[Federal Register: November 18, 2008 (Volume 73, Number 223)]
[Notices]
[Page 68432-68433]
[DOCID:fr18no08-89]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Orthopaedic and Rehabilitation Devices Panel of
the Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 9, 2008, from 8
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Ronald P. Jean, Center for Devices and Radiological
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850,<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area), code<PHONE_NUMBER>. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
    Agenda: The committee will discuss, make recommendations and vote
on a premarket approval application for

Synvisc-One, sponsored by Genzyme Corp. This device is indicated for
the treatment of pain in osteoarthritis of the knee in patients who
have failed to respond adequately to conservative nonpharmacologic
therapy and simple analgesics, e.g., acetaminophen.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 25, 2008. Oral presentations from the public will be scheduled
for 30 minutes at the beginning of the committee deliberations and for
30 minutes near the end of the deliberations. Those desiring to make
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before November 19, 2008. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by November 20, 2008.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff,<PHONE_NUMBER>, at least 7 days in advance
of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: November 10, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-27255 Filed 11-18-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Pages 57621-57623]
[FR Doc No: 2015-24228]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1837]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Electronic User Fee
Payment Request Forms

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 October
26, 2015.

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 title Electronic User Fee
Payment Request Forms. 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, 8455

Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
<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.

Electronic User Fee Payment Request Forms--(OMB Control Number 0910--
NEW)

    The Government Paperwork Elimination Act (GPEA) (Pub. L. 105-277,
title XVII), was signed into law on October 21, 1998. GPEA requires
Federal Agencies to allow individuals or entities that deal with the
Agencies the option to submit information or transact business with the
Agency electronically, when practicable, and to maintain records
electronically, when practicable. Its goal is to encourage Agencies to
incorporate technologically improved respondent reporting, as this
process typically lowers the burden on the respondent. GPEA allows FDA
to collect information relating to a user fee payment refund request
and transfer request.
    Form FDA 3913, User Fee Payment Refund Request, is designed to
provide the minimum necessary information for FDA to review and process
a user fee payment refund. The information collected includes the
organization, contact, and payment information. The information is used
to determine the reason for the refund, the refund amount, and who to
contact if there are any questions regarding the refund request. A
submission of the User Fee Payment Refund Request form does not
guarantee that a refund will be issued. FDA estimates an average of
0.40 hours per response, including the time to review instructions,
search existing data sources, gather and maintain the data needed, and
complete and review the collection of information. The estimated hours
are based on past FDA experience with the user fee payment refund
request.
    In fiscal year 2014, approximately 1,741 user fee refunds were
processed for cover sheets and invoices including 27 for Animal Drug
User Fee Act, 5 for Animal Generic Drug User Fee Act, 3 for Biosimilar
Drug User Fee Act, 1 for a Center for Tobacco Products Civil Money
Penalties, 216 for Export Certificate Program, 79 for Freedom of
Information Act requests, 523 for Generic Drug User Fee Amendments, 539
for Medical Device User Fee Amendments, 266 for Mammography inspection
fee, 81 for Prescription Drug User Fee Act, and 1 for a Tobacco product
fee.
    Form FDA 3914, User Fee Payment Transfer Request, is designed to
provide the minimum necessary information for FDA to review and process
a user fee payment transfer request. The information collected includes
payment and organization information. The information is used to
determine the reason for the transfer, how the transfer should be
performed, and who to contact if there are any questions regarding the
transfer request. A submission of the User Fee Payment Transfer Request
form does not guarantee that a transfer will be performed. FDA
estimates an average of 0.25 hours per response, including the time to
review instructions, search existing data sources, gather and maintain
the data needed, and complete and review the collection of information.
FDA estimated hours are based on past FDA experience with the user fee
payment transfer request.
    In fiscal year 2014, approximately 1,291 user fee payment transfers
were processed for cover sheets and invoices including 21 for Animal
Drug User Fee Act, 2 for Animal Generic Drug User Fee Act, 544 for
Generic Drug User Fee Amendments, 627 for Medical Device User Fee
Amendments, and 97 for Prescription Drug User Fee Act.
    Respondents for the electronic request forms include domestic and
foreign firms (including pharmaceutical, medical device, etc.).
Specifically, refund request forms target respondents who submitted a
duplicate payment or overpayment for a user fee cover sheet or invoice.
Respondents may also include firms that withdrew an application or
submission. Transfer request forms target respondents who submitted
payment for a user fee cover sheet or invoice and need that payment to
be re-applied to another cover sheet or invoice (transfer of funds).
    The electronic user fee payment request forms will streamline the
refund and transfer processes, facilitate processing, and improve the
tracking of requests. The burden for this collection of information is
the same for all customers (small and large organizations). The
information being requested or required has been held to the absolute
minimum required for the intended use of the data. Customers will be
able to request a user fee payment refund and transfer online at http://www.fda.gov/forindustry/userfees/default.htm. This electronic
submission is intended to reduce the burden for customers to submit a
user fee payment refund and transfer request.
    In the Federal Register of June 26, 2015 (80 FR 36822), 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 collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                 Number of
               21 CFR section                    Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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User Fee Payment Refund Request--Form FDA              1,700               1           1,700  0.40 (24 minutes).........................             680
 3913.
User Fee Payment Transfer Request--Form FDA            1,700               1           1,700  0.25 (15 minutes).........................             425
 3914.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................            1105
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: September 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24228 Filed 9-23-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 86 (Wednesday, May 4, 2022)]
[Notices]
[Page 26351]
[FR Doc No: 2022-09545]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2816-050; Project No. 12766-007]

North Hartland, LLC; Green Mountain Power Corporation; Notice of
Availability of Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380, the Office of Energy Projects has
reviewed the application for a new license for the North Hartland
Hydroelectric Project No. 2816 (North Hartland Project), and the
application for a new license for the Clay Hill Road Line 66
Transmission Project No. 12766 (Clay Hill Project), and has prepared an
Environmental Assessment (EA) for the projects. The North Hartland
Project is on the Ottauquechee River in Windsor County, Vermont, and
occupies 20.8 acres of federal land administered by the U.S. Army Corps
of Engineers. The Clay Hill Project serves as part of the primary
transmission line for the North Hartland Project, and is located along
Clay Hill Road in Windsor County, Vermont.
    The EA contains staff's analysis of the potential environmental
effects of the projects and concludes that licensing the projects, with
appropriate environmental protective measures, would not constitute a
major federal action that would significantly affect the quality of the
human environment.
    The Commission provides all interested persons with an opportunity
to view and/or print the EA via the internet through the Commission's
Home Page (http://www.ferc.gov) using the ``eLibrary'' link. Enter the
docket number, excluding the last three digits in the docket number
field, to access the document. For assistance, contact FERC Online
Support at [email protected] or toll-free at<PHONE_NUMBER>,
or for TTY,<PHONE_NUMBER>.
    You may also register online at https://ferconline.ferc.gov/eSubscription.aspx to be notified via email of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    Any comments should be filed within 45 days from the date of this
notice. The Commission strongly encourages electronic filings. Please
file comments using the Commission's eFiling system at https://ferconline.ferc.gov/eFiling.aspx. Commenters can submit brief comments
up to 6,000 characters, without prior registration, using the eComment
system at https://ferconline.ferc.gov/QuickComment.aspx. You must
include your name and contact information at the end of your comments.
For assistance, please contact FERC Online Support. In lieu of
electronic filing, you may submit a paper copy. Submissions sent via
the U.S. Postal Service must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Room 1A, Washington, DC 20426. Submissions sent via any other carrier
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
The first page of any filing should include docket number P-2816-050
for the North Hartland Project and/or docket number P-12766-007 for the
Clay Hill Project.
    For further information, contact Bill Connelly at<PHONE_NUMBER> or
by email at [email protected].

    Dated: April 28, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-09545 Filed 5-3-22; 8:45 am]
BILLING CODE 6717-01-P