           Outline of Key Provisions in OSHA's Infectious Diseases
                             Regulatory Framework

This outline of the infectious diseases regulatory framework does not address every provision completely; the infectious diseases regulatory framework should be consulted for the complete description of all requirements.

Section 1: Scope
This section delineates worker tasks being considered for coverage.
Occupational exposure of workers to contact, droplet, or airborne transmissible infectious agents during provision of direct patient care or performance of other covered tasks would be covered.

Section 2: Definitions
This section explains the Agency's intended meaning of terms used in the body of the regulatory framework, including:
   * Occupational exposure means exposure, which is or should be reasonably anticipated, to sources of infectious agents resulting from an employee's execution of job duties that involve the provision of direct patient care or the performance of other covered tasks.
   * Direct patient care generally includes job duties that involve the provision of healthcare services with hands-on or face-to-face contact with patients, but does not include job duties of employees who perform first aid only (see regulatory framework for full definition).
   * Other covered tasks include job duties that do not involve direct patient care but still involve occupational exposure in four settings: (1) where direct patient care is provided, (2) where there are contaminated materials originating from settings where direct patient care is provided (3) where there is exposure to human remains, and (4) in diagnostic, research or production facilities where there is exposure to contaminated materials (see regulatory framework for full definition).

Section 3: Worker Infection Control Plan (WICP)
This section provides an overall framework for an infection control plan that all affected employers would be required to develop.
   * Ensure the WICP is a written plan.
   * Prepare an exposure determination.
   * Have a WICP that contains at least the following elements:
         o          Designated plan administrator responsible for implementation and oversight of the WICP;
         o          Name of person(s) responsible for daily management of the WICP;
         o          Exposure determination; and
         o          Standard operating procedures (SOPs) for infection control measures.
   * Make a copy of the WICP accessible to workers.  The WICP could be part of a larger document.
   * Review/update the WICP at least annually, and when necessary if there are changes in exposure due to:
         o          New or modified job tasks and procedures;
         o          New or revised job classifications;
         o          Changes in technology; and
         o          New or emerging infectious agents or changes in community patterns of infectious diseases (e.g., emergence of an antibiotic resistant infectious agent, an outbreak or a change in prevalence of an infectious disease).
      *       During development and reviews of the WICP:
         o          Solicit input from non-managerial workers with occupational exposure;
         o          Establish and maintain records for each review and/or update of the WICP.
      *       Host employers  -
         o          Ensure that contractors, vendors, and licensed independent practitioners with privileges adhere to infection control practices consistent with, or more protective than, the host employer's WICP.
         o          Ensure that the WICP is followed by employees (but see exception noted in regulatory framework).
         o          Ensure a copy of the WICP is provided and accessible to contractors, vendors, and licensed independent practitioners with privileges.
         o          Note:  Employers that are contractors, vendors, and licensed independent practitioners with privileges would also be obligated to comply with all components of regulatory framework.
      *       Ensure the WICP is available to the Assistant Secretary upon request.

Section 4: Standard Operating Procedures Development and Implementation
This section describes the general considerations and sources that employers would be required to consider in developing their SOPs.  In addition, this section provides a list of SOPs that employers in all affected work settings would be required to develop as part of their WICPs, and specific SOPs that employers with workers that provide direct patient care or workers that perform other covered tasks would be required to develop.
General considerations.  In general, develop SOPs consistent with recognized and generally accepted good infection control practices.  In developing SOPs, consider applicable regulations and guidelines.
   In all work settings, have, and ensure employees follow, SOPs for:

   * Infectious agent hazard evaluations, which would not need to be written if incorporated into routine activities, such as triage.
   * Communicating hazard evaluation results to responsible person(s);
   * Hand hygiene;
   * Restricting some activities (e.g., eating and drinking) where occupational exposure could occur;
   * Using engineering, administrative and work practice controls, and personal protective equipment (PPE);
         o          Ensure controls are used in accordance with recognized and generally accepted good infection control practices;
         o          Provide access to, and ensure proper use of, PPE;
         o          Develop regular schedule for inspecting, maintaining, and replacing engineering controls; and
         o          Ensure procedures are performed in a manner that prevents or minimizes the generation/transmission of infectious agents.
Note: OSHA would permit the required hierarchy of controls to be modified in accordance with recognized and generally accepted good infection control practices.
   * Decontamination;
         o          Provide for the routine and targeted decontamination of all contaminated materials (i.e., contaminated items and/or surfaces) in the work setting;
         o          Inspect and decontaminate equipment prior to servicing or shipping.
   * Handling, containerization, transport, or disposal of contaminated materials;
         o          Place contaminated materials in appropriate containers that are labeled/color-coded and leak proof;
         o          Minimize or prevent employee contact with contaminated materials.
   * Occupational health services, including vaccinations, post-exposure treatment, and medical removal protection;
   * Investigating exposure incidents;
   * Using appropriate signage and labeling/color-coding; and
   * Notifying other employers of occupational exposure during transfer, transport, shipping, or receipt of infectious agent sources.

   Direct patient care settings  -  in addition to SOPs developed for all work settings, have, and ensure employees follow, SOPs for:

   * Patient scheduling and intake/admittance;
   * Standard precautions;
   * Contact precautions;
   * Droplet precautions;
   * Airborne precautions, including where applicable, procedures for:
         o          If the employer does not have an airborne infection isolation room (AIIR), use of temporary isolation and inter-facility transfer of infectious individuals;
         o          If the employer has an AIIR, ensuring proper AIIR operation;
         o          Respiratory protection.
   * Patient transport;
   * Medical surge procedures;
   * Any other worker protection precautions necessary to address specific circumstances.

   Employers with employees who perform other covered tasks  -  in addition to SOPs developed for all work settings, have, and ensure employees follow, SOPs for:

   * Handling and intake of contaminated materials;
   * Implementing control measures to prevent or minimize transmission of infectious agents;
   * In diagnostic, research, and production facilities, implementing standard microbiological practices and any special practices for handling infectious agents, including:
         o          Engineering controls properly constructed, operated and maintained;
         o          Measures necessary to address uncontrolled releases of infectious agents.
   * Any other worker protection precautions necessary to address specific circumstances.

Section 5: Medical surveillance and vaccination
This section specifies, among other things, the medical screening, surveillance and vaccinations that would be required to be provided to workers who have occupational exposure, and the procedures that would be required to be followed after an exposure incident.
      *       General.
   o          Make available medical screening, surveillance and vaccinations to workers with occupational exposure, and post-exposure evaluation and follow-up for each employee who has had an exposure incident.
   o          Ensure all medical evaluations and procedures are performed by or under supervision of a physician or other licensed healthcare professional (PLHCP) and that lab tests are conducted by accredited laboratories.
      *       Vaccinations.
   o          Make available all appropriate vaccinations consistent with recognized and generally accepted good infection control practices;
   o          In a facility other than a research and production facility, make available the following vaccinations: influenza, MMR, Tdap, Varicella and any other vaccination specified in the employer's WICP or determined to be medically appropriate by a PLHCP;
   o          Review and update vaccinations specified in the WICP at least annually and when necessary to reflect changes in exposure;
   o          Exception:  vaccinations would not need to be made available to an employee who has immunity or where the vaccine is contraindicated;
   o          Monitor vaccination series until complete;
   o          Make vaccinations available after training and prior to initial assignment to a job with occupational exposure;
   o          Ensure worker signs declination statement if vaccination(s) declined, and make vaccination available later if worker decides to accept it;
   o          Make available revaccinations or boosters in accordance with recognized and generally accepted good infection control practices.
   * Medical screening and surveillance.
   * Medical evaluation and follow-up.
   * Establish and maintain exposure incident records.
   * Provide information to PLHCP, including description of exposed employee's job duties.
   * Obtain and provide to employee a copy of the PLHCP's written opinion within 15 days of the completion of the evaluation.
   * Medical removal protection.
   o          Employee restrictions or removal based on PLHCP's recommendation.
   o          Medical removal protection benefits: pay employee's total normal earnings and maintain employee's seniority and other rights and benefits (except generally in cases of the common cold or influenza).
   * Establish and maintain medical records for each worker with occupational exposure.
   * Ensure the confidentiality of employee medical records.

Section 6: Training
This section specifies the types and periods of training that employers would be required to provide to workers with occupational exposure to infectious agents.
   * Information and training: Prior to initial assignment; at least annually thereafter and whenever deemed necessary to address deficiencies.
   * Training program: conducted by knowledgeable person; material appropriate for worker's education level and language; opportunity for interactive worker questions.
   * Initial training program: contains a copy of the standard; explanation of its contents; and appropriate explanation of WICP, SOPs, control measures, PPE, and vaccines (for other potential elements, see regulatory framework).
   * Annual training elements: information on PPE; SOPs applicable to worker; information on vaccines.

Section 7:  Recordkeeping
This section specifies the types of records that would be required to be retained by the employer, the retention period that would be required for each record, and the employer's potential obligation to make certain records available to the worker and OSHA upon request.
   * Record maintenance.
   o          Maintain medical records for duration of employment + 30 years;
   o          Maintain exposure incident records for duration of employment + 30 years; and
   o          Maintain WICP review records for 3 years.
   * Make exposure incident records, the WICP, and WICP review records available to workers or their representatives; make medical records available to the worker or to anyone having written consent of the worker; and make all records available to the Assistant Secretary upon request.

Section 8: Cost and Availability
This section specifies that costs incurred by employee(s) would be compensable and that any activities that would be required of employees be conducted at a reasonable time and place.
   * Implement the provisions of the regulatory framework at no cost to the employee; any time spent by employees to comply is considered compensable time.
   * Make medical evaluations and procedures and training available at reasonable times and places.

Appendices
Appendix A.  Common Infectious Diseases/Conditions/Agents and Their Modes of Transmission in Healthcare Settings (non-mandatory)
Appendix B.  Vaccine Declination (mandatory)


[Federal Register: June 10, 2008 (Volume 73, Number 112)]
[Notices]
[Page 32715-32717]
[DOCID:fr10jn08-53]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Food Protection Task Force Conference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of conference grant funding for meetings of State Food
Protection Task Forces. The original announcement of availability of
funding for State Food Safety Task Force Meetings, published in the
Federal Register June 25, 2004 (69 FR 35651) and February 4, 2005 (70
FR 6015) as revised on May 3, 2005 (70 FR 22889). This revised
announcement provides for a change in the name of the grant program to
align with the FDA Food Protection Plan and new policies that apply to
the State Food Protection Task Force Meetings conference Grant Program.
FDA anticipates providing approximately $160,000 in direct costs only
in support of this program in fiscal year (FY) 2008. It is anticipated
that 32 awards will be made for up to $5,000 per award.

FOR FURTHER INFORMATION CONTACT:
     Regarding the administrative and financial management aspects of
this notice: Gladys M. Bohler, Grants Management Specialist at 301-827-
7168 or by e-mail at<EMAIL_ADDRESS>    Regarding the programmatic aspects of this notice: Jennifer Gabb,
(DFSR), Office of Regulatory Affairs, FDA at<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>or access the Internet at: http://
www.fda.gov/ora/fedlstate/default.htm.
    Announcement Type: New limited competition Request for Applications
(RFA) (R13)
    Request for Application Number: RFA-FD-08-06
    Catalog of Federal Domestic Assistance Number(s): 93.103
    Dates: The application receipt date is July 15, 2008.
    Paper Applications will not be accepted. Applications may be
submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5 p.m. local time (of the
applicant institution/organization) on the application submission/
receipt date(s). If an application is not submitted by the receipt
date(s) and time, the application may be delayed in the review process
or not reviewed.
    The required application, SF 424 (5161) can be completed and
submitted online. The package should be labeled, ``Response to RFA FD-
08-006.'' If you experience technical difficulties with your online
submission you should contact Gladys M. Bohler by telephone at 301-827-
7168 or by e-mail at<EMAIL_ADDRESS>    Please visit Grants.gov to view the full version of this Request
for Applications. A full version of the RFA can also be found on the
Grants.gov Web site along with the application package. FDA urges
applicants to read the full version RFA in its entirety prior to
submitting application packets. A publishing of this announcement in
the Federal Register a copy of the full version RFA can also be
requested from the ORA and Grants Management contacts listed in the
following paragraphs.
    Funding Opportunity Description

I. Background

    The FDA's Office of Regulatory Affairs (ORA) is the inspection
component of the FDA and has 1,000 investigators and inspectors who
cover the approximately 95,000 FDA regulated businesses in the United
States and inspect more than 15,000 facilities a year. In addition to
the standard inspection program, FDA's investigators and inspectors
conduct special investigations, food inspection recall audits, and
perform consumer complaint inspections and sample collections.
    In the past, FDA has relied on the States in assisting with the
previous duties through formal contracts, partnership agreements, and
other informal arrangements. The inspection demands on both the Agency
and the States are expected to increase. Accordingly, procedures need
to be reviewed and innovative changes made that will increase
effectiveness, efficiency, and conserve resources. Examples of support
include providing effective and efficient compliance of regulated
products and, providing high quality, science based work that maximizes
consumer protection.

II. Research Objectives

    FDA views State based Food Protection Task Forces as an important
mechanism for providing food safety and food defense program
coordination, and information exchange within each State (``Food''
includes human food and animal feed and is defined in section 201 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 (f))). This
grant announcement is intended to encourage the development of a Task
Force within each State and to provide funding for Task Force meetings.
Conference grant funding is available to States that have an existing
Food Safety and Food Defense Task Force, as well as to States that are
in the process of developing a new Food Protection Task Force. State
Food Protection Task Force meetings should foster communication and
cooperation among State, local, and

tribal food protection public health, agriculture, and regulatory
agencies.
    Before submission of an application, the State shall designate one
public health or food safety agency to lead, coordinate, and host the
Food Protection and Food Security Task Force and its meetings. The
formation of Food Protection and Food Security Task Force meetings
shall not interfere with existing Federal-state advisory mechanisms.

III. Project Goals

    The purpose of the Food Protection Task Force meetings is to foster
communication and cooperation and collaboration within the States among
State local and tribal food protection public health, agriculture and
regulatory agencies. (For the purposes of this document and to be
consistent with the FDA Food Protection Plan: Food means human food and
animal feeds as defined in 21 U.S.C. 321(f). The meetings should: (1)
Provide a forum for all the stakeholders of the food protection
system--regulatory agencies, academia, industry, consumers, State
legislators, Boards of Health and Agriculture and other interested
parties; (2) assist in adopting or implementing the Food Code and other
food protection regulations; and (3) promote the integration of an
efficient statewide food protection/defense system that maximizes the
protection of the public health through prevention, intervention and
response including the early detection and containment of foodborne
illness. Each Task Force shall develop its own guidelines for work,
consensus decision making, size and format, at its initial meeting.
FDA's Division of Federal State Relations (DFSR) will provide meeting
guidelines and organization documents as requested.
    Conference grant funds will be awarded only for the direct costs.
Each Task Force shall develop its own guidelines for work, consensus
decision making, size, and format at its initial meeting. Federal
agency representatives may be invited to be nonmember liaisons or
advisors to the task force and its meetings. Conference grant funds may
not be used for Federal employees to travel to or participate in these
meetings.
    The following are the allowable and unallowable costs:
    Allowable costs include but are not limited to: (1) Salary (in
proportion to the time or effort spent directly on the conference/
meeting); (2) facility and necessary equipment rental; (3) in-state
travel and per diem or subsistence allowances; (4) supplies needed for
conduct of the meeting (only if received for use during the budget
period); (5) conference services; (6) publication costs; (7)
registration fees; and (8) speakers' fees.
    Non-allowable costs include but are not limited to: (1) Travel or
expenses other than local mileage for local participants; (2)
organization dues; (3) travel or per diem costs for Federal employees;
(4) purchase of equipment; (5) transportation costs exceeding U.S.
carrier coach class fares; (6) visas; (7) passports; (8) entertainment;
(9) tips; (10) bar charges; (11) personal telephone calls; (12) laundry
charges; (13) honoraria or other payments for the purpose of conferring
distinction or communicating respect, esteem or admiration; (14)
patient care; (15) alterations or renovations; and (16) facilities and
administrative costs/indirect costs.
    Please also refer to the DHHS Grants Policy Statement for
additional information regarding costs http://www.hhs.gov/grantsnet/
adminis/gpd/index.htm.

IV. Reporting Requirements

    A Financial Status Report (FSR) and Mid-Year Progress Reports are
required no later than 90 days after the end of a budget period. The
Mid-Year Progress Report should contain a description of a specific
plan for the next meeting, as well as all criteria listed in the
previous paragraph.
    Program monitoring of recipients will be conducted on an ongoing
basis and written reports will be reviewed and evaluated at least semi-
annually by the project officer. Project monitoring may also be in the
form of telephone conversations between the project officer/grants
management specialist and the principal investigator.
    When multiple years are awarded, awardees will be required to
submit the PHS Non-Competing Grant Progress Report (PHS 2590) annually
(http://grants.nih.gov/grants/funding/2590/2590.htm).
    The PHS 2590 must be submitted at least 2 months prior to the next
budget period start date and should include a report of the previous
meeting supported by the current grant, as well as a full description
of the next planned meeting.
    A final Progress Report of the meeting(s) (or Conference
Proceedings), and FSR SF-269 are required within 90 days of the
expiration date of the project period. An original and two copies of
each report shall be submitted to FDA's Grants Management staff
contact. The report of the meeting should include: (1) The grant
number; (2) the title, date and place of time of the meeting; (3) the
name of the person shown on the application as the conference director,
principal investigator, or program director; (4) the name of the
organization that conducted the meeting; (5) a list of individuals and
their institutional affiliations who participated as speakers or
facilitators in the formally planed sessions of the meeting; and, (6) a
summary of topics discussed, next steps and conclusions.

V. Mechanism of Support

A. Award Instrument

    This funding opportunity will use the Conference/Scientific Meeting
(R13) grant award mechanism. Under the R13 mechanism, the applicant
will be solely responsible for planning, directing, and executing the
proposed project. Multiple year awards may be awarded to one
permanently sponsoring organization for conferences held annually or
biennially on a recurring topic. The total project period for an
application requesting support may not exceed 5 years.
    This funding opportunity uses just-in-time budget concepts. It also
uses the non-modular budget format. Applicants must complete and submit
a detailed categorical budget in the SF424 application.
    Meetings covered by this notice will be supported under section
1701-1706 of the Public Service (PHS) Act (42 U.S.C. 300u-300u-5).
FDA's Task Force Conference Grant program is described in the Catalog
of Federal Domestic Assistance No. 93-103. These grants will be subject
to all policies and requirements that govern the Conference Grant
Programs of the PHS, including the provisions of 42 CFR part 52 and 45
CFR parts 74 and 92. The regulations issued under Executive Order 12372
also apply to this program and are implemented through the Department
of Health and Human Service's regulations at 45 CFR part 100. Executive
Order 12372 sets up a system for State and local government review of
applications for Federal financial assistance.

B. Eligibility

    These grants are available to State public health, agriculture and
food protection agencies that have an existing Food Safety and Food
Defense Task Force, as well as to States that are in the process of
developing a new Food Protection Task Force. Only one grant will be
awarded per State per year. States are urged to collaborate between
agencies to submit a single application.

C. Length of Support

    It is anticipated that FDA will fund these grants at a level
requested but not

exceeding $5,000 total direct costs only for the first year. An
additional 4 years of support, up to $5,000 (direct costs only) each
year may be available, depending upon fiscal year appropriations and
successful performance of the conference.

D. Funding Plan

    Continued funding for future year, noncompetitive segments, will be
contingent upon satisfactory progress as determined annually by the
FDA, the receipt of a PHS 2590 application, the approval of yearly task
force reports, and the availability of Federal funds. An estimated
amount of $160,000 is available in FY 2008. The number of grants funded
will depend on the quality of the applications received, their
relevance to FDA's mission, priorities, and the availability of funds.

VI. Review Procedure and Criteria

    All applications submitted in response to this request for
applications (RFA) will first be reviewed for responsiveness by grants
management and program staff. Responsiveness is defined as submission
of a complete on or before the required submission date as listed in
the previous paragraphs. If applications are found to be nonresponsive,
they will be returned to the applicant without further consideration.
    Responsive applications will be reviewed and evaluated for
scientific and technical merit by an ad hoc panel of experts. The
following will be considered in making funding decisions: (1)
Scientific merit of the proposed conference/scientific meeting as
determined by the evaluation process; (2) availability of funds; and
(3) relevance of program priorities. Final funding decisions will be
made by the Commissioner of Food and Drugs or his or her designee.
    Applicants are strongly encouraged to contact FDA Program staff to
resolve any questions regarding criteria before the submission of their
application.

VII. Submission Requirements

    FDA is accepting new applications for this program electronically
via www.grants.gov. To download the SF424 (5161) Application forms for
this Funding Opportunity Announcement (FOA) link to http://
www.grants.gov/Apply and follow the directions provided on that site. A
one-time registration is required for institutions at: Grants.gov
(http://www.grants.gov/GetStarted). The application receipt date is
July 15, 2008.
    Your organization will need to obtain a Data Universal Number
System (DUNS) number as part of the Grants.gov registration process.
The DUNS number is a 9-digit identification number, which uniquely
identifies business entities. Obtaining a DUNS number is easy and there
is no charge. The D&B number can be obtained by calling<PHONE_NUMBER> or
through the Web site at http://www.dnb.com/us.
    The applicant must also register in the Central Contractor
Registration (CCR) database in order to be able to submit the
application. Information about the CCR is available at http://
www.grants.gov/applicants/get_registered.jsp.

VIII. Method of Application

A. Submission Instructions

    The SF424 (5161) application has several components. Some
components are required, others are optional. The forms package
associated with this FOA in Grants.gov/APPLY includes all applicable
components, required, and optional.

B. Format for Application

    A completed application in response to this FOA includes the data
in the following components:
    The face page of the application should indicate ``Response to Food
Protection Task Force Conference Grant Program RFA FD 08-006''.
    Applications should include the following: (1) A title which has
the term ``state food protection task force meetings'', ``conference'',
``council'', ``workshop'', ``alliance'' or other similar description to
assist in the identification of the request; (2) location of the
conference; (3) expected number of registrants and type of audience
expected with their credentials; (4) dates of conference(s); (5)
conference format and projected agenda(s), including list of principal
areas or topics to be addressed; (6) physical facilities required for
the conduct of the meeting; (7) justification of the conference(s),
including the problems it intends to clarify and any developments it
may stimulate; (8) brief biographical sketches of individuals
responsible for planning the conference(s) and details concerning
adequate support staff; (9) information about all related conferences
held on this subject during the last 3 years (if available); (10)
details of proposed per diem/subsistence rates, transportation,
printing, supplies and facility rental costs; and (11) the necessary
checklist and assurances pages provided in each application package.

IX. Freedom of Information

    Data included in the application which have been specifically
identified by the applicant as containing restricted and/or proprietary
information may be entitled to confidential treatment as trade secret
or confidential commercial information within the meaning of the
Freedom of Information Act, (5 U.S.C. 552(b)(4), and FDA's implementing
regulations (21 CFR 20.61).

    Dated: June 3, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13015 Filed 6-9-08; 8:45 am]

BILLING CODE 4160-01-S


Appendix- Chapter 5

5a.1 Cost Information for Non-EGU and area sources

(Full details on controls can be found in Appendix 3)

Low Emission Combustion (LEC)

The average cost effectiveness for large IC engines using LEC technology
was estimated to be $532/ton (ozone season).  The EC/R report on IC
engines (Ec/R, September 1, 2000) estimates the average cost
effectiveness for IC engines using LEC technology to range from
$420-840/ton (ozone season) for engines in the 2,000-8,000 bhp range.
The key variables in determining average cost effectiveness for LEC
technology are the average uncontrolled emissions at the existing
source, the projected level of controlled emissions, annualized costs of
the controls, and number of hours of operation in the ozone season.  The
ACT document uses an average uncontrolled level of 16.8 g/bhp-hr, a
controlled level of 2.0 g/bhp-hr (87% decrease), and nearly continuous
operation in the ozone season.  The EPA believes the ACT document
provides a reasonable approach to calculating cost effectiveness for LEC
technology.

Leak Detection and Repair (LDAR) for Fugitive Leaks

The control efficiency is 80 percent reduction of VOC at an annualized
cost of $4,800 per ton.  We do not include the costs of this control
measure in our analyses in the Houston nonattainment area since these
controls are already included in the 8-hour Ozone SIP for this area.

Enhanced LDAR for Fugitive Leaks

The control efficiency of this measure is estimated at 50 percent at a
cost of $3,050/ton of VOC reduced.

Flare Gas Recovery

The control efficiency of this measure is 98 percent reduction of VOC
emissions at a cost of $2,700/ton. Costs may become negligible as the
size of the flare increases due to recovery credit.

Cooling Towers

There is not a general estimate of control efficiency for this measure;
one is to apply a continuous flow monitor until VOC emissions have
reached a level of 1.7 tons/year for a given cooling tower.  The
annualized cost for a continuous flow monitor is $63,000 – this is
constant over a variety of cooling tower sizes.

Wastewater Drains and Separators

The control efficiency is 65 percent reduction of VOC emissions at a
cost of $3,050/ton.  This is based on actual sampling and cost data for
5 refineries in the Bay Area Air Quality Management District (BAAQMD).

5a.2 Cost Information for EGU sources

(Full details on controls can be found in Appendix 3)

Cost of Controls as a Result of Lower Sub-regional Caps within the MWRPO
and OTC and other Local Controls outside of these Regions within CAIR

As previously discussed, the power sector will achieve significant
emission reductions under the Clean Air Interstate Rule (CAIR) over the
next 10 to 15 years.  When fully implemented, CAIR (in conjunction with
NOx SIP Call) will reduce ozone season NOx emissions by over 60 percent
from 2003 levels within the CAIR states. These reductions will greatly
improve air quality and will lessen the challenges that some areas face
when solving nonattainment issues significantly.

Power sector impacts analyzed in detail in the Final PM NAAQS RIA 15/35
(  HYPERLINK "http://www.epa.gov/ttn/ecas/ria.html"
http://www.epa.gov/ttn/ecas/ria.html  ) provides the baseline for this
RIA. The analysis and projections in this section attempt to show the
potential impacts of the additional controls applied (see section 3.3.3
of this RIA) to facilitate attainment of the more stringent 8-hr ozone
standard of 0.070 ppm. Generally, the incremental impacts of these
controls on the power sector are marginal.

Projected Costs. EPA projects that the annual incremental cost of the
proposed new ozone standard approach is $0.2billion in 2020.  The
additional annual costs reflect additional retrofits (SCR and SNCR) and
generation shifts,. Annualized cost of CAIR is projected to be $6.17
billion in 2020. The proposed approach applied in this RIA would add
$0.2 billion incremental to this cost.

Projected Generation Mix. Coal-fired generation and natural
gas/oil-fired generation are projected to remain almost unchanged.
Installation of approximately 3.7 GWs of SCR and 1.1 GWs of SNCR
incremental to the base case are projected as a result of the lower
sub-regional caps. There are very small changes in the generation mix.
Coal-fired generation increases about 12 GWh (an increase of
approximately 0.25% of the total generation) and gas-fired generation
decreases a similar amount.  Hydo, nuclear, other, and renewable based
generation projected to remain the same. Projected retirements of coal
units is marginal, accounting to about 0.4 GWs compared to the base case
approach.

Projected Nationwide Retail Electricity Prices. Retail electricity
prices are projected to change marginally, only about 1%. The extension
of the cap-and-trade approach in the form of lower sub-regional caps
allows industry to meet the requirements of CAIR in the most
cost-effective manner, thereby minimizing the costs passed on to
consumers. Retail electricity prices are projected to increase less than
1% within the MWRPO and OTC regions, and decrease about 1% in the rest
of the CAIR region.

5a.3 Cost information for Onroad and Nonroad Mobile Sources

(Full details on controls can be found in Appendix 3)

Diesel Retrofits and Vehicle Replacement

To calculate costs for the use of selective catalytic reduction as a
retrofit technology, the assumption was made that all relevant vehicles
would be affected by the control. Therefore, all on-road heavy duty
diesel vehicles that received a retrofit were assumed to employ
selective catalytic reduction as a retrofit technology. The average cost
of a selective catalytic reduction system ranges from $10,000 to $20,000
per vehicle depending on the size of the engine, the sales volume, and
other factors (Pechan, 2003). For AirControlNET analysis, the average
estimated cost of this system is $15,000 per heavy duty diesel vehicle.
(Source: AirControlNET Documentation, III-160).  OTAQ conducted an
additional assessment of current SCR costs and calculated that for the
year 2020, the cost of SCRs will be approximately $13,000 per unit.
This estimate reflects an economy of scale cost reduction of 33%, which
is consistent with trends in other mobile source control technologies
that enter large scale production.

The rebuild/upgrade kit is applied to nonroad equipment.  OTAQ estimates
the cost of this kit to be $2,000 to $4,000 per vehicle.  For this
analysis, the average estimated cost is $3,000 per vehicle.

Table 5a.1: Summary of Cost Effectiveness for Rebuild/Upgrade Kit for
Various Nonroad Vehicles

Nonroad Vehicle	Retrofit Technology	Range of $/ton NOx Emission Reduced
Range of $/ton HC Emission Reduced

Tractors/Loaders/Backhoes	Rebuild/  Upgrade kit	$1,300	$2,200	$9,600
$18,900

Excavators

$1,100	$4,200	$8,100	$43,400

Crawler Tractor/Dozers

$1,100	$4,200	$8,300	$43,500

Skid Steer Loaders

$1,000	$1,600	$7,400	$14,800

Agricultural Tractors

$1,200	$4,900	$9,300	$34,300

Table 5a.2: Summary of Cost Effectiveness for SCR for Various Nonroad
Vehicles

Nonroad Vehicle	Retrofit Technology	Range of $/ton NOx Emission Reduced
Range of $/ton HC Emission Reduced

Tractors/Loaders/Backhoes	SCR	$2,900	$5,300	$32,200	$63,700

Excavators

$2,700	$10,400	$27,400	$146,200

Crawler Tractor/Dozers

$2,800	$10,400	$27,900	$146,700

Skid Steer Loaders

$2,600	$4,000	$24,900	$52,100

Agricultural Tractors

$3,000	$7,600	$31,200	$115,500

Table 5a.3: Summary of Cost Effectiveness for SCR for Various Highway
Vehicles

Highway Vehicle	Retrofit Technology	Range of $/ton NOx Emission Reduced
Range of $/ton HC Emission Reduced

Class 6&7 Truck	SCR	$5,600	$14,100	$46,900	$126,200

Class 8b Truck

$1,100	$2,500	$14,900	$44,600

Implement Continuous Inspection and Maintenance Using Remote Onboard
Diagnostics (OBD)

Continuous I/M can significantly lower test costs and “convenience”
costs of I/M programs.  Using radio frequency transmission, there is a
one-time cost for the Continuous I/M device and its installation.  In
the case of Oregon, this cost is $50.  The unit is then good for the
life of the vehicle.  Annual or biennial test fees are not required
beyond this initial fee to operate the system but there may be
additional operational costs to cover data processing, reporting, and
oversight.  For the proposal RIA, we present estimated cost savings of
the Continuous I/M program, but do not include the cost savings in the
overall cost estimates.  For the final RIA, we plan to include the
Continuous I/M cost savings in the overall costs.  This will result in a
significant reduction of overall cost.

We can compare the costs of periodic testing to Continuous I/M.  The
cost of data processing, reporting and oversight is estimated to be $2
per vehicle per year in the typical I/M area.  If we assume an average
vehicle life span of 14 years, with the first test at 4 years of age,
vehicles will get 5 inspections in a biennial program and 10 in an
annual program (not including additional change of ownership
inspections, which are required in some areas).  Thus, in a Continuous
I/M program, an additional cost of $10-$20 will be incurred for each
vehicle over its life, assuming the same costs apply in a Continuous I/M
program as in a tailpipe test program.

In addition to test costs, Continuous I/M avoids most of the convenience
costs associated with I/M – the time and fuel it takes to drive to the
station, get a test, and return home.   The one-time installation of the
transmitter requires a visit to the test station, but no further visits
are required after that.  So, if we assume, conservatively, that the
typical test cycle requires a total of two hours of time at $20 per hour
and a half-gallon of gas (10 miles round trip with an average fuel
economy of 20 mpg) at $3 per gallon gives us a cost of $41.50.  Over the
life of the vehicle that works out to $207.50 in a biennial program or
$415 in an annual program.  Compare this to the one time trip for
Continuous I/M OBD at a cost of $41.50 and substantial savings are
realized.  Application of Continuous I/M resulted in NOx reductions of
4.2 to 6.5 percent, depending on the geographic area, vehicle class, and
type of existing I/M program.  Some areas have no I/M, some I/M programs
require annual testing, some require biennial testing, and some areas
are piloting continuous I/M.  We applied continuous I/M reductions only
to those areas that currently have annual or biennial programs.

Putting it all together, the table below shows the lifetime inspection
and convenience costs of Continuous I/M versus periodic I/M  (assuming
the current mix of annual and biennial testing and current test costs).
Periodic I/M testing costs about $20 billion over a 10 year lifecycle
with an additional $25 billion in convenience costs for a total of $45
billion.  By contrast, Remote OBD has a test and installation cost of
$4.3 billion dollars over the same 10 year period, and a convenience
cost of $2.5 billion for a total of $6.8 billion.  Thus, nationwide
installation of Remote OBD would save the nation’s motorists about $38
billion in inspection and convenience costs over a 10 year period.

Table 5a.4 Lifetime Inspection and Convenience Costs of I/M

	Test/Install Cost	Convenience Cost	Total

Cost

Continuous I/M	$20 billion	$25 billion	$45 billion

Remote I/M 	$4.3 billion	$2.5 billion	$6.8 billion

Savings	$15.7 billion	$22.5 billion	$38.2 billion

Given that Continuous I/M will actually reduce the cost of I/M,
implementation of this measure is highly cost-effective..   More
information on I/M can be found at   HYPERLINK
"http://www.epa.gov/otaq/regs/im/im-tsd.pdf"
http://www.epa.gov/otaq/regs/im/im-tsd.pdf  and
www.epa.gov/obd/regtech/inspection.htm

Eliminating Long Duration Truck Idling

For purposes of this RIA, we identified this measure as a no cost
strategy i.e. $0/ton NOx.  Both TSEs and MIRTs have upfront capital
costs, but these costs can be fully recovered by the fuel savings.  The
examples below illustrate the potential rate of return on investments in
idle reduction strategies.

TSE

The average price of TSE technology is $11,500 per parking space.  The
average service life of this technology is 15 years.  Truck engines at
idle consume approximately 1 gallon per hour of idle.  Current TSE
projects are operating in environments where trucks are idling, on
average, for 8 hours per day per space for 365 days per year (or about
2,920 hours per year).  Since TSE technology can completely eliminate
long duration idling at truck spaces (i.e. a 100% fuel savings), this
translates into 2,920 gallons of fuel saved per year per space. At
current diesel prices ($2.90/gallon), this fuel savings translates into
$8,468.  Therefore, an $11,500 capital investment should be recovered
within about 17 months.  In this scenario, TSE investments offer over a
70% annual rate of return over the life of the technology.

While it is technically feasible to electrify all parking spaces that
support long duration idling trucks, we should note that TSE technology
is generally deployed at a minimum of 25-50 parking spaces per location
to maximize economies of scale.  The financial attractiveness of
installing TSE technology will depend on the demonstrated truck idling
behavior – the greater the rates of idling, the greater the potential
emissions reductions and associated fuel and cost savings.

MIRTs

The price of MIRT technologies ranges from $1,000-$10,000.  The most
popular of these technologies is the auxiliary power unit (APU) because
it provides air conditioning, heat, and electrical power to operate
appliances.  The average price of an APU is $7,000.  The average service
life of an APU is 10 years.  An APU consumes two-tenths of a gallon per
hour, so the net fuel savings is 0.80 gallons per hour.  EPA estimates
that trucks idle for 7 hours per rest period, on average, and about 300
days per year (or 2,100 hours per year).  Since idling trucks consume 1
gallon of fuel per hour of idle, APUs can reduce fuel consumption for
truck drivers/owners by approximately 1,680 gallons per year.  At
current diesel prices ($2.90/gallon), truck drivers/owners would save
$4,872 on fuel if they used an APU.  Therefore, a $7,000 capital
investment should be recovered within about 18 months.  In this
scenario, APU investments offer almost a 70% annual rate of return over
the life of the technology.

Cost-Effectiveness of Measure: $0/ton NOx

Commuter Programs

We used the Transportation Research Board’s (TRB) cost-effectiveness
analysis of Congestion Mitigation and Air Quality Improvement Program
(CMAQ) projects to estimate the cost-effectiveness of this measure.  TRB
conducted an extensive literature review and then synthesized the data
to develop comparable estimates of cost-effectiveness of a wide range of
CMAQ-funded measures.  We took the average of the median
cost-effectiveness of a sampling of CMAQ-funded measures and then
applied this number to the overarching commuter reduction measure.  The
CMAQ-funded measures we selected were:

regional rideshares

vanpool programs

park-and-ride lots

regional transportation demand management

employer trip reduction programs

We felt that these measures were a representative sampling of commuter
reduction incentive programs.  There is a great deal of variability,
however, in the type of programs and the level of incentives that
employers offer which can impact both the amount of emissions reductions
and the cost of commuter reduction incentive programs.

We chose to apply the resulting average cost-effectiveness estimate to
one pollutant – NOx – in order to be able to compare commuter
reduction programs to other NOx reduction strategies. TRB reported the
cost-effectiveness of each measure, however, as a $/ton reduction of
both VOC and NOx by applying the total cost of the program to a 1:4
weighted sum of VOC and NOx [[total emissions reduction = (VOC * 1) +
(NOx * 4)).  There was not enough information in the TRB study to
isolate the $/ton cost-effectiveness for just NOx reductions, so we used
the combined NOx and VOC estimate.  The results are presented in Table
5a.5.

Table 5a.5 Cost-Effectiveness of Best Workplaces for Commuters Type
Measures from the 2002 TRB Study,

$/ton (2000$) 1:4 VOC:NOx (reported in the RIA as $/ton NOx)

	 	Low	High	Median

Regional Rideshare	$1,200 	$16,000 	$7,400

Vanpool Programs	$5,200 	$89,000 	$10,500

Park-and-ride lots	$8,600 	$70,700 	$43,000

Regional TDM	$2,300 	$33,200 	$12,500

Employer trip reduction programs	$5,800 	$175,500 	$22,700

Average of All Measures	$4,620 	$76,900 	$19,200

Cost-Effectiveness of Measure: $19,200/ton NOx

Reduce Gasoline RVP from 7.8 to 7.0 in Remaining Nonattainment Areas

Cost-Effectiveness of Measure: Cost per ton will be $5,700 to $36,000 /
ton VOC

For more information on RVP:

Michigan Department of Environmental Quality and Southeast Michigan
Council 	of Governments. Proposed Revision to State of Michigan State
Implementation Plan for 7.0 Low Vapor Pressure Gasoline Vapor Request
for Southeast Michigan.  May 24, 2006.

U.S. EPA. Guide on Federal and State Summer RVP Standards for
Conventional Gasoline Only. EPA420-B-05-012. November 2005

 “NOx Emissions Control Costs for Stationary Reciprocating Internal
Combustion Engines in the NOx SIP Call States,”  E.H. Pechan and
Associates, Inc., Springfield, VA, August 11, 2000.  Available on the
Internet at   HYPERLINK
"http://www.epa.gov/ttn/ecas/regdata/cost/pechan8-11.pdf"
http://www.epa.gov/ttn/ecas/regdata/cost/pechan8-11.pdf

 “Suggested Short List and Evaluation of Point and Area Source
Emission Control Measures for the Houston-Galveston-Brazoria 8-Hour
Ozone Nonattainment Area,” Texas Council on Environmental Quality,”
Prepared by ENVIRON International Corp. for Lamar Univ.   June 15, 2006.
 Available on the Internet at    HYPERLINK
"http://www.h-gac.com/NR/rdonlyres/e4cgpdlu4wd3tiguvvxkg5ziefqy36adm2o5c
z5jpm36c67ksxbtfurvvwvgdquy362skyhnsel5uh4rdkfz2rusphd/Final+Short+List+
%26+Evaluations.pdf"
http://www.h-gac.com/NR/rdonlyres/e4cgpdlu4wd3tiguvvxkg5ziefqy36adm2o5cz
5jpm36c67ksxbtfurvvwvgdquy362skyhnsel5uh4rdkfz2rusphd/Final+Short+List+%
26+Evaluations.pdf .

 MARAMA Multipollutant Rule Basis for Flares, part of “Assessment of
Control Technology Options for Petroleum Refineries in the mid-Atlantic
Region.”  February 19, 2007.  Found on the Internet at   HYPERLINK
"http://www.marama.org/reports/021907_Refinery_Control_Options_TSD_Final
.pdf"
http://www.marama.org/reports/021907_Refinery_Control_Options_TSD_Final.
pdf .

 Bay Area Air Quality Management District (BAAQMD).  Proposed Revision
of Regulation 8, Rule 8: Wastewater Collection Systems.  Staff Report,
March 17, 2004.

 Bay Area Air Quality Management District (BAAQMD).  Proposed Revision
of Regulation 8, Rule 8: Wastewater Collection Systems.  Staff Report,
March 17, 2004.

 Transportation Research Board, National Research Council, 2002. The
Congestion Mitigation and Air Quality Improvement Program: assessing 10
years of experience, Committee for the Evaluation of the Congestion
Mitigation and Air Quality Improvement Program.

 PAGE

 PAGE

5a-  PAGE   7


[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26054-26056]
[FR Doc No: 2021-09962]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3614]

M9 Biopharmaceutics Classification System-Based Biowaivers;
International Council for Harmonisation; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``M9
Biopharmaceutics Classification System-Based Biowaivers.'' The guidance
was prepared under the auspices of the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use (ICH), formerly the International Conference on Harmonisation of
Technical Requirements for Registration of Pharmaceuticals for Human
Use. The guidance provides recommendations to support the
biopharmaceutics classification of drug substances and the
Biopharmaceutics Classification System (BCS)-based waiver of the in
vivo bioequivalence (BE) study requirement for certain drug products.
The guidance is intended to avoid or reduce the need for human BE
trials based on extensive in vitro characterization of the drug
substance and drug product properties. The guidance replaces the
existing FDA guidance issued December 26, 2017, entitled ``Waiver of In
Vivo Bioavailability and Bioequivalence Studies for Immediate-Release
Solid Oral Dosage Forms Based on a Biopharmaceutics Classification
System.'' The guidance also finalizes the draft ICH guidance, ``M9
Biopharmaceutics Classification System-Based Biowaivers,'' issued on
October 26, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on May 12, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-3614 for ``M9 Biopharmaceutics Classification System-Based
Biowaivers.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper

submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Mehul Mehta,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, Rm. 2178, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>; or Stephen Ripley, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``M9 Biopharmaceutics Classification System-Based
Biowaivers.'' The guidance was prepared under the auspices of ICH. ICH
has the mission of achieving greater regulatory harmonization worldwide
to ensure that safe, effective, high-quality medicines are developed,
registered, and maintained in the most resource-efficient manner.
    By harmonizing the regulatory requirements in regions around the
world, ICH guidelines have substantially reduced duplicative clinical
studies, prevented unnecessary animal studies, standardized the
reporting of important safety information, standardized marketing
application submissions, and made many other improvements in the
quality of global drug development and manufacturing and the products
available to patients.
    The six Founding Members of the ICH are FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. Additionally, the
Membership of ICH has expanded to include other regulatory authorities
and industry associations from around the world (refer to https://www.ich.org/).
    ICH works by involving technical experts from both regulators and
industry parties in detailed technical harmonization work and the
application of a science-based approach to harmonization through a
consensus-driven process that results in the development of ICH
guidelines. The regulators around the world are committed to
consistently adopting these consensus-based guidelines, realizing the
benefits for patients and for industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
    In the Federal Register of October 26, 2018 (83 FR 54107), FDA
published a notice announcing the availability of a draft guidance
entitled ``M9 Biopharmaceutics Classification System-Based
Biowaivers.'' The notice gave interested persons an opportunity to
submit comments by January 24, 2019.
    After consideration of the comments received and revisions to the
guideline, a final draft of the guideline was submitted to the ICH
Assembly and endorsed by the regulatory agency members in November
2019.
    The guidance provides recommendations to support the
biopharmaceutics classification of drug substances and the BCS-based
waiver of the in vivo BE study requirement for drug products. The BCS-
based biowaiver approach is intended to reduce the need for in vivo
bioequivalence studies. In vivo bioequivalence studies may be waived if
an assumption of equivalence in in vivo performance can be justified by
satisfactory in vitro data. The BCS is a scientific approach based on
the aqueous solubility and intestinal permeability characteristics of
the drug substance or substances. The BCS categorizes drug substances
into one of four BCS classes as follows:
     Class I: High solubility, high permeability
     Class II: Low solubility, high permeability
     Class III: High solubility, low permeability
     Class IV: Low solubility, low permeability
    In vivo BE studies are needed to demonstrate lack of impact of
significant formulation changes on a drug's bioavailability during its
development, for post approval line extensions, and when developing a
generic product. Utilizing the critical properties of the drug
substance and the drug product, and applying the BCS framework,
extensive in vitro studies

can support the waiver of the in vivo BE requirement for certain drug
products.
    Following the public consultation period, clarifications were made
to the guidance based on the comments received.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``M9 Biopharmaceutics Classification System-
Based Biowaivers.'' It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required. However, this final guidance refers to previously approved
FDA collections of information. The previously approved collections of
information are subject to review by OMB under the PRA. The following
collections of information have been approved under OMB control number
0910-0001:
     Submitting under 21 CFR 314.50 content and format of new
drug applications, including the pharmacokinetics and bioavailability
sections.
     Submitting under 21 CFR 314.70 postapproval changes.
     Submitting under 21 CFR 314.94 content and format of
abbreviated new drug applications.
    The collections of information for submitting under 21 CFR 312.23
information about pharmacokinetics and biological disposition of the
drug has been approved under OMB control number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: May 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09962 Filed 5-11-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 142 (Wednesday, July 26, 2023)]
[Notices]
[Pages 48242-48243]
[FR Doc No: 2023-15833]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER23-2440-000]

McFarland Solar B, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
McFarland Solar B, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 9, 2023.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: July 20, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-15833 Filed 7-25-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Pages 44945-44947]
[FR Doc No: 2020-16021]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89341; File No. SR-Phlx-2020-36]

Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend the
Exchange's Pricing Schedule at Equity 7, Section 3

July 20, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 9, 2020, Nasdaq PHLX LLC (``Phlx'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. 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\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the Exchange's pricing schedule at
Equity 7, Section 3.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/phlx/rules, at the
principal office of the Exchange, 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 Exchange 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 these 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 aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is to provide additional
credits to the Qualified Market Maker (``QMM'') Program. More
specifically, the Exchange proposes to provide a credit of $0.0003 per
share executed in Tape A securities and a credit of $0.0002 per share
executed in Tape B and Tape C securities with respect to all displayed
orders of a QMM in securities priced at $1 or more per share that
provide liquidity, provided that the QMM provides 0.12% or more of
total Consolidated Volume during the month and quotes the NBBO at least
10% of the time during Market Hours in an average of at least 850
securities per day during a month. Such credit will be in addition to
any credit provided under Equity 7, Section 3. The Exchange believes
these new credits will help improve market quality on its platform, as
discussed below.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\3\ in general, and furthers the objectives of Sections
6(b)(4) and 6(b)(5) of the Act,\4\ in particular, in that it provides
for the equitable allocation of reasonable dues, fees and other charges
among members and issuers and other persons using any facility, and is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers. The proposal is also consistent with
Section 11A of the Act relating to the establishment of the national
market system for securities.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

The Proposal Is Reasonable
    The Exchange's proposed additional credits provided to its QMMs are
reasonable in several respects. As a threshold matter, the Exchange is
subject to significant competitive forces in the market for equity
securities transaction services that constrain its pricing
determinations in that market. The fact that this market is competitive
has long been recognized by the courts. In NetCoalition v. Securities
and Exchange Commission, the D.C. Circuit stated as follows: ``[n]o one
disputes that competition for order flow is `fierce.' . . . As the SEC
explained, `[i]n the U.S. national market system, buyers and sellers of
securities, and the broker-dealers that act as their order-routing
agents, have a wide range of choices of where to route orders for
execution'; [and] `no exchange can afford to take its market share
percentages for granted' because `no exchange possesses a monopoly,
regulatory or otherwise, in the execution of order flow from broker
dealers'. . . .'' \5\
---------------------------------------------------------------------------

    \5\ NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010)
(quoting Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-
21)).
---------------------------------------------------------------------------

    The Commission and the courts have repeatedly expressed their
preference for competition over regulatory intervention in determining
prices, products, and services in the securities markets. In Regulation
NMS, while adopting a series of steps to improve the current market
model, the Commission highlighted the importance of market forces in
determining prices and SRO revenues and, also, recognized that current
regulation of the market system ``has been remarkably successful in
promoting market competition in its broader forms that are most
important to investors and listed companies.'' \6\
---------------------------------------------------------------------------

    \6\ Securities Exchange Act Release No. 51808 (June 9, 2005), 70
FR 37496, 37499 (June 29, 2005) (``Regulation NMS Adopting
Release'').
---------------------------------------------------------------------------

    Numerous indicia demonstrate the competitive nature of this market.
For example, clear substitutes to the Exchange exist in the market for
equity security transaction services. The Exchange is only one of
several equity venues to which market participants may direct their
order flow. Competing equity exchanges offer similar tiered pricing
structures to that of the Exchange, including schedules of rebates and
fees that apply based upon members achieving certain volume thresholds.
    Within this environment, market participants can freely and often
do shift their order flow among the Exchange and competing venues in
response to changes in their respective pricing schedules. As such, the
proposal represents a reasonable attempt by the Exchange to increase
its liquidity and market share relative to its competitors.
    In particular, the Exchange proposes to add an additional QMM
rebate that would provide a credit of $0.0003 per share executed in
Tape A and a credit of $0.0002 per share executed in Tape B and Tape C
with the goal of increasing the overall incentive to QMMs to further
increase their liquidity addition activity on the Exchange. The
proposal will also provide an incentive for QMMs to add liquidity at
the NBBO in more securities, which is intended to improve market
quality. To the extent that this proposed change leads to an increase
in overall liquidity activity on the Exchange and more competitive
pricing, this will improve the quality of the Exchange's market and
increase its attractiveness to existing and prospective participants.

The Proposal Is an Equitable Allocation of Credits
    The Exchange believes its proposal will allocate its proposed
credits fairly among its market participants. The proposal will provide
a QMM with an additional opportunity to receive credits for adding
liquidity to the Exchange. It is equitable for the Exchange to provide
an additional means for QMMs to receive credits whose orders add
liquidity to the Exchange as a means of incentivizing increased
liquidity addition activity. An increase in overall liquidity addition
activity on the Exchange will improve the quality of the Exchange's
equity market and increase its attractiveness to existing and
prospective participants. Furthermore, it is equitable for the Exchange
to propose credit for participants with orders in securities in Tapes A
due to the Exchange's goal to specifically promote increased liquidity
in securities in Tape A. An increase in overall liquidity adding
activity on the Exchange will improve the quality of the PSX market and
increase its attractiveness to existing and prospective participants.
    Any participant that is dissatisfied with the proposed new credits
is free to shift their order flow to competing venues that provide more
favorable pricing or less stringent qualifying criteria.
The Proposal Is Not Unfairly Discriminatory
    The Exchange believes that the proposal is not unfairly
discriminatory. As an initial matter, the Exchange believes that
nothing about its pricing model is inherently unfair; instead, it is a
rational pricing model that is well-established and ubiquitous in
today's economy among firms in various industries--from co-branded
credit cards to grocery stores to cellular telephone data plans--that
use it to reward the loyalty of their best customers that provide high
levels of business activity and incent other customers to increase the
extent of their business activity. It is also a pricing model that the
Exchange and its competitors have long employed with the assent of the
Commission. It is fair because it incentivizes customer activity that
increases liquidity, enhances price discovery, and improves the overall
quality of the equity markets.
    The Exchange's proposal to add additional credits to the QMM
Program is not unfairly discriminatory because any member organization
may quote at the NBBO at the levels required by the proposed additional
credit criteria and may provide the level of liquidity required by the
proposed additional credit criteria, and in fact, the proposed
additional credits will not only enable a member organization to meet
the qualifications for a QMM, it would also enable the member
organization to obtain a credit in addition to any credit provided for
under Equity 7, Section 3.

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 not necessary or appropriate in
furtherance of the purposes of the Act.
Intramarket Competition
    The Exchange does not believe that its proposal will place any
category of Exchange participants at a competitive disadvantage. The
Exchange's proposed credit for quoting at the NBBO and providing
liquidity will not place any burden on intramarket competition because
all members will have the opportunity to obtain the additional proposed
credits if the member increases liquidity and quotes at the NBBO, which
will further improve overall market quality.
    Moreover, the Exchange's proposal to modify its QMM Program will
not burden intramarket competition because the proposed additional
credits within the QMM Program will provide members with an added
incentive to continue to provide all member organizations with an
opportunity to obtain supplemental credits for transactions if they
improve the market by providing significant quoting at the NBBO in a
large number of securities which the Exchange believes will improve
market quality.
Intermarket Competition
    Addressing whether the proposed credits could impose a burden on
competition on other SROs that is not necessary or appropriate, the
Exchange believes that its proposed modification to its QMM Program
will not impose a burden on competition because the Exchange's
execution services are completely voluntary and subject to extensive
competition both from the other 12 live exchanges and from off-exchange
venues, which include 34 alternative trading systems that trade
national market system stock. The Exchange notes that it operates in a
highly competitive market in which market participants can readily
favor competing venues if they deem fee levels at a particular venue to
be excessive, or rebate opportunities available at other venues to be
more favorable. In such an environment, the Exchange must continually
adjust its credits to remain competitive with other exchanges and with
alternative trading systems that have been exempted from compliance
with the statutory standards applicable to exchanges. Because
competitors are free to modify their own fees in response, and because
market participants may readily adjust their order routing practices,
the Exchange believes that the degree to which new credits in this
market may impose any burden on competition is extremely limited.
    The proposed credits for adding liquidity are reflective of this
competition because, as a threshold issue, the Exchange is a relatively
small market so its ability to burden intermarket competition is
limited. In this regard, even the largest U.S. equities exchange by
volume only has 17-18% market share, which in most markets could hardly
be categorized as having enough market power to burden competition.
Moreover, as noted above, price competition between exchanges is
fierce, with liquidity and market share moving freely between exchanges
in reaction to fee and credit changes. This is in addition to free flow
of order flow to and among off-exchange venues which comprised more
than 41% of industry volume for the month of June 2020.
    In sum, the Exchange intends for the proposed credits to increase
member incentives to add liquidity to the Exchange and to contribute to
market quality, which is reflective of fierce competition for order
flow noted above; however, if the proposed credit and QMM Program
incentives are unattractive to market participants, it is likely that
the Exchange will either fail to increase its market share or even lose
market share as a result. Accordingly, the Exchange does not believe
that the proposed new credits will impair the ability of members or
competing order execution venues to maintain their competitive standing
in the financial markets.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\7\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is: (i)
Necessary or appropriate in the public interest; (ii) for the
protection of investors; or (iii) otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or 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 email to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2020-36 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Phlx-2020-36. This file
number should be included on the subject line if email 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 website (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 website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-Phlx-2020-36, and should be submitted on
or before August 14, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-16021 Filed 7-23-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 126 (Thursday, June 30, 2011)]
[Notices]
[Pages 38446-38447]
[FR Doc No: 2011-16448]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64746; File No. SR-NYSEAmex-2011-45]

Self-Regulatory Organizations; NYSE Amex LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change to Extend the
Operation of the Pilot Program That Allows Nasdaq Stock Market
Securities To Be Traded on the Exchange Pursuant to a Grant of Unlisted
Trading Privileges

June 24, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 21, 2011, NYSE Amex LLC (the ``Exchange'' or ``NYSE
Amex'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the Exchange. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78a.
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend NYSE Amex Equities Rule 500 to
extend the operation of the pilot program that allows Nasdaq Stock
Market (``Nasdaq'') securities to be traded on the Exchange pursuant to
a grant of unlisted trading privileges. The pilot is currently
scheduled to expire on August 1, 2011; the Exchange proposes to extend
it until the earlier of Securities and Exchange Commission
(``Commission'') approval to make such pilot permanent or January 31,
2012. The text of the proposed rule change is available at the
Exchange, the Commission's Public Reference Room, and http://www.nyse.com.

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 Amex Equities Rules 500-525, as a pilot program, govern the
trading of any Nasdaq-listed security on the Exchange pursuant to
unlisted trading privileges (``UTP Pilot Program'').\3\ The Exchange
hereby seeks to extend the operation of the UTP Pilot Program,
currently scheduled to expire on August 1, 2011, until the earlier of
Commission approval to make such pilot permanent or January 31, 2012.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 62479 (July 9,
2010), 75 FR 41264 (July 15, 2010) (SR-NYSEAmex-2010-31). See also
Securities Exchange Act Release No. 62857 (September 7, 2010), 75 FR
55837 (September 14, 2010) (SR-NYSEAmex-2010-89) and 63601 (December
22, 2010), 75 FR 82117 (December 29, 2010) (SR-NYSEAmex-2010-124).
---------------------------------------------------------------------------

    The UTP Pilot Program includes any security listed on Nasdaq that
(i) is designated as an ``eligible security'' under the Joint Self-
Regulatory Organization Plan Governing the Collection, Consolidation
and Dissemination of Quotation and Transaction Information for Nasdaq-
Listed Securities Traded on Exchanges on an Unlisted Trading Privilege
Basis, as amended (``UTP Plan''),\4\ and (ii) has been admitted to
dealings on the Exchange pursuant to a grant of unlisted trading
privileges in accordance with Section 12(f) of the Securities Exchange
Act of 1934, as amended (the ``Act''),\5\ (collectively, ``Nasdaq
Securities'').\6\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 58863 (October 27,
2008), 73 FR 65417 (November 3, 2008). The Exchange's predecessor,
the American Stock Exchange LLC, joined the UTP Plan in 2001. See
Securities Exchange Act Release No. 55647 (April 19, 2007), 72 FR
20891 (April 27, 2007) (S7-24-89). In March 2009, the Exchange
changed its name to NYSE Amex LLC. See Securities Exchange Act
Release No. 59575 (March 13, 2009), 74 FR 11803 (March 19, 2009)
(SR-NYSEALTR-2009-24).
    \5\ 15 U.S.C. 78l.
    \6\ ``Nasdaq Securities'' is included within the definition of
``security'' as that term is used in the NYSE Amex Equities Rules.
See NYSE Amex Equities Rule 3. In accordance with this definition,
Nasdaq Securities are admitted to dealings on the Exchange on an
``issued,'' ``when issued,'' or ``when distributed'' basis. See NYSE
Amex Equities Rule 501.
---------------------------------------------------------------------------

    The Exchange notes that its New Market Model Pilot (``NMM Pilot''),
which, among other things, eliminated the function of specialists on
the Exchange and created a new category of market participant, the
Designated Market Maker (``DMM''),\7\ is also scheduled to end on
August 1, 2011.\8\ The timing of the operation of the UTP Pilot Program
was designed to correspond to that of the NMM Pilot. In approving the
UTP Pilot Program, the Commission acknowledged that the rules relating
to DMM benefits and duties in trading Nasdaq Securities on the Exchange
pursuant to the UTP Pilot Program are consistent with the Act \9\ and
noted the similarity to the NMM Pilot, particularly with respect to DMM
obligations and benefits.\10\ Furthermore, the UTP Pilot Program rules
pertaining to the assignment of securities to DMMs are substantially
similar to the rules implemented through the NMM Pilot.\11\ The
Exchange has similarly filed to extend the operation of the NMM Pilot
until the earlier of Commission approval to make the NMM Pilot
permanent or January 31, 2012.\12\
---------------------------------------------------------------------------

    \7\ See NYSE Amex Equities Rule 103.
    \8\ See Securities Exchange Act Release No. 60758 (October 1,
2009), 74 FR 51639 (October 7, 2009) (SR-NYSEAmex-2009-65). See also
Securities Exchange Act Release Nos. 61030 (November 19, 2009), 74
FR 62365 (November 27, 2009) (SR-NYSEAmex-2009-83); 61725 (March 17,
2010), 75 FR 14223 (March 24, 2010) (SR-NYSEAmex-2010-28); 62820
(September 1, 2010), 75 FR 54935 (September 9, 2010) (SR-NYSEAmex-
2010-86); and 63615 (December 29, 2010), 76 FR 611 (January 5, 2011)
(SR-NYSEAmex-2010-123).
    \9\ 15 U.S.C. 78.
    \10\ See supra note 1, at 41271.
    \11\ Id.
    \12\ See SR-NYSEAmex-2010-122.
---------------------------------------------------------------------------

    Extension of the UTP Pilot Program in tandem with the NMM Pilot,
both from August 1, 2011 until the earlier of Commission approval to
make such pilots permanent or January 31, 2012,

will provide for the uninterrupted trading of Nasdaq Securities on the
Exchange on a UTP basis and thus continue to encourage the additional
utilization of, and interaction with, the NYSE Amex Equities market,
and provide market participants with improved price discovery,
increased liquidity, more competitive quotes and greater price
improvement for Nasdaq Securities.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange. In particular,
the Exchange believes that its proposal is consistent with (i) Section
6(b) of the Act,\13\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\14\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to remove impediments to and perfect
the mechanism of a free and open market and a national market system,
and, in general, to protect investors and the public interest; (ii)
Section 11A(a)(1) of the Act,\15\ in that it seeks to ensure the
economically efficient execution of securities transactions and fair
competition among brokers and dealers and among exchange markets; and
(iii) Section 12(f) of the Act,\16\ which governs the trading of
securities pursuant to UTP consistent with the maintenance of fair and
orderly markets, the protection of investors and the public interest,
and the impact of extending the existing markets for such securities.
Under the UTP Pilot Program Nasdaq Securities trade on the Exchange
pursuant to rules governing the trading of Exchange-Listed securities
that previously have been approved by the Commission. NYSE Amex made
certain minor modifications to the operation of these rules, and added
certain new rules, to accommodate the trading of Nasdaq Securities on a
UTP basis; the Commission also approved all of these modifications and
additions.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
    \15\ 15 U.S.C. 78k-1(a)(1).
    \16\ 15 U.S.C. 78l(f).
---------------------------------------------------------------------------

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \17\ and Rule 19b-4(f)(6) thereunder.\18\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.\19\
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \18\ 17 CFR 240.19b-4(f)(6).
    \19\ 17 CFR 240.19b-4(f)(6)(iii). Rule 19b-4(f)(6)(iii) requires
that a self-regulatory organization submit to the Commission written
notice of its intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

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-NYSEAmex-2011-45 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-NYSEAmex-2011-45. 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 Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of the filing also will be
available for inspection and copying at the principal office of the
Exchange. 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-
NYSEAmex-2011-45 and should be submitted on or before July 21, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-16448 Filed 6-29-11; 8:45 am]
BILLING CODE 8011-01-P