[Federal Register Volume 78, Number 64 (Wednesday, April 3, 2013)]
[Notices]
[Pages 20172-20174]
[FR Doc No: 2013-07762]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket Number NHTSA-2013-0044]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA), U.S.
Department of Transportation (DOT).

ACTION: Request for public comment on extension of a currently approved
collection of information.

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SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections. This
document describes an existing collection of information for an
existing regulation for the aftermarket modification of vehicles to
accommodate people with disabilities, for which NHTSA intends to seek
renewed OMB approval.

DATES: Comments must be received on or before June 3, 2013.

ADDRESSES: Comments must refer to the docket number cited at the
beginning of this notice, and may be submitted by any of the following
methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between
9 a.m. and 5 p.m. Eastern Time, Monday through Friday, except Federal
holidays. Telephone: 1-800-647-2251.
     Instructions: All submissions must include the docket
number for this document. Please identify the collection of information
for which a comment is provided by referencing the OMB Control Number,
2127-0635. Note that all comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by tile name of the
individual submitting the comment (or signing the comment, if submitted
on behalf of an association, business, labor union, etc.). You may
review DOT's complete Privacy Act Statement in the Federal Register
published on April 11, 2000 (65 FR 19477-78) or you may visit http://Docketslnfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Ms. Gayle Dalrymple, NHTSA, 1200 New
Jersey Avenue SE., Room W45-333, NVS-123, Washington, DC 20590. Ms.
Dalrymple's telephone number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following:
    (1) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (3) How to enhance the quality, utility, and clarity of the
information to be collected;
    (4) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following collection of information:
    Title: Exemption for the Make Inoperative Prohibition.
    OMB Control Number: 2127-0635.
    Form Number: This collection of information uses no standard form.
    Type of Request: Extension of a currently approved collection of
information.
    Abstract: On February 27, 2001, NHTSA published a final rule (66
FR12638) to facilitate the modification of motor vehicles so that
persons with disabilities can drive or ride in them as passengers. In
that final rule, the agency issued a limited exemption from a statutory
provision that prohibits specified types of commercial entities from
either removing safety equipment or features installed on motor
vehicles pursuant to the Federal motor vehicle safety standards or
altering the equipment or features so as to adversely affect their
performance. The exemption is limited in that it allows repair
businesses to modify only certain types of Federally-required safety
equipment and features, under specified circumstances. The regulation
is found at 49 CFR Part 595 Subpart C, ``Vehicle Modifications to
Accommodate People with Disabilities.''
    This final rule included two new ``collections of information,'' as
that term is defined in 5 CFR Part 1320 ``Controlling Paperwork Burdens
on the Public'': Modifier identification and a document to be provided
to the owner of the modified vehicle stating the exemptions used for
that vehicle and any reduction in load carrying capacity of the vehicle
of more than 100 kg (220 lbs).
    Modifiers who take advantage of the exemption created by this rule
are required to furnish NHTSA with a written document providing the
modifier's name, address, and telephone number, and a statement that
the modifier is availing itself of the exemption. The rule requires:
    ``S595.6 Modifier Identification.
    (a) Any motor vehicle repair business that modifies a motor vehicle
to enable a person with a disability to operate, or ride as a passenger
in, the motor vehicle and intends to avail itself of the exemption
provided in 49 CFR 595.7 shall furnish the information specified in
paragraphs (a)(1) through (3) of this section to: Administrator,
National Highway Traffic Safety Administration, 400 Seventh Street SW.,
Washington, DC 20590.\1\
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    \1\ The address of NHTSA has changed since 2001 and is now 1200
New Jersey Ave. SE., Washington, DC 20590.
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    (1) Full individual, partnership, or corporate name of the motor
vehicle repair business.
    (2) Residence address of the motor vehicle repair business and
State of incorporation if applicable.
    (3) A statement that the motor vehicle repair business modifies a
motor vehicle to enable a person with a disability to operate, or ride
as a passenger in, the motor vehicle and intends to avail itself of the
exemption provided in 49 CFR 595.7.
    (b) Each motor vehicle repair business required to submit
information under paragraph (a) of this section shall submit the
information not later than August 27, 2001. After that date, each motor
vehicle repair business that modifies a motor vehicle to enable a
person with a disability to operate, or ride as a passenger in, the
motor vehicle and intends to avail itself of the exemption provided in
49 CFR 595.7 shall submit the information required under paragraph (a)
not later than 30 days after it first modifies a motor vehicle to
enable a person with a disability to operate, or ride as a passenger
in, the motor vehicle. Each motor vehicle repair business who has
submitted required information shall keep its entry current, accurate
and complete by submitting revised information not later than 30 days
after the relevant changes in the business occur.''
    This requirement is a one-time submission unless changes are made
to the business as described in paragraph (b). NHTSA estimates that
there are currently 700 businesses making modifications to motor
vehicles to accommodate persons with disabilities. Of those 700, we
estimate 85 percent will need to use the exemptions provided by 49 CFR
595.7 (595 businesses). The initial registration of modifiers wishing
to use the exemptions occurred in 2001. Based on letters received since
then, we estimate that 90 businesses currently modifying vehicles will
need to change their information or new registrants will elect to use
the exemptions annually. We estimate the burden of new or changed
registrations from 90 businesses each year of: 90 businesses x 10
minutes/business = 15 hours.
    We estimate the material cost associated with each submission to be
56 cents per responding business, or $50.04 nationwide annually.
    Burden means the total time, effort, or financial resources
expended by a person to generate, maintain, retain, disclose or provide
information to or for a Federal agency. This includes 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;
and transmit or otherwise disclose the information.
    We seek comment on:
    1. Is our estimate of 700 businesses engaged in vehicle
modification to accommodate people with disabilities correct?
    2. Are we correct in assuming that a maximum of 85 percent of those
700 businesses, or 595 businesses, will need to use the exemptions
provided by 49 CFR 595.7?
    3. Are our estimates of the burden hours and material cost of
compliance with 49 CFR 595.6 reasonable?
    Modifiers who avail themselves of the exemptions in 49 CFR 595.7
are required to keep a record, for each applicable vehicle, listing
which standards, or portions thereof, no longer

comply with the Federal motor vehicle safety standards and to provide a
copy to the owner of the vehicle modified (see 49 CFR 595.7 (b) and (e)
as published in the final rule).
    We estimate that:
    1. There are approximately 4013 vehicles modified for persons with
disabilities per year by 700 businesses; \2\
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    \2\ The agency does not require modifiers to submit information
to us for every vehicle that is modified. Therefore, we have no
exact count of the number of modifications made each year.
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    2. If 85 percent of the 700 businesses use the exemptions provided
by 49 CFR 595.7, those 595 businesses will modify 3411 vehicles
annually; and
    3. The burden for producing the record required by 49 CFR 595.7 in
accordance with paragraph (e) for those vehicles will be 1137 hours per
year nationwide.
    In the final rule we anticipated that the least costly way for a
repair business to comply with this portion of the new rule would be to
annotate the vehicle modification invoice as to the exemption, if any,
involved with each item on the invoice. The cost of preparing the
invoice is not a portion of our burden calculation, as that preparation
would be done in the normal course of business. The time needed to
annotate the invoice, we estimate, is 20 minutes. Therefore, the burden
hours for a full year are calculated as: 3411 vehicles x 20 minutes/
vehicle = 1137 hours.
    This burden includes the calculation required by 49 CFR 595.7(e),
but not the gathering of the information required for the calculation.
That information would be gathered in the normal course of the vehicle
modification. The only extra burden required by the rule is the
calculation of the reduction in loading carrying capacity and conveying
this information to the vehicle owner. Again, we are assuming that
annotation on the invoice is the least burdensome way to accomplish
this customer notification.
    There will be no additional material cost associated with
compliance with this requirement since no additional materials need be
used above those used to prepare the invoice in the normal course of
business. We are assuming it is normal and customary in the course of
vehicle modification business to prepare an invoice, to provide a copy
of the invoice to the vehicle owner, and to keep a copy of the invoice
for five years after the vehicle is delivered to the owner in finished
form.
    We seek comment on whether our assumptions about the following are
reasonable:
    1. The document required by 49 CFR595.7(b) and specified in
paragraph (e) will need to be prepared for approximately 3411 vehicles
modified nationwide per year,
    2. Annotation of each vehicle modification invoice as to which
exemptions were used will take an average of 20 minutes, and
    3. It is normal in the course of vehicle modification business to
prepare an invoice, to provide a copy of the invoice to the vehicle
owner, and to keep a copy of the invoice for five years after the
vehicle is delivered to the owner in finished form.
    Affected Public: Business or other for profit.
    Estimated Annual Burden: 1152 hours, and $50.04
    Estimated Number of Respondents: 595.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

    Issued on: March 28, 2013.
Christopher J. Bonanti,
Associate Administrator for Rulemaking .
[FR Doc. 2013-07762 Filed 4-2-13; 8:45 am]
BILLING CODE 4910-59-P


                 PAPERWORK REDUCTION ACT SUBMISSION WORKSHEET
                    Part II: Information Collection Detail

IMPORTANT:  A separate Part II must be completed for each Information Collection (IC) activity associated with the ICR.  If more than one Part II is required, create a separate Part II document for each IC.  For more information see OEI's ICR website at http://intranet.epa.gov/icrintra/.  There you will find information on completing this form (see OEI's ICRAS instructions under the Prepare an ICR tab) and information on how break your ICR into ICs (see OMB's ROCIS IC Q&A under the Download Guidance tab).
1. Title of Information Collection:  FFederal Implementation Plans Under the Clean Air Act for Indian Reservations in ID, OR, and WA
2. Is this a common form?
  Yes
  No

(Select Yes to identify forms that EPA is willing to host for potential use by other Federal Agencies.)

3. Obligation to respond (check one):
       Voluntary
       Required to obtain or retain benefits
        Mandatory

Note: Only one selection may be made.  If multiple categories apply, you must create additional ICs to account for the burden associated with each category.
4. Frequency of reporting (only to be completed if there are reporting requirements, check all that apply):

  Hourly
  Daily
  Weekly
  Monthly
  Yearly
    Every Decade
    Quarterly
    Semi-Annually
  Biennially
  Once
  Occasionally
5.  CFR Citation(s) for the information collection under review (if applicable):

Title  General Rule for open burning  Part  40  Section  49.131
Title              Part              Section
Title              Part              Section
Title              Part              Section
6. Information Collection Instruments/Forms (if applicable) :

Form Name:
Form Number:
URL (required if electronic) :
Is this form available electronically?        Yes        No
If yes, can this form be submitted electronically?        Yes        No

Form Name:
Form Number:
URL (required if electronic) :
Is this form available electronically?        Yes        No
If yes, can this form be submitted electronically?        Yes        No

Form Name:
Form Number:
URL (required if electronic) :
Is this form available electronically?        Yes        No
If yes, can this form be submitted electronically?        Yes        No

Attach additional sheets if necessary.

Note: Instruments/Forms must be submitted/uploaded as a separate attachment.

7.  Federal Enterprise Architecture Business Reference Model:

Line of Business (check one) :                                                                         Subfunction (check one) :
  Environmental Management
  Environmental Monitoring and Forecasting
  Environmental Remediation
  Pollution Prevention and Control
  Health
  Illness Prevention
  Immunization Management
  Public Health Monitoring
  Health Care Services
  Consumer Health and Safety
  Natural Resources
  Water Resource Management
  Conservation, Marine and Land Management
  Recreational Resource Management and Tourism
  Agricultural Innovation and Services
Note: Most EPA ICRs will be aligned with the Environmental Management FEA Line of Business.  Other likely categories are also listed.  For a full listing of the FEA Business Reference Model categories and definitions, see: http://www.whitehouse.gov/omb/egov/documents/FY07_Ref_Model_Mapping_QuickGuide.pdf.
8. Privacy Act System of Records (if applicable) :

Title:
Federal Register Citation:    Volume                Page Number                Publication Date
9. Respondents

Total Number:  3
Small Entity Number:  3
Percentage of responses collected electronically:  100

Affected Public (check one) :

  Individuals or Households
  Private Sector (if private sector, check all that apply)
                  Business or other for-profit
                  Not-for-profit institutions
                  Farms
  State, Local, or Tribal Governments
  Federal Government

Note:  Only one selection may be made.  If multiple categories apply, you must create additional ICs to account for the burden associated with each category.  Selecting multiple subcategories within "Private Sector" will not affect then number of ICs required.
10. Frequency: How often on average will each respondent respond to the Information Collection?

Calculated Annual Frequency:  1
   (responses per respondent per year)

Calculated Annual Number of Responses:  3
  Year

  Hour
  Business hour
  Day
  Business Day
  Week
  Month
  Decade
  Quarter
  Half-year

Number of Respondents 1  per

11. Hour and Cost Burden: Enter the hours and cost (per response) broken out by reporting, record keeping, and third party disclosure:

                              Hours per Response
                           Total Annual Hour Burden
                               Cost per Response
                           Total Annual Cost Burden
Reporting
                                       3
                                       9

Recordkeeping

Third Party Disclosure

Total
                                       3
                                       9

IMPORTANT: "Cost per Response" and "Total Annual Cost Burden" should include Capital/Startup and O&M costs only.

12. Annual Responses and Burden Change

                                Total Requested
                       Program Change due to New Statute
                    Program Change due to Agency Discretion
                  Change due to Adjustment in Agency Estimate
                      Change due to Violation of the PRA
                              Currently Approved
Annual Responses
                                       3

                                       0

                                       3
Annual Hour Burden
                                       9

                                       0

                                       9
Annual Cost Burden
                                       0

                                       0

                                       0


[Federal Register: June 12, 2007 (Volume 72, Number 112)]
[Proposed Rules]
[Page 32269-32275]
[DOCID:fr12jn07-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2007-0297; FRL-8325-7]
RIN A2060-AO44

Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2008

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to allocate essential use allowances for
import and production of Class I ozone-depleting substances (ODSs) for
calendar year 2008. 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
substances solely for the designated essential purpose. The proposed
allocations total 27.0 metric tons (MT) of chlorofluorocarbons (CFCs)
for use in metered dose inhalers (MDIs) for 2008.

DATES: Written comments on this proposed rule must be received by the
EPA Docket on or before July 12, 2007, unless a public hearing is
requested. Comments must then be received on or before 30 days
following the public hearing. 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 June 18, 2007. If a hearing
is held, it will take place on June 27, 2007 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-2007-0297, 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>.
     Mail: Air Docket, Environmental Protection Agency,
Mailcode 2822T,

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 3334, Mail
Code 2822T, Washington, DC 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-
2007-0297. EPA's policy is that all comments received by the docket
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
through http://www.regulations.gov or e-mail that you consider to be CBI or

otherwise protected. If you would like the Agency to consider comments
that include CBI, EPA recommends that you submit the comments to the
docket that exclude the CBI portion but that you provide a complete
version of your comments, including the CBI, to the person listed under
ADDRESSES above. 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 3334, 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: Kirsten M. Cappel, 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 1047C,
Washington DC, 20005; by telephone:<PHONE_NUMBER>; or by e-mail:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
    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 2008
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

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 ODSs in the U.S. for purposes that have been deemed
``essential'' by the U.S. Government and by the Parties to the Montreal
Protocol on Substances that Deplete the Ozone Layer (Montreal
Protocol).
    The Montreal Protocol is the international agreement aimed at
reducing and eliminating the production and consumption \1\ of ODSs.
The elimination of production and consumption of Class I ODSs is
accomplished through adherence to

phaseout schedules for specific Class I ODSs,\2\ which include 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.
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    \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.
---------------------------------------------------------------------------

    However, the Montreal Protocol and the Clean Air Act (the Act)
provide exemptions that allow for the continued import and/or
production of Class I ODSs for specific uses. Under the Montreal
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 Montreal 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 phaseout
date for the following essential uses:
---------------------------------------------------------------------------

    \3\ See Section 614(b) of the Act. EPA's regulations
implementing the essential use provisions of the Act and the
Protocol are located in 40 CFR part 82.
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    (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. Prior to that date, EPA 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 MDIs that use CFCs as propellant for the treatment of
asthma and chronic obstructive pulmonary disease.
    (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.
    An additional essential use exemption under the Montreal Protocol,
as agreed in Decision X/19, is the 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
exemption 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. EPA plans to update this exemption in accordance with
future Decisions from the Parties and its own regulations.

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

    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 Parties. The Parties make the
final decisions on whether to approve a Party's essential use
nomination at their annual meeting. This nomination process occurs
approximately two years before the year in which the allowances would
be in effect. The allowances proposed for allocation for 2008 were
first nominated by the United States in January 2006.
    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 Montreal 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 2008, the Parties authorized the United States to allocate up to
385 MT of CFCs for essential uses. In the 2008 nomination for essential
use allowances, the United States did not request CFCs for use in MDIs
where the sole active ingredient is albuterol.

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 2008 calendar year.
    1. On January 17, 2007, 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 1/1/06 to
12/31/06.

    c. The number of units anticipated to be produced in 2007.
    d. The number of units anticipated to be produced in 2008.
    e. The gross target fill weight per unit (grams).
    f. Total amount of CFCs to be contained in the MDI product for
2008.
    g. The additional amount of CFCs necessary for production.
    h. The total CFC request per MDI product for 2008.

    The 114 letters are available for review in the Air Docket ID No.
EPA-HQ-OAR-2007-0297. The companies requested that their responses be
treated as confidential business information; for this reason, EPA has
placed the responses in the confidential portion of the docket.
    2. At the end of January 2007, as required by 40 CFR 82.13(u), EPA
received information from MDI manufacturers that included such data as
the type and quantity of CFCs held at the end of the year (i.e. stocks
of pre-1996 and post-1996 CFCs). The data submitted in reports from
each MDI manufacturer is available for review in the Air Docket ID No.
EPA-HQ-OAR-2007-0297. The companies requested that their responses be
treated as confidential business information; for this reason, EPA has
placed the individual responses in the confidential portion of the
docket.
    3. On February 28, 2007, EPA sent FDA the information MDI
manufacturers provided in response to the 114 letters and information
required by 40 CFR 82.13(u) with a letter requesting that FDA make a
determination regarding the amount of CFCs necessary for MDIs for
calendar year 2008. This letter is available for review in Air Docket
ID No. EPA-HQ-OAR-2007-0297.
    4. On May 1, 2007 FDA sent a letter to EPA stating the amount of
CFCs determined by the Commissioner to be necessary for each MDI
company in 2008. This letter is available for review in the Air Docket
ID No. EPA-HQ-OAR-2007-0297. FDA's letter informed EPA that it had
determined that 27.0 MT of CFCs were medically necessary for use in
MDIs in 2008. The letter stated: ``Our determination 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 propellant in 2006, their estimated
production in 2007, their estimated production in 2008, their
anticipated essential-use allocations in 2007, and their current (as of
December 31, 2006) stockpile levels. Our determination took into
account any transferred CFCs as well as pre-1996 CFC amounts. We also
considered the different types and blends of CFCs necessary to produce
specific MDIs. Finally, we based our determination for 2008 on an
estimate of the quantity of CFCs that would allow manufacturers to have
a 12-month stockpile at the end of 2008 in accordance with paragraph 3
of Decision XVI/12 and paragraph 2 of Decision XVII/5.''
    The letter stated that in making its determination, FDA made the
following assumptions:
     All manufacturers will receive the full essential-use
allocation proposed by EPA for calendar year 2007 (71 FR 64668,
November 3, 2006);
     All manufacturers will procure the full quantity of CFCs
allocated to them for calendar year 2007;
     The number of albuterol CFC MDIs produced in 2008 will be
no more than half of the number produced in 2007, with albuterol HFA
MDIs making up the remainder; and
     No bulk CFC currently held by, or allocated to, any
manufacturer will be exported from the United States.
    FDA's determination specified that the essential use allowances
allocated for 2008 should only be used to acquire CFC-114 for the
production of epinephrine MDIs. FDA's letter stated: ``In recent years,
we aggregated the amounts for CFC-11, -12, and -114 and provided
recommendations on the total amounts necessary to protect the public
health. This year, as sponsors transition to non-CFC alternative and
require smaller amounts of CFCs to produce CFC MDIs, we considered
individual amounts of CFCs necessary to protect the public health and
recommend an allocation of 27.0 tonnes of CFC-114 to Armstrong for the
manufacture of epinephrine CFC MDIs.'' Consistent with FDA's
determination letter, EPA is proposing to allocate 27.0 MT of CFC-114
to Armstrong for the production of epinephrine MDIs for 2008.
    EPA has confirmed with FDA that this determination is consistent
with Decision XVII/5, including 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 its analysis of a one-year operational supply
of CFCs for the production of CFC-albuterol MDIs, FDA informed EPA that
it calculates volumes to allow the manufacturer to end the calendar
year with the appropriate stock of CFCs for essential uses. Allowing
manufacturers to maintain up to a one-year operational supply accounts
for unexpected variability in the demand for MDI products or other
unexpected occurrences in the market and therefore ensures that MDI
manufacturers are able to produce their essential use MDIs.
    In accordance with the FDA determination, today's action proposes
to allocate essential use allowances to Armstrong for a total of 27.0
MT of CFC-114 for the production of epinephrine MDIs only for calendar
year 2008.
    The amounts listed in this proposal are subject to additional
review, and revision, by EPA and FDA if information demonstrates that
the proposed allocations are either too high or too low. We
specifically request comment on the extent to which the proposed
allocation of CFCs is sufficient to protect public health and ensure
the manufacture and continuous availability of CFCs necessary to meet
the expected demand. We also request comment on whether the proposed
allocation, when considered along with current stocks, will best
protect consumers by providing a smooth transition to non-CFC
alternatives. Commenters requesting increases or decreases of essential
use allowances should provide detailed information supporting a 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
2008

        Table I.--Essential Use Allowances for Calendar Year 2008
------------------------------------------------------------------------
                                                           2008 Quantity
              Company                     Chemical         (metric tons)
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals.........  CFC-114 (production             27.0
                                     of epinephrine MDIs
                                     only).
------------------------------------------------------------------------

    EPA proposes to allocate essential use allowances for calendar year
2008 to the entity listed in Table I. 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), this
action is a ``significant regulatory action'' because it raises novel
legal or policy issues. Accordingly, EPA submitted this action to the
Office of Management and Budget (OMB) for review under EO 12866 and any
changes made in response to OMB recommendations have been documented in
the docket for this action.
    EPA prepared an analysis of the potential costs and benefits
related to this action. This analysis is contained in the Agency's
Regulatory Impact Analysis (RIA) for the entire Title VI phaseout
program (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). A copy of the
analysis is available in the docket for this action and the analysis is
briefly summarized here. The RIA 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 MDIs.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
The recordkeeping and reporting requirements included in this action
are already included in an existing information collection burden and
this action does not propose any changes that would affect the burden.
However, the Office of Management and Budget (OMB) has previously
approved the information collection requirements contained in the
existing regulations at 40 CFR 82.8(a) under the provisions of the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB
control number 2060-0170, EPA ICR number 1432.25. A copy of the OMB
approved Information Collection Request (ICR) may be obtained from
Susan Auby, Collection Strategies Division; U.S. Environmental
Protection Agency (2822T); 1200 Pennsylvania Ave., NW., Washington, DC
20460 or by calling<PHONE_NUMBER>.
    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 in 40 CFR are listed in 40 CFR part 9.

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 proposed 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 its field.
    After considering the economic impacts of today's proposed rule on
small entities, I certify 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 action, once finalized, will provide 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), Public
Law 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 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 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 proposed 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 Executive Order 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 Executive Order 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 Executive Order 13045 because it implements Section
604(d)(2) of the Clean Air Act which states that the Agency shall
authorize essential use exemptions should the Food and Drug
Administration determine that such exemptions are 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 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.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629 (February 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because any change in the
level of environmental protection for any affected populations will not
have any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. Any impacts of this proposed rule will be equally
distributed among all populations.

List of Subjects in 40 CFR Part 82

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

    Dated: June 6, 2007.
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  Grant of essential use allowances and critical use
allowances.

    (a) * * *

        Table I.--Essential Use Allowances for Calendar Year 2008
------------------------------------------------------------------------
                                                           2008 Quantity
              Company                     Chemical         (metric tons)
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals.........  CFC-114 (production             27.0
                                     of epinephrine MDIs
                                     only).
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-11299 Filed 6-11-07; 8:45 am]

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