[Federal Register: June 25, 2008 (Volume 73, Number 123)]
[Notices]
[Page 36077-36080]
[DOCID:fr25jn08-75]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0170; FRL-8367-9]

Pesticide Registration Review; New Dockets Opened for Review and
Comment; Closure of the Phosalone Registration Review Case

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has established registration review dockets for the
pesticides listed in the table in Unit III.A. With this document, EPA
is opening the public comment period for these registration reviews.
The Agency is also announcing the closure of the phosalone registration
review case (0027). Registration review is EPA's periodic review of
pesticide registrations to ensure that each pesticide continues to
satisfy the statutory standard for registration, that is, the pesticide
can perform its intended function without unreasonable adverse effects
on human health or the environment. Registration review dockets contain
information that will assist the public in understanding the types of
information and issues that the Agency may consider during the course
of registration reviews. Through this program, EPA is ensuring that
each pesticide's registration is based on current scientific and other
knowledge, including its effects on human health and the environment.

DATES: Comments must be received on or before September 23, 2008.

ADDRESSES: Submit your comments identified by the docket identification
(ID) number for the specific pesticide of interest provided in the
table in Unit III.A., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID numbers listed
in the table in Unit III.A. for the pesticides you are commenting on.
EPA's policy is that all comments received will be included in the
docket without change and may be made available on-line at http://
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or e-mail. The
regulations.gov website is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through regulations.gov, your e-mail
address

will be automatically captured and included as part of the comment that
is placed in the docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available electronically at http://www.regulations.gov, or, if only
available in hard copy, at the OPP Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For information about the pesticides
included in this document, contact the specific Chemical Review
Managers for these pesticides as identified in the table in Unit III.A.
    For general questions on the registration review program, contact
Kevin Costello, Special Review and Reregistration Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5026; fax number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farmworker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental Justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Authority

    EPA is initiating its reviews of the pesticides identified in this
document pursuant to section 3(g) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and the Procedural Regulations
for Registration Review published in the Federal Register of August 9,
2006, and effective on October 10, 2006 (71 FR 45719) (FRL-8080-4). You
may also access the Procedural Regulations for Registration Review at
40 CFR part 155 or on the Agency's website at http://www.epa.gov/
fedrgstr/EPA-PEST/2006/August/Day-09/p12904.htm. Section 3(g) of FIFRA
provides, among other things, that the registrations of pesticides are
to be reviewed every 15 years. Under FIFRA section 3(a), a pesticide
product may be registered or remain registered only if it meets the
statutory standard for registration given in FIFRA section 3(c)(5).
When used in accordance with widespread and commonly recognized
practice, the pesticide product must perform its intended function
without unreasonable adverse effects on the environment; that is,
without any unreasonable risk to man or the environment, or a human
dietary risk from residues that result from the use of a pesticide in
or on food.

III. Registration Reviews

A. What Action is the Agency Taking?

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations identified in the Table of this unit to assure that they
continue to satisfy the FIFRA standard for registration--that is, they
can still be used without unreasonable adverse effects on human health
or the environment. A pesticide's registration review begins when the
Agency establishes a docket for the pesticide's registration review
case and opens the

docket for public review and comment. At present, EPA is opening
registration review dockets for the cases identified in the following
table.

               Table--Registration Review Dockets Opening
------------------------------------------------------------------------
                                                        Chemical Review
  Registration Review Case Name                       Manager, Telephone
           and Number              Docket ID Number     Number, E-mail
                                                            Address
------------------------------------------------------------------------
Bensulide Case 2035      EPA-HQ-OPP-2008-00  Susan Bartow,
                                   22<PHONE_NUMBER>,
<EMAIL_ADDRESS>                                                       ov
------------------------------------------------------------------------
Oxydemeton-methyl Case 0258                            28<PHONE_NUMBER>,
                                                      friedman.dana@epa.
                                                       gov
------------------------------------------------------------------------
Temephos Case 0006       EPA-HQ-OPP-2008-04  Katherine St.
                                   44                  Clair, (703) 347-
                                                       8778,
                                                      stclair.katherine@
                                                       epa.gov
------------------------------------------------------------------------
Dicrotophos Case 0145    EPA-HQ-OPP-2008-04  Rusty Wasem, (703)
                                   40                  305-6979,
                                                      wasem.russell@epa.
                                                       gov
------------------------------------------------------------------------
Benszenemethanaminium Case        EPA-HQ-OPP-2008-04  Joy Schnackenbeck,
 7625                     41<PHONE_NUMBER>,
                                                      schnackenbeck.joy@
                                                       epa.gov
------------------------------------------------------------------------
Coumaphos Case 0018      EPA-HQ-OPP-2008-00  Wilhelmena
                                   23                  Livingston, (703)
                                                       308-8025,
                                                      livingston.wilhelm
<EMAIL_ADDRESS>------------------------------------------------------------------------
Diazinon Case 0238       EPA-HQ-OPP-2008-03  Jude Andreasen,
                                   51<PHONE_NUMBER>,
                                                      andreasen.jude@epa
                                                       .gov
------------------------------------------------------------------------
Profenofos Case 2540     EPA-HQ-OPP-2008-03  Christina
                                   45                  Scheltema, (703)
                                                       308-2201,
                                                      scheltema.christin
                                                       a @epa.gov
------------------------------------------------------------------------
Propetamphos Case 2550   EPA-HQ-OPP-2007-11  Monica Wait, (703)
                                   95                  347-8019,
<EMAIL_ADDRESS>                                                       v
------------------------------------------------------------------------
Terbufos Case 0109       EPA-HQ-OPP-2008-01  Tracy Perry, (703)
                                   19                  308-0128,
<EMAIL_ADDRESS>                                                       v
------------------------------------------------------------------------
Tetrachlorvinphos Case 0321                            16<PHONE_NUMBER>,
<EMAIL_ADDRESS>                                                       ov
------------------------------------------------------------------------

    The Agency is also announcing the closure of the phosalone
registration review case (0027). In October 2006, the Agency issued
schedules for upcoming registration reviews and included phosalone as
one of the pesticides scheduled for registration review. The Agency
opened a docket for the phosalone registration review case on February
19, 2008. Since first identifying phosalone as a Registration Review
pesticide, the Agency has determined that there are no current
phosalone Section 3 or Section 24(c) registrations. Therefore, the
Agency has determined that phosalone is no longer subject to
registration review and has closed the phosalone registration review
case pursuant to 40 CFR 155.42(c).

B. Docket Content

    1. Review dockets. The registration review dockets contain
information that the Agency may consider in the course of the
registration review. The Agency may include information from its files
including, but not limited to, the following information:
     An overview of the registration review case status.
     A list of current product registrations and registrants.
     Federal Register notices regarding any pending
registration actions.
     Federal Register notices regarding current or pending
tolerances.
     Risk assessments.
     Bibliographies concerning current registrations.
     Summaries of incident data.
     Any other pertinent data or information.
    Each docket contains a document summarizing what the Agency
currently knows about the pesticide case and a preliminary work plan
for anticipated data and assessment needs. Additional documents provide
more detailed information. During this public comment period, the
Agency is asking that interested persons identify any additional
information they believe the Agency should consider during the
registration reviews of these pesticides. The Agency identifies in each
docket the areas where public comment isspecifically requested, though
comment in any area is welcome.
    2. Other related information. More information on these cases,
including the active ingredients for each case, may be located in the
registration review schedule on the Agency's website at http://
www.epa.gov/oppsrrd1/registration_review/schedule.htm. Information on
the Agency's registration review program and its implementing
regulation may be seen at http://www.epa.gov/oppsrrd1/registration_
review.
    3. Information submission requirements. Anyone may submit data or
information in response to this document. To be considered during a
pesticide's registration review, the submitted data or information must
meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion, consider
data or information submitted at a later date.
     The data or information submitted must be presented in a
legible and useable form. For example, an English translation must
accompany any material that is not in English and a written transcript
must accompany any information submitted as an audiographic or
videographic record.

Written material may be submitted in paper or electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
     As provided in 40 CFR 155.58, the registration review
docket for each pesticide case will remain publicly accessible through
the duration of the registration review process; that is, until all
actions required in the final decision on the registration review case
have been completed.

List of Subjects

    Environmental protection, Pesticides and pests, Bensulide,
Oxydemeton-methyl, Temephos, Dicrotophos, Benszenemethanaminium,
Coumaphos, Diazinon, Profenofos, Propetamphos, Terbufos,
Tetrachlorvinphos, Phosalone

    Dated: May 29, 2008.
Steven Bradbury,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E8-14238 Filed 6-24-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: November 4, 2005 (Volume 70, Number 213)]
[Notices]
[Page 67161]
[DOCID:fr04no05-39]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Ready for Environmental Analysis and
Soliciting Comments, Recommendations, Terms and Conditions, and
Prescriptions

October 28, 2005.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 1971-079.
    c. Date Filed: July 21, 2003.
    d. Applicant: Idaho Power Company.
    e. Name of Project: Hells Canyon Hydropower Project.
    f. Location: On the Snake River in Washington and Adams, Counties,
Idaho; and Wallowa and Baker Counties, Oregon. About 5,270 acres of
Federal lands administered by the Forest Service and the Bureau of Land
Management (Payette and Wallowa-Whitman National Forests and Hells
Canyon National Recreational Area) are included within the project
boundary.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. Sec. Sec.
791(a)-825(r).
    h. Applicant Contact: Mr. Robert W. Stahman, Vice President,
Secretary, and General Counsel, Idaho Power Company, P.O. Box 70,
Boise, Idaho 83707.
    i. FERC Contact: Alan Mitchnick,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Emily Carter,<PHONE_NUMBER>,

<EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions is 90 days from the issuance of this
notice; reply comments are due 135 days from the issuance date of this
notice.
    All documents (original and eight copies) should be filed with:
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    Comments, recommendations, terms and conditions, and prescriptions
may be filed electronically via the Internet in lieu of paper. The
Commission strongly encourages electronic filings. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
(http://www.ferc.gov) under the ``e-Filing'' link.

    k. This application has been accepted, and is ready for
environmental analysis at this time.
    l. The existing Hells Canyon Project consists of three
developments: Brownlee Development consists of a 395-foot-high earth
and rockfill dam, a 14,621-acre impoundment, and a powerhouse with five
generating units producing 585.4 megawatts (MW); Oxbow Development
consists of a 209-foot-high earth and rockfill dam, a 1,150-acre
impoundment, and a powerhouse with four generating units producing 460
MW; and Hells Canyon Development consists of a 320-foot-high concrete
gravity dam, a 2,412-acre impoundment, and a powerhouse with three
generating units producing 391.5 MW. Idaho Power also operates four
fish hatcheries and four adult fish traps.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site 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. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item h above.
    All filings must (1) Bear in all capital letters the title
``COMMENTS'', ``REPLY COMMENTS'', ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b), and 385.2010.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-6114 Filed 11-3-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 23 (Monday, February 6, 2017)]
[Notices]
[Pages 9382-9383]
[FR Doc No: 2017-02411]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]

Advisory Committee Nominations; Modification To Process for
Collecting and Posting Curricula Vitae

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
modifying the process by which we collect and post curricula vitae
(CVs) of advisory committee members so that the CVs will be posted to
our Web site without removing or redacting any information. Posting CVs
without removing or redacting any information will increase the
transparency of FDA's selection of officials who serve on advisory
committees, and will ensure greater public access to the qualifications
of advisory committee members on an ongoing basis. Because advisory
committee members are best situated to determine whether there is
confidential information in their CVs, this modified collection and
posting process will conserve FDA resources because FDA personnel will
no longer be responsible for reviewing and redacting the CVs.

DATES: All nominees for positions on an FDA advisory committee will be
required to submit a consent form on or after the date of the Office of
Management and Budget (OMB) approval for this information collection,
authorizing FDA to publicly post an un-redacted copy of their CV on
FDA's Web site. Elsewhere in this issue of the Federal Register, FDA is
publishing the notice for the proposed information collection.
Additionally, effective March 8, 2017, all existing advisory committee
members who submit an updated version of their CV to FDA will be
required to submit a consent form along with their CV.

FOR FURTHER INFORMATION CONTACT: Questions should be sent
electronically to<EMAIL_ADDRESS>or by mail to Advisory
Committee Oversight and Management Staff, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA generally has posted the CVs of FDA advisory committee members
publicly on http://www.fda.gov/AdvisoryCommittees/ after reviewing the
CVs and redacting information that appeared to be confidential.
Currently, FDA requires the submission of a CV for each nominee as part
of the nomination process for advisory committee members. FDA also
requests that existing advisory committee members submit updated
versions of their CVs, typically on a yearly basis.
    In furtherance of FDA's goal of ensuring transparency regarding the
qualifications of individuals selected to serve on FDA advisory
committees, and in recognition that individual advisory committee
members are best situated to evaluate the confidentiality of
information contained in their CVs, including any considerations raised
by their relationships and agreements with third parties, FDA will be
requiring that all CVs submitted as part of the nomination process for
positions on FDA advisory committees be accompanied by a written
consent form stating that, if the nominee is accepted as a member of an
FDA advisory committee, the individual consents to the publication of
the individual's CV to FDA's Web site, without FDA removing or
redacting any information. The consent form requires that the nominee
affirm that the CV does not include any confidential information,
including information pertaining to third parties that the nominee is
not permitted to disclose. A nominee will be required to submit a
signed consent form in order for the nomination to be considered
complete. The consent form will need to be submitted along with the
four other types of documents currently requested as part of the
nomination process: (1) A CV for each nominee; (2) a written
confirmation that the nominee is aware of the nomination (unless self-
nominated); (3) a letter(s) of recommendation; and (4) for Consumer
Representative applications, a cover letter that lists consumer or
community organizations for which the candidate can demonstrate active
participation. In addition to the consent form submitted as part of the
application process, FDA will also be requiring that a nearly identical
consent form be submitted by all existing advisory committee members
each time they submit an updated version of their CV to FDA. The
language of the consent for existing advisory committee members will
differ only in that it will not include the language ``if [the nominee
is] selected to serve on an [FDA] advisory committee''.
    Every day, FDA makes important health and safety decisions about
foods, drugs, medical devices, cosmetics, and other widely used
consumer products. Transparency in FDA's activities and decision making
allows the public to better understand the Agency's decisions,
increasing credibility and promoting accountability. Transparency helps
the Agency to more effectively protect and promote the public health.
Ensuring greater public awareness of the qualifications of individuals
responsible for assisting the Agency in making important policy
decisions is an important factor in ensuring such transparency. Posting
the CVs of advisory committee members helps increase public awareness.
Additionally, requiring advisory committee nominees and advisory
committee members to attest that their CVs do not include any
confidential information, including information pertaining to third
parties that they are not permitted to disclose, will help conserve
limited FDA resources by ensuring that the individual most familiar
with the information contained in the CV, as well as any contractual or
confidentiality agreements that might affect their ability to disclose
that information, assumes the responsibility for determining whether
the information may be released publicly. Because advisory committee
nominees and members are most familiar with the information contained
in their CVs, FDA will not be advising potential or current members
about whether specific information in their CVs is confidential or
otherwise should be removed.

II. Advisory Committee Member CVs and Confidential Information

    The consent form will be required to be submitted each time an
advisory committee nominee's or existing

advisory committee member's CV is submitted to FDA. All information
contained in the CV submission for individuals who are selected for or
currently serving on an FDA advisory committee will be available for
public posting. Specifically, for nominees for positions on an FDA
advisory committee, the required consent will state as follows:

    If I am selected to serve on an advisory committee, I consent to
publication of my curriculum vitae (CV), and any subsequent updates
to my CV that I provide FDA, on FDA's Web site, without removing or
redacting any information. My CV does not include any confidential
information, including information pertaining to third parties that
I am not permitted to disclose.

For existing advisory committee members who submit updated CVs, the
required consent will state as follows:

    I consent to publication of my curriculum vitae (CV), and any
subsequent updates to my CV that I provide FDA, on FDA's Web site,
without removing or redacting any information. My CV does not
include any confidential information, including information
pertaining to third parties that I am not permitted to disclose.

III. Date of Implementation

    All nominations for new advisory committee members will be required
to be submitted through FDA's Web site at https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or any
successor system, and the submission will be required to be accompanied
by the required consent form, on or after the date of OMB approval for
this information collection. All updated CVs for existing advisory
committee members will be required to be submitted to FDA along with
the required consent form after March 8, 2017.

    Dated: February 1, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-02411 Filed 2-3-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 49 (Wednesday, March 13, 2019)]
[Notices]
[Pages 9130-9132]
[FR Doc No: 2019-04572]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0363]

Cancer Clinical Trial Eligibility Criteria: Patients With Human
Immunodeficiency Virus, Hepatitis B Virus, or Hepatitis C Virus
Infections; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Cancer
Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B
Virus, or Hepatitis C Virus Infections.'' This draft guidance is one in
a series of guidances that provide recommendations regarding
eligibility criteria for clinical trials of drugs or biological
products regulated by the Center for Drug Evaluation and Research
(CDER) and the Center for Biologics Evaluation and Research (CBER) for
the treatment of cancer. Specifically, this draft guidance includes
recommendations on the inclusion of patients with human
immunodeficiency virus (HIV), hepatitis B virus (HBV) infections, and
hepatitis C virus (HCV) infections. Exclusion of patients with HIV,
HBV, or HCV infections remains common in most studies of
investigational drugs. Expanding cancer clinical trial eligibility to
be more inclusive of patients with HIV, HBV, or HCV infections is
justified in many cases, and may accelerate the development of
effective therapies in cancer patients with these chronic infections.

DATES: Submit either electronic or written comments on the draft
guidance by May 13, 2019 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-2019-D-0363 for ``Cancer Clinical Trial Eligibility Criteria:
Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus
Infections.'' 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.
     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.gpo.gov/fdsys/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.
    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 Office of Communication, Outreach and Development, CBER, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002; Division of Drug Information, CDER, Food
and Drug Administration, 10001 New Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. The
draft guidance may also be obtained by mail by calling CBER at 1-800-
835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911; or Julia Beaver, Center for Drug Evaluation and Research,
Food and Drug Administration, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240-
402-0489.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Cancer Clinical Trial Eligibility Criteria: Patients with
HIV, Hepatitis B Virus, and Hepatitis C Virus Infections.'' This draft
guidance provides recommendations on the inclusion of patients with
HIV, HBV, and HCV infections in clinical trials of drugs or biological
products regulated by CDER and CBER for the treatment of cancer.
    A clinical trial's eligibility criteria are essential components of
the trial, defining the characteristics of the study population.
Eligibility criteria should be developed taking into consideration the
mechanism of action of the drug, the targeted disease or patient
population, the anticipated safety of the investigational drug, and the
ability to recruit trial participants from the patient population to
meet the objectives of the clinical trial. However, some eligibility
criteria have become commonly accepted over time or used as a template
across trials without clear scientific or clinical rationale.
Unnecessarily restrictive eligibility criteria may slow patient
accrual, limit patients' access to clinical trials, and lead to trial
results that do not fully represent treatment effects in the patient
population that will ultimately use the drug. Broadening cancer trial
eligibility criteria can maximize the generalizability of trial results
and the ability to understand the therapy's benefit-risk profile across
the patient population likely to use the drug in clinical practice
without jeopardizing patient safety.
    The draft guidance recommends that eligibility criteria regarding
patients with HIV, HBV, or HCV infections address requirements
regarding relevant concurrent antiviral and other therapies (e.g.,
antibiotic prophylaxis) and degree of immunocompetence appropriate for
a given cancer, investigational drug, and intended use population. The
recommendations for eligibility criteria for patients with cancer and
concurrent HIV infection are focused on evaluation of immune function
and HIV therapy. The recommendations for eligibility criteria for
cancer patients with evidence of chronic HBV or with current or history
of HCV are focused on liver-related laboratories and HBV/HCV therapy.
    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 ``Cancer
Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B
Virus, and Hepatitis C Virus Infections.'' 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. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 312 have been approved under OMB
control number 0910-0014; the collections of information in 21 CFR
201.56 and 201.57 have been approved under OMB control number 0910-
0572.

III. Electronic Access

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

    Dated: March 7, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04572 Filed 3-12-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58777-58778]
[FR Doc No: 2022-20998]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-512-000]

WBI Energy Transmission, Inc.; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on September 19, 2022, WBI Energy Transmission,
Inc. (WBI Energy), 1250 West Century Avenue, Bismarck, North Dakota
58503, filed a prior notice request pursuant to Sections 157.205 and
157.210 of the Federal Energy Regulatory Commission's (Commission)
regulations, for authorization to construct and operate a new
compressor station, tie-in facilities including pipeline, and
associated measurement facilities on its Line Section 27 located in
McKenzie County, North Dakota to provide 175,000 equivalent dekatherms
per day incremental natural gas firm transportation service. WBI Energy
proposes to construct and operate these facilities under authorities
granted by its blanket certificate issued in Docket No. CP82-487-000,
all as more fully set forth in the application which is on file with
the Commission and open to public inspection.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (https://ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
Lori Myerchin, Director, Regulatory Affairs and Transportation
Services, WBI Energy Transmission, Inc., 1250 West Century Avenue,
Bismarck, North Dakota 58503, at<PHONE_NUMBER> or
[email protected].
    Pursuant to Section 157.9 of the Commission's Rules of Practice and
Procedure,\1\ within 90 days of this Notice the Commission staff will
either: complete its environmental review and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or environmental
assessment (EA) for this proposal. The filing of an EA in the
Commission's public record for this proceeding or the issuance of a
Notice of Schedule for Environmental Review will serve to notify
federal and state agencies of the timing for the completion of all
necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
---------------------------------------------------------------------------

    \1\ 18 CFR (Code of Federal Regulations) Sec.  157.9.
---------------------------------------------------------------------------

Public Participation

    There are three ways to become involved in the Commission's review
of this project: you can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on November 21, 2022.
How to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\2\ any person \3\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for

authorization will be considered by the Commission.
---------------------------------------------------------------------------

    \2\ 18 CFR 157.205.
    \3\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\4\ and must be submitted by
the protest deadline, which is November 21, 2022. A protest may also
serve as a motion to intervene so long as the protestor states it also
seeks to be an intervenor.
---------------------------------------------------------------------------

    \4\ 18 CFR 157.205(e).
---------------------------------------------------------------------------

Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \5\ and the regulations under the NGA \6\ by the
intervention deadline for the project, which is November 21, 2022. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \5\ 18 CFR 385.214.
    \6\ 18 CFR 157.10.
---------------------------------------------------------------------------

    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before November 21, 2022. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP22-512-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \7\
---------------------------------------------------------------------------

    \7\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.
---------------------------------------------------------------------------

    (2) You can file a paper copy of your submission by mailing it to
the address below. Your submission must reference the Project docket
number CP22-512-000.
    To mail via USPS, use the following address:

Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426

    To mail via any other courier, use the following address:

Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, Maryland 20852

    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at: Lori
Myerchin, Director, Regulatory Affairs and Transportation Services, WBI
Energy Transmission, Inc., 1250 West Century Avenue, Bismarck, North
Dakota 58503 or [email protected].
    Any subsequent submissions by an intervenor must be served on the
applicant and all other parties to the proceeding. Contact information
for parties can be downloaded from the service list at the eService
link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at www.ferc.gov using the
``eLibrary'' link as described above. The eLibrary link also provides
access to the texts of all formal documents issued by the Commission,
such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to https://www.ferc.gov/docs-filing/esubscription.asp.

    Dated: September 22, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-20998 Filed 9-27-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 119 (Thursday, June 20, 2019)]
[Rules and Regulations]
[Pages 28732-28734]
[FR Doc No: 2019-12957]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0451]
RIN 1625-AA00

Safety Zone; Ohio River, Miles 110.5 to 111.5, Moundsville, WV

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
all navigable waters of the Ohio River from mile 110.5 to mile 111.5.
This safety zone is necessary to protect persons, vessels, and the
marine environment from potential hazards associated with shoreside
demolition activities. Entry of persons or vessels into this zone is
prohibited unless authorized by the Captain of the Port Marine Safety
Unit Pittsburgh or a designated representative.

DATES: This rule is effective from June 22, 2019 through June 30, 2019.
The rule will be enforced from 6 a.m. through noon on one day between
June 22, 2019 and June 30, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2019-0451 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Jennifer Haggins, Marine Safety Unit
Pittsburgh, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Marine Safety Unit Pittsburgh
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that
good cause exists for not publishing a notice of proposed rulemaking
(NPRM) with respect to this rule because it is impracticable. This
safety zone must be established by June 22, 2019 and we lack sufficient
time to provide a reasonable comment period and then consider those
comments before issuing this rule. The NPRM process would delay the
establishment of the safety zone until after the date of the building
demolition and compromise public safety.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying this rule would be
contrary to the public interest because immediate action is necessary
to respond to the potential safety hazards associated with the
shoreside building demolition.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Marine Safety Unit Pittsburgh (COTP) has
determined that potential hazards associated with shoreside demolition
activities will be a safety hazard for anyone within a one-mile stretch
of the Ohio River. The rule is needed to protect persons, vessels, and
the marine environment on the navigable waters within the safety zone
before, during, and after the building demolition.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from 6 a.m. through
noon on one day between June 22, 2019 and June 30, 2019. The rule will
be enforced from 6 a.m. through noon on one day between June 22, 2019
and June 30, 2019. The safety zone will cover all navigable waters of
the Ohio River, from mile 110.5 to mile 111.5. The duration of the zone
is intended to protect persons, vessels, and the marine environment on
these navigable waters before, during, and after the building
demolition. No vessel or person will be permitted to enter the safety
zone without obtaining permission from the COTP or a designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard assigned to units under the
operational control of USCG Marine Safety Unit Pittsburgh. Persons and
vessels seeking entry into this safety zone must request permission
from the COTP or a designated representative. They may be contacted on
VHF-FM Channel 16 or by telephone at<PHONE_NUMBER>. Persons and
vessels permitted to enter this safety zone must transit at their
slowest safe speed and comply with all lawful instructions of the COTP
or a designated representative. The COTP or a designated representative
will inform the public of the enforcement period for the safety zone as
well as any changes in the schedule through Broadcast Notices to
Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety
Information Bulletins (MSIBs) as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
duration, and location of the safety zone. This rule will impact a one-
mile stretch of the Ohio River for 6 hours. Moreover, the Coast Guard
will issue Local Notices to Mariners (LNMs), Marine Safety Information
Bulletins (MSIBs), and BNMs via VHF-FM marine channel 16 about the
zones and the rule allows vessels to seek permission to enter the
zones.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
temporary safety zone may be small entities, for the reasons stated in
section V.A above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have
determined that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves a temporary safety zone lasting one
hour and prohibiting entry on a one-mile stretch of the Ohio River. It
is categorically excluded from further review under paragraph L60(a) in
Table 3-1 of U.S. Coast Guard Environmental Planning Implementing
Procedures 5090.1. A Record of Environmental Consideration supporting
this determination is available in the docket where indicated under
ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T08-0451 to read as follows:

Sec.  165.T08-0451  Safety Zone; Ohio River, miles 110.5 to 111.5,
Moundsville, WV.

    (a) Location. The following area is a safety zone: all navigable
waters of the Ohio River from mile 110.5 to mile 111.5.
    (b) Effective period. This section is effective from June 22, 2019
through June 30, 2019.
    (c) Enforcement period. This section will be enforced from 6 a.m.
through noon on one day between June 22, 2019 and June 30, 2019.
    (d) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into this zone is prohibited unless authorized by
the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a
designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Marine Safety
Unit Pittsburgh.
    (2) Persons and vessels seeking entry into this safety zone must
request permission from the COTP or a designated representative. They
may be contacted on VHF-FM Channel 16 or by telephone at (412) 221-
0807.
    (3) Persons and vessels permitted to enter this safety zone must
transit at their slowest safe speed and comply with all lawful
instructions of the COTP or a designated representative.
    (e) Informational broadcasts. The COTP or a designated
representative will inform the public of the enforcement period for the
safety zone as well as any changes in the schedule through Broadcast
Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or
Marine Safety Information Bulletins (MSIBs) as appropriate.

A.W. Demo,
Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit
Pittsburgh.
[FR Doc. 2019-12957 Filed 6-19-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Proposed Rules]
[Pages 34819-34820]
[FR Doc No: 2018-15714]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2011-0941; FRL-9979-23]

Proposed Modification of Significant New Uses of a Certain
Chemical Substance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This action is a notification that additional data has been
added to the docket for the proposal to amend the significant new use
rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act
(TSCA) for oxazolidine, 3,3'-methylenebis [5-methyl-. This action also
reopens the comment period for an additional 30 days for public
comments based on the additional data added to the docket. The proposal
would amend the SNUR to allow certain new uses reported in the
significant new use notice (SNUN) without requiring additional SNUNs
and make the lack of certain worker protections a new use.

DATES: Comments must be received on or before August 22, 2018.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0941, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division, Office of Pollution Prevention
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture,
process, or use the chemical substance contained in this rule. The
following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Manufacturers or processors of the chemical substance
(NAICS codes 325 and 324110), e.g., chemical manufacturing and
petroleum refineries.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to a SNUR must certify their
compliance with the SNUR requirements. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of a proposed or final SNUR are subject
to the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) (see Sec.  721.20), and must comply with the export
notification requirements in 40 CFR part 707, subpart D.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. What action is the agency taking?

    On February 8, 2018 (83 FR 5598) (FRL-9973-02), document, EPA
proposed to amend the SNUR under section 5(a)(2) of TSCA) for
oxazolidine, 3,3'-methylenebis [5-methyl- (40 CFR 721.10461), which was
the subject of a premanufacture notice (PMN) and a significant new use
notice (SNUN). The proposal would amend the SNUR to allow certain new
uses reported in the SNUN without requiring additional SNUNs and make
the lack of certain worker protections a new use.
    In response to public comments on the proposed SNUR, EPA has added
additional information to the docket that further explains EPA's risk
assessment and includes additional data used in the assessment. EPA is
hereby reopening the comment period for 30 days to allow interested
parties to consider the data and submit any additional comments.
    To submit comments, or access the docket, please follow the
detailed instructions provided under ADDRESSES. If you have questions,
consult the technical person listed under FOR FURTHER INFORMATION
CONTACT.

List of Subjects in 40 CFR Part 721

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

    Dated: July 9, 2018.
Jeffery T. Morris,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2018-15714 Filed 7-20-18; 8:45 am]
BILLING CODE 6560-50-P