[Federal Register Volume 78, Number 226 (Friday, November 22, 2013)]
[Notices]
[Page 70062]
[FR Doc No: 2013-27916]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0002]

Withdrawal of Approval of New Animal Drug Applications;
Carbarsone; Roxarsone

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of three new animal drug applications (NADAs) for roxarsone or
carbarsone Type A medicated articles at the sponsor's request because
the products are no longer manufactured or marketed.

DATES: Withdrawal of approval is effective December 2, 2013.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007, has requested that FDA withdraw approval of the following three
NADAs because the products, used to manufacture Type B and Type C
medicated feeds, are no longer manufactured or marketed: NADA 007-891
for 3-NITRO (roxarsone) Type A medicated article, NADA 092-953 for
Roxarsone Type A Medicated Articles, and NADA 010-285 for CARB-O-SEP
(carbarsone) Type A medicated article.
    Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec.  514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADAs
007-891, 092-953, and 010-285, and all supplements and amendments
thereto, is hereby withdrawn.
    Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.

    Dated: November 18, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-27916 Filed 11-21-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13354-13355]
[FR Doc No: 2016-05648]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-78-000]

TC Offshore LLC; Notice of Application

    Take notice that on February 24, 2016, TC Offshore LLC (TC
Offshore), 700 Louisiana Street, Suite 700, Houston, Texas 77002-2700,
filed in Docket No. CP16-78-000 an application pursuant to section 7(b)
of the Natural Gas Act (NGA) requesting an order authorizing the
abandonment by sale to Avocet LNG, LLC (Avocet) of certain facilities
located in state and federal waters offshore Louisiana in the Gulf of
Mexico, and onshore in the state of Louisiana, all as more fully set
forth in the application which is on file with the Commission and open
to public inspection. The filing may also be viewed on the web at
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, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to Linda
Farquhar, Manager, Project Determinations and Regulatory
Administration, TC Offshore LLC, 700 Louisiana Street, Suite 700,
Houston, Texas 77002 at<PHONE_NUMBER>.
    Specifically, TC Offshore proposes to abandon the jurisdictional
transmission facilities of its Grande Chenier System and associated
appurtenances, which includes four segments totaling 39.74 miles of
pipeline from WC Block 167 to

the onshore Grand Chenier liquid handling facility.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either complete
its environmental assessment (EA) and place it into the Commission's
public record (eLibrary) for this proceeding; or issue a Notice of
Schedule for Environmental Review. If a Notice of Schedule for
Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit original and 7 copies of filings made with the Commission and
must mail a copy to the applicant and to every other party in the
proceeding. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
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 on-line 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 email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on March 29, 2016.

    Dated: March 8, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-05648 Filed 3-11-16; 8:45 am]
 BILLING CODE 6717-01-P


Schools and Educational Services, NEC ( except professional and management training, aviation and flight training, fine arts schools, language schools, exam preparation and tutoring, automobile driving schools, and educational support services) Schools and Educational Services NEC ( educational support services)

Individual and Family Social Services ( child and youth services) Individual and Family Social Services ( services for the elderly and disabled) Individual and Family Social Services ( except services for children, youth, elderly, and disabled; community food assistance services; housing services ( except temporary), emergency and relief services, and government parole or probation offices) Individual and Family Social Services ( community food assistance services) Individual and Family Social Services ( temporary shelter) Individual and Family Social Services ( housing services except temporary shelter) Individual and Family Social Services ( emergency and relief services)

Individual and Family Social Services ( government parole and probation offices) Job Training and Vocational Rehabilitation Services Child Day Care Services Residential Care ( homes for the mentally handicapped with incidental health care) Residential Care ( mental health and substance abuse facilities)

Residential Care ( homes for the elderly) Residential Care ( except mental health and substance abuse facilities, homes for the elderly, and homes for the mentally handicapped with incidental health care) Social Services, NEC ( voluntary health organizations) Social Services, NEC ( grantmaking and giving) Social Services, NEC ( human rights organizations) Social Services, NEC ( environment, conservation, and wildlife advocacy) Social Services, NEC ( except human rights, environment, conservation and wildlife advocacy organizations, grantmaking and giving, and voluntary health organizations) Museums and Art Galleries ( except historic and heritage sites) Museums and Art Galleries ( historic and heritage sites) Arboreta and Botanical or Zoological Gardens ( except nature parks and reserves) Arboreta and Botanical or Zoological Gardens ( nature parks and reserves) Business Associations Professional Membership Organizations Labor Unions and Similar Labor Organizations Civic, Social, and Fraternal Associations ( taxpayers' associations, tenants' advocacy associations, temperance organizations) Civic, Social, and Fraternal Associations ( except condominium and homeowner associations, taxpayers associations, tenants advocacy associations, temperance organizations, and Indian and Alaska Native Tribal Councils) Civic, Social, and Fraternal Associations ( condominium and homeowner associations) Civic, Social, and Fraternal Associations ( Indian and Alaska Native Tribal Councils) Political Organizations Religious Organizations Membership Organizations, NEC ( travel motor clubs)

Membership Organizations, NEC ( humane societies)

Membership Organizations, NEC ( except humane societies, farm business organizations, athletic associations, and travel motor clubs)

Membership Organizations, NEC ( farm business organizations) Membership Organizations, NEC ( athletic associations)

Engineering Services Architectural Services Surveying Services ( geophysical surveying ) Surveying Services ( except geophysical surveying)

Accounting, Auditing, and Bookkeeping Services ( auditing accountants) Accounting, Auditing, and Bookkeeping Services ( payroll services) Accounting, Auditing, and Bookkeeping Services ( other accounting services) Commercial Physical and Biological Research Commercial Economic, Sociological, and Educational Research ( social sciences and humanities) Commercial Economic, Sociological, and Educational Research ( market research and opinion research) Noncommercial Research Organizations ( physical, engineering, and life sciences) Noncommercial Research Organizations ( social sciences and humanities) Testing Laboratories ( except veterinary testing laboratories) Testing Laboratories ( veterinary testing laboratories) Management Services ( single family housing construction management) Management Services ( multifamily housing construction management)

Management Services ( residential remodeling construction management) Management Services ( industrial building and nonbuilding structure construction management) Management Services ( commercial and institutional building construction management) Management Services ( construction management of water, sewer, and related structure construction projects) Management Services ( construction management of oil and gas pipelines and related structure construction projects) Management Services ( construction management of power generation [ except hydroelectric] facilities, and transmission and distribution station construction projects) Management Services ( highway, street, and bridge construction management) Management Services ( construction management for other heavy and civil engineering construction) Management Services ( except construction management) Management Consulting Services ( administrative management and general management consulting) Management Consulting Services ( human resources and personnel management consulting) Management Consulting Services ( marketing consulting) Management Consulting Services ( manufacturing management, physical distribution, and site location consulting) Public Relations Services Facilities Support Management Services Business Consulting Services, NEC ( urban planners and industrial development organizations) Business Consulting Services, NEC ( traffic consultants) Business Consulting Services, NEC ( except educational testing and consulting, economic consulting, safety and security, agriculture consulting, environmental consulting firms, urban planning and industrial development organizations) Business Consulting Services, NEC ( safety, security, agriculture, and economic consultants) Business Consulting Services, NEC ( educational test development and evaluation services, educational testing services, and educational consultants) Private Households Services, NEC ( record production) Services, NEC ( music publishing) Services, NEC ( Internet broadcasting, special interest web sites, entertainment sites, and interactive game sites) Services, NEC ( Internet web search portals) Services, NEC ( actuarial consulting)

Services, NEC ( environmental consultants) Services, NEC ( scientific and related consulting services)

Services, NEC ( weather forecasting services)

Services, NEC ( authors, artists, and related technical services, independent) Executive Offices Legislative Bodies Executive and Legislative Office Combined General Government, NEC Courts Police Protection Legal Counsel and Prosecution Correctional Institutions Fire Protection Public Order and Safety, NEC Public Finance, Taxation, and Monetary Policy Administration of Educational Programs Administration of Public Health Programs Administration of Social, Human Resource and Income Maintenance Programs Administration of Veterans' Affairs, Except Health and Insurance Air and Water Resource and Solid Waste Management Land, Mineral, Wildlife, and Forest Conservation Administration of Housing Programs Administration of Urban Planning and Community and Rural Development Administration of General Economic Programs Regulation and Administration of Transportation Programs ( government air traffic control) Regulation and Administration of Transportation Programs ( except air traffic control) Regulation and Administration of Communications, Electric, Gas, and Other Utilities Regulation of Agricultural Marketing and Commodities Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors Space Research and Technology National Security International Affairs These establishments were included as auxiliaries in the 1987 Standard Industrial Classification Null Set for U. S. Null Set for U. S. tributors)


[Federal Register: November 18, 2009 (Volume 74, Number 221)]
[Notices]
[Page 59555-59556]
[DOCID:fr18no09-56]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0251]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; User Fee Cover Sheet;
Form FDA 3397

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
December 18, 2009.

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 e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0297.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Liz Berbakos, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER><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.

User Fee Cover Sheet; Form FDA 3397--(OMB Control Number 0910-0297)--
Extension

    Under sections 735 and 736 of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 379g and 379h), the Prescription Drug User Fee
Act of 1992 (PDUFA) (Public Law 102-571), as amended by the Food and
Drug Administration Modernization Act of 1997 (Public Law 105-115), the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002, which includes the Prescription Drug User Fee Amendments of
2002 (Public Law 107-188), and most recently by the Food and Drug
Administration Amendments Act of 2007 (Public Law 110-85), FDA has the
authority to assess and collect user fees for certain drug and
biologics license applications and supplements. Under this authority,
pharmaceutical companies pay a fee for certain new human drug
applications, biologics license applications, or supplements submitted
to the agency for review. Because the submission of user fees
concurrently with applications and supplements is required, review of
an application by FDA cannot begin until the fee is submitted. Form FDA
3397, the user fee cover sheet, is designed to provide the minimum
necessary information to determine whether a fee is required for review
of an application, to determine the amount of the fee required, and to
account for and track user fees. The form provides a cross-reference of
the fee submitted for an application by using a unique number tracking
system. The information collected is used by FDA's Center for Drug
Evaluation and Research (CDER) and Center for Biologics Evaluation and
Research (CBER) to initiate the administrative screening of new drug
applications, biologics license applications, and supplemental
applications.
    Respondents to this collection of information are new drug and
biologics manufacturers. Based on FDA's database system for fiscal year
(FY) 2008, there are an estimated 255 manufacturers of products subject
to the user fee provisions of PDUFA. However, not all manufacturers
will have any submissions, and some may have multiple submissions in a
given year. The total number of annual responses is based on the number
of submissions received by FDA in FY 2008. CDER received 3,107 annual
responses that include the following submissions: 147 new drug
applications; 13 biologics license applications; 1,813 manufacturing
supplements; 987 labeling supplements; and 147 efficacy supplements.
CBER received 810 annual responses that include the following
submissions: 9 biologics license applications; 743 manufacturing
supplements; 48 labeling supplements; and 10 efficacy supplements.
Based on the previous submissions that were received, the rate of these
submissions is not expected to change significantly in the next few
years. The estimated hours per response are based on past FDA
experience with the various submissions, and the average is 30 minutes.
    FDA is revising Form FDA 3397 in the following ways: (1) By
including an additional question regarding redemption of a priority
review voucher; (2) by deleting the exclusion for certain applications
submitted under section 505(b)(2) of the act (21 U.S.C. 355(b)(2)); and
(3) by making several minor editorial changes.
    In the Federal Register of June 8, 2009 (74 FR 27145), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on the information
collection.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
     Form          Respondents         per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
FDA 3397                      255                 15.36              3,917                0.5              1,959
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27719 Filed 11-17-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 52 (Monday, March 20, 2017)]
[Notices]
[Pages 14359-14360]
[FR Doc No: 2017-05434]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC17-89-000.
    Applicants: Comanche Solar PV, LLC.
    Description: Application for Authorization under Section 203 of the
Federal Power Act and Request for Waivers, Confidential Treatment,
Expedited Action and Shortened Comment Period of Comanche Solar PV,
LLC.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5249.
    Comments Due: 5 p.m. ET 3/30/17.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG17-73-000.
    Applicants: Midway Solar, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Midway Solar, LLC.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5094.
    Comments Due: 5 p.m. ET 3/30/17.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-2669-010; ER10-2670-010; ER14-1219-003; ER13-
2477-008; ER10-2674-010; ER10-2585-006; ER11-3589-004; ER15-1596-003;
ER15-1597-002; ER15-1598-003; ER15-1599-003; ER14-1569-004; ER15-1600-
002; ER15-1602-002; ER10-2619-006; ER15-1603-002; ER15-1604-002; ER10-
2616-010; ER15-1605-002; ER11-4398-006; ER10-2590-005; ER10-2593-005;
ER11-4400-007; ER15-1958-002; ER15-1606-002; ER15-1607-002; ER15-1608-
002; ER10-3247-011; ER10-1547-010; ER14-922-004; ER14-883-005; ER14-
924-004; ER13-2475-008; ER11-3866-013; ER12-192-011; ER11-3867-013;
ER15-2535-001; ER11-3857-013; ER14-1699-003; ER10-1974-018; ER10-1550-
011; ER10-1975-019; ER10-2619-007; ER10-2677-010; ER11-4266-012; ER10-
2613-006; ER10-2678-009.
    Applicants: ANP Bellingham Energy Company, LLC, Northeastern Power
Company, Sithe/Independence Power Partners, L.P., Richland-Stryker
Generation LLC, Pleasants Energy, LLC, Ontelaunee Power Operating
Company, LLC, Milford Power, LLC, Milford Power Company, LLC, Midwest
Electric Power, Inc., MASSPOWER, Liberty Electric Power, LLC, Lake Road
Generating Company, L.P., Kincaid Generation, L.L.C., Illinois Power
Resources Generating, LLC, Illinois Power Marketing Company, Illinois
Power Generating Company, Hopewell Cogeneration Limited Partnership,
Electric Energy, Inc., Dynegy Zimmer, LLC, Dynegy Stuart, LLC, Dynegy
Resources Management, LLC, Dynegy Power Marketing, LLC, Dynegy Oakland,
LLC, Dynegy Moss Landing, LLC, Dynegy Midwest Generation, LLC, Dynegy
Miami Fort, LLC, Dynegy Marketing and Trade, LLC, Dynegy Lee II, LLC,
Dynegy Killen, LLC, Dynegy Kendall Energy, LLC, Dynegy Fayette II, LLC,
Dynegy Energy Services, LLC, Dynegy Energy Services (East), LLC, Dynegy
Dicks Creek, LLC, Dynegy Conesville, LLC, Dynegy Commercial Asset
Management, LLC, Dighton Power, LLC, Casco Bay Energy Company, LLC,
Calumet Energy Team, LLC, Brayton Point Energy, LLC, Armstrong Power,
LLC, ANP Blackstone Energy Company, LLC, Dynegy Hanging Rock II, LLC,
Dynegy Washington II, LLC, Northeast Energy Associates, A Limited
Partnership, North Jersey Energy Associates, A Limited Partnership.,
Troy Energy, LLC.
    Description: Notification of Change in Status of the Dynegy MBR
Sellers.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5248.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1137-000.
    Applicants: Florida Power & Light Company.
    Description: Sec.  205(d) Rate Filing: FPL and New Hope Power
Company Standard LGIA Service Agreement No. 336 to be effective 2/28/
2017.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5214.
    Comments Due: 5 p.m. ET 3/30/17.

    Docket Numbers: ER17-1138-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Revisions to the OATT and
RAA RE External Capacity Performance Enhancements to be effective 5/9/
2017.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5215.
    Comments Due: 5 p.m. ET 3/30/17.

    Take notice that the Commission received the following qualifying
facility filings:

    Docket Numbers: QF17-742-000.
    Applicants: Department of Veteran Affairs, VHA.
    Description: Form 556 of Department of Veteran Affairs, VHA.
    Filed Date: 3/9/17.
    Accession Number: 20170309-5240.
    Comments Due: None Applicable.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 10, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-05434 Filed 3-17-17; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 15, 2007 (Volume 72, Number 31)]
[Notices]
[Page 7486]
[DOCID:fr15fe07-114]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon written request, copies available from: Securities and Exchange
Commission, Office of Filings and Information Services, Washington, DC
20549.

Extension: Form N-Q; SEC File No. 270-519; OMB Control No. 3235-0578

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.) the Securities and Exchange Commission
(``Commission'') has submitted to the Office of Management and Budget
(``OMB'') a request for extension of the previously approved collection
of information discussed below.
     Form N-Q--Quarterly Schedule of Portfolio Holdings of
Registered Management Investment Company
    Form N-Q (17 CFR 249.332 and 274.130) is a reporting form under
Sections 13 and 15(d) of the Securities Exchange Act of 1934 (15 U.S.C.
78a et seq.), in addition to the Investment Company Act of 1940 (15
U.S.C. 80a-1 et seq.) (``Investment Company Act'') that requires a fund
to file its complete portfolio schedule as of the end of its first and
third fiscal quarters with the Commission. Form N-Q contains collection
of information requirements. The respondents to this information
collection will be management investment companies subject to Rule 30e-
1 under the Investment Company Act registering with the Commission on
Forms N-1A, N-2, or N-3. Approximately 3,237 entities, including 8,963
portfolios, are required to file Form N-Q, which is estimated to
require an average of 21 hours per portfolio per year to complete. The
estimated annual burden of complying with the filing requirement is
approximately 188,223 hours. The estimates of average burden hours are
made solely for the purposes of the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.) and are not derived from a comprehensive or even
representative survey or study of the cost of Commission rules and
forms. The collection of information under Form N-Q is mandatory. The
information provided by the Form is not kept confidential. 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
control number.
    General comments regarding the above information should be directed
to the following persons: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or e-mail to:
<EMAIL_ADDRESS>and (ii) R. Corey Booth, Director/Chief

Information Officer, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, VA 22312, or send an e-
mail to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    February 5, 2007.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-2629 Filed 2-14-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 84, Number 105 (Friday, May 31, 2019)]
[Notices]
[Pages 25283-25289]
[FR Doc No: 2019-11283]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1845]

Fixed-Quantity Unit-of-Use Blister Packaging for Certain
Immediate-Release Opioid Analgesics for Treatment of Acute Pain;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the establishment of a docket to solicit public comment on a
potential modification to the Opioid Analgesic Risk Evaluation and
Mitigation Strategy (OA REMS) to require that certain solid, oral
dosage forms of immediate-release (IR) opioid analgesics commonly
prescribed for treatment of acute pain be made available in fixed-
quantity unit-of-use blister packaging for outpatient dispensing. This
could reduce the amount of unused opioid analgesics, thereby reducing
opportunities for misuse, abuse, inappropriate access, and overdose,
and possibly reducing the development of new opioid addiction.

DATES: Submit either electronic or written comments by July 30, 2019.

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 July 30, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 30, 2019. 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
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    Submit written/paper submissions as follows:
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FDA-2019-N-1845 for ``Fixed-Quantity Unit-of-Use Blister Packaging for
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FOR FURTHER INFORMATION CONTACT: Patrick Raulerson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6260, Silver Spring, MD 20993, 301-796-
3522<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In 2017, opioid-involved overdoses killed more than 47,000 people,
with

more than a third of those deaths involving prescription opioids (Ref.
1). The volume of prescription opioid analgesics dispensed has
decreased from a peak in 2012 and continues to trend downward. However,
opioid analgesics continue to be prescribed at a high rate--an
estimated 196 million retail prescriptions, resulting in an estimated
13 billion units (e.g., tablets or capsules) dispensed in 2017 from
U.S. outpatient retail pharmacies (Ref. 2). Approximately 89 percent of
people who report misuse or abuse of prescription opioid pain relievers
state they obtained their most recently used drugs from their own
prescriptions or from a friend or relative (Ref. 3). In addition, many
people who begin with misuse or abuse of prescription opioids
transition to illicit substances (Refs. 4 to 7).
    Accordingly, FDA's efforts to address the opioid crisis will
continue to include a focus on encouraging rational, ``right-size''
prescribing of opioid analgesics. This includes efforts aimed at
reducing both the number of people unnecessarily exposed to opioid
analgesics (either through legitimate prescriptions or due to
inappropriate access) and encouraging healthcare providers to prescribe
amounts that better reflect the quantity expected to meet the needs of
the patient with acute pain. At the same time, we must help ensure
appropriate access to opioid analgesics to address the medical needs of
patients experiencing acute pain severe enough to require opioid
analgesic treatment.
    The Substance Use-Disorder Prevention that Promotes Opioid Recovery
and Treatment for Patients and Communities Act (SUPPORT Act), signed
into law on October 24, 2018, provides FDA several new authorities to
address the opioid crisis. The new law allows FDA to require certain
packaging and disposal systems under a REMS for opioids and other drugs
that pose a serious risk of abuse or overdose if, among other things,
FDA determines that such packaging or disposal system may mitigate such
risks (see section 505-1(e)(4) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 355-1(e)(4))). The purpose of this notice is
to seek public comment on application of this new authority, including
the potential application of this authority to require under the OA
REMS that certain solid oral dosage forms of IR opioid analgesics
commonly used to treat acute pain be made available in fixed-quantity
unit-of-use blister packaging for outpatient dispensing.
    FDA recognizes that the fixed-quantity unit-of-use blister
packaging requirement the Agency is considering as part of the OA REMS
is just one possible application of FDA's new authorities related to
packaging and disposal. We are considering, and invite comment on,
other potential mandates, including mail-back pouches or other safe
disposal options. Furthermore, we actively encourage drug manufacturers
and others to innovate in this space. We are aware of many promising
packaging and disposal technologies that could have a positive impact
on reducing misuse, abuse, inappropriate access, accidental poisoning,
or overdose, or could otherwise facilitate the safe and appropriate use
of prescription opioid analgesics. We believe that the potential
packaging requirement outlined here could be a significant and readily
achievable step towards improving the safe use of opioids, one that
could be supplemented in the future by other safety-enhancing measures.
    FDA is establishing this docket to solicit input from stakeholders
on all aspects of this potential requirement under the OA REMS,
including comments on specific questions posed in section III.

II. Fixed-Quantity Unit-of-Use Blister Packaging for Certain IR Opioid
Analgesics for Treatment of Acute Pain

    In this section, we describe data suggesting that many patients who
are prescribed an opioid analgesic to treat acute pain use
substantially fewer units of the drug than they receive, resulting in
millions of excess opioid analgesic tablets and capsules dispensed
every year. We then describe a potential requirement, as part of the OA
REMS, that fixed-quantity unit-of-use blister packs for certain IR
opioid analgesics be made available to be dispensed in the outpatient
setting. We discuss how these proposed new packaging configurations
could encourage more appropriate prescribing, reducing the amount of
unused opioid analgesics available for misuse, abuse, inappropriate
access, and accidental poisoning or overdose. We also discuss other
potential safety benefits associated with blister packs.

A. Actual Opioid Use Compared to Prescribed Amounts for Common Surgical
Procedures and Other Conditions That Cause Acute Pain

    FDA has reviewed published studies that compared the amount of
opioid analgesics patients received to treat their acute pain with
their reported actual use after several common surgical procedures.
Most of these studies focused on opioid-na[iuml]ve adults. Opioid-
na[iuml]ve is defined in various ways across the studies; one common
definition is a patient who filled no opioid analgesic prescriptions in
the prior 12 months. We also analyzed patterns of additional fills
after an initial opioid analgesic prescription fill for acute pain in
post-surgical and primary care settings. We define an additional fill
as a second prescription fill for an opioid analgesic in a short period
after the first fill.
    In the post-surgical setting, following several common minimally or
less-invasive surgical procedures,\1\ most opioid-na[iuml]ve adults who
used an opioid analgesic appeared to use only 1 to 3 days' worth, or 15
or fewer, opioid analgesic tablets or capsules despite receiving
prescriptions exceeding the number they used (Refs. 8 to 11). Patients
reported that they usually retain these unused tablets or capsules and
store them in unsecure locations (Ref. 8), providing opportunities for
later misuse, abuse, inappropriate access, and accidental poisoning or
overdose.
---------------------------------------------------------------------------

    \1\ These surgical procedures included dermatologic surgery,
carotid endarterectomy, inguinal/femoral hernia repair, breast
lumpectomy, partial mastectomy, parathyroidectomy, thyroidectomy,
vaginal or laparoscopic hysterectomy, laparoscopic cholecystectomy,
laparoscopic colectomy, laparoscopic appendectomy, small-bowel
resection/enterolysis, minimally-invasive prostatectomy, knee
arthroscopic meniscectomy, tooth extraction, bunionectomy, carpal
tunnel release, ovarian cancer cytoreduction, breast lumpectomy, and
arteriovenous fistula creation.
---------------------------------------------------------------------------

    For example, after a less-invasive cholecystectomy, the median
number of opioid analgesic tablets prescribed to treat pain was 18,
even though 75 percent of patients used 9 or fewer tablets (each tablet
equivalent to an oxycodone 5 milligram (mg) dose). Of the 75 percent of
patients who used 9 or fewer tablets, 35 percent reported using no
opioids (Ref. 10). In an FDA analysis of surgical procedures in opioid-
na[iuml]ve adults, our model estimated that less than 20 percent of
patients undergoing laparoscopic cholecystectomy might need an
additional fill if they were given a 1-day supply of an opioid
analgesic, but the median days actually supplied to patients was 4,
with a median of 30 tablets per prescription filled (Ref. 11).
    The unused tablets from each opioid analgesic prescription for a
common surgical procedure such as cholecystectomy--there were an
estimated 950,000 cholecystectomies in community hospitals in the
United States in 2014 (Ref. 12)--contribute significantly to the number
of unused tablets available for misuse, abuse,

inappropriate access, and accidental poisonings or overdose. In our
analyses of opioid analgesic prescription fills after surgical
procedures and published studies in which patients were asked about
their opioid analgesic use after surgical procedures, we also found
that about 30 percent of patients either never filled their
prescriptions or filled them but did not actually consume any of the
tablets or capsules following several types of minimally or less-
invasive surgical procedures (e.g., laparoscopic cholecystectomy,
laparoscopic hysterectomy, laparoscopic appendectomy) (Refs. 10 and
13).
    We observed a similar pattern of prescribing more than patients
appeared to use for several other common non-surgical acute pain
conditions in the primary care setting. For example, for headaches,
muscular strains and sprains, and certain forms of acute back pain, in
our modeling of additional fill patterns, most patients could be
expected to only need an opioid analgesic for up to 3 days, but they
often received enough doses to treat pain for a significantly longer
period (Ref. 14).

B. Proposal: 5-, 10-, and 15-Count Blister Packages of Certain IR
Opioid and IR Opioid/Acetaminophen Products

    As discussed above, we have found that for many common, minimally
or less-invasive surgical procedures and some common acute pain
conditions treated in the primary care setting for which opioid
analgesics are prescribed, we expect most opioid-na[iuml]ve adult
patients to use significantly fewer tablets or capsules than the
average prescription has historically provided. Most of these patients
appeared to use an opioid for 1 to 3 days and used 15 or fewer tablets
or capsules when they used an opioid analgesic to treat their pain.
    Accordingly, we anticipate that if 5-, 10-, and 15-count blister
package configurations of certain IR opioid analgesics commonly used
for treatment of acute pain were made available, one or more of these
options could be expected to meet the needs of most opioid-na[iuml]ve
adults who require opioid therapy following many common minimally or
less-invasive procedures and other acute pain conditions for which
opioid analgesics are prescribed. We further anticipate that
utilization of these fixed-quantity unit-of use blister package
configurations would substantially reduce the quantity of opioid
analgesics dispensed per prescription compared to the status quo. Table
1 below compares the morphine milligram equivalent (MME) of 5-, 10-,
and 15-count packaging of seven commonly prescribed opioid analgesic
products to the mean MME and mean number of tablets per ``new-to-
therapy start prescriptions'' (NTS Rx) dispensed in 2017. This table
illustrates the potential for utilization of fixed-quantity unit-of-use
blister packages to substantially reduce the amount of opioid
analgesics prescribed for opioid-na[iuml]ve patients receiving
prescriptions for seven commonly prescribed products.

 Table 1--5-, 10-, and 15-Count Packages by MME Content/Package Compared to Mean MME and Mean Tablets per NTS Rx
                                          Dispensed in 2017
----------------------------------------------------------------------------------------------------------------
                                                 MME per package                            2017 NTS Rx
                                --------------------------------------------------------------------------------
          Oral tablets             5-Count (1      10-Count (2     15-Count (3     Mean MME/NTS    Mean tabs/NTS
                                     days *)         days *)         days *)            Rx              Rx
----------------------------------------------------------------------------------------------------------------
Hydrocodone 5 mg/APAP 325 mg...              25              50              75              108              22
Tramadol 50 mg.................              25              50              75              180              36
Oxycodone 5 mg/APAP 325 mg.....            37.5              75           112.5              199              27
Codeine 30 mg/APAP 300 mg......            22.5              45            67.5               96              21
Hydrocodone 7.5 mg/APAP 325 mg.            37.5              75           112.5              192              26
Hydrocodone 10 mg/APAP 325 mg..              50             100             150              393              39
Oxycodone 5 mg.................            37.5              75           112.5              261              35
----------------------------------------------------------------------------------------------------------------
 New to Therapy Start Prescriptions (NTS Rx): Nationally estimated number of first opioid analgesic
  prescriptions dispensed to patients with no opioid analgesic dispensed in previous 12 months. Source: IQVIA,
  National Prescription Audit New To Brand (NPA NTB), year 2017. Extracted January 2019.
* Days' supply does not correlate well with the number of units to package, estimated days supply based on
  around-the-clock dosing of 1-2 tablets every 4-6 hours PRN.
MME Estimates based on CMS's Opioid Oral Morphine Milligram Equivalent (MME) Conversion Factors. Accessed at
  https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-Aug-2017.pdf.

    Our analyses revealed that the number of days for which opioids are
prescribed or used does not correlate well with a specific number of
tablets or capsules per day, as what is considered an appropriate
amount of an opioid analgesic for a day's worth of treatment varies
across procedures and patients. This type of variation is reflected in
the labeling of IR opioid analgesics, which describes the need to
individualize dosing regimens based on patient treatment goals.
Accordingly, we are considering requiring that applicants or
application holders make available 5-, 10-, and 15-count blister pack
configurations without prespecifying that any of these given
configurations constitutes an appropriate amount of opioid analgesic
for a specified duration, such as a specific number of days of
treatment. Rather, we anticipate that prescribers would use their
expertise and consult appropriate prescribing guidelines to determine
which, if any, of the newly available blister packages is appropriate
for their patients on a case-by-case basis.
    We note that several existing prescribing guidelines recommend
outpatient days of treatment or quantity of tablets or capsules for
common minimally or less-invasive surgical procedures or acute pain
conditions treated in primary care and emergency department settings
that are in line with our proposal for 5-, 10-, and 15-count packages
of certain IR opioid analgesics (Refs. 15 to 21). Additionally, section
3002 of the SUPPORT Act requires FDA to develop evidence-based opioid
analgesic prescribing guidelines for the indication-specific treatment
of acute pain only for the relevant therapeutic areas where such
guidelines do not exist. These guidelines, once available, should help
to encourage more appropriate, ``right-sized'' opioid analgesic
prescribing. We anticipate that these prescribing guidelines, as well
as prescribing guidelines developed by others, would provide
appropriate recommendations regarding the use of blister pack
configurations made available pursuant to an OA REMS packaging
requirement, facilitating

prescriber understanding and uptake of such product packaging
configurations.

C. New Packaging/Disposal REMS Element

    Section 3032 of the SUPPORT Act amends FDA's REMS authority.
Specifically, as a part of a REMS, FDA may now require that a drug for
which there is a serious risk of an adverse event occurring from abuse
or overdose be made available for dispensing to certain patients in
unit-dose packaging, packaging that provides a set duration, or another
packaging system that FDA determines may mitigate such serious risk (21
U.S.C. 355-1(e)(4)). FDA may also require that such drugs be dispensed
to certain patients with a safe disposal packaging or safe disposal
system for purposes of rendering drugs non-retrievable if FDA
determines that such safe disposal packaging or system may mitigate a
serious risk of an adverse event occurring from abuse or overdose of
the drug and is sufficiently available (see section 505-1(e)(4) of the
FD&C Act).
    A packaging or disposal requirement under this provision is
applicable to prescription drugs that are the subject of applications
approved under section 505(b) of the FD&C Act (21 U.S.C. 355(b)) or
section 351 of the Public Health Service Act (42 U.S.C. 242), as well
as drugs that are the subject of abbreviated new drug applications
(ANDAs) approved under section 505(j) of the FD&C Act if a packaging or
disposal requirement is required for the applicable listed drug (see
section 505(i)(1)(B) of the FD&C Act). The law provides that FDA will
permit packaging systems and safe disposal packaging or safe disposal
systems for drugs that are the subject of ANDAs that are different from
those required for the applicable listed drugs (see section
505(i)(2)(B) of the FD&C Act). FDA must take into consideration the
burden on patients' access to the drug and the burden on the healthcare
delivery system that would be associated with any such packaging or
disposal requirement and must consult with other relevant Federal
Agencies with authorities over drug disposal packaging in certain
circumstances (see section 505-1(e)(4) of the FD&C Act).
    FDA is contemplating using this new authority to require fixed-
quantity unit-of-use blister packaging for certain IR opioid analgesics
under the OA REMS, as described in this notice. For purposes of
soliciting comments, FDA is considering the following general process
for any packaging requirement under the OA REMS.
    First, for already-approved opioid analgesic products, FDA would
notify the application holders by letter that the Agency is requiring a
modification to the OA REMS to include a packaging requirement. The
notification letter would set forth details of the required
modification, including the specific products subject to the new
requirement, the number of blister packaging configurations required
for each product and the number of units in each, key information
regarding safe and effective use of opioid analgesics to be printed on
the blister packaging, and other data and information needed for FDA to
review and approve new blister package configurations (e.g., stability
data).
    Second, the application holders subject to the OA REMS would submit
a proposed REMS modification within 120 days or such other reasonable
time as FDA specifies. FDA anticipates that the proposed OA REMS
modification would include all necessary specifications and timeframes
for the blister packages. FDA would expect for the notification
letters, the proposed REMS modifications, and the REMS approval to be
sufficiently general that they are uniform across all affected
application holders and products, to the extent possible.
    Third, the application holders of products that are subject to the
blister packaging requirement would individually submit a prior
approval supplement (PAS) to their respective applications to obtain
approval of the new packaging configurations.
    For new drug applications (NDAs) or ANDAs for opioid analgesics
that have not yet been approved, FDA anticipates that it would work
with applicants at an appropriate stage in the application process to
discuss blister packaging configurations that should be included as a
part of the application to comply with the REMS.
    FDA is also considering whether a staggered blister packaging
requirement, a conditional requirement, or both would be appropriate.
First, we are considering whether it may be appropriate to first
require blister packages be made available for the most commonly
prescribed IR opioid analgesics for treatment of acute pain, and then
to require the blister packages be made available for other, less
commonly prescribed products. In table 2, FDA has identified four
opioid analgesics, alone or in combination with acetaminophen,
formulated as seven specific drugs at specific strengths, that together
account for almost 90 percent of all NTS Rx.\2\
---------------------------------------------------------------------------

    \2\ These data reflect recent dispensing patterns and should not
be interpreted as appropriate starting doses for opioid-na[iuml]ve
patients. The data may include patients who are not, in fact,
opioid-na[iuml]ve because they received opioids not captured in the
database (e.g., inpatient or emergency room prescribing).

   Table 2--Nationally Estimated Number of First Opioid Analgesic Prescriptions Dispensed to Patients With No
      Opioid Analgesic Prescription Dispensed in Previous 12 Months From U.S. Outpatient Retail Pharmacies
----------------------------------------------------------------------------------------------------------------
                                      Prescriptions dispensed as ``New to Opioid Analgesic Patients'' year 2017
      Oral solid formulations      -----------------------------------------------------------------------------
                                           NTS Rx *            Percent              Tabs              Percent
----------------------------------------------------------------------------------------------------------------
Hydrocodone 5 mg/APAP 325 mg......  11.2M................              32   242M................              26
Tramadol 50 mg....................  5.8M.................              17   208M................              22
Oxycodone 5 mg/APAP 325 mg........  4.7M.................              14   126M................              13
Codeine 30 mg/APAP 300 mg.........  4.6M.................              13   98M.................              10
Hydrocodone 7.5 mg/APAP 325 mg....  2.7M.................               8   69M.................               7
Hydrocodone 10 mg/APAP 325 mg.....  14M..................               4   55M.................               6
Oxycodone 5 mg....................  1.3M.................               4   46M.................               5
All Others........................  2.7M.................               8   92M.................              10
                                   -----------------------------------------------------------------------------

    Total New to Opioids            34.4M................             100   937M................             100
     Prescriptions.
----------------------------------------------------------------------------------------------------------------
Source: IQVIA, National Prescription Audit New to Brand (NPA NTB), year 2017. Extracted January 2019.
* New-to-Therapy Start Prescriptions (NTS Rx): Nationally estimated number of first opioid analgesic
  prescriptions dispensed to patients with no opioid analgesic dispensed in previous 12 months.

    Starting with these products could help expedite the availability
of blister packs for products in a way that could have the greatest
public health impact, based on current prescribing patterns.
    We are continuing to consider the potential public health
consequences of requiring these specific products to be made available
in fixed-quantity unit-of-use blister packages, and, if so, in what
specific configurations, including the precise number of units to be
included in each configuration. We are also continuing to consider for
which other products, in addition to those identified in table 2, it
could be appropriate to mandate blister packaging, and, if so, in what
specific configurations. We recognize that the products in table 2 do
not represent the lowest available strengths available for opioid
analgesics. For example, although hydrocodone 2.5 mg/325 mg
acetaminophen combination products are available, they accounted for
less than 0.1 percent of total prescriptions dispensed to patients with
no previous opioid analgesic prescription dispensed in the prior 12-
month period. Additionally, we note that the proposed fixed-quantity
unit-of-use blister packages containing hydrocodone 10 mg would have a
substantially higher MME than the other products on this list in the
same quantities.
    Furthermore, we are considering whether it may be appropriate to
impose only a conditional mandate on approved but discontinued
products, whereby the application holders of such products would only
need to seek approval to produce blister package configurations of
those products if they decide to reintroduce them to the market. This
would reduce the burden on both application holders and FDA associated
with the production and evaluation of blister package configurations
for products that may not ever be marketed.
    Finally, we are considering what measures may be appropriate to
help ensure that blister packaging required as part of the OA REMS is
sufficiently available in the market. How could the REMS be designed to
set bright-line and evenhanded standards for the availability of
blister packages and facilitate the Agency's ability to monitor
compliance? For example, should FDA consider requiring that a certain
fraction of marketed product be in blister package configurations to
encourage the broader use of these products, or that the application
holder continually has product available for sale in the required
blister package configurations? Should FDA consider requiring that
application holders periodically report on the production and uptake of
their blister package configurations?

D. Safety-Enhancing Benefits of Fixed-Quantity Blister Packaging for
Opioid Analgesics for Treatment of Acute Pain

    The availability of fixed-quantity unit-of-use blister packages for
certain IR opioid analgesics dispensed in the outpatient setting could
help encourage and facilitate more rational ``right-size'' opioid
analgesic prescribing by providing a range of convenient options to
prescribers that corresponds well with the expected needs of many
opioid-na[iuml]ve patients with acute pain. The availability of such
product configurations could help ``nudge'' prescribers to more
carefully consider prescribing an amount of opioid analgesics better
matched to the patient's needs. We anticipate that opioid prescribing
guidelines, including those required to be developed under the SUPPORT
Act, will provide appropriate recommendations regarding the use of any
available blister packaging configurations. Furthermore, assuming these
configurations are on their drug formularies, prescribers could readily
select one of these configurations in computer physician order entry
systems. Of course, prescribers will continue to exercise their
clinical judgement to prescribe opioid analgesics in the quantity
appropriate for a given patient; the blister packaging configurations
contemplated in this notice would not be required to be the only
packaging option available for these products.
    In short, FDA anticipates that the widespread availability of
fixed-quantity unit-of-use blister packaging could play a significant
role in reducing overprescribing that leads to unused opioid analgesics
without impairing access to opioid analgesics for patients who need
them. Unused opioid medication is often retained and stored in unsecure
locations (Ref. 8) where it can be accessed for prescription opioid
analgesic misuse and abuse. Reducing the amount of unused opioid
analgesics reduces opportunities for misuse, abuse, inappropriate
access, or overdose, and could reduce the development of new addiction.
    In addition, blister packaging could help reduce the incidence of
accidental childhood poisoning. FDA expects that, for blister packaging
that may be required under the OA REMS, each tablet or capsule would be
individually protected with child-resistant packaging,\3\ making it
harder for a child to be exposed to a toxic or lethal dose compared to
a child-resistant pill bottle in the event that the child-resistant
packaging is defeated. That is, even if a child accesses one of the
tablets or capsules (for example, from a broken seal on a blister pack
well), the remaining tablets or capsules would remain sealed.
Furthermore, blister packaging offers passive protection with no
further intervention required from an adult to keep the packaging child
resistant. In contrast, when an adult opens a child-resistant pill
bottle, he or she must take an additional step to close the cap
properly to prevent a child from accessing the contents.
---------------------------------------------------------------------------

    \3\ All drugs consisting in whole or in part of a controlled
substance in a dosage form intended for oral administration must be
in child-resistant packaging (see 16 CFR 1700.14(a)(4), 16 CFR
1700.15; see generally 15 U.S.C. 1471-76, 16 CFR part 1700).
---------------------------------------------------------------------------

    Blister packaging can also be designed to include additional
information regarding the safe and appropriate use of the drug. If this
information were printed on the blister packaging itself, it could not
be easily separated from the drug nor could it be easily discarded. As

such, blister packaging presents an opportunity to educate patients
each time the drug is administered, potentially improving patient
understanding of and compliance with key information regarding
appropriate dosing, storage, disposal, or other important information
regarding the safe and appropriate use of opioid analgesics. FDA is
continuing to consider what information concerning the safe and
appropriate use of opioid analgesics would be beneficial to include on
blister packaging.
    Furthermore, blister packaging may make it easier for a patient or
caregiver to identify whether a third party, such as a member of the
household or a visitor, has inappropriately accessed the opioid
medication. While such packaging would not thwart a determined attempt
to access the drug, the patient or caregiver is more likely to be
alerted to inappropriate access of opioids contained in a blister pack
compared to opioids contained in a standard pill bottle. Additionally,
the fact that monitoring for inappropriate access may be easier with
certain blister packaging (compared to a standard pill bottle) may
serve as a partial deterrent to inappropriate access.

III. Request for Comments

    FDA is soliciting comment from stakeholders regarding the potential
blister packaging requirement described in this notice. In addition to
any other aspects of or issues raised by the potential mandate
stakeholders may care to comment upon, FDA is interested in comments on
the following topics:
    1. Comment on the potential safety advantages and public health
impact of broadly available, fixed-quantity unit-of-use blister
packages of opioid analgesics for treatment of acute pain in adults.
    2. Comment on the specific IR opioid analgesic drug products for
which it may be appropriate to require that blister packaging be made
available, as well as the specific blister packaging configuration(s)
it may be appropriate to require for each product or class of products,
including the number of tablets or capsules to be included in the
configuration(s). Specifically, please comment on the potential utility
of the 5-, 10-, and 15-count configurations discussed in section II.B.
    3. Comment on what specific information regarding the safe and
effective use of opioid analgesics would be most beneficial to include
in blister packaging configurations of these products.
    4. Comment on possible negative impacts of mandatory blister
packaging, including any unintended consequences. For example, what
steps could help ensure that the blister packaging contemplated here
would not inadvertently lead to underprescribing for patients who need
opioid analgesics to treat acute pain conditions and blister packs
being inappropriately prescribed and/or dispensed to patients who may
have difficulty accessing drugs contained in blister packaging?
    5. Comment on the potential challenges, including technical and
logistical challenges, with the potential blister packaging
requirement. What factors could impact application holders' ability to
produce blister packaging of the type described in this notice?
    6. How much time would be needed for application holders to submit
prior approval supplements for blister packaging that would satisfy the
proposed REMS requirements discussed in section II.C? How much time
would be needed for an application holder to develop REMS-compliant
packaging and manufacture sufficient quantities to perform the
stability and other product quality testing necessary to support the
approval of a PAS, and how much time would be needed to perform such
testing? How much time after approval of a PAS would be needed for an
application holder to manufacture and make the product commercially
available?
    7. Comment on the idea of implementing a blister packaging mandate
in a staggered fashion, targeting the products most commonly prescribed
to treat acute pain first, as well as the idea of imposing a
conditional mandate for discontinued products. Are there other ways the
Agency could consider staggering implementation of this requirement to
minimize burden on manufacturers and other stakeholders, while
maximizing the public health benefit?
    8. Comment on how the OA REMS modification could be designed and
implemented to help ensure that required blister packaging is
sufficiently available. Comment on the impact of any opioid analgesic
blister packaging requirement on other stakeholders, including
prescribers, payers, and pharmacies. What steps could be taken to help
encourage uptake and mitigate any adverse impacts associated with such
a mandate?
    9. As noted, FDA recognizes that the approach described in this
notice is only one possible use of the Agency's REMS authority
concerning packaging. Comment on other possible uses of this authority.

IV. References

    The following references marked with an asterisk (*) are on display
at 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 also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

* 1. Scholl, L., Seth, P., Kariisa, M., et al., ``Drug And Opioid-
Involved Overdose Deaths--United States, 2013-2017.'' Morbidity and
Mortality Weekly Report (MMWR), vol. 67, pp. 67:1419-1427, 2019
(available at http://dx.doi.org/10.15585/mmwr.mm675152e1).
* 2. Mundkur, M., ``Background and Rationale for the Development of
Opioid-Sparing and Opioid-Replacement Drugs.'' Anesthetic and
Analgesic Drug Products Advisory Committee Meeting. Presented on
November 15, 2018. Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM626666.pdf.
Accessed April 1, 2019.
* 3. Substance Abuse and Mental Health Services Administration
(2018), ``Key Substance Use and Mental Health Indicators in the
United States: Results from the 2017 National Survey on Drug Use and
Health'' (HHS Publication No. SMA 18-5068, NSDUH Series H-53).
Rockville, MD: Center for Behavioral Health Statistics and Quality,
Substance Abuse and Mental Health Services Administration (available
at https://www.samhsa.gov/data/).
4. Carlson, R., Nahhas, R., Martins, S., et al., ``Predictors of
Transition to Heroin Use Among Initially Non-Opioid Dependent
Illicit Pharmaceutical Opioid Users: A Natural History Study.'' Drug
and Alcohol Dependence, vol. 160, pp. 127-134, 2016.
5. Harocopos, A., Allen, B., and Paone, D., ``Circumstances and
Contexts of Heroin Initiation Following Non-Medical Opioid Analgesic
Use in New York City.'' International Journal of Drug Policy, vol.
28, pp. 106-112, 2016.
6. Surratt, H., Kurtz, S., Buttram, M., et al., ``Heroin Use Onset
Among Nonmedical Prescription Opioid Users in the Club Scene.'' Drug
and Alcohol Dependence, vol. 179, pp. 131-138, 2017.
7. Lankenau, S., Teti, M., Silva, K., et al., ``Initiation into
Prescription Opioid Misuse Among Young Injection Drug

Users.'' International Journal of Drug Policy, vol. 33, pp. 23:37-
44, 2012.
8. Bicket, M., Long, J., Pronovost, P., et al., ``Prescription
Opioid Analgesics Commonly Used After Surgery: A Systematic
Review.'' JAMA Surgery, vol. 152, pp. 1066-1071, 2017 (available at
doi:10.1001/jamasurg.2017.0831, published online August 2, 2017).
9. Howard, R., Fry, B., Gunaseelan, V., et al., ``Association of
Opioid Prescribing with Opioid Consumption After Surgery in
Michigan.'' JAMA Surgery, vol. 154, p. e184234, 2019 (available at
doi:10.001/jamasurg.2018.4234, published online November 7, 2018).
10. Thiels, C., Ubl, D., Yost, K., et al., ``Results of a
Prospective, Multicenter Initiative Aimed at Developing Opioid-
Prescribing Guidelines After Surgery.'' Annals of Surgery, vol. 268,
pp. 457-468, 2018 (available at doi:10.1097/SLA.0000000000002919).
11. Mundkur, M., Meyer, T., Menzin, T., et al., ``Estimating the
Optimal Duration of Initial Opioid Analgesic Prescriptions in Post-
Surgical Populations Using FDA's Sentinel Distributed Database.''
Pharmacoepidemiology and Drug Safety, S2: Abstracts of the 34th
International Conference on Pharmacoepidemiology & Therapeutic Risk
Management, Abstract #392, vol. 27, p. 181 (available at
doi:10.1002/pds.4629).
12. Steiner, C.A., Karaca, Z., Moore, B.J., et al., ``Surgeries in
Hospital-Based Ambulatory Surgery and Hospital Inpatient Settings,
2014.'' HCUP Statistical Brief #223, 2017 (available at www.hcup-us.ahrq.gov/reports/statbriefs/sb223-Ambulatory-Inpatient-Surgeries-2014.pdf).
13. Mundkur, M., unpublished data.
* 14. Mundkur, M., Franklin, J., Abdia, Y., et al., ``Days' Supply
of Initial Opioid Analgesic Prescriptions and Additional Fills for
Acute Pain Conditions Treated in the Primary Care Setting--United
States, 2014.'' Morbidity and Mortality Weekly Report, vol. 68, pp.
140-143, 2019.
* 15. Dowel, D., Haegerich, T., and Chou, R., ``CDC Guideline for
Prescribing Opioids for Chronic Pain--United States, 2016.''
Morbidity and Mortality Recommended Weekly Report, vol. 65(1), pp.
1-49, 2016.
16. Opiate Prescribing Engagement Network, ``Emergency Department
Prescribing Recommendations'' (available at http://michigan-open.org/emergency-department-prescribing-recommendations/),
accessed January 5, 2019.
17. Ohio Opiate Action Team, ``Ohio Guidelines for Emergency and
Acute Care Facility Opioid and Other Controlled Substances (OOCS)
Prescribing'' (available at https://mha.ohio.gov/Portals/0/assets/Initiatives/GCOAT/Guidelines-ED-Acute-Care.pdf), accessed January 5,
2019.
18. New York City Emergency Department, ``Discharge Opioid
Prescribing Guidelines'' (available at https://www1.nyc.gov/assets/doh/downloads/pdf/basas/opioid-prescribing-guidelines.pdf), accessed
January 5, 2019.
19. Thiels, C., Ubl, D., Yost, K., et al., ``Results of a
Prospective, Multicenter Initiative Aimed at Developing Opioid-
Prescribing Guidelines After Surgery.'' Annals of Surgery, vol. 268,
pp. 457-468, 2018.
20. The Regents of the University of Michigan, ``Opioid Prescribing
Recommendations for Surgery'' (available at https://opioidprescribing.info/), last updated April 11, 2019, accessed
April 17, 2019.
21. Overton, H., Hanna, M., Bruhn, W., et al., ``Opioid-Prescribing
Guidelines for Common Surgical Procedures: An Expert Panel
Consensus.'' Journal of the American College of Surgeons, vol. 227,
pp. 411-418, 2018.

    Dated: May 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11283 Filed 5-30-19; 8:45 am]
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[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Page 65835]
[FR Doc No: 2015-27394]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, October
29, 2015 at 12:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matter at the Closed Meeting.
    Commissioner Stein, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Adjudicatory matters;
    Opinion;
    Post argument discussion; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: October 22, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-27394 Filed 10-23-15; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register: March 13, 2007 (Volume 72, Number 48)]
[Notices]
[Page 11350-11351]
[DOCID:fr13mr07-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 120-020]

Southern California Edison Company; Notice of Application and
Amended Preliminary Draft Environmental Assessment Tendered for Filing
With the Commission, and Establishing Procedual Schedule for Licensing
and Deadline for Submission of Final Amendments

March 7, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New License for Major Project-Existing Dam.
    b. Project No: P-120-020.
    c. Date Filed: February 23, 2007.
    d. Applicant: Southern California Edison Company.
    e. Name of Project: Big Creek No. 3 Hydroelectric Power Project.
    f. Location: The Big Creek No. 3 Hydroelectric Project is located
in Fresno and Madera Counties, California near the town of Auberry
within the San Joaquin River watershed. The Project occupies 377.16
acres of Federal lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Russ W. Krieger, Vice President, Power
Production, Southern California Edison Company, 300 North Lone Hill
Ave., San Dimas, California 91773. Phone:<PHONE_NUMBER>.
    i. FERC Contact: Jim Fargo,<PHONE_NUMBER>, or e-mail:
<EMAIL_ADDRESS>
    j. Cooperating Agencies: We are asking Federal, State, local, and
tribal agencies with jurisdiction and/or special expertise with respect
to environmental issues to cooperate with us in the preparation of the
environmental document. Agencies who would like to request cooperating
status should follow the instructions for filing comments described in
item k below. Agencies granted cooperating status will be precluded
from being an intervenor in this proceeding consistent with the
Commission's regulations.
    k. Deadline for requests for cooperating agency status: 60 days
from the date of this notice. All documents (original and eight copies)
should be filed with: Philis J. Posey, Acting Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
Comments may be filed electronically via the Internet in lieu of paper;
see 18 CFR 385.2001(a)(1)(iii) and the instructions

on the Commission's Web site (http://www.ferc.gov) under the ``e-

Filing'' link. After logging into the e-Filing system, select ``Comment
on Filing'' from the Filing Type Selection screen and continue with the
filing and process. The Commission strongly encourages electronic
filing.
    l. Status: This application has not been accepted for filing. We
are not soliciting motions to intervene, protests, or final terms and
conditions at this time.
    m. Description of Project: The existing Big Creek No. 3
Hydroelectric Power Project consists of one powerhouse; one moderate-
sized dam and forebay; and one water conveyance system. The Project is
operated as a reservoir-storage type plant with an installed operating
capacity of 174.45 MW. Water for the Project is taken from the San
Joaquin River just downstream of its confluence with Big Creek and
conveyed to the Big Creek No. 3 Powerhouse through Tunnel No. 3. The
energy generated by the Project is transmitted to the SCE transmission
and distribution system and used for public utility purposes. The
project would have an average annual generation of 804,240 megawatt-
hours.
     Powerhouse: Big Creek Powerhouse No. 3, with five turbine
generator units.
     Moderate-sized dam and forebay: Dam 6 and Dam 6
Impoundment, with a capacity of about 933 ac-ft, at an elevation of
about 2,230 ft above mean sea level (msl).
     Water conveyance system: Powerhouse No. 3 water conveyance
system, about 5.3 miles long, conveys water from Dam No. 6 Impoundment
to Big Creek Powerhouse No. 3 through a tunnel with a capacity of about
3,250 cfs. The system includes a pressure-relief valve system and
penstocks providing pressurized water from the tunnel to the turbine.
    n. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the three digits in the docket
number field to access the document. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>or toll free at (866)
208-3676, or for TTY, contact<PHONE_NUMBER>. A copy is also available
for inspection and reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    o. With this notice, we are initiating consultation with the
California State Historic Preservation Officer (SHPO), as required by
section 106, National Historic Preservation Act, and the regulations of
the Advisory Council on Historic Preservation, 36 CFR 800.4.
    p. Procedural schedule and final amendments: The application will
be processed according to the following Hydro Licensing Schedule.
Revisions to the schedule will be made if the Commission determines it
necessary to do so:

------------------------------------------------------------------------
             Milestone                          Tentative date
------------------------------------------------------------------------
Issue Acceptance/Deficiency Letter   June 2007.
 and request Additional
 Information, if needed.
Notice asking for final terms and    September 2007.
 conditions.
Notice of the availability of the    March 2008.
 draft EIS.
Notice of the availability of the    September 2008.
 final EIS.
------------------------------------------------------------------------

    Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
soliciting final terms and conditions.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-4477 Filed 3-12-07; 8:45 am]

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[Federal Register: November 8, 2007 (Volume 72, Number 216)]
[Notices]
[Page 63171]
[DOCID:fr08no07-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP08-12-000]

Southern Star Central Gas Pipeline, Inc.; Notice of Application

November 1, 2007.
    Take notice that on October 30, 2007, Southern Star Central Gas
Pipeline, Inc. (Southern Star), 4700 State Highway 56, Owensboro,
Kentucky 42301, filed in Docket No. CP08-12-000, an application
pursuant to section 7(b) of the Natural Gas Act (NGA) and Part 157 of
the Commission's Regulations, for an order permitting and approving the
abandonment by reclaim of two 660-horsepower White Superior compressor
units located in Johnson County, Kansas, all as more fully set forth in
the application which is on file with the Commission and open to public
inspection. This filing is accessible on-line 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<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Southern Star states that due to the abandonment of the Craig
storage field as authorized by order of the Commission in Docket No.
CP98-280-000 (85 FERC ]61,184) the compressor engines are no longer
required to provide the storage field compression service for which
they were originally installed. Southern Star stated in the
aforementioned application that the compressor engines at the Craig
station were being evaluated at that time for use elsewhere on its
pipeline system.
    Southern Star further states that one compressor engine will be
removed from the Craig compressor station, refurbished and installed at
the South Welda storage field as booster compression. Southern Star has
requested authorization for said engine installation at South Welda
storage field in Docket No. CP08-4-000, which is currently pending
before the Commission. The other compressor engine will be removed and
warehoused at Southern Star's Welda compressor station. The existing
Craig compressor building will remain in place to be used as a
warehouse facility for pipe, equipment and supplies.
    Any questions regarding this application should be directed to
David N. Roberts, Manager, Regulatory Affairs, at<PHONE_NUMBER>.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link at http://www.ferc.gov. The Commission strongly encourages

intervenors to file electronically. 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.
    Comment Date: November 23, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-21919 Filed 11-7-07; 8:45 am]

BILLING CODE 6717-01-P