[Federal Register Volume 85, Number 181 (Thursday, September 17, 2020)]
[Rules and Regulations]
[Pages 57965-57967]
[FR Doc No: 2020-20439]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0560; Product Identifier 2018-CE-056-AD; Amendment
39-21255; AD No. 2020-19-12]
RIN 2120-AA64

Airworthiness Directives; Glasflugel

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2018-21-04
for Glasflugel Models Club Libelle 205, H 301 ``Libelle,'' H 301B
``Libelle,'' Kestrel, Mosquito, Standard ``Libelle,'' and Standard
Libelle-201B gliders. This AD results from mandatory continuing
airworthiness information (MCAI) originated by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as jamming
between the double two-ring end of the towing cable and the deflector
angles of the center of gravity (C.G.) release mechanism. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective October 22, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 13,
2018 (83 FR 53573, October 24, 2018).

ADDRESSES: For service information identified in this final rule,
contact Glasfaser Flugzeug-Service GmbH, Hansjorg Streifeneder, Hofener
Weg 61, 72582 Grabenstetten, Germany; telephone: +49 (0)7382/1032; fax:
+49 (0)7382/1629; email<EMAIL_ADDRESS>internet: https://www.streifly.de/kontakt-e.htm. You may review this referenced service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 901 Locust, Kansas City, Missouri 64106. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.
It is also available on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2019-0560.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0560; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations is Docket
Operations, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, General Aviation & Rotorcraft Section, International Validation
Branch, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone:
(816) 329-4165; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by removing AD 2018-21-04, Amendment 39-19462 (83 FR 53573,
October 24, 2018) (``AD 2018-21-04'') and adding a new AD. AD 2018-21-
04 applied to Glasflugel Models Club Libelle 205, H 301 ``Libelle,'' H
301B ``Libelle,'' Kestrel, Mosquito, Standard ``Libelle,'' and Standard
Libelle-201B gliders and required inspecting the distance between the
deflector-angles of the C.G. release mechanism and revising the
operations section of the sailplane flight manual (SFM) before the next
winch launch. The NPRM published in the Federal Register on August 5,
2019 (84 FR 37974).
    AD 2018-21-04 was based on MCAI originated by the European Aviation
Safety Agency (EASA), which is the Technical Agent for the Member
States of the European Community. EASA issued Emergency AD No. 2018-
0143-E, dated July 6, 2018 (referred to after this as ``the MCAI''), to
correct an unsafe condition for the specified products. The MCAI
states:

    Jamming between the double two ring end of the towing cable and
the deflector angles of the C.G. release mechanism was reported.
Subsequent investigation identified incorrect geometry of the
deflector angles of the affected part as likely cause of the
jamming.
    This condition, if not detected and corrected, could lead to
failure to disconnect the towing cable, possibly resulting in
reduced or loss of control of the sailplane.
    To address this potential unsafe condition, Glasfaser Flugzeug-
Service GmbH issued the TN [Technical Note] to provide inspection
instructions and corrective action.
    For the reasons described above, this [EASA] AD requires
repetitive inspections of the affected part, and, depending on
findings, accomplishment of applicable corrective action(s). This
[EASA] AD also requires amendment of the sailplane Aircraft Flight
Manual (AFM).

You may examine the MCAI on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2019-0560.
    The FAA issued AD 2018-21-04 as an interim action to address the
immediate need for the initial inspection of the distance between the
deflector-angles of the C.G. release mechanism, any necessary
corrective action, and the revision of the flying operations section of
the SFM. In the NPRM, the FAA proposed to supersede AD 2018-21-04 to
address the long-term need to repeat the inspection of the C.G. release
mechanism for the distance between the deflector-angles at intervals
not to exceed 12 months.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. No comments were received on the NPRM or on
the determination of the cost to the public.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Glasfaser-Flugzeug-Service GmbH Technical Note No.
5-2018, dated June 25, 2018, which is incorporated by reference in AD
2018-21-04. The service information provides instructions for measuring
the distance between the deflector-angles at the C.G. release and
modifying the deflector-angles if necessary. This service information
is reasonably available because the interested parties have access to
it through their normal course of business or by the means identified
in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD will affect 177 products of U.S.
registry. The FAA also estimates that it would take about 1 work-hour
per product to comply with the inspection requirements and revision of
the flying operations section of the sailplane flight manual of this
AD. The average labor rate is $85 per work-hour.
    Based on these figures, the FAA estimates the cost of this AD on
U.S. operators to be $15,045, or $85 per product, per inspection cycle.
    The FAA estimates that any modification of the deflector-angles
that may be necessary as a result of the inspection would take about 4
work-

hours and require parts costing $100, for a cost of $440 per product.
The FAA has no way of determining the number of products that may need
these actions.
    This AD retains the actions of AD 2018-21-04. The estimated costs
of the initial inspection, any necessary modification, and revision of
the flying operations section of the SFM remain the same as AD 2018-21-
04 and do not impose an additional burden beyond the cost of repeating
the inspection every 12 months.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2018-21-04, Amendment 39-19462
(83 FR 53573, October 24, 2018); and
0
b. Adding the following new AD:

2020-19-12 Glasflugel: Amendment 39-21255; Docket No. FAA-2019-0560;
Product Identifier 2018-CE-056-AD.

(a) Effective Date

    This AD is effective October 22, 2020.

(b) Affected ADs

    This AD replaces AD 2018-21-04, Amendment 39-19462 (83 FR 53573,
October 24, 2018) (``AD 2018-21-04'').

(c) Applicability

    This AD applies to Glasflugel Models Club Libelle 205, H 301
``Libelle,'' H 301B ``Libelle,'' Kestrel, Mosquito, Standard
``Libelle,'' and Standard Libelle-201B gliders, certificated in any
category, with a center of gravity (C.G.) tow release installed.

(d) Subject

    Air Transport Association of America (ATA) Code 25: Equipment/
Furnishing.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as jamming between
the double two-ring end of the towing cable and the deflector angles
of the C.G. release mechanism. The FAA is issuing this AD to prevent
failure of the towing cable to disconnect, which could result in
reduced or loss of control of the glider or the cable breaking and
causing injury to people on the ground.

(f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) through (3) of this AD.
    (1) Before the next winch launch after November 13, 2018 (the
effective date of AD 2018-21-04) and then within 30 days after the
effective date of this AD or 12 months after the initial inspection,
whichever occurs later, and thereafter at intervals not to exceed 12
months, inspect the distance between the deflector-angles by
following paragraph 1 in the Actions section of Glasfaser-Flugzeug-
Service GmbH Technical Note No. 5-2018, dated June 25, 2018.
    (2) If the distance is less than 36 mm during any inspection
required in paragraph (f)(1) of this AD, before the next winch
launch, do the corrective action in paragraph 2 in the Actions
section of Glasfaser-Flugzeug-Service GmbH Technical Note No. 5-
2018, dated June 25, 2018.
    (3) Before the next winch launch after November 13, 2018 (the
effective date of AD 2018-21-04), revise the flying operations
section of the sailplane flight manual by inserting the text in
paragraph (f)(3)(i) of this AD into the winch tow section.
    (i) Winch launching is permissible only with a connecting ring
pair that conforms to aeronautical standard LN 65091.
    (ii) This action may be done by the owner/operator (pilot)
holding at least a private pilot certificate and must be entered
into the aircraft records showing compliance with this AD by
following 14 CFR 43.9 (a)(1) through (4) and 14 CFR 91.417(a)(2)(v).
The record must be maintained as required by 14 CFR 91.417, 121.380,
or 135.439.

(g) Alternative Methods of Compliance

    The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to Jim
Rutherford, Aerospace Engineer, FAA, General Aviation & Rotorcraft,
International Validation Branch, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.

(h) Related Information

    Refer to MCAI EASA AD 2018-0143-E, dated July 6, 2018 for
related information. You may examine the MCAI on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2019-0560.

(i) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (3) The following service information was approved for IBR on
November 13, 2018 (83 FR 53573, October 24, 2018).
    (i) Glasfaser-Flugzeug-Service GmbH Technical Note No. 5-2018,
dated June 25, 2018.
    (ii) [Reserved]
    (4) For service information identified in this AD, contact
Glasfaser Flugzeug-Service GmbH, Hansjorg Streifeneder, Hofener Weg
61, 72582 Grabenstetten, Germany; phone: +49 (0)7382/1032; fax: +49
(0)7382/1629; email<EMAIL_ADDRESS>internet: https://www.streifly.de/kontakt-e.htm.
    (5) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. In
addition, you can access this service information on the internet at
https://www.regulations.gov by

searching for and locating Docket No. FAA-2019-0560.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 10, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-20439 Filed 9-16-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)]
[Notices]
[Pages 3002-3004]
[FR Doc No: 2017-00200]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-2175]

Recommendations for Assessment of Blood Donor Eligibility, Donor
Deferral and Blood Product Management in Response to Ebola Virus;
Guidance for Industry; 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 a document entitled ``Recommendations for
Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product
Management in Response to Ebola Virus; Guidance for Industry.'' The
guidance document notifies blood establishments that FDA has determined
Ebola virus to be a transfusion-transmitted infection (TTI) and
provides blood establishments that collect blood and blood components
for transfusion or further manufacture, including Source Plasma, with
FDA recommendations for assessing blood donor eligibility, donor
deferral, and blood product management in the event that an outbreak of
Ebola virus disease (EVD) with widespread transmission is declared in
at least one country. The guidance document applies to Ebola virus
(species Zaire ebolavirus). The recommendations apply to routine
collection of blood and blood components for transfusion or further
manufacture, including Source Plasma. The guidance announced in this
notice finalizes the draft guidance of the same title dated December
2015.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-2175 for ``Recommendations for Assessment of Blood Donor
Eligibility, Donor Deferral and Blood Product Management in Response to
Ebola Virus; Guidance for Industry.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jessica T. Walker, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Recommendations for Assessment of Blood Donor Eligibility, Donor
Deferral and Blood Product Management in Response to Ebola Virus;
Guidance for Industry.'' The guidance document notifies blood
establishments that FDA has determined Ebola virus to be a TTI under 21
CFR

630.3(l) because of the severity of the disease and the risk of
transmission by blood and blood products. The guidance also provides
blood establishments that collect blood and blood components for
transfusion or further manufacture, including Source Plasma, with FDA
recommendations for assessing blood donor eligibility, donor deferral,
and blood product management in the event that an outbreak of EVD with
widespread transmission occurs in at least one country.
    Ebola virus is a member of the family Filoviridae that can cause
severe hemorrhagic fever in humans and non-human primates with
historically high morbidity and mortality rates of up to 90 percent.
However, in the 2014 outbreak in West Africa, the mortality rate was
markedly lower. In humans, EVD is typically characterized at onset by
fever, severe headache, muscle pain, and weakness, followed by
diarrhea, vomiting, abdominal pain, and sometimes diffuse hemorrhage
(bleeding or bruising). In previous outbreaks of EVD, symptoms
generally appeared within 21 days and most often within 4 to 10 days
following infection; however, based on mathematical models, symptom
onset later than 21 days is estimated as possible in 0.1 to 12 percent
of cases. Although viremia in survivors typically resolves within 21
days of disease onset, infectious virus and viral ribonucleic acid
(RNA) has been detected in other body components or fluids (e.g.,
aqueous humor, semen, and vaginal fluids) for longer periods. For
instance, infectious virus and viral RNA have been detected in semen up
to 82 and 272 days post-EVD onset, respectively, and a case of sexual
transmission of Ebola virus was reported in which the patient was
exposed to Ebola virus through sexual contact with a survivor 179 days
after likely disease onset.
    Transmission of Ebola virus from human to human occurs by direct
contact with body fluids (such as blood, urine, stool, saliva, semen,
vaginal fluids, or vomit) of symptomatic infected individuals.
Therefore, blood and blood products from symptomatic individuals, if
they were to donate, would have the potential of transmitting Ebola
virus to recipients.
    Under 21 CFR 630.10(a) and (f)(1), a donor must be in good health
and have a normal temperature at the time of donation. Standard
procedures that are in place to assure that the donor feels healthy at
the time of donation serve as an effective safeguard against collecting
blood or blood components from a donor who seeks to donate after the
onset of clinical symptoms of EVD. FDA is providing guidance to reduce
the risks of collecting blood and blood components from potentially
Ebola virus-infected persons during the asymptomatic incubation period
before the onset of clinical symptoms, as well as from individuals with
a history of Ebola virus infection or disease.
    The guidance recommends blood establishments update their donor
educational materials to instruct donors with a history of Ebola virus
infection or disease to not donate blood or blood components. In the
event that one or more countries is classified by Centers for Disease
Control and Prevention (CDC) as having widespread transmission of Ebola
virus, blood establishments must update their donor history
questionnaire (DHQ), including the full-length and abbreviated DHQ and
accompanying materials, to assess donors for a history of Ebola virus
infection or disease and travel to, or residence in, an area endemic
for Ebola virus. The guidance recommends indefinite deferral of a donor
with a history of Ebola virus infection or disease and for a donor who
has been a resident of or has travelled to a country with widespread
transmission of EVD, FDA recommends that establishments defer a donor
for 8 weeks from the time of the donor's departure from that country.
The guidance document provides additional recommendations for blood
establishments in the event that one or more countries are classified
by CDC as having widespread transmission of Ebola virus. For a donor
who has had close contact with a person confirmed to have EVD or a
person under investigation for Ebola virus infection or disease in whom
diagnosis is pending, FDA recommends that establishments defer a donor
for 8 weeks after the last contact. In addition, FDA recommends that
establishments defer a donor for 8 weeks after the last sexual contact
with a person known to have recovered from EVD, regardless of the time
since the person's recovery. FDA also recommends that establishments
defer for a period of 8 weeks after exposure a donor who has been
notified by a Federal, State, or local public health authority that he
or she may have been exposed to a person with EVD.
    The guidance includes FDA recommendations on retrieval and
quarantine of blood and blood components from a donor later determined
to have Ebola virus infection or disease or risk factors for Ebola
virus infection or disease, notification of consignees, and reporting a
biological product deviation to FDA. The guidance also addresses
convalescent plasma intended for transfusion.
    In the Federal Register of December 3, 2015 (80 FR 75681), FDA
announced the availability of the draft guidance of the same title
dated December 2015. FDA received comments on the draft guidance and
those comments were considered as the guidance was finalized. A summary
of changes made in the final guidance includes: (1) Notifying blood
establishments that FDA has determined Ebola virus to be a TTI under
Sec.  630.30(l); (2) providing a recommendation that the donor
educational materials instruct donors with a history of EVD to self-
defer; (3) adding a recommended timeframe for when blood establishments
should discontinue donor questioning after CDC declares there is no
longer widespread transmission of Ebola virus; and (4) clarifying
certain recommendations on product retrieval, quarantine, and
notification of consignees of blood and blood components from donors at
risk of Ebola virus infection or disease. In addition, editorial
changes were made to improve clarity. The guidance announced in this
notice finalizes the draft guidance of the same title dated December
2015.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on recommendations for assessment of blood
donor eligibility, donor deferral, and blood product management in
response to Ebola virus. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
600.14 and 606.171 have been approved under OMB control number 0910-
0458; the collections of information in 21 CFR 601.12 and Form FDA 356h
have been approved under OMB control number 0910-0338; the collections
of information in 21 CFR 606.160 have been approved under OMB control
numbers 0910-0116 and 0910-0795; and the collections of information in
21

CFR 630.10 and 630.40 have been approved under OMB control number 0910-
0795.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: January 3, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00200 Filed 1-9-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 218 (Tuesday, November 16, 2021)]
[Notices]
[Pages 63372-63374]
[FR Doc No: 2021-24987]

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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
rate filings:

    Docket Numbers: ER13-738-008; ER11-3097-012; ER10-1186-011; ER12-
421-004; ER11-2731-004; ER10-1329-011.
    Applicants: DTE Electric Company; DTE Energy Trading, Inc.; DTE
Energy Supply, Inc.; DTE Garden Wind Farm, LLC; DTE Stoney Corners Wind
Farm, LLC; St. Paul Cogeneration, LLC.
    Description: Response to October 7, 2021 Deficiency Letter of DTE
MBR Entities.
    Filed Date: 11/5/21.
    Accession Number: 20211105-5214.
    Comment Date: 5 p.m. ET 11/26/21.

    Docket Numbers: ER16-1275-003; ER16-2071-002; ER17-2342-003; ER17-
2343-003; ER18-348-003; ER21-2532-001; ER21-2533-001.
    Applicants: Bay Tree Lessee, LLC; Bay Tree Solar, LLC; Innovative
Solar 43,

LLC; Innovative Solar 46, LLC; Shoe Creek Solar, LLC.
    Description: Notice of Change in Status of Innovative Solar 46,
LLC, et al.
    Filed Date: 11/8/21.
    Accession Number: 20211108-5244.
    Comment Date: 5 p.m. ET 11/29/21.

    Docket Numbers: ER20-686-005.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Compliance filing: Compliance Filing to be effective
10/1/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5171.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER21-2942-000.
    Applicants: EnerSmart El Cajon BESS LLC.
    Description: Report Filing: Supplement to Market-Based Rate
Application to be effective N/A.
    Filed Date: 11/8/21.
    Accession Number: 20211108-5171.
    Comment Date: 5 p.m. ET 11/22/21.

    Docket Numbers: ER22-86-000.
    Applicants: EnerSmart Chula Vista BESS LLC.
    Description: Report Filing: Supplement to Market-Based Rate
Application to be effective N/A.
    Filed Date: 11/8/21.
    Accession Number: 20211108-5176.
    Comment Date: 5 p.m. ET 11/22/21.

    Docket Numbers: ER22-359-000.
    Applicants: Brookfield Renewable Trading and Marketing, LP.
    Description: Brookfield Renewable Trading and Marketing, LP submits
Petition for Limited Prospective Waiver and Request for Shortened
Comment Period and Expedited Consideration.
    Filed Date: 11/5/21.
    Accession Number: 20211105-5219.
    Comment Date: 5 p.m. ET 11/26/21.

    Docket Numbers: ER22-362-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 2827R7 KPP and Evergy Kansas
Central Meter Agent Agreement to be effective 11/1/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5028.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-363-000.
    Applicants: American Electric Power Service Corporation,
Appalachian Power Company, PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: American Electric Power
Service Corporation submits tariff filing per 35.13(a)(2)(iii: AEP
submits one FA with City of Danville re: SA No. 2104 to be effective 1/
9/2022.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5095.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-364-000.
    Applicants: Southern California Edison Company.
    Description: Tariff Amendment: Cancel GIA DSA Tajiguas WDT222 SA No
168 169 to be effective 1/9/2022.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5110.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-365-000.
    Applicants: Georgia Power Company.
    Description: Sec.  205(d) Rate Filing: GPCo 2021 PBOP Filing to be
effective 1/1/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5123.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-366-000.
    Applicants: Mississippi Power Company.
    Description: Sec.  205(d) Rate Filing: PBOP 2021 Filing to be
effective 1/1/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5124.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-367-000.
    Applicants: Southern Electric Generating Company.
    Description: Sec.  205(d) Rate Filing: SEGCo 2021 PBOP Filing to be
effective 1/1/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5125.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-368-000.
    Applicants: Alabama Power Company.
    Description: Initial rate filing: Chipola River Affected System
Upgrade Agreement Filing to be effective 10/18/2021.
    Filed Date: 11/9/21
    Accession Number: 20211109-5154
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-369-000.
    Applicants: Georgia Power Company.
    Description: Initial rate filing: Chipola River Affected System
Upgrade Agreement Filing to be effective 10/18/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5155.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-370-000.
    Applicants: Mississippi Power Company.
    Description: Initial rate filing: Chipola River Affected System
Upgrade Agreement Filing to be effective 10/18/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5156.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-371-000.
    Applicants: Alabama Power Company.
    Description: Initial rate filing: Slavic Solar Affected System
Upgrade Agreement Filing to be effective 10/18/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5157.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-372-000.
    Applicants: Georgia Power Company.
    Description: Initial rate filing: Slavic Solar Affected System
Upgrade Agreement Filing to be effective 10/18/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5159.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-373-000.
    Applicants: Mississippi Power Company.
    Description: Initial rate filing: Slavic Solar Affected System
Upgrade Agreement Filing to be effective 10/18/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5160.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-374-000.
    Applicants: Basin Electric Power Cooperative.
    Description: Sec.  205(d) Rate Filing: Basin Electric Submission of
Certificates of Concurrence to be effective 11/9/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5176.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-375-000.
    Applicants: Northern States Power Company, a Minnesota corporation.
    Description: Sec.  205(d) Rate Filing: 2021-11-09 Huntley-Wilmarth-
OMA-658-0.0.0 to be effective 11/10/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5178.
    Comment Date: 5 p.m. ET 11/30/21.

    Docket Numbers: ER22-376-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Sec.  205(d) Rate Filing: Initial Filing of Rate
Schedule No. 896 to be effective 11/3/2021.
    Filed Date: 11/9/21.
    Accession Number: 20211109-5181.
    Comment Date: 5 p.m. ET 11/30/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by 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: November 9, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-24987 Filed 11-15-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 21, 2008 (Volume 73, Number 77)]
[Notices]
[Page 21335-21336]
[DOCID:fr21ap08-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

April 11, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP03-36-031.
    Applicants: Dauphin Island Gathering Partners.
    Description: Dauphin Island Gathering Partners submits Fourth
Revised Sheet 10A to FERC Gas Tariff, First Revised Volume 1, to be
effective 4/9/08.
    Filed Date: 04/08/2008.
    Accession Number: 20080409-0028.
    Comment Date: 5 p.m. Eastern Time on Monday, April 21, 2008.

    Docket Numbers: RP96-272-072.
    Applicants: Northern Natural Gas Company.
    Description: Northern Natural Gas Company submits 48 Revised Sheet
66A to FERC Gas Tariff, Fifth Revised Volume 1, to be effective on
April 11, 2008.
    Filed Date: 04/10/2008.
    Accession Number: 20080411-0092.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 22, 2008.

    Docket Numbers: RP96-312-181.
    Applicants: Tennessee Gas Pipeline Company.
    Description: Tennessee Gas Pipeline Co submits a revised Exhibit A
to the Gas Transportation Agreement pursuant Rate Schedule FT-A with
AFG Industries, Inc, to be effective 4/1/08.
    Filed Date: 04/07/2008.
    Accession Number: 20080408-0009.
    Comment Date: 5 p.m. Eastern Time on Monday, April 21, 2008.

    Docket Numbers: RP99-518-104.
    Applicants: Gas Transmission Northwest Corporation.
    Description: Gas Transmission Northwest Corporation submits
Fourteenth Revised Sheet 24 et al to FERC Gas Tariff, Third Revised
Volume 1-A, to be effective 4/9/08.
    Filed Date: 04/08/2008.
    Accession Number: 20080409-0029.
    Comment Date: 5 p.m. Eastern Time on Monday, April 21, 2008.

    Docket Numbers: RP08-311-000.
    Applicants: Northwest Pipeline GP.
    Description: Northwest Pipeline GP submits First Revised Sheet 9 et
al of its FERC Gas Tariff.
    Filed Date: 04/07/2008.
    Accession Number: 20080408-0099.
    Comment Date: 5 p.m. Eastern Time on Monday, April 21, 2008.

    Docket Numbers: RP08-312-000.
    Applicants: Williston Basin Interstate Pipeline Co.
    Description: Williston Basin Interstate Pipeline Company submits
Second Revised Volume 1 et al to be effective April 10, 2008.
    Filed Date: 04/10/2008.
    Accession Number: 20080410-0132.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 22, 2008.

    Docket Numbers: RP08-313-000.
    Applicants: Transwestern Pipeline Company, LLC.
    Description: Transwestern Pipeline Co, LLC submits First Revised
Sheet 6 et al to FERC Gas Tariff, Third Revised Volume 1, to be
effective 4/11/08.
    Filed Date: 04/10/2008.
    Accession Number: 20080411-0091.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 22, 2008.

    Docket Numbers: CP05-357-009.
    Applicants: Cheniere Creole Trail Pipeline, L.P.
    Description: Cheniere Creole Trail Pipeline, LP submits First
Revised Sheet No. 5 to FERC Gas Tariff, Original Volume, proposed to be
effective 4/24/08.
    Filed Date: April 4, 2008.
    Accession Number: 20080410-0036.
    Comment Date: 5 p.m. Eastern Time on Monday, April 21, 2008.

    Docket Numbers: CP08-119-000.

    Applicants: Columbia Gulf Transmission Company.
    Description: Columbia Gulf Transmission Company submits their
abbreviated application for permission and approval to abandon certain
FERC Gas Tariff, Volume 2 Rate Schedules.
    Filed Date: April 8, 2008.
    Accession Number: 20080410-0035.
    Comment Date: 5 p.m. Eastern Time on Monday, April 21, 2008.

    Docket Numbers: CP08-124-000.
    Applicants: Transcontinental Gas Pipe Line Corporation.
    Description: Transcontinental Gas Pipe Line Corporation submits an
Application for Order Permitting and Approving Abandonment of Services.
    Filed Date: April 9, 2008.
    Accession Number: 20080410-0133.
    Comment Date: 5 p.m. Eastern Time on Monday, April 21, 2008.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-8462 Filed 4-18-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 242 (Tuesday, December 18, 2018)]
[Notices]
[Pages 64817-64818]
[FR Doc No: 2018-27306]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AC19-46-000]

Tennessee Gas Pipeline Company, L.L.C.; Notice of Filing

    Take notice that on December 6, 2018, Tennessee Gas Pipeline
Company, L.L.C. filed a request for approval to use Account 439,
authorized by the Financial Accounting Standards Board.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 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
website 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
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comments: 5:00 p.m. Eastern Time on December 26, 2018.

    Dated: December 12, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-27306 Filed 12-17-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 145 (Thursday, July 28, 2011)]
[Notices]
[Pages 45308-45309]
[FR Doc No: 2011-19051]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64948; File No. SR-NASDAQ-2011-077]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order
Granting Approval of Proposed Rule Change To Adopt a Risk Monitor
Mechanism

July 22, 2011.

I. Introduction

    On June 1, 2011, The NASDAQ Stock Market LLC (``Exchange'' or
``NASDAQ'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to adopt a new risk monitor mechanism. The
proposed rule change was published for comment in the Federal Register
on June 13, 2011.\3\ The Commission received no comment letters on the
proposed rule change. This order approves the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 64616 (June 7,
2011), 76 FR 34281 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    NASDAQ proposes to adopt new Chapter VI, Section 19, Risk Monitor
Mechanism \4\ to provide protection from the risk of multiple
executions across multiple series of an option. The Exchange proposes
to offer the Risk Monitor Mechanism functionality to all Participant
types to help liquidity providers generally, Market Makers and other
participants alike, in managing risk and providing deep and liquid
markets to investors. The Exchange believes that the Risk Monitor
Mechanism will be most useful for Market Makers,\5\ who are required to
continuously quote in assigned options. Quoting across many series in
an option creates the possibility of ``rapid fire'' executions that can
create large, unintended principal positions that expose the Market
Maker to unnecessary market risk. The Risk Monitor Mechanism is
intended to assist such Participants in managing their market risk. The
Exchange also believes that firms that trade on a proprietary basis and
provide liquidity to the Exchange could potentially benefit, similarly
to Market Makers, from the Risk Monitor Mechanism.
---------------------------------------------------------------------------

    \4\ The proposal is very similar to NASDAQ OMX PHLX (``PHLX'')
Rule 1093 and is intended to bring this aspect of PHLX's
technological functionality to NOM.
    \5\ Unlike the PHLX Risk Monitor Mechanism, the NOM Risk Monitor
Mechanism will be available to all Participants, not just Market
Makers.
---------------------------------------------------------------------------

    Pursuant to proposed Section 19(a), the Risk Monitor Mechanism
operates by the System maintaining a counting program for each
Participant, which counts the number of contracts traded in an option
by each Participant within a specified time period, not to exceed 15
seconds, established by each Participant (the ``specified time
period''). The specified time period will commence for an option when a
transaction occurs in any series in such option. Furthermore, the
System engages the Risk Monitor Mechanism in a particular option when
the counting program has determined that a Participant has traded a
Specified Engagement Size (as defined below) established by such
Participant during the specified time period. When such Participant has
traded the Specified Engagement Size during the specified time period,
the Risk Monitor Mechanism automatically removes such Participant's
orders in all series of the particular option.
    As provided in proposed subparagraph (b)(ii), the Specified
Engagement Size is determined by the following: (A) For each series in
an option, the counting program will determine the percentage that the
number of contracts executed in that series represents relative to the
Participant's total size at all price levels in that series (``series
percentage''); (B) The counting program will determine the sum of the
series percentages in the option issue (``issue percentage''); (C) Once
the counting program determines that the issue percentage equals or
exceeds a percentage established by the Participant (``Specified
Percentage''), the

number of executed contracts in the option issue equals the Specified
Engagement Size.
    While the Risk Monitor Mechanism serves an important risk
management purpose, the Exchange states that it operates consistent
with the firm quote obligations of a broker-dealer pursuant to Rule 602
of Regulation NMS. Specifically, proposed paragraph (c) provides that
any marketable orders or quotes that are executable against a
Participant's quotation that are received prior to the time the Risk
Monitor Mechanism is engaged will be automatically executed at the
price up to the Participant's size, regardless of whether such an
execution results in executions in excess of the Participant's
Specified Engagement Size. Accordingly, the Risk Monitor Mechanism
cannot be used to circumvent a Participant's firm quote obligation.
    Proposed Section 19(d) further provides that the system will
automatically reset the counting program and commence a new specified
time period when: (i) A previous counting period has expired and a
transaction occurs in any series in such option; or (ii) the
Participant refreshes his/her quotation, in a series for which an order
has been executed (thus commencing the specified time period) prior to
the expiration of the specified time period.

III. Discussion and Commission's Findings

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of Section 6 of the Act \6\
and the rules and regulations thereunder applicable to a national
securities exchange.\7\ In particular, the Commission finds that the
proposed rule change is consistent with Section 6(b)(5) of the Act,\8\
which requires, among other things, that the Exchange's rules be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in facilitating transactions in
securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. The Commission believes that
the proposed rule change should provide NOM Participants assistance in
effectively managing their quotations.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f.
    \7\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

IV. Conclusion

    It Is Therefore Ordered, pursuant to Section 19(b)(2) of the
Act,\9\ that the proposed rule change (SR-NASDAQ-2011-077) be, and
hereby is, approved.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-19051 Filed 7-27-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 107 (Wednesday, June 4, 2014)]
[Notices]
[Pages 32277-32279]
[FR Doc No: 2014-12876]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory

[Docket No. AD14-9-000]

Reliability Technical Conference; Supplemental Notice With Agenda

    As announced in the Notice of Technical Conference issued on April
16, 2014, the Commission will hold a technical conference on Tuesday,
June 10, 2014 from 8:45 a.m. to 5:00 p.m. to discuss policy issues
related to the reliability of the Bulk-Power System. The agenda for
this conference is attached. Commission members will participate in
this conference.
    After the close of the conference, the Commission will accept
written comments regarding the matters discussed at the technical
conference. Any person or entity wishing to submit written comments
regarding the matters discussed at the conference should submit such
comments in Docket No. AD14-9-000 on or before July 15, 2014.
    Information on this event will be posted on the Calendar of Events
on the Commission's Web site, www.ferc.gov, prior to the event. The
conference will be transcribed. Transcripts will be available for a fee
from Ace Reporting Company<PHONE_NUMBER> or 1-800-336-6646). A free
webcast of this event is also available through www.ferc.gov. Anyone
with Internet access who desires to listen to this event can do so by
navigating to www.ferc.gov's Calendar of Events and locating this event
in the Calendar. The event will contain a link to the Webcast. The
Capitol Connection provides technical support for webcasts and offers
the option of listening to the meeting via phone-bridge for a fee. If
you have any questions, visit www.CapitolConnection.org or call 703-
993-3100.
    Commission conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For more information about this conference, please contact: Sarah
McKinley, Office of External Affairs, Federal Energy Regulatory
Commission, 888 First Street NE., Washington, DC 20426,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
    Dated: May 28, 2014.
Kimberly D. Bose,
Secretary.
[GRAPHIC] [TIFF OMITTED] TN04JN14.003

Reliability Technical Conference

Commissioner-Led Reliability Technical Conference

July 10, 2014

8:45 a.m.-5:00 p.m.

8:45 a.m. Commissioners' Opening Remarks
9:00 a.m. Introductions
Acting Chairman Cheryl LaFleur, Conference Chair
9:15 a.m. Panel I: 2014 State of Reliability Report and Emerging
Challenges

    Presentations: Panelists will be asked to address the following
issues:

    a. What priorities have been identified in the 2014 report and how
are these different from the 2013 report? What does the 2014 State of
Reliability Report show about the effectiveness of the ERO's
reliability activities and related industry efforts? What progress has
been made with respect to the recommendations in the 2013 report and
what are the obstacles to continued progress? What are the successes/
strengths? What areas need the most improvement? What resource needs
and limitations are associated with these areas and what criteria can
be used to address them?
    b. The 2014 State of Reliability report draws attention to two risk
issues that contribute to system disturbances and automatic
transmission outage severity: Protection system misoperations and AC
substation outage failures. What actions have been taken to address
these issues and have these actions been effective in improving
performance?
    c. What has NERC done, and what can it do, to foster a culture of
reliability excellence in the industry? What are the best indicators of
an effective culture of reliability excellence?
    Panelists:
1. Gerry W. Cauley--President and Chief Executive Officer, North
American Electric Reliability Corp. (NERC)
2. Tom Burgess--Vice President and Director of Reliability Assessment
Performance Analysis, NERC
3. William O. Ball--Executive Vice President, Southern Company
Services, Inc., on behalf of Edison Electric Institute
4. Asim Haque--Commissioner and Vice Chairman, Public Utilities
Commission of Ohio, on behalf of the National Association of Regulatory
Utility Commissioners
5. Peter Fraser--Vice President, Industry Operation & Performance,
Ontario Energy Board

11:15 a.m. Break
11:30 a.m. Panel II: Emerging Issues

    Presentations: Our Nation's power supply portfolio and
infrastructure are changing rapidly due to factors such as the
affordability of domestic natural gas, Federal and state policies on
renewable and demand response resources, and new environmental
regulations such as the Mercury and Air Toxics Standard. How does the
industry expect the overall resources mix to change in the next 5 to 10
years? What approaches are being developed to maintain reserve margins
and address real-time operational challenges related to changes in
resource mixes in the following areas:
    a. Gas Electric Interdependency: How has an increased dependency on
natural gas impacted reliability in various regions, and what actions
will be needed to maintain reliability?
    b. Variable Resources: How are entities addressing operational
concerns related to variable resources as described in the 2013 Special
Reliability Assessment ``Maintaining Bulk Power System Reliability
While Integrating Variable Energy Resources--CAISO Approach'' a joint
report published by NERC and the CAISO. What additional work is needed
to integrate variable resources in ways that ensure adequate operating
reserves, frequency response, and other operational issues?
    Panelists:
1. Gerry Cauley--President and Chief Executive Officer, NERC
2. Tom Burgess--Vice President and Director of Reliability Assessment
and Performance Analysis, NERC
3. Peter Brandien--Vice President, System Operations, ISO New England
4. Brad Bouillon--Director, Day-Ahead Market and Real-Time Operations
Support, California Independent System Operator
5. Allen Mosher--Vice President, Policy Analysis and Reliability
Standards, American Public Power Association
6. Bradley Albert--General Manager of Resource Management, Arizona
Public Service
7. Robert Hayes--Vice President, Natural Gas Trading, Calpine

12:45 p.m. Lunch
1:30 p.m. Panel III: ERO Initiatives

    Presentations: Panelists will be asked to address the following
issues:
    a. Risk Registration initiative: What is the status of the Risk-
Based Registration Initiative? How does this effort align with existing
practices and other initiatives?
    b. Several Reliability Standards and ERO initiatives depend on
prioritizing or differentiating facilities based on how critical they
are to the reliable and secure operation of the Bulk Power System. How
should this ``tiering'' of facilities be determined? Should a set of
common, uniform criteria apply in all contexts or does the appropriate
approach depend on the particular context?
    c. BES: What issues or trends has NERC observed regarding the
implementation of the revised BES definition? To what extent is the
exceptions process being utilized and how is it working?
    d. Reliability Assurance Initiative: What have NERC and the
Regional Entities learned from the Reliability Assurance Initiative
(RAI) pilot projects? What are the essential factors NERC and the
Regions will use to evaluate internal controls and on what objective
basis will NERC determine the quality of one internal control program
versus another? What potential impact could the ARI have on the need
for and scope of audits?
     How does NERC plan to integrate the results of the pilots
into a uniform national program? What obstacles will NERC face in
ensuring consistent application of RAI across the eight regions?
    Panelists:

1. Tom Burgess--Vice President and Director of Reliability Assessment
and Performance Analysis, NERC
2. Jerry Hedrick--Director of Regional Entity Assurance and Oversight,
NERC
3. Scott Henry--Chief Executive Officer and President, SERC Reliability
Corporation
4. Steven T. Naumann--Vice President, Transmission and NERC Policy,
Exelon
5. Barry T. Lawson--Associate Director, Power Delivery and Reliability,
National Rural Electric Cooperative Association
6. Sylvain Clermont--Manager, Transmission Services, Hydro-Quebec
TransEnergie, on behalf of the Canadian Electricity Association

2:45 p.m. Break
3:00 p.m. Panel IV: ERO Performance

    Presentations: Panelists will be asked to address the following
issues:
    a. Standards Development Process
     What efficiencies have resulted from the revision of
NERC's standards development process?
     In what ways has the RISC improved the standards
development process? On what bases have the current standards
development projects been prioritized and have they deviated from last
year?
    b. Compliance and Enforcement: What are the trends in the
compliance and enforcement of Reliability Standards requirements? Which
are the most violated Reliability Standards requirements and what steps
are being taken to address this problem?
    c. Security Issues
     What is the status of the effort to enhance physical
security of the grid?
     What progress has been made regarding CIP version 5
implementation?
    i. What issues have entities discovered during the initial effort
to implement CIP version 5?

    ii. How is NERC planning to address these issues and are there any
issues that require Commission action?
    iii. What are NERC and the Regional Entities doing to prepare for
the enforcement of the CIP version 5 standards to ensure consistent
enforcement across the regions?
    Panelists:

1. Sonia Mendonca--Associate General Counsel and Director of
Enforcement, NERC
2. Steve Noess--Associate Director of Standards Development, NERC
3. Tim Gallagher--Chief Executive Officer and President, Reliability
First Corporation
4. Brian Murphy--Manager, NERC Reliability Standards, NextEra Energy
5. Jon Eric Thalman--Director, Regulatory Strategy and Transmission
Asset Management, Pacific Gas & Electric Company
6. Carol Chinn--Regulatory Compliance Officer, Florida Municipal Power
Agency, on behalf of Transmission Access Policy Study Group

4:30 p.m. Commissioner Closing Remarks

[FR Doc. 2014-12876 Filed 6-3-14; 8:45 am]
BILLING CODE 6717-01-P