 

by any of the following methods. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. FDA– 

2015–N–0648 for this rulemaking. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

in section VIII of the SUPPLEMENTARY

INFORMATION section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Sandra Benton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6340, 

Silver Spring, MD 20993–0002, 301– 

796–2500. 

SUPPLEMENTARY INFORMATION: 


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