[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Page 13784]
[FR Doc No: 2016-05774]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14751-000]

Alpine Pacific Utilities, LLC; Notice of Intent To File License
Application, Filing of Pre-Application Document, Approving Use of the
Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 14751-000.
    c. Date Filed: January 28, 2016.
    d. Submitted By: Alpine Pacific Utilities, LLC.
    e. Name of Project: Fresno Dam Site Water Power Project.
    f. Location: On the Milk River in Hill County, Montana near the
town of Kremlin at the existing Bureau of Reclamation Fresno Dam.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Justin D. Ahmann, Alpine Pacific
Utilities, LLC, 111 Legend Trail, Kalispell, MT 59901.
    i. FERC Contact: Ryan Hansen at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Alpine Pacific Utilities, LLC filed its request to use the
Traditional Licensing Process on February 2, 2016. Alpine Pacific
Utilities, LLC provided public notice of its request on February 8,
2016. In a letter dated March 9, 2016, the Director of the Division of
Hydropower Licensing approved Alpine Pacific Utilities, LLC's request
to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service under section 7 of the Endangered
Species Act and the joint agency regulations thereunder at 50 CFR part
402; and NOAA Fisheries under section 305(b) of the Magnuson-Stevens
Fishery Conservation and Management Act and implementing regulations at
50 CFR 600.920. We are also initiating consultation with the Montana
State Historic Preservation Officer, as required by section 106,
National Historic Preservation Act, and the implementing regulations of
the Advisory Council on Historic Preservation at 36 CFR 800.2.
    l. Alpine Pacific Utilities, LLC filed a Pre-Application Document
(PAD; including a proposed process plan and schedule) with the
Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
    m. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(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_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    n. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: March 9, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-05774 Filed 3-14-16; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 10, 2009 (Volume 74, Number 26)]
[Notices]
[Page 6640-6641]
[DOCID:fr10fe09-83]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0626]

Draft Guidance for Industry on Bioequivalence Recommendation for
Vancomycin HCl; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to March
19, 2009, the comment period for the draft guidance for industry
entitled ``Bioequivalence Recommendation for Vancomycin HCl'' that
published in the Federal Register of December 16, 2008 (73 FR 76362).
The draft guidance provides specific guidance on the design of
bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for vancomycin HCl capsules. FDA is taking this
action in response to requests for an extension of the comment period
to allow interested persons additional time to submit comments.

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 written or electronic comments on the draft guidance
by March 19, 2009.

ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 16, 2008 (73 FR 76362), FDA
published a notice announcing the availability of a draft guidance for
industry entitled ``Bioequivalence Recommendation for Vancomycin HCl.''
As described in the notice, the draft guidance further clarifies FDA's
recommendations on the design of BE studies to support ANDAs for
vancomycin HCl capsules. As also described in the notice, FDA will
consider comments on the draft guidance as it finalizes its BE
recommendations and addresses the complicated issues raised in
ViroPharma Inc.'s (ViroPharma's) petitions for stay of action
challenging FDA's revised BE recommendations (Docket No. FDA-2006-P-
0007).
    By letter dated December 19, 2008, ViroPharma requested that FDA
extend the comment period for the draft guidance by 60 days. In support
of its request, ViroPharma provided several reasons that explained why
it believes an extension is appropriate, including that the issues
involved with the draft guidance are complex and that the current 60-
day comment period for the notice includes the months of December and
early January when many interested persons are on holiday vacation.
While ViroPharma acknowledges that the Federal Register notice
announcing the availability of this draft guidance indicates that
comments to guidance documents may be submitted at any time, ViroPharma
states that it is essential that FDA be able to review and consider
comprehensive comments from all stakeholders before finalizing the
guidance. In addition, by letter dated January 23, 2009, the
Biotechnology Industry Organization (BIO) requested that FDA extend the
comment period for the draft guidance to provide interested persons
additional time to submit comments, and by letter dated February 2,
2009, Akorn Inc. objected to BIO's extension request.
    FDA has considered ViroPharma's and BIO's requests and Akorn's
objection. FDA does not believe that a 60-day extension as requested by
ViroPharma is warranted, but in response to ViroPharma's and BIO's
requests, FDA is extending the comment period for the draft guidance
for 30 days, until March 19, 2009. This extension will provide
interested

persons with a total of 90 days to submit comments before FDA begins
work on the final version of the guidance. The agency believes that
this 30-day extension allows adequate time for interested persons to
submit comments without significantly delaying FDA consideration of
these important issues.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on this document. Submit
a single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: February 4, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-2800 Filed 2-9-09; 8:45 am]

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[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Pages 36530-36532]
[FR Doc No: 2014-15020]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0636]

Global Unique Device Identification Database; Guidance for
Industry and Food and Drug Administration Staff; 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 the guidance entitled

``Global Unique Device Identification Database (GUDID): Guidance for
Industry and Food and Drug Administration Staff.'' This guidance
finalizes, as a single document, all sections of, ``Global Unique
Device Identification (GUDID): Draft Guidance for Industry.'' The
guidance includes, with minor modifications, the previously finalized
sections on how device labelers will interface with the GUDID,
establish GUDID accounts and begin initial submissions. The guidance
also finalizes the sections on the Device Identifier (DI) record,
Health Level 7 Structured Product Labeling (HL7 SPL) submission,
search/retrieval of devices information, and GUDID submissions and
maintaining and submitting electronic records. The guidance also
finalizes Appendix A--GUDID Package Information Examples.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Global Unique Device Identification Database (GUDID): Guidance for
Industry and Food and Drug Administration Staff'' to the Office of the
Center Director, Guidance and Policy Development, Center for Devices
and Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5431, Silver Spring, MD 20993-0002 or to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Bldg. 71, rm. 3128, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to the office from which you are ordering to assist in
processing your request.
    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. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: For information concerning the
guidance as it relates to devices regulated by CDRH: Indira Konduri,
UDI Regulatory Policy Support, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 3303, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    For information concerning the guidance as it relates to devices
regulated by CBER: Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 226 of the Food and Drug Administration Amendments Act of
2007 (Pub. L. 110-85) and section 614 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144) amended the
Federal Food, Drug, and Cosmetic Act to add section 519(f) (21 U.S.C.
360i(f)), which directs FDA to issue regulations establishing a unique
device identification (UDI) system for medical devices along with
implementation timeframes for certain medical devices. The UDI system
final rule was published on September 24, 2013 (78 FR 58786).
    In developing the final rule, FDA solicited and considered input
from a variety of stakeholders including manufacturers, global
regulatory bodies, the clinical community, and patient advocates to
ensure that as many perspectives as possible were incorporated. The
GUDID is a critical component of the UDI System. The UDI assigned to
each device is a globally unique, yet unintelligent code identifying
the device, and is composed of the static DI portion and the dynamic
production identifier. The GUDID will house the DI, along with key
descriptive or ``attribute'' information about the device, which is
reported and updated to the GUDID by the device labeler. Being unique
for each device, the DI component of the UDI can be effectively used by
stakeholders to access the GUDID attribute information for that device.
    On September 24, 2013 (78 FR 58545), FDA released a document titled
``Global Unique Device Identification (GUDID): Draft Guidance for
Industry'' (the draft guidance). During the 60-day comment period,
which ended on November 25, 2013, more than 300 comments were received
from 21 entities. In order to finalize the sections with the most
questions from GUDID submitters, FDA released the first part of this
finalized guidance on June 11, 2014 (79 FR 33568), providing general
information to labelers to enable them to obtain a GUDID account and
begin initial submissions to the GUDID.
    FDA is now, in a single document, finalizing all sections of the
draft guidance. The finalized guidance includes, with minor
modifications, the previously released information on how device
labelers will interface with the GUDID, establish GUDID accounts, and
begin initial submissions. The principal modifications include
reformatting changes to rearrange sections from 3.2. to 3.1 to improve
the document flow, adding a paragraph in section 2 in response to an
industry comment, and adding a paragraph in section 4 that had been
inadvertently omitted in the document released on June 11, 2014. In
addition, this guidance finalizes sections in the draft guidance on the
DI record, HL7 SPL submission, search/retrieval of devices information,
and GUDID submissions and 21 CFR part 11 requirements. We also are
finalizing Appendix A--GUDID Package Information Examples. This
guidance supersedes the June 11, 2014, guidance entitled ``Global
Unique Device Identification Database (GUDID): Guidance for Industry.''
    Elsewhere, we continue to make available on the Internet at the
FDA/UDI Web site (http://www.fda.gov/udi) updated versions of two
appendices of the draft guidance: The section formerly identified as
``Appendix B'' which summarizes the device attribute information that
will populate the GUDID, renamed as ``GUDID Data Elements Reference
Table'' and the section formerly identified as ``Appendix C'' which
summarizes the UDI formats accepted by the issuing Agencies that FDA
has accredited to date, renamed as ``UDI Formats by FDA-Accredited
Issuing Agency.'' These two documents contain technical specifications
and will not be published as a part of this guidance that describes the
Agency's interpretation of or policy on a regulatory issue. For those
without Internet access or who otherwise would like to receive a hard
copy of the currently updated version of either of these documents,
formerly published as Appendix B and Appendix C of the draft guidance,
should call the people listed under FOR FURTHER INFORMATION CONTACT to
request the document(s).

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking about the GUDID. 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 for interfacing with the GUIDID may be
used with prior FDA

approval if such approach satisfies the technical requirements of the
GUDID and the requirements of the applicable statute and regulations.
If you wish to use an alternative approach for submitting a specific
required data element, you may request FDA approval by email or writing
to: UDI Regulatory Policy Support, Center for Devices and Radiological
Health, Food and Drug Administration, Bldg. 66, Rm. 3303, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, email<EMAIL_ADDRESS>(Attention: UDI Regulatory Policy Support). If a labeler has a waiver
from electronic submission of GUDID data under 21 CFR 830.320(c), the
labeler should send a letter containing all of the information
otherwise required by this guidance, as well as any permitted ancillary
information that the labeler wishes to submit, within the time
permitted to: UDI Regulatory Policy Support at the address indicated in
the previous sentence. See 21 CFR 830.320(c)(3).

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or at http://www.regulations.gov. Persons unable to download an electronic copy of
``Global Unique Device Identification Database (GUDID): Guidance for
Industry'' may send an email request to<EMAIL_ADDRESS>to
receive an electronic copy of the document. Please use the document
number 1831 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information described 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 collection of information in 21 CFR part 830 pertaining to
GUDID labeler accounts and data submissions addressed in this guidance
document have been approved under OMB control number 0910-0720.

V. 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.

    Dated: June 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15020 Filed 6-26-14; 8:45 am]
BILLING CODE 4164-01-P