[Federal Register: March 3, 2006 (Volume 71, Number 42)]
[Notices]
[Page 10964-10965]
[DOCID:fr03mr06-41]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EC06-40-000, et al.]

Xcel Energy Services, Inc. et al.; Electric Rate and Corporate
Filings

February 24, 2006.
    The following filings have been made with the Commission. The
filings are listed in ascending order within each docket
classification.

1. Xcel Energy Services, Inc.

[Docket No. EC06-40-000]

    Take notice that on February 17, 2006, Xcel Energy Services Inc. on
behalf of Southwestern Public Service Company tenders for filing a
notice of withdrawal of section 203 Federal Power Act application filed
on December 13, 2005.
    Comment Date: 5 p.m. Eastern Time on March 10, 2006.

2. Cadillac Renewable Energy LLC, Decker Energy Cadillac, Inc., Seville
Energy LLC

[Docket No. EC06-82-000]

    Take notice that on February 15, 2006, Cadillac Renewable Energy
LLC, Decker Energy Cadillac, Inc. and Seville Energy LLC (Applicants)
submitted an application pursuant to section 203 of the Federal Power
Act for authorization of disposition of jurisdictional facilities.
    Comment Date: 5 p.m. Eastern Time on March 8, 2006.

3. NewCorp Resources Electric Cooperative, Inc.

[Docket No. EC06-83-000]

    Take notice that on February 17, 2006, NewCorp Resources Electric
Cooperative, Inc. (NewCorp) tendered for filing pursuant to section 203
of the Federal Power Act an application requesting all authorizations
and approvals necessary for the indirect disposition of jurisdictional
facilities in connection with the proposed acquisition of all of the
capital stock of Cap Rock by Cap Rock Holding Corporation.
    Comment Date: 5 p.m. Eastern Time on March 10, 2006.

4. Avista Corporation; Avista Energy, Inc.; Spokane Energy, LLC; Avista
Turbine Power, Inc.; Rathdrum Power, LLC

[Docket Nos. EC06-85-000; ER99-1435-012; ER96-2408-024; ER98-4336-014;
ER99-3320-004]

    Take notice that on February 17, 2006, Avista Corporation d/b/a
Avista Utilities, Avista Energy, Inc., Spokane Energy, LLC, Avista
Turbine Power, Inc., and Rathdrum Power, LLC (collectively Applicants)
submitted an Application pursuant to section 203 of the Federal Power
Act seeking authorization for the disposition of jurisdictional
facilities resulting from a proposed corporate reorganization, and
providing notice of a change in status relating to Applicants' market-
based rate authorization.
    Comment Date: 5 p.m. Eastern Time on March 10, 2006.

5. TransCanada Energy, Ltd.

[Docket No. EG06-38-000]

    Take notice that on February 19, 2006, TransCanada Energy, Ltd.
filed pursuant to section 366.1 of the Commission's regulations, as
recently promulgated in Order No. 665, a notice of self-certification
that it is an exempt wholesale generator within the meaning of section
366.1 of the Commission's regulations.
    Comment Date: 5 p.m. Eastern Time on March 10, 2006.

6. Pittsfield Generating Company, L.P.

[Docket No. ER06-262-001]

    Take notice that on February 16, 2006, Pittsfield Generating
Company, L.P. (Applicant) tendered for filing its responses to the
January 23, 2006 deficiency letter requesting additional information
for the cost-of-service Reliability Must Run Agreement between ISO-New
England, Inc. (ISO-NE) and Sempra Energy Trading Corporation, as agent
for Applicant, filed November 30, 2005. In addition, ISO-NE tendered
for filing its responses to the deficiency letter on February 22, 2006.
    Comment Date: 5 p.m. Eastern Time on March 9, 2006.

7. Southwest Power Pool, Inc.

[Docket No. ER06-578-001]

    Take notice that on February 15, 2006, Southwest Power Pool, Inc.
(SPP) submitted for filing a revised unexecuted service agreement for
Network Integration Transmission Service between SPP and Southwestern
Public Service Company filed on January 1, 2006.
    Comment Date: 5 p.m. Eastern Time on March 6, 2006.

8. International Transmission Company

[Docket No. ES06-26-000]

    Take notice that on February 14, 2006, International Transmission
Company (International Transmission) submitted an application pursuant
to section 204 of the Federal Power Act seeking authorization to extend
the maturity date on its existing revolving credit facility until March
10, 2010.
    International Transmission also requests a waiver from the
Commission's competitive bidding and negotiated placement requirements
at 18 CFR 34.2.
    Comment Date: 5 p.m. Eastern Time on March 10, 2006.

9. El Paso Electric Company

[Docket No. ES06-27-000]

    Take notice that on February 17, 2006, El Paso Electric Company (El
Paso Electric), submitted an application pursuant to Section 204 of the
Federal Power Act seeking authorization to issue short-term
indebtedness in an amount not to exceed $200 million outstanding at any
one time.
    Comment Date: 5 p.m. Eastern Time on March 15, 2006.

Standard Paragraph

    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, 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 comment date. On or
before the comment date, it is not necessary to 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
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-3042 Filed 3-2-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45249-45251]
[FR Doc No: 2018-19303]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-1999-D-0081, FDA-2008-D-0205, FDA-2018-D-2173, FDA-
2018-D-2236, FDA-2018-D-2238, and FDA-2018-D-2258]

Draft Guidances Relating to the Development of Human Gene Therapy
Products; Availability; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notices of availability for six
draft guidance documents relating to the development of human gene
therapy products that appeared in the Federal Register of July 12,
2018. The Agency is taking this action in response to requests for an
extension to allow interested persons additional time to submit
comments and any new information.

DATES: FDA is extending the comment period on the six documents that
published on July 12, 2018 (see SUPPLEMENTARY INFORMATION). Submit
either electronic or written comments by December 10, 2018, to ensure
that the Agency considers your comment on these draft guidances before
it begins work on the final version of the guidances.

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 December 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 10, 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-1999-D-0081 for ``Testing of Retroviral Vector-Based Human Gene
Therapy Products for Replication Competent Retrovirus During Product
Manufacture and Patient Follow-up; Draft Guidance for Industry;''
Docket No. FDA-2008-D-0205 for ``Chemistry, Manufacturing, and Control
Information for Human Gene Therapy Investigational New Drug
Applications; Draft Guidance for Industry;'' Docket No. FDA-2018-D-2173
for ``Long Term Follow-Up After Administration of Human Gene Therapy
Products; Draft Guidance for Industry;'' Docket No. FDA-2018-D-2236 for
``Human Gene Therapy for Retinal Disorders; Draft Guidance for
Industry;'' Docket No. FDA-2018-D-2238 for ``Human Gene Therapy for
Hemophilia; Draft Guidance for Industry;'' or Docket No. FDA-2018-D-
2258 for ``Human Gene Therapy for Rare Diseases; Draft Guidance for
Industry.'' 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 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: Jenifer Stach, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 12, 2018, FDA published notices of
availability with a 90-day comment period for six draft guidance
documents listed in the following table. Three of the six draft
guidance documents provide recommendations to stakeholders developing
gene therapies for retinal disorders, hemophilia, and rare diseases.
The remaining three guidance documents provide recommendations to
sponsors manufacturing gene therapies; namely, how to provide
chemistry, manufacturing and controls information for gene therapy
products, additional recommendations regarding the testing for
replication competent retrovirus during the manufacture of retroviral
vector-based gene therapy products and during the follow-up monitoring
of patients who received retroviral vector-based gene therapy products,
and recommendations regarding the design of long-term follow-up
observational studies for the collection of data on delayed adverse
events following administration of a gene therapy product. Comments
were requested on these draft guidances by October 10, 2018.

               Six Draft Guidances Published July 12, 2018
------------------------------------------------------------------------
                                     Draft guidance
           Docket No.                document title          FR cite
------------------------------------------------------------------------
FDA-1999-D-0081................  Testing of Retroviral  83 FR 32309
                                  Vector-Based Human
                                  Gene Therapy
                                  Products for
                                  Replication
                                  Competent Retrovirus
                                  During Product
                                  Manufacture and
                                  Patient Follow-up;
                                  Draft Guidance for
                                  Industry.
FDA-2008-D-0205................  Chemistry,             83 FR 32307
                                  Manufacturing, and
                                  Control Information
                                  for Human Gene
                                  Therapy
                                  Investigational New
                                  Drug Applications;
                                  Draft Guidance for
                                  Industry.
FDA-2018-D-2173................  Long Term Follow-Up    83 FR 32311
                                  After Administration
                                  of Human Gene
                                  Therapy Products;
                                  Draft Guidance for
                                  Industry.
FDA-2018-D-2236................  Human Gene Therapy     83 FR 32302
                                  for Retinal
                                  Disorders; Draft
                                  Guidance for
                                  Industry.
FDA-2018-D-2238................  Human Gene Therapy     83 FR 32306
                                  for Hemophilia;
                                  Draft Guidance for
                                  Industry.

FDA-2018-D-2258................  Human Gene Therapy     83 FR 32303
                                  for Rare Diseases;
                                  Draft Guidance for
                                  Industry.
------------------------------------------------------------------------

    The Agency has received requests for a 60-day extension of the
comment period for the six draft guidance documents. These requests
conveyed concern that the current 90-day comment period does not allow
sufficient time to develop a meaningful or thoughtful response to the
draft guidance documents.
    FDA has considered these requests and is extending the comment
period for the six draft guidance documents for 60 days, until December
10, 2018. The Agency believes that a 60-day extension allows adequate
time for interested persons to submit comments.

II. References

    The following references are on display in the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov.

1. Letter from Robert Falb, Director, U.S. Policy and Advocacy,
Alliance for Regenerative Medicine, to Dr. Peter Marks, Director,
Center for Biologics Evaluation and Research, FDA (July 23, 2018).
2. Letter from Sesquile Ramon, Ph.D., Director, Science and
Regulatory Affairs, Biotechnology Innovation Organization, to FDA
Dockets Management Staff (August 3, 2018).

    Dated: August 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19303 Filed 9-5-18; 8:45 am]
 BILLING CODE 4164-01-P