[Federal Register Volume 77, Number 160 (Friday, August 17, 2012)]
[Rules and Regulations]
[Pages 49719-49720]
[FR Doc No: 2012-20138]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2012-0392; Airspace Docket No. 12-AGL-3]

Amendment of Class D Airspace; Sault Ste Marie, ON

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class D airspace at Sault Ste Marie, ON.
Additional controlled airspace is necessary to coincide with the
Canadian control zone over Sault Ste Marie Airport. The FAA is taking
this action to enhance the safety and management of Instrument Flight
Rule (IFR) operations at the airport.

DATES: Effective date: 0901 UTC, November 15, 2012. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone 817-321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On May 21, 2012, the FAA published in the Federal Register a notice
of proposed rulemaking (NPRM) to amend Class D airspace for the Sault
Ste Marie, ON, area, creating additional controlled airspace at Sault
Ste Marie Airport (77 FR 29916) Docket No. FAA-2012-0392. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received. Class D airspace designations are published in paragraph
5000 of FAA Order 7400.9V dated August 9, 2011, and effective September
15, 2011, which is incorporated by reference in 14 CFR Part 71.1. The
Class D airspace designations listed in this document will be published
subsequently in the Order.

The Rule

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

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011, is amended as follows:

Paragraph 5000 Class D Airspace

* * * * *

AGL ON D Sault Ste Marie, ON [Amended]

Sault Ste Marie Airport, ON, Canada
    (Lat. 46[deg]29'06'' N., long. 84[deg]30'34'' W.)

    That airspace in the United States at or below 3,000 feet MSL
within a 5-mile radius of Sault Ste Marie Airport.

    Issued in Fort Worth, Texas, on August 1, 2012.
David P. Medina,
Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2012-20138 Filed 8-16-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 11, 2008 (Volume 73, Number 155)]
[Notices]
[Page 46696-46698]
[DOCID:fr11au08-130]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58305; File No. SR-NASDAQ-2008-063]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Modify the Rules Governing the Requirements for Market Maker
Quotations on the NASDAQ Options Market

August 5, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on July 15, 2008, The NASDAQ Stock Market LLC (``NASDAQ'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared by NASDAQ. NASDAQ has designated the proposed rule
change as constituting a non-controversial rule change under Rule 19b-
4(f)(6) under the Act,\3\ which renders the proposal effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to modify Chapter VII, Section 6 of the Nasdaq
rules governing the requirements for market maker quotations on the
NASDAQ Options Market (``NOM''). The text of the proposed rule change
is below. Proposed new language is italicized; proposed deletions are
in brackets.\4\
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    \4\ Changes are marked to the rule text that appears in the
electronic Nasdaq Manual found at http://nasdaq.complinet.com.
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* * * * *

Chapter VII, Sec. 6 Market Maker Quotations

    (a) Size Associated with Quotes. A Market Maker's bid and offer for
a series of options contracts shall be accompanied by the number of
contracts at that price the Market Maker is willing to buy or sell. The
best bid and best offer entered by a Market Maker must have a size of
at least [ten (10)] one (1) contract[s].
    (b)-(e) No Change.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, NASDAQ included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. NASDAQ has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    On March 12, 2008, the Commission approved SR-NASDAQ-2007-004 and
SR-NASDAQ-2007-080, proposals to create the NASDAQ Options Market or

NOM.\5\ NOM has been performing above expectations since NASDAQ
launched trading on March 31, 2008. There are multiple firms registered
as market makers and over two dozen additional firms providing
liquidity through NOM's system. NOM's market share of listed options
continues to grow although NOM trades only a small percentage of all
available options classes and series. Despite this early success,
NASDAQ continues to monitor the market to identify instances where
market efficiency can be enhanced.
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    \5\ Securities Exchange Act Release No. 57478 (March 12, 2008),
73 FR 14521 (March 18, 2008) (order approving SR-NASDAQ-2007-004 and
2007-080).
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    NASDAQ believes that the efficiency of its market can be enhanced
by permitting market makers to enter quotations for one or more
contracts rather than requiring that they enter quotations for 10 or
more contracts in series in which they are registered. NASDAQ projects
that modifying the quotations requirements in this manner will
encourage more options trading firms to register as market makers on
NOM and to provide more liquidity to NOM participants. An overall
increase in liquidity will benefit investors and serve the public
interest.
    The NOM Rules will continue to ensure that market makers actively
quote. For example, NOM Rule Chapter VII, Section 6(d)(i) states that,
on a daily basis, a market maker must maintain continuous two-sided
quotations and participate in the pre-opening phase in 75% of the
options series in which the market maker is registered. In addition,
NOM provides functionality that allows registered market makers to
automatically input a quotation on the side of the market that has been
depleted. Moreover, pursuant to paragraph (d)(ii) of Section 6, Nasdaq
Regulation may call upon a market maker registered in a particular
series to maintain continuous bids or offers. Thus, Nasdaq may require
a market maker to continuously quote if it is the only registered
market maker in the series.
    NASDAQ believes that this proposal is consistent with the Act and
also with the Commission's well-settled position that the Act does not
mandate any particular market model:

    The Commission agrees that the Act does not mandate a particular
market model for national securities exchanges, and believes that
many different types of market models could satisfy the requirements
of the Act. The Commission does not believe that the Act requires an
exchange to have market makers. Although Market Makers could be an
important source of liquidity on NOM, they likely will not be the
only source. In particular, the NOM System is designed to match
buying and selling interest of all Participants on NOM. The
Commission therefore believes that the NOM structure is consistent
with the Act.\6\
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    \6\ Id. at 14527 (footnotes omitted).

    The Commission went on to note that ``[i]n its release adopting
Regulation ATS, the Commission rejected the suggestion that a
guaranteed source of liquidity was a necessary component of an
exchange'' and that the approved rules of the Archipelago Exchange did
not include a market maker requirement.\7\
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    \7\ Id. at note 92.
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    Nasdaq's proposal is also consistent with the current practice of
the NYSE/Arca Exchange of permitting options market makers to enter
quotations for one contract. The NYSE/Arca Options Market Maker
Orientation Manual states that a market maker quotation must be entered
for a minimum of one contract:

    All Market Makers must contribute to the maintenance of a fair
and orderly market. Market Makers must honor the number of contracts
entered into the system in all series of options classes within
their Appointment. Any change to a quote (including reduction of
volume) causes the quote to lose priority. The minimum size is one
contract. Neither LMMs or MMs are required to quote on the Opening
Auction. (emphasis added).\8\
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    \8\ http://www.nyse.com/pdfs/Options_MM_Orientation_
Manual.pdf at page 2.

Nasdaq proposes to adopt the same requirement and to make it
transparent by including it in Nasdaq's official rule manual.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\9\ in general and with Section
6(b)(5) of the Act,\10\ in particular, in that it is designed to
promote just and equitable principles of trade, to foster cooperation
and coordination with persons engaged in regulating, clearing,
settling, processing information with respect to, and 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; and are not
designed to permit unfair discrimination between customers, issuers,
brokers, or dealers.
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    \9\ 15 U.S.C. 78f.
    \10\ 15 U.S.C. 78f(b)(5).
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    The proposed changes are consistent with the statute in that they
are designed to facilitate transactions in options on the Nasdaq
Options Market by encouraging participants to provide liquidity through
Nasdaq's system. If the proposal succeeds in attracting additional
liquidity providers and additional liquidity, the Nasdaq system will
then match more buying and selling interest between and among all NOM
participants.

B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. To the contrary, the proposal
is designed to enhance competition and is based upon the rules of
another national securities exchange that trades standardized options.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Nasdaq has designated this rule filing as non-controversial under
Section 19(b)(3)(A) of the Act,\11\ and Rule 19b-4(f)(6)
thereunder.\12\ Nasdaq believes that the rule change should take effect
immediately upon filing because it will effect a change that: (1) Does
not significantly affect the public interest or the protection of
investors, and (2) does not impose any significant burden on
competition, and (3) does not become operative for 30 days after the
date of this filing. As such, the proposal is effective upon filing
with the Commission. Nasdaq intends to make this rule proposal
operative 30 days after the date of filing.
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate the rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in the furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-NASDAQ-2008-063 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2008-063. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of NASDAQ. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2008-063 and should
be submitted on or before September 2, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-18459 Filed 8-8-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Rules and Regulations]
[Pages 2089-2090]
[FR Doc No: 2016-00654]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0021]

Drawbridge Operation Regulation; Lake Washington Ship Canal,
Seattle, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Montlake Bridge across the Lake
Washington Ship Canal, mile 5.2, at Seattle, WA. The deviation is
necessary to allow the bridge to operate in single leaf mode during day
light hours, and a full closure (both bascule leafs in the closed-to-
navigation position) during night time hours while work crews replace
bridge decking. This deviation allows a single leaf opening with a one
hour advance notice during the day, and remains in the closed-to-
navigation position at night.

DATES: This deviation is effective from 6 a.m. on February 27, 2016 to
6 p.m. on February 28, 2016.

ADDRESSES: The docket for this deviation, [USCG-2016-0021] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Washington Department of Transportation has
requested a temporary deviation from the operating schedule for the
Montlake Bridge across the Lake Washington Ship Canal, at mile 5.2, at
Seattle, WA. The deviation is necessary to accommodate work crews
conducting timely bridge deck repairs.
    The Montlake Bridge in the closed position provides 30 feet of
vertical clearance throughout the navigation channel, and 46 feet of
vertical clearance throughout the center 60 feet of the bridge;
vertical clearance references to the Mean Water Level of Lake
Washington. When half the span is open with a single leaf, 46 feet of
vertical clearance will be reduced

throughout the center to 30 feet of the bridge.
    To facilitate this event, the north half of the bridge span, or
single leaf, will open with at least a one hour advance notice provided
to the bridge operator from 6 a.m. to 6 p.m. on February 27, 2016. From
6 p.m. on February 27, 2016 to 5 a.m. on February 28, 2016, the
Montlake Bridge span will remain in the closed-to-navigation position,
or full closure. Then, from 5 a.m. to 6 p.m. on February 28, 2016, the
north half of the bridge span will open with at least a one hour
advance notice to the bridge operator. The normal operating schedule
for the Montlake Bridge operates in accordance with 33 CFR 117.1051(e).
    The deviation period is from 6 a.m. on February 27, 2016 to 6 p.m.
on February 27, 2016 (north single leaf opening if a one hour notice is
given); from 6 p.m. on February 27, 2016 to 5 a.m. on February 28, 2016
(remain in the closed-to-navigation position); from 5 a.m. on February
28, 2016 to 6 p.m. on February 28, 2016 (north single leaf opening if a
one hour notice is given).
    Waterway usage on the Lake Washington Ship Canal ranges from
commercial tug and barge to small pleasure craft. Vessels able to pass
through the bridge in the closed-to-navigation position may do so at
any time. The bridge will be able to open for emergency vessels in
route to a call when an hour notice is given to the bridge operator,
and a single leaf opening will be provided. The Lake Washington Ship
Canal has no immediate alternate route for vessels to pass. The Coast
Guard will also inform the users of the waterways through our Local and
Broadcast Notices to Mariners of the change in operating schedule for
the bridge so that vessels can arrange their transits to minimize any
impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: January 11, 2016.
Steven M Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2016-00654 Filed 1-14-16; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 122 (Tuesday, June 25, 2013)]
[Notices]
[Pages 38053-38055]
[FR Doc No: 2013-15101]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0010]

Regulatory Systems Strengthening

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the support of the Office of
International Programs. The goal of the Cooperative Agreement is to
strengthen global regulatory capacity through activities that may
include: Development of global norms and standards for product
regulation; generation and analysis of evidence of regulatory systems
performance; and provision of technical support to national regulatory
systems strengthening efforts.

DATES: Important dates are as follows:
    1. The application due date is August 9, 2013.
    2. The anticipated start date is September 10, 2013.
    3. The opening date is July 10, 2013.
    4. The expiration date is August 10, 2013.

ADDRESSES: Submit electronic applications to: http://www.grants.gov.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.

FOR FURTHER INFORMATION CONTACT: Charles Preston, Office of Science
Policy Analysis/Office of International Programs, HFG-1, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Silver Spring, MD
20993,<PHONE_NUMBER><EMAIL_ADDRESS>or Daniel Lukash,
Office of Acquisitions and Grants Services, Food and Drug
Administration, 5630 Fishers Lane, Rm. 2028, Rockville, MD 20857, 301-
827-6771<EMAIL_ADDRESS>    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at http://www.fda.gov/InternationalPrograms/CapacityBuilding/default.htm.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-13-024
93.103

A. Background

    The World Health Organization (WHO) has responsibility for helping
to ensure access to essential medical products of assured safety,
quality, and efficacy within its 193 Member States. It does so in three
primary areas: (1) Setting global norms and standards; (2) articulating
evidence-based policy options, including those relating to regulatory
systems performance; and (3) providing technical support to national
regulatory authorities and governments. These activities help to
strengthen national regulatory systems. In this era of globalization,
products can be imported from anywhere in the world within increasingly
complex supply chains. As national and global health programs work to
scale up access to medicines and health products, strong national
regulatory systems are more important than ever before.
    What are the necessary constituents of an effective medical
products regulatory system? This is an important question, and one
which the U.S. Institute of Medicine recently addressed, identifying
some core elements of a successful regulatory system. These include
sound government; good manufacturing, clinical, and laboratory
practices; staff development and professionalization; monitoring and
evaluation of product quality using laboratories; inspection and
surveillance of products throughout the supply chain; risk assessment,
analysis, and management; and emergency response. WHO helps to
strengthen medical products regulatory systems through activities that
include disseminating global quality norms and standards; facilitating
the exchange of regulatory information; assessing regulatory
authorities; providing training; distributing scientific materials and
information on aspects of regulation from regional and global
perspectives; expanding the global monitoring and surveillance system
for falsified and substandard products; supporting national
pharmacovigilance programs; and building capacity as a component of
WHO's prequalification programs.
    Another important area of work on regulatory systems strengthening
is through a new Member State Mechanism (MSMech) on Substandard,
Spurious, Falsified, Falsely-labeled, and Counterfeit (SSFFC) medical
products, which was established as part of a resolution at the 65th
World Health Assembly in May 2012. The MSMech is designed to address
SSFFC issues and advance medical product safety and quality through the
strengthening of national regulatory capacities. The first meeting of
the MSMech occurred in Buenos Aires, Argentina, in November 2012, and
the representatives agreed to form a global steering committee with
representation from the WHO regions to support implementation of the
workplan; the creation and management of selected work groups to
address specific work areas; and the development of data-driven
approaches to SSFFC issues. Participants also stressed the need for
initiatives to educate consumers on the threats of SSFFC, for
methodologies and instruments to obtain more accurate information about
the nature and magnitude of the SSFFC problem, and for guidelines on
how to better respond to the detection of SSFFC medical products.
    FDA has been actively engaged with WHO on a number of these fronts.
FDA experts participate in WHO drug and vaccine safety advisory
committees, which develop important international norms and standards
for the regulation of medical products. In addition, FDA has
implemented a number of Cooperative Agreements with WHO on medical
product safety and quality in recent years. In 2010, the Office of
International Programs (OIP)/FDA set up a Cooperative Agreement with
WHO to develop a global monitoring platform for SSFFC medical products.
A steering group of experts from relevant FDA Centers provides
guidance, direction, and advice regarding this cooperative effort. The
overarching priority is the exchange of information about and expertise
on matters relating to SSFFC so that data can be collected and
contribute to the formulation of policies and programs that combat the
problem. The system allows participating countries to report SSFFC
information using a simple, electronic rapid alert form. Once the
information has been submitted, WHO can take the appropriate first-
response measures to circulate such information to governments, WHO
regional offices, and other stakeholders as necessary. Analyses, threat
assessments, thematic reporting, and bulletins based on the reported
data may also be completed and shared.

B. Research Objectives

    The Cooperative Agreement announced in this FOA represents the
further expansion of well-established collaborations between WHO and
OIP/FDA in support of data-driven and science-based public health
strategies and approaches. These collaborations align well with FDA
domestic and global goals, as outlined in its 2011 Pathway Report to
Global Product Safety and Quality, including addressing medical product
safety and quality problems. Relevant strategies include: (1)
Developing global norms and standards; (2) generating and analyzing
evidence on regulatory systems performance; and (3) providing technical
support to national regulatory systems strengthening efforts. This
Cooperative Agreement is expected to support the following types of
collaboration:

 Developing global norms and standards
     Enabling the sharing of scientific findings and data
through expert meetings and technical consultations;
     Assisting Member States in the implementation and
subsequent evaluation of internationally recognized standards and
guidelines, e.g. WHO guidelines and standards and those emerging from
standards development venues such as the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH);
     Utilizing WHO's convening power to engage with relevant
stakeholders on science-based norms and standards;
 Generating and analyzing evidence of regulatory systems
performance
     Contributing to the knowledge base of the current state of
medical product regulation globally, including challenges, risks, and
emerging trends;
     Enabling and/or further strengthening the development of
data/information systems as sources of inputs for evidence-based
regulatory decisions and actions and enhanced knowledge management
systems, coalitions, and networks;
 Providing technical support to national regulatory systems
strengthening efforts
     Enabling the strengthening of regulatory systems at the
national and international levels in such critical domains as good
manufacturing, clinical, and laboratory practices; developing curricula
that supports regulatory professionalization; monitoring and evaluating
product quality; laboratory capacity; inspection and surveillance of
products throughout the supply chain; pharmacovigilance systems
building and analyses; risk assessment, analysis, and

management; and making the business case for investments in regulatory
systems.

C. Eligibility Information

    This is a Single Source Cooperative Agreement.

II. Award Information/Funds Available

A. Award Amount

    An award of up to $1,500,000 for this cooperative agreement will be
available the first year (fiscal year (FY) 2013) based on available
appropriations. Funding for subsequent years for this 5-year award will
be contingent on the availability of appropriations and successful
performance in the award not to exceed $1,500,000 per year.

B. Length of Support

    The initial period of performance is 1 year. Contingent upon
successful performance, additional awards may be available in FYs 2014,
2015, 2016, and 2017.

III. Electronic Application, Registration, and Submission

    Only electronic applications will be accepted. To submit an
electronic application in response to this FOA, applicants should first
review the full announcement located at http://www.fda.gov/InternationalPrograms/CapacityBuilding/default.htm. (FDA has verified
the Web site addresses throughout this document, but FDA is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.) For all electronically
submitted applications, the following steps are required.

 Step 1: Obtain a Dun and Bradstreet (DUNS) Number
 Step 2: Register With System for Award Management (SAM)
 Step 3: Obtain Username & Password
 Step 4: Obtain Authorized Organization Representative (AOR)
Authorization
 Step 5: Track AOR Status
 Step 6: Register With Electronic Research Administration (eRA)
Commons

    Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit electronic applications to: http://www.grants.gov.

    Dated: June 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15101 Filed 6-24-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 123 (Wednesday, June 28, 2023)]
[Notices]
[Pages 41984-41985]
[FR Doc No: 2023-13694]

=======================================================================
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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2009-0041]

The Formaldehyde Standard Extension of the Office of Management
and Budget's (OMB) Approval of Information Collection (Paperwork)
Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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

SUMMARY: OSHA solicits public comments concerning the proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements specified in the Formaldehyde
Standard.

DATES: Comments must be submitted (postmarked, sent, or received) by
August 28, 2023.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov. Documents in the docket are
listed in the http://www.regulations.gov index; however, some
information (e.g., copyrighted material) is not publicly available to
read or download through the website. All submissions, including
copyrighted material, are available for inspection through the OSHA
Docket Office. Contact the OSHA Docket Office at<PHONE_NUMBER> (TTY
(877) 889-5627) for assistance in locating docket submissions.
    Instructions: All submissions must include the agency name and OSHA
docket number OSHA-2009-0041 for the Information Collection Request
(ICR). OSHA will place all comments, including any personal
information, in the public docket, which may be made available online.
Therefore, OSHA cautions interested parties about submitting personal
information such as social security numbers and birthdates.
    For further information on submitting comments, see the ``Public
Participation'' heading in the section of this notice titled
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Seleda Perryman or Theda Kenney,

Directorate of Standards and Guidance, OSHA, U.S. Department of Labor;
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of the continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, the collection instruments are clearly understood, and
OSHA's estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et
seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of effort in
obtaining information (29 U.S.C. 657).
    The following sections describe who uses the information collected
under each requirement, as well as how they use it.
    The standard protects workers from the adverse health effects from
occupational exposure to formaldehyde, including an itchy, runny, and
stuffy nose; a dry or sore throat; eye irritation; headaches; and
cancer of the lung, buccal cavity (mouth), and pharynx (throat).
Formaldehyde solutions can damage the skin and burn the eyes.
    The standard specifies a number of collections of information. The
following is a brief description of the collections of information
contained in the Formaldehyde Standard. The standard requires employers
to conduct worker exposure monitoring to determine workers' exposure to
formaldehyde, notify workers of their formaldehyde exposures, provide
medical surveillance to workers, provide examining physicians with
specific information, ensure that workers receive a copy of their
medical examination results, maintain workers' exposure monitoring and
medical records for specific periods, and provide access to these
records by the affected workers and their authorized representatives.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the agency's functions to
protect workers, including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection, and transmission techniques.

III. Proposed Actions

    OSHA is requesting an adjusted increase in the burden hours from
240,924 to 263,172 hours, for a total increase of 22,848 hours.
    OSHA will summarize the comments submitted in response to this
notice and will include this summary in the request to OMB to extend
the approval of the information collection requirements.
    Type of Review: Extension of a currently approved collection.
    Title: The Formaldehyde Standard.
    OMB Control Number: 1218-0145.
    Affected Public: Business or other for-profits.
    Number of Respondents: 86,575.
    Number of Responses: 990,175.
    Frequency of Responses: On occasion.
    Average Time per Response: Varies.
    Estimated Total Burden Hours: 263,172.
    Estimated Cost (Operation and Maintenance): $54,153,624.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax), if your comments, including
attachments, are not longer than 10 pages you may fax them to the OSHA
Docket Office at<PHONE_NUMBER>; or (3) by hard copy. All comments,
attachments, and other material must identify the agency name and the
OSHA docket number for the ICR OSHA-2009-0041. You may supplement
electronic submissions by uploading document files electronically.
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download from this
website. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov website to submit comments and
access the docket is available at the website's ``User Tips'' link.
Contact the OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>)
for information about materials not available from the website, and for
assistance in using the internet to locate docket submissions.

V. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 8-2020
(85 FR 58393).

    Signed at Washington, DC, on June 22, 2023.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2023-13694 Filed 6-27-23; 8:45 am]
BILLING CODE 4510-26-P


Hazardous Waste Generator Initiative

Background Meeting

November 22, 2004

Purpose of Briefing: To discuss findings from hazardous waste generator
initiative public meetings and ANPRM comments with Office Director, and
identify possible follow-on strategies for subsequent discussion.

Outline of Briefing

- Background

Goals of Initiative

Why Undertake this Initiative

Approach to Effort

- Findings

- Potential Strategies

- Next Steps

Goals of Hazardous Waste Generator Initiative

Evaluate the current generator program, and based on the results of this
evaluation, design a program strategy that:

-	 fosters improved program effectiveness

-	 reduces compliance costs, where practicable

-	 fosters a pollution prevention stewardship philosophy

-	 fosters an improved relationship among EPA, States and regulated
community

Why Did We Undertake This Initiative?

- Hazardous Waste generators are our biggest stakeholder group

- Over 130,000 generators with annual compliance cost of $640 million

- Current generator rules are, for the most part, over 20 years old

- We have never really conducted an in-depth evaluation of this program
since the rules were           issued

- We need to ensure this program is protecting the environment in an
efficient and effective manner

Strategy:  A Three-Phased Approach

Phase 1:  Evaluate Program

-	 Public Meetings to listen and understand concerns of stakeholders

-	 Advanced Notice of Proposed Rule Making (ANPRM)  to solicit comments
on key components of program

-		 Published April 22, 2004

-	    Comment period closed on July 21, 2004

-	    Received over 500 comments

- Positive response to public meetings and ANPRM from key stakeholders

Phase 2: Develop Options for Program Improvement Strategy

Phase 3: Implement Program Improvement Strategy, if necessary and
desirable

Emphasis of this Initiative: A broad review and evaluation of the
hazardous waste generator program designed to answer questions such as:

- Is the program working effectively? Is environment being protected
from the mismanagement of hazardous wastes by generators?

- What areas of the program need improvement?

- Can the program be streamlined; i.e., eliminate any redundancies?

- Are there aspects of State programs EPA should review and evaluate?

- Are there innovations EPA should consider?

- Where and how can EPA’s compliance assistance activities be
improved?

- How can EPA better measure program success?

Scope of Public Meetings And ANPRM

- Rules for all categories of generators (large, small, conditionally
exempt)

--	 Including rules associated with waste accumulation, waste
management, employee training, contingency management, emergency
response, and land disposal restrictions requirements for small and
large generators

- The Program Evaluation did not consider the following:

-	 Definition of Solid Waste

-	 Definition of Hazardous Waste

-	 Hazardous Waste Manifest

-	 Export Rules

-	 Land Disposal Restrictions, except those requirements associated with
small and large quantity generators

Four Public Meetings Held During May, 2004

- Boston, Massachusetts		- Washington, DC

- Chicago, Illinois			- Seattle, Washington

Topics addressed in Public Meetings

- Program effectiveness

- Program improvements

-		 Program redundancies

-		 State Programs

-		 Compliance assistance

-		 Performance measures

-		 Pollution prevention and recycling

-		 Program priorities

- Meetings were dynamic and interactive. Participants were engaged.

- Comments in public meetings and ANPRM constructive and far ranging in
each of the above topic areas.

We received over 500 comments from 55 organizations and individuals in
response to our ANPRM

- Respondents consisted of:

-		 2 Universities (Northeastern and Rutgers)

-		 9 States (NY, TX, FL, NC, MI, WY, GA, DE, AL) + ASTSWMO

-		 5 federal agencies (Postal Service, Army, Navy, DOE, TVA)

-		 22 Private sector companies

-		 12 Trade associations (e.g., CMA, API, SOCMA, USWAG)

-		 3 Private citizens

-		 1 State DOT agency (New York)

- No environmental groups commented

Findings and Observations from Public Meetings and ANPRM

- The RCRA hazardous waste generator program has made significant
improvements to the management of hazardous waste

-	 Less releases of hazardous waste to the environment

-	 Current program protective of  human health and the environment

-	 Infrastructure established to manage hazardous wastes more
protectively

- Yet, important cost-effective improvements to the program can be
undertaken

Industry wants HW Generator program brought into the 21st Century

Simplify the regulations to make them easy to understand

- Reorganize regulatory text to make more user-friendly (e.g., eliminate
cross-referencing)

- Codify guidance into regulations, where applicable (e.g., treatment in
containers)

Improve efficiency of program by clarifying ambiguities and removing
potential redundancies. Examples include:

- Employee training (e.g., clarifying precisely what is required)

- Contingency planning (e.g., simplify requirements, defer to local
authorities)

- Air emissions (e.g., RCRA vs. CAA requirements)

- Land disposal restrictions (e.g., clarifying when sampling vs.
generator knowledge can be used)

Provide greater flexibility to generators in how they can comply with
requirements

- Episodic generation (e.g., allow generators to remain SQGs if waste
quantity thresholds exceeded infrequently)

- Waste consolidation (e.g., allow wastes to be shipped from remote
locations to centralized location for better waste management)

- Waste accumulation times (e.g., allow generators to exceed 90 day
waste accumulation times provided waste managed safely)

- Focus efforts on improving environmental results and creating
incentives for industry to go beyond regulations, including facilitation
of waste minimization opportunities

State comments generally similar to industry’s

Major Themes:

 Reorganize/clarify the regulations

-	 restructure the regulations to make more user friendly

-          eliminate cross-referencing

Modify and/or clarify key components of generator regulations,
including:

- on-site treatment (e.g., codify in regulations)

- employee training (e.g., clarifying precisely what is required)

-	  satellite accumulation (e.g., clarifying “at or near the point of
generation”, etc)

- re-notification (e.g., periodic re-notification (5 years) to ensure
SQG facilities still exist)

- record-keeping (e.g., eliminating certain employee training records
such as job descriptions)

     Provide additional compliance assistance (technical support,
training and grants)

Address gaps in regulations (e.g., secondary containment for containers,
re-notification)

Topics Receiving Greatest Number of Responses and Recommendations for
Change by Stakeholders

Clarifying our regulations – general consensus by large majority of
all types of stakeholders that existing regulations need to be:

-	 simplified

-	 written more clearly; and

-	 reorganized to eliminate confusion with cross referencing

Container Standards – majority of comments from industry and States
focused on clarifying what constitutes a closed container, and what
types of treatment are allowed in containers.

Tank Standards – wide range of comments - from implementing
performance-based system to simplifying rules for small above-ground
storage tank systems. Several comments from industry also focused on
reducing inspection frequencies.

Employee Training – Majority of industry comments focused on reducing
paperwork burden (employee training records, job descriptions, etc.) as
well as eliminating redundancy with other statutes with very similar
training (i.e., OSHA and DOT), or simply relying on internal management
systems; i.e., EMS’s.

Topics Receiving Greatest Number of Most Responses  (Continued)

 – State comments more diverse. Included clarifying content and format
of HW generator training requirements, and eliminating hazardous waste
job titles and job descriptions, since they serve little purpose.

Satellite Accumulation – most comments (i.e., industry, ASTSWMO and
other federal agencies) focused on revising and clarifying requirements
associated with such phrases as:  “at or near,” “under the control
of,” and “operator of the process,”  “55 gallon limitation in
accumulation areas.”

Waste Accumulation – several industry commenters recommended extending
accumulation times from 90 to 180 days, if not longer. Texas also
recommended that accumulation times be extended only for facilities that
exceed performance requirements.

Contingency Planning and Emergency Response – wide range of comments -
from eliminating the contingency plan requirement to providing one-pager
of basic information to local authorities; i.e., storage capacity, etc.,
and reducing redundancy with other statutes, where applicable.

Hazardous Waste Determinations – most comments (from industry)
centered on EPA clarifying when it is appropriate to use generator
knowledge instead of analytical sampling.

Potential Program Improvement Strategies - a range of options exist

1. Simplify and clarify regulations (Rewrite/reorganize existing
framework to make user-friendly)

2. Focus on developing and implementing  program strategy that measures
and monitors program effectiveness and environmental results

3. Focus on rule changes that improve program efficiency and
effectiveness; i.e., employee training, contingency planning, waste
accumulation, etc.

4. Focus on compliance assistance for key industry sectors

5. Systematic overhaul of program (Options 1-4 in sequence)

6. Eclectic approach. Pick and choose among components found in Options
1-4.

7. Do not move forward with strategy at this time, but delay start
pending completion of other priority projects

Next Steps

- Present and discuss alternative program improvement strategies in
greater detail. Currently  scheduled for December 8, 2004

- Obtain management decision on potential program improvement strategy

- If subsequent action:

-		 Initiate development of detailed project plan with associated
milestones

-		 Discuss recommendations with Regions, OECA and ASTSWMO

-		 Communicate strategy with other stakeholders

 PAGE  16