[Federal Register Volume 85, Number 238 (Thursday, December 10, 2020)]
[Notices]
[Pages 79499-79500]
[FR Doc No: 2020-27179]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4570-DR; Docket ID FEMA-2020-0001]

Louisiana; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Louisiana (FEMA-4570-DR), dated October 16,
2020, and related determinations.

DATES: The declaration was issued October 16, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated October 16, 2020, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Louisiana resulting from Hurricane Delta during the period of
October 6 to October 10, 2020, is of sufficient severity and
magnitude to warrant a major disaster declaration under the Robert
T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (the ``Stafford Act''). Therefore, I declare that such
a major disaster exists in the State of Louisiana.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Individual Assistance and
assistance for debris removal and emergency protective measures,
including direct Federal assistance, under the Public Assistance
program in the designated areas, Hazard Mitigation throughout the
State, and any other forms of assistance under the Stafford Act that
you deem appropriate subject to completion of Preliminary Damage
Assessments (PDAs).
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance, Hazard Mitigation, and Other Needs Assistance
under section 408 will be limited to 75 percent of the total
eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The time period prescribed for the implementation of section
310(a), Priority to Certain Applications for Public Facility and Public
Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed
six months after the date of this declaration.
    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, John E. Long, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Louisiana have been designated
as adversely affected by this major disaster:

    Acadia, Calcasieu, Cameron, Jefferson Davis, and Vermilion
Parishes for Individual Assistance.
    Acadia, Calcasieu, Cameron, Jefferson Davis, and Vermilion
Parishes for debris removal and emergency protective measures
(Categories A and B), including direct federal assistance, under the
Public Assistance program.
    All areas within the State of Louisiana are eligible for
assistance under the Hazard Mitigation Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially

Declared Disaster Areas; 97.049, Presidentially Declared Disaster
Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidentially Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-27179 Filed 12-9-20; 8:45 am]
BILLING CODE 9111-23-P


May 27, 2014

Mr. Michael Walsh
Environmental Protection Agency (EPA)
Office of Pesticide Programs
Biopesticides and Pollution Prevention Division (7511P) / Registration Division (7505P)
1200 Pennsylvania Ave. NW
Washington, D.C. 20460-0001

Dear Mr. Walsh:

We, the undersigned institutional investors, representing $47 billion in assets under management and led by the Interfaith Center on Corporate Responsibility (ICCR), are writing to express our concerns about the use of 2,4-dichlorophenoxyacetic acid (2,4-D) on new genetically engineered (GE) corn, cotton and soybean crops designed to survive repeated spraying of the herbicide.  We are disappointed by the recent news of the Agency's proposed decision to approve this new version of 2,4-D. We ask that, under the proposed new use registrations for 2,4-D-resistant crops, EPA incorporate widely accepted estimates for significantly increased use and altered use patterns of 2,4-D.

As investors, we are conscious of the long-term risks associated with these products and believe it is prudent to await thorough assessment before releasing these products to the market.  Without adequate understanding of the environmental consequences and health impacts of the 2,4-D resistant crops and subsequent increase in herbicide use, we cannot be sure that our companies are sufficiently considering potential risks of these products to human health and the environment.  As a regulator responsible for understanding the effects of herbicide use on humans and the environment, the U.S. Environmental Protection Agency (EPA) must carefully consider its role in determining the use, sale, and labeling of 2,4-D and make a thorough and accurate assessment of the potential impacts.

The EPA has reported that 2,4-D is the seventh largest source of dioxins in the United States.  2,4-D is a toxic herbicide associated with serious health risks. The 2,4-D resistant crops will also, like their predecessors, lead to much greater use of even more dangerous chemicals, the development of more herbicide-resistant weeds, destruction and genetic contamination of neighboring crops, and severe economic impacts on other farmers.

As shareholders, we engage seed and chemical companies, including Dow AgroSciences, about risks and impacts related to herbicide utilization with its seed products on human health and the environment. Deregulation of Dow's 2,4-D resistant crops will drive up use of 2,4-D, an antiquated and dangerous herbicide known to drift beyond target crops. Shareholders are aware that Dow's Enlist Duo system utilizes a less volatile form of 2,4-D, however this does not mitigate its inherently dangerous characteristics linked to causing cancer, Parkinson's disease, endocrine disruption, and reproductive problems in humans.

We ask that as you consider Dow's 2,4-D New Use Registration Applications for the new uses of 2,4-D choline salt that will be associated with the new 2,4-D resistant crops, you consider the mounting evidence about the risks of increased and compounded 2,4-D use. We  join more than half a million individuals and organizations, including medical doctors and public health scientists, farmers, food and health experts, consumers, environmental organizations and many others in calling on you to undertake a thorough assessment and complete your findings prior to undertaking any regulatory changes.

Noted agricultural scientist Charles Benbrook projects that widespread planting of Dow's Enlist corn alone could trigger as much as a 25-fold increase in use of 2,4-D, from an estimated 4.2 million pounds at present to over 100 million pounds by 2019.  The consequent increase of the use of further herbicide resistant crops is troubling for ecosystems and water supplies.  As a result, Monsanto and other firms that manufacture pesticides are focusing the bulk of their Research and Development on new crops engineered with resistances to even more herbicides. Monsanto is awaiting approval of soybean seeds that are resistant to dicamba and glyphosate, with triple herbicide resistant corn and cotton in the pipeline.

The instructions that the seed companies provide to end-users is dependent on the findings of the EPA. Your role in setting the conditions for the herbicide's use and placement in the labeling instructions that a user must follow are critical for protecting the health of farmers and the environment. We encourage you to use caution and restraint when establishing these instructions.

Further, the MSDS sheet for Enlist Duo is alarming:

   * Environmental precautions: Prevent from entering into soil, ditches, sewers, waterways and/or groundwater.
   * Personal precautions, protective equipment and emergency procedures: Isolate area. Keep unnecessary and unprotected personnel from entering the area.
   * Potential Health Effects (extracted from listing)
         o Eye Contact: May cause moderate eye irritation. May cause slight corneal injury.
         o Skin Contact: Brief contact may cause slight skin irritation with local redness. May cause drying and flaking of the skin.
         o Skin Absorption: Prolonged skin contact is unlikely to result in absorption of harmful amounts.
         o Skin Sensitization: Has demonstrated the potential for contact allergy in mice.
         o Inhalation: No adverse effects are anticipated from single exposure to mist. Based on the available data, narcotic effects were not observed. Based on the available data, respiratory irritation was not observed.
         o Ingestion: Low toxicity if swallowed. Small amounts swallowed incidentally as a result of normal handling operations are not likely to cause injury; however, swallowing larger amounts may cause injury.
         o Effects of Repeated Exposure: For similar active ingredient(s). 2,4-Dichlorophenoxyacetic acid. In animals, effects have been reported on the following organs: Gastrointestinal tract. Kidney. Liver. Muscles. Observations in animals include: Gastrointestinal irritation. Vomiting. For the minor component(s): In rare cases, repeated excessive exposure to propylene glycol may cause central nervous system effects.
         o Birth Defects/Developmental Effects: For similar active ingredient(s). Has been toxic to the fetus in laboratory animals at doses toxic to the mother.

How can deregulation of 2,4-D corn, cotton and soy align with EPA's announced proposed changes to the agricultural Worker Protection Standard (WPS) to increase protections from pesticide exposure for the nation's 2 million agricultural workers and their families and EPA's commitment to Environmental Justice?

Farmers are deeply concerned that Dow's Enlist corn, cotton and soy system will threaten their crops. 2,4-D is known to drift  --  directly and through volatilization  --  which poses a very real threat to rural economies and farmers growing crops not engineered to withstand application of these potent chemicals. 2,4-D drift is already responsible for more episodes of crop injury than any other herbicide, and its vastly increased use promises still more damage to non-2,4-D resistant crops like soybeans, cotton, vegetables and fruit.

This chemical is used because Roundup Ready GE crops have caused an epidemic of glyphosate-resistant weeds, so another herbicide is needed. Monsanto's RoundUp Ready seed line is responsible for a dramatic rise in glyphosate-resistant "superweeds," which have afflicted millions of acres of farmland across the Midwest and South.  Dow is promoting GE 2,4-D corn, cotton and soy as the solution to glyphosate (the ingredient in Roundup) resistant weeds, but GE crop systems caused the glyphosate resistant weeds in the first place. Additionally, Enlist Duo also utilizes glyphosate.

We ask that, under the proposed new use registrations for 2,4-D-resistant crops, EPA incorporate widely accepted estimates for significantly increased use and altered use patterns of 2,4-D.

Sincerely,

Ellen Kennedy
Manager, Environment, Water and Climate Change
Calvert Investments
Luan Steinhilber
Director of Shareholder Advocacy
Miller/Howard Investments, Inc.

Kathleen Coll
CHE Trinity Health
William Stoddart
Founder and Principal
Northfork Financial

Shelley Alpern
Director of Social Research & Shareholder Advocacy
Clean Yield Asset Management
Julie N.W. Goodridge
President & CEO
NorthStar Asset Management, Inc.

James A Frazin
President/CEO
Communitas Financial Management
Judy Byron
Director
Northwest Coalition for Responsible Investment

Sally Ann Brickner
Coordinator of Justice, Peace and Ecology
Congregation of Sisters of St. Agnes
Catherine Cartier
President
Progressive Asset Management

Margaret Weber
Corporate Responsibility Director
Congregation of St. Basil
Jo Marie Chrosniak, HM
Coordinator
Region VI Coalition for Responsible Investment

Joellen Sbrissa, CSJ
SRI Representative
Congregation of St. Joseph
Steve Zielinski
SRI Consultant
Servants of the Paraclete

Susan Vickers
VP Community Health
Dignity Health
Ruth Kuhn, SC
Chair - Corporate Responsibility Committee
Sisters of Charity of Cincinnati

Steve Zielinski
SRI Consultant
Diocese of Springfield, IL
Margaret O'Brien, SC
Congregation Treasurer
Sisters of Charity of New York

Steve Zielinski
SRI Consultant
Dominican Sisters
Sister Barbara Aires
Coordinator of Corporate Responsibility
Sisters of Charity of Saint Elizabeth

Linda Hincken
Chief Financial Officer
Dominican Sisters of Amityville
Sister Patricia Daly, OP
Corporate Responsibility Representative
Sisters of St. Dominic of Caldwell NJ

Valerie Heinonen
Director, Shareholder Advocacy
Dominican Sisters of Hope
Toni Palamar
Province Business Administrator
Sisters of the Good Shepherd-Province of NY

Sr. Donna Graham
OSF Director, JPIC Office
Franciscan Friars (OFM), St. John the Baptist Province
Steve Zielinski
SRI Consultant
Sisters of the Presentation

Lura Mack
Director
General Council of the Adrian Dominican Sisters
Mary Lardner
Social Justice Committee Chair
Social Justice Committee at UUCSR

Leslie Samuelrich
President
Green Century Capital Management
Lars M Lewander
Chief Executive Officer
Spring Water Asset Management

Nadira Narine
Program Director, Strategic Initiatives
Interfaith Center on Corporate Responsibility

Theodore Casparian
Educator
Sustainable Investing 4 All

Cathy Rowan
Corporate Responsibility Coordinator
Maryknoll Sisters
Susan Baker
Vice President, Shareholder Advocacy & Corporate Engagement
Trillium Asset Management

Marcela Pinilla
Director, Shareholder Advocacy
Mercy Investment Services
Valerie Heinonen
Director, Shareholder Advocacy
Ursuline Sisters of Tildonk

Barbara Jennings
Coordinator
Midwest Coalition for Responsible Investment
Sonia Kowal
Director of Socially Responsible Investing
Zevin Asset Management, LLC


[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71710-71711]
[FR Doc No: 2013-28685]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2009-0074]

Petition for Waiver of Compliance

    In accordance with part 211 of Title 49 Code of Federal
Regulations, this document provides the public notice that by a
document dated October 15, 2013, the Canadian National Railway (CN),
Brotherhood of Locomotive Engineers and Trainmen (BLET), and United
Transportation Union (UTU) have jointly petitioned the Federal Railroad
Administration (FRA) for an extension of their waiver of compliance
from certain provisions of the Federal hours of service laws contained
at 49 U.S.C. 21103(a)(4). FRA assigned the petition Docket Number FRA-
2009-0074.
    In their petition, CN, BLET, and UTU seek relief from 49 U.S.C.
21103(a)(4), which, in part, requires a train employee to receive 48
hours off duty after initiating an on-duty period each day for 6
consecutive days. Specifically, CN, BLET, and UTU seek a 1-year
extension of the waiver to allow a train employee to initiate an on-
duty period each day for 6 consecutive days

followed by 24 hours off duty. In support of the request, CN provided
an analysis of its safety data. The analysis found that since 2012 only
one human factor-caused accident occurred on a job where employees were
working a scheduled assignment allowed under the existing waiver.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by January 13, 2014 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2013-28685 Filed 11-27-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 87, Number 202 (Thursday, October 20, 2022)]
[Rules and Regulations]
[Pages 63680-63681]
[FR Doc No: 2022-22186]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0416; Airspace Docket No. 21-ANM-30]
RIN 2120-AA66

Revocation of Jet Route J-591; Bellingham, WA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action revokes Jet Route J-591 in the vicinity of
Bellingham, WA, due to actions of NAV CANADA revoking the entire route
in Canada, effective February 25, 2021.

DATES: Effective date 0901 UTC, December 29, 2022. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: FAA Order JO 7400.11G, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in

Title 49 of the United States Code. Subtitle I, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies the air traffic service route structure in the northwest
United States to maintain the efficient flow of air traffic within the
National Airspace System.

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA 2021-0416 in the Federal Register (86 FR 29530; June 2, 2021),
revoking Jet Route J-591 in the vicinity of Bellingham, WA. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal. No comments were received.
    Jet Routes are published in paragraph 2004 of FAA Order JO
7400.11G, dated August 19, 2022, and effective September 15, 2022,
which is incorporated by reference in 14 CFR 71.1. The Jet Route listed
in this document will be removed subsequently in FAA Order JO 7400.11.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order JO 7400.11G, Airspace Designations
and Reporting Points, dated August 19, 2022, and effective September
15, 2022. FAA Order JO 7400.11G is publicly available as listed in the
ADDRESSES section of this document. FAA Order JO 7400.11G lists Class
A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends 14 CFR part 71 by revoking Jet Route J-591 due
to NAV CANADA's actions revoking the route within Canada. The change is
outlined below.
    J-591: J-591 extended between the Whatcom, WA, VHF Omnidirectional
Range/Tactical Air Navigation (VORTAC) and the Kelowna, BC, Canada,
navigational aids, excluding the segment within Canada, before NAV
CANADA revoked the route within Canadian airspace in 2021. The route
currently extends between the Whatcom VORTAC and the United States/
Canada border. The route is revoked in its entirety.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under
Department of Transportation (DOT) Regulatory Policies and Procedures
(44 FR 11034; February 26, 1979); and (3) does not warrant preparation
of a regulatory evaluation as the anticipated impact is so minimal.
Since this is a routine matter that only affects air traffic procedures
and air navigation, it is certified that this rule, when promulgated,
does not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this airspace action of revoking Jet
Route J-591 in the vicinity of Bellingham, WA, qualifies for
categorical exclusion under the National Environmental Policy Act (42
U.S.C. 4321 et seq.) and its implementing regulations at 40 CFR part
1500, and in accordance with FAA Order 1050.1F, Environmental Impacts:
Policies and Procedures, paragraph 5-6.5a, which categorically excludes
from further environmental impact review rulemaking actions that
designate or modify classes of airspace areas, airways, routes, and
reporting points (see 14 CFR part 71, Designation of Class A, B, C, D,
and E Airspace Areas; Air Traffic Service Routes; and Reporting
Points). As such, this action is not expected to result in any
potentially significant environmental impacts. In accordance with FAA
Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the
FAA has reviewed this action for factors and circumstances in which a
normally categorically excluded action may have a significant
environmental impact requiring further analysis. Accordingly, the FAA
has determined that no extraordinary circumstances exist that warrant
preparation of an environmental assessment or environmental impact
study.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p.389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 2004 Jet Routes.

* * * * *

J-591 [Removed]

* * * * *

    Issued in Washington, DC, on October 5, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-22186 Filed 10-19-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 2, 2009 (Volume 74, Number 104)]
[Proposed Rules]
[Page 26312-26315]
[DOCID:fr02jn09-20]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0465; Directorate Identifier 2007-NM-244-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A310-203, -204, -221, -
222, -304, -322, -324, and -325 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above that would supersede an existing AD. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as:

    DGAC [Direction G[eacute]n[eacute]rale de l'Aviation Civile]
France issued AD F-2005-078 [which corresponds to FAA AD 2006-02-06]
to require the modification (Airbus modification 13023), defined in
Airbus SB [service bulletin] A310-53-2124, to increase the service
life of junctions of center box upper frame bases to upper fuselage
arches. This structural modification falls within the scope of the
work related to the extension of the service life of A310 aircraft
and widespread fatigue damage evaluations.
    The threshold timescales for accomplishment of the tasks as
defined in SB A310-53-2124 were refined and reduced. * * *
* * * * *
    The unsafe condition is fatigue cracking of the frame foot run-
outs, which could lead to rupture of the frame foot and cracking in
adjacent frames and skin, and which could result in reduced structural
integrity of the fuselage. The proposed AD would require actions that
are intended to address the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by July 2, 2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus SAS--EAW (Airworthiness Office), 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; e-mail<EMAIL_ADDRESS>Internet http://
www.airbus.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue, SW., Renton, Washington. For information on the availability of
this material at the FAA, call<PHONE_NUMBER> or<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Tom Stafford, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (425)
227-1622; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-0465;
Directorate Identifier 2007-NM-244-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2008-0212, dated December 4, 2008 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    DGAC [Direction G[eacute]n[eacute]rale de l'Aviation Civile]
France issued AD F-2005-078 [which corresponds to FAA AD 2006-02-06,
Amendment 39-14458, 71 FR 3214, January 20, 2006] to require the
modification (Airbus modification 13023), defined in Airbus SB
[service bulletin] A310-53-2124, to increase the service life of
junctions of center box upper frame bases to upper fuselage arches.
This structural modification falls within the scope of the work
related to the extension of the service life of A310 aircraft and
widespread fatigue damage evaluations.
    The threshold timescales for accomplishment of the tasks as
defined in SB A310-53-2124 were refined and reduced. Consequently,
EASA issued AD 2007-0238 to require compliance with Revision 1 of SB
A310-53-2124 at the reduced compliance times, superseding (the
requirements of) DGAC France AD F-2005-078. Subsequently, Airbus
identified reference material that was erroneously introduced into
Airbus SB A310-53-2124 Revision 1. As a result, the SB instructions
could not be accomplished properly. Operators that tried to apply SB
A310-53-2124 at Revision 1 had to contact Airbus; see also Airbus
SBIT [service bulletin information telex] ref. 914.0135/08, dated 03
March 2008.
    Consequently, AD 2007-0238 was revised to exclude reference to
Airbus SB A310-53-2124 Revision 1 and to require accomplishment of
the task(s) as described in the original SB A310-53-2124 instead,
although retaining the reduced compliance times introduced by AD
2007-0238 at original issue. This new [EASA] AD is published to
refer to Airbus SB A310-53-2124 Revision 02, the corrected version
that is to be used to meet the requirements of this AD.

    The unsafe condition is fatigue cracking of the frame foot run-
outs, which could lead to rupture of the frame foot and cracking in
adjacent frames and skin, and which could result in reduced structural
integrity of the fuselage. You may obtain further information by
examining the MCAI in the AD docket.

Relevant Service Information

    Airbus has issued Mandatory Service Bulletin A310-53-2124, Revision
02, dated May 22, 2008. The actions described in this service
information are intended to correct the unsafe condition identified in
the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in Note within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 68 products of U.S. registry. We also estimate that
it would take about 41 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $80 per
work-hour. Required parts would cost about $4,400 per product. Where
the service information lists required parts costs that are covered
under warranty, we have assumed that there will be no charge for these
costs. As we do not control warranty coverage for affected parties,
some parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $522,240, or $7,680 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing Amendment 39-14458 (71 FR
3214, January 20, 2006) and adding the following new AD:

Airbus: Docket No. FAA-2009-0465; Directorate Identifier 2007-NM-
244-AD.

Comments Due Date

    (a) We must receive comments by July 2, 2009.

Affected ADs

    (b) The proposed AD supersedes AD 2006-02-06, Amendment 39-
14458.

Applicability

    (c) This AD applies to Airbus Models A310-203, -204, -221, -222,
-304, -322, -324 and -325 airplanes; all serial numbers;
certificated in any category; except those airplanes on which Airbus
Mandatory Service Bulletin A310-53-2124, dated April 4, 2005, has
been accomplished, or Airbus Modification 13023 has been
accomplished in production.

Subject

    (d) Air Transport Association (ATA) of America Code 53:
Fuselage.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    DGAC [Direction G[eacute]n[eacute]rale de l'Aviation Civile]
France issued AD F-2005-078 [which corresponds to FAA AD 2006-02-06,
Amendment 39-14458, 71 FR 3214, January 20, 2006] to require the
modification (Airbus modification 13023), defined in Airbus SB
[service bulletin] A310-53-2124, to increase the service life of
junctions of center box upper frame bases to upper fuselage arches.
This structural modification falls within the scope of the work
related to the extension of the service life of A310 aircraft and
widespread fatigue damage evaluations.
    The threshold timescales for accomplishment of the tasks as
defined in SB A310-53-2124 were refined and reduced. Consequently,
EASA issued AD 2007-0238 to require compliance with Revision 1 of SB
A310-53-2124 at the reduced compliance times, superseding (the
requirements of) DGAC France AD F-2005-078. Subsequently, Airbus
identified reference material that was erroneously introduced into
Airbus SB A310-53-2124 Revision 1. As a result, the SB instructions
could not be accomplished properly. Operators that tried to apply SB
A310-53-2124 at Revision 1 had to contact Airbus; see also Airbus
SBIT [service bulletin information telex] ref. 914.0135/08, dated 03
March 2008.
    Consequently, AD 2007-0238 was revised to exclude reference to
Airbus SB A310-53-2124 Revision 1 and to require accomplishment of
the task(s) as described in the original SB A310-53-2124 instead,
although retaining the reduced compliance times introduced by AD
2007-0238 at original issue. This new [EASA] AD is published to
refer to Airbus SB A310-53-2124 Revision 02, the corrected version
that is to be used to meet the requirements of this AD.
    The unsafe condition is fatigue cracking of the frame foot run-
outs, which could lead to rupture of the frame foot and cracking in
adjacent frames and skin, and which could result in reduced
structural integrity of the fuselage.

New Requirements of This AD: Actions and Compliance

    (f) Unless already done, do the following actions.
    (1) Except for airplanes identified in paragraph (f)(2) of this
AD, at the later of the times specified in paragraphs (f)(1)(i) and
(f)(1)(ii) of this AD, accomplish inspections by rotating probe for
cracking of holes H1 through H29 on FR 43 through 46 inclusive, and
inspections of holes H1 through H29 on FR 43 through 46 inclusive to
determine the edge distance of the hole, in accordance with the
Accomplishment Instructions of Airbus Mandatory Service Bulletin
A310-53-2124, Revision 02, dated May 22, 2008 (``the service
bulletin''). If no cracking is found and the edge distance is equal
to or greater than the distance specified in the Accomplishment
Instructions of the service bulletin, before further flight, do the
cold expansion of the most fatigue sensitive fastener holes, as
identified in the service bulletin.
    (i) Inspect at the applicable time indicated in Table 1 of this
AD. Airbus Model A310-304, -322, -324, and -325 airplanes with an
average flight time (AFT) equal to or less than 3.17 flight hours
are short range airplanes. Airbus Model A310-304, -322, -324, and -
325 with an AFT exceeding 3.17 flight hours are long range
airplanes.
    (ii) Within 500 flight cycles or 800 flight hours after the
effective date of this AD, whichever occurs first.

                        Table 1--Compliance Times
------------------------------------------------------------------------

------------------------------------------------------------------------
     Affected airplanes           Inspection modification threshold,
                                         whichever occurs later
------------------------------------------------------------------------
Model A310-304, -322, -324    Prior to              Within 3,000 flight
 and -325 short range          accumulation of       cycles after the
 airplanes.                    26,500 flight         effective date of
                               cycles or 74,300      this AD, without
                               flight hours since    exceeding 29,200
                               first flight of the   flight cycles or
                               airplane, whichever   81,800 flight hours
                               occurs first.         since first flight,
                                                     whichever occurs
                                                     first.
Model A310-304, -322, -324    Prior to              Within 3,000 flight
 and -325 long range           accumulation of       cycles after the
 airplanes.                    23,400 flight         effective date of
                               cycles or 117,100     this AD, without
                               flight hours since    exceeding 25,800
                               first flight of the   flight cycles or
                               airplane, whichever   129,000 flight
                               occurs first.         hours since first
                                                     flight, whichever
                                                     occurs first.
Model A310-203, -204, -221,   Prior to              Within 3,000 flight
 and A310-222.                 accumulation of       cycles after the
                               23,400 flight         effective date of
                               cycles or 46,800      this AD, without
                               flight hours since    exceeding 28,800
                               first flight of the   flight cycles or
                               airplane, whichever   57,700 flight hours
                               occurs first.         since first flight,
                                                     whichever occurs
                                                     first.
------------------------------------------------------------------------

    Note 1:  To establish the average flight time, take the
accumulated flight time (counted from the take-off up to the
landing) and divide by the number of accumulated flight cycles. This
gives the average flight time per flight cycle.

    (2) For airplanes that have been modified before the effective
date of this AD in accordance with Airbus Mandatory Service Bulletin
A310-53-2124, Revision 01, dated May 3, 2007: Within 500 flight
cycles or 800 flight hours after the effective date of this AD,
whichever occurs first, contact Airbus and follow their corrective
actions.
    (3) If, during any inspection required by paragraph (f)(1) of
this AD, any cracking is found or if the edge distance is less than
the distance specified in Airbus Mandatory Service Bulletin A310-53-
2124, Revision 02, dated May 22, 2008, before further flight,
contact Airbus and follow their corrective actions.

FAA AD Differences

    Note 2:  This AD differs from the MCAI and/or service
information as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, Transport Airplane Directorate, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Tom
Stafford, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton,
Washington 98055-4056; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required

to assure the product is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act, the
Office of Management and Budget (OMB) has approved the information
collection requirements and has assigned OMB Control Number 2120-
0056.

Related Information

    (h) Refer to MCAI European Union Airworthiness Directive 2008-
0212, dated December 4, 2008; and Airbus Mandatory Service Bulletin
A310-53-2124, Revision 02, dated May 22, 2008; for related
information.

    Issued in Renton, Washington, on May 15, 2009.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-12740 Filed 6-1-09; 8:45 am]

BILLING CODE 4910-13-P


Draft Opening Remarks Prepared for

U.S. Secretary of Labor Elaine L. Chao

Transatlantic Economic Council

Monday, May 12, 2008

Thank you, Vice President Verheugen.

The Department of Labor recognizes that SDoC is an important issue for
the EU.  We have spent significant time meeting with EU experts on SDoC,
analyzing the SDoC system and reaching out to all interested parties.
Following last month’s meeting of the High Level Regulatory
Cooperation Forum, the Department has agreed to issue a second Request
for Information on SDoC.

As you know, one of the primary missions of the Labor Department is to
protect the health and safety of workers.  So third party approval of
electrical equipment is required before it enters the workplace.  Safety
testing is done by Nationally Recognized Testing Laboratories, or
“NRTLs.”  These requirements apply uniformly to all products,
regardless of country of origin.

Let me note that the NRTL system already has many features that
facilitate trade.  Among them are the following:

The NRTL system is open to third-party entities from any country.

The NRTL system is simple to use; there are no elaborate rules or
complicated bureaucracies governing how the system operates.

The NRTL system has flexibilities that reduce the cost and time for
manufacturers to get their products approved.

The system relies heavily on the private sector, minimizing the need for
large government resources and regulations.

Last, and most important, the NRTL system has proven to be very
effective in ensuring the safety of products used in the workplace.

Notwithstanding this history, the Department has taken the EC’s
request very seriously and has devoted significant time analyzing the
SDoC system.

In addition to meeting with EC representatives numerous times—most
recently on May 5th—the Department has met with many other
stakeholders to explore SDoC more fully.  These stakeholders include:

The Information Technology Industry Council

The American National Standards Institute

Other U.S. Government agencies, and

Representatives from foreign and domestic testing laboratories.

In that regard, let me note that any proposal to change to the current
NRTL system would need to involve all stakeholders, including organized
labor.

In addition, the Department would also like to consult with the
institutions in member States that actually administer and enforce
electrical safety laws and directives.  This would help us better
understand how SDoC is implemented, since each country uses varying
approaches.

Finally, let me note that adopting an SDoC system for the safety of
electrical products in the United States would not be a simple
administrative matter.  It could be perceived as negatively impacting
worker safety and would, therefore, be controversial.

Adopting an SDoC system, in whole or in part, could require a
significant increase in the budget of the Department’s Health and
Safety Administration.  And from what we have learned to date, this
could also require an expansion of OSHA’s authority to include post
market surveillance and recall in its jurisdiction.  This would require
legislative changes that must be approved by the U.S. Congress.  All of
these will be problematical in the current budgetary and political
environment.

Let me also emphasize that the rulemaking process in the United States
is very public and transparent.  All interested parties may comment, and
by law each comment must be recorded, analyzed and taken into account.
It is also worth noting that regulatory decisions are based not on the
volume of comments received, but on their substance and quality.  The
most weight is given to hard data and to peer-reviewed research and
documentation.  And rulemaking is a lengthy process, taking several
years to complete. Failure to follow the process exactly can be, and
frequently is, the basis for lawsuits delaying or stopping regulations
from going forward.

In conclusion, the Department would like to discuss with the EC ways to
facilitate trade in electrical products in addition to the issue of
SDoC.  The Department recently proposed a new component to its NRTL
Program, which could further facilitate trade in electrical products
worldwide.  And we would welcome the opportunity to share this with you.

We also would like to discuss some of the barriers to trade that exist
within the EU with respect to conformity assessment. I refer to the
requirement  that designated safety conformity organizations, known as
“notified bodies,” must be physically located within the EU. The
NRTL system has no comparable requirement—recognized organizations can
be based in any country, close to manufacturers.

So there are many opportunities for further discussion.  Thank you, and
I look forward to our continued cooperation on this issue.

###


[Federal Register: April 2, 2010 (Volume 75, Number 63)]
[Notices]
[Page 16891-16894]
[DOCID:fr02ap10-133]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61797; File No. SR-BX-2010-009]

Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Order
Approving Proposed Rule Change, as Modified by Amendments No. 1 and 3
Thereto, Relating to the Directed Order Process on the Boston Options
Exchange Facility

March 29, 2010.

I. Introduction

    On January 25, 2010, NASDAQ OMX BX, Inc. (``Exchange'') filed with
the Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act

of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule
change amending the rules of the Boston Options Exchange Group, LLC
(``BOX'') to modify the Directed Order process on BOX. The Exchange
filed Amendment No 1. to the proposed rule change on February 10, 2010.
The proposed rule change, as modified by Amendment No. 1, was published
in the Federal Register on February 24, 2010.\3\ On March 22, 2010, the
Exchange filed Partial Amendment No. 2 (``Amendment No. 2'') to the
proposed rule change, and on March 24, 2010, the Exchange filed Partial
Amendment No. 3 (``Amendment No. 3'') to the proposed rule change.\4\
The Commission received no comments on the proposal. This order
approves the proposed rule change, as modified by Amendments No. 1 and
3.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 61531 (February 17,
2010), 75 FR 8416 (hereinafter referred to as ``Notice'').
    \4\ Amendment No. 3 replaced and superseded Amendment No. 2 in
its entirety. In Amendment No. 3, the Exchange made conforming
changes to its rule text to reflect a recently approved proposed
rule change. See Securities Exchange Act Release No. 61577 (February
24, 2010), 75 FR 9496 (March 2, 2010) (SR-BX-2010-017). This
technical amendment does not require notice and comment as it did
not materially affect the substance of the rule filing.
---------------------------------------------------------------------------

II. Description of the Proposal

    The Exchange is proposing modifications to the Directed Order
process on BOX.\5\ Specifically, the Exchange is proposing to automate
the creation of the Guaranteed Directed Order (``GDO'') and the manner
in which the quote of an Executing Participant (``EP'') \6\ is handled
during the Directed Order process.
---------------------------------------------------------------------------

    \5\ See Chapter VI, Section 5(c). A Directed Order is any
Customer Order to buy or sell which has been directed to a
particular Market Maker by an OFP. See Chapter I, Section 1(a)(21)
of the BOX Rules. Terms not otherwise defined herein shall have the
meaning assigned to them in the BOX Rules.
    \6\ When a BOX Market Maker indicates its interest in receiving
Directed Orders, the receiving Market Maker is referred to as the
EP.
---------------------------------------------------------------------------

A. Quote Shelving and GDO

    Currently, upon receipt of a Directed Order an EP must either
submit the Directed Order to the PIP \7\ or send the Directed Order to
the BOX Book. When the EP sends the Directed Order to the BOX Book and
the EP's quotation on the opposite side of the market from the Directed
Order is equal to the National Best Bid or Offer (``NBBO'') and the
Directed Order is also executable against the NBBO, the EP must
guarantee execution of the Directed Order at the current NBBO for at
least the size of his quote. This guarantee is called the GDO. Under
the current rule, the EP must immediately send the Directed Order with
the GDO to the Trading Host. Sending the GDO to the Trading Host
enables it to simultaneously take down or ``shelve'' the EP's quote and
any pending quote updates while the Directed Order is being exposed on
the BOX Book.
---------------------------------------------------------------------------

    \7\ See Chapter V, Section 18 of the BOX Rules.
---------------------------------------------------------------------------

    Under the proposal, if the Directed Order is executable against the
current NBBO and the EP is also quoting at such NBBO on the opposite
side of the Directed Order, the GDO will be automatically created by
the Trading Host and the EP's quote will be automatically shelved. In
addition, the GDO creation and the quote shelving will be moved to an
earlier point in the Directed Order process. Where presently they occur
only when the Directed Order is sent to the BOX Book by the EP, they
will now take place immediately upon the Trading Host's receipt of the
Directed Order from the submitting order flow provider (``OFP'').\8\
---------------------------------------------------------------------------

    \8\ The proposal clarifies that if a GDO has been automatically
generated and is pending, then upon receipt by the Trading Host of a
subsequent Directed Order for the same EP for the same series and
side of the market, such subsequent order will not be considered a
Directed Order but will be treated as a regular order. The Trading
Host will not send the order to the EP, but will immediately release
it to the BOX Book as a regular order. If no GDO has been
automatically generated, then such subsequent order will be sent to
the EP and treated as a new Directed Order. See electronic mail from
Wayne Pestone, Chief Legal Officer, BOX, to Heather Seidel, Terri
Evans and Sarah Schandler, Division of Trading and Markets,
Commission, dated February 3, 2010 (confirming that the Directed
Order process currently functions in this manner on BOX).
---------------------------------------------------------------------------

    Once the GDO has been generated by the Trading Host, the EP will
systemically be prohibited from posting a quotation. The EP's pending
quote that was taken down by the Trading Host will not be released
until: (i) The Directed Order is modified by the submitting OFP; (ii)
the EP sends the Directed Order to the PIP; or (iii) the EP submits the
Directed Order to the BOX Book, and either one of the following occurs:
(a) the Directed Order trades in full; (b) the Directed Order
exposition ends; or (c) the Directed Order is modified or cancelled by
the submitting OFP during such exposition.
    Under the proposal, if the Directed Order is modified by the
submitting OFP once the Trading Host has automatically established the
GDO, then the modified Directed Order shall no longer be considered a
Directed Order and shall be immediately released to the BOX Book and
treated as a regular order.\9\ If no GDO had been established, then the
modified Directed Order shall be resubmitted to the EP. The proposal
provides that it shall be considered by the Exchange to be conduct
inconsistent with just and equitable principles of trade for any
Options Participant or person to communicate with an EP about the terms
or conditions of a Directed Order prior to its outcome in the BOX
Trading Host (e.g. execution, cancellation).
---------------------------------------------------------------------------

    \9\ Upon modification or cancellation of the Directed Order, the
Trading Host will immediately reestablish the EP's quote, including
any of the EP's pending quote modifications, with a new time
priority; or in the case of a pending quote cancellation, the EP's
quote will be cancelled.
---------------------------------------------------------------------------

    Under the proposal, the EP's obligations when using the PIP remain
the same as under the current rule, however in some instances the
obligation will be met automatically by the Trading Host. For example,
if a GDO has been automatically generated, then the Trading Host will
prohibit the EP from adjusting his quotation prior to submitting the
Directed Order to the PIP process. Moreover, upon submission of the
Directed Order to the PIP, the Trading Host will only accept a Primary
Improvement Order priced at or better than (i) the GDO or (ii) the NBBO
at the time the EP sent the Directed Order to the PIP, whichever is
better for the Directed/PIP Order.
    The Exchange proposes to add certain details and clarifications to
the rule regarding the treatment of Directed Orders that have been
released to the BOX Book for exposure when a GDO has been automatically
generated. The proposal clarifies that when the EP does not PIP the
Directed Order and releases it to the BOX Book, if a GDO has been
automatically generated and the Directed Order is not executable
against the current NBBO, then the Trading Host will expose the order
at the better GDO price for three (3) seconds.\10\ Under the proposal,
if a GDO has been automatically generated and the Directed Order is
executable against the current NBBO, the Directed Order will
immediately execute against the BOX Book if the BOX Best Bid or Offer
is equal to or better than the NBBO and GDO. Any remaining quantity not
executed will immediately be exposed to BOX Participants at the better
of the NBBO or GDO price. As is the case under the current rule, this
exposure period will last three (3) seconds, during which time any
Options Participant,

except for the EP, may submit an order to the BOX Book in response, and
any orders submitted to the BOX Book during this period will execute
immediately against any remaining quantity of the Directed Order, in
time priority. Also as is the case under the current rule, after
exposure of the Directed Order for three (3) seconds, the Trading Host
will release the GDO, where it will be able to execute against any
remaining quantity of the Directed Order.
---------------------------------------------------------------------------

    \10\ See electronic mail from Wayne Pestone, Chief Legal
Officer, BOX, to Heather Seidel, Terri Evans and Sarah Schandler,
Division of Trading and Markets, Commission, dated February 3, 2010
(confirming that the Directed Order process currently functions in
this manner on BOX).
---------------------------------------------------------------------------

    During the exposure period, the EP may not decrement the size,
worsen the price of his GDO or submit a contra order. Because the
Trading Host will now automatically create the GDO and shelve the EP's
quote, it will not process such changes to the GDO or pending quote,
except a decrementation of the GDO size down to the size of the
remaining Directed Order after execution with the BOX Book. The EP may
increase the size of his GDO, the same as today. Under the proposal the
EP also may better the price of his GDO or modify his pending quote to
be reestablished, but the Trading Host will not apply such modification
until the quote is reestablished. Following execution of the Directed
Order, the Trading Host will reestablish the quote of the EP with a new
time priority, decremented by any executed portion of the GDO or as
modified by the EP.
    The Exchange also proposes to make several additional changes to
the text of Chapter VI, Section 5(c). The Exchange proposes to change
several references to ``Market Maker'' to ``EP'' to more closely align
the rule text with the terminology used to describe the Directed Order
process. In addition, the Exchange proposes to add the word ``current''
before certain instances of the term ``NBBO'' in order to clarify which
NBBO is being referenced at a particular stage in the Directed Order
process. The Exchange also is proposing to remove from Section
5(c)(iii)(1) certain language about the function of the NBBO filter
process pursuant to Chapter V, Section 16(b), which the Exchange views
as unnecessary and duplicative.

B. Market Maker Quoting Obligations

    The Exchange proposes to add new Supplementary Material .02 to
Chapter VI, Section 5(c)(ii). The proposed Supplementary Material .02
states that when a Market Maker's quote is shelved while acting as EP,
such time without posting a quote will not count towards fulfilling his
obligations for purposes of the Market Maker's quoting obligations
under Chapter VI, Section 6(d) of the BOX Rules.

C. Implementation

    The Exchange has represented that after Commission approval and at
least one week prior to implementation of the rule change, Boston
Options Exchange Regulation LLC will issue a regulatory circular to all
Participants that will inform Participants of the implementation date
and will give Participants an opportunity to make any necessary
modifications to coincide with the implementation date.

III. Discussion and Commission's Findings

    After careful review, the Commission finds 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.
Specifically, the Commission finds that the proposal is consistent with
Section 6(b)(5) of the Act,\11\ which requires, among other things,
that the rules of an exchange are designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in
securities, 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.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b)(5).
    \12\ 15 U.S.C. 78f(b)(4). In approving the proposed rule change,
the Commission has considered the proposed rule's impact on
efficiency, competition and capital formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    As noted above, BOX Rules currently provide that if an EP is at the
NBBO and the Directed Order is marketable, the EP must guarantee
execution of that order at the NBBO for at least the size of his quote.
Under the current rule, the EP is responsible for submitting a GDO to
the Trading Host. Pursuant to the proposed rule change, the Exchange is
proposing to automate the GDO process. The Commission believes that
automating the GDO process, including ``shelving'' the EP's quote,
should help ensure that GDOs are generated in compliance with BOX
rules. Further, the Commission believes that automating the creation of
the GDO by the Trading Host will aid Market Makers in complying with
the BOX rules regarding Directed Orders.
    The Exchange has proposed the addition of language to the rule text
to describe the treatment of a Directed Order when the Directed Order
is subsequently modified or cancelled, depending upon whether a GDO has
been automatically generated. The Commission believes that the
Exchange's proposed treatment of modified or cancelled Directed Orders
is consistent with the Act. As discussed above, the Exchange has
proposed that it would be conduct inconsistent with just and equitable
principles of trade for any Options Participant or person to
communicate with an EP about the terms or conditions of a Directed
Order prior to its outcome in the BOX Trading Host. Moreover, when a
Directed Order is modified or cancelled after a GDO has been
automatically generated, the EP's quote will be reestablished with a
new time priority. The Commission believes that these provisions should
ensure that Directed Orders are not modified or cancelled in a manner
that would be inconsistent with the Act.
    As set forth above, the Exchange has proposed the addition of
language to the rule text to describe what occurs on BOX when a GDO has
been automatically generated and is pending and the Trading Host
receives a subsequent Directed Order for the same EP. The Exchange has
also proposed the addition of language to the rule text to clarify the
treatment of Directed Orders that have been released to the Box Book
for exposure after a GDO has been automatically generated. The Exchange
has represented that the processes described by this additional and
clarifying language are currently a part of the Directed Order process
on BOX although not specifically set forth in the current rule text.
The Exchange also proposes to make several non-substantive changes in
the text of Chapter VI, Section 5(c) to more closely align the rule
text with the terminology used to describe the Directed Order process
and to remove duplicative language. The Commission believes that these
changes and additions, which will provide greater clarity throughout
the Directed Order process for Market Makers, OFPs and other
Participants on BOX and will more closely align the rule text with the
Directed Order process as it occurs on BOX, are consistent with the
Act.
    The Commission also believes that the Exchange's proposed addition
of Supplementary Material .02, clarifying that the time that a Market
Maker's quote is shelved does not count towards fulfilling his quoting
obligations under Chapter VI, Section 6(d) of the BOX Rules, is
appropriate and consistent with the Act. The Commission notes that
Market Makers are subject to quoting requirements under Chapter VI,
Section 6(d). Specifically, Market Makers are required on a daily basis
to post quotes at least 80 percent of the

time an options class is open for trading in 90 percent of their
appointed classes. Furthermore, Market Makers must post valid
quotations at least 60 percent of the time in each of their appointed
classes during the time that the class is open for trading.
Accordingly, the Commission believes that it is appropriate for the
Exchange to exclude the time a Market Maker's quote is shelved under
the Directed Order process in determining whether a Market Maker has
satisfied his quoting obligations as no quote will be posted by the
Market Maker during such time the quote is shelved.

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\13\ that the proposed rule change (SR-BX-2010-009), as modified by
Amendments No. 1 and 3 thereto, be, and it hereby is, approved.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-7431 Filed 4-1-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Page 68775]
[FR Doc No: 2012-27968]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9752-4]

Notice of Proposed Administrative Settlement Pursuant to the
Comprehensive Environmental Response, Compensation, and Liability Act

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for public comment.

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SUMMARY: In accordance with Section 122 (i) of the Comprehensive
Environmental Response, Compensation, and Liability Act, as amended
(``CERCLA''), notice is hereby given of a proposed administrative
settlement concerning the Agrifos Phosphoric Acid Release Superfund
Site in Pasadena, Harris County, Texas.
    The settlement requires the settling party to pay a total of
$385,000 as payment of response costs to the Hazardous Substances
Superfund. The settlement includes a covenant not to sue pursuant to
Section 107 of CERCLA.
    For thirty (30) days following the date of publication of this
notice, the Agency will receive written comments relating to this
notice and will receive written comments relating to the settlement.
The Agency will consider all comments received and may modify or
withdraw its consent to the settlement if comments received disclose
facts or considerations which indicate that the settlement is
inappropriate, improper, or inadequate. The Agency's response to any
comments received will be available for public inspection at 1445 Ross
Avenue, Dallas, Texas 75202-2733.

DATES: Comments must be submitted on or before December 17, 2012.

ADDRESSES: The proposed settlement and additional background
information relating to the settlement are available for public
inspection at 1445 Ross Avenue, Dallas, Texas 75202-2733. A copy of the
proposed settlement may be obtained from Robert Werner at 1445 Ross
Avenue, Dallas, Texas 75202-2733 or by calling<PHONE_NUMBER>. Comments
should reference the Agrifos Phosphoric Acid Release Site, Pasadena,
Harris County, Texas and EPA Docket Number 06-01-13, and should be
addressed to Robert Werner at the address listed above.

FOR FURTHER INFORMATION CONTACT: Elizabeth Pletan, Assistant Regional
Counsel, 1445 Ross Avenue, Dallas, Texas 75202-2733 or call (214) 665-
8525.

    Dated: November 7, 2012.
Samuel Coleman,
Acting Regional Administrator (6RA).
[FR Doc. 2012-27968 Filed 11-15-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 18, 2008 (Volume 73, Number 76)]
[Rules and Regulations]
[Page 21042-21043]
[DOCID:fr18ap08-6]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage Form New Animal Drugs; Insulin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Intervet, Inc. The supplemental NADA
provides for the veterinary prescription use of an injectable
suspension of porcine insulin zinc for the reduction of hyperglycemia
and hyperglycemia-associated clinical signs in cats with diabetes
mellitus.

DATES: This rule is effective April 18, 2008.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet
Lane, Millsboro, DE 19966, filed a supplement to NADA 141-236 providing
for the veterinary prescription use of VETSULIN (porcine insulin zinc)
Suspension for the reduction of hyperglycemia and hyperglycemia-
associated clinical signs in cats with diabetes mellitus. The
application also provides for a lower initial dosage of insulin for
dogs. The supplemental NADA is approved as of March 24, 2008, and the
regulations are amended in 21 CFR 522.1160 to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(d)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and
Cosmetic Act 21 U.S.C 360b(c)(2)(F)(iii)), this approval qualifies for
3 years of marketing exclusivity beginning on the date of approval. The
three years of marketing exclusivity applies only to the indication for
use in cats for which this supplement is approved.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. In Sec.  522.1160, revise paragraphs (a) and (c) to read as follows:

Sec.  522.1160  Insulin.

    (a) Specifications. Each milliliter of porcine insulin zinc
suspension contains 40 international units (IU) of insulin.
* * * * *
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer an initial
once-daily dose of 0.5 IU per kilogram of body weight by subcutaneous
injection concurrently with or right after a meal. Adjust this once-
daily dose at appropriate intervals based on clinical signs, urinalysis
results, and glucose curve values until adequate glycemic control has
been attained. Twice-daily therapy should be initiated if the duration
of insulin action is determined to be inadequate. If twice-daily
treatment is initiated, the two doses should be 25 percent less than
the once daily dose required to attain an acceptable nadir.
    (ii) Indications for use. For the reduction of hyperglycemia and
hyperglycemia-associated clinical signs in dogs with diabetes mellitus.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) Cats--(i) Amount. Administer an initial dose of 1 to 2 IU by
subcutaneous

injection. Injections should be given twice daily at approximately 12-
hour intervals. For cats fed twice daily, the injections should be
concurrent with or right after a meal. For cats fed ad libitum, no
change in feeding is needed. Adjust the dose at appropriate intervals
based on clinical signs, urinalysis results, and glucose curve values
until adequate glycemic control has been attained.
    (ii) Indications for use. For the reduction of hyperglycemia and
hyperglycemia-associated clinical signs in cats with diabetes mellitus.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

    Dated: April 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-8347 Filed 4-17-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: April 25, 2008 (Volume 73, Number 81)]
[Notices]
[Page 22361]
[DOCID:fr25ap08-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER08-536-002]

Polytop Corporation; Notice of Filing

April 18, 2008.
    Take notice that on April 16, 2008, Polytop Corporation tendered
for filing a Petition for Acceptance of Initial Tariff, Waivers and
Blanket Authority.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on May 7, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-9018 Filed 4-24-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62416-62417]
[FR Doc No: 2022-22386]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2316]

Discussion Paper: Distributed Manufacturing and Point-of-Care
Manufacturing of Drugs; Request for Information and Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information and comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
publication of a discussion paper providing information for
stakeholders and soliciting public comments on specific areas of
emerging and advanced manufacturing technologies. The discussion paper
presents areas for consideration and policy development identified by
the Center for Drug Evaluation and Research (CDER) scientific and
policy experts associated with distributed manufacturing (DM) and
point-of-care (POC) manufacturing for drugs, including biological
products regulated by CDER and the Center for Biologics Evaluation and
Research (CBER). FDA recognizes that regulatory policies and programs
may need to evolve to enable the timely adoption of these technologies.
The discussion paper includes a series of questions for each technology
to stimulate feedback from the public.

DATES: Either electronic or written comments and information on the
discussion paper must be submitted by December 13, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 13, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

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-2022-N-2316 for ``Discussion Paper: Distributed Manufacturing and
Point-of-Care Manufacturing of Drugs; Request for Information and
Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), 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>.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm. 4162, Silver Spring, MD 20993, 240-
402-7930, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Advanced manufacturing is a general term for an innovative
pharmaceutical manufacturing technology or approach that has the
potential to improve the reliability and robustness of the
manufacturing process and supply chain, and increase timely access to
quality medicines for the American public. For the purposes of the
discussion paper, all references to drugs include both human drugs and
biological products (including those regulated by CBER), unless
otherwise specified. Advanced manufacturing can: (1) integrate novel
technological approaches, (2) use established techniques in an
innovative way, or (3) apply production methods in a new domain.
Advanced manufacturing can potentially be used for new or existing and
large or small molecule drugs.
    FDA has recognized and embraced the potential of advanced
manufacturing for many years. CDER established the Emerging Technology
Program in 2014 to work collaboratively with companies to support the
use of advanced manufacturing. CDER has observed a rapid emergence of
advanced manufacturing technologies through the Emerging Technology
Program and recognizes that regulatory policies and programs may need
to evolve to enable the timely adoption of these technologies. The
National Academies of Sciences, Engineering, and Medicine issued a 2021
report entitled ``Innovation in Pharmaceutical Manufacturing on the
Horizon: Technical Challenges, Regulatory Issues, and
Recommendations'', noting potential innovations in integrated,
flexible, and distributed manufacturing. These potential innovations
include modular approaches to streamline drug development and
production, and the deployment and use of highly portable manufacturing
units. A range of drug manufacturers have recently engaged CDER through
the Emerging Technology Program specifically regarding the development
of portable and distributed manufacturing platforms.
    CBER established the CBER Advanced Technologies Team in 2019 to
promote dialogue, education, and input between CBER and prospective
innovators and developers of advanced manufacturing technologies.
Through these interactions, CBER has observed interest from
manufacturers in the implementation of novel manufacturing approaches
for CBER-regulated products. CBER also recognizes the need to consider
developing a regulatory framework to facilitate the adoption of these
emerging technologies. CBER expects the development of advanced
manufacturing technologies associated with DM and POC manufacturing for
products that it regulates.
    The discussion paper (available on FDA's website at: CDER's
Framework for Regulatory Advanced Manufacturing Evaluation (FRAME)
Initiative [verbar] FDA) presents areas for consideration and policy
development identified by CDER scientific and policy experts associated
with DM and POC manufacturing that would be valuable as FDA considers
developing a regulatory framework that contemplates these technologies
for CDER- and CBER-regulated drug and biological products. For the
purposes of the discussion paper, CDER and CBER define DM to be a
decentralized manufacturing strategy consisting of a manufacturing
platform of manufacturing units deployed to multiple locations; POC
manufacturing is defined as a subset of DM that uses manufacturing
units distributed to host sites in proximity to patient care (e.g.,
healthcare facilities). Regulatory areas of consideration include
applicable statutory provisions, regulations, and guidance related to
quality assessment and inspections that could affect an applicant's
ability to comply with the current regulatory framework or FDA's
assessment of a marketing application.

II. Requested Information and Comments

    Interested persons are invited to provide detailed comments to CDER
and CBER (see ADDRESSES) on all aspects described in the discussion
paper. The discussion paper is available on FDA's website for the FRAME
initiative at: CDER's Framework for Regulatory Advanced Manufacturing
Evaluation (FRAME) Initiative [verbar] FDA. To facilitate input, FDA
has developed a series of questions after each technology described in
the discussion paper. The questions are not meant to be exhaustive, and
FDA is also interested in any other pertinent information stakeholders
would like to share on this topic. This feedback will help inform the
Agency's policy development regarding the technologies described in the
discussion paper. FDA encourages stakeholders to provide the specific
rationale and basis for their comments, including any available
supporting data and information.

    Dated: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22386 Filed 10-13-22; 8:45 am]
BILLING CODE 4164-01-P