[Federal Register Volume 81, Number 113 (Monday, June 13, 2016)]
[Notices]
[Page 38168]
[FR Doc No: 2016-13896]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice Of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP16-1003-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) rate filing per 154.204: Non-Conforming
Agreement--Narragansett 510209 to be effective 6/1/2016.
    Filed Date: 6/1/16.
    Accession Number: 20160601-5124.
    Comments Due: 5 p.m. ET 6/13/16.

    Docket Numbers: RP16-1004-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Sec.  4(d) rate filing per 154.204: Cap Rel Neg Rate
Agmt (QEP 37657 to Trans LA 46521) to be effective 6/2/2016.
    Filed Date: 6/1/16.
    Accession Number: 20160601-5181.
    Comments Due: 5 p.m. ET 6/13/16.

    Docket Numbers: RP16-1005-000.
    Applicants: Equitrans, L.P.
    Description: Sec.  4(d) rate filing per 154.204: Negotiated
Capacity Release Agreements--6/01/2016 to be effective 6/1/2016.
    Filed Date: 6/1/16.
    Accession Number: 20160601-5227.
    Comments Due: 5 p.m. ET 6/13/16.

    Docket Numbers: RP16-1006-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Sec.  4(d) rate filing per 154.204: GEH--Multi-Party
Contracts to be effective 7/1/2016.
    Filed Date: 6/1/16.
    Accession Number: 20160601-5289.
    Comments Due: 5 p.m. ET 6/13/16.

    Docket Numbers: RP16-1007-000.
    Applicants: Columbia Gulf Transmission, LLC.
    Description: Sec.  4(d) rate filing per 154.204: GEH--Multi-Party
Contracts to be effective 7/1/2016.
    Filed Date: 6/1/16.
    Accession Number: 20160601-5290.
    Comments Due: 5 p.m. ET 6/13/16.

    Docket Numbers: RP16-1009-000.
    Applicants: Crossroads Pipeline Company.
    Description: Sec.  4(d) rate filing per 154.204: GEH--Multi-Party
Contracts to be effective 7/1/2016.
    Filed Date: 6/1/16.
    Accession Number: 20160601-5293.
    Comments Due: 5 p.m. ET 6/13/16.

    Docket Numbers: RP16-1010-000.
    Applicants: Central Kentucky Transmission Company.
    Description: Sec.  4(d) rate filing per 154.204: GEH--Multi-Party
Contracts to be effective 7/1/2016.
    Filed Date: 6/1/16.
    Accession Number: 20160601-5300.
    Comments Due: 5 p.m. ET 6/13/16.

    Docket Numbers: RP16-1011-000.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Sec.  4(d) rate filing per 154.204: Operational Sales
at Pool Filing to be effective 7/1/2016.
    Filed Date: 6/1/16.
    Accession Number: 20160601-5301.
    Comments Due: 5 p.m. ET 6/13/16.

    Docket Numbers: RP16-1012-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: Sec.  4(d) rate filing per 154.204: Neg Rate 2016-06-
01 Perm Partial BP to be effective 6/1/2016.
    Filed Date: 6/1/16.
    Accession Number: 20160601-5338.
    Comments Due: 5 p.m. ET 6/13/16.

    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 Sec.  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: June 2, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-13896 Filed 6-10-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Page 47799]
[FR Doc No: 2020-17113]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3771]

Report on the Performance of Drug and Biologics Firms in
Conducting Postmarketing Requirements and Commitments; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the Agency's annual report entitled ``Report on the
Performance of Drug and Biologics Firms in Conducting Postmarketing
Requirements and Commitments.'' Under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), FDA is required to report annually on the
status of postmarketing requirements (PMRs) and postmarketing
commitments (PMCs) required of, or agreed upon by, application holders
of approved drug and biological products. The report on the status of
the studies and clinical trials that applicants have agreed to, or are
required to, conduct is on the FDA's ``Postmarketing Requirements and
Commitments: Reports'' web page.

FOR FURTHER INFORMATION CONTACT: Kathy Weil, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5367, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 506B(c) of the FD&C Act (21 U.S.C. 356b(c)) requires FDA to
publish an annual report on the status of postmarketing studies that
applicants have committed to, or are required to conduct, and for which
annual status reports have been submitted.
    Under Sec. Sec.  314.81(b)(2)(vii) and 601.70 (21 CFR
314.81(b)(2)(vii) and 601.70), applicants of approved drugs and
licensed biologics are required to submit annually a report on the
status of each clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical toxicology study or clinical trial either
required by FDA (PMRs) or that they have committed to conduct (PMCs),
either at the time of approval or after approval of their new drug
application, abbreviated new drug application, or biologics license
application. The status of PMCs concerning chemistry, manufacturing,
and production controls and the status of other studies or clinical
trials conducted on an applicant's own initiative are not required to
be reported under Sec. Sec.  314.81(b)(2)(vii) and 601.70 and are not
addressed in this report. Furthermore, section 505(o)(3)(E) of the FD&C
Act (21 U.S.C. 355(o)(3)(E)) requires that applicants report
periodically on the status of each required study or clinical trial and
each study or clinical trial ``otherwise undertaken . . . to
investigate a safety issue . . . . ''
    An applicant must report on the progress of the PMR/PMC on the
anniversary of the drug product's approval \1\ until the PMR/PMC is
completed or terminated and FDA determines that the PMR/PMC has been
fulfilled or that the PMR/PMC is either no longer feasible or would no
longer provide useful information.
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    \1\ An applicant must submit an annual status report on the
progress of each open PMR/PMC within 60 days of the anniversary date
of U.S. approval of the original application or on an alternate
reporting date that was granted by FDA in writing. Some applicants
have requested and been granted by FDA alternate annual reporting
dates to facilitate harmonized reporting across multiple
applications.
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II. Fiscal Year 2019 Report

    With this notice, FDA is announcing the availability of the
Agency's annual report entitled ``Report on the Performance of Drug and
Biologics Firms in Conducting Postmarketing Requirements and
Commitments.'' Information in this report covers any PMR/PMC that was
established, in writing, at the time of approval or after approval of
an application or a supplement to an application and summarizes the
status of PMRs/PMCs in fiscal year (FY) 2019 (i.e., as of September 30,
2019). Information summarized in the report reflects combined data from
the Center for Drug Evaluation and Research and the Center for
Biologics Evaluation and Research and includes the following: (1) The
number of applicants with open PMRs/PMCs; (2) the number of open PMRs/
PMCs; (3) the timeliness of applicant submission of the annual status
reports (ASRs); (4) FDA-verified status of open PMRs/PMCs reported in
Sec.  314.81(b)(2)(vii) or Sec.  601.70 ASRs; (5) the status of closed
PMRs/PMCs; and (6) the distribution of the status by fiscal year of
establishment \2\ (FY2013 to FY2019) for PMRs and PMCs open at the end
of FY2019, or those closed within FY2019. Additional information about
PMRs/PMCs is provided on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments.
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    \2\ The establishment date is the date of the formal FDA
communication to the applicant that included the final FDA-required
(PMR) or requested (PMC) postmarketing study or clinical trial.

    Dated: July 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17113 Filed 8-5-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 93 (Tuesday, May 14, 2013)]
[Rules and Regulations]
[Pages 28132-28133]
[FR Doc No: 2013-11182]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-1242; Airspace Docket No. 11-AWP-16]

Amendment of Class D Airspace; El Monte, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class D airspace at El Monte Airport, El
Monte, CA. This action, initiated by the FAA's biennial review of the
El Monte Airspace area, creates additional Class D airspace to
accommodate aircraft departures and arrivals. This improves the safety
and management of Instrument Flight Rules (IFR) operations at the
airport.

DATES: Effective date, 0901 UTC, August 22, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Rick Roberts, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA, 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On March 4, 2013, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend Class D airspace at El
Monte, CA (78 FR 14031). Interested parties were invited to participate
in this rulemaking effort by submitting written comments on the
proposal to the FAA. No comments were received.
    Class D airspace designations are published in paragraph 5000, of
FAA Order 7400.9W dated August 8, 2012, and effective September 15,
2012, which is incorporated by reference in 14 CFR 71.1. The Class D
airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by amending Class D airspace at El Monte Airport, El Monte, CA.
The FAA's biennial review of the airspace found additional controlled
airspace necessary laterally for the safety and management of aircraft
departing and arriving under IFR operations at El Monte Airport, along
with a reduction in the ceiling from 2,800 feet MSL to and including
2,400 feet MSL due to arrivals to Los Angeles International Airport
that overfly El Monte Airport.
    The FAA has determined this regulation only involves an established
body of technical regulations for which frequent and routine amendments
are necessary to keep them operationally current. Therefore, this
regulation: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act. The FAA's authority to issue rules
regarding aviation safety is found in Title 49 of the U.S. Code.
Subtitle 1, Section 106 discusses the authority of the FAA
Administrator. Subtitle VII, Aviation Programs, describes in more
detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it amends
controlled airspace at El Monte Airport, El Monte, CA.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,''

paragraph 311a. This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air)

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9W, Airspace Designations and
Reporting Points, dated August 8, 2012, and effective September 15,
2012 is amended as follows:

Paragraph 5000 Class D airspace areas.

* * * * *

AWP CA D El Monte Airport, CA [Amended]

El Monte Airport, CA
    (lat. 34[deg]05'10'' N., long. 118[deg]02'05'' W.)

    That airspace extending upward from the surface to and including
2,400 feet MSL within a 4-mile radius of El Monte Airport and within
1.8 miles each side of the El Monte Airport 097[deg] bearing
extending from the 4-mile radius to 4.5 miles east of the airport.
This Class D airspace area is effective during the specific dates
and times established by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

    Issued in Seattle, Washington, on May 2, 2013.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-11182 Filed 5-13-13; 8:45 am]
BILLING CODE 4910-13-P