[Federal Register Volume 80, Number 217 (Tuesday, November 10, 2015)]
[Notices]
[Page 69773]
[FR Doc No: 2015-28713]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Sunshine Act Meetings; Unified Carrier Registration Plan Board of
Directors

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of Unified Carrier Registration Plan Board of Directors
meeting.

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TIME AND DATE: The meeting will be held on December 9, 2015, from 8
a.m. to 1 p.m. Pacific Standard Time.

PLACE: The meetings will be open to the public at the Courtyard
Marriott- San Diego Downtown, 530 Broadway, San Diego, CA 92101 and via
conference call. Those not attending the meetings in person may call 1-
877-422-1931, passcode<PHONE_NUMBER>, to listen and participate in the
meetings.

STATUS: Open to the public.

MATTERS TO BE CONSIDERED: The Unified Carrier Registration Plan Board
of Directors (the Board) will continue its work in developing and
implementing the Unified Carrier Registration Plan and Agreement and to
that end, may consider matters properly before the Board.

FOR FURTHER INFORMATION CONTACT: Mr. Avelino Gutierrez, Chair, Unified
Carrier Registration Board of Directors at<PHONE_NUMBER>.

     Issued on: October 30, 2015.
Larry W. Minor,
Associate Administrator, Office of Policy, Federal Motor Carrier Safety
Administration.
[FR Doc. 2015-28713 Filed 11-6-15; 4:15 pm]
BILLING CODE 4910-EX-P


1 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 82 [ FRL]

RIN 2060 AM50 Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2005.

AGENCY: Environmental Protection Agency ( EPA).

ACTION: Final rule.

SUMMARY: With this action, EPA is allocating essential use allowances for import and production of class I stratospheric ozone depleting substances ( ODSs) for calendar year 2005.

Essential use allowances enable a person to obtain controlled class I ODSs as an exemption to the regulatory ban of production and import of these chemicals, which became effective on January 1, 1996. EPA allocates essential use allowances for exempted production or import of a specific quantity of class I ODS solely for the designated essential purpose. The allocations total 1,820.48 metric tons of chlorofluorocarbons for use in metered 2 dose inhalers.

DATES: This final rule is effective [ insert date of publication in FR].

ADDRESSES: Materials related to this rulemaking are contained in EPA Air Docket OAR 2004 0063. The EPA Air Docket is located at EPA West Building, Room B102, 1301 Constitution Avenue, NW,

Washington, D. C., 20460. The Air Docket is open from 8: 30 a. m.

until 4: 30 p. m. Monday through Friday. Materials related to previous EPA actions on the essential use program are contained in EPA Air Docket No. A 93 39.

FOR FURTHER INFORMATION CONTACT: Scott Monroe, Essential Use Program Manager, by regular mail: U. S. Environmental Protection Agency, Stratospheric Protection Division ( 6205J), 1200 Pennsylvania Avenue, NW, Washington, DC, 20460; by telephone:

202 343 9712; by fax: 202 343 2363; or by email:

monroe. scott@ epa. gov.

SUPPLEMENTARY INFORMATION:

Table of Contents I. General Information 3 A. How can I get copies of related information?

II. Basis for Allocating Essential Use Allowances A. What are essential use allowances?

B. Under what authority does EPA allocate essential use allowances?

C. What is the process for allocating essential use allowances?

III. Response to Comments IV. Allocation of Essential Use Allowances for Calendar Year 2005 V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction C. Regulatory Flexibility D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act J. Congressional Review Act 4 VI. Judicial Review VII. Effective Date of this Final Rule I. General Information A. How can I get copies of related information?

1. Docket EPA has established an official public docket for this action at Air Docket ID No. OAR 2004 0063. The official public docket consists of the documents specifically referenced in this action and other information related to this action. Hard copies of documents related to previous essential use allocation rulemakings and other actions may be found in EPA Air Docket ID No. A 93 39. The public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The public docket is available for viewing at the Air and Radiation Docket in the EPA Docket Center,

( EPA/ DC) EPA West, Room B102, 1301 Constitution Ave., NW,

Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday,

excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1741, and the telephone number for the Air and Radiation Docket is ( 202) 566 1742. EPA may charge a reasonable fee for copying docket materials.

2. Electronic Access An electronic version of the public docket is available 1 " Consumption" is defined as the amount of a substance produced in the United States, plus the amount imported into the United States, minus the amount exported to Parties to the Montreal Protocol ( see Section 601( 6) of the Clean Air Act).

2 Class I ozone depleting substances are listed at 40 CFR Part 82 subpart A, appendix A.

5 through EPA's electronic public docket and comment system, " EPA Dockets." You may use EPA Dockets at http:// www. epa. gov/ edocket/

to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the appropriate docket identification number.

II. Basis for Allocating Essential Use Allowances A. What are essential use allowances?

Essential use allowances are allowances to produce or import certain ozone depleting chemicals in the U. S. for purposes that have been deemed " essential" by the Parties to the Montreal Protocol and the U. S. Government.

The Montreal Protocol on Substances that Deplete the Ozone Layer ( Protocol) is an international agreement aimed at reducing and eliminating the production and consumption1 of stratospheric ozone depleting substances ( ODSs). The elimination of production and consumption of class I ODSs is accomplished through adherence to phaseout schedules for specific class I ODSs2, including:

chlorofluorocarbons ( CFCs), halons, carbon tetrachloride, and 6 methyl chloroform. As of January 1, 1996, production and import of most class I ODSs were phased out in developed countries,

including the United States.

However, the Protocol and the Clean Air Act ( Act) provide exemptions that allow for the continued import and/ or production of class I ODS for specific uses. Under the Protocol, exemptions may be granted for uses that are determined by the Parties to be " essential." Decision IV/ 25, taken by the Parties to the Protocol in 1992, established criteria for determining whether a specific use should be approved as essential, and set forth the international process for making determinations of essentiality.

The criteria for an essential use, as set forth in paragraph 1 of Decision IV/ 25, are the following:

"( a) that a use of a controlled substance should qualify as ` essential' only if:

( i) it is necessary for the health, safety or is critical for the functioning of society ( encompassing cultural and intellectual aspects); and ( ii) there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health;

( b) that production and consumption, if any, of a controlled substance for essential uses should be permitted only if:

( i) all economically feasible steps have been taken to 3 According to Section 614( b) of the Act, Title VI " shall be construed, interpreted, and applied as a supplement to the terms and conditions of the Montreal Protocol . . . and shall not be construed, interpreted, or applied to abrogate the responsibilities or obligations of the United States to implement fully the provisions of the Montreal Protocol. In the case of conflict between any provision of this title and any provision of the Montreal Protocol, the more stringent provision shall govern." EPA's regulations implementing the essential use provisions of the Act and the Protocol are located in 40 CFR part 82.

7 minimize the essential use and any associated emission of the controlled substance; and ( ii) the controlled substance is not available in sufficient quantity and quality from existing stocks of banked or recycled controlled substances, also bearing in mind the developing countries' need for controlled substances."

B. Under what authority does EPA allocate essential use allowances?

Title VI of the Act implements the Protocol for the United States. 3 Section 604( d) of the Act authorizes EPA to allow the production of limited quantities of class I ODSs after the phase out date for the following essential uses:

( 1) Methyl Chloroform, " solely for use in essential applications ( such as nondestructive testing for metal fatigue and corrosion of existing airplane engines and airplane parts susceptible to metal fatigue) for which no safe and effective substitute is available." Under the Act, this exemption was available only until January 1, 2005. Prior to that date, EPA 8 issued methyl chloroform allowances to the U. S. Space Shuttle and Titan Rocket programs.

( 2) Medical Devices ( as defined in section 601( 8) of the Act), " if such authorization is determined by the Commissioner [ of the Food and Drug Administration], in consultation with the Administrator [ of EPA] to be necessary for use in medical devices." EPA issues allowances to manufacturers of metered dose inhalers ( MDIs), which use CFCs as propellant for the treatment of asthma and chronic obstructive pulmonary diseases.

( 3) Aviation Safety, for which limited quantities of halon

1211, halon 1301, and halon 2402 may be produced " if the Administrator of the Federal Aviation Administration, in consultation with the Administrator [ of EPA] determines that no safe and effective substitute has been developed and that such authorization is necessary for aviation safety purposes."

Neither EPA nor the Parties have ever granted a request for essential use allowances for halon, because in most cases alternatives are available and because existing quantities of this substance are large enough to provide for any needs for which alternatives have not yet been developed.

The Protocol, under Decision XV/ 8, additionally allows a general exemption for laboratory and analytical uses through December 31, 2007. This exemption is reflected in EPA's regulations at 40 CFR part 82, subpart A. While the Act does not 9 specifically provide for this exemption, EPA has determined that an allowance for essential laboratory and analytical uses is allowable under the Act as a de minimis exemption. The de minimis exemption is addressed in EPA's final rule of March 13,

2001 ( 66 FR 14760 14770). The Parties to the Protocol subsequently agreed ( Decision XI/ 15) that the general exemption does not apply to the following uses: testing of oil and grease,

and total petroleum hydrocarbons in water; testing of tar in road paving materials; and forensic finger printing. EPA incorporated this exclusion at Appendix G to Subpart A of 40 CFR part 82 on February 11, 2002 ( 67 FR 6352).

C. What is the process for allocating essential use allowances?

Before EPA will allocate essential use allowances, the Parties to the Protocol must first approve the United States'

request to produce or import essential class I ODSs. The procedure set out by Decision IV/ 25 calls for individual Parties to nominate essential uses and the total amount of ODSs needed for those essential uses on an annual basis. The Protocol's Technology and Economic Assessment Panel ( TEAP) evaluates the nominated essential uses and makes recommendations to the Protocol Parties. The Parties make the final decisions on whether to approve a Party's essential use nomination at their annual meeting. This nomination cycle occurs approximately two years before the year in which the allowances would be in effect. 10 The allowances allocated through today's action were first nominated by the United States in January 2003.

Once the U. S. nomination is approved by the Parties, EPA allocates essential use exemptions to specific entities through notice and comment rulemaking in a manner consistent with the Act. For MDIs, EPA requests information from manufacturers about the number and type of MDIs they plan to produce, as well as the amount of CFCs necessary for production. EPA then forwards the information to the Food and Drug Administration ( FDA), which determines the amount of CFCs necessary for MDIs in the coming calendar year. Based on FDA's determination, EPA proposes allocations to each eligible entity. Under the Act and the Protocol, EPA may allocate essential use allowances in quantities that together are below or equal to the total amount approved by the Parties. EPA will not allocate essential use allowances in amounts higher than the total approved by the Parties. For 2005,

the Parties authorized the United States to allocate up to 1,902 metric tons of CFCs for essential uses.

EPA published a proposed rule on December 22, 2004 ( 69 FR 76655) that would have allocated a total of 1,524.58 metric tons of allowances. EPA subsequently determined that the amount proposed to be allocated to one company, Armstrong Pharmaceuticals, was incorrect. Specifically, EPA had proposed to allocate to Armstrong 29 metric tons, but the amount should 11 have been 270.90 metric tons. EPA published a supplemental proposal on February 23, 2005 ( 70 FR 8753) to correct the error,

which increased the total amount of proposed allowances to 1,766.48 metric tons. Today's rule finalizes both the proposed rule and the supplemental proposed rule.

III. Response to Comments EPA received eight sets of comments from six individual commenters on the proposed rule and the supplemental proposed rule, four of which were late comments. One commenter objected to the granting of essential use status generally. One commenter requested additional allowances for 2005. The other four commenters presented arguments related to EPA's obligations under the Montreal Protocol and the Clean Air Act with respect to the proposed allocations. The comments are addressed in more detail below.

A. EPA should not allocate essential use allowances generally.

One commenter opposed exempting Class I substances for any purpose, including asthma medication, because non ozone depleting alternatives have been developed ( OAR 2004 0063 0006). EPA disagrees with this comment. Section 604 of the Act directs EPA to authorize production of CFCs for essential MDIs if FDA, in consultation with EPA, determines such production to be necessary. FDA has found the use of ozone depleting substances to be essential in certain metered dose inhalers for the 12 treatment of asthma and chronic pulmonary disease ( see 21 CFR 2.125( e)). As established by final rule on July 24, 2002 ( 67 FR 48370), FDA will determine through rulemaking when an MDI is no longer essential due to the availability of safe and effective alternatives.

[ Should this be in its own section?] The same commenter also stated, "[ A] ll of the information these polluting companies submit should be open to the public." While EPA has made public information that is not subject to confidentiality restrictions,

somee information submitted was claimed as confidential. That information is being treated in accordance with EPA's regulations on confidential business information at 40 CFR § § 2.201 to 2.311.

B. EPA should not allocate essential use allowances for production of albuterol MDIs.

One commenter wrote that EPA should not allocate essential use allowances for use in CFC albuterol MDIs because they are " non essential" and the allocations would be " inconsistent with Decisions of the Parties to the Montreal Protocol" ( OAR 2004

0063 0012). [ Why mention this letter and response? Why not just make the point made in the letter by taking the quote out of quotes? Alternatively, why not skip directly to the point that the FDA has concluded that CFC albuterol MDIs are essential until 2008?] The commenter referenced a letter sent by the Natural Resources Defense Council ( NRDC) to EPA on May 13, 2004, that 13 addressed the inclusion of CFCs for albuterol MDIs in the United States' 2006 essential use nomination. EPA responded with a letter dated July 12, 2004, in which we said, " Until FDA issues a final rule to delist albuterol MDIs ( with an identified effective date) in accordance with its own regulations and the Administrative Procedures Act, it is premature and contrary to law for EPA unilaterally to conclude that CFC albuterol MDIs are in fact no longer essential in the United States and to remove this essential use from the U. S. nomination for 2006." These letters have been placed in EPA Docket no. OAR 2004 0063. FDA since announced its decision that CFC albuterol MDIs will no longer be essential after December 31, 2008 ( 70 FR 17168, April 4, 2005). Thus, FDA continues to regard CFC albuterol MDIs as essential for the current control period. EPA is therefore allocating essential use allowances for CFC albuterol MDIs in this final rule.

C. Aventis Pharmaceuticals requested additional CFCs for 2005.

[ Could EPA clarify the purpose of this response? Is there a letter from Aventis protesting the EPA decision? We would prefer to delete the second paragraph after its first sentence.]

Aventis Pharmaceuticals submitted to the docket a request for additional allowances in the amount of 60 metric tons, which if allocated would bring the company's total allocation for 2005 to 117 metric tons. A portion of the additional CFCs would be used 14 for products exported outside the United States. EPA and FDA considered this request and determined to grant additional allowances for MDI products marketed in the United States; the relevant correspondence has been placed in EPA Docket no. OAR

2004 0063.

EPA is not granting additional allowances to Aventis for production of CFC MDIs that would be sold outside the United States. Under Section 604( d)( 2) of the Act, EPA authorizes production of class I substances " if such authorization is determined by the Commissioner in consultation with the Administrator, to be necessary for use in medical devices." FDA does not have jurisdiction over medications in foreign countries and is unable to render a determination on whether the MDIs in question are essential in those countries or whether production of CFCs for the MDIs intended for export is necessary. Without such determinations, EPA is not authorized under the Act to allocate allowances for those MDIs. EPA regulations at sections 9( g) and 12( a) and ( d) of 40 CFR Part 82 do allow domestic and international transfers of essential use allowances as well as essential use CFCs, but Aventis did not request such a transfer.

EPA received separate but similar sets of comments from the International Pharmaceutical Aerosol Consortium ( IPAC), NRDC, the US Stakeholders Group on MDI Transition, and GlaxoSmithKline ( GSK), a pharmaceutical company and member of IPAC. EPA's 15 responses to these comments are grouped below in accordance with the major points made by the commenters. EPA references the GSK comments most frequently because they were the most comprehensive and detailed. [ Is this normal procedure?]

[ There's no point in getting into this technical point here. GSK doesn't make any arguments that follow from this point other than those noted in the next section. Moreover, even if we disagree with the fine points, we are not acting inconsistently with Protocol decisions. It would be best to delete this section, and add the few edits suggested in the next section.]

E. EPA must reevaluate FDA's determinations as to essential use allowance volumes.

GSK argues that EPA must adhere to Montreal Protocol decisions and comments, " The fact that FDA has recommended [ certain allocation] levels does not absolve EPA from evaluating consistency with Protocol decisions at the time it makes* * *

allocations" ( OAR 2004 0063 0008, p. 3). It also argues that EPA may not rely on the decisions of the Parties to the Protocol, but must reevaluate those decisions in its rulemaking process to ensure consistency with the Protocol.

EPA understands today's rulemaking to be fully consistent with the relevant Protocol decisions and with its obligations under the Protocol and federal law. It has, in fact, authorized 16 allocations of CFC albuterol MDIs at a lower volume than that decided by the Parties to the Protocol. But, as noted above, FDA has the expertise and the authority under federal law to evaluate whether CFC albuterol MDIs are essential under the Montreal Protocol, and EPA agrees with the judgment of FDA.

F. EPA may not allocate allowances to companies that fail to demonstrate research and development of alternatives.

GSK argues that each company which has submitted an application for an essential use allowance must have provided information on its research and development efforts in order to obtain an essential use allowance. It argues that it is " highly likely" that not all companies which will receive allowances have submitted such information, and suggests that the U. S. nomination may have been non responsive on this point. As an example, GSK cites a company whose parent has submitted research and development information instead of submitting such information itself. GSK argues that Decisions VIII/ 10, XV/ 5, and IV/ 25 require EPA to deny allowances to companies which have not submitted sufficient research and development information.

EPA disagrees with this analysis. Decision VIII/ 10 requests countries to " request companies applying for MDI essential use exemptions to demonstrate ongoing research and development of alternatives to CFC MDIs with all due diligence" as well as to report in confidence on resources and progress in alternatives 17 development. In accordance with this decision, since 1997, EPA has requested applicants to provide the relevant information specified in the TEAP Handbook when submitting requests for CFC essential use nominations. 67 FR 66148, October 30, 2002.

Contrary to GSK's suggestion, Decision VIII/ 10 does not require any action to be taken at the permitting stage. See, e. g., 67 FR 6355, February 11, 2002. Thus, EPA has acted in accordance with Decision VIII/ 10.

GSK suggests that Decision XV/ 5 somehow changes this analysis, but does not cite any specific language to support its suggestion. In fact, this suggestion is incorrect. Decision XV/ 5 does not address research and development reporting, nor does it affect EPA's authority with regard to the granting of essential use allowances on this ground.

GSK's citation of Decision IV/ 25 is also inapposite. That Decision states criteria to be used by the Parties to the Protocol when they collectively assess whether to permit production and consumption for essential uses. Moreover,

Paragraph 1( b)( i) of that Decision speaks to minimization of particular essential uses, not to general research and development. Thus, none of the decisions GSK cites mandates EPA to deny essential use allowances.

GSK cites only one example of a company which it believes did not deserve an allowance. In that case, the parent of the 18 company in question submitted significant information demonstrating continued research and development of alternatives.

None of the Protocol decisions directly address the question of whether a country should request subsidiaries of a company to demonstrate research and development of alternatives, if their their parent companies are already doing so. Decision VIII/ 10( 1), however, allows companies to " collaborate with other companies in such efforts." EPA considers this language, as well as the underlying purpose of the Decision to encourage research and development by the industry as a whole and the lack of formal corporate distinctions in the Protocol, to sufficiently cover the case of parent subidiary relations in this situation.

o Meanwhile, companies may elect to drop their CFC products and withdraw from the essential use program over time in accordance with their business plans. EPA has seen at least two instances in which companies   Sciarra Laboratories and PLIVA   withdrew from the essential use program ( by no longer requesting essential use allowances) without ultimately reformulating their products in a non CFC version, leaving the need for their products to be filled by other essential MDIs or alternatives.

( EPA has placed in Docket no. OAR 2004 0063 Federal Register notices from 2001 and 2002 indicating Sciarra's withdrawal from the program, as well as the Federal Register notice from 2004 19 indicating the last year in which PLIVA received allowances ( PLIVA is not included in today's rule). Additionally, EPA has docketed the U. S. response to Decision XIV/ 5, sent to the Ozone Secretariat on February 23, 2005, in which the U. S. identified all CFC and non CFC inhalers sold domestically.) This process is consistent with the goal of promoting a " smooth and efficient transition."

G. EPA must reduce allocations of essential use allowances by the amount that CFC stockpiles exceed a one year supply.

Commenters argue that because Decision XVI/ 12 states that countries should give " due consideration to existing stocks . . .

with the objective of maintaining no more than one year's operational supply" and because Decision IV/ 25 states that the Parties to the Protocol should permit production and consumption only if " the controlled substance is not available in sufficient quantity and quality from existing stocks" that EPA must reduce allocations if stockpiles of CFCs amount to more than a one year supply. ol should permit ",

EPA believes that this argument misreads the Decisions in question. At the last meeting of the Montreal Protocol, the Parties specifically negotiated over, and addressed in text, this very issue. They concluded in Decision XVI/ 12 that " Parties,

when preparing essential use nominations for CFCs, should give due consideration to existing stocks . . . with the objective of 20 maintaining no more than one year's operational supply." First,

by its very terms, the Decision only applies prospectively, when countries make a nomination, not during any later domestic permitting process.

Second, the decision only asks countries to give " due consideration" to stocks in the nomination process. Decision XVI/ 12 did not exist at the time of the 2005 U. S. nomination.

Nonetheless, EPA does give " due consideration" to stocks in its nomination process, and in fact reduced the 2007 U. S. nomination significantly to take into account known stockpiles. The first nomination subject to Decision XVI/ 12, which the United States delivered to the Parties on February 2, 2005, stated, " The USEPA monitors reserves through information provided by companies that receive essential use allowances. In putting forward our 2007 essential use exemption nomination, the United States carefully reviewed the size of company reserves, bearing in mind that information on reserves at the end of 2003 or 2004 is not a reliable indicator of the amounts that will be held, and their distribution at the beginning of 2007. Bearing in mind this uncertainty, the United States has given due consideration to the existence of stocks in accordance with Decision XVI/ 12" ( p. 16).

Thus, the United States has acted in conformance with Decision XVI/ 12. 21 Third, Decision XVI/ 12 only sets an objective of a oneyear's operational supply. It does not mandate it as an absolute requirement. As noted above, EPA gives " due consideration" to stockpiles in its nominations, and does so with an objective of maintaining no more than a one year's operational supply, taking into account FDA's determinations and the circumstances of the nomination.

Finally, Decision IV/ 25 does not alter the plain meaning of Decision XVI/ 12, and indeed, it could not: it was decided by the Parties twelve years before they decided Decision XVI/ 12. As noted above, Decision IV/ 25 sets criteria for the Parties to consider when deciding whether to approve countries' nominations.

GSK also referred to Decision XV/ 5( 2), in which the Parties decided, among other things, "[ t] o request that Parties * * *

when submitting their nominations for essential use exemptions for CFCs for metered dose inhalers, specify, for each nominated use, the active ingredients* * * and the quantity of CFCs required." The commenter stated that the combined effect of Decisions IV/ 25 and XV/ 5 is that EPA must, "[ i] n most cases* * *

assess stockpiles on a company specific basis" ( OAR 2004 0063

0008, p. 13). As a consequence, the commenter argued, EPA must 22 consider both available stockpiles in the aggregate and as held by individual companies. If a single company holds stockpiles greater than one year's operational supply, then according to the commenter EPA must reduce the amount of that company's allocation.

The commenter has incorrectly interpreted a Decision that explicitly refers to individual Parties' nominations as referring to individual Parties' licensing processes. The United States acted in accordance with Decision XV/ 5, which was taken in November 2003, by submitting the requested information in a letter to the TEAP co chairs ( dated April 21, 2004) in connection with the 2006 essential use nomination. The United States also sent updated information to the TEAP co chairs on February 23,

2005, in connection with the 2007 essential use nomination.

Decision XV/ 5, whether considered alone or together with Decision IV/ 25, does not require the United States to take any action other than to submit the requested information as part of its essential use nomination. The commenter does not explain the assertion that the two Decisions, taken together, provide more direction than either provides on its face, nor is there any indication of a direct relationship between the two Decisions.

Decision XV/ 5 does not make reference to Decision IV/ 25 Furthermore, the U. S. nomination for 2005 had already been submitted at the time the Parties took Decision XV/ 5 and thus 23 Decision XV/ 5 did not apply to that nomination because that Decision applies to the process of submitting a nomination, not to domestic licensing procedures.

Another commenter quoted the May 2004 TEAP Report ( see Docket no. OAR 2004 0063) to the effect that " individual companies may hold a substantial and, perhaps, disproportionate amount" of a Party's stockpile ( OAR 2004 0063 0011, p. 2).

EPA does not agree with the commenter that the statements in the TEAP report regarding individual holdings mean that Decision XVI/ 12 must be read as relating to individual holdings. TEAP serves as an advisory body to the Parties to inform their decisionmaking. It is not a directive body. Moreover, the natural reading of Decision XVI/ 12 is that each Party's objective should be to maintain no more than one year's ( aggregate) supply.

Paragraph 3 of that Decision states that " Parties * * * should give due consideration to existing stocks * * * with the objective of maintaining no more than one year's operational supply." The " Parties" are the subject of the sentence and are thus the entities to which the " objective of maintaining no more than one year's operational supply" pertains.

H. EPA must comply with the Act's requirements for notice and comment rulemaking.

One commenter stated that EPA, in our supplemental proposal to correct Armstrong's allocation, failed to comply with section 24 307( d) of the Act. Section 307( d)( 3) directs EPA to make available, among other items, the factual data on which a proposed rule is based and the methodology used in obtaining and analyzing those data. The commenter stated that the supplemental proposal was based on information that had not been placed in the docket, and also that the supplemental proposal was not justified based on information that EPA had made public. The commenter also stated, " Even if it were correct that a requesting company has sufficient information to comment on its own proposed allocation, neither EPA nor FDA have [ sic] provided any basis for a different interested party to meaningfully comment on that allocation" ( OAR 2004 0063 0016, p. 3).

As stated above, the information on which FDA, in consultation with EPA, based the proposed allocations was claimed confidential by the submitting companies, including Armstrong Pharmaceuticals. As a consequence, EPA has treated this information in accordance with our regulations on confidential business information at 40 CFR § § 2.201 to 2.311. EPA has entered placeholder documents in the public portion of the docket to indicate the documents that we placed in the confidential portion.

With respect to the methodology used to determine the proposed allocations, EPA described the process for allocating essential use allowances in the preamble to the proposed rule 25 published on December 22, 2004 ( 69 FR 76657). Section 604( d)( 2)

of the Act directs the Agency to authorize production of class I substances " if such authorization is determined by the Commissioner, in consultation with the Administrator, to be necessary for use in medical devices." EPA entered the Acting Commissioner's letter of determination ( OAR 2004 0063 0005), as well as the FDA's subsequent letter of correction ( OAR 2004 0063

0010), into the public docket for comment. EPA also explained in the preamble of the supplemental proposal that the allocation originally proposed for Armstrong Pharmaceuticals was based on an error, and the purpose of the supplemental notice was to correct the error. Portions of the correspondence regarding the nature of the error have been placed in the confidential portion of the docket due to concerns regarding disclosure of information claimed as confidential. A placeholder has been entered in the public portion of the docket with respect to this information.

EPA thus has made public the most information possible given our obligations regarding the treatment of information claimed as confidential. Therefore, EPA has acted in accordance with section 307( d) of the Act with respect to making public the basis and methodology for our proposed allocations. EPA has also acted in accordance with section 604( d)( 2) of the Act. EPA does not have discretion to refuse to authorize production that is consistent with the Montreal Protocol and that has been 26 determined to be necessary by FDA in consultation with EPA.

I. The increase in Armstrong's proposed allocation was not supported by publicly available information.

One commenter [ Why do we sometimes refer to GSK as " one commenter" and sometimes as " GSK"?] stated that the corrected allocation proposed for Armstrong Pharmaceuticals in the supplemental notice was too high and " cannot be supported under the CAA or the Montreal Protocol" ( OAR 2004 0063 0016, p. 6).

This commenter argued that Armstrong's actual MDI production in recent years, according to publicly available data, was far less than would warrant the amount of CFC production allowances that Armstrong would receive according to the supplemental proposed rule. Also, the commenter stated that Armstrong " must be holding huge stockpiles of CFCs   at least sufficient to supply its production for more than a year," and that by allocating additional allowances to Armstrong in 2005 EPA would violate the terms of the Montreal Protocol ( OAR 2004 0063 0016, p. 5).

Because Armstrong has claimed its 2005 essential use allowance documentation as confidential, EPA is unable to respond to the points made by the commenter specifically with regard to Armstrong's proposed allocation. However, the commenter made several assumptions that EPA may respond to in general terms.

First, the commenter assumed that a company uses all of the allowances it is allocated in a given year. This is not the 27 case, as evidenced by the U. S. Accounting Framework, which since 2001 has shown that the amount authorized has consistently exceeded the amount actually acquired ( Accounting Frameworks for 2001 2004 have been placed in Docket no. OAR 2004 0063). In the 2004 Accounting Framework, for example, the United States reported 964 metric tons of CFCs authorized but not acquired.

This fact reflects an important aspect of the essential use program: both the U. S. nomination and the subsequent allocation rule issued for a given year involve projections, and there is unavoidably some uncertainty associated with projections of demand for CFC MDIs. In the interest of ensuring public access to essential MDIs, EPA believes it is safer for public health to risk allocating more allowances than may be used than to allocate too few and risk a shortage.

Second, the commenter assumed that a company would be able to generate a large stockpile of essential use CFCs by using all of its allowances to produce or import CFCs without actually using those CFCs to manufacture MDIs during the same control period. However, a company engaging in this practice would reveal itself in its reporting to EPA in accordance with regulations at 40 CFR 82.13( u). As discussed above, EPA does not agree with the commenter that the Agency is required to reduce any individual company's allocation to the extent its stockpiles exceed a one year supply. However, EPA expects companies to 28 manage their allowances in good faith consistent with the goals of the essential use program and EPA believes based on data collected that the companies to date have done so.

Third, the commenter assumed that a company's allocations must be based on the company's prior record of production. If a company's projected need for CFCs is higher than past usage, the commenter suggests, then EPA should not authorize additional CFCs. It is true that a company's prior usage of CFCs is relevant to EPA's proposed allocations, and EPA and FDA do take this factor into account in assessing essential use allowance needs. This is why EPA's February 24, 2004, letter to MDI manufacturers required them to include in their essential use applications prior year production data ( OAR 2004 0063 0002).

Nevertheless, past production alone is an insufficient basis for allocating allowances in light of the fact that market conditions may change, and a company may increase or decrease its levels of production accordingly. Thus, EPA's February 24, 2004, letter also requested information regarding anticipated needs during 2005. For this reason and the other reasons explained above, EPA disagrees with the conclusions reached by the commenter with regard to the proposed allocation for Armstrong.

IV. Allocation of Essential Use Allowances for Calendar Year 2005 29 With today's action, EPA is allocating essential use allowances for calendar year 2005 to the entities listed in Table 1. These allowances are for the production or import of the specified quantity of class I controlled substances solely for the specified essential use.

TABLE I  ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2005 Company Chemical Quantity ( metric tons)

Metered Dose Inhalers ( for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary Disease Armstrong Pharmaceuticals CFC  11 or CFC 12 or CFC 114 270.90 Aventis Pharmaceutical Products CFC  11 or CFC 12 or CFC 114 111 Boehringer Ingelheim Pharmaceuticals CFC 11 or CFC 12 or CFC 114 480 Schering Plough Corporation CFC 11 or CFC 12 or CFC 114 816 30 3M Pharmaceuticals CFC 11 or CFC 12 or CFC 114 69.18 Wyeth Pharmaceuticals CFC 11 or CFC 12 or CFC 114 73.40 V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866 ( 58 FR 51735, October 4, 1993),

the Agency must determine whether this regulatory action is " significant" and therefore subject to review by the Office of Management and Budget ( OMB) and the requirements of the Executive Order. The Order defines " significant regulatory action" as one that is likely to result in a rule that may:

( 1) Have an annual effect on the economy of $ 100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment,

public health or safety, or State, local, or tribal governments or communities;

( 2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

( 3) Materially alter the budgetary impact of entitlements,

grants, user fees, or loan programs or the rights and obligations of recipients thereof; or ( 4) Raise novel legal or policy issues arising out of legal 31 mandates, the President's priorities, or the principles set forth in the Executive Order.

Pursuant to the terms of Executive Order 12866, OMB has notified EPA that it considers this rule a " significant regulatory action" within the meaning of the Executive Order.

[ PLACEHOLDER: EPA submitted this action to OMB for review and incorporated changes as a result. A copy of the rule showing changes that were made is available in EPA Docket no. OAR 2004

0063.]

Under Section 6( a)( 3)( B)( ii) of Executive Order 12866, the Agency must provide to OMB's Office of Information and Regulatory Affairs an " assessment of the potential costs and benefits of the regulatory action, including an explanation of the manner in which the regulatory action is consistent with a statutory mandate and, to the extent permitted by law, promotes the President's priorities and avoids undue interference with State,

local, and tribal governments in the exercise of their governmental functions."

EPA is undertaking today's final action under the mandate established by Section 604( d) of the Clean Air Act Amendments of 1990, which directs the Administrator to authorize the production of limited quantities of class I substances solely for use in medical devices, if the Commissioner of FDA determines that the authorization is necessary. The final allocations in today's 32 rule are the amounts determined by FDA to be necessary for calendar year 2005.

EPA has not assessed the costs and benefits specific to today's final action. The Agency examined the costs and benefits associated with a related regulation. The Agency's Regulatory Impact Analysis ( RIA) for the entire Title VI phaseout program examined the projected economic costs of a complete phaseout of consumption of ozone depleting substances, as well as the projected benefits of phased reductions in total emissions of CFCs and other ozone depleting substances, including essentialuse CFCs used for metered dose inhalers ( U. S. Environmental Protection Agency, " Regulatory Impact Analysis: Compliance with Section 604 of the Clean Air Act for the Phaseout of Ozone Depleting Chemicals," July 1992).

B. Paperwork Reduction Act This action does not add any information collection requirements or increase burden under the provisions of the Paperwork Reduction Act, 44 U. S. C. 3501 et. seq. OMB previously approved the information collection requirements contained in the final rule promulgated on May 10, 1995, and assigned OMB control number 2060 0170 ( EPA ICR No. 1432.21).

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes 33 the time needed to review instruction; develop, acquire, install,

and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information;

search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 1.

C. Regulatory Flexibility EPA has determined that it is not necessary to prepare a regulatory flexibility analysis in connection with this final rule. EPA has also determined that this rule will not have a significant economic impact on a substantial number of small entities. For purposes of assessing the impact of today's rule on small entities, small entities are defined as: ( 1)

pharmaceutical preparations manufacturing businesses ( NAICS code 325412) that have less than 750 employees; ( 2) a small governmental jurisdiction that is a government of a city, county, 34 town, school district or special district with a population of less than 50,000; and ( 3) a small organization that is any notfor profit enterprise that is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's final rule on small entities, EPA has concluded that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives " which minimize any significant economic impact of the proposed rule on small entities." 5 U. S. C. Sections 603 and 604. Thus, an agency may conclude that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule. This rule provides an otherwise unavailable benefit to those companies that are receiving essential use allowances.

We have therefore concluded that today's final rule will relieve regulatory burden for all small entities.

D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA), 35 P. L. 104 4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local,

and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement,

including a cost benefit analysis, for proposed and final rules with " Federal mandates" that may result in expenditures to State,

local, and tribal governments, in the aggregate, or to the private sector, of $ 100 million or more in any one year.

Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost effective, or least burdensome alternative, if the Administrator publishes with the final rule an explanation why that alternative was not adopted.

Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed a small government agency plan under section 203 of the UMRA. The plan must provide for notifying potentially affected small governments, enabling 36 officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing,

educating, and advising small governments on compliance with the regulatory requirements.

Today's rule contains no Federal mandates ( under the regulatory provisions of Title II of the UMRA) for State, local,

or tribal governments or the private sector, since it merely provides exemptions from the 1996 phaseout of class I ODSs.

Similarly, EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments, because this rule merely allocates essential use exemptions to entities as an exemption to the ban on production and import of class I ODSs.

E. Executive Order 13132: Federalism Executive Order 13132, entitled " Federalism" ( 64 FR 43255,

August 10, 1999), requires EPA to develop an accountable process to ensure " meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications." " Policies that have federalism implications" is defined in the Executive Order to include regulations that have " substantial direct effects on the States,

on the relationship between the national government and the States, or on the distribution of power and responsibilities 37 among the various levels of government."

This final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. Thus, Executive Order 13132 does not apply to this rule.

F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments Executive Order 13175, entitled " Consultation and Coordination with Indian Tribal Governments" ( 65 FR 67249,

November 9, 2000), requires EPA to develop an accountable process to ensure " meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications." This final rule does not have tribal implications, as specified in Executive Order 13175. Today's rule affects only the companies that requested essential use allowances. Thus, Executive Order 13175 does not apply to this rule.

G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks Executive Order 13045, " Protection of Children from Environmental Health risks and Safety Risks" ( 62 FR 19885, April 23, 1997), applies to any rule that ( 1) is determined to be 38 ' economically significant" as defined under E. O. 12866, and ( 2)

concerns an environmental health and safety risk that EPA has reason to believe may have a disproportionate effect on children.

If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. EPA interprets E. O. 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5 501 of the Order has the potential to influence the regulation. This rule is not subject to E. O. 13045 because it implements the phaseout schedule and exemptions established by Congress in Title VI of the Clean Air Act.

H. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use This rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply,

Distribution, or Use ( 66 Fed. Reg. 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The rule affects only the pharmaceutical companies that requested essential use allowances.

I. National Technology Transfer and Advancement Act 39 Section 12( d) of the National Technology Transfer and Advancement Act of 1995 (" NTTAA), Public Law No. 104 113, section 12( d) ( 15 U. S. C. 272 note) directs EPA to use voluntary consensus standards in this regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical.

Voluntary consensus standards are technical standards ( e. g.,

materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

This final rule does not involve technical standards. Therefore,

EPA did not consider the use of any voluntary consensus standards.

J. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Therefore, EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States 40 prior to publication of the rule in the Federal Register. This rule is not a " major rule" as defined by 5 U. S. C. 804( 2). This rule will be effective [ insert date of FR publication].

VI. Judicial Review Under section 307( b)( 1) of the Act, EPA finds that these regulations are of national applicability. Accordingly, judicial review of the action is available only by the filing of a petition for review in the United States Court of Appeals for the District of Columbia Circuit within sixty days of publication of the action in the Federal Register. Under section 307( b)( 2), the requirements of this rule may not be challenged later in judicial proceedings brought to enforce those requirements.

VII. Effective Date of this Final Rule Section 553( d) of the Administrative Procedures Act ( APA)

generally provides that rules may not take effect earlier than 30 days after they are published in the Federal Register. Today's final rule is issued under section 307( d) of the CAA, which states, " The provisions of section 553 through 557* * * of Title 5 shall not, except as expressly provided in this subsection,

apply to actions to which this subsection applies." Thus,

section 553( d) of the APA does not apply to this rule. EPA nevertheless is acting consistently with the policies underlying APA section 553( d) in making this rule effective [ insert date of publication in the Federal Register]. APA section 553( d) 41 provides an exception for any action that grants or recognizes an 42 Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2005 ( p. 51 of 53)

exemption or relieves a restriction. Because today's action grants an exemption to the phaseout of production and consumption of CFCs, EPA is making this action effective immediately to ensure continued availability of CFCs for medical devices.

List of Subjects in 40 CFR Part 82 Administrative practice and procedure, Air pollution control, Chemicals, Chlorofluorocarbons, Exports, Environmental protection, Imports, Methyl Chloroform, Ozone, Reporting and recordkeeping requirements.

Dated: _______________________________________

______________________________________________

Stephen L. Johnson, Acting Administrator 43 40 CFR Part 82 is amended as follows:

PART 82   PROTECTION OF STRATOSPHERIC OZONE 1. The authority citation for part 82 continues to read as follows:

Authority: 42 U. S. C. 7414, 7601,7671 7671q.

Subpart A   Production and Consumption Controls 1. Section 82.8 is amended by revising paragraph ( a) to read as follows:

§ 82.8 Prohibitions for class I controlled substances.

( a) * * *

TABLE I  ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2005 Company Chemical Quantity ( metric tons)

Metered Dose Inhalers ( for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary Disease Armstrong Pharmaceuticals CFC  11 or CFC 12 or CFC 114 270.90 Aventis Pharmaceutical Products CFC  11 or CFC 12 or CFC 114 111 44 Boehringer Ingelheim Pharmaceuticals CFC 11 or CFC 12 or CFC 114 480 Schering Plough Corporation CFC 11 or CFC 12 or CFC 114 816 3M Pharmaceuticals CFC 11 or CFC 12 or CFC 114 69.18 Wyeth Pharmaceuticals CFC 11 or CFC 12 or CFC 114 73.40 BILLING CODE 6560 50 P


[Federal Register Volume 81, Number 1 (Monday, January 4, 2016)]
[Notices]
[Pages 138-139]
[FR Doc No: 2015-33063]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Fifteenth Meeting: RTCA Special Committee (209) ATCRBS/Mode S
Transponder MOPS (Joint With EUROCAE WG-49, EUROCAE WG-51 Subgroup 1,
and RTCA SC-186 Working Group 3)

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Notice of Fifteenth RTCA Special Committee 209 Meeting.

-----------------------------------------------------------------------

SUMMARY: The FAA is issuing this notice to advise the public of the
Fifteenth RTCA Special Committee 209 meeting.

DATES: The meeting will be held February 1-5, 2016 from 9:00 a.m.-5:00
p.m.

ADDRESSES: The meeting will be held at RTCA, Inc., 1150 18th Street
NW., Suite 910, Washington, DC, 20036, Tel:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org or
Harold Moses, Program Director, RTCA, Inc<EMAIL_ADDRESS>(202)
330-0654.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a) (2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of RTCA Special Committee 209. The agenda
will include the following:

Monday-Friday, February 1-5, 2016

1. Host and Co-Chairs Welcome, Introductions, and Remarks
2. Review and Approval of the Agenda
3. Discussion of current issues proposed to be addressed in this
revision of DO 181/ED 73 and DO 260/ED 102

    a. Mode-S reply rate capabilities
    b. Removal of Mode A/C/S All Call
    c. Operations above 60,000 feet
    d. Description of TABS/LPAT
    e. 1090 MHz spectrum mitigation
    f. Phase modulation method on 1090 MHz
    g. Enhanced reception techniques
    h. Support for ACAS X
    i. Weather data to support future operations
    j. Support for advanced FIM
    k. Other topics as they present themselves
4. Other Business
    a. Request for Proposed Changes to DO 181/ED 73 and DO 260/ED 102
5. Date, Place, Time and Frequency of Future Meetings
6. Adjournment

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Plenary information will be
provided upon request. Persons who wish to present statements or obtain
information should contact the person listed in the FOR FURTHER
INFORMATION CONTACT section. Members of the public may present a
written statement to the committee at any time.

    Issued in Washington, DC, on December 29, 2015.
Latasha Robinson,
Management & Program Analyst, Next Generation, Enterprise Support
Services Division, Federal Aviation Administration.
[FR Doc. 2015-33063 Filed 12-31-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 170 (Thursday, September 1, 2011)]
[Notices]
[Pages 54530-54531]
[FR Doc No: 2011-22316]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-1998-4334; FMCSA-2003-14504; FMCSA-2005-20560; FMCSA-
2007-27897; FMCSA-2009-0121]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
32 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent to
or greater than the level of safety maintained without the exemptions
for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective September 13, 2011. Comments must be
received on or before October 3, 2011.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) numbers: FMCSA-1998-4334; FMCSA-2003-14504;
FMCSA-2005-20560; FMCSA-2007-27897; FMCSA-2009-0121, using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this notice. Note that DOT posts all comments
received without change to http://www.regulations.gov, including any
personal information included in a comment. Please see the Privacy Act
heading below.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Federal Docket Management System (FDMS) is
available 24 hours each day, 365 days each year. If you want
acknowledgment that we received your comments, please include a self-
addressed, stamped envelope or postcard or print the acknowledgement
page that appears after submitting comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to or greater than the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This notice addresses 32 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 32 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are the
following:

Daniel F. Albers
John A. Bridges
Eddie M. Brown
Edwin L. Bupp
Clifford D. Carpenter
Duane C. Conway
Brian W. Curtis
Roger D. Davidson, Sr.
Robin C. Duckett
Marco A. Esquivel
Tomie L. Estes
Raymond L. Herman
Jesse R. Hillhouse, Jr.
Billy R. Holdman
Ray C. Johnson
Terry R. Jones
Randall H. Keil
James J. Mitchell
Andrew M. Nurnberg
Kenneth R. Pedersen
Joshua R. Perkins
Eligio M. Ramirez
Victor C. Richert
Craig R. Saari
Jerry L. Schroder
Gerald J. Shamla
William C. Smith
Larry D. Steiner
Scott C. Teich
Anthony T. Truiolo
Gregory A. VanLue
Kevin W. Wunderlin

    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) By
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10), and
(b) by a medical examiner who attests that the individual is otherwise
physically qualified under 49 CFR 391.41; (2) that each individual
provides a copy of the ophthalmologist's or optometrist's report to the
medical examiner at the time of the annual medical examination; and (3)
that each individual provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file and
retains a copy of the certification on his/her person while driving for
presentation to a duly authorized Federal, State, or local enforcement
official. Each exemption

will be valid for two years unless rescinded earlier by FMCSA. The
exemption will be rescinded if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136(e) and 31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 32 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (63 FR 66226; 64 FR 16517; 66 FR 41656; 68 FR 19598; 68 FR
33570; 68 FR 44837; 70 FR 17504; 70 FR 25878; 70 FR 30997; 70 FR 41811;
72 FR 27624; 72 FR 28093; 72 FR 39879; 72 FR 40362; 72 FR 52419; 74 FR
20523; 74 FR 26461; 74 FR 34630; 74 FR 41971). Each of these 32
applicants has requested renewal of the exemption and has submitted
evidence showing that the vision in the better eye continues to meet
the standard specified at 49 CFR 391.41(b)(10) and that the vision
impairment is stable. In addition, a review of each record of safety
while driving with the respective vision deficiencies over the past two
years indicates each applicant continues to meet the vision exemption
standards. These factors provide an adequate basis for predicting each
driver's ability to continue to drive safely in interstate commerce.
Therefore, FMCSA concludes that extending the exemption for each
renewal applicant for a period of two years is likely to achieve a
level of safety equal to that existing without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by October 3, 2011.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published notices of final disposition
announcing its decision to exempt these 32 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was made on the merits of each
case and made only after careful consideration of the comments received
to its notices of applications. The notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

    Issued on: August 19, 2011.
Larry W. Minor,
Associate Administrator Office of Policy.
[FR Doc. 2011-22316 Filed 8-31-11; 8:45 am]
BILLING CODE 4910-EX-P


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                                the notional amount(s)
                                is expressed.
(c)(5).......................  Inter-Dealer Swap Flag...  ......................................................
(c)(6).......................  Intention To Clear Flag..  intentToClear.
(c)(7).......................  If applicable, any flags   ......................................................
                                pertaining to the
                                transaction that are
                                specified in the
                                policies and procedures
                                of the registered SDR to
                                which the transaction
                                will be reported.
(d)(1).......................  The counterparty ID [on    onBehalfOf.
                                the reporting side].
                                                          partyId.
(d)(1).......................  The execution agent ID     partyId.
                                [on the reporting side],
                                as applicable.
                                                          partyRole.
(d)(1).......................  The counterparty ID [on    partyId.
                                the non-reporting side].
                                                          partyRole.
(d)(1).......................  The execution agent ID of  partyId.
                                each counterparty, as
                                applicable.
                                                          partyRole.
(d)(1).......................  [As applicable] the        relatedBusinessUnit.
                                branch ID of the direct
                                counterparty on the
                                reporting side.
                                                          role.
(d)(1).......................  [As applicable] the        relatedBusinessUnit.
                                broker ID of the direct
                                counterparty on the
                                reporting side.
                                                          role.

(d)(1).......................  [As applicable] the        relatedBusinessUnit.
                                execution agent ID of
                                the direct counterparty
                                on the reporting side.
                                                          role.
(d)(2).......................  [As applicable] the        relatedBusinessUnit.
                                trader ID of the direct
                                counterparty on the
                                reporting side.
                                                          role.
(d)(2).......................  [As applicable] the        relatedBusinessUnit.
                                trading desk ID of the
                                direct counterparty on
                                the reporting side.
                                                          role.
(d)(3).......................  the terms of any fixed or  genericProduct.
                                floating rate payments,
                                or otherwise customized
                                or non-standard payment
                                streams.
(d)(3).......................  the frequency of any       paymentFrequency.
                                fixed or floating rate
                                payments, or otherwise
                                customized or non-
                                standard payment streams.
                                                          resetFrequency.
(d)(3).......................  the contingencies of any   feature.
                                fixed or floating rate
                                payments, or otherwise
                                customized or non-
                                standard payment streams.
(d)(4).......................  title of any master        masterAgreement.
                                agreement.
                                                          masterAgreementId.
(d)(4).......................  the date of any master     masterAgreement.
                                agreement.
                                                          masterAgreementDate.
(d)(4).......................  the title of any           creditSupportAgreement.
                                collateral agreement.
                                                          identifier.
(d)(4).......................  the date of any            creditSupportAgreement.
                                collateral agreement.
                                                          date.
(d)(4).......................  the title of any margin    ......................................................
                                agreement.
(d)(4).......................  the date of any margin     ......................................................
                                agreement.
(d)(4).......................  the title of any other     contractualTermsSupplement, et al.
                                agreement.
                                                          identifier.
(d)(4).......................  the date of any other      contractualTermsSupplement, et al.
                                agreement.
                                                          date.
(d)(5).......................  any additional data        ......................................................
                                elements included in the
                                agreement between the
                                counterparties that are
                                necessary for a person
                                to determine the market
                                value of the
                                transaction;
(d)(6).......................  the name of the clearing   partyId.
                                agency to which the
                                security-based swap will
                                be submitted for
                                clearing.
                                                          partyRole.
(d)(7).......................  whether they have invoked  endUserException.
                                the exception in Section
                                3C(g) of the Exchange
                                Act (15 U.S.C. 78c-
                                3(g));
(d)(8).......................  a description of the       cashSettlementTerms.
                                settlement terms.
(d)(8).......................  whether the security-      physicalSettlementTerms.
                                based swap is cash-
                                settled or physically
                                settled.
(d)(8).......................  the method for             valuationMethod.
                                determining the
                                settlement value.
(d)(9).......................  The platform ID, if        partyId.
                                applicable.
                                                          partyRole.
(d)(10)......................  the transaction ID of an   originatingEvent.
                                allocated security-based
                                swap.
                                                          originatingTradeId.
                                                          allocationTradeId.
(d)(10)......................  the transaction ID of a    terminatingEvent.
                                terminated security-
                                based swap.
                                                          originatingTradeId.
(d)(10)......................  the transaction ID of a    novation.
                                novated security-based
                                swap.
                                                          originatingTradeId.
(d)(10)......................  the transaction ID of an   novation.
                                assigned security-based
                                swap.
                                                          originatingTradeId.
(e)(1)(i)....................  A life cycle event, and    originatingEvent.
                                any adjustment due to a
                                life cycle event, that
                                results in a change to
                                information previously
                                reported pursuant to
                                paragraph (c), (d), or
                                (i) of this section
                                shall be reported by the
                                reporting side [except
                                that the reporting side
                                shall not report whether
                                or not a security-based
                                swap has been accepted
                                for clearing].
                                                          trade.
(e)(1)(ii)...................  Acceptance for clearing..  ......................................................
(e)(2).......................  All reports of life cycle  originatingTradeId.
                                events and adjustments
                                due to life cycle events
                                shall, within the
                                timeframe specified in
                                paragraph (j) of this
                                section, be reported to
                                the entity to which the
                                original security-based
                                swap transaction will be
                                reported or has been
                                reported and shall
                                include the transaction
                                ID of the original
                                transaction.
(f)..........................  Time stamp, to the         timestamps.
                                second, its receipt of
                                any information
                                submitted to it pursuant
                                to paragraph (c), (d),
                                (e), or (i) of this
                                section.
                                                          nonpubliclyReported.
(g)..........................  A transaction ID to each   originatingTradeId.
                                security-based swap, or
                                establish or endorse a
                                methodology for
                                transaction IDs to be
                                assigned by third
                                parties.
----------------------------------------------------------------------------------------------------------------

                   Table 2--Mapping of Common Data Model Data Concepts to FIXML Data Elements
[When the FIXML column includes a list of terms, this means that FIXML expresses the concept as a combination of
data elements from that list. Blank entries mean that the concept does not presently have an exact equivalent in
                                                     FIXML.]
----------------------------------------------------------------------------------------------------------------
       Sec.   901 ref.         Common data model concept                    FIXML data elements
----------------------------------------------------------------------------------------------------------------
(c)(1).......................  Product ID...............  Prod.
                                                          SecTyp.
                                                          PxDtrmnMeth.
                                                          SettlMeth.
                                                          SwapClss.
                                                          SwapSubClss.
(c)(1)(i)....................  Asset Class..............  CFI.
(c)(1)(i)....................  Underlying Reference       Undly.
                                Asset(s).
(c)(1)(i)....................  Underlying Reference       Issr.
                                Issuer(s).
(c)(1)(i)....................  Underlying Reference       NdxSeries.
                                Index.
(c)(1)(ii)...................  Effective Date...........  EfctvDt.
(c)(1)(iii)..................  Scheduled Termination      TrmntDt.
                                Date.
(c)(1)(iv)...................  Terms of any standardized  PmtStrm.
                                fixed rate payments.
                                                          CalcDts.
                                                          Rt.
                                                          Amt.
                                                          Ccy.
(c)(1)(iv)...................  Frequency of any fixed     PmtDts.
                                rate payments.
(c)(1)(iv)...................  Terms of any standardized  ResetDts.
                                floating rate payments.
(c)(1)(iv)...................  Frequency of any floating  PmtDts.
                                rate payments.
(c)(1)(v)....................  Custom Swap Flag.........  ......................................................
(c)(2).......................  The date and time, to the  TrdRegTS.
                                second, of execution,
                                expressed using
                                Coordinated Universal
                                Time (UTC).
                                                          TS.
                                                          Typ.
                                                          Src.
(c)(3).......................  The price................  Px.
(c)(3).......................  The currency in which the  Ccy.
                                price is expressed.
(c)(3).......................  The amount(s) of any up-   UpfrontPx.
                                front payments.
(c)(3).......................  The currenc(ies) of any    ......................................................
                                up-front payments.
(c)(4).......................  The notional amount(s)...  Strm.
                                                          Notl.
(c)(4).......................  The currenc(ies) in which  Ccy.
                                the notional amount(s)
                                is expressed.
(c)(5).......................  Inter-Dealer Swap Flag...  Pty.
                                                          Typ.
(c)(6).......................  Intention To Clear Flag..  ClrIntn.
(c)(7).......................  If applicable, any flags   ......................................................
                                pertaining to the
                                transaction that are
                                specified in the
                                policies and procedures
                                of the registered
                                security-based swap data
                                repository to which the
                                transaction will be
                                reported.
(d)(1).......................  The counterparty ID [on    Pty.
                                the reporting side].
                                                          ID.
                                                          Src.
                                                          R.
                                                          R.
                                                          Sub.
                                                          ID.
                                                          Typ.
(d)(1).......................  The execution agent ID     R.
                                [on the reporting side],
                                as applicable.
(d)(1).......................  The counterparty ID [on    R.
                                the non-reporting side].
(d)(1).......................  The execution agent ID of  R.
                                each counterparty, as
                                applicable.
(d)(1).......................  [As applicable] the        R.
                                branch ID of the direct
                                counterparty on the
                                reporting side.
(d)(1).......................  [As applicable] the        R.
                                broker ID of the direct
                                counterparty on the
                                reporting side.
(d)(1).......................  [As applicable] the        R.
                                execution agent ID of
                                the direct counterparty
                                on the reporting side.
(d)(2).......................  [As applicable] the        R.
                                trader ID of the direct
                                counterparty on the
                                reporting side.
(d)(2).......................  [As applicable] the        R.
                                trading desk ID of the
                                direct counterparty on
                                the reporting side.
(d)(3).......................  the terms of any fixed or  ......................................................
                                floating rate payments,
                                or otherwise customized
                                or non-standard payment
                                streams.
(d)(3).......................  the frequency of any       PmtDts.
                                fixed or floating rate
                                payments, or otherwise
                                customized or non-
                                standard payment streams.
                                                          PmtDts.
(d)(3).......................  the contingencies of any   ContingencyType.
                                fixed or floating rate
                                payments, or otherwise
                                customized or non-
                                standard payment streams.
(d)(4).......................  title of any master        FinDetls.
                                agreement.
                                                          AgmtDesc.
(d)(4).......................  date of any master         AgmtDt.
                                agreement.
(d)(4).......................  title of any collateral    CrdSuprtDesc.
                                agreement.
(d)(4).......................  date of any collateral     CrdSuprtDt.
                                agreement.
(d)(4).......................  title of any margin        ......................................................
                                agreement.
(d)(4).......................  date of any margin         ......................................................
                                agreement.

(d)(4).......................  title of any any other     CnfmDesc.
                                agreement.
                                                          BrkrCnfmDesc.
(d)(4).......................  date of any any other      CnfmDt.
                                agreement.
(d)(5).......................  any additional data        ......................................................
                                elements included in the
                                agreement between the
                                counterparties that are
                                necessary for a person
                                to determine the market
                                value of the transaction.
(d)(6).......................  the name of the clearing   R.
                                agency to which the
                                security-based swap will
                                be submitted for
                                clearing.
                                                          ID.
(d)(7).......................  whether they have invoked  ClrReqmtExcptn.
                                the exception in Section
                                3C(g) of the Exchange
                                Act (15 U.S.C. 78c-3(g)).
(d)(8).......................  a description of the       ......................................................
                                settlement terms.
(d)(8).......................  whether the security-      SettlMeth.
                                based swap is cash-
                                settled or physically
                                settled.
                               the method for             SettlNdx.
                                determining the
                                settlement value.
                                                          SettlNdxLctn.
(d)(9).......................  The platform ID, if        R.
                                applicable.
                                                          ID.
                                                          Src.
(d)(10)......................  the transaction ID of an   AllExc.
                                allocated security-based
                                swap.
                                                          TransTyp.
                                                          TrdID.
(d)(10)......................  the transaction ID of a    RegTrdID.
                                terminated security-
                                based swap.
                                                          TrmTyp.
                                                          TrdID.
(d)(10)......................  Novation transaction ID..  TrdContntn.
                                                          TrdContntn.
                                                          OrigTrdID.
                                                          Side.
(d)(10)......................  the transaction ID of an   AsgnTyp.
                                assigned security-based
                                swap.
                                                          TrdID.
(e)(1)(i)....................  A life cycle event, and    TrdContntn.
                                any adjustment due to a
                                life cycle event, that
                                results in a change to
                                information previously
                                reported pursuant to
                                paragraph (c), (d), or
                                (i) of this section
                                shall be reported by the
                                reporting side [except
                                that the reporting side
                                shall not report whether
                                or not a security-based
                                swap has been accepted
                                for clearing].
                                                          TrdContntn.
(e)(1)(ii)...................  Acceptance for clearing..  RskLmitChkStat.
(e)(2).......................  All reports of life cycle  OrigTrdID.
                                events and adjustments
                                due to life cycle events
                                shall, within the
                                timeframe specified in
                                paragraph (j) of this
                                section, be reported to
                                the entity to which the
                                original security-based
                                swap transaction will be
                                reported or has been
                                reported and shall
                                include the transaction
                                ID of the original
                                transaction.
(f)..........................  Time stamp, to the         TrdRegTS.
                                second, its receipt of
                                any information
                                submitted to it pursuant
                                to paragraph (c), (d),
                                (e), or (i) of this
                                section.
                                                          TS.
                                                          Typ.
                                                          Src.
(g)..........................  A transaction ID to each   TrdID.
                                security-based swap, or
                                establish or endorse a
                                methodology for
                                transaction IDs to be
                                assigned by third
                                parties.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-31703 Filed 12-22-15; 8:45 am]
BILLING CODE 8011-01-P