[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Notices]
[Pages 42006-42007]
[FR Doc No: 2014-16917]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9914-05-OA]

Request for Nominations of Experts To Augment the Science
Advisory Board Ecological Process and Effects Committee for the
Consultation and Review of Lake Erie Phosphorous Objectives

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office requests public nominations of scientific
experts to augment the SAB Ecological Process and Effects Committee
(EPEC) to form a panel to provide early advice on and subsequent review
of preliminary bi-national phosphorous objectives, loading targets and
allocations for the nearshore and offshore waters to achieve the Lake
Ecosystem Objectives for Lake Erie, pursuant to the Nutrients Annex
(Annex 4) of the 2012 Great Lakes Water Quality Agreement (GLWQA).

DATES: Nominations should be submitted by August 8, 2014 per the
instructions below.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information regarding this Notice and Request for Nominations
may contact the Designated Federal Officer. Nominators unable to submit
nominations electronically as described below may contact the
Designated Federal Officers for assistance. General information
concerning the EPA SAB can be found at the EPA SAB Web site at http://www.epa.gov/sab.

SUPPLEMENTARY INFORMATION: Background: The SAB (42 U.S.C. 4365) is a
chartered Federal Advisory Committee that provides independent
scientific and technical peer review, advice, consultation, and
recommendations to the EPA Administrator on the technical basis for EPA
actions. As a Federal Advisory Committee, the SAB conducts business in
accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C.
App. 2) and related regulations. The SAB Ecological Process and Effects
Committee (EPEC) is a subcommittee of the SAB that provides advice
through the chartered SAB on technical issues related to EPA
environmental programs and the supporting science and research to
protect, sustain and restore the health of ecosystems. The SAB and the
EPEC, augmented with additional experts, will comply with the
provisions of FACA and all appropriate SAB Staff Office procedural
policies.
    EPA Region 5 is co-leading a binational workgroup to develop and
implement the Nutrients Annex (``Annex 4'') of the 2012 Great Lakes
Water Quality Agreement (GLWQA) in accordance with Article 3(b)(i) of
the GLWQA. Under Annex 4, the U.S. and Canada are charged with
establishing binational Substance Objectives for phosphorus
concentrations, loading targets and allocations for the nearshore and
offshore waters of Lake Erie by February 2016. The general approach is
to use an ensemble of Lake Erie ecosystem models to compute appropriate
load-response relationships for eutrophication response indicators of
concern. EPA Region 5 requested an SAB consultation (i.e., early
advice) on the appropriateness of modeling approaches to meet the GLWQA
Lake Ecosystem Objectives. EPA is also requesting a subsequent review
of the modeled phosphorus targets and loads to obtain advice on (1)
whether these targets and loads are sufficient to meet the Lake
Ecosystem Objectives as defined in the GLWQA and (2) whether the
modeled results reflect the best available information on the
phosphorous sources and trophic status of Lake Erie.
    Technical Contact for EPA's draft assessments: For information
concerning the GLWQA Annex 4 please contact Ms. Santina Wortman, Water
Division, US EPA Region 5, 77 West Jackson Boulevard (WW-16J), Chicago,
Illinois 60604, phone<PHONE_NUMBER>.
    Request for Nominations: The SAB Staff Office is seeking
nominations of nationally and internationally recognized scientists
with demonstrated expertise and research to augment the EPEC and form
an augmented standing committee for an early consultation and
subsequent review of the binational phosphorous objectives, loading
targets and allocations for the nearshore and offshore waters to
achieve the Lake Ecosystem Objectives for Lake Erie. For this effort
the SAB Staff Office seeks experts in one or more of the following
areas, algal and cyanobacteria ecology, aquatic ecology, hydrology,
limnology, ecosystem modeling, and nutrient fate and transport.
Questions regarding this advisory activity should be directed to Mr.
Thomas Carpenter, Designated Federal Officer (DFO), SAB Staff Office,
by telephone/voice mail at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, or
via email at<EMAIL_ADDRESS>    Process and Deadline for Submitting Nominations: Any interested
person or organization may nominate qualified individuals in the areas
of expertise described above for possible service on the augmented EPEC
panel identified in this notice. Nominations should be submitted in
electronic format (preferred over hard copy) following the instructions
for ``Nominating Experts to Advisory Panels and Ad Hoc Committees Being
Formed,'' provided on the SAB Web site (see the ``Nomination of
Experts'' link on the blue navigational bar at http://www.epa.gov/sab).
To receive full consideration, nominations should include all of the
information requested

below. EPA's SAB Staff Office requests contact information about the
person making the nomination; contact information about the nominee;
the disciplinary and specific areas of expertise of the nominee; the
nominee's resume or curriculum vitae; sources of recent grant and/or
contract support; and a biographical sketch of the nominee indicating
current position, educational background, research activities, and
recent service on other national advisory committees or national
professional organizations.
    Persons having questions about the nomination procedures, or who
are unable to submit nominations through the SAB Web site, should
contact Mr. Thomas Carpenter as indicated above in this notice.
Nominations should be submitted in time to arrive no later than August
8, 2014. EPA values and welcomes diversity. In an effort to obtain
nominations of diverse candidates, EPA encourages nominations of women
and men of all racial and ethnic groups.
    The EPA SAB Staff Office will acknowledge receipt of nominations.
The names and biosketches of qualified nominees identified by
respondents to this Federal Register notice, and additional experts
identified by the SAB Staff, will be posted in a List of Candidates for
each of the three panels on the SAB Web site at http://www.epa.gov/sab.
    Public comments on each List of Candidates will be accepted for 21
days. The public will be requested to provide relevant information or
other documentation on nominees that the SAB Staff Office should
consider in evaluating candidates.
    For the EPA SAB Staff Office a balanced review panel includes
candidates who possess the necessary domains of knowledge, the relevant
scientific perspectives (which, among other factors, can be influenced
by work history and affiliation), and the collective breadth of
experience to adequately address the charge. In forming these expert
panels, the SAB Staff Office will consider public comments on the Lists
of Candidates, information provided by the candidates themselves, and
background information independently gathered by the SAB Staff Office.
Selection criteria to be used for panel membership include: (a)
Scientific and/or technical expertise, knowledge, and experience
(primary factors); (b) availability and willingness to serve; (c)
absence of financial conflicts of interest; (d) absence of an
appearance of a loss of impartiality; (e) skills working in committees,
subcommittees and advisory panels; and, (f) for the panel as a whole,
diversity of expertise and scientific points of view.
    The SAB Staff Office's evaluation of an absence of financial
conflicts of interest will include a review of the ``Confidential
Financial Disclosure Form for Special Government Employees Serving on
Federal Advisory Committees at the U.S. Environmental Protection
Agency'' (EPA Form 3110-48). This confidential form allows government
officials to determine whether there is a statutory conflict between a
person's public responsibilities (which include membership on an EPA
federal advisory committee) and private interests and activities, or
the appearance of a lack of impartiality, as defined by federal
regulation. The form may be viewed and downloaded from the following
URL address http://yosemite.epa.gov/sab/sabproduct.nsf/Web/ethics?OpenDocument.
    The approved policy under which the EPA SAB Office selects members
for subcommittees and review panels is described in the following
document: Overview of the Panel Formation Process at the Environmental
Protection Agency Science Advisory Board (EPA-SAB-EC-02-010), which is
posted on the SAB Web site at http://www.epa.gov/sab/pdf/ec02010.pdf.

    Dated: July 10, 2014.
Thomas H. Brennan,
Deputy Director, Science Advisory Board Staff Office.
[FR Doc. 2014-16917 Filed 7-17-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Notices]
[Pages 12778-12780]
[FR Doc No: 2011-5186]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64012; File No. SR-ISE-2011-11]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to a Market Maker Incentive Plan for Foreign Currency
Options

March 2, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 22, 2011, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change, as
described in Items I and II below, which items have been prepared by
the self-regulatory organization. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its incentive plan for market makers
in foreign currency (``FX'') options. Specifically, ISE proposes to add
six currently listed FX options to the incentive plan. The text of the
proposed rule change is available on the Exchange's Web site (http://www.ise.com), at the principal office of the Exchange, on the
Commission's Web site at http://www.sec.gov, and at the Commission's
Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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. The self-regulatory organization
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
    The purpose of this proposed rule change is to amend the Exchange's
incentive plan for market makers in FX options. The Exchange currently
has an incentive plan for FX options that was initially adopted on
August 3, 2009 for the following three FX options: the New Zealand
dollar (``NZD''), the Mexican peso (``PZO''), the Swedish krona
(``SKA'').\3\ The Exchange subsequently added the Brazilian real
(``BRB'') to the incentive plan.\4\ The Exchange now proposes to add
the following FX options to the incentive plan: the Australian dollar
(``AUX''), the British pound (``BPX''), the Canadian dollar (``CDD''),
the euro (``EUI''), the Japanese yen (``YUK'') and the Swiss franc
(``SFC'').\5\ Market makers will be able to enter into the incentive
plan until March 31, 2011.\6\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 60536 (August 19,
2009) [sic], 74 FR 43204 (August 26, 2009) (SR-ISE-2009-59).
    \4\ See Securities Exchange Act Release No. 61459 (January 19,
2010), 75 FR 6248 (February 8, 2010) (SR-ISE-2010-07).
    \5\ The Commission previously approved the trading of options on
AUX, BPX, CDD, EUI, YUK and SFC. See Securities Exchange Act Release
No. 55575 (April 3, 2007), 72 FR 17963 (April 10, 2007) (SR-ISE-
2006-59).
    \6\ See Securities Exchange Act Release No. 63639 (January 4,
2011), 76 FR 1488 (January 10, 2011) (SR-ISE-2010-121).
---------------------------------------------------------------------------

    Options on AUX, BPX, CDD, EUI, YUK and SFC began trading on the
Exchange on April 17, 2007. Until now, the market maker currently
appointed to these FX options has been trading these products without
the benefit of the privileges afforded by the incentive plan. The
Exchange notes that competition between exchanges that trade like
products, in this case, the World Currency Options traded on NASDAQ OMX
PHLX, Inc., [sic] has intensified. In order to promote the continued
growth and trading in these products, the Exchange now proposes to add
AUX, BPX, CDD, EUI, YUK and SFC to the incentive plan, effective March
1, 2011.
    Participants in the incentive plan are known on the Exchange's
Schedule of Fees as Early Adopter Market Makers. Under the incentive
plan, the Exchange waives the applicable transaction fees for both the
Early Adopter FXPMM \7\

and all Early Adopter FXCMMs \8\ that make a market in AUX, BPX, CDD,
EUI, YUK and SFC for as long as the incentive plan is in effect.
Further, pursuant to a revenue sharing agreement entered into between
an Early Adopter Market Maker and ISE, the Exchange pays the Early
Adopter FXPMM forty percent (40%) of the transaction fees collected on
any customer trade in AUX, BPX, CDD, EUI, YUK and SFC and pays up to
ten (10) Early Adopter FXCMMs that participate in the incentive plan
twenty percent (20%) of the transaction fees collected for trades
between a customer and that FXCMM. Market makers that do not
participate in the incentive plan are charged regular transaction fees
for trades in these products.
---------------------------------------------------------------------------

    \7\ A FXPMM is a primary market maker selected by the Exchange
that trades and quotes in FX Options only. See ISE Rule 2213.
    \8\ A FXCMM is a competitive market maker selected by the
Exchange that trades and quotes in FX Options only. See ISE Rule
2213.
---------------------------------------------------------------------------

    The Exchange currently charges an execution fee of $0.40 per
contract for all Public Customer Orders \9\ in options on AUX, BPX,
CDD, EUI, YUK and SFC.\10\ The amount of the execution fee for all Firm
Proprietary orders for options on AUX, BPX, CDD, EUI, YUK and SFC is
$0.20 per contract and the execution fee for all non-Early Adopter ISE
Market Makers in options on AUX, BPX, CDD, EUI, YUK and SFC is equal to
the execution fee currently charged by the Exchange for ISE Market
Maker orders in equity options.\11\ Finally, the amount of the
execution fee for all non-ISE Market Maker orders for options on AUX,
BPX, CDD, EUI, YUK and SFC is $0.45 per contract.\12\ The Exchange does
not charge a Payment for Order Flow fee for these products.
---------------------------------------------------------------------------

    \9\ Public Customer Order is defined in Exchange Rule 100(a)(39)
as an order for the account of a Public Customer. Public Customer is
defined in Exchange Rule 100(a)(38) as a person or entity that is
not a broker or dealer in securities.
    \10\ These fees are will be [sic] charged only to Exchange
members.
    \11\ The Exchange applies a sliding scale, between $0.01 and
$0.18 per contract side, based on the number of contracts an ISE
market maker trades in a month.
    \12\ The amount of the execution fee for non-ISE Market Maker
transactions executed in the Exchange's Facilitation and
Solicitation Mechanisms and for Orders entered into the Price
Improvement Mechanism by the member initiating the price improvement
order is $0.20 per contract.
---------------------------------------------------------------------------

    The Exchange also proposes to waive transaction charges for all
Early Adopter Market Makers in AUX, BPX, CDD, EUI, YUK and SFC in order
to further encourage trading in these products. The Exchange believes
that the revenue generated from customer, firm proprietary and non-ISE
market maker transaction charges and increased order flow will offset
the transaction fees that would otherwise be applied to market makers
in AUX, BPX, CDD, EUI, YUK and SFC, thereby allowing the Exchange to
recoup those fees while increasing order flow and generating increased
revenues.
    The Exchange believes the proposed rule change will further the
Exchange's goal of promoting trading of its FX options through
competitive pricing.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\13\ in general, and
furthers the objectives of Section 6(b)(4),\14\ in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees and other charges among its members and other persons using
its facilities. The Exchange believes that extending the incentive plan
to options on AUX, BPX, CDD, EUI, YUK and SFC will generate additional
order flow in these products to the Exchange.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\15\ At any time within 60 days of the
filing of such proposed rule change, the Commission summarily may
temporarily suspend such 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 furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposal 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-ISE-2011-11 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
All submissions should refer to File No. SR-ISE-2011-11. 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 changes 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 Web site viewing and
printing 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 ISE. 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 No. SR-ISE-2011-11 and should be
submitted on or before March 29, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-5186 Filed 3-7-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 29, 2010 (Volume 75, Number 82)]
[Notices]
[Page 22678]
[DOCID:fr29ap10-139]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2008-0211]

Pipeline Safety: Implementation of Electronic Filing for Recently
Revised Incident/Accident Report Forms for Distribution Systems, Gas
Transmission and Gathering Systems, and Hazardous Liquid Systems

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice; Issuance of Advisory Bulletin.

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

SUMMARY: This notice advises owners and operators of gas pipeline
facilities and hazardous liquid pipeline facilities that the new
incident/accident report forms for their pipeline systems are now
available for electronic filing.

FOR FURTHER INFORMATION CONTACT: Jamerson Pender, Information Resources
Manager,<PHONE_NUMBER> or by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On February 3, 2010 (75 FR 5460), PHMSA published Advisory Bulletin
ADB-10-01 in the Federal Register to notify operators of gas and
hazardous liquid pipeline facilities of newly revised incident/accident
report forms and instructions. In ADB-10-01, PHMSA announced that the
revised forms are to be used for all incidents/accidents occurring on
or after January 1, 2010. PHMSA further noted that hard copy filing was
required until PHMSA launched a new online system which was targeted
for early March 2010. The new online system became available on March
8, 2010, and is available at the following URL: http://
pipelineonlinereporting.phmsa.dot.gov/.

Advisory Bulletin (ADB-10-04)

    To: Owners and Operators of Gas Pipeline Facilities and Hazardous
Liquid Pipeline Facilities.
    Subject: Implementation of Electronic Filing for Recently Revised
Incident/Accident Report Forms for Gas Distribution Systems, Gas
Transmission and Gathering Systems, and Hazardous Liquid Systems.
    Advisory: This notice advises owners and operators of gas pipeline
facilities and hazardous liquid pipeline facilities that the new
electronic incident/accident reporting system is available online at
the following URL: http://pipelineonlinereporting.phmsa.dot.gov/. The
new online system can also be accessed through the old system at the
following URL: http://opsweb.phmsa.dot.gov and click on ``Incidents on
or after Jan 1, 2010'' for the respective report type. Each operator
may use their current operator ID and PIN from the old system to access
the new system. The new online system is for incidents/accidents
occurring on or after January 1, 2010. The old online system is still
available for filing supplemental reports for incidents/accidents that
occurred prior to January 1, 2010, and is still the system for filing
annual reports and Gas Integrity Management Program (IMP) reports.
    Incidents and accidents that were previously filed in hard copy are
being entered by PHMSA staff and should not be reentered by the
operator into the system. Operators that have already submitted a hard
copy 2010 incident report as previously instructed in ADB-10-01 should
not re-submit that report using the online system. Where data quality
checks are indicated for the hard copy filed reports, PHMSA will
contact operators as needed to facilitate complete data entry for the
initial submissions. Once all reports received in hard copy have been
entered by PHMSA, operators will be able to submit supplemental reports
online if needed. In addition, PHMSA is aligning the hard copy forms
with the new online system by replacing the double asterisks with the
single asterisks for those data fields deemed required for an initial
submission to PHMSA.
    PHMSA notes that for hazardous liquid small releases (identified as
the areas shaded in gray on the hard copy version of the hazardous
liquid accident form), the new online system will accept reporting and
does the required logic checks for small releases (those under five
barrels that do not involve a fatality, injury, property damage of
$50,000 or more, as described in 49 CFR 195.50). However, the new
online system does not exclude or hide questions that are not
applicable to small releases. Therefore, PHMSA recommends that
operators who report such events follow the shaded sections on the hard
copy accident form and the guidance provided in the hard copy
instructions while entering those events with the online system until a
system enhancement is in place to further streamline the online
reporting process.
    PHMSA appreciates the cooperation of all users of the new online
system. For questions regarding filing, please contact Jamerson Pender
at<PHONE_NUMBER> or by e-mail at<EMAIL_ADDRESS>    Any questions regarding this new online system requirement can be
directed to the Office of Pipeline Safety operator helpline at 202-366-
8075.

    Issued in Washington, DC, on April 22, 2010.
Jeffrey D. Wiese,
Associate Administrator for Pipeline Safety.
[FR Doc. 2010-10018 Filed 4-28-10; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Pages 25490-25491]
[FR Doc No: 2022-09237]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0140]

Ulcerative Colitis: Developing Drugs for Treatment; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Ulcerative
Colitis: Developing Drugs for Treatment.'' This draft guidance
addresses FDA's current thinking about necessary attributes of clinical
trials for developing drugs for the treatment of ulcerative colitis in
adults, including recommendations for trial population, trial design,
and efficacy and safety considerations. This draft guidance replaces
the draft guidance for industry entitled ``Ulcerative Colitis: Clinical
Trial Endpoints,'' which is being withdrawn.

DATES: Submit either electronic or written comments on the draft
guidance by June 28, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-0140 for ``Ulcerative Colitis: Developing Drugs for
Treatment.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Kelly Richards, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5378, Silver Spring, MD 20993, 240-402-
4276, or Stephen Ripley, Center for

Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Ulcerative Colitis: Developing Drugs for Treatment.'' This
guidance addresses FDA's current thinking about necessary attributes of
clinical trials for developing drugs for ulcerative colitis in adults
including recommendations for trial population, trial design, and
efficacy and safety considerations. This draft guidance replaces the
draft guidance for industry entitled ``Ulcerative Colitis: Clinical
Trial Endpoints,'' issued on August 8, 2016 (81 FR 52449), which is
being withdrawn.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Ulcerative
Colitis: Developing Drugs for Treatment.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 have been approved under OMB control
number 0910-0014. FDA receives information described in FDA's guidance
entitled ``Patient-Reported Outcome Measures: Use in Medical Product
Development to Support Labeling Claims'' to support the medical
product's effectiveness and to support claims in approved medical
product labeling; the collections of information in 21 CFR 314.50(d)(5)
and 21 CFR 601.2 have been approved under OMB control numbers 0910-0001
and 0910-0338, respectively, and the collections of information in 21
CFR 201.56 and 201.57 for medical product labeling have been approved
under OMB control number 0910-0572. The collections of information in
21 CFR parts 50 and 56 for protection of human subjects in clinical
trials and institutional review board considerations have been approved
under OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or https://www.regulations.gov.

    Dated: April 25, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09237 Filed 4-28-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Page 19129]
[FR Doc No: 2014-07840]

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

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, April
10, 2014 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matter at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting will be:

Institution and settlement of injunctive actions;
institution and settlement of administrative proceedings;
adjudicatory matters; and
other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: April 3, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-07840 Filed 4-3-14; 4:15 pm]
BILLING CODE 8011-01-P