PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. EPA/ Office of Air and Radiation 2. OMB control number b. X None a__ __ __ __  __ __ __ __ 2060 __

3. Type of information collection ( check one) a. X New collection b. G Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title Secondary Non Ferrous Metals Processing Area Source Standard Development Questionnaire 8. Agency form number( s) ( If applicable) EPA ICR # 2200.01 9. Keywords Air pollution control, environmental protection, secondary non ferrous metals 10. Abstract Respondents are secondary non ferrous metals processing establishments, excluding facilities that perform secondary processing of aluminum, copper, or lead. Secondary non ferrous metals processing is one of the area source categories listed for regulation under EPA's Integrated Urban Air Toxics Strategy. Current information on HAP emissions and controls are needed to determine the appropriate scope and level of control and to estimate environmental, cost, and economic impacts.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents ______ 110________ b. Total annual responses ____________ 37_______ 1. Percentage of these responses collected electronically 33 % c. Total hours requested _______ 2,281_________ d. Current OMB inventory ___________ 0_________ e. Difference _____________ 2,281_________ f. Explanation of difference 1. Program Change _________ 2,281_________ 2. Adjustment ______________ 0_________ 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs ___ 0_____________ b. Total annual costs ( O& M) ______________ 0_____________ c. Total annualized cost requested ___________ 0_____________ d. Current OMB inventory __________________ 0_____________ e. Difference ___________________ 0_____________ f. Explanation of difference 1. Program change _________________ 0____________ 2. Adjustment ______________________ 0____________

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P__ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biennially 8. X Other ( describe) Once 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: _ Karen Rackley, ESD____________________ Phone: __ ( 919) 541 0634_________________________

OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any 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."

OMB 83 I ( Instructions) 10/ 95


[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Notices]
[Pages 25726-25727]
[FR Doc No: 2011-11061]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange

Commission will hold a roundtable discussion on money market funds and
systemic risk on Tuesday, May 10, 2011, in the Multipurpose Room, L-
006, beginning at 2 p.m. The roundtable will be webcast on the
Commission's Web site at http://www.sec.gov and will be archived for
later viewing.
    The agenda for the roundtable will include a panel discussion on
money market funds and systemic risk and will provide a forum for
various stakeholders in money market funds to exchange views on the
potential effectiveness of certain options in mitigating systemic risks
associated with money market funds. These will include, but are not
limited to, options raised in the President's Working Group report on
possible money market fund reforms that was issued in October 2010
(http://www.treasury.gov/press-center/press-releases/Documents/10.21%20PWG%20Report%20Final.pdf).
    This Sunshine Act notice is being issued because a majority of the
Commission may attend the roundtable.
    For further information, please contact the Office of the Secretary
at<PHONE_NUMBER>.

    May 2, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-11061 Filed 5-3-11; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 91 (Wednesday, May 11, 2011)]
[Proposed Rules]
[Pages 27294-27296]
[FR Doc No: 2011-11208]

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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Part 721

[EPA-HQ-OPPT-2011-0109; FRL-8871-3]
RIN 2070-AB27

Proposed Revocation of the Significant New Use Rule on a Certain
Chemical Substance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke a significant new use rule (SNUR)
promulgated under section 5(a)(2) of the Toxic Substances Control Act
(TSCA) for a chemical substance identified generically as substituted
ethoxyethylamine phosphonate, which was the subject of premanufacture
notice (PMN) P-95-1950. EPA issued a ``non-5(e)'' SNUR (i.e. SNUR on a
substance that is not subject to a TSCA section 5(e) consent order),
designating certain activities as significant new uses based on the
concern criteria. EPA has received and reviewed new information and
test data for the chemical substance and proposes to revoke the SNUR.

DATES: Comments must be received on or before June 10, 2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0109, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2011-0109. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is<PHONE_NUMBER>. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0109. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to

4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number of the EPA/DC Public Reading Room is<PHONE_NUMBER>,
and the telephone number for the OPPT Docket is<PHONE_NUMBER>. Docket
visitors are required to show photographic identification, pass through
a metal detector, and sign the EPA visitor log. All visitor bags are
processed through an X-ray machine and subject to search. Visitors will
be provided an EPA/DC badge that must be visible at all times in the
building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Virginia Lee, Chemical Control Division (7405 M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-4142; e-mail address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
import, process, or use the chemical substance contained in this
proposed rule. Potentially affected entities may include, but are not
limited to:
     Manufacturers, importers, or processors of the subject
chemical substance (NAICS codes 325 and 324110), e.g., chemical
manufacturers and petroleum refineries. This listing is not intended to
be exhaustive, but rather provides a guide for readers regarding
entities likely to be affected by this action. Other types of entities
not listed in this unit could also be affected. The North American
Industrial Classification System (NAICS) codes have been provided to
assist you and others in determining whether this action might apply to
certain entities. To determine whether you or your business may be
affected by this action, you should carefully examine the applicability
provisions in Sec.  721.5. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
    This action may also affect certain entities because of import
certification and export notification requirements under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127;
see also 19 CFR 127.28. Chemical importers must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA. The EPA policy in support of import
certification appears at 40 CFR part 707, subpart B. Importers of the
chemical, the subject of this action, would no longer be required to
certify compliance with the SNUR requirements if the revocation becomes
effective. In addition, if this proposed SNUR revocation becomes
effective, persons who export or intend to export the chemical that is
the subject of this action would no longer be subject to the TSCA
section 12(b) (15 U.S.C. 2611(b)) export notification requirements at
40 CFR part 707, that are currently triggered by the SNUR.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What action is the agency taking?

    In the Federal Register of January 22, 1998 (63 FR 3393) (FRL-5720-
3), EPA promulgated a SNUR at 40 CFR 721.6078 for the chemical
substance identified generically as substituted ethoxyethylamine
phosphonate (PMN P-95-1950). This SNUR designated certain activities as
significant new uses based on the environmental effect criteria
identified in Sec.  721.170(b)(4)(ii) for analogous polyanionic
monomers. EPA has received and reviewed aquatic toxicity test data for
the chemical substance and based on its review of these data, EPA now
proposes to revoke the SNUR pursuant to Sec.  721.185. In this unit,
EPA provides a brief description of this chemical substance, including
the PMN number, generic chemical name, the Federal Register publication
date and reference, the docket number, the basis for revoking the SNUR
under Sec.  721.185, and the CFR citation of the SNUR.
PMN Number P-95-1950
    Chemical name: Substituted ethoxyethylamine phosphonate (generic).
    CAS number: Not available.
    Federal Register publication date and reference: January 22, 1998
(63 FR 3393).
    Docket number: OPPTS-50628.
    Basis for revocation of SNUR: EPA issued a SNUR for this substance
based on the environmental effect criteria at Sec.  721.170(b)(4)(ii)
for analogous polyanionic monomers. Subsequently, the PMN submitter
petitioned EPA to revoke the SNUR based on the results of submitted
aquatic toxicity testing in fish, daphnids, and algae. The aquatic
toxicity testing demonstrated that the substance has inherently low
toxicity, mitigating EPA's concern for toxicity to aquatic organisms.
Therefore, EPA rescinds its finding that releases to water resulting in
stream concentrations that exceed 30 parts per billion (ppb) may cause
significant adverse environmental effects. Based on available
information, the substance no longer meets the concern criteria at
Sec.  721.170(b)(4)(ii). Therefore, EPA proposes that the SNUR for this

chemical substance be revoked pursuant to Sec.  721.185(a)(4).
    CFR citation: 40 CFR 721.6078.

B. What is the agency's authority for taking this action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires persons to submit a significant
new use notice (SNUN) to EPA at least 90 days before they manufacture,
import, or process the chemical substance for that use. The mechanism
for reporting under this requirement is established under Sec.  721.5.
    Upon conclusion of the review for P-95-1950, based on the concern
criteria in Sec.  721.170(b)(4)(ii) discussed in Unit II.A., EPA
determined that there was a concern for potential environmental effects
of the substance at a concentration as low as 30 ppb of the PMN
substance in surface waters and promulgated a non-5(e) SNUR for this
chemical substance.
    Under Sec.  721.185, EPA may at any time revoke a SNUR for a
chemical substance which has been added to subpart E of 40 CFR part 721
if EPA makes one of the determinations set forth in Sec.  721.185(a)(1)
through (a)(6). Revocation may occur on EPA's initiative or in response
to a written request. Under Sec.  721.185(b)(3), if EPA concludes that
a SNUR should be revoked, the Agency will propose the changes in the
Federal Register, briefly describe the grounds for the action, and
provide interested parties an opportunity to comment.
    EPA has determined that the criteria set forth in Sec.
721.185(a)(4) have been satisfied for the chemical substance;
therefore, EPA is proposing to revoke the SNUR for this chemical
substance. The significant new use notification and the recordkeeping
requirements at 40 CFR 721.6078 would terminate if and when this
proposed revocation becomes effective. In addition, export notification
under TSCA section 12(b) and 40 CFR part 707, subpart D triggered by
the SNUR would no longer be required.

III. Statutory and Executive Order Reviews

    This proposed rule would revoke or eliminate an existing regulatory
requirement and does not contain any new or amended requirements. As
such, the Agency has determined that this proposed SNUR revocation
would not have any adverse impacts, economic or otherwise.
    The Office of Management and Budget (OMB) has exempted these types
of regulatory actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
proposed rule does not contain any information collections subject to
approval under the Paperwork Reduction Act (PRA), (44 U.S.C. 3501 et
seq.). Since this proposed rule eliminates a reporting requirement, the
Agency certifies pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), that this SNUR revocation
would not have a significant economic impact on a substantial number of
small entities.
    For the same reasons, this action does not require any action under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.
104-4). This proposed rule has neither Federalism implications, because
it would not have substantial direct effects on 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, entitled Federalism
(64 FR 43255, August 10, 1999), nor Tribal implications, because it
would not have substantial direct effects on one or more Indian Tribes,
on the relationship between the Federal Government and Indian Tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian Tribes, as specified in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 9, 2000).
    This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined under Executive Order 12866,
and it does not address environmental health or safety risks
disproportionately affecting children. It is not subject to Executive
Order 13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001),
because this action is not expected to affect energy supply,
distribution, or use. Because this action does not involve any
technical standards, section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note), does not apply to this action. This action does
not involve special considerations of environmental justice related
issues as required by Executive Order 12898, entitled Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: April 29, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

    Therefore, it is proposed that 40 CFR part 721 be amended as
follows:

PART 721--[AMENDED]

    1. The authority citation for part 721 continues to read as
follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).

Sec.  721.6078  [Removed]

    2. Remove Sec.  721.6078.

[FR Doc. 2011-11208 Filed 5-10-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 170 (Tuesday, September 5, 2023)]
[Notices]
[Pages 60732-60734]
[FR Doc No: 2023-18993]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0107; FMCSA-2014-0385; FMCSA-2014-0386; FMCSA-
2021-0014; FMCSA-2018-0135; FMCSA-2018-0138]

Qualification of Drivers; Exemption Applications; Hearing

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

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

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SUMMARY: FMCSA announces its decision to renew exemptions for eight
individuals from the hearing requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these hard of hearing and deaf
individuals to continue to operate CMVs in interstate commerce.

DATES: The exemptions are applicable on September 12, 2023. The
exemptions expire on September 12, 2025. Comments must be received on
or before October 5, 2023.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System Docket No. FMCSA-2014-0107, Docket No. FMCSA-2014-
0385, Docket No. FMCSA-2014-0386, Docket No. FMCSA-2021-0014, Docket
No. FMCSA-2018-0135, or Docket No. FMCSA-2018-0138 using any of the
following methods:
     Federal eRulemaking Portal: Go to www.regulations.gov/,
insert the docket number (FMCSA-2014-0107, FMCSA-2014-0385, FMCSA-2014-
0386, FMCSA-2021-0014, FMCSA-2018-0135, or FMCSA-2018-0138) in the
keyword box and click ``Search.'' Next, sort the results by ``Posted
(Newer-Older),'' choose the first notice listed, and click on the
``Comment'' button. Follow the online instructions for submitting
comments.
     Mail: Dockets Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, 1200 New Jersey
Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5 p.m. ET
Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the

``Public Participation'' portion of the SUPPLEMENTARY INFORMATION
section for instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room
W64-224, Washington, DC 20590-0001,<PHONE_NUMBER>,
[email protected]. Office hours are 8:30 a.m. to 5 p.m. ET Monday
through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2014-0107, Docket No. FMCSA-2014-0385, Docket
No.
    FMCSA-2014-0386, Docket No. FMCSA-2021-0014, Docket No. FMCSA-2018-
0135, or Docket No. FMCSA-2018-0138), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that FMCSA can contact you if there are questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov/, insert
the docket number (FMCSA-2014-0107, FMCSA-2014-0385, FMCSA-2014-0386,
    FMCSA-2021-0014, FMCSA-2018-0135, or FMCSA-2018-0138) in the
keyword box and click ``Search.'' Next, sort the results by ``Posted
(Newer-Older),'' choose the first notice listed, click the ``Comment''
button, and type your comment into the text box on the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. FMCSA will consider all comments and
material received during the comment period.

B. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number (FMCSA-2014-0107, FMCSA-2014-0385, FMCSA-2014-0386, FMCSA-2021-
0014, FMCSA-2018-0135, or FMCSA-2018-0138) in the keyword box and click
``Search.'' Next, sort the results by ``Posted (Newer-Older),'' choose
the first notice listed, and click ``Browse Comments.'' If you do not
have access to the internet, you may view the docket online by visiting
Dockets Operations on the ground floor of the DOT West Building, 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m. ET Monday through Friday, except Federal holidays. To be sure
someone is there to help you, please call<PHONE_NUMBER> or (202) 366-
9826 before visiting Dockets Operations.

C. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption requests. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov. As described in the system of records
notice DOT/ALL 14 (Federal Docket Management System), which can be
reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the name of
the submitter.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-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 statutes also allow the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding hearing
found in 49 CFR 391.41(b)(11) states that a person is physically
qualified to drive a CMV if that person first perceives a forced
whispered voice in the better ear at not less than 5 feet with or
without the use of a hearing aid or, if tested by use of an audiometric
device, does not have an average hearing loss in the better ear greater
than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a
hearing aid when the audiometric device is calibrated to American
National Standard (formerly ASA Standard) Z24.5--1951.
    This standard was adopted in 1970 and was revised in 1971 to allow
drivers to be qualified under this standard while wearing a hearing
aid, (35 FR 6458, 6463 (Apr. 22, 1970) and 36 FR 12857 (July 8, 1971),
respectively).
    The eight individuals listed in this notice have requested renewal
of their exemptions from the hearing standard in Sec.  391.41(b)(11),
in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated
these applications for renewal on their merits and decided to extend
each exemption for a renewable 2-year period.

III. Request for Comments

    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(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the
eight applicants has satisfied the renewal conditions for obtaining an
exemption from the hearing requirement. The eight drivers in this
notice remain in good standing with the Agency. In addition, for
commercial driver's license (CDL) holders, the Commercial Driver's
License Information System and the Motor Carrier Management Information
System are searched for crash and violation data. For non-CDL holders,
the Agency reviews the driving records from the State Driver's
Licensing Agency. These factors provide an adequate basis for
predicting each driver's ability to continue to safely operate a CMV in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each of these drivers for a period of 2 years is likely
to achieve a level of safety equal to that existing without the
exemption.
    As of September 12, 2023, and in accordance with 49 U.S.C. 31136(e)
and 31315(b), the following eight individuals have satisfied the
renewal conditions for obtaining an exemption from the hearing
requirement in the FMCSRs for interstate CMV drivers:

Daniel Alcozer (IL)
Courtney Bertling (OR)
Mark Howard (NY)
David Jakubowski (CA)
Jay Larson (TX)
Tia Matthews (TX)
Eduwin Pineiro (TX)

Jason Swearington (TX)

    The drivers were included in docket numbers FMCSA-2014-0107, FMCSA-
2014-0385, FMCSA-2014-0386, FMCSA-2021-0014, FMCSA-2018-0135, or FMCSA-
2018-0138. Their exemptions are applicable as of September 12, 2023 and
will expire on September 12, 2025.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) each driver must report any crashes or accidents as defined in
Sec.  390.5T; and (2) report all citations and convictions for
disqualifying offenses under 49 CFR parts 383 and 391 to FMCSA; and (3)
each driver prohibited from operating a motorcoach or bus with
passengers in interstate commerce. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official. In addition, the
exemption does not exempt the individual from meeting the applicable
CDL testing requirements. Each exemption will be valid for 2 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(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the eight exemption applications,
FMCSA renews the exemptions of the aforementioned drivers from the
hearing requirement in Sec.  391.41(b)(11). In accordance with 49
U.S.C. 31136(e) and 31315(b), each exemption will be valid for 2 years
unless revoked earlier by FMCSA.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-18993 Filed 9-1-23; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: April 11, 2006 (Volume 71, Number 69)]
[Proposed Rules]
[Page 18262-18267]
[DOCID:fr11ap06-36]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2006-0158; FRL-8157-3]
RIN 2060-AN29

Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2006

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to allocate essential use allowances for
import and production of class I stratospheric ozone depleting
substances (ODSs) for calendar year 2006. Essential use allowances
enable a person to obtain controlled class I ODSs as part of an
exemption to the regulatory ban on the production and import of these
chemicals which became effective as of 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 proposed allocations total 1,002.40 metric tons of
chlorofluorocarbons (CFCs) for use in metered dose inhalers for 2006.

DATES: Written comments on this proposed rule must be received by the
EPA Docket on or before May 11, 2006, unless a public hearing is
requested. Comments must then be received on or before May 22, 2006.
Any party requesting a public hearing must notify the contact listed
below under FOR FURTHER INFORMATION CONTACT by 5 p.m. Eastern Standard
Time on April 17, 2006. If a hearing is held, it will take place on
April 21, 2006 at EPA headquarters in Washington DC. EPA will post a
notice on our Web site http://www.epa.gov/ozone announcing further

information on the hearing if it is requested.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2006-0158, by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>, attn: Hodayah Finman
     Mail: Air Docket, Environmental Protection Agency,
Mailcode 6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery or Courier. Deliver your comments to: EPA
Air Docket, EPA West 1301 Constitution Avenue, NW., Room B108, Mail
Code 6102T, Washington, D.C. 20460. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2006-0158. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov website

is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

    Docket: All documents in the docket are listed in the http://www.regulations.gov
 index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Docket, EPA/

DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC.
This Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Public Reading Room is<PHONE_NUMBER>, and the telephone number for the
Air Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Hodayah Finman, Team Leader, by
regular mail: U.S. Environmental Protection Agency, Stratospheric
Protection Division (6205J), 1200 Pennsylvania Avenue, NW., Washington,
DC 20460; by courier service or overnight express: 1301 L Street, NW.,
Room 827M Washington DC 20005, by telephone:<PHONE_NUMBER>; or by e-
mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
    A. What Should I Consider When Preparing My Comments?
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. Essential Use Allowances for Medical Devices
IV. Proposed Allocation of Essential Use Allowances for Calendar
Year 2006
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    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

I. General Information

A. What Should I Consider When Preparing My Comments?

1. Confidential Business Information
    Do not submit this information to EPA through http://www.regulations.gov
 or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for Preparing Your Comments
    When submitting comments, remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

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 the international agreement aimed at reducing and
eliminating the production and consumption of stratospheric ozone-
depleting substances. The elimination of production and consumption of
class I ODSs is accomplished through adherence to phase-out schedules
for specific class I ODSs \1\, including: chlorofluorocarbons (CFCs),
halons, carbon tetrachloride, and 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.
---------------------------------------------------------------------------

    \1\ Class I ozone-depleting substances are listed at 40 CFR Part
82 subpart A, appendix A.
---------------------------------------------------------------------------

    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 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.\2\ 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:
---------------------------------------------------------------------------

    \2\ 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.
---------------------------------------------------------------------------

    (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 section 604(d)(1) of the Act, this exemption was available only
until January 1, 2005.
    (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, 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
alternatives are available or 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 X/19, additionally allows a general
exemption for laboratory and analytical uses. This exemption is
reflected in EPA's regulations at 40 CFR part 82, subpart A. While the
Act does not specifically provide for this exemption, EPA has
determined that an exemption 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). In a
December 29, 2005 final rule, EPA extended the general exemption for
laboratory and analytical uses through December 31, 2007 (70 FR 77048),
in accordance with Decision XV/8 of the Parties to the Protocol.

C. What Is the Process for Allocating Essential Use Allowances?

    Before EPA may 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
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. The allowances allocated
through today's action were first nominated by the United States in
January 2004.
    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 medical
devices, EPA requests information from manufacturers about the number
and type of devices 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 metered-dose inhalers in the coming calendar year. Based
on FDA's assessment, 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 may not allocate essential use
allowances in amounts higher than the total approved by the Parties.
For 2006, the Parties authorized the United States to allocate up to
1,100 metric tons of CFCs for essential uses.

III. Essential Use Allowances for Medical Devices

    The following is a step-by-step list of actions EPA and FDA have
taken thus far to implement the exemption for medical devices found at
section 604(d)(2) of the Act for the 2006 control period.
    1. On March 24, 2005, EPA sent letters to MDI manufacturers
requesting the following information under section 114 of the Act
(``114 letters''):
    a. The MDI product where CFCs will be used.
    b. The number of units of each MDI product produced from 1/1/04 to
12/31/04.
    c. The number of units anticipated to be produced in 2005.
    d. The gross target fill weight per unit (grams).
    e. Total amount of CFCs to be contained in the MDI product for
2006.
    f. The additional amount of CFCs necessary for production.
    g. The total CFC request per MDI product for 2006.
    The 114 letters are available for review in the Air Docket ID No.
EPA-HQ-OAR-2006-0158. The companies requested that their responses be
treated as confidential business information; for this reason, EPA has
not placed the responses in the docket.
    2. On July 5, 2005, EPA sent FDA the information MDI manufacturers
provided in response to the 114 letters with a letter requesting that
FDA make a determination regarding the amount of CFCs necessary for
MDIs for calendar year 2006. This letter is available for review in Air
Docket ID No. EPA-HQ-OAR-2006-0158.
    3. On October 12, 2005, FDA sent a letter to EPA stating the amount
of CFCs determined by the Commissioner to be necessary for each MDI
company in 2006. This letter is available for review in the Air Docket
ID No. EPA-HQ-OAR-2006-0158. In their letter, FDA informed EPA that
they had determined that 1,002.40 metric tons of CFCs were necessary
for use in medical devices in 2006. The letter stated: ``Our
recommendation for the allocation of CFCs is lower than the total
amount requested by sponsors. In reaching this estimate, we took into
account the sponsors' production of MDIs that used CFCs as a propellant
in 2004, their estimated production in 2005, their estimated production
in 2006, their current stockpile levels, and the presence on the market
of two albuterol MDIs that do not use CFCs. We have also based our
recommendation for 2006 on an estimate of the quantity of MDIs using
CFCs as a propellant that would be necessary for sponsors to maintain a
12-month stockpile, consistent with paragraph 3 of Decision XVI/12.''
EPA has confirmed with FDA that this determination is consistent with
Decision XVII/5, including new language on stocks that states that
``Parties shall take into account pre- and post-1996 stocks of
controlled substances as described in paragraph 1 (b) of decision IV/
25, such that no more than a one-year operational supply is maintained
by that manufacturer.''
    In accordance with the determination made by FDA, today's action
proposes to allocate essential use allowances for a total of 1,002.40
metric tons of CFCs for use in MDIs for calendar year 2006.
    The amounts listed in this proposal are subject to additional
review by EPA and FDA if new information demonstrates that the proposed
allocations are either too high or too low. Commentors requesting
increases or decreases of essential use allowances should provide
detailed information supporting their claim for additional or fewer
CFCs. Any company that needs less than the full amount listed in this
proposal should notify EPA of the actual amount needed.

IV. Proposed Allocation of Essential Use Allowances for Calendar Year
2006

        Table I.--Essential Use Allocation for Calendar Year 2006
------------------------------------------------------------------------
                                                           2006 Quantity
             Company                      Chemical         (metric tons)
------------------------------------------------------------------------
(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
 and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals........  CFC-11 or CFC-12 or            147.50
                                    CFC-114.
Boehringer Ingelheim               CFC-11 or CFC-12 or            116.50
 Pharmaceuticals.                   CFC-114.
Inyx (Aventis)...................  CFC-11 or CFC-12 or            106.40
                                    CFC-114.
Schering-Plough Corporation......  CFC-11 or CFC-12 or            556.00
                                    CFC-114.
3M Pharmaceuticals...............  CFC-11 or CFC-12 or               0.0
                                    CFC-114.

Wyeth............................  CFC-11 or CFC-12 or              76.0
                                    CFC-114.
------------------------------------------------------------------------

    EPA proposes to allocate essential use allowances for calendar year
2006 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.

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
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    It has been determined by OMB and EPA that this proposed action is
not a ``significant regulatory action'' under the terms of Executive
Order 12866, and is therefore not subject to OMB review under the
Executive Order.
    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 proposed 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 proposed allocations in today's rule are the amounts determined by
FDA to be necessary for calendar year 2006. EPA has not assessed the
costs and benefits specific to today's proposed 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 essential-use 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 proposed 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 the time
needed to review instructions; 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 Act

    The RFA generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute unless the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations, and small
governmental jurisdictions.
    For purposes of assessing the impact of today's rule on small
entities, small entity is 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, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of today's proposed rule on
small entities, EPA certifies 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 rule on small entities.'' 5 U.S.C. 603 and 604.
Thus, an agency may certify 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 proposed rule provides an otherwise unavailable benefit to
those companies that are receiving essential use allowances by creating
an exemption to the regulatory phaseout of chlorofluorocarbons. We have
therefore concluded that today's proposed rule will relieve regulatory
burden for all small entities. We continue to be interested in the
potential impact of the proposed rule on small entities and welcome
comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.
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 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 proposed 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 phase out 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 among the various levels of government.''
    This proposed 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 proposed 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 ``economically significant''
under E.O. 12866, and (2) concerns an environmental health or 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 as the analysis
required under section 5-501 of the Order has the potential to
influence the regulation. This proposed rule is not subject to E.O.
13045 because it implements a mandatory requirement as per Section
604(d)(2) of the Clean Air Act which compels the Agency to allocate
essential use exemptions should the Food and Drug Administration finds
that the exemption is necessary.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This proposed rule is not subject to Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 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

    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 its
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
proposed rule does not involve technical standards. Therefore, EPA did
not consider the use of any voluntary consensus standards.

List of Subjects in 40 CFR Part 82

    Administrative practice and procedure, Air pollution control,
Chemicals, Chlorofluorocarbons, Environmental protection, Imports,
Methyl Chloroform, Ozone, Reporting and recordkeeping requirements.

    Dated: April 5, 2006.
Stephen L. Johnson,
Administrator.
    40 CFR Part 82 is proposed to be 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

    2. Section 82.8 is amended by revising the table in paragraph (a)
to read as follows:

Sec.  82.8  Grants of essential use allowances and critical use
allowances.

    (a) * * *

        Table I.--Essential Use Allocation for Calendar Year 2006
------------------------------------------------------------------------
                                                           2006 Quantity
             Company                      Chemical         (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            147.50
                                    CFC-114.
Boehringer Ingelheim               CFC-11 or CFC-12 or            116.50
 Pharmaceuticals.                   CFC-114.
Inyx (Aventis)...................  CFC-11 or CFC-12 or            106.4
                                    CFC-114.
Schering-Plough Corporation......  CFC-11 or CFC-12 or            556.00
                                    CFC-114.
3M Pharmaceuticals...............  CFC-11 or CFC-12 or              0.0
                                    CFC-114.
Wyeth............................  CFC-11 or CFC-12 or             76.0
                                    CFC-114.
------------------------------------------------------------------------

* * * * *
 [FR Doc. E6-5329 Filed 4-10-06; 8:45 am]

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[Federal Register: February 2, 2009 (Volume 74, Number 20)]
[Notices]
[Page 5880-5881]
[DOCID:fr02fe09-89]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59270; File No. SR-NYSEArca-2009-01]

Self-Regulatory Organizations; Notice of Filing of Proposed Rule
Change by NYSE Arca, Inc. Relating to Reduction of Annual Fee for
Certain Issues Listed Under Rule 5.2(j)(6).

January 21, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on January 6, 2009, NYSE Arca, Inc. (``NYSE Arca'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange, through its wholly owned subsidiary NYSE Arca
Equities, Inc. (``NYSE Arca Equities''), is proposing to amend its
Schedule of Fees and Charges for Exchange Services (``Fee Schedule'')
to revise the Annual Fees applicable to securities listed in calendar
year 2009 under Rule 5.2(j)(6) on NYSE Arca, LLC (``NYSE Arca
Marketplace''), the equities facility of NYSE Arca Equities. The text
of the proposed rule change is available on the Exchange's Web Site at
http://www.nyx.com, at the Exchange's principal office, and at the
Commission's public reference room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    NYSE Arca has determined to amend the Exchange's Fee Schedule to
revise the Annual Fee applicable to securities listed on the NYSE Arca
Marketplace in calendar year 2009 under Rule 5.2(j)(6) (Equity Index-
Linked Securities, Commodity-Linked Securities, Currency-Linked
Securities, Fixed Income Index-Linked Securities, Futures-Linked
Securities and Multifactor Indexed-Linked Securities). Specifically,
the Exchange proposes to add new footnote 10 to the Fee Schedule to
state that, during 2009, the Annual Fee for an issue of securities
listed under Rule 5.2(j)(6) of up to 500,000 shares outstanding will be
$5,000, pro-rated based on days remaining in 2009.
    Under the current Fee Schedule for Structured Products, which
include securities listed under Rule 5.2(j)(6), the Annual Fee ranges
from $10,000 to $55,000, based on the total number of securities
outstanding per listed issue. The current Annual Fee for issues with up
to 6 million shares outstanding is $10,000. The proposed reduced Annual
Fee would apply for calendar year 2009 to issues newly listed on the
NYSE Arca Marketplace beginning as of January 1, 2009, and would not
apply to issues listed prior to or after calendar year 2009.
    As an example of how the Annual Fee would apply to such issues, if
an Equity Index-Linked Security lists on the NYSE Arca Marketplace on
July 1, 2009 with 500,000 shares outstanding, such security would pay a
pro-rated Annual Fee for 2009 of $2500 (\1/2\ x $5,000).
    The Exchange believes that temporarily reducing the Annual Fee for
newly listed securities listed under Rule 5.2(j)(6), which include
Exchange Traded Notes or ``ETNs'', will provide an incentive for
issuers to introduce and list more such products on the NYSE Arca
Marketplace in 2009, thereby increasing competition among such
products.

2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \4\ of the
Act in general and Section 6(b)(4) \5\ of the Act, in particular, in
that it provides for the equitable allocation of reasonable dues, fees
and other charges among its issuers and other persons using its
facilities. The Exchange believes that temporarily reducing the Annual
Fee for newly listed securities listed under Rule 5.2(j)(6) will
provide an incentive for issuers to introduce and list more such
products on the NYSE Arca Marketplace in 2009, thereby increasing
competition among such products.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve the proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2009-01 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2009-01. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Section, 100 F Street,
NE., Washington, DC 20549-1090 on official business days between the
hours of 10 a.m. and 3 p.m. Copies of the filing will also be available
for inspection and copying at NYSE Arca's principal office and on its
Internet Web site at http://www.nyse.com. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEArca-2009-01 and should be submitted
on or before February 23, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-2121 Filed 1-30-09; 8:45 am]

BILLING CODE 8011-01-P