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Natural Gas STAR Program Partnership Agreement

The Natural Gas STAR Program is a flexible, voluntary partnership between EPA and the oil and natural gas industry aimed at demonstrating the cost-effectiveness and environmental benefits of methane emission reduction opportunities.
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This is a voluntary agreement between                                                                     (company name) and the U.S. Environmental Protection Agency (EPA) for the purpose of reducing methane releases to the atmosphere by implementing cost-effective emission reduction technologies and practices. Responsibilities for both parties and General Terms are outlined on the following page.
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Please select which sector segment(s) this partnership will cover (check all that apply):
☐ Production	 ☐ Gathering and Processing	☐ Transmission	 ☐ Distribution
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Authorized Partner Company Representative: (name and title)
______________________________________________________
Name, Title

Signature:                                                                                Date:

EPA Representative:
Paul M. Gunning: Director, Climate Change Division, U.S. Environmental Protection Agency
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Signature:                                                                                Date:
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Partner Designated Natural Gas STAR Implementation Manager:

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Name:
Title:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The public reporting and recordkeeping burden for this collection of information is estimated to average 57 hours per response. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The public reporting and recordkeeping burden for this collection of information is estimated to average 57 hours per response. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.
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E-mail:                                                                                Address:
City/State/Zip:
Telephone:
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EPA's Responsibilities
    Provide contact information for an EPA Program Manager to assist the Partner in Program implementation.
    Assist Partners with Program implementation with the following, as appropriate:
 Analyzing and developing information on emerging technologies and practices;
 Developing workshops and training courses; and
 Providing technical assistance to Partners in implementing the Program Best Management Practices (BMPs) found at www.epa.gov/natural-gas-star-program
    Provide public recognition for Partner company commitments to the Program through acknowledgement on EPA's web site.
    EPA will only release information obtained from the Partner company without prior authorization from that company if required to do so under the Freedom of Information Act, the Agency's regulations at 40 CFR part 2, subpart B, or other applicable law.
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Natural Gas STAR Partner's Responsibilities
    Appoint a company representative as the Natural Gas STAR Program Implementation Manager responsible for implementing this voluntary agreement.
    Develop a company-specific approach for active participation in the Program, including identifying expected activities and scope of implementation.  This may include development of an Implementation Plan to be shared with EPA.
    Annually evaluate cost-effective methane emission reduction opportunities and voluntarily implement BMPs to the extent feasible across operations within the United States.
    Engage and share information with the Program on voluntary emission reduction activities annually, including one or more of the following activities:
 Providing EPA with annual reports describing the BMPs implemented;
 Presenting at a Natural Gas STAR workshop or other Program event; or
 Developing technical documents that can be shared with Partners, such as through the Natural Gas STAR website.
    Communicate participation to employees and cooperate with EPA efforts to publicize the Program.
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General Terms
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   This agreement can be terminated by either party at any time, with no penalties and no further obligation. EPA requests that Partners notify EPA immediately if they plan to withdraw from the Partnership. EPA agrees not to publicize a Partner's withdrawal from the Program.
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   The Partner agrees that the activities it undertakes connected with this agreement are not intended to provide services to the federal government and that the Partner will not seek compensation from a federal agency.
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   The Partner agrees that it will not claim or imply that its participation in the Program constitutes EPA approval or endorsement of anything other than the commitment to the Program.
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   The Partner agrees to only share non-Confidential Business Information (CBI) to fulfill Gas STAR Program requirements, and understands that information submitted to the Program is subject to the Freedom of Information Act.
Please sign this form and send to:
EPA Natural Gas STAR Program
USEPA Headquarters
1200 Pennsylvania Avenue, NW
Mail Code: 6207A
Washington, DC 20460
<EMAIL_ADDRESS>If overnight, send to:
1201 Constitution Ave NW
Room Number 4353PP
Washington, DC 20004


[Federal Register Volume 79, Number 81 (Monday, April 28, 2014)]
[Notices]
[Pages 23359-23360]
[FR Doc No: 2014-09470]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0220]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for Industry
on Pharmacogenomic Data Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 28,
2014.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0557.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Guidance for Industry on Pharmacogenomic Data Submissions--(OMB Control
Number 0910-0557)--Extension

    The guidance provides recommendations to sponsors submitting or
holding investigational new drug applications (INDs), new drug
applications (NDAs), or biologics license applications (BLAs) on what
pharmacogenomic data should be submitted to the Agency during the drug
development process. Sponsors holding, and applicants submitting, INDs,
NDAs, or BLAs are subject to FDA requirements for submitting to the
Agency data relevant to drug safety and efficacy (21 CFR 312.22,
312.23, 312.31, 312.33, 314.50, 314.81, 601.2, and 601.12).
    The guidance interprets FDA regulations for IND, NDA, or BLA
submissions, clarifying when the regulations require pharmacogenomics
data to be submitted and when the submission of such data is voluntary.
The pharmacogenomic data submissions described in the guidance that are
required to be submitted to an IND, NDA, BLA, or annual report are
covered by the information collection requirements under parts 312,
314, and 601 (21 CFR parts 312, 314, and 601) and are approved by OMB
under control numbers 0910-0014 (part 312, INDs); 0910-0001 (part 314,
NDAs and annual reports); and 0910-0338 (part 601, BLAs).
    The guidance distinguishes between pharmacogenomic tests that may
be considered valid biomarkers appropriate for regulatory
decisionmaking, and other, less well-developed exploratory tests. The
submission of exploratory pharmacogenomic data is not required under
the regulations, although the Agency encourages the voluntary
submission of such data.
    The guidance describes the voluntary genomic data submission (VGDS)
that can be used for such a voluntary submission. The guidance does not
recommend a specific format for the VGDS, except that such a voluntary
submission be designated as a VGDS. The data submitted in a VGDS and
the level of detail should be sufficient for FDA to be able to
interpret the information and independently analyze the data, verify
results, and explore possible genotype-phenotype correlations across
studies. FDA does not want the VGDS to be overly burdensome and time-
consuming for the sponsor.
    FDA has estimated the burden of preparing a voluntary submission
described in the guidance that should be designated as a VGDS. Based on
FDA's experience with these submissions over the past few years, and on
FDA's familiarity with sponsors' interest in submitting pharmacogenomic
data during the drug development process, FDA estimates that
approximately four sponsors will submit approximately one VGDS each,
and that, on average, each VGDS will take approximately 50 hours to
prepare and submit to FDA.
    In the Federal Register of February 6, 2014 (79 FR 7198), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this information collection as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Voluntary Genomic Data                         4               1               4              50             200
 Submissions....................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: April 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09470 Filed 4-25-14; 8:45 am]
BILLING CODE 4160-01-P


am.
                                          Location: The
                                          regulated area includes all
                                          waters in the vicinity of
                                          North Beach, Burlington,
                                          Vermont within the following
                                          points (NAD 83):
                                            44[deg]29'31'' N,
                                             073[deg]14'22'' W.
                                            44[deg]29'12'' N,
                                             073[deg]14'14'' W.
                                            44[deg]29'17'' N,
                                             073[deg]14'34'' W.
------------------------------------------------------------------------
9.5 Eliot Festival Day Fireworks.......   Event Type: Fireworks
                                          Display.
                                          Sponsor: Eliot
                                          Festival Day Committee.
                                          Date: A one day event
                                          on Saturday during the fourth
                                          weekend of September. The
                                          specific calendar date upon
                                          which the listed event falls
                                          for each calendar year will be
                                          specified in the USCG District
                                          1 Local Notice to Mariners.
                                          Time: 8:00 pm to 10:30
                                          pm.
                                          Location: In the
                                          vicinity of Eliot Town Boat
                                          Launch, Eliot, Maine in
                                          approximate position:
                                            43[deg]08'56'' N,
                                             070[deg]49'52'' W (NAD 83).
------------------------------------------------------------------------

    Dated: December 8, 2011.
C. L. Roberge,
Captain, U.S. Coast Guard, Captain of the Port Sector Northern New
England.
[FR Doc. 2011-33032 Filed 12-23-11; 8:45 am]
BILLING CODE 9110-04-P