[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Pages 57279-57280]
[FR Doc No: 2020-20268]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34005; File No. 811-07963]

Nysa Series Trust

September 9, 2020.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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    Notice of an application for deregistration under Section 8(f) of
the Investment Company Act of 1940 (``Act'').

Summary of Application: Applicant seeks an order declaring that it has
ceased to be an investment company.

Applicant: Nysa Series Trust (``Trust'').

Filing Date: The application was filed on September 9, 2020.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing by emailing the Commission's
Secretary at<EMAIL_ADDRESS>and serving Applicant with a
copy of the request by email. Hearing requests should be received by
the Commission by 5:30 p.m. on September 28, 2020, and should be
accompanied by proof of service on the Applicant, in the form of an
affidavit or, for lawyers, a certificate of service. Pursuant to rule
0-5 under the Act, hearing requests should state the nature of the
writer's interest, any facts bearing upon the desirability of a hearing
on the matter, the reason for the request, and the issues contested.
Persons who wish to be notified of a hearing may request by emailing
the Commission's Secretary.

ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F
Street NE, Washington, DC 20549-1090; Applicant, Joseph Masella, 507
Plum Street, Suite 120, Syracuse, NY 13204.

FOR FURTHER INFORMATION CONTACT: Chief Counsel's Office at (202) 551-
6821; SEC, Division of Investment Management, Chief Counsel's Office,
100 F Street NE, Washington, DC 20549-8010.

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's website by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>.

Applicant's Representations

    1. Applicant, an open-end management investment company registered
under the Act, seeks an order declaring that it has ceased to be an
investment company. Applicant consists of a single series, the NYSA
Fund (``Fund'').
    2. On September 8, 2020, Applicant made a cash distribution of
64.4% of its assets to its shareholders on the basis of net assets.
Applicant's board of trustees (``Board''), including a majority of
disinterested Board members, determined that it was in the best
interests of its shareholders to deregister the Applicant under the
Act. The Board also determined that Applicant should remain in
existence temporarily for the limited purposes of (i) holding an
illiquid asset pending (a) a liquidity event regarding such asset that
will provide the Applicant with cash to distribute to shareholders or
(b) the Board's determination that such asset has no value; and (ii)
continuing as plaintiff in a pending lawsuit. Applicant will maintain a
cash reserve of $188,565 to be used for expenses in connection with its
dissolution.

Applicant's Legal Analysis

    1. In relevant part, Section 8(f) of the Act provides that
``[w]henever the Commission, on its own motion or upon application,
finds that a registered investment company has ceased to be an
investment company, it shall so declare by order and upon the taking
effect of such order the registration of such company shall cease to be
in effect. If necessary for the protection of investors, an order under
this subsection may be made upon appropriate conditions.'' Applicant
has filed an application for an order under Section 8(f). In support of
its request, Applicant states that it has made a cash distribution of
64.4% of its assets to its shareholders on the basis of net assets, and
has retained certain illiquid assets and cash temporarily for the
limited purposes noted above. Applicant further states that the cash
distribution of its assets was made pursuant to a provision in its
Declaration of Trust that permits the Trust to redeem shares if the
Board determines in its sole discretion that failure to redeem the
shares may have materially adverse consequences to all or any of the
Trust's shareholders. Applicant states that at a meeting held

on August 28, 2020, the Board unanimously determined that failure to
redeem the Fund's shares would likely result in adverse consequences to
all of the Fund's shareholders.

Applicant's Conditions

    Applicant has agreed to the following as conditions to
deregistration under the Act:
    1. Applicant will continue to maintain its internet website and
shall post its semi-annual (unaudited) and annual (audited by the
Applicant's independent accountants) financial statements to its
website. As of the date of the filing of the application, Applicant has
not engaged an independent accounting firm to audit the Applicant.
However, the Board and Applicant's management are actively seeking a
firm to perform any required audits. The Applicant's financial
statements will be prepared in conformity with generally accepted
accounting practices in the United States of America and comply with
Regulation S-X, as if the Applicant were a registered management
investment company, and will be posted to the Applicant's website
within 60 days of the period's end. Within 60 days of the period's end,
Applicant will send notifications to the shareholders (i) informing
them that its financial statements are available online, (ii) providing
the internet address where the financial statements can be found and
(iii) offering to send them a paper copy, free of charge, upon their
request.
    2. Applicant will continue to maintain a Board that complies with
the fund governance standards under Rule 0-1(a)(7) under the Act as if
Applicant were a registered management investment company. The
Applicant's Board will continue to meet no less frequently than
quarterly. The Board shall continue to approve the selection of the
Applicant's independent public accountant in accordance with Rule 32a-4
under the Act as if the Applicant were a registered management
investment company. No less frequently than quarterly, the Applicant's
Board shall determine the fair value of the illiquid asset in a manner
consistent with Section 2(a)(41) of the Act. In the event that the
value ascribed to that asset decreases 25% or more with respect to its
prior value, such decrease shall be promptly communicated in writing to
(i) the shareholders and (ii) staff of the Commission's Division of
Investment Management.
    3. Applicant shall continue to maintain and implement the policies
and procedures required by Rules 17j-1 and 38a-1 under the Act as if it
were a registered management investment company.
    4. Applicant will comply with the books and records provisions of
Section 31 of the Act, and the rules thereunder as set forth in the
response to Item 7 of the application. Such books and records shall
promptly be made available to the staff of the Commission as requested.
    5. Applicant will operate in compliance with Section 17 of the Act
as if it were a registered management investment company.
    6. Neither (i) the Applicant's investment adviser, (ii) any
``affiliated person'' (as defined in the Act) of the investment
adviser, (iii) any affiliated person of the Applicant, nor (iv) any
affiliated person of the persons described in clauses (ii) or (iii)
will receive any fee or other payment, directly or indirectly, from
Applicant; provided, however, that Applicant is permitted to make pro
rata liquidation distributions.

    For the Commission, by the Division of Investment Management,
under delegated authority.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-20268 Filed 9-14-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 29, 2007 (Volume 72, Number 102)]
[Notices]
[Page 29496-29497]
[DOCID:fr29my07-43]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2007-0142; FRL-8319-1]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Cooling Water Intake Structure Phase II Existing
Facilities (Renewal), EPA ICR No. 2060.03, OMB Control No. 2040-0257

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. This ICR is scheduled to expire on May 31, 2007.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
The ICR which is abstracted below describes the nature of the
collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before June 28, 2007.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OW-2007-0142, to (1) EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA

Docket Center (EPA/DC), Environmental Protection Agency, Water Docket,
Mail Code 4101T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and
(2) OMB at: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW, Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Amelia Letnes, State and Regional
Branch, Water Permits Division, OWM, Mail Code: 4203M, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On March 1, 2007 (72 FR 9328), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments on the draft ICR.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2007-0142, which is available for public viewing online
at http://www.regulations.gov, or in person viewing at the Water Docket

in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW, Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Reading
Room is<PHONE_NUMBER>, and the telephone number for the Water Docket
is<PHONE_NUMBER>. Use EPA's electronic docket and comment system at
http://www.regulations.gov, to submit or view public comments, access

the index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above.

    Any comments related to this ICR should be submitted to EPA and OMB
within 30 days of this notice. EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing at http://www.regulations.gov, as EPA receives them

and without change, unless the comment contains copyrighted material,
CBI, or other information whose public disclosure is restricted by
statute. When EPA identifies a comment containing copyrighted material,
EPA will provide a reference to that material in the version of the
comment that is placed in the electronic docket. The entire printed
comment, including the copyrighted material, will be available in the
public docket. Although identified as an item in the official docket,
information claimed as CBI, or whose disclosure is otherwise restricted
by statute, is not included in the official public docket, and will not
be available for public viewing in the electronic docket.
    Title: Cooling Water Intake Structure Phase II Existing Facilities
(Renewal).
    ICR Numbers: EPA ICR Number 2060.03, OMB Control Number 2040-0257.
    Abstract: The section 316(b) Phase II Existing Facility rule
requires the collection of information from existing point source
facilities that generate and transmit electric power (as a primary
activity) or generate electric power but sell it to another entity for
transmission, use a cooling water intake structure (CWIS) that uses at
least 25 percent of the water it withdraws from waters of the United
States for cooling purposes, and have a design intake flow of 50
million gallons per day (MGD) or more. Section 316(b) of the Clean
Water Act (CWA) requires that any standard established under section
301 or 306 of the CWA and applicable to a point source must require
that the location, design, construction and capacity of CWISs at that
facility reflect the best technology available (BTA) for minimizing
adverse environmental impact. Such impact occurs as a result of
impingement (where fish and other aquatic life are trapped on
technologies at the entrance to CWIS) and entrainment (where aquatic
organisms, eggs, and larvae are taken into the cooling system, passed
through the heat exchanger, and then pumped back out with the discharge
from the facility). The 316(b) Phase II rule establishes requirements
applicable to the location, design, construction, and capacity of CWISs
at Phase II existing facilities. These requirements establish the BTA
for minimizing adverse environmental impact associated with the use of
CWISs.
    On January 25, 2007, the United States Court of Appeals for the
Second Circuit remanded to EPA certain provisions in the 2004 Final
Regulations to Establish Requirements for Cooling Water Intake
Structures at Phase II Existing Facilities (See Riverkeeper, Inc. v.
U.S. EPA, No. 04-6692-ag(L) [2d Cir. Jan. 25, 2007]). EPA is continuing
to review the decision to determine its impact on the Phase II Rule.
This ICR does not address changes to EPA regulations as a result of the
court decision, since those revisions are not yet finalized.
    Burden Statement: The annual average reporting and record keeping
burden for the collection of information by facilities responding to
the Section 316(b) Phase II Existing Facility rule is estimated to be
2,983 hours per facility respondent (i.e., an annual average of
1,157,216 hours of burden divided among an anticipated annual average
of 388 facilities). The state Director reporting and record keeping
burden for the review, oversight, and administration of the rule is
estimated to average 2,034 hours per state respondent (i.e. an annual
average of 83,383 hours of burden divided among an anticipated 41
States on average per year). Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and use technology and systems for the purposes of collecting,
validating, and verifying information, processing and maintaining
information, and disclosing and providing information; adjust the
existing ways to comply with any previously applicable instructions and
requirements; train personnel to be able to respond to a collection of
information; search data sources; complete and review the collection of
information; and transmit or otherwise disclose information.
    Respondents/Affected Entities: 316(b) Phase II existing facilities
and NPDES authorized states.
    Estimated Annual Number of Respondents: 429 (388 facilities and 41
states)
    Frequency of Response: Bi-annually, every five years.
    Estimated Total Annual Hour Burden: 1,240,599 hours.
    Estimated Total Annual Cost: $80,556,134. This includes an
estimated labor burden cost of $65,592,289 and an estimated cost of
$14,963,845 for capital investment or operating and maintenance.
    Changes in the Estimates: The change in burden results mainly from
the shift from the approval period to the renewal period of the 316(b)
Phase II Existing Facilities rule. This ICR covers the last 2 years of
the permit approval period (i.e. years 4 and 5 after implementation)
and the first year of the renewal period (i.e. year 6 after
implementation). Activities for renewing an NPDES permit already issued
under the 316(b) Phase II Existing Facilities rule are less burdensome
than those for issuing a permit for the first time. Additionally, for
the approval period ICR (EPA ICR No. 2060.02), EPA assumed that all
facilities complying with the rule would be in NPDES-authorized States.
EPA has moved away from this assumption, and, for this ICR, all
calculations are based on the estimated number and type of facilities
in authorized and non-authorized States.

    Dated: May 17, 2007.
Sara Hisel-McCoy,
Acting Director, Collection Strategies Division.
[FR Doc. E7-10223 Filed 5-25-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Rules and Regulations]
[Pages 60252-60254]
[FR Doc No: 2016-20826]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-6414; Directorate Identifier 2015-NM-175-AD;
Amendment 39-18633; AD 2016-18-03]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440)
airplanes. This AD was prompted by two in-service incidents of a loss
of all air data information in the flight deck. This AD requires a
revision of the airplane flight manual (AFM) emergency procedures
section to provide procedures to guide the crew on how to stabilize the
airplane airspeed and attitude for continued safe flight when a loss of
all air data information has occurred in the flight deck. We are
issuing this AD to prevent loss of control when a loss of all air data
information has occurred in the flight deck.

DATES: This AD is effective October 6, 2016.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 6,
2016.

ADDRESSES: For service information identified in this final rule,
contact Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. You may view this referenced service information at
the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6414.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6414; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (telephone
800-647-5527) is Docket Management Facility, 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: Assata Dessaline, Aerospace Engineer,
Avionics and Services Branch, ANE-172, FAA, New York Aircraft
Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury,
NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Bombardier, Inc.
Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The NPRM
published in the Federal Register on May 10, 2016 (81 FR 28764) (``the
NPRM''). The NPRM was prompted by two in-service incidents of a loss of
all air data information in the flight deck. The NPRM proposed to
require a revision of the AFM emergency procedures section to provide
procedures to guide the crew on how to stabilize the airplane airspeed
and attitude for continued safe flight when a loss of all air data
information has occurred in the flight deck. We are issuing this AD to
prevent loss of control when a loss of all air data information has
occurred in the flight deck.
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2015-12, dated June 23, 2015 (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes. The MCAI states:

    Two in-service incidents have been reported on CL-600-2C10
aeroplanes

regarding a loss of all air data information in the cockpit. The air
data information was recovered as the aeroplane descended to lower
altitudes. An investigation determined that the root cause in both
events was high altitude icing (ice crystal contamination). If not
addressed, this condition may affect continued safe flight.
    Due to similarities in the air data systems, such events could
happen on all Bombardier CRJ models, CL-600-2B19, CL-600-2C10, CL-
600-2D15, CL-600-2D24 and CL-600-2E25. Therefore, the corrective
actions for these models will be mandated once their respective
Airplane Flight Manual (AFM) revisions become available.
    This [Canadian] AD mandates the incorporation of AFM procedures
to guide the crew to stabilize the aeroplane's airspeed and attitude
for continued safe flight.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
6414.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comment received on the NPRM and
the FAA's response to that comment.

Request To Determine Root Cause of Unsafe Condition

    The Airline Pilots Association International (ALPA) requested
further investigation and system modifications for the ice crystal
contamination. ALPA stated that although the NPRM proposed an amendment
to the AFM procedures for the crew, it does not believe that this AFM
procedure addresses the root cause of the unsafe condition.
    The Air Line Pilots Association stated that the AFM revision will
not address the root cause of the high-altitude icing (ice crystal
contamination), and requested that further investigation be done for
the ice crystal contamination issue and remedies be provided in
addition to the AFM amendments.
    We agree that the AFM revision will not address the root cause of
the high-altitude icing (ice crystal contamination). The manufacturer
is investigating the issue, but there is no timetable for a final
resolution. Should the manufacturer develop modifications to prevent
this problem, the FAA will consider further rulemaking. The
incorporation of the AFM procedures is meant to be used to guide the
crew on how to stabilize the airplane airspeed and altitude for
continued safe flight in icing conditions. However, further
investigation into this matter extends beyond the scope of this AD.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting
this AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Bombardier, Inc. has issued Section 03-19, ``Unreliable Airspeed,''
of Chapter 3, ``Emergency Procedures,'' in the Bombardier CRJ Series
Regional Jet Model CL-600-2B19 Airplane Flight Manual CSP A-012,
Revision 64B, dated December 8, 2015. The service information describes
procedures to guide the crew to stabilize the airplane's airspeed and
attitude for continued safe flight when a loss of all air data
information has occurred in the flight deck. 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

    We estimate that this AD affects 500 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
              Action                        Labor cost            Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Revision..........................  1 work-hour x $85 per                  $0              $85          $42,500
                                     hour = $85.
----------------------------------------------------------------------------------------------------------------

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.
    We are 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

    We determined that 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. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. 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 adding the following new airworthiness
directive (AD):

2016-18-03 Bombardier, Inc.: Amendment 39-18633; Docket No. FAA-
2016-6414; Directorate Identifier 2015-NM-175-AD.

(a) Effective Date

    This AD is effective October 6, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model CL-600-2B19 (Regional
Jet Series 100 & 440) airplanes, certificated in any category,
serial numbers 7003 and subsequent.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Reason

    This AD was prompted by two in-service incidents of a loss of
all air data information in the flight deck. We are issuing this AD
to prevent loss of control when a loss of all air data information
has occurred in the flight deck.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Airplane Flight Manual (AFM) Revision

    Within 30 days after the effective date of this AD, revise the
emergency procedures section of the AFM by incorporating Section 03-
19, ``Unreliable Airspeed'', of Chapter 3, ``Emergency Procedures,''
in the Bombardier CRJ Series Regional Jet Model CL-600-2B19 Airplane
Flight Manual CSP A-012, Revision 64B, dated December 8, 2015.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO,
ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(i) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
Canadian Airworthiness Directive CF-2015-12, dated June 23, 2015,
for related information. This MCAI may be found in the AD docket on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2016-6414.

(j) 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 this AD specifies otherwise.
    (i) Section 03-19, ``Unreliable Airspeed,'' of Chapter 3,
``Emergency Procedures,'' in the Bombardier CRJ Series Regional Jet
Model CL-600-2B19 Airplane Flight Manual CSP A-012, Revision 64B,
dated December 8, 2015.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; email<EMAIL_ADDRESS>Internet http://www.bombardier.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) 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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on August 19, 2016.
Dorr M. Anderson,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-20826 Filed 8-31-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45619-45621]
[FR Doc No: 2012-18771]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0813]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Applications for Food and Drug Administration Approval
To Market a New Drug; Revision of Postmarketing Reporting
Requirements--Discontinuance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information
including each proposed extension of an existing collection of
information and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting requirements
contained in FDA's regulations on postmarketing reporting of
information pertaining to drug shortages.

DATES: Submit either electronic or written comments on the collection
of information by October 1, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information [,including
each proposed [extension/reinstatement] of an existing collection of
information,] before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing notice of the proposed
collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques,

when appropriate, and other forms of information technology.

Applications for Food and Drug Administration Approval To Market a New
Drug; Revision of Postmarketing Reporting Requirements--Discontinuance
(OMB Control Number 0910-0699)--Extension

    FDA published an interim final rule on December 19, 2011 (76 FR
78530) amending its postmarketing reporting regulations implementing
certain provisions of the Federal Food, Drug and Cosmetic Act. The
provisions of the Federal Food, Drug and Cosmetic Act require
manufacturers who are the sole manufacturers of certain drug products
to notify FDA at least 6 months before discontinuance of manufacture of
the products. The interim final rule modified the term
``discontinuance'' and clarified the term ``sole manufacturer'' with
respect to notification of discontinuance requirements. The broader
reporting resulting from these changes will enable FDA to improve its
collection and distribution of drug shortage information to physician
and patient organizations and to work with manufacturers and other
stakeholders to respond to potential drug shortages.
    Sections 314.81(b)(3)(iii) and 314.91 of FDA's regulations
implement section 506C of the Federal Food, Drug and Cosmetic Act.
Section 314.81(b)(3)(iii) requires entities who are the sole
manufacturers of certain drug products to notify us at least 6 months
before discontinuance of manufacture of the product. For the
regulations to apply, a product must meet the following three criteria:
    1. The product must be life supporting, life sustaining, or
intended for use in the prevention of a debilitating disease or
condition;
    2. The product must have been approved by FDA under section 505(b)
or 505(j) of the Federal Food, Drug, and Cosmetic Act; and
    3. The product must not have been originally derived from human
tissue and replaced by a recombinant product.
    Under Sec.  314.81(b)(3)(iii)(c), FDA will publicly disclose
information about drug products subject to section 506C that are to be
discontinued. Section 314.91 allows us to reduce the 6-month
notification period if we find that good cause exists for the
reduction. A manufacturer may request that we reduce the notification
period by certifying that good cause for the reduction exists.
    FDA added Sec. Sec.  314.81(b)(3)(iii) and 314.91 to its
regulations in the Federal Register of October 18, 2007 (72 FR 58993).
Sections 314.81(b)(3)(iii) and 314.91 require two new reporting
requirements to FDA that are subject to OMB approval under the PRA:
Notification of Discontinuance and Certification of Good Cause. The
December 19, 2011, interim final rule added two new definitions to
Sec.  314.81(b)(3)(iii): ``Discontinuance'' and ``sole manufacturer.''
The interim final rule clarified the scope of manufacturers required to
report and expanded the range of circumstances required to be reported
to the Agency under Sec.  314.81(b)(3)(iii), but did not change the
substantive content of the reports required to be submitted to the
Agency. This PRA analysis covers the information collection resulting
from the October 18, 2007, final rule and also includes estimates of
how the number of Notifications of Discontinuance and Certifications of
Good Cause may increase as a result of the interim final rule.

A. Notification of Discontinuance

    Under Sec.  314.81(b)(3)(iii), at least 6 months before a sole
manufacturer intends to discontinue manufacture of a drug product
subject to section 506C, the manufacturer must send us notification of
the discontinuance. The notification of discontinuance generally
contains the name of the manufacturer, the name of the product to be
discontinued, the reason for the discontinuance, and the date of
discontinuance. FDA will work with relevant manufacturers during the 6-
month notification period to help minimize the effect of the
discontinuance on patients and health care providers, and to distribute
appropriate information about the discontinuance to physician and
patient organizations. The interim final rule added definitions of
``discontinuance'' and ``sole manufacturer'' to Sec.
314.81(b)(3)(iii). The inclusion of these definitions expands
notification requirements under Sec.  314.81(b)(3)(iii) to additional
discontinuance circumstances and clarifies the scope of manufacturers
who must report discontinuances. The interim final rule also required
that notifications of discontinuance be submitted either electronically
or by telephone according to instructions on FDA's Drug Shortage Web
site at http://www.fda.gov/Drugs/DrugSafety/DrugShortages. This change
ensures that the appropriate offices are timely notified of all
relevant discontinuances. It also reflects existing practice for
submitting notices of discontinuance, and reduces the burden on
industry to submit multiple copies of the notification.

B. Certification of Good Cause

    FDA may reduce the 6-month notification period if we find good
cause for the reduction. As described in Sec.  314.91, a manufacturer
can request a reduction in the notification period by submitting
written certification that good cause exists to the following
designated offices: (1) The CDER Drug Shortage Coordinator at the
address of the Director of CDER; (2) the CDER Drug Registration and
Listing Team, Division of Compliance Risk Management and Surveillance
in CDER; and (3) the director of either the CDER division or the CBER
office that is responsible for reviewing the application. The following
circumstances may establish good cause:
     A public health problem may result from continuation of
manufacturing for the 6-month period (Sec.  314.91(d)(1));
     A biomaterials shortage prevents the continuation of
manufacturing for the 6-month period (Sec.  314.91(d)(2));
     A liability problem may exist for the manufacturer if the
manufacturing is continued for the 6-month period (Sec.  314.91(d)(3));
     Continuation of the manufacturing for the 6-month period
may cause substantial economic hardship for the manufacturer (Sec.
314.91(d)(4));
     The manufacturer has filed for bankruptcy under chapter 7
or 11 of title 11, United States Code (Sec.  314.91(d)(5));
     The manufacturer can stop making the product but still
distribute it to satisfy existing market need for 6 months (Sec.
314.91(d)(6)); or
     Other good cause exists for a reduction in the
notification period (Sec.  314.91(d)(7)).
    With each certification described previously, the manufacturer must
describe in detail the basis for its conclusion that such circumstances
exist. We require that the written certification that good cause exists
be submitted to the offices identified previously to ensure that our
efforts to address the discontinuance take place in a timely manner.
The interim final rule made no changes to the requirements or process
for certification of good cause.
    Description of Respondents: An applicant that is the sole
manufacturer and who is discontinuing manufacture of a drug product
that meets the following criteria: (1) Is life supporting, life
sustaining, or intended for use in the prevention of a debilitating
disease or condition; (2) was approved by FDA under section 505(b) or
(j) of the Federal Food, Drug, and Cosmetic Act; and (3) was not
originally derived from human tissue and replaced by a recombinant
product.

    Burden Estimate: The table below provides an estimate of the annual
reporting burden for notification of a product discontinuance and
certification of good cause under Sec. Sec.  314.81(b)(3)(iii) and
314.91, as amended by the interim final rule.
    Notification of Discontinuance: Based on data collected from the
CDER Drug Shortage Coordinator since December 17, 2007, when Sec. Sec.
314.81(b)(3)(iii) and 314.91 went into effect, one manufacturer during
each year reported to FDA a discontinuance of one drug product meeting
the criteria of section 506C and its implementing regulations (i.e.,
the drug product was approved under section 505(b) or (j) of the
Federal Food, Drug, and Cosmetic Act, the drug product was ``life-
supporting, life-sustaining or intended for use in the prevention of a
debilitating disease or condition,'' the drug product was produced by a
sole manufacturer, and the drug product was permanently discontinued).
CDER's Drug Shortages Coordinator tracked 220 drug shortages between
January and October of 2011. The Agency estimates that 30 percent (66)
of these shortages would relate to discontinuances subject to mandatory
reporting under section 506C as a result of the interim final rule.
Adjusting to include an additional two months of reporting (November
and December), we estimate that FDA will receive a total of 80
notifications of a discontinuance per year under section 506C, as
amended by the interim final rule. Based on experience, a manufacturer
submits only one notification of a discontinuance per year, thus the
total number of manufacturers who would be required to notify us of a
discontinuance would be 80. Therefore, the number of respondents is
estimated to be 80. The hours per response is the estimated number of
hours that a respondent would spend preparing the information to be
submitted with a notification of product discontinuance, including the
time it takes to gather and copy the statement. Based on experience in
working with manufacturers to submit notifications under Sec.
314.81(b)(3)(iii), we estimate that approximately 2 hours on average
are needed per response. We do not expect the changes in the interim
final rule to affect the number of hours per response. Therefore, we
estimate that respondents will spend 160 hours per year notifying us of
a product discontinuance under these regulations.
    Certification of Good Cause: Based on data collected from the CDER
drug shortage coordinator since 2007, one manufacturer each year
reported a discontinuance of one drug product under section 506C and
its implementing regulations. Each manufacturer has the opportunity
under Sec.  314.91 to request a reduction in the 6-month notification
period by certifying to us that good cause exists for the reduction.
The Agency has received no certifications of good cause since 2007.
Although we expect we will receive an increase in the number of reports
of discontinuances as a result of the changes in the interim final
rule, because of the limited circumstances under which good cause can
be requested or would be appropriately granted, we do not expect a
correspondingly large increase in the number of manufacturers
requesting a certification of good cause. We estimate that only 5
manufacturers will request a certification of good cause each year.
Therefore, the number of respondents is estimated to be 5. The total
annual responses are the total number of certifications of good cause
that are expected to be submitted to us in a year. We estimate that the
total annual responses will remain small, averaging one response per
respondent. The hours per response is the estimated number of hours
that a respondent spends preparing the detailed information certifying
that good cause exists for a reduction in the notification period,
including the time it takes to gather and copy the documents. We
estimate that approximately 16 hours on average are needed per
response. Therefore, we estimate that 80 hours will be spent per year
by respondents certifying that good cause exists for a reduction in the
6-month notification period under Sec.  314.91.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Notification of Discontinuance                80               1              80               2             160
 (314.81(b)(3)(iii).............
Certification of Good Cause                    5               1               5              16              80
 (314.91).......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             240
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: July 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18771 Filed 7-31-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 6 (Monday, January 10, 2011)]
[Notices]
[Page 1416]
[FR Doc No: 2011-181]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6552-021]

HDI Associates V; Sprague Hydro LLC; Notice of Application for
Transfer of License, and Soliciting Comments and Motions To Intervene

December 29, 2010.
    On December 10, 2010, HDI Associates V (transferor) and Sprague
Hydro LLC (transferee) filed an application for transfer of license for
the North Fork Sprague River Hydroelectric Project No. 6552, located on
the North Fork Sprague River in Klamath County, Oregon.
    Applicants seek Commission approval to transfer the license for the
North Fork Sprague River Hydroelectric Project from transferor to
transferee.
    Applicants' Contact: Transferor: Craig Smith, Grayco, LLC, P.O. Box
566, Gresham, Oregon 97030,<PHONE_NUMBER> ext. 105. For Transferee:
Ted S. Sorenson, Sprague Hydro LLC, 5203 South 11th East, Idaho Falls,
Idaho 83404,<PHONE_NUMBER>.
    FERC Contact: Jeremy M. Jessup,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments and motions to intervene: 30 days from
the issuance date of this notice. Comments and motions to intervene may
be filed electronically via the Internet. See 18 CFR 385.2001(a)(1) and
the instructions on the Commission's Web site under http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. If unable to be filed electronically, documents may be paper-
filed. To paper-file, an original plus seven copies should be mailed
to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. More information about
this project can be viewed or printed on the eLibrary link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-6552) in the docket number field to access
the document. For assistance, call toll-free 1-866-208-3372.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-181 Filed 1-7-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37128-37129]
[FR Doc No: 2011-15905]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0541]

Determination of Regulatory Review Period for Purposes of Patent
Extension; INVEGA SUSTENNA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for INVEGA SUSTENNA and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of Patents and Trademarks, Department of Commerce, for the
extension of a patent which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L.. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product INVEGA
SUSTENNA (paliperidone palmitate). INVEGA SUSTENNA is indicated for the
acute and maintenance treatment of schizophrenia in adults. Subsequent
to this approval, the Patent and Trademark Office received a patent
term restoration application for INVEGA SUSTENNA (U.S. Patent No.
5,254,556) from Janssen, L.P., and the Patent and Trademark Office
requested FDA's assistance in determining this patent's eligibility for
patent term restoration and that FDA determine the product's regulatory
review period. In a letter dated June 1, 2011, FDA advised the Patent
and Trademark Office that this human drug product had undergone a
regulatory review period and that the approval of INVEGA SUSTENNA
represented the first permitted commercial marketing or use of the
product.
    FDA has determined that the applicable regulatory review period for
INVEGA SUSTENNA is 2,253 days. Of this time, 1,608 days occurred during
the testing phase of the regulatory review period, while 645 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: June 2, 2003. FDA has verified the applicant's claim that
the date the investigational new drug application became effective was
on June 2, 2003.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: October
26, 2007. FDA has verified the applicant's claim that the new drug
application (NDA) for Invega Sustenna (NDA 22-264) was submitted on
October 26, 2007.
    3. The date the application was approved: July 31, 2009. FDA has
verified the applicant's claim that NDA 22-264 was approved on July 31,
2009.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,449 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by August 23, 2011. Furthermore, any interested person
may petition FDA for a determination regarding whether the

applicant for extension acted with due diligence during the regulatory
review period by December 21, 2011. To meet its burden, the petition
must contain sufficient facts to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions
should be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. It is no longer
necessary to send three copies of mailed comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
    Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 2, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-15905 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)]
[Notices]
[Page 28929]
[FR Doc No: 2017-13259]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Fourteenth RTCA SC-228 Plenary Session

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Fourteenth RTCA SC-228 Plenary Session.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of Fourteenth RTCA SC-228 Plenary Session.

DATES: The meeting will be held July 14, 2017, 9:00 a.m.-5:00 p.m.

ADDRESSES: The meeting will be held at: RTCA Headquarters, 1150 18th
Street NW., Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: Al Secen at<EMAIL_ADDRESS>or 202-
330-0647, or The RTCA Secretariat, 1150 18th Street NW., Suite 910,
Washington, DC 20036, or by telephone at<PHONE_NUMBER>, fax at (202)
833-9434, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of the Fourteenth RTCA SC-228 Plenary
Session. The agenda will include the following:

Friday, July 14, 2017 9:00 a.m.-5:00 p.m.

1. Welcome and Introductions
2. Agenda Overview
3. DAA MOPS Approval
4. WG-1 White Paper Status Update--FRAC Announcement
5. WG-2 White Paper Status Update--FRAC Announcement
6. SC-228 and WG-105 Leadership Coordination
7. Leadership Meeting Update
8. Action Item Review
9. Adjourn

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on June 21, 2017.
Mohannad Dawoud,
Management & Program Analyst, Partnership Contracts Branch, ANG-A17
NextGen, Procurement Services Division, Federal Aviation
Administration.
[FR Doc. 2017-13259 Filed 6-23-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: October 14, 2010 (Volume 75, Number 198)]
[Notices]
[Page 63169-63170]
[DOCID:fr14oc10-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. DI10-21-000]

Dirk Wiggins; Notice of Petition for Declaratory Order and
Soliciting Comments, Protests, and/or Motions To Intervene

October 6, 2010.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Petition for Declaratory Order.
    b. Docket No.: DI10-21-000.
    c. Date Filed: September 9, 2010.
    d. Applicant: Dirk Wiggins.
    e. Name of Project: Duane Wiggins Hydro Project.
    f. Location: The existing Duane Higgins Hydro Project is located on
Spring Creek, near the town of Joseph, Wallowa County, Oregon,
affecting T. 03 S., R. 45 E., sec. 28, Willamette Meridian.
    g. Filed Pursuant to: Section 23(b)(1) of the Federal Power Act, 16
U.S.C. 817(b).
    h. Applicant Contact: Dirk Wiggins, 84646 Ponderosa Lane, Joseph,
Oregon 97846; telephone:<PHONE_NUMBER>; E-mail: http://
<EMAIL_ADDRESS>    i. FERC Contact: Any questions on this notice should be addressed
to Henry Ecton,<PHONE_NUMBER>, or E-mail address:
<EMAIL_ADDRESS>    j. Deadline for filing comments, protests, and/or motions: November
8, 2010.
    All documents should be filed electronically via the Internet. See
18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be
filed electronically, documents may be paper-filed. To paper-file, an
original and seven copies should be filed with: Secretary, Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    Commenters can submit brief comments up to 6,000 characters,
without prior registration, using the eComment system at http://
www.ferc.gov/docs-filing/ecomment.asp. Please include the docket number
(DI10-21-000) on any comments, protests, and/or motions filed.
    k. Description of Project: The existing Duane Wiggins Hydro Project
consists of: (1) A 13-foot-long, 3.75-foot-wide, 2-foot-deep pond; (2)
a 1-foot-high lumber diversion into 2.5-foot-high, 3.75-foot-wide
wooden box; (2) a 4.5-inch-diameter, 1,367-foot-long steel pipe
penstock; (3) a 8-foot-long, 10-foot-wide steel powerhouse containing a
20-kW Pelton-type turbine/generator; (4) a 40-foot-long tailrace to
Spring Creek; (5) a 1,000-foot-long transmission line; and (6)
appurtenant facilities. The project will be connected to an interstate
grid.
    When a Petition for Declaratory Order is filed with the Federal
Energy Regulatory Commission, the Federal Power Act requires the
Commission to investigate and determine if the interests of interstate
or foreign commerce would be affected by the proposed project. The
Commission also determines whether or not the project: (1) Would be
located on a navigable waterway; (2) would occupy or affect public
lands or reservations of the United States; (3) would utilize surplus
water or water power from a government dam; or (4) if applicable, has
involved or would involve any construction subsequent to 1935 that may
have increased or would increase the project's head or generating
capacity, or have otherwise significantly modified the project's pre-
1935 design or operation.
    l. Locations of the Application: Copies of this filing are on file
with the Commission and are available for public inspection. This
filing may 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. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>,
or TTY, contact<PHONE_NUMBER>. A copy is also available for inspection
and reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214.

In determining the appropriate action to take, the Commission will
consider all protests or other comments filed, but only those who file
a motion to intervene in accordance with the Commission's Rules may
become a party to the proceeding. Any comments, protests, or motions to
intervene must be received on or before the specified comment date for
the particular application.
    o. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', and/
or ``MOTIONS TO INTERVENE'', as applicable, and the Docket Number of
the particular application to which the filing refers. A copy of any
motion to intervene must also be served upon each representative of the
Applicant specified in the particular application.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-25794 Filed 10-13-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: September 11, 2006 (Volume 71, Number 175)]
[Rules and Regulations]
[Page 53335-53337]
[DOCID:fr11se06-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 710

[EPA-HQ-OPPT-2006-0691; FRL-8088-5]

2006 Reporting Notice; Partial Update of Inventory Database;
Chemical Substance Production, Processing, and Use Site Reports

AGENCY: Environmental Protection Agency (EPA).

ACTION: Announcement of 2006 reporting period.

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SUMMARY: This document announces the 2006 reporting period for
Inventory Update Reporting (IUR) under the Toxic Substances Control Act
(TSCA). The IUR rule requires manufacturers and importers of certain
chemical substances included on the TSCA Chemical Substances Inventory
to report current data on the manufacturing, processing, and use of the
substances. The 2006 reporting period is from August 25, 2006 to
December 23, 2006. This is the first reporting period since the
original inventory in which manufacturers and importers of inorganic
chemical substances as well as manufacturers and importers of organic
chemical substances are required to report. Also, the 2006 reporting
period is the first to require reporting of processing and use
information for certain chemical substances manufactured in volumes of
300,000 pounds or more at a site in addition to manufacturing
information. While information can continue to be submitted through the
mail or other delivery service, the Agency strongly encourages
reporting through the Internet using EPA's Central Data Exchange (CDX).

DATES: The 2006 reporting period is from August 25, 2006 to December
23, 2006.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
    For technical information contact: Susan Sharkey, Project Manager,
Economics, Exposure and Technology Division (7406M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-8789; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you manufacture (defined by
statute at 15 U.S.C. 2602(7) to include import) chemical substances,
including inorganic chemical substances, subject to reporting under the
Inventory Update Reporting (IUR) regulations at 40 CFR part 710,
subpart C. Any use of the term ``manufacture'' in this document will
encompass import, unless otherwise stated.
    Potentially affected entities may include, but are not limited to:
     Chemical manufacturers and importers, including chemical
manufacturers and importers of inorganic chemical substances (NAICS
codes 325, 32411).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions at 40 CFR 710.48. If you
have any questions regarding the applicability of this action to a
particular entity, consult the technical contact person listed

under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Documents?

    You may access this Federal Register document electronically
through the EPA Internet under the Federal Register listings athttp://www.epa.gov/fedrgstr.
 Copies of TSCA Regulations or additional

assistance on the IUR reporting requirements can be obtained by writing
TSCA Hotline, U.S. Environmental Protection Agency, Office of Pollution
Prevention and Toxics (7408M), 1200 Pennsylvania Ave., NW., Washington,
DC 20460; calling<PHONE_NUMBER>; or sending an e-mail
<EMAIL_ADDRESS>

II. Background

A. What Action is the Agency Taking?

    The Agency is announcing the 2006 reporting period for Inventory
Update Reporting (IUR) under TSCA. IUR requires manufacturers and
importers of certain chemical substances included on the TSCA Chemical
Substances Inventory to report current data on the manufacturing,
processing, and use of the substances. The 2006 reporting period is
from August 25, 2006 to December 23, 2006.
    The 2006 reporting period is the first time that reporting has been
required since the promulgation of amendments on January 7, 2003 (68 FR
848). The 2003 Amendments and further subsequent revisions thereto have
substantially altered the reporting requirements. For 2006,
manufacturers of both organic and inorganic chemical substances listed
on the TSCA Inventory are required to report company, site, and
manufacturing information. IUR submitters may be required to report
processing and use information for chemical substances manufactured
(including imported) in amounts of 300,000 pounds or more during
calendar year 2005.

B. What is the Agency's Authority for Taking this Action?

    EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to
compile and keep current an inventory of chemical substances
manufactured or processed in the United States. This inventory is known
as the TSCA Chemical Substances Inventory (the TSCA Inventory). In
1977, EPA promulgated a rule (42 FR 64572, December 23, 1977) under
TSCA section 8(a), 15 U.S.C. 2607(a), to compile an inventory of
chemical substances in commerce at that time. In 1986, EPA promulgated
the initial IUR rule under TSCA section 8(a), codified at 40 CFR part
710 (51 FR 21438, June 12, 1986), to facilitate the periodic updating
of the TSCA Inventory and to support activities associated with the
implementation of TSCA. In 2003, EPA promulgated extensive amendments
to the IUR rule (68 FR 848, January 7, 2003) (FRL-6767-4) (2003
Amendments) to collect additional information regarding the manufacture
of chemical substances and also, for chemicals produced in amounts of
300,000 pounds or more at a site, information regarding the processing
and use of chemical substances. Minor corrections to the IUR rule were
made in July of 2004 (69 FR 40787, July 7, 2004) (FRL-7332-3), and
additional revisions to the IUR rule were made on December 19, 2005 (70
FR 75059) (FRL-7743-9).
    After the initial reporting during 1986, recurring reporting was
required every 4 years. Subsequent reporting cycles took place in 1990,
1994, 1998, and 2002. The next reporting period is from August 25, 2006
to December 23, 2006. Persons subject to the IUR must submit the
required information during this period.
    TSCA section 8(a)(1) authorizes the EPA Administrator to promulgate
rules under which manufacturers and processors of chemical substances
and mixtures (referred to hereinafter as chemical substances) must
maintain such records and submit such information as the Administrator
may reasonably require. TSCA section 8(a) generally excludes small
manufacturers and processors of chemical substances from the reporting
requirements established in TSCA section 8(a). However, EPA is
authorized by TSCA section 8(a)(3) to require TSCA section 8(a)
reporting from small manufacturers and processors with respect to any
chemical substance that is the subject of a rule proposed or
promulgated under TSCA section 4, 5(b)(4), or 6, or that is the subject
of an order under TSCA section 5(e), or that is the subject of relief
that has been granted pursuant to a civil action under TSCA section 5
or 7. The standard for determining whether an entity qualifies as a
small manufacturer for purposes of 40 CFR part 710 generally is
identified in 40 CFR 704.3. Processors are not currently subject to the
regulations at 40 CFR part 710.

C. How Do I Know What Information is Currently in the TSCA Chemical
Substances Inventory?

    The Agency publishes, via the National Technical Information
Service (NTIS), an updated public TSCA Inventory twice a year, normally
around January/February and July/August each year. Specifically, each
of the chemical substances included in these products is identified by
a Chemical Abstracts Service (CAS) Index or Preferred Name, the
corresponding CAS registry number, molecular formula, and if
applicable, the chemical definition and appropriate EPA special flags
as found in the printed Inventory. The substances are sequenced in
ascending order of the corresponding CAS registry numbers. The products
do not include chemical synonyms that are copyrighted by the CAS.
Furthermore, generic names or EPA accession numbers for substances with
confidential chemical identities are not included on the public TSCA
Inventory.
    For confidential substances, the Agency also publishes data linking
the PMN case number to the corresponding accession number. The
publication of the accession number will facilitate IUR reporting.
These data are also available at the NTIS.
    These products are available for sale from: National Technical
Information Service (NTIS), U.S. Department of Commerce, Springfield,
VA 22161; telephone:<PHONE_NUMBER>, toll free: 1-800-553-NTIS;
Internet address: http://www.ntis.gov/fcpc. The NTIS order number for the TSCA

Inventory database CD ROM is SUB5423; for the accession number database
CD ROM is PB2006500013; and for TSCA Tracker is SUB5435 or SUB5468.

D. How Do I Know If I Have to Report?

    You have to report if you manufacture or import IUR reportable
chemical substances included on the TSCA Chemical Substances Inventory
in an amount of 25,000 pounds or more at a single site during the 2005
calendar year. EPA has developed an instructions manual (Instructions
for Reporting for the 2006 Partial Updating of the TSCA Chemical
Substances Inventory (Instructions for Reporting)) that provides
guidance to assist manufacturers and importers in reporting under the
2006 IUR, including relevant citations to the CFR. For further and more
specific information, please review the IUR reporting regulations
beginning at 40 CFR 710.43.

E. How Do I Get a 2006 Reporting Package?

    Materials and other information needed to report under the 2006 IUR
are available from the Agency's Internet homepage,http://www.epa.gov/oppt/iur.
 The IUR website Documents, Tools, and Resources page contains

information, software, and documents needed to

report in 2006. The eIUR reporting software is a downloadable software
program to enable you to electronically complete and submit the IUR
reporting form (Form U). The Instructions for Reporting provides
guidance for completing the 2006 Form U. In addition, the presentation
used during a past EPA IUR training workshop is available on the
website.
    In an effort to streamline the reporting process, reduce
administrative costs, and accelerate processing, the Agency is relying
more heavily on electronic methods of information dissemination and
collection. In the past, EPA mailed a reporting package to persons who
reported during the previous IUR reporting period. EPA is no longer
mailing such a package, and is instead relying on the Internet for
disseminating reporting information. If you do not have access to the
Internet, traditional hard copies or CD ROMs containing the eIUR
software or guidance documents will be made available through the TSCA
Hotline listed under Unit I.B.

F. How Do I Submit My Report?

    The regulation at 40 CFR 710.39 requires submitters to report using
EPA's Form U. Submitters may report using the printed or the electronic
2006 Form U, although electronic reporting is preferred. Reporting
options are further described on EPA's Internet website at http://www.epa.gov/oppt/iur
 under ``Reporting Options and Deadline.''

    i. Electronic reporting. Instructions for electronic reporting are
contained in the eIUR software and in the Instructions for Reporting.
Electronic reporting consists of two steps. Electronic reporters are
required to use the eIUR reporting software to develop a validated,
correctly formatted, and encrypted data file. Once the software has
completed the data file, the user will be provided with directions for
submitting the data file. The data file can be delivered to EPA on a CD
ROM or can be submitted through the Internet using the Agency's Central
Data Exchange (CDX). Note that registration is required to submit
through CDX. Please allow 2 weeks for the registration process. The
eIUR software contains everything you need to report.
    Because electronic reporting reduces the chances of errors in
reporting and reduces resources needed to report and process reports,
EPA is encouraging submitters to use the reporting software and file
through the Internet using CDX or on a CD ROM.
    ii. Paper reporting. Your completed Form U can be printed using the
eIUR software. Form U is also available as a PDF on EPA's website or
upon request from the TSCA Hotline at the address listed above.

G. Where Do I Submit My 2006 Report?

    Instructions for submitting your report are included in the eIUR
software and in the Instructions for Reporting. Reports can be
submitted in two ways.
    i. Using the Internet. You can submit your completed Form U through
the Internet using EPA's CDX. To register with CDX, go to the CDX
homepage at http://www.epa.gov/cdx. Click on ``Log-in to CDX'' and then

``Registration.'' Allow 2 weeks for the registration process. Once
registered, follow the directions in the eIUR software to submit your
report. The eIUR software must be used to submit through the Internet.
    ii. By mail or delivery service. You can submit your completed Form
U either on a CD ROM or on paper. Mail your submission to OPPT IUR
Submission Coordinator, Mail code 7407M, ATTN: Inventory Update
Reporting, Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If using a delivery service, please deliver your submission to OPPT IUR
Submission Coordinator, Attn: Inventory Update Reporting, U.S.
Environmental Protection Agency, Office of Pollution Prevention and
Toxics, EPA East Bldg., Room 6428, 1201 Constitution Avenue, NW.,
Washington, DC.

H. What Happens If I Fail to Report During the 2006 Reporting Period?

    If you fail to report as required, the Agency can take
enforcementaction against you. Section 16 of the Act provides that any
person whoviolates a provision of TSCA shall be liable to the United
States for acivil penalty not to exceed $25,000 for each such
violation.

I. Does this Action Involve Any New Information Collection Activities,
Such as Reporting, Recordkeeping, or Notification?

    No. The information collection requirements contained in 40 CFR
part 710, subpart C, have already been approved by the Office of
Management and Budget (OMB) pursuant to the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., under OMB control number 2070-0070 (EPA
ICR No. 1884.03). The annual public burden for this collection of
information is estimated at 560 hours per response for organic
chemicals, and 265 hours per response for inorganic chemicals. Under
the PRA, ``burden'' means the total time, effort or financial resources
expended by persons to generate, maintain, retain, or disclose
information to or for a Federal agency. For this collection, it
includes the time needed to review instructions, search existing data
sources, gather and maintain the data needed, and complete and review
the collection of information. 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 OMB number. The OMB control number
for this information collection appears above. In addition, the OMB
control numbers for EPA's regulations, after initial display in the
final rule, are listed in 40 CFR part 9 and appear on any form that is
required to be used.
    Send any comments on the accuracy of the provided burden estimates,
and any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques to the Director,
Regulatory Information Division, Office of Policy, Economics and
Innovation, U.S. Environmental Protection Agency, Mail Code 1806A, 1200
Pennsylvania Ave., NW., Washington, DC 20460. Include the OMB control
number in any correspondence. Send only comments on the accuracy of the
burden estimates to this address. Do not send your 2006 IUR submission
information to this address. Your 2006 IUR submission should be
submitted in accordance with the reporting instructions. The
instructions are included in the reporting software.

List of Subjects in 40 CFR Part 710

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: August 28, 2006.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.

[FR Doc. E6-14993 Filed 9-8-06; 8:45 am]

BILLING CODE 6560-50-S