[Federal Register: September 9, 2008 (Volume 73, Number 175)]
[Notices]
[Page 52341]
[DOCID:fr09se08-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12498-003]

Ocean Renewable Power Company, LLC; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

September 3, 2008.
    On March 13, 2008, Ocean Renewable Power Company, LLC filed an
application, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Ft. Lauderdale OCGen Power
Project, located on the Gulf Stream in the Atlantic Ocean, near Broward
County, Florida. No federal land or facilities would be used. The
project uses no dam or impoundment.
    The proposed project would consist of: (1) 500 proposed OCGen
module units, with a total installed capacity of 150-megawatts, (2) a
proposed 12-mile-long, 33-kilovolt transmission line, and (3)
appurtenant facilities. The project is estimated to have an annual
generation of 500-gigawatt-hours, which would be sold to a local
utility.
    Applicant Contact: Mr. Paul Wells, Chairman & Founder, Ocean
Renewable Power Company, LLC, 2430 NE 199th Street, N. Miami Beach, FL
33180, phone<PHONE_NUMBER>.
    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at  http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of the Commission's Web site at http:/
/www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
12498-003) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-20860 Filed 9-8-08; 8:45 am]

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[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13070-13071]
[FR Doc No: 2013-04386]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-0742] (formerly 1999D-4396)

Guidance for Clinical Investigators, Industry, and Food and Drug
Administration Staff: Financial Disclosure by Clinical Investigators;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Clinical
Investigators, Industry, and FDA Staff: Financial Disclosure by
Clinical Investigators.'' This guidance is intended to assist clinical
investigators, industry, and FDA staff in interpreting and complying
with the regulations governing financial disclosure by clinical
investigators. This guidance provides FDA's responses to the most
frequently asked questions regarding financial disclosure by clinical
investigators. The guidance announced in this notice finalizes the
draft guidance of the same title dated May 2011 and replaces the
guidance entitled, ``Guidance for Industry: Financial Disclosure by
Clinical Investigators,'' dated March 2001.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the 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 (1-888-463-6332 or 301-796-
3400), or the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448 (1-800-835-4709 or<PHONE_NUMBER>); or the Division of Small
Manufacturers, International and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993 (1-800-
638-2041 or<PHONE_NUMBER>). Send one self-addressed adhesive label to
assist the office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

    Submit electronic comments on the 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: Marsha Melvin, Office of Good Clinical
Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, rm. 5170, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled,
``Guidance for Clinical Investigators, Industry, and FDA Staff:
Financial Disclosure by Clinical Investigators.'' This guidance is
intended to assist clinical investigators, industry, and FDA staff in
interpreting and complying with the regulations governing financial
disclosure by clinical investigators. This guidance provides FDA's
responses to the most frequently asked questions regarding financial
disclosure by clinical investigators.
    This guidance also responds to recommendations made by the Office
of the Inspector General (OIG), Department of Health and Human
Services, in their report entitled ``The Food and Drug Administration's
Oversight of Clinical Investigators' Financial Information.'' \1\ The
OIG's recommendations were intended to strengthen FDA's oversight and
review of clinical investigators' financial disclosures. Specifically,
the guidance describes: (1) The sponsor's responsibility to collect the
financial disclosure information prior to an investigator participating
in a study and ensure that all required forms and attachments are
submitted in marketing applications, (2) what is meant by ``due
diligence'' in obtaining financial disclosures from investigators, and
(3) how FDA will review financial disclosure information. FDA also
reiterates its policy on public release of individual clinical
investigator financial disclosure information and states its intention
to provide summary information about clinical investigator financial
interests/arrangements in the new product reviews FDA posts for an
approval decision.
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    \1\ OIG report OEI-05-07-00730 available at https://oig.hhs.gov/oei/reports/oei-05-07-00730.pdf. (FDA has verified the Web site
address, but FDA is not responsible for any subsequent changes to
the Web site after this document publishes in the Federal Register.)
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    In the Federal Register of May 24, 2011 (76 FR 30175), FDA
announced the availability of the draft guidance of the same title
dated May 2011. FDA received several comments on the draft guidance,
and those comments were considered in preparing the final guidance.
Changes include: Clarifications related to the terms ``due diligence,''
``covered clinical study,'' and ``material support;'' identification of
a dependent child for purposes of part 54; and explanation of FDA's
review of clinical investigator financial disclosure information. In
addition, editorial changes were made to improve clarity. The guidance
announced in this notice finalizes the draft guidance dated May 2011
and replaces the guidance entitled, ``Guidance for Industry: Financial
Disclosure by Clinical Investigators,'' dated March 2001.
    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. 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

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 54, 312, and 812 have been
approved under OMB control numbers 0910-0396, 0910-0014, and 0910-0078.

III. Comments

    Interested persons may submit either electronic 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 guidance at
either http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm or http://www.regulations.gov.

    Dated: February 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04386 Filed 2-25-13; 8:45 am]
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