UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, D.C.

Issued by the Department of Transportation on February 5, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST 2003-16718

________________________________________________________________________
_______________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of    Mesa Airlines, Inc.  filed  12/11/03 for:

XX  Exemption for two years under 49 U.S.C. §40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between Los Angeles, California, and Puerto Vallarta, Mexico.

Applicant rep:   Brian S. Gillman<PHONE_NUMBER>    DOT Analyst:  Linda
L. Lundell<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted, subject to conditions (See below).

The action above was effective when taken:   February 5, 2004, through
February 5, 2006    .

Action taken by:   Paul L. Gretch, Director

		        Office of International Aviation

XX  Authority granted is consistent with the aviation agreement between
the United States and Mexico.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:

XX  Holder’s certificates of public convenience and necessity

XX  Standard Exemption Conditions (attached)

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

Special Conditions:  The U.S.-Mexico exemption authority granted is
subject to the dormancy notice requirements set forth in condition 7 of
Appendix A of Order 88-10-2.  Consistent with our policy, the dormancy
notice period will begin June 1, 2004, Mesa’s proposed startup date
for these services.

________________________________________________________________________
_____________________________

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

- see next page -

													2

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the application was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
 To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov/reports_aviation.asp

						APPENDIX

U.S. Carrier Standard Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security.  To assure compliance with all applicable U.S.
Government requirements concerning security, the holder shall, before
commencing any new service (including charter flights) to or from a
foreign airport, contact its Principal Security Inspector (PSI) to
advise the PSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

											8/2003

   Mesa states that, as part of this service, it will place the “HP”
code of America West on Mesa’s flights in the subject market.  Under
the U.S.-Mexico aviation agreement, up to two U.S. carriers may be
designated to operate direct-carrier service (own-aircraft flights), and
up to four U.S. carriers may be authorized to provide code-share
services in a given city-pair market.  At the time this application was
filed, Alaska Airlines, Inc., held one of the designations to serve the
Los Angeles-Puerto Vallarta route, and the second designation was
available.  However, four carriers already held the Los Angeles-Puerto
Vallarta code-share authorizations (Continental Airlines, Inc.; Delta
Air Lines, Inc.; Northwest Airlines, Inc.; and Hawaiian Airlines, Inc.
(Hawaiian)).  Thus, there were no code-share authorizations available
for the Mesa/America West code-share proposal here.  Subsequently,
Hawaiian filed a dormancy notice for the Los Angeles-Puerto Vallarta
market, and we withdrew Hawaiian’s code-share authorization.  As a
result, both the requisite designation and code-share authorizations
were available to allow us to proceed with the instant application.


[Federal Register: July 10, 2008 (Volume 73, Number 133)]
[Notices]
[Page 39688-39689]
[DOCID:fr10jy08-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

July 2, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP96-320-092.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company LP submits two capacity
release agreements containing negotiated rate provisions executed with
Q-West Energy Company.
    Filed Date: 06/27/2008.
    Accession Number: 20080630-0020.
    Comment Date: 5:00 p.m. Eastern Time on Wednesday, July 09, 2008.

    Docket Numbers: RP99-176-163.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America LLC submits an
Amendment to the Firm Transportation and Storage Negotiated Rate
Agreement etc.
    Filed Date: 06/27/2008.
    Accession Number: 20080630-0019.
    Comment Date: 5:00 p.m. Eastern Time on Wednesday, July 09, 2008.

    Docket Numbers: RP01-382-018.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas submits for filing its annual
report setting forth the Carlton Resolution buyout and surcharge
dollars reimbursed to the Carlton Sourcers.
    Filed Date: 06/26/2008.
    Accession Number: 20080626-5030.
    Comment Date: 5:00 p.m. Eastern Time on Tuesday, July 08, 2008.

    Docket Numbers: RP03-36-032.
    Applicants: Dauphin Island Gathering Partners.
    Description: Dauphin Island Gathering Partners submits Thirty-
Seventh Revised Sheet 9 et al. to FERC Gas Tariff, First Revised Volume
1.
    Filed Date: 06/27/2008.
    Accession Number: 20080630-0018.
    Comment Date: 5:00 p.m. Eastern Time on Wednesday, July 09, 2008.

    Docket Numbers: RP06-200-044.
    Applicants: Rockies Express Pipeline LLC.
    Description: Rockies Express Pipeline, LLC submits Third Revised
Sheet 9H et al. to FERC Gas Tariff, Second Revised Volume 1, to be
effective 7/1/08.
    Filed Date: 06/26/2008.
    Accession Number: 20080627-0007.
    Comment Date: 5:00 p.m. Eastern Time on Tuesday, July 08, 2008.

    Docket Numbers: RP96-272-077.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas Co submits Eighth Revised Sheet
66B.01 et al. to FERC Gas Tariff, Fifth Revised Volume 1, to become
effective 7/1/08.
    Filed Date: 06/30/2008.
    Accession Number: 20080701-0102.
    Comment Date: 5:00 p.m. Eastern Time on Monday, July 14, 2008.

    Docket Numbers: RP00-426-037.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits Original Sheet 55D
et al. to FERC Gas Tariff, Second Revised Volume 1.
    Filed Date: 06/30/2008.
    Accession Number: 20080701-0103.
    Comment Date: 5:00 p.m. Eastern Time on Monday, July 14, 2008.

    Docket Numbers: RP00-632-029.
    Applicants: Dominion Transmission, Inc.
    Description: Dominion Transmission, Inc. files its Informational
Annual Fuel Report.
    Filed Date: 06/30/2008.
    Accession Number: 20080630-5051.
    Comment Date: 5:00 p.m. Eastern Time on Monday, July 14, 2008.

    Docket Numbers: RP08-423-000.
    Applicants: Viking Gas Transmission Company.
    Description: Viking Gas Transmission Co submits Third Revised Sheet
12A to FERC Gas Tariff, First Revised Volume 1, to be effective 7/1/08.
    Filed Date: 06/26/2008.
    Accession Number: 20080627-0122.
    Comment Date: 5:00 p.m. Eastern Time on Tuesday, July 08, 2008.

    Docket Numbers: RP08-424-000.
    Applicants: Tres Palacios Gas Storage LLC.
    Description: Tres Palacios Gas Storage, LLC submits Original Sheet
0 et al. to FERC Gas Tariff Original Volume 1, Volume 1; Part 2 of 3.
    Filed Date: 06/27/2008.
    Accession Number: 20080630-0022.
    Comment Date: 5:00 p.m. Eastern Time on Wednesday, July 09, 2008.

    Docket Numbers: RP08-426-000.
    Applicants: El Paso Natural Gas Company.

    Description: El Paso Natural Gas Company submits tariff sheets that
propose a system-wide increase in rates and several incremental
refinements to EPNG's existing service and penalty structure etc.,
effective 1/1/09.
    Filed Date: 06/30/2008.
    Accession Number: 20080701-0153.
    Comment Date: 5:00 p.m. Eastern Time on Tuesday, July 15, 2008.

    Docket Numbers: RP08-427-000.
    Applicants: Questar Overthrust Pipeline Company.
    Description: Questar Overhurst Pipeline Company submits Second
Revised Sheet 83 to its FERC Gas Tariff, Second Revised Volume 1-A.
    Filed Date: 06/30/2008.
    Accession Number: 20080701-0101.
    Comment Date: 5:00 p.m. Eastern Time on Monday, July 14, 2008.

    Docket Numbers: RP08-428-000.
    Applicants: National Fuel Gas Supply Corporation.
    Description: National Fuel Gas Supply submits the 116th Revised
Sheet 9 to its FERC Gas Tariff, Fourth Revised Volume 1, to become
effective 7/1/08.
    Filed Date: 06/30/2008.
    Accession Number: 20080701-0100.
    Comment Date: 5:00 p.m. Eastern Time on Monday, July 14, 2008.

    Docket Numbers: RP08-429-000.
    Applicants: Trunkline LNG Company, LLC.
    Description: Trunkline LNG Company, LLC submits Fourteenth Revised
Sheet 5 to FERC Gas Tariff, Second Revised Volume 1-A, to become
effective 8/1/08.
    Filed Date: 06/30/2008.
    Accession Number: 20080701-0099.
    Comment Date: 5:00 p.m. Eastern Time on Monday, July 14, 2008.

    Docket Numbers: RP08-430-000.
    Applicants: Trunkline LNG Company, LLC.
    Description: Trunkline LNG Company submits FERC Gas Tariff Second
Revised Volume 1-A, to become effective 8/1/08.
    Filed Date: 06/30/2008.
    Accession Number: 20080701-0098.
    Comment Date: 5:00 p.m. Eastern Time on Monday, July 14, 2008.

    Docket Numbers: RP08-431-000.
    Applicants: Cheyenne Plains Gas Pipeline Company LLC.
    Description: Cheyenne Plains Gas Pipeline Company, LLC submits
First Revised Sheet 241 et al., to become effective 8/7/08.
    Filed Date: 06/30/2008.
    Accession Number: 20080701-0097.
    Comment Date: 5:00 p.m. Eastern Time on Monday, July 14, 2008.

    Docket Numbers: RP08-435-000.
    Applicants: Dominion Transmission, Inc.
    Description: Report of Annual Overrun/Penalty Revenue Distribution
of Dominion Transmission, Inc.
    Filed Date: 07/01/2008.
    Accession Number: 20080701-5126.
    Comment Date: 5:00 p.m. Eastern Time on Monday, July 14, 2008.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5:00 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    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 should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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 email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E8-15609 Filed 7-9-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: March 4, 2010 (Volume 75, Number 42)]
[Notices]
[Page 9959-9960]
[DOCID:fr04mr10-113]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-29161]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

February 26, 2010.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
February, 2010. A copy of each application may be obtained via the
Commission's Web site by searching for the file number, or an applicant
using the Company name box, at http://www.sec.gov/search/search.htm or
by calling<PHONE_NUMBER>. An order granting each application will be
issued unless the SEC orders a hearing. Interested persons may request
a hearing on any application by writing to the SEC's Secretary at the
address below and serving the relevant applicant with a copy of the
request, personally or by mail. Hearing requests should be received by
the SEC by 5:30 p.m. on March 23, 2010, and should be accompanied by
proof of service on the applicant, in the form of an affidavit or, for
lawyers, a certificate of service. Hearing requests should state the
nature of the writer's interest, the reason for the request, and the
issues contested. Persons who wish to be notified of a hearing may
request notification by writing to the Secretary, U.S. Securities and
Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

FOR FURTHER INFORMATION CONTACT: Diane L. Titus at<PHONE_NUMBER>, SEC,
Division of Investment Management, Office of Investment Company
Regulation, 100 F Street, NE., Washington, DC 20549-4041.

Oppenheimer Baring Japan Fund [File No. 811-21954]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On August 8, 2009, applicant transferred its
assets to Oppenheimer International Growth Fund, based on net asset
value. Expenses of $33,608 incurred in connection with the
reorganization were paid by applicant.
    Filing Date: The application was filed on February 2, 2010.
    Applicant's Address: 6803 S. Tucson Way, Centennial, CO 80112.

Samarnan Investment Corporation [File No. 811-2824]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On December
2, 2009, applicant made a final liquidating distribution to its
shareholders, based on net asset value. Expenses of $93,115 incurred in
connection with the liquidation were paid by applicant. Applicant has
retained $37,700 in cash to pay certain outstanding expenses.
    Filing Date: The application was filed on February 1, 2010.
    Applicant's Address: 214 North Ridgeway Dr., Cleburne, TX 76033.

North Track Funds, Inc. [File No. 811-4401]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On July 31, 2009, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses of $74,209 incurred in connection with the liquidation were
paid by applicant and Ziegler Capital Management, LLC, applicant's
investment adviser.
    Filing Date: The application was filed on February 5, 2010.
    Applicant's Address: 200 South Wacker Dr., Suite 2000, Chicago, IL
60606.

Cohen & Steers European Realty Shares, Inc. [File No. 811-22010]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On September 18, 2009, applicant transferred
its assets to Cohen & Steers International Realty Fund, Inc., based on
net asset value.

Expenses of $107,423 incurred in connection with the reorganization
were paid by Cohen & Steers Capital Management, Inc., applicant's
investment adviser.
    Filing Date: The application was filed on January 22, 2010.
    Applicant's Address: 280 Park Ave., 10th Floor, New York, NY 10017.

Grosvenor Registered Multi-Strategy Fund NewSub, LLC [File No. 811-
22373]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Date: The application was filed on January 22, 2010.
    Applicant's Address: c/o Banc of America Investment Advisors, Inc.,
One Financial Center, Boston, MA 02111.

Dow Jones EURO STOXX 50 Premium & Dividend Income Fund Inc. [File No.
811-22089]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Date: The application was filed on January 26, 2010.
    Applicant's Address: 4 World Financial Center, 6th Floor, New York,
NY 10080.

T Funds Investment Trust [File No. 811-21655]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Dates: The application was filed on December 24, 2009, and
amended on February 19, 2010.
    Applicant's Address: 555 South Flower St., Suite 3300, Los Angeles,
CA 90071.

Fortress Registered Investment Trust [File No. 811-9751]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant has
never made a public offering of its securities and does not propose to
make a public offering or engage in business of any kind.
    Filing Dates: The application was filed on January 7, 2010, and
amended on February 23, 2010.
    Applicant's Address: 1345 Avenue of the Americas, 46th Floor, New
York, NY 10105.

W.P. Stewart & Co. Growth Fund, Inc. [File No. 811-8128]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On November 30, 2009, applicant transferred
its assets to W.P. Stewart & Co. Growth Fund, a series of Investment
Managers Series Trust, based on net asset value. Expenses of $314,876
incurred in connection with the reorganization were paid by W.P.
Stewart & Co., Inc., applicant's investment adviser, and UMB Fund
Services, Inc., the co-administrator and transfer agent for the
acquiring fund.
    Filing Dates: The application was filed on December 16, 2009, and
amended on February 8, 2010.
    Applicant's Address: c/o W.P. Stewart & Co., Inc., 527 Madison
Ave., New York, NY 10022.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-4499 Filed 3-3-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Notices]
[Page 38161]
[FR Doc No: 2018-16668]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4366-DR; Docket ID FEMA-2018-0001]

Hawaii; Amendment No. 2 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Hawaii (FEMA-4366-DR), dated May 11, 2018, and related
determinations.

DATES: The amendment was issued on July 13, 2018.

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: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Benigno Bern
Ruiz, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Willie G. Nunn as Federal
Coordinating Officer for this disaster.

(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.)

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-16668 Filed 8-2-18; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: April 29, 2010 (Volume 75, Number 82)]
[Rules and Regulations]
[Page 22519-22521]
[DOCID:fr29ap10-8]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0385; Directorate Identifier 2010-NM-068-AD;
Amendment 39-16269; AD 2010-09-04]
RIN 2120-AA64

Airworthiness Directives; Honeywell International Inc., Primus
EPIC and Primus APEX Flight Management Systems, Installed on, but not
Limited to, Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model ERJ
170 and ERJ 190 Airplanes, and Pilatus Aircraft Ltd. Model PC-12/47E
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Honeywell International Inc., Primus EPIC and Primus APEX flight
management systems (FMS), as installed on the airplanes described
above. This AD requires revising the Limitations section of the
airplane flight manual to incorporate the procedures necessary to
recover from or work around a software anomaly in the FMS. This AD
results from discovery of software anomalies which, in certain
situations, can cause the FMS to generate misleading navigational
guidance to the pilots and to the autopilot system of various airplanes
having this same system software. We are issuing this AD to provide the
flightcrew with procedures to recover from or work around these
software anomalies during flight, which could lead to an airplane
departing from its scheduled flight path, and result in possible
collision with other aircraft or terrain.

DATES: This AD is effective May 14, 2010.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of May 14, 2010.
    We must receive comments on this AD by June 14, 2010.

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 W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Honeywell
Technical Operations Center, 1944 E. Sky Harbor Circle, Phoenix,
Arizona 85034; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax 602-365-
3343; e-mail<EMAIL_ADDRESS>Internet http://
portal.honeywell.com/wps/portal/aero.

Examining the AD Docket

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

FOR FURTHER INFORMATION CONTACT: For transport airplanes: Chip Adam,
Flight Test Pilot, Flight Test Branch, ANM-160L, FAA, Los Angeles
Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood,
California 90712-4137; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    For small airplanes: Doug Rudolph, Aerospace Engineer, Small
Airplane Directorate, FAA, 901 Locust Street, Room 301, Kansas City,
Missouri 64106; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We were notified of two software anomalies discovered in the
Honeywell Primus EPIC and Primus APEX flight management systems (FMS):
The first anomaly can occur when the destination runway is changed
without an arrival or approach entered and the runway is the TO
waypoint, which causes the destination runway to become the departure
runway; the second anomaly can occur when crossing the 180 degree
meridian, which causes the FMS longitude position calculation to move
by approximately 180 degrees. These software anomalies can cause the
FMS to generate misleading navigational guidance to the pilots and to
the autopilot system of various airplanes having this same system
software. These conditions, if not corrected, could result in an
airplane departing from its scheduled flight path, which could result
in possible collision with other aircraft or terrain.

Relevant Service Information

    We reviewed the Honeywell service information letters (SILs)
specified in the following table. The SILs describe the procedures
necessary to recover from or to work around the identified software
anomalies in the FMS described above.

                                  Table--Honeywell Service Information Letters
----------------------------------------------------------------------------------------------------------------
  Honeywell service information
             letter--                     Revision--               Model--                    Dated--
----------------------------------------------------------------------------------------------------------------
D201002000007....................  Original................  PC-12/47E airplanes  February 16, 2010.
D201002000051....................  1.......................  ERJ 170 and ERJ 190  March 26, 2010.
                                                              airplanes.
D201002000052....................  Original................  ERJ 170 and ERJ 190  March 3, 2010.
                                                              airplanes.
----------------------------------------------------------------------------------------------------------------

FAA's Determination and Requirements of This AD

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of these same type
designs. This AD requires accomplishing the actions specified in the
service information described previously, except as discussed under
``Difference Between the AD and the Service Information.''

Difference Between the AD and the Service Information

    The SILs identified in the previous table do not specify revising
the AFMs of the affected airplanes to include the information in the
General Information section of the SIL; however, this AD requires
revising the applicable AFM to

include that information in order to ensure that the flightcrew has the
necessary procedures to recover from or work around the identified
anomalies during flight.

Interim Action

    We consider this AD interim action. The FMS manufacturer is
currently developing a modification that will address the unsafe
condition identified in this AD. Once this modification is developed,
approved, and available, we might consider additional rulemaking.

FAA's Justification and Determination of the Effective Date

    Certain Honeywell FMS software anomalies, in certain situations,
can cause the FMS to generate misleading navigational guidance to the
pilots and to the autopilot system of various airplanes having this
same system. This misleading navigational guidance to the pilots and to
the autopilot system causes the airplane to depart from its scheduled
flight path, which could result in possible collision with other
aircraft or terrain. We have determined that it is imperative that we
notify flightcrews of these anomalies and provide them with procedures
to recover from or work around these anomalies during flight. Because
of our requirement to promote safe flight of civil aircraft and thus
the critical need to assure proper navigational guidance from Honeywell
FMS, coupled with the short compliance time involved with this action,
this AD must be issued immediately.
    Because an unsafe condition exists that requires the immediate
adoption of this AD, we find that notice and opportunity for prior
public comment hereon are impracticable and that good cause exists for
making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
``Docket No. FAA-2010-0385; Directorate Identifier 2010-NM-068-AD'' at
the beginning of your comments. We specifically invite comments on the
overall regulatory, economic, environmental, and energy aspects of this
AD. We will consider all comments received by the closing date and may
amend this AD because of 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 AD.

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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under 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.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
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]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2010-09-04 Honeywell International Inc.: Amendment 39-16269. Docket
No. FAA-2010-0385; Directorate Identifier 2010-NM-068-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective May 14, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Honeywell International Inc., Primus EPIC
and Primus APEX flight management systems (FMS), having the FMS part
numbers (P/N) listed in Table 1 of this AD, installed on, but not
limited to, Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model
ERJ 170 and ERJ 190 airplanes, and Pilatus Aircraft Ltd. Model PC-
12/47E airplanes, certificated in any category.

                          Table 1--Part Numbers
------------------------------------------------------------------------
          FMS Part Number                           Model
------------------------------------------------------------------------
Primus EPIC FMS P/N PS7027709-00127  ERJ 170 airplanes.
 (Load 23.1), and PS7027709-00129
 (Load 23.2), both with NZ7.1
 VAR12ZS FMS software.
Primus EPIC FMS P/N PS7027709-00214  ERJ 190 airplanes.
 (Load 23.1), and PS7027709-00217
 (Load 23.2), both with NZ7.1
 VAR12ZS FMS software.
Primus APEX FMS P/N EB7037248-       PC-12/47E airplanes.
 00103, with NZ7.1 VAR12 FMS
 software.
------------------------------------------------------------------------

Subject

    (d) Air Transport Association (ATA) of America Code 34:
Navigation.

Unsafe Condition

    (e) This AD results from discovery of software anomalies which,
in certain situations, can cause the FMS to generate misleading
navigational guidance to the pilots and to the autopilot system of
various airplanes having this same system software. The Federal
Aviation Administration is issuing this AD to provide the flightcrew
with procedures to recover from or work around these software
anomalies during flight, which could lead to an airplane departing
from its scheduled flight path, and result in possible collision
with other aircraft or terrain.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Revise the Airplane Flight Manual (AFM)

    (g) Within 14 days after the effective date of this AD, revise
the Limitations section of the applicable AFM to include the
information in the applicable service information letter (SIL)
specified in Table 2 of this AD.

                                          Table 2--Service Information
----------------------------------------------------------------------------------------------------------------
  Honeywell Service Information
             Letter--                     Revision--               Model--                    Dated--
----------------------------------------------------------------------------------------------------------------
D201002000007....................  Original................  PC-12/47E airplanes  February 16, 2010.
D201002000051....................  1.......................  ERJ 170 and ERJ 190  March 26, 2010.
                                                              airplanes.
D201002000052....................  Original................  ERJ 170 and ERJ 190  March 3, 2010.
                                                              airplanes.
----------------------------------------------------------------------------------------------------------------

    Note 1: The actions required by paragraph (g) of this AD may be
done by inserting a copy of the applicable SIL specified in Table 2
of this AD into the applicable AFM. When the applicable SIL has been
included in the general revisions of the applicable AFM, the general
revisions may be inserted into the AFM, provided the relevant
information in the general revision is identical to that in the SIL.

Alternative Methods of Compliance (AMOCs)

    (h) The manager of the office having certificate responsibility
for the affected airplanes has the authority to approve AMOCs for
this AD, if requested using the procedures found in 14 CFR 39.19.
Before using any approved AMOC on any aircraft 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.
    (1) For transport airplanes: Send information to ATTN: Chip
Adam, Flight Test Pilot, Flight Test Branch, ANM-160L, FAA, Los
Angeles Aircraft Certification Office, 3960 Paramount Boulevard,
Lakewood, California 90712-4137; telephone<PHONE_NUMBER>; fax (562)
627-5210.
    (2) For small airplanes: Send information to ATTN: Doug Rudolph,
Aerospace Engineer, Small Airplane Directorate, FAA, 901 Locust
Street, Room 301, Kansas City, Missouri 64106; telephone (816) 329-
4059; fax<PHONE_NUMBER>.

Material Incorporated by Reference

    (i) You must use the applicable service information contained in
Table 3 of this AD to do the actions required by this AD, unless the
AD specifies otherwise.

                                   Table 3--Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
                Document                              Revision                              Date
----------------------------------------------------------------------------------------------------------------
Honeywell Service Information Letter      Original.......................  February 16, 2010.
 D201002000007.
Honeywell Service Information Letter      1..............................  March 26, 2010.
 D201002000051.
Honeywell Service Information Letter      Original.......................  March 3, 2010.
 D201002000052.
----------------------------------------------------------------------------------------------------------------

     (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Honeywell Technical Operations Center, 1944 E. Sky Harbor Circle,
Phoenix, Arizona 85034; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
602-365-3343; e-mail<EMAIL_ADDRESS>Internet http://
portal.honeywell.com/wps/portal/aero.
    (3) You may review copies of the 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>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington on April 8, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-9090 Filed 4-28-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Proposed Rules]
[Pages 78744-78749]
[FR Doc No: 2014-30528]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

[Docket No. FDA-2014-N-1484]

Revisions to Exceptions Applicable to Certain Human Cells,
Tissues, and Cellular and Tissue-Based Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing
this proposed rule to amend certain regulations regarding donor
eligibility, including the screening and testing of donors of
particular human cells, tissues, and cellular and tissue-based products
(HCT/Ps), and related labeling. FDA is proposing this action in
response to our enhanced understanding in this area and in response to
comments from stakeholders regarding the importance of embryos to
individuals and couples seeking access to donated embryos.

DATES: Submit either electronic or written comments on the proposed
rule by March 31, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No.
FDA-2014-N-1484 for this rulemaking. All comments received may be
posted without change to http://www.regulations.gov, including any
personal information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Melissa Segal, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

    FDA is issuing this proposed rule to amend certain regulations
regarding donor eligibility, including the screening and testing of
donors of particular HCT/Ps, and related labeling. We are proposing
these changes in response to our enhanced understanding in this area
and in response to comments from stakeholders regarding the importance
of embryos to individuals and couples seeking access to donated
embryos.
    FDA is proposing this rulemaking under the authority of section 361
of the Public Health Service Act (PHS Act) (42 U.S.C. 264). Under
section 361 of the PHS Act, FDA may issue and enforce regulations
necessary to prevent the introduction, transmission, or spread of
communicable disease between the States or from foreign countries into
the States.

Summary of the Major Provisions of the Regulatory Action

    FDA is proposing to amend existing regulations to provide
additional flexibility to HCT/P establishments to make available for
reproductive use embryos originally intended for reproductive use for a
specific individual or couple when those embryos are subsequently
intended for directed or anonymous donation. Specifically, this
proposed rulemaking would redesignate the current Title 21 of the Code
of Federal Regulations (CFR) 1271.90(b) (Sec.  1271.90(b)) to new Sec.
1271.90(c), and would insert a new Sec.  1271.90(b) entitled
``Exceptions for Reproductive Use'' to clarify that if an embryo was
originally intended for reproductive use for a specific individual or
couple, its use for directed or anonymous donation, would not be
prohibited under Sec.  1271.45(c), even when the applicable donor
eligibility requirements under part 1271, subpart C, are not met. FDA
also clarifies that we are not creating an exception for deficiencies
that occurred in making the donor eligibility determination for either
the oocyte donor or the semen donor as required under Sec.  1271.45(b),
or for deficiencies in performing donor screening or testing, as
required under Sec. Sec.  1271.75, 1271.80, and 1271.85.
    The proposed rule also would require appropriate labeling for
embryos that would describe the donor eligibility status of the
individual donors whose gametes were used to form the embryo. The
content of the labeling is not different from that required under
current regulations. Consistent with current regulations, the intent of
the proposed labeling is to help ensure that physicians have specific
and accurate information to provide to recipients for use in making
informed medical decisions.

Costs and Benefits

    The proposed rule would ensure that any related costs and burdens
are kept to a minimum.

I. Background

    Under the authority of section 361 of the PHS Act, by delegation
from the Surgeon General and the Secretary of Health and Human
Services, FDA may make and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases.
Communicable diseases include, but are not limited to, those
transmitted by viruses, bacteria, fungi, parasites, and transmissible
spongiform encephalopathy agents. Certain diseases are transmissible
through implantation, transplantation, infusion, or transfer of HCT/Ps
derived from donors infected with those diseases. To prevent the
introduction, transmission, or spread of such communicable diseases, we
consider it necessary to require establishments to take appropriate
measures to prevent the use of cells or tissues from infected donors.
FDA regulates HCT/Ps intended for implantation, transplantation,
infusion, or transfer into a human recipient under part 1271 that was
issued under the authority of section 361 of the PHS Act. Part 1271
requires HCT/P establishments to screen and test donors for relevant
communicable disease agents and diseases, to prepare and follow written
standard operating procedures for the prevention of the spread of
communicable diseases, and to maintain records. Part 1271 also requires
that for most HCT/Ps, the cell or tissue donor must be determined to be
eligible, based on the results of screening and testing for relevant
communicable disease agents and diseases. In most cases, a donor who
tests reactive for a particular communicable disease, or who possesses
clinical evidence of, or risk factors for, communicable disease agents
and diseases, would be considered ineligible, and cells or tissues from
that donor would not ordinarily be used.
    FDA has published three final rules that make up part 1271. In the
Federal Register of January 19, 2001 (66 FR 5447), FDA published
regulations requiring HCT/P establishments to register and list their
HCT/Ps with FDA (registration final rule). In the Federal Register of
May 25, 2004 (69 FR 29786), we published regulations requiring most
cell and tissue donors to be tested and screened for relevant
communicable disease agents and diseases (donor eligibility final
rule). In the Federal Register of November 24, 2004 (69 FR 68612), we
published regulations requiring HCT/P establishments to follow current
good tissue practice (CGTP), which governs the methods used in, and the
facilities and controls used for, the manufacture of HCT/Ps,
recordkeeping, and the establishment of a quality program (CGTP final
rule). These regulations apply to HCT/Ps recovered on or after May 25,
2005.
    As part of our ongoing effort to implement our framework for
regulating HCT/Ps, in the Federal Register of May 25, 2005 (70 FR
29949), we issued an interim final rule entitled ``Human Cells,
Tissues, and Cellular and Tissue-Based Products; Donor Screening and

Testing, and Related Labeling'' (2005 interim final rule), which had an
effective date simultaneous with publication. This interim final rule
was then adopted without change in the Federal Register of June 19,
2007, in the final rule entitled ``Human Cells, Tissues, and Cellular
and Tissue-Based Products; Donor Screening and Testing, and Related
Labeling'' (72 FR 33667) (2007 final rule). The 2007 final rule amended
regulations regarding the screening and testing of donors of HCT/Ps,
timing of specimen collection, record retention requirements, and
related labeling requirements in response to public comments concerning
the importance of cryopreserved embryos to individuals seeking access
to donated embryos. The 2007 final rule also added an exception to the
donor eligibility requirements in Sec.  1271.90(a)(4) for cryopreserved
embryos that, while originally exempt from the donor eligibility
requirements because the donors were sexually intimate partners, are
later intended for directed or anonymous donation.
    In recent years, industry and the medical community have raised
concerns that the current regulations restrict the use of embryos that
were intended for personal reproductive use and therefore impose
limitations on individuals and couples involved in family building. In
response to these concerns, we are proposing this rulemaking to clarify
and further develop the current exceptions to the donor eligibility
requirements. If finalized, the proposed rule will provide HCT/P
establishments with the flexibility to make available any embryos
originally formed for reproductive use for a specific individual or
couple and now intended for reproductive use, provided that specific
criteria are met, including requirements for labeling.

II. Description of the Proposed Rule

    The proposed rule is intended to allow the use of all embryos for
reproductive use by expanding the current exceptions to the prohibition
on use under Sec.  1271.90. This proposal is in response to our
enhanced understanding in this area and to increase the options for
individuals and couples seeking access to these HCT/Ps.

A. Current Exceptions to Prohibition on Use

    As set forth in the donor eligibility final rule, an HCT/P must not
be implanted, transplanted, infused, or transferred until the donor has
been determined to be eligible (Sec.  1271.45(c)) based on the results
of donor screening (Sec.  1271.75) and testing (Sec. Sec.  1271.80 and
1271.85) for relevant communicable disease agents and diseases. These
donor eligibility requirements apply to all donors of HCT/Ps, including
donors of reproductive cells or tissues. In the case of an embryo or of
cells derived from an embryo, a donor eligibility determination is
required for both the oocyte donor and the semen donor (Sec.
1271.45(b)).
    Section 1271.90(a) contains exceptions from the requirement of
determining donor eligibility for the following HCT/Ps: (1) Cells and
tissues for autologous use; (2) reproductive cells or tissue donated by
a sexually intimate partner of the recipient for reproductive use; (3)
cryopreserved cells or tissues for reproductive use that are for
autologous use or donated by a sexually intimate partner and are
subsequently intended for directed donation; and (4) a cryopreserved
embryo that is formed from gametes of sexually intimate partners and is
subsequently intended for directed or anonymous donation.
    The 2007 final rule added the Sec.  1271.90(a)(4) exception to
allow for directed or anonymous donation of cryopreserved embryos
originally intended for use by a sexually intimate partner, without the
need for a donor eligibility determination. This exception addresses
the situation where sexually intimate partners who were not screened
and tested at the time of cryopreservation of their embryos later wish
to make a directed or anonymous donation of their cryopreserved
embryos. As explained in the preamble to the 2005 interim final rule,
we recognize that because the embryos were intended for use in a
sexually intimate relationship, the donors would not have been required
to be screened and tested for communicable disease agents and diseases
at the time that the oocytes and semen were recovered. While the 2005
interim final rule recommended that appropriate measures be taken to
screen and test the semen and oocyte donors before transfer of the
embryo to a recipient, the rule also specifically stated that ``[I]f
screening and testing of the semen and oocyte donors are not performed,
this rule would not prohibit the transfer of the embryo into a
recipient'' (70 FR 29949 at 29951).
    The Agency provided additional guidance on this point in the
guidance entitled, ``Guidance for Industry: Eligibility Determination
for Donors of Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps)'' dated August 2007. The guidance states that, as in
other cases involving directed donations of reproductive tissue, the
regulatory language in Sec.  1271.90(a)(4) allows for the use of
embryos from a directed, ineligible donor. In the guidance, FDA also
clarified that we intend to apply this policy to a sexually intimate
couple's cryopreserved embryos where one of the gametes is from a
qualified (i.e., eligible) third party gamete donor, and the other
gamete is from the sexually intimate partner of the intended recipient.
As specifically stated in the guidance in section VIII.A, ``. . .
although FDA requires appropriate screening and testing when possible,
if appropriate screening and testing are not possible (e.g., because
one of the donors is unavailable), you may still transfer the embryo
into a recipient.'' In this proposed rulemaking, our intent is to
expand this exception beyond the current exception in Sec.  1271.90(a)
for reproductive cells or tissue donated by a sexually intimate partner
of the recipient for reproductive use. Under this proposed rule, an
embryo, originally intended for reproductive use for a specific
individual or couple, may be subsequently used for directed or
anonymous donation even when the applicable donor eligibility
requirements under part 1271, subpart C are not met. As stated in the
new Sec.  1271.90(b), nothing in this paragraph creates an exception
for deficiencies that occurred in making the donor eligibility
determination for either the oocyte donor or the semen donor as
required under Sec.  1271.45(b), or for deficiencies in performing
donor screening or testing, as required under Sec. Sec.  1271.75,
1271.80, and 1271.85.

B. Continued Obligations Under HCT/P Regulations

    As discussed previously, this proposed rule would clarify and
further develop the current exceptions to the prohibition on use and
provide greater accommodation to individuals and couples wanting access
to embryos intended for reproductive use, while continuing to emphasize
the applicability of the donor eligibility screening and testing
requirements for individual gamete donors. FDA reminds industry of its
continued obligations under part 1271, subpart C to determine donor
eligibility based on the results of donor screening (Sec.  1271.75) and
testing (Sec. Sec.  1271.80 and 1271.85). Establishments must also
continue to comply with part 1271 requirements applicable to
reproductive HCT/Ps to prevent the introduction, transmission, or
spread of communicable disease.

C. Labeling Requirements

    This proposed rule describes the continued applicability of
labeling requirements for embryos intended for reproductive use that
would be excepted from the prohibition on use. This proposed rule would
require prominent labeling that describes the donor eligibility status
of the individual donors whose gametes were used to form the embryo.
The required labeling would provide information to the treating
physician to permit discussion of the potential risks of communicable
diseases with the recipient. We expect that a recipient would be fully
informed of the risks involved in using an embryo for reproductive
purposes as described under proposed Sec.  1271.90(b) even when the
donor eligibility requirements under part 1271, subpart C are not met.
    Specifically, under proposed Sec.  1271.90(c)(2) through (c)(6), an
embryo originally intended for reproductive use for a specific
individual or couple that is subsequently intended for directed or
anonymous donation must be prominently labeled with the following
statements as they are applicable:
     ``NOT EVALUATED FOR INFECTIOUS SUBSTANCES'';
     ``WARNING: Advise recipient of communicable disease
risk'';
     the BIOHAZARD legend shown in Sec.  1271.3(h);
     ``WARNING: Reactive test results for (name of disease
agent or disease)'';
     ``Advise recipient that screening and testing of the
donor(s) were not performed at the time of recovery or cryopreservation
of the reproductive cells or tissue, but have been performed
subsequently.''
    The proposed labeling requirements are based on the expectation
that a physician will be closely involved in the decision to use an
embryo and the recognition that physicians are under legal and ethical
obligations that require them to discuss the risks of communicable
disease transmission stemming from the use of HCT/Ps. FDA relies on
physicians to meet these obligations when discussing procedures
involving HCT/Ps with recipients. FDA expects that HCT/P establishments
will take appropriate measures to screen and test the semen and oocyte
donor(s) before making available for reproductive use the embryo
excepted under proposed Sec.  1271.90(b). For this reason, proposed
Sec.  1271.90(b) also specifically states that ``[N]othing in this
paragraph creates an exception for deficiencies that occurred in making
the donor eligibility determination for either the oocyte donor or the
semen donor as required under Sec.  1271.45(b), or for deficiencies in
performing donor screening or testing, as required under Sec. Sec.
1271.75, 1271.80, and 1271.85.''

III. Proposed Revisions to FDA Regulations

    We are proposing revisions to the following FDA regulations:

A. Proposed Amendments to Sec.  1271.90

    Section 1271.90 sets forth exceptions where HCT/P establishments
are not required to make a donor eligibility determination under Sec.
1271.50 or to perform donor screening or testing under Sec. Sec.
1271.75, 1271.80, and 1271.85. We are proposing to add language to the
exceptions listed in this section to provide clarity and update the
regulation by allowing for an embryo originally intended for
reproductive use for a specific individual or couple, to be
subsequently used for directed or anonymous donation, even when the
donor eligibility requirements under part 1271, subpart C are not met.
    We are proposing to amend Sec.  1271.90 as follows:
     Changing the heading of this section by deleting ``from
the requirement of determining donor eligibility,'' and inserting
``other'' before ``exceptions.'' If this change is finalized, the
heading for Sec.  1271.90 would read ``Are there other exceptions and
what labeling requirements apply?'' We made this change for clarity;
the new heading would be more accurate.
     Changing Sec.  1271.90(a)(3) by replacing ``exempt'' with
``excepted,'' which is the term used in the introductory title for this
provision. Thus, this change would make the language more consistent.
If this change is finalized, the beginning of Sec.  1271.90(a)(3) would
read, ``Cryopreserved cells or tissues for reproductive use, other than
embryos, originally excepted. . . .''
     Changing current Sec.  1271.90(a)(4) by replacing
``exempt'' with ``excepted,'' and by adding ``(a)(1) and'' before
``(a)(2)'' to clarify that as proposed, Sec.  1271.90(a)(4) would refer
to a cryopreserved embryo formed for autologous use and the
reproductive cells or tissue were donated by a sexually intimate
partner of the recipient for reproductive use. If this change is
finalized, Sec.  1271.90(a)(4) would read, ``A cryopreserved embryo,
originally excepted under paragraphs (a)(1) and (a)(2). . . .''
     Redesignating current Sec.  1271.90(b) as Sec.  1271.90(c)
and adding a new paragraph (b) to Sec.  1271.90.
     Changing newly designated Sec.  1271.90(c) by adding ``and
(b)'' after ``(a)'' in the introductory text, revising Sec.
1271.90(c)(2) to replace ``(b)(6)'' with ``(c)(6)'', and by adding
``recovery or'' before ``cryopreservation'' in new Sec.  1271.90(c)(6)
to clarify that some testing and screening activities may take place
before recovery, not just before cryopreservation.

B. Proposed Sec.  1271.90(b)

    We are proposing to redesignate the current Sec.  1271.90(b) to
Sec.  1271.90(c), and insert a new Sec.  1271.90(b) entitled
``Exceptions for Reproductive Use.'' Under proposed Sec.  1271.90(b),
an embryo originally intended for reproductive use for a specific
individual or couple that is subsequently intended for directed or
anonymous donation is excepted from the prohibition on use under Sec.
1271.45(c) even when the applicable donor eligibility requirements
under part 1271, subpart C are not met. Accordingly, when an
establishment fails to comply with applicable donor eligibility
requirements under part 1271, subpart C, the establishment would not be
prohibited from making available for reproductive use such embryos for
reproductive purposes in accordance with this section. The proposed
exception from the prohibition on use does not create an exception for
deficiencies that occurred in making the donor eligibility
determination for either the oocyte donor or the semen donor as
required under Sec.  1271.45(b), or for deficiencies in performing
donor screening or testing, as required under Sec. Sec.  1271.75,
1271.80, and 1271.85.
    We note that the language we are proposing to add to the exceptions
currently listed in Sec.  1271.90 is additive. It creates an additional
exception for the use of certain reproductive HCT/Ps that are not
currently excepted, but it does not impact or restrict the exceptions
currently provided for in the regulations.

C. Proposed Sec.  1271.90(c)

    Under proposed Sec.  1271.90(c), HCT/P establishments must
prominently label an HCT/P described in paragraphs (a) and (b) of this
section as required in paragraph (c). The labeling requirements are
intended to help ensure that physicians have specific and accurate
information to provide to recipients for use in making informed medical
decisions.
    If finalized, the nonsubstantive change to Sec.  1271.90(c)(2)
would clarify that the labeling requirements contained in Sec.
1271.90(c)(2) do not apply to reproductive cells or tissue labeled in
accordance with Sec.  1271.90(c)(6). The proposed change to Sec.
1271.90(c)(6) would include ``recovery or'' before the word
``cryopreservation''. Thus, the

proposed Sec.  1271.90(c)(6) provision requires HCT/P establishments to
prominently label an HCT/P described in Sec.  1271.90(a)(3) or (a)(4)
with ``Advise recipient that screening and testing of the donor(s) were
not performed at the time of recovery or cryopreservation of the
reproductive cells or tissue, but have been performed subsequently''
for HCT/Ps described in Sec.  1271.90(a)(3) or (a)(4). This proposed
change is made to recognize that some testing and screening activities
may take place even before recovery of HCT/Ps, not just before
cryopreservation.

D. Proposed Amendments to Sec.  1271.370

    Section 1271.370 sets forth labeling requirements in addition to
those that apply under Sec. Sec.  1271.55, 1271.60, 1271.65, and
1271.90. Because, as discussed previously, this rule is proposing to
redesignate the current labeling requirements under Sec.  1271.90(b) to
Sec.  1271.90(c), we are proposing to amend Sec.  1271.370(b)(4) to
revise the reference from Sec.  1271.90(b) to Sec.  1271.90(c).

IV. Legal Authority

    FDA is proposing this rulemaking under the authority of section 361
of the PHS Act. Under section 361 of the PHS Act, FDA may issue and
enforce regulations necessary to prevent the introduction,
transmission, or spread of communicable disease between the States or
from foreign countries into the States. It is important to recognize
that HCT/Ps recovered in one State may be sent to another for
processing, and then shipped for use throughout the United States, or
beyond. FDA has been involved in many recalls where HCT/Ps processed in
a single establishment have been distributed in many States. In any
event, intrastate transactions affecting interstate communicable
disease transmission may also be regulated under section 361 of the PHS
Act. (See Louisiana v. Mathews, 427 F. Supp. 174, 176 (E.D. La. 1977);
Independent Turtle Farmers of Louisiana, Inc. v. United States of
America, et al., 2010 U.S. Dist. LEXIS 31117). This rulemaking proposes
changes in response to our enhanced understanding of the uses of
certain types of HCT/Ps in specific situations and in response to
comments from stakeholders regarding the importance of embryos to
individuals and couples seeking access to donated embryos.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). This proposed rule is not a significant regulatory action as
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the costs associated with this rule are
expected to be minimal, we propose to certify that this rule will not
have a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in a 1-year expenditure that would meet or
exceed this amount.
    This rule proposes to amend certain regulations regarding donor
eligibility and labeling related to the screening and testing of donors
of particular HCT/Ps. The proposed rule would provide additional
flexibility to HCT/P establishments to make available for reproductive
use embryos originally intended for reproductive use for a specific
individual or couple and subsequently intended for directed or
anonymous donation. Specifically, the proposed rule would clarify that
if an embryo was originally intended for reproductive use for a
specific individual or couple, its use for directed or anonymous
donation would not be prohibited under Sec.  1271.45(c), even when the
applicable donor eligibility requirements under part 1271, subpart C
are not met. This proposed exception from prohibition for use would not
create an exception for deficiencies that occurred in making the donor
eligibility determination for either the oocyte donor or the semen
donor as required under Sec.  1271.45(b), or for deficiencies in
performing donor screening or testing, as required under Sec. Sec.
1271.75, 1271.80, and 1271.85. The proposed rule also requires
appropriate labeling that describes the donor eligibility status of the
individual donors whose gametes were used to form the embryo.
    This rule will provide greater accommodation of individuals and
couples wanting access to embryos originally intended for reproductive
use, while continuing to emphasize the applicability of the donor
eligibility screening and testing requirements for individual gamete
donors. If finalized, the proposed rule will provide HCT/P
establishments with the flexibility to make available embryos
originally intended for reproductive use, provided that specific
criteria are met. Consistent with current regulations, the proposed
labeling requirements will help ensure that physicians have specific
and accurate information to provide to recipients for use in making
informed medical decisions. Because this proposed rule would impose no
additional regulatory burdens, the costs associated with this rule are
expected to be minimal. FDA requests comment on this conclusion.

VI. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) 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.

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that have
substantial direct effects on the States, on the relationship between
the National Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
Accordingly, the Agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

VIII. The Paperwork Reduction Act of 1995

    The labeling requirements contained in this proposed rule are not
subject to review by the Office of Management and Budget (OMB) because
they do not constitute a ``collection of information''

under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). Rather, the requirement to label HCT/Ps in accordance with the
proposed rule is a ``public disclosure of information originally
supplied by the Federal government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)). Therefore, FDA
tentatively concludes that these proposed requirements in this document
are not subject to review by OMB because they do not constitute a
``collection of information'' under the PRA.

IX. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

List of Subjects in 21 CFR Part 1271

    Biologics, Drugs, Human cells and tissue-based products, Medical
devices, Reporting and recordkeeping requirements.

    Therefore, under the Public Health Service Act and under the
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 1271 be amended as follows:

PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS

0
1. The authority citation for 21 CFR part 1271 continues to read as
follows:

    Authority: 42 U.S.C. 216, 243, 263a, 264, 271.

0
2. In Sec.  1271.90:
0
a. Revise the heading;
0
b. Revise paragraphs (a)(3) and (a)(4) by removing ``exempt'' and by
adding in its place ``excepted'';
0
c. Revise paragraph (a)(4) by removing ``paragraph'' and by adding in
its place ``paragraphs ''; and by adding ``(a)(1) and'' before
``(a)(2)'';
0
d. Redesignate paragraph (b) as paragraph (c);
0
e. Add a new paragraph (b);
0
f. Revise newly designated paragraph (c) by removing ``paragraph'' and
by adding in its place ``paragraphs'' and by adding ``and (b)'' after
``(a)'' in the introductory text;
0
g. Revise newly designated paragraph (c)(2) by removing ``(b)(6)'' and
by adding in its place ``(c)(6)''; and
0
h. Revise newly designated paragraph (c)(6) by adding ``recovery or''
before ``cryopreservation''.
    The revisions read as follows:

Sec.  1271.90  Are there other exceptions and what labeling
requirements apply?

    (a) * * *
    (3) Cryopreserved cells or tissue for reproductive use, other than
embryos, originally excepted under paragraphs (a)(1) or (a)(2) of this
section at the time of donation, that are subsequently intended for
directed donation, provided that
* * * * *
    (4) A cryopreserved embryo, originally excepted under paragraphs
(a)(1) and (a)(2) of this section at the time of cryopreservation, that
is subsequently intended for directed or anonymous donation. When
possible, appropriate measures should be taken to screen and test the
semen and oocyte donors before transfer of the embryo to the recipient.
    (b) Exceptions for Reproductive Use. An embryo originally intended
for reproductive use for a specific individual or couple that is
subsequently intended for directed or anonymous donation for
reproductive use is excepted from the prohibition on use under Sec.
1271.45(c) even when the applicable donor eligibility requirements
under part 1271, subpart C are not met. Nothing in this paragraph
creates an exception for deficiencies that occurred in making the donor
eligibility determination for either the oocyte donor or the semen
donor as required under Sec.  1271.45(b), or for deficiencies in
performing donor screening or testing, as required under Sec. Sec.
1271.75, 1271.80, and 1271.85.
    (c) Required labeling. As applicable, you must prominently label an
HCT/P described in paragraphs (a) and (b) of this section as follows:
    (1) * * *
    (2) ``NOT EVALUATED FOR INFECTIOUS SUBSTANCES,'' unless you have
performed all otherwise applicable screening and testing under
Sec. Sec.  1271.75, 1271.80, and 1271.85. This paragraph does not apply
to reproductive cells or tissue labeled in accordance with paragraph
(c)(6) of this section.
* * * * *
    (6) ``Advise recipient that screening and testing of the donor(s)
were not performed at the time of recovery or cryopreservation of the
reproductive cells or tissue, but have been performed subsequently,''
for paragraphs (a)(3) or (a)(4) of this section.
* * * * *
0
3. Amend Sec.  1271.370(b)(4) by removing ``Sec.  1271.90(b)'' and by
adding in its place ``Sec.  1271.90(c)''.

    Dated: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30528 Filed 12-30-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Page 2103]
[FR Doc No: 2012-587]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66124; File No. SR-FICC-2008-01]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Designation of Longer Period for Commission Action on
Proposed Rule Change To Allow the Mortgage-Backed Securities Division
To Provide Guaranteed Settlement and Central Counterparty Services

January 10, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder \2\ on March 12, 2008, the
Fixed Income Clearing Corporation (``FICC'') filed with the Securities
and Exchange Commission (``Commission''), and on November 21, 2011,
amended a proposed rule change to allow the Mortgage-Backed Securities
Division (``MBSD'') to provide guaranteed settlement and central
counterparty services. The proposed rule change was published for
comment in the Federal Register on December 12, 2011.\3\ The Commission
received one comment letter on the proposal.\4\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 65899 (Dec. 6, 2011), 76
FR 77287 (Dec. 12, 2011) (``Notice'') and Securities Exchange Act
Release No. 65899A (Dec. 12, 2011), 76 FR 77865 (Dec. 14, 2011)
(correcting a non-substantive portion of the Notice).
    \4\ See Letter from Christopher Killian, Managing Director,
Securities Industry and Financial Markets Association, to Elizabeth
M. Murphy, Secretary, Commission, dated December 19, 2011.
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    Prior to amendments introduced by the Dodd-Frank Wall Street Reform
and Consumer Protection Act (``Dodd-Frank Act''), Section 19(b)(2) of
the Act \5\ provided that, within thirty-five days of the publication
of notice of the filing of a proposed rule change, or within such
longer period as the Commission may designate up to ninety days of such
date if it finds such longer period to be appropriate and publishes its
reasons for so finding, the Commission shall either approve the
proposed rule change or institute proceedings to determine whether the
proposed rule change should be disapproved.\6\ The thirty-fifth day
after publication of notice of this filing is Monday, January 16, 2012,
a national holiday. The last business day preceding that date is
Friday, January 13, 2012.
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    \5\ 15 U.S.C. 78s(b)(2) (2010), amended by Section 916 of Pub.
L. 111-203, 124 Stat. 1376 (2010).
    \6\ Because the original rule proposal was received by the
Commission prior to the Dodd-Frank Act amendments to Section
19(b)(2) of the Act, the operative timing and procedural
requirements for Commission action are those that applied at the
time the Commission received the original rule proposal.
---------------------------------------------------------------------------

    The proposed rule change would modify the rules of FICC's MBSD to
allow MBSD to provide guaranteed settlement and central counterparty
(``CCP'') services to the mortgage-backed securities market. As FICC
notes in the proposed rule change, the conversion of the MBSD to a CCP
would increase the amount of risk to FICC because FICC would assume
risk currently borne by bilateral counterparties in the market. The
Commission finds it appropriate to designate a longer period within
which to take action on the proposed rule change so that it has
sufficient time to consider the risk management implications of the
proposed rule change in light of, among other things, initiatives FICC
proposed to develop under the proposed rule change and any other
initiatives FICC may develop during the extended period.
    Accordingly, pursuant to Section 19(b)(2) of the Act,\7\ the
Commission designates March 9, 2012, as the date by which the
Commission should either approve or institute proceedings to determine
whether to disapprove the proposed rule change.
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    \7\ 15 U.S.C. 78s(b)(2) (2010), amended by Section 916 of Pub.
L. 111-203, 124 Stat. 1376 (2010).

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

    \8\ 17 CFR 200.30-3(a)(31).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-587 Filed 1-12-12; 8:45 am]
BILLING CODE 8011-01-P