IUR Petition for Consideration for Inclusion in the Specific Chemical Substances Partial Exemption Docket Cover Sheet The Environmental Protection Agency ( EPA) has received a petition dated December 30, 2003, from Dow Chemical, to exempt Methane, tetrachloro ( CAS No. 56 23 5, also called carbon tetrachloride), Methane, trichloro ( CAS No. 67 66 3, also called chloroform), and Methane, chloro ( CAS No. 74 87 3, also called methyl chloride) from the reporting of processing and use elements of the EPA Inventory Update Rule ( IUR), 40 C. F. R. 710. This docket contains the petition, EPA's decision document, and other support documents.

What is the Inventory Update Rule?

The TSCA Inventory Update Rule ( IUR) requires the submission of basic production data every four years on chemical substances manufactured ( including imported) for commercial purposes in amounts of 25,000 pounds or more at a single site. Out of 80,000 chemicals on the TSCA Chemical Substance Inventory, reports are required for approximately 9,000 substances. For those substances with annual volumes of 300,000 lbs or more per site, reporters also submit chemical processing and use information. To learn more about the IUR, access http:// www. epa. gov/ opptintr/ iur/.

What is the " low current interest" partial exemption?

Certain chemicals for which the IUR processing and use information is of " low current interest" are now partially exempt from reporting and manufacturers and importers of such chemicals are not required to report processing and use information for that chemical; see 40 C. F. R § 710.46( b)( 2). EPA has determined that, at this time, the IUR downstream information associated with the listed chemicals is of low current interest. EPA may amend the list of partially exempt chemicals on its own initiative or in response to a request from the public. This petition is a request from the public for a chemical to be added to the partial exemption.

In making its determination of whether this partial exemption should apply to a particular chemical substance, EPA will consider the totality of information available for the chemical substance in question, including but not limited to, one or more of the following considerations:

( A) Whether the chemical qualifies or has qualified in past IUR collections for the reporting of the information described in § 710.52( c)( 4) ( i. e., at least one site manufactures 300,000 pounds or more of the chemical).

( B) The chemical substance's chemical and physical properties or potential for persistence, bioaccumulation, health effects, or environmental effects ( considered independently or together).

( C) The information needs of EPA, other federal agencies, tribes, states, and local governments, as well as members of the public.

( D) The availability of other complementary risk screening information.

( E) The availability of comparable processing and use information.

( F) Whether the potential risks of the chemical substance are adequately managed by EPA or another agency or authority.

How will the Agency's decision be made known? Petition status will be listed on EPA's website. Access http:// www. epa. gov/ opptintr/ iur for further information concerning this petition.


[Federal Register: June 29, 2006 (Volume 71, Number 125)]
[Notices]
[Page 37063]
[DOCID:fr29jn06-39]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-393-000]

National Fuel Gas Supply Corporation; Notice of Service
Agreements

June 20, 2006.
    Take notice that on June 14, 2006, National Fuel Gas Supply
Corporation (National Fuel) tendered for filing six FT Service
Agreements between National Fuel and Beacon Landfill Gas Holdings, LLC
(Beacon); two interconnection agreements between National Fuel and
Beacon, and a Consent to Assignment and Agreement by and among National
Fuel, Beacon and JPMorgan Chase Bank, N.A. as Trustee.
    National Fuel requests that the Service Agreements, the
interconnection agreements and the Consent to Assignment and Agreement
be accepted for filing as material deviations and that the associated
tariff sheet become effective on June 26, 2006.
    National Fuel states that copies of this filing were served upon
its customers and interested state commissions.
    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 and 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 date as indicated
below. Anyone filing an intervention or protest must serve a copy of
that document on the Applicant. Anyone filing an intervention or
protest on or before the intervention or protest date need not serve
motions to intervene or protests on persons other than the Applicant.
    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 online 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 June 27, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-10154 Filed 6-27-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Notices]
[Pages 6026-6028]
[FR Doc No: 2018-02767]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-2327]

Determination of Regulatory Review Period for Purposes of Patent
Extension; GILOTRIF

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for GILOTRIF and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
13, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 13, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 13, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is 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-2014-E-2327 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; GILOTRIF.'' 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.
     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 Sec.  10.20 (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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product GILOTRIF
(afatinib dimaleate). GILOTRIF is indicated for the first-line
treatment of patients with metastatic non-small cell lung cancer whose
tumors have epidermal growth factor receptor exon 19 deletions or exon
21 substitution mutations as detected by an FDA approved test.
Subsequent to this approval, the USPTO received a patent term
restoration application for GILOTRIF (U.S. Patent No. RE43,431) from
Boehringer Ingelheim Pharma Gmbh & Co., KG, and the USPTO requested
FDA's assistance in determining this patent's eligibility for patent
term restoration. In a letter dated November 3, 2015, FDA advised the
USPTO that this human drug product had undergone a regulatory review
period and that the approval of GILOTRIF represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
GILOTRIF is 3,453 days. Of this time, 3,213 days occurred during the
testing phase of the regulatory review period, while 240 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: January 30, 2004. FDA has verified the Boehringer Ingelheim
Pharma Gmbh & Co., KG claim that January 30, 2004, is the date the
investigational new drug application (IND) became effective.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b)of the FD&C Act: November
15, 2012. FDA has verified the applicant's claim that the new drug
application (NDA) for GILOTRIF (NDA 201292) was initially submitted on
November 15, 2012.
    3. The date the application was approved: July 12, 2013. FDA has
verified the applicant's claim that NDA 201292 was approved on July 12,
2013. This determination of the regulatory review period establishes
the maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,057 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and ask for
a redetermination (see DATES). Furthermore, as specified in Sec.  60.30
(21 CFR 60.30), any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period. To meet its burden,
the petition must be timely comply with all the requirements of Sec.
60.30, including but

not limited to: Must be timely (see DATES), must be filed in accordance
with Sec.  10.20, must contain sufficient facts to merit an FDA
investigation, and must certify that a true and complete copy of the
petition has been served upon the patent applicant. (See H. Rept. 857,
part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02767 Filed 2-9-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: January 25, 2006 (Volume 71, Number 16)]
[Notices]
[Page 4127-4128]
[DOCID:fr25ja06-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

January 18, 2006.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER01-48-004.
    Applicants: Powerex Corporation.
    Description: Powerex Corp submits an errata to Exhibits A and B of
its 4/20/05 change in status filing.
    Filed Date: 01/11/2006.
    Accession Number: 20060113-0089.
    Comment Date: 5 p.m. eastern time on Wednesday, February 1, 2006.

    Docket Numbers: ER02-73-007.
    Applicants: Llano Estacado Wind, LP.
    Description: Llano Estacado Wind, LP submits revised tariffs
designated as Original Sheet Nos. 1-4, FERC Electric Tariff, First
revised Volume No. 1.
    Filed Date: 01/11/2006.
    Accession Number: 20060113-0143.
    Comment Date: 5 p.m. eastern time on Wednesday, February 1, 2006.

    Docket Numbers: ER02-580-005.
    Applicants: Pawtucket Power Associates Limited Partnership.
    Description: Pawtucket Power Associates L.P. submits an errata to
its 6/16/05 filing of FERC Electric Tariff, Second Revised Volume No.
1.
    Filed Date: 01/11/2006.
    Accession Number: 20060113-0137.
    Comment Date: 5 p.m. eastern time on Wednesday, February 1, 2006.

    Docket Numbers: ER06-15-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc and Midwest ISO submit a
compliance filing in response to FERC's 12/05/05 deficiency letter.
    Filed Date: 01/11/2006.
    Accession Number: 20060113-0144.
    Comment Date: 5 p.m. eastern time on Wednesday, February 1, 2006.

    Docket Numbers: ER06-39-001.
    Applicants: California Independent System Operator Corporation.
    Description: The California Independent System Operator Corp
submits its filing in compliance with FERC's 12/9/05 Order.
    Filed Date: 01/09/2006.
    Accession Number: 20060112-0354.
    Comment Date: 5 p.m. eastern time on Monday, January 30, 2006.

    Docket Numbers: ER06-140-001.
    Applicants: American Electric Power Service Corporation.
    Description: American Electric Power Service Corp as agent for
Indiana Michigan Power Co's response to FERC's 12/22/05 letter re Cost-
Based Formula Rate Agreement.
    Filed Date: 01/11/2006.
    Accession Number: 20060113-0141.
    Comment Date: 5 p.m. eastern time on Wednesday, February 1, 2006.

    Docket Numbers: ER06-147-000; ER06-462-000.
    Applicants: Kentucky Utilities Company.
    Description: Letter Requesting that the Commission Delay the
Effective Date of

the Notice of Cancellation Filing of Kentucky Utilities Co.
    Filed Date: 01/05/2006.
    Accession Number: 20060105-5031.
    Comment Date: 5 p.m. eastern time on Monday, January 30, 2006.

    Docket Numbers: ER06-268-001.
    Applicants: Los Esteros Critical Energy Facility LLC.
    Description: Los Esteros Critical Energy Facility, LLC submits
Attachment A--corrections to Rate Schedule No.130 of its Reliability
Must-Run Agreement with the California Independent System Operator
Corp.
    Filed Date: 01/11/2006.
    Accession Number: 20060113-0142.
    Comment Date: 5 p.m. eastern time on Wednesday, February 1, 2006.

    Docket Numbers: ER06-332-001.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc submits a page providing the
missing text from its informational filing submitted on 12/15/05.
    Filed Date: 01/10/2006.
    Accession Number: 20060117-0220.
    Comment Date: 5 p.m. eastern time on Tuesday, January 31, 2006.

    Docket Numbers: ER06-472-000.
    Applicants: LG&E Energy Marketing Inc.
    Description: LG&E Energy Marketing , Inc submits an Agreement for
Electric Service with Kenergy Corp.
    Filed Date: 01/11/2006.
    Accession Number: 20060113-0135.
    Comment Date: 5 p.m. eastern time on Wednesday, February 1, 2006.

    Docket Numbers: ER06-473-000.
    Applicants: Central Vermont Public Service Corporation.
    Description: Central Vermont Public Service Corp submits a non-
conforming point-to-point service agreement under ISO New England Inc
Tariff Schedule 20A.
    Filed Date: 01/11/2006.
    Accession Number: 20060113-0134.
    Comment Date: 5 p.m. eastern time on Wednesday, February 1, 2006.

    Docket Numbers: ER06-475-000.
    Applicants: Colorado Power Partners.
    Description: Colorado Power Partners submits revised sheets to its
market based rate tariff, FERC Electric Tariff Volume No. 1.
    Filed Date: 01/11/2006.
    Accession Number: 20060117-0213.
    Comment Date: 5 p.m. eastern time on Wednesday, February 1, 2006.

    Docket Numbers: ER06-476-000.
    Applicants: Westar Energy, Inc.
    Description: Westar Energy, Inc submits a Notice of Cancellation of
Supplement No.15, Service Schedule M under their First Revised Rate
Schedule Federal Power Commission No. 93.
    Filed Date: 01/11/2006.
    Accession Number: 20060117-0214.
    Comment Date: 5 p.m. eastern time on Wednesday, February 1, 2006.

    Docket Numbers: ER88-478-001; ER91-576-002.
    Applicants: Ocean State Power; Ocean State Power II.
    Description: Ocean State Power and Ocean State Power II report a
change in status to reflect certain departures from the facts the
Commission relied upon in granting market-based rate authority.
    Filed Date: 01/11/2006.
    Accession Number: 20060113-0138.
    Comment Date: 5 p.m. eastern time on Wednesday, February 1, 2006.

    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 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 and 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 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>.

 Magalie R. Salas,
Secretary.
[FR Doc. E6-826 Filed 1-24-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 74, Number 99 (Tuesday, May 26, 2009)]
[Notices]
[Pages 24866-24867]
[FR Doc No: E9-12174]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1829-DR; Docket ID FEMA-2008-0018]

North Dakota; Amendment No. 4 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 North Dakota (FEMA-1829-DR), dated March 24, 2009, and
related determinations.

DATES: Effective Date: May 13, 2009.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of North Dakota is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of March 24, 2009.

    The Turtle Mountain Band of Chippewa Indian Reservation for
Individual Assistance and Public Assistance.
    Ramsey County for Individual Assistance (already designated for
Public Assistance).
    Rolette and Sheridan Counties for Public Assistance.
    Billings County for Public Assistance [Categories A and C-G]
(already designated for Individual Assistance and emergency
protective measures [Category B], including direct Federal
assistance, under the Public Assistance 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.

Nancy Ward,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. E9-12174 Filed 5-22-09; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 221 (Monday, November 17, 2014)]
[Notices]
[Pages 68451-68454]
[FR Doc No: 2014-27022]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1461]

Rare Pediatric Disease Priority Review Vouchers, Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Rare Pediatric
Disease Priority Review Vouchers.'' Under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), FDA will award priority review vouchers to
sponsors of certain rare pediatric disease product applications that
meet the criteria specified in that section. These vouchers can be used
when submitting future human drug marketing applications that would not
otherwise qualify for priority review. These vouchers can be sold or
transferred for use to another sponsor any number of times before the
voucher is used, as long as the sponsor making the transfer has not yet
submitted the application. Because there exists a need for products for
rare pediatric diseases, this program is intended to encourage
development of new drug and biological products for prevention and
treatment of certain rare pediatric diseases.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 16, 2015. Submit either electronic or written
comments concerning the collection of information proposed in the draft
guidance by January 16, 2015.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communications, Division of Drug Information,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-
0002, or Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, Bldg.
71, Rm. 3128, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002;
or Office of Orphan Products Development, Office of Special Medical
Programs,

Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring,
MD 20993. Send one self-addressed adhesive label to assist the office
that will be processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Henry Startzman, Food and Drug
Administration, Office of Orphan Products Development, Bldg. 32, Rm.
5295, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
8660.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Rare Pediatric Disease Priority Review Voucher.''
    This draft guidance clarifies FDA's plans to implement section 908
of the Food and Drug Administration Safety and Innovation Act (FDASIA),
which added section 529 to the Federal Food Drug and Cosmetic Act (21
U.S.C. 360ff) (the FD&C Act). Under this statutory section, a sponsor
who receives an approval for a drug or biological product to treat or
prevent a rare pediatric disease (as defined by statute) may, if the
statute's criteria are met, qualify for a voucher which can be used to
receive a priority review for a subsequent marketing application for a
different product. The draft guidance is intended to assist developers
of rare pediatric disease products in assessing whether their product
may be eligible for rare pediatric disease designation and a rare
pediatric disease priority review voucher. It also clarifies the
process for requesting such designations and vouchers, sponsor
responsibilities upon approval of a rare pediatric disease product
application, and the parameters for using and transferring a rare
pediatric disease priority review voucher.
    The draft guidance provides FDA's interpretation of a variety of
terms in the statute. It defines ``rare pediatric disease'' as a
disease or condition with an entire prevalence of less than 200,000 in
the United States and with more than 50 percent of patients living with
the disease aged 0 through 18 years. It provides sponsors information
on how to calculate and document prevalence in their requests for
designation. It explains that, in order for an application to qualify
for a rare pediatric disease priority review voucher, it must meet
several statutory requirements, including being for a human drug that
contains no active ingredient (including any ester or salt of the
active ingredient) that has been previously approved in any other
application under section 505(b)(1), 505(b)(2), or 505(j) of the FD&C
Act (21 U.S.C. 355(b)(1), 355(b)(2), or 355(j)) or section 351(a) or
351(k) of the Public Health Service Act (42 U.S.C. 262(a) or 42 U.S.C.
262(k).
    The draft guidance also outlines for sponsors the procedures for
requesting rare pediatric disease designation and rare pediatric
disease priority review vouchers and describes the information to
include in the designation request and the voucher request.
Additionally, it describes how FDA will respond to requests for rare
pediatric disease designation and vouchers.
    Finally, the draft guidance describes the processes by which a rare
pediatric disease priority review voucher is to be awarded, used, and
transferred to another sponsor. This draft guidance is being issued
consistent with FDA's good guidance practices regulation (21 CFR
10.115). The draft guidance, when finalized, will represent the
Agency's current thinking on Rare Pediatric Disease Priority Review
Vouchers. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comment on: (1) Whether the proposed collection of information
is necessary for the proper performance of FDA's functions, including
whether the information will have practical utility; (2) the accuracy
of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection on respondents, including through the use of automated
collection techniques and other forms of information technology, when
appropriate.
    Title: Rare Pediatric Disease Priority Review Vouchers, Draft
Guidance for Industry.
    Description of Respondents: Respondents to this collection of
information are sponsors that develop drugs and biological products.
    Burden Estimate: This draft guidance on Rare Pediatric Disease
Priority Review Vouchers is intended to assist developers of rare
pediatric disease products in assessing whether their product may be
eligible for rare pediatric disease designation and a rare pediatric
disease priority review voucher.
    The draft guidance clarifies the process for requesting such
designations and vouchers, sponsor responsibilities upon approval of a
rare pediatric disease product application, and the parameters for
using and transferring a rare pediatric disease priority review
voucher.
    FDA has OMB approval under the PRA for the submission of new drug
applications (NDAs) and related submissions under 21 CFR part 314 (OMB
control number 0910-0001), biologics license applications (BLAs) and
related submissions under 21 CFR part 601 (OMB control number 0910-
0338), and orphan-drug designation requests and related submissions
under 21 CFR part 316 (OMB control number 0910-0167). The draft
guidance describes five collections of information that are not
currently approved by OMB under the PRA: (1) The request for a rare
pediatric disease designation, (2) the request for a rare pediatric
disease priority review voucher, (3) the notification of intent to use
a voucher, (4) the notification to transfer a voucher, and (5) the
post-approval report.
    These collections of information will be used by the Agency to
issue rare pediatric disease designations and vouchers, prepare for an
incoming priority review, and maintain awareness

about which sponsors currently hold vouchers.

A. Request for Rare Pediatric Disease Designation

    Under the draft guidance, a stakeholder interested in obtaining a
rare pediatric disease designation should include information about the
drug product and its proposed mechanism of action, a description of the
rare pediatric disease for which the drug is being or will be
investigated, and documentation that the disease or condition for which
the drug is proposed is a ``rare pediatric disease'' as defined in
section 529(a)(3) of the FD&C Act.
    FDA estimates that annually a total of approximately 30 respondents
will complete one rare pediatric disease designation request as
described in question 8 of the draft guidance. FDA estimates that
preparing these designation requests will take approximately 75 hours
for each designation request. This includes the time that may be needed
to respond to FDA actions and requests.

B. Request for Rare Pediatric Disease Priority Review Voucher

    As described more fully in the draft guidance, the information to
be provided in a request for a priority review voucher will depend on
whether the sponsor has previously received rare pediatric disease
designation. Sponsors who have received rare pediatric disease
designation will include the designation letter with the voucher
request explaining how the application meets all of the remaining
eligibility criteria. Sponsors who have not requested rare pediatric
disease designation should include in a voucher request prevalence
estimates as of the time of NDA/BLA submission, with supporting
documentation, and explain how the application meets all of the
remaining eligibility criteria.
    We estimate that annually a total of approximately 20 respondents
will complete one rare pediatric disease priority review voucher
request as described in response to question 14 of the draft guidance.
We estimate that preparing these designation requests will take
approximately 40 hours for each rare pediatric disease priority review
voucher request. This includes the time that may be needed to respond
to FDA actions and requests.

C. Notification of Intent To Use Voucher

    The sponsor redeeming a rare pediatric disease voucher must notify
FDA of its intent to submit an application with a priority review
voucher at least 90 days before submission of the application, and must
include the date the sponsor intends to submit the application.
    FDA estimates that annually a total of approximately 3 respondents
will complete one Notification of Intent to Use a Voucher as described
in response to question 18 of the draft guidance. We estimate that
preparing each of these Notifications of Intent to Use a Voucher will
take approximately 8 hours.

D. Transfer Notification

    Each person to whom a voucher is transferred must notify FDA of the
change of voucher ownership within 30 days after the transfer. This
notification should include a letter from the previous owner to the
current owner and a letter from the current owner to the previous
owner, each acknowledging the transfer. Any sponsor redeeming a voucher
should include these transfer letters in the application submitted to
FDA. A complete record of transfer must be made available to FDA to
redeem a transferred voucher.
    FDA estimates that annually a total of approximately 2 respondents
will complete Transfer Notifications as described in response to
question 20 of the draft guidance. We estimate that preparing each of
these Transfer Notifications will take approximately 8 hours.

E. Post-Approval Report

    The sponsor of an approved rare pediatric disease product
application must submit a report to FDA no later than 5 years after
approval that addresses the following, for each of the first four post-
approval years: (1) The estimated population in the United States with
the rare pediatric disease for which the product was approved (both the
entire population and the population aged 0 through 18 years); (2) The
estimated demand in the United States for the product; and (3) the
actual amount of product distributed in the United States.
    FDA estimates that annually a total of approximately 2 respondents
will complete post-approval reports, as described in response to
question 6 of the draft guidance. We estimate that each of these post-
approval reports will take about 20 hours to complete.
    The total estimated annual reporting burdens for the draft guidance
are as follows:

                                   Table 1--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                     Number of
      Description of burden          Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Rare pediatric disease                        30               1              30              75           2,250
 designation request............
Rare pediatric disease priority               20               1              20              40             800
 review voucher request.........
Notification of intent to use a                3               1               3               8              24
 voucher........................
Transfer notification...........               2               1               2               8              16
Post-approval report............               2               1               2              20              40
                                 -------------------------------------------------------------------------------
    Total burden hours..........  ..............  ..............  ..............  ..............           3,130
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Send comments regarding this burden estimate or suggestions for
reducing this burden to: Office of Orphan Products Development, Food
and Drug Administration, Bldg. 32, Rm. 5295, 10903 New Hampshire Ave.,
Silver Spring, MD 20993.

III. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm, or http://www.regulations.gov.

    Dated: November 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-27022 Filed 11-14-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 76 (Friday, April 19, 2013)]
[Notices]
[Pages 23631-23633]
[FR Doc No: 2013-09295]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Notice of Intent To Grant Buy America Waiver to Amtrak To Use
Three Non-Domestic Component Parts in No. 32.75 136RE Special Turnouts
Manufactured in the U.S. by voestalpine Nortrak, Inc.

AGENCY: Federal Railroad Administration (FRA), United States Department
of Transportation (DOT).

ACTION: Notice of intent to grant Buy America waiver.

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

SUMMARY: FRA is issuing this notice to advise the public that it
intends to grant the National Railroad Passenger Corporation
(``Amtrak'') a waiver to purchase four (4) No. 32.75 136RE Special
Turnouts (``Turnouts'') manufactured by voestalpine Nortrak,

Inc. (``Nortrak'') for use in the New York City to Trenton, NY, High-
Speed Rail Improvements Program (the ``High-Speed Rail Improvements
Program'' or ``Program''). The Turnouts will be manufactured by Nortrak
in the United States at its facility in Birmingham, Alabama, but will
contain two components (ZU1-60 steel switch point rail sections and
Schwihag roller assemblies and plates) that are not produced in the
U.S. The cost of the Turnouts is approximately $2 million. The foreign
material comprises approximately thirteen percent of the Turnouts' cost
or approximately $260,000. FRA intends to grant the waiver because
domestically-produced components meeting the specific needs of Amtrak
for this application (i.e., specialized high-speed turnouts) are not
produced in sufficient and reasonably available amount or are not of a
satisfactory quality.

DATES: Written comments on FRA's determination to grant Amtrak's Buy
America waiver request should be provided to FRA on or before April 22,
2013.

ADDRESSES: Please submit your comments by one of the following means,
identifying your submissions by docket number FRA-2012-0033. All
electronic submissions must be made to the U.S. Government electronic
site at http://www.regulations.gov. Commenters should follow the
instructions below for mailed and hand-delivered comments.
    (1) Web site: http://www.regulations.gov. Follow the instructions
for submitting comments on the U.S. Government electronic docket site;
    (2) Fax:<PHONE_NUMBER>;
    (3) Mail: U.S. Department of Transportation, 1200 New Jersey Avenue
SE., Docket Operations, M-30, Room W12-140, Washington, DC 20590-0001;
or
    (4) Hand Delivery: Room W12-140 on the first floor of the West
Building, 1200 New Jersey Avenue SE., Washington DC, 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Instructions: All submissions must make reference to the ``Federal
Railroad Administration'' and include docket number FRA-2012-0033. Due
to security procedures in effect since October 2001, mail received
through the U.S. Postal Service may be subject to delays. Parties
making submissions responsive to this notice should consider using an
express mail firm to ensure the prompt filing of any submissions not
filed electronically or by hand. Note that all submissions received,
including any personal information therein, will be posted without
change or alteration to http://www.regulations.gov. For more
information, you may review DOT's complete Privacy Act Statement in the
Federal Register published on April 11, 2000 (65 FR 19477), or visit
http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For questions about this notice,
please contact Ms. Linda Martin, Senior Attorney-Advisor, FRA Office of
Chief Counsel,<PHONE_NUMBER> or via email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FRA is issuing this notice to advise the
public that it intends to grant Amtrak's request for a waiver from
FRA's Buy America requirement, 49 U.S.C. 24405(a). The letter granting
Amtrak's request provides as follows:

Mr. Jeff Martin, Chief Logistics Officer, National Railroad Passenger
Corporation, 30th Street Station, Box 12, 5th Floor, SE Tower,
Philadelphia, Pennsylvania 19104.

Re: Request for Waiver of Buy America Requirement

    Dear Mr. Martin: This letter is in response to your August 8, 2012
request that the National Railroad Passenger Corporation (``Amtrak'')
be granted a waiver from the Federal Railroad Administration's
(``FRA'') Buy America provision, at 49 U.S.C. Sec.  24405(a)(1) to
purchase four (4) No. 32.75 136RE Special Turnouts (``Turnouts'')
manufactured by voestalpine Nortrak, Inc. (``Nortrak'') for use in the
New York City to Trenton, NY, High-Speed Rail Improvements Program
(``NY-NJ HSR Program''). For the reasons set forth below, FRA is
granting Amtrak's request.
    The NY-NJ HSR Program, funded through a $449,944,000 American
Recovery and Reinvestment Act grant from FRA, will upgrade and improve
the catenary, power, track and signal systems on the Northeast Corridor
primarily between New Brunswick, New Jersey and Trenton, New Jersey. It
will also improve the western approach tracks in New York Penn Station
to facilitate increased speeds and improved reliability for all users
and eventual higher levels of service. As you know, the Turnouts will
be used as part of track and structures upgrades that will progress
between New Brunswick, NJ and Trenton, NJ. Specifically, the Turnouts
will be included in the design of new high speed interlockings known as
``Delco'' and ``Adams'' to support high speed train operations by
adding high speed diverging moves not currently possible. The new
interlockings will allow New Jersey Transit (``NJT'') zone express
trains to diverge from the high speed tracks to the local tracks. The
new interlockings will allow an 80 mph (possibly higher) movement for
NJT trains and other Regional Amtrak services operating simultaneously.
    The cost of the Turnouts is approximately $2 million. The foreign
material comprises approximately thirteen percent of the Turnouts' cost
or approximately $260,000. The Turnouts will be manufactured by Nortrak
at its plant in Birmingham, Alabama, but will contain several
components (ZU1-60 steel left and right switch point rail sections and
Schwihag roller assemblies and plates) that are not produced in the
U.S.
    Section 24405(a)(1) authorizes the Secretary of Transportation
(``Secretary'') to obligate grant funds only if the steel, iron, and
manufactured goods used in the project are produced in the United
States. FRA believes a waiver is appropriate under 49 U.S.C. Sec.
24405(a)(2)(B) for the ZUI-60 steel switch point rail sections and
Schwihag roller assemblies and plates because domestically-produced
components meeting the specific needs of Amtrak for this application
(i.e., specialized high-speed turnouts) are not currently ``produced in
sufficient and reasonably available amount or are not of a satisfactory
quality.'' Amtrak also requested a waiver for the Turnout's vee point.
However, FRA determined that a waiver is not necessary with regard to
the vee point. FRA considers manufactured goods produced in the U.S. if
they are manufactured in the U.S. from components that are manufactured
in the U.S. No restrictions are placed upon the subcomponents of the
manufactured goods. See http://www.fra.dot.gov/Page/P0391 (FAQ no. 6).
Because the vee point is a subcomponent of one of the Turnout's
components (the moveable point frog), a waiver from the Buy America
requirement is not necessary.
    In order to determine whether to grant Amtrak's request, FRA
provided notice and an opportunity for comment on its public Web site.
FRA received six comments to the Web site notice. All commenters
encouraged finding domestic sources for the components. Two commenters
stated that the cost information should be considered when evaluating
the waiver request. No commenter identified a supplier for the
components. FRA also used the services of the National Institute for
Standards and Technology Manufacturing

Extension Partnership (MEP) in order to scout for domestic sources for
the components. The MEP supplier scouting revealed that the ZU1-60
steel sections from which the switch point rails are machined (by
Nortrak) appeared to be currently available from a domestic
manufacturing source. However, follow up discussions between MEP,
Amtrak, and that potential source revealed that though it was
determined that the source could roll the necessary steel it was not
currently doing so. Moreover, the source reported that it would take,
at best, six months to one year to produce the rail sections and
questioned whether the quantity needed for these types of rails (four
left and four right rails for this project) would justify the business
expense of doing so.
    MEP also found that roller assemblies and plates potentially
meeting the specific requirements of the Turnouts were available from
domestic manufacturers. However, follow up discussions with these
companies revealed that though several companies made similar items,
the current ability to produce the items to the specification required
by Amtrak did not exist without retool and retest in the No. 32.75
136RE Special Turnout needed for this project.
    Importantly, FRA is currently funding a grant to Nortrak for the
research and development of a high speed rail turnout design that is
based on U.S. specifications. The goal of the research is to yield a
``Buy America'' compliant high speed turnout. The grant runs through
June 2013 and is expected to yield as a deliverable a drawing package
suitable for bid. The next phase of the project (if funded) would be
construction and test of the turnout at FRA's Transportation Testing
Center in Pueblo, Colorado. Despite this research, the potential for a
compliant turnout that may be available in the future and the timing of
this waiver, the current availability of compliant components is at
issue.
    As you know, Amtrak is currently in the early stages of procurement
of the Turnouts, which require approximately 300 days for delivery.
Once delivered, Amtrak must assemble the Turnouts at one of its
Maintenance of Way facilities, which takes approximately one to two
months. Then, once assembled, Amtrak must deliver the Turnouts by train
to the locations where they will be installed. The tracks at Adams and
Delco are scheduled to go out of service in February 2014 in order for
the Turnouts to be installed. This outage has been planned with and
agreed to by NJT. Accordingly, in order to have enough time to assemble
the Turnouts prior to their installation in February 2014, the Turnouts
must be delivered to Amtrak no later than early January 2014. This
means that Amtrak must be able to place its order for the Turnouts not
later than the end of March 2013. For this reason, even if a U.S.
specification could be designed and steel switch point rail sections
rolled and roller assemblies and plates meeting the needs of these
specific turnouts fabricated and retested, it would happen too late to
meet the tight project deadline for the long lead time Turnouts needed
for this project.
    Pursuant to 49 U.S.C. Sec.  24405(a)(4), FRA will publish this
letter granting Amtrak's request in the Federal Register and provide
notice of such finding and an opportunity for public comment after
which this waiver will become effective. This waiver applies only to
the ZUI-60 steel switch point rail sections and Schwihag roller
assemblies and plates as manufactured into the four No. 32.75 Turnouts
installed on the NY-NJ HSR Program. As you are aware, discussions
between MEP, Amtrak, Nortrak, and other companies that have the
potential to produce these items are ongoing and future requests for a
waiver will not be granted without a specific showing that significant
good faith efforts to obtain a domestic source for the items have been
made. FRA staff will stay involved in these discussions and will assist
in whatever way needed.
    Question about this letter can be directed to, Linda Martin, Senior
Attorney-Advisor, at<EMAIL_ADDRESS>or<PHONE_NUMBER>.

Joseph C. Szabo,
Administrator.
    This Federal Register notice is issued in Washington, DC on
April 16, 2013.
Melissa Porter,
Chief Counsel, Federal Railroad Administration.
[FR Doc. 2013-09295 Filed 4-18-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 119 (Tuesday, June 21, 2011)]
[Rules and Regulations]
[Pages 35978-35979]
[FR Doc No: 2011-15352]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0481]

Drawbridge Operation Regulations; Long Island, New York Inland
Waterway From East Rockaway Inlet to Shinnecock Canal, Nassau, NY

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Long Beach Bridge at mile 4.7, across Reynolds Channel at Nassau, New
York. The deviation is necessary to facilitate public safety for a
public event. This deviation allows the bridge to remain in the closed
position for two hours.

DATES: This deviation is effective from 10 p.m. on June 25, 2011,
through 11:59 p.m. on June 26, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2011-0481 and are available online
at http:[sol][sol]www.regulations.gov, inserting USCG-2011-0481 in the
``Keyword'' and then clicking ``Search''. They are also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mr. Judy Leung-Yee, Project Officer, First Coast Guard
District<EMAIL_ADDRESS>or telephone<PHONE_NUMBER>. If
you have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Long Beach Bridge, across Reynolds
Channel at mile 4.7, at Nassau, New York, has a vertical clearance in
the closed position of 20 feet at mean high water and 24 feet at mean
low water. The drawbridge operation regulations are listed at 33 CFR
117.799(g).
    The waterway users are mostly commercial operators.
    The owner of the bridge, Nassau County Department of Public Works,
requested a temporary deviation from the regulations to facilitate
public safety during a public event, the Annual Salute to Veterans
Fireworks Display on Saturday June 25, 2011.
    Under this temporary deviation the Long Beach Bridge may remain in
the closed position between 10 p.m. and 11:59 p.m. on June 25, 2011. In
the event of inclement weather on the scheduled date the fireworks
display will occur between 10 p.m. and 11:59 p.m. on June 26, 2011.
Vessels that can pass under the bridge in the closed position may do so
at any time.
    The commercial users were notified. No objections were received.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: June 8, 2011.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2011-15352 Filed 6-20-11; 8:45 am]
BILLING CODE 9110-04-P


<EMAIL_ADDRESS> 09/18/2006 05:37 PM

To

Dave Mckee/RTP/USEPA/US@EPA

cc

Subject

Docket ID No. EPA-HQ-OAR-2005-0172

Dr Mckee:

Please consider the attached documents as ExxonMobil Comments on the Review

of the National Ambient Air Quality Standards for Ozone, Policy Assessment

of Scientific and Technical Information OAQPS Staff Paper – Second Draft,

and Ozone Health Risk Assessment for Selected Urban Areas (FR Vol. 71, No.

1371/Thursday, July 18, 2006, pages 40718 - 40720).

Two paper copies have also been sent to the EPA office.

(See attached file: ExxonMobil Comments_Coverletter_Ozone Staff Paper 8

09-18.pdf)(See attached file:

OzoneStaffPaper_2ndDraft_ExxonMobil_detailed_comments.pdf)

Regards,

Mark Nicolich

   Mark J Nicolich

   Statistician

        Epidemiology and Health Surveillance

        ExxonMobil Biomedical Sciences, Inc.

        1545 Route 22 East

        P.O. Box 971

        Annandale, NJ 08801-0971

        Tel:<PHONE_NUMBER>

        Fax:<PHONE_NUMBER>


ISC AMVAC 5 April 2006 1 AMVAC Overview EPA Human Studies Review Board.

Ian Chart Vice President Director of Regulatory Affairs Amvac Chemical Corporation ISC AMVAC 5 April 2006 2 HUMAN DATA " EPA believes that in general it can best protect public health by considering all, available, relevant,

scientifically sound information,

including information developed through research with human subjects" ISC AMVAC 5 April 2006 3 Human Testing and DDVP Database

All DDVP human studies were commissioned or completed before 1996.

They were not performed in response to FQPA.

The DDVP human database addresses the 10X default interspecies factor.

The DDVP database is so robust that it can also address the intraspecies factor. ISC AMVAC 5 April 2006 4 DDVP HUMAN DATA AND HSRB PROCESS

The amount of time made available for

Registrant s response to the EPA charge

HSRB review of all data was totally inadequate.

Some of the critical data ( more than one dozen technical documents) were made available to the HSRB only days ago.

AMVAC disagrees with EPA's position that a WOE argument is only as robust as the individual studies. ISC AMVAC 5 April 2006 5 Human Testing and DDVP Database

AMVAC has neither commissioned nor advocated clinical trials on pregnant women and children.

DDVP is unique as it has/ had pharmaceutical,

veterinary, and public health pesticidal uses.

The DDVP human database has been developed by many organizations ( WHO, CDC and FAA),

over many years, all over the world.

There are hundreds of human studies on DDVP and it unlikely that such a vast database will ever be developed for a pesticide again. ISC AMVAC 5 April 2006 6 Human Testing and DDVP Database

The DDVP human database is unique and should be treated in totality.

The human studies considered together are scientifically relevant and ethically valid.

The assessment of the " true" interspecies uncertainty factor for DDVP is dependent on the totality of the data, not on any one study.

It is inappropriate to dismiss individual studies without considering the database as a whole ISC AMVAC 5 April 2006 7 Meta Analysis Research

Meta analysis of adult only biomarker data should not be disqualified merely because some of the data in the full database are available on children and/ or pregnant women.

The " research" is the meta analysis.

It contains data only on non pregnant adults.

This research is in compliance with the rule. ISC AMVAC 5 April 2006 8 PRODUCT IN USE STUDIES

Registered consumer products have been approved by the EPA for general use, which includes approval of exposure to children and pregnant women.

It is inappropriate, scientifically, ethically and legally, to selectively exclude data from studies of exposures to these products. ISC AMVAC 5 April 2006 9 Conclusion

It is inappropriate to dismiss individual studies without considering the database as a whole

The human studies considered together are scientifically relevant and ethically valid.

The DDVP human database provides more than sufficient scientifically sound information to warrant reduction of the interspecies uncertainty factor.


[Federal Register: May 25, 2010 (Volume 75, Number 100)]
[Proposed Rules]
[Page 29264-29268]
[DOCID:fr25my10-20]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2010-0003; Internal Agency Docket No. FEMA-B-1112]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule.

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

SUMMARY: Comments are requested on the proposed Base (1% annual-chance)
Flood Elevations (BFEs) and proposed BFE modifications for the
communities listed in the table below. The purpose of this notice is to
seek general information and comment regarding the proposed regulatory
flood elevations for the reach described by the downstream and upstream
locations in the table below. The BFEs and modified BFEs are a part of
the floodplain management measures that the community is required
either to adopt or to show evidence of having in effect in order to
qualify or remain qualified for participation in the National Flood
Insurance Program (NFIP). In addition, these elevations, once
finalized, will be used by insurance agents and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents in those buildings.

DATES: Comments are to be submitted on or before August 23, 2010.

ADDRESSES: The corresponding preliminary Flood Insurance Rate Map
(FIRM) for the proposed BFEs for each community is available for
inspection at the community's map repository. The respective addresses
are listed in the table below.
    You may submit comments, identified by Docket No. FEMA-B-1112, to
Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>, or (e-mail<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Kevin C. Long, Acting Chief,
Engineering Management Branch, Mitigation Directorate, Federal
Emergency Management Agency, 500 C Street, SW., Washington, DC 20472,
(202) 646-2820, or (e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) proposes to make determinations of BFEs and modified BFEs for
each community listed below, in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR
67.4(a).
    These proposed BFEs and modified BFEs, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. These proposed elevations
are used to meet the floodplain management requirements of the NFIP and
also are used to calculate the appropriate flood insurance premium
rates for new buildings built after these elevations are made final,
and for the contents in these buildings.
    Comments on any aspect of the Flood Insurance Study and FIRM, other
than the proposed BFEs, will be considered. A letter acknowledging
receipt of any comments will not be sent.
    National Environmental Policy Act. This proposed rule is
categorically excluded from the requirements of 44 CFR part 10,
Environmental Consideration. An environmental impact assessment has not
been prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Executive Order 12866, Regulatory Planning and Review. This
proposed rule is not a significant regulatory action under the criteria
of section 3(f) of Executive Order 12866, as amended.
    Executive Order 13132, Federalism. This proposed rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This proposed rule
meets the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.

    Accordingly, 44 CFR part 67 is proposed to be amended as follows:

PART 67--[AMENDED]

    1. The authority citation for part 67 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.4  [Amended]

    2. The tables published under the authority of Sec.  67.4 are
proposed to be amended as follows:

----------------------------------------------------------------------------------------------------------------
                                                                  * Elevation in feet
                                                                (NGVD)  + Elevation in
                                                                feet (NAVD)
                                                                  Depth in feet above
         Flooding source(s)            Location of referenced       ground  [caret]        Communities affected
                                             elevation            Elevation in meters
                                                                         (MSL)
                                                              --------------------------
                                                                Effective     Modified
----------------------------------------------------------------------------------------------------------------
                                 Carter County, Kentucky, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Barrett Creek (Backwater from Little  From the confluence             None         +581  Unincorporated Areas of
 Sandy River).                         with the Little Sandy                              Carter County.
                                       River to approximately
                                       0.5 mile upstream of
                                       Eagle Drive.
Bens Run (Backwater from Tygarts      From the confluence             None         +752  Unincorporated Areas of
 Creek).                               with Tygarts Creek to                              Carter County.
                                       approximately 0.6 mile
                                       upstream of the
                                       confluence with
                                       Tygarts Creek.

Big Sinking Creek (Backwater from     From the confluence             None         +610  Unincorporated Areas of
 Little Sandy River).                  with the Little Sandy                              Carter County.
                                       River to approximately
                                       0.5 mile upstream of
                                       the confluence with
                                       the Little Sandy River.
Davy Run (Backwater from Little Fork  From the confluence             None         +613  Unincorporated Areas of
 Little Sandy River).                  with Little Fork                                   Carter County.
                                       Little Sandy River to
                                       approximately 0.6 mile
                                       upstream of the
                                       confluence with Little
                                       Fork Little Sandy
                                       River.
Dry Branch (Backwater from Tygarts    From the confluence             None         +804  Unincorporated Areas of
 Creek).                               with Tygarts Creek to                              Carter County.
                                       just downstream of
                                       U.S. Route 60.
Fourmile Creek (Backwater from        From the confluence             None         +604  Unincorporated Areas of
 Little Sandy River).                  with the Little Sandy                              Carter County.
                                       River to approximately
                                       400 feet upstream of
                                       Glory Lane.
Huff Run (Backwater from Little Fork  From the confluence             None         +616  Unincorporated Areas of
 Little Sandy River).                  with Little Fork                                   Carter County.
                                       Little Sandy River to
                                       approximately 0.7 mile
                                       upstream of the
                                       confluence with Little
                                       Fork Little Sandy
                                       River.
Johns Run (Backwater from Little      From the confluence             None         +623  Unincorporated Areas of
 Fork Little Sandy River).             with Little Fork                                   Carter County.
                                       Little Sandy River to
                                       approximately 0.6 mile
                                       upstream of the
                                       confluence with Little
                                       Fork Little Sandy
                                       River.
Lost Creek (Backwater from Dry Fork)  From the confluence             None         +632  Unincorporated Areas of
                                       with Dry Fork to                                   Carter County.
                                       approximately 0.5 mile
                                       downstream of Eddie
                                       Dean Road.
Straight Creek (Backwater from        From the confluence             None         +609  Unincorporated Areas of
 Little Fork Little Sandy River).      with Little Fork                                   Carter County.
                                       Little Sandy River to
                                       approximately 1,750
                                       feet downstream of
                                       Mount Savage Lane.
Wolf Creek (Backwater from Little     From the confluence             None         +603  Unincorporated Areas of
 Sandy River).                         with the Little Sandy                              Carter County.
                                       River to approximately
                                       0.6 mile upstream of
                                       the confluence with
                                       the Little Sandy River.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

                                      Unincorporated Areas of Carter County
Maps are available for inspection at 300 West Main Street, Grayson, KY 41143.
----------------------------------------------------------------------------------------------------------------
                                 Butler County, Nebraska, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Platte River........................  Approximately 100 feet          None       +1,309  Unincorporated Areas of
                                       downstream of the                                  Butler County.
                                       Saunders County
                                       boundary.
                                      Approximately 575 feet          None       +1,442
                                       downstream of the Polk
                                       County boundary.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

                                      Unincorporated Areas of Butler County
Maps are available for inspection at 451 North 5th Street, David City, NE 68632.
----------------------------------------------------------------------------------------------------------------
                                  Otoe County, Nebraska, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Missouri River......................  At easternmost tip of           +913         +914  City of Nebraska City,
                                       the Otoe County limits.                            Unincorporated Areas
                                                                                of Otoe County.
                                      At Nebraska Highway 2/          +930         +931
                                       Burlington Northern
                                       Railroad.
                                      At Everett Lane                 +940         +943
                                       extended.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.

+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

City of Nebraska City
Maps are available for inspection at 1409 Central Avenue, Nebraska City, NE 68410.

                                       Unincorporated Areas of Otoe County
Maps are available for inspection at the Otoe County Courthouse, 1021 Central Avenue, Nebraska City, NE 68410.
----------------------------------------------------------------------------------------------------------------
                              Rio Arriba County, New Mexico, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Llano Ditch Tributary...............  Just downstream of              None       +5,655  Unincorporated Areas of
                                       McCurdy Road Northwest.                            Rio Arriba County,
                                                                                Pueblo of Ohkay
                                                                                Owingeh.
                                      Just upstream of                None       +5,705
                                       Simmons Lane.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

Pueblo of Ohkay Owingeh
Maps are available for inspection at the Governor's Office, 1 Kee Road, Espanola, NM 87532.

                                    Unincorporated Areas of Rio Arriba County
Maps are available for inspection at the County Clerk's Office, 1122 Industrial Park Road, Espanola, NM 87532.
----------------------------------------------------------------------------------------------------------------
                               Wake County, North Carolina, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Basin 10, Stream 13.................  At the confluence with          +277         +276  Unincorporated Areas of
                                       Basin 10, Stream 14.                               Wake County.
                                      Approximately 1,400             +277         +276
                                       feet upstream of the
                                       confluence with Basin
                                       10, Stream 14.
Basin 10, Stream 14.................  Approximately 0.5 mile          +269         +268  Unincorporated Areas of
                                       upstream of the                                    Wake County.
                                       confluence with the
                                       Little River.
                                      At the Wake County              +306         +307
                                       boundary.
Horse Creek Tributary 1.............  At the downstream side          None         +341  Unincorporated Areas of
                                       of Keighley Forest                                 Wake County.
                                       Drive.
                                      Approximately 850 feet          None         +345
                                       upstream of Keighley
                                       Forest Drive.
Richland Creek......................  Approximately 850 feet          +302         +301  Town of Wake Forest.
                                       upstream of the
                                       confluence with
                                       Richland Creek
                                       Tributary 2.
                                      Approximately 500 feet          +312         +315
                                       downstream of the
                                       confluence with
                                       Hattles Branch.
Richland Creek Tributary 2..........  Approximately 750 feet          None         +301  Town of Wake Forest.
                                       upstream of the
                                       confluence with
                                       Richland Creek.
                                      Approximately 0.4 mile          None         +317
                                       upstream of the
                                       confluence with
                                       Richland Creek.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

Town of Wake Forest
Maps are available for inspection at the Planning Department, 401 Elm Street, Wake Forest, NC 27587.

                                       Unincorporated Areas of Wake County
Maps are available for inspection at the Wake County Office Building, Environmental Services, 1st Floor, 337
 Salisbury Street, Raleigh, NC 27601.
----------------------------------------------------------------------------------------------------------------
                                Wagoner County, Oklahoma, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Adams Creek.........................  Approximately 717 feet          None         +600  Town of Fair Oaks.
                                       downstream of the
                                       confluence with School
                                       Creek.
                                      Approximately 0.61 mile         None         +605
                                       upstream of the
                                       confluence with School
                                       Creek.
Salt Creek..........................  Approximately 0.60 mile         None         +557  Town of Fair Oaks.
                                       downstream of 305th
                                       Avenue.
                                      Approximately 365 feet          None         +607
                                       upstream of 257th
                                       Avenue.
Verdigris River.....................  Approximately 245 feet          None         +516  Town of Okay.
                                       downstream of 72nd
                                       Street.
                                      Approximately 0.45 mile         None         +516
                                       upstream of 72nd
                                       Street.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

Town of Fair Oaks
Maps are available for inspection at the Office of the County Commissioner, 219 South Missouri Street,
 Claremore, OK 74017.

Town of Okay
Maps are available for inspection at the Office of the County Commissioner, 306 East Cherokee Street, Wagoner,
 OK 74107.
----------------------------------------------------------------------------------------------------------------
                                   Erath County, Texas, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
North Bosque River..................  Just upstream of East           None       +1,265  Unincorporated Areas of
                                       Lingleville Road.                                  Erath County.
                                      Approximately 0.5 mile          None       +1,276
                                       upstream of State
                                       Highway 108.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

                                      Unincorporated Areas of Erath County
Maps are available for inspection at the Erath County Courthouse, 100 West Washington, Stephenville, TX 76401.
----------------------------------------------------------------------------------------------------------------
                                 Limestone County, Texas, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Salt River..........................  Just upstream of State          None         +473  Unincorporated Areas of
                                       Highway 14.                                        Limestone County.
                                      Approximately 0.66 mile         None         +483
                                       upstream of State
                                       Highway 14.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal
 Emergency Management Agency, 500 C Street, SW., Washington, DC 20472.

                                                    ADDRESSES

                                    Unincorporated Areas of Limestone County
Maps are available for inspection at the Limestone County Courthouse, 200 West State Street, Groesbeck, TX
 76642.
----------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance'')

    Dated: May 11, 2010.
Sandra K. Knight,
Deputy Federal Insurance and Mitigation Administrator, Mitigation,
Department of Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2010-12490 Filed 5-24-10; 8:45 am]
BILLING CODE 9110-12-P