80 FR 52217 - Update of Overflight Fee Rates
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration Federal Register Volume 80, Issue 167 (August 28, 2015)
Federal Aviation Administration
Federal Register Volume 80, Issue 167 (August 28, 2015)
| Page Range | 52217-52224 | |
| FR Document | 2015-21293 |
[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)] [Proposed Rules] [Pages 52217-52224] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-21293] ----------------------------------------------------------------------- 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 [email protected]. [[Page 52218]] 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.cros[email protected]. 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 ------------------------------------------------------------------------ Enroute rate Oceanic rate (per 100 (per 100 Revision date nautical nautical miles) 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. --------------------------------------------------------------------------- \1\ ICAO's Policies on Charges for Airports and Air Navigation Services, Document 9082, at 15-06 (2009). --------------------------------------------------------------------------- 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. --------------------------------------------------------------------------- \2\ Pub. 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). \4\ TFMS was formerly known as the Enhanced Traffic Management System (ETMS). \5\ 76 FR 43112 (Jul. 20, 2011). --------------------------------------------------------------------------- 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\ --------------------------------------------------------------------------- \6\ A 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. --------------------------------------------------------------------------- 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: [[Page 52219]] Table 2--ARC Proposed Rate Increases for Enroute and Oceanic Overflights ------------------------------------------------------------------------ ARC-Proposed ARC-Proposed enroute rate oceanic rate Revision date (per 100 (per 100 nautical nautical miles) 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. --------------------------------------------------------------------------- \7\ See 76 FR 43112, 43114-43116 (Jul. 20, 2011). --------------------------------------------------------------------------- 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 flight-following 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. --------------------------------------------------------------------------- \8\ A copy of the ``Costing Methodology Report Fiscal Year 2013'' is available in the docket for this rulemaking. --------------------------------------------------------------------------- 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 [[Page 52220]] 2013, is shown in the ``Overflight Fee Rate Development Report.'' \10\ --------------------------------------------------------------------------- \9\ A copy of the ``Description of U.S.-Controlled Airspace'' is available in the docket for this rulemaking. \10\ A copy of the ``Overflight Fee Rate Development Report'' is available in the docket for this rulemaking. --------------------------------------------------------------------------- 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 ------------------------------------------------------------------------ Enroute rate Oceanic rate (per 100 (per 100 Revision date nautical nautical miles) 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 Sec. Sec. 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 Sec. 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 Sec. 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. --------------------------------------------------------------------------- \11\ 54 FR 777 (Dec. 27, 1988). --------------------------------------------------------------------------- In new Sec. 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 Sec. 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 Sec. 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 [[Page 52221]] 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\ --------------------------------------------------------------------------- \12\ Office of Management and Budget, Circular A-94, ``Guidelines and Discount Rates for Benefit-Cost Analysis of Federal Programs,'' October 29, 1992, p. 8. --------------------------------------------------------------------------- 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-for-profit 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. [[Page 52222]] 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 [[Page 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.thefederalregister.org/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 0 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. 0 2. Revise Sec. 187.1 to read as follows: Sec. 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. 0 3. Add Sec. 187.3 to read as follows: Sec. 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. 0 4. Add Sec. Sec. 187.51, 187.53, and 187.55 to read as follows: Sec. 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. Sec. 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 [[Page 52224]] 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, 58.45 23.15 2016................................... October 1, 2016 through September 30, 60.07 24.77 2017................................... October 1, 2017 and beyond.............. 61.75 26.51 ------------------------------------------------------------------------ (d) The formula for the total overflight fee is: R ij = 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. Sec. 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 Sec. 187.15(d). Appendix B to Part 187--[Removed and Reserved] 0 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
![Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Proposed Rules 52217
(e) Reason to which the AMOC applies, notify your services it provides. The FAA proposes
This AD was prompted by mandatory appropriate principal inspector (PI) in the to increase the rates for Enroute and
continuing airworthiness information (MCAI) FAA Flight Standards District Office (FSDO), Oceanic overflights based on fiscal year
originated by an aviation authority of another or lacking a PI, your local FSDO.
(2) Airworthy Product: For any requirement
2013 cost and air traffic activity data.
country to identify and correct an unsafe The FAA proposes to phase in this rate
condition on an aviation product. The MCAI in this AD to obtain corrective actions from
a manufacturer or other source, use these increase over three years in equal
describes the unsafe condition as humidity in
the horizontal stabilizer on airplanes subject actions if they are FAA-approved. Corrective percentage terms. This is a less
to severe environmental conditions. We are actions are considered FAA-approved if they burdensome approach than the
issuing this AD to detect and correct are approved by the State of Design Authority alternative of phasing in the new rates
corrosion of the horizontal stabilizer (HS) (or their delegated agent). You are required in equal absolute terms, and is the same
spar, which could lead to result in buckling to assure the product is airworthy before it methodology used in the previous
and permanent HS distortion, possibly is returned to service.
rulemaking. Finally, the FAA proposes
resulting in reduced control. (h) Related Information several organizational and clarifying
(f) Actions and Compliance Refer to MCAI European Aviation Safety revisions to the overflight fee
Unless already done, do the actions in Agency (EASA) AD No. 2015–0130, dated requirements.
paragraphs (f)(1) through (f)(5) of this AD: July 7, 2015; and DAHER–SOCATA TB
DATES: Send comments on or before
(1) Within 13 months after the effective Aircraft Recommended Service Bulletin SB
10–152, dated May 2013, for related October 27, 2015.
date of this AD and repetitively thereafter at
information. You may examine the MCAI on ADDRESSES: Send comments identified
intervals not to exceed 72 months, do a
special detailed inspection of the HS spar the Internet at http://www.regulations.gov by by docket number FAA–2015–3597
following the instructions of DAHER– searching for and locating Docket No. FAA– using any of the following methods:
SOCATA TB Aircraft Mandatory Service 2015–3642. For service information related to • Federal eRulemaking Portal: Go to
Bulletin SB 10–152, Amendment 1, dated this AD, contact SOCATA, Direction des http://www.regulations.gov and follow
April 2015. Services, 65921 Tarbes Cedex 9, France; the online instructions for sending your
(2) If no discrepancy is detected during any telephone: 33 (0)5 62.41.73.00; fax: 33 (0)5
62.41.76.54; or SOCATA North America,
comments electronically.
inspections required by paragraph (f)(1) of
North Perry Airport, 7501 S Airport Rd., • Mail: Send comments to Docket
this AD, protect the HS spar following the Operations, M–30; U.S. Department of
instructions of DAHER–SOCATA TB Aircraft Pembroke Pines, Florida 33023, telephone:
(954) 893–1400; fax: (954) 964–4141; Transportation (DOT), 1200 New Jersey
Mandatory Service Bulletin SB 10–152,
Amendment 1, dated April 2015. Internet: http://www.socata.com. You may Avenue SE., Room W12–140, West
(3) If any discrepancy is detected during review this referenced service information at Building Ground Floor, Washington, DC
any inspection required by paragraph (f)(1) of the FAA, Small Airplane Directorate, 901 20590–0001.
this AD, before further flight, do the Locust, Kansas City, Missouri 64106. For • Hand Delivery or Courier: Take
applicable corrective action(s) following the information on the availability of this comments to Docket Operations in
material at the FAA, call (816) 329–4148.
instructions of DAHER–SOCATA TB Aircraft Room W12–140 of the West Building
Mandatory Service Bulletin SB 10–152, Ground Floor at 1200 New Jersey
Issued in Kansas City, Missouri, on August
Amendment 1, dated April 2015. Avenue SE., Washington, DC, between 9
20, 2015.
(4) Accomplishment of protection or a.m. and 5 p.m., Monday through
corrective actions on an airplane as required Earl Lawrence,
by paragraph (f)(2) or (f)(3) of this AD, as Manager, Small Airplane Directorate, Aircraft Friday, except Federal holidays.
applicable, does not constitute terminating Certification Service. • Fax: Fax comments to Docket
action for the repetitive inspections as [FR Doc. 2015–21283 Filed 8–27–15; 8:45 am]
Operations at 202–493–2251.
required by paragraph (f)(1) of this AD for Privacy: In accordance with 5 U.S.C.
BILLING CODE 4910–13–P
that airplane. 553(c), DOT solicits comments from the
(5) Inspections and corrective actions on an public to better inform its rulemaking
airplane, done before the effective date of this
DEPARTMENT OF TRANSPORTATION process. DOT posts these comments,
AD following the instructions of DAHER– without edit, including any personal
SOCATA TB Aircraft Recommended Service information the commenter provides, to
Federal Aviation Administration
Bulletin SB 10–152, dated May 2013, are www.regulations.gov, as described in
acceptable to comply with the requirements
14 CFR Part 187 the system of records notice (DOT/ALL–
of this AD for that airplane. After the
effective date of this AD, repetitive 14 FDMS), which can be reviewed at
[Docket No.: FAA–2015–3597; Notice No. www.dot.gov/privacy.
inspections and applicable corrective actions, 15–06]
as required by this AD, must be done as Docket: Background documents or
required by paragraph (f)(1) of this AD RIN 2120–AK53 comments received may be read at
following the instructions of DAHER– http://www.regulations.gov at any time.
SOCATA TB Aircraft Mandatory Service Update of Overflight Fee Rates Follow the online instructions for
Bulletin SB 10–152, Amendment 1, dated accessing the docket or go to the Docket
April 2015. AGENCY: Federal Aviation
Administration (FAA), DOT. Operations in Room W12–140 of the
(g) Other FAA AD Provisions West Building Ground Floor at 1200
ACTION: Notice of proposed rulemaking
The following provisions also apply to this New Jersey Avenue SE., Washington,
(NPRM).
AD: DC, between 9 a.m. and 5 p.m., Monday
(1) Alternative Methods of Compliance SUMMARY: This proposed rule would through Friday, except Federal holidays.
(AMOCs): The Manager, Standards Office, update existing overflight fee rates using FOR FURTHER INFORMATION CONTACT: For
Lhorne on DSK5TPTVN1PROD with PROPOSALS
FAA, has the authority to approve AMOCs more current FAA cost accounting and technical questions concerning this
for this AD, if requested using the procedures air traffic activity data. Overflight fees action, contact Aleksandra Damsz,
found in 14 CFR 39.19. Send information to
are charges for aircraft flights that transit Financial Analyst, Office of Financial
ATTN: Albert Mercado, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, U.S.-controlled airspace, but neither Analysis, AFA–400, Federal Aviation
Room 301, Kansas City, Missouri 64106; land in nor depart from the United Administration, 800 Independence
telephone: (816) 329–4119; fax: (816) 329– States. Overflight fee rates were last Avenue SW., Washington, DC 20591;
4090; email: albert.mercado@faa.gov. Before updated in 2011. As a result, the FAA telephone (202) 267–8055; email
using any approved AMOC on any airplane is not recovering the full cost of the aleksandra.damsz@faa.gov.
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![52224 Federal Register / Vol. 80, No. 167 / Friday, August 28, 2015 / Proposed Rules
airspace divided by 100 (because the (GCD) from the point of entry into U.S.- will use the best available flight data to
Oceanic rate is expressed per 100 controlled airspace to the point of exit calculate the entry and exit points.
nautical miles). from U.S.-controlled airspace based on (c) The rate for each 100 nautical
(b) Distance flown through each FAA flight data. Where actual entry and miles flown through Enroute or Oceanic
segment of Enroute or Oceanic airspace exit points are not available, the FAA airspace is:
is based on the great circle distance
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 DEPARTMENT OF HEALTH AND DATES: Submit either electronic or
fee is: HUMAN SERVICES written comments on the proposed rule
Rij = E*DEij/100 + O*DOij/100 by November 12, 2015. See section IV of
Food and Drug Administration this document for the proposed effective
Where: date of any final rule that may publish
Rij = the total fee charged to aircraft flying 21 CFR Part 299 based on this proposal.
between entry point i and exit point j. ADDRESSES: You may submit comments
DEij = total distance flown through each [Docket No. FDA–2015–N–0648]
by any of the following methods.
segment of Enroute airspace between
RIN 0910–AH25 Electronic Submissions
entry point i and exit point j.
DOij = total distance flown through each Designation of Official Names and Submit electronic comments in the
segment of Oceanic airspace between Proper Names for Certain Biological following way:
entry point i and exit point j. Products • Federal eRulemaking Portal: http://
E and O = the Enroute and Oceanic rates,
www.regulations.gov. Follow the
respectively, set forth in paragraph (c) of AGENCY: Food and Drug Administration, instructions for submitting comments.
this section. HHS.
ACTION: Proposed rule. Written Submissions
(e) The FAA will review the rates
described in this section at least once Submit written submissions in the
SUMMARY: The Food and Drug following ways:
every 2 years and will adjust them to Administration (FDA) is proposing a
reflect the current costs and volume of • Mail/Hand delivery/Courier (for
regulation to designate official names
the services provided. paper submissions): Division of Dockets
and proper names for certain biological
Management (HFA–305), Food and Drug
products. These products are filgrastim-
§ 187.55 Overflight fees billing and Administration, 5630 Fishers Lane, Rm.
sndz (Biologics License Application
payment procedures. 1061, Rockville, MD 20852.
(BLA) 125553), filgrastim (BLA 103353),
Instructions: All submissions received
(a) The FAA will send an invoice to tbo-filgrastim (BLA 125294),
must include the Docket No. FDA–
each user when fees are owed to the pegfilgrastim (BLA 125031), epoetin alfa
2015–N–0648 for this rulemaking. All
FAA. If the FAA cannot identify the (BLA 103234), and infliximab (BLA
comments received may be posted
user, then an invoice will be sent to the 103772). The official names and proper
without change to http://
registered owner. Users will be billed at names of these products would include
www.regulations.gov, including any
the address of record in the country distinguishing suffixes composed of
personal information provided. For
where the aircraft is registered, unless a four lowercase letters and would be
additional information on submitting
billing address is otherwise provided. designated as filgrastim-bflm (BLA
comments, see the ‘‘Comments’’ heading
125553), filgrastim-jcwp (BLA 103353),
(b) The FAA will send an invoice if in section VIII of the SUPPLEMENTARY
filgrastim-vkzt (BLA 125294),
the monthly (based on Universal INFORMATION section of this document.
pegfilgrastim-ljfd (BLA 125031), epoetin
Coordinated Time) fees equal or exceed Docket: For access to the docket to
alfa-cgkn (BLA 103234), and infliximab-
$250. read background documents or
hjmt (BLA 103772). Although FDA is
comments received, go to http://
(c) Payment must be made by one of continuing to consider the appropriate
www.regulations.gov and insert the
the methods described in § 187.15(d). naming convention for biological
docket number, found in brackets in the
products, including how such a
Appendix B to Part 187—[Removed and heading of this document, into the
convention would be applied
Reserved] ‘‘Search’’ box and follow the prompts
retrospectively to currently licensed
and/or go to the Division of Dockets
products, FDA is proposing to take
■ 5. Remove and reserve Appendix B to Management, 5630 Fishers Lane, Rm.
action with respect to these six products
Part 187. 1061, Rockville, MD 20852.
because of the need to encourage
FOR FURTHER INFORMATION CONTACT:
Lhorne on DSK5TPTVN1PROD with PROPOSALS
Issued under authority provided by 49 routine usage of designated suffixes in
U.S.C. 106(f) and 45302, in Washington, DC, ordering, prescribing, dispensing, Sandra Benton, Center for Drug
on August 24, 2015. recordkeeping, and pharmacovigilance Evaluation and Research, Food and
David Rickard, practices for the biological products Drug Administration, 10903 New
subject to this rulemaking, and to avoid Hampshire Ave., Bldg. 51, Rm. 6340,
Director, Office of Financial Analysis.
inaccurate perceptions of the safety and Silver Spring, MD 20993–0002, 301–
[FR Doc. 2015–21293 Filed 8–27–15; 8:45 am]
effectiveness of biological products 796–2500.
BILLING CODE 4910–13–P
based on their licensure pathway. SUPPLEMENTARY INFORMATION:
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Document Created: 2015-12-15 11:04:21
Document Modified: 2015-12-15 11:04:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notice of proposed rulemaking (NPRM). | |
| Dates | Send comments on or before October 27, 2015. | |
| 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 [email protected] | |
| FR Citation | 80 FR 52217 | |
| RIN Number | 2120-AK53 | |
| CFR Associated | Administrative Practice and Procedure and Air Transportation |
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