[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Pages 12611-12613]
[FR Doc No: 2017-04229]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0136]

Public Meeting on Patient-Focused Drug Development for Autism;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public meeting and an opportunity for public comment on
Patient-Focused Drug Development for autism. Patient-Focused Drug
Development is part of FDA's performance commitments made as part of
the fifth authorization of the Prescription Drug User Fee Act (PDUFA
V). The public meeting is intended to allow FDA to obtain patient
perspectives on the impact of autism on daily life as well as patient
views on treatment approaches for autism.

DATES: The public meeting will be held on May 4, 2017, from 1 p.m. to 5
p.m. Registration to attend the meeting must be received by April 24,
2017 (see SUPPLEMENTARY INFORMATION for instructions). Submit either
electronic or written comments on the public meeting by July 5, 2017.
Late, untimely filed comments will not be considered. Electronic
comments must be submitted on or before July 5, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 5, 2016. Comments received by
mail/hand delivery/courier (for written paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date. See the SUPPLEMENTARY
INFORMATION section for registration date and information.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For more
information on parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-0136 for ``Public Meeting on Patient-Focused Drug
Development for Autism.'' Received comments, those filed in a timely
manner (see DATES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    FDA will post the agenda approximately 5 days before the meeting
at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm529043.htm.

FOR FURTHER INFORMATION CONTACT: Shanon Woodward, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1141, Silver Spring, MD 20993-0002, 240-
402-6167, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected autism as the focus of a public meeting under
Patient-Focused Drug Development, an initiative that involves obtaining
a better understanding of patient perspectives on the severity of a
disease and the available therapies for that condition. Patient-Focused
Drug Development is being conducted to fulfill FDA performance
commitments that are part of the reauthorization of the PDUFA under
Title I of the Food and Drug Administration Safety and Innovation Act
(Pub. L. 112-144). The full set of performance commitments is available
at http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA committed to obtain the patient perspective on at least 20
disease areas during the course of PDUFA V. For each disease area, the
Agency is conducting a public meeting to discuss the disease and its
impact on patients' daily lives, the types of treatment benefit that
matter most to patients, and patients' perspectives on the adequacy of
the available therapies. These meetings will include participation of
FDA review divisions, the relevant patient communities, and other
interested stakeholders.
    On April 11, 2013, FDA published a notice in the Federal Register
(78 FR 08441) announcing the disease areas for meetings in fiscal years
(FYs) 2013-2015, the first 3 years of the 5-year PDUFA V time frame.
The Agency used several criteria outlined in that notice to develop the
list of disease areas. FDA obtained public comment on the Agency's
proposed criteria and potential disease areas through a public docket
and a public meeting that was convened on October 25, 2012. In
selecting the set of disease areas, FDA carefully considered the public
comments received and the perspectives of review divisions at FDA. FDA
initiated a second public process for determining the disease areas for
FY 2016-2017, and published a notice in the Federal Register on July 2,
2015, announcing the selection of eight disease areas. More
information, including the list of disease areas and a general schedule
of meetings, is posted at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm.

II. Purpose and Scope of the Meeting

    As part of Patient-Focused Drug Development, FDA will obtain input
of patients and patient representatives on the symptoms of autism that
matter most to patients and on current approaches to treating autism.
Autism is a neurodevelopmental disorder characterized in varying
degrees by difficulties with social interaction, verbal and non-verbal
communication challenges, and repetitive behavior patterns. FDA has
approved products for irritability related to autism including
risperidone and aripiprazole. In addition to pharmacological
treatments, behavioral and educational interventions are also common
treatment options. FDA is interested in the perspectives of patients
with autism and caregivers on (1) symptoms and the daily impacts of
their condition, (2) current approaches to treatment, and (3) decision
factors taken into account when selecting a treatment.
    The questions that will be asked of patients and patient
representatives at the meeting are listed in this section, organized by
topic. For each topic, a brief initial patient/caregiver panel
discussion will begin the dialogue. This will be followed by a
facilitated discussion inviting comments from other patient and patient
representative participants. In addition to input generated through
this public meeting, FDA is interested in receiving patient input
addressing these questions through written comments, which can be
submitted to the public docket (see ADDRESSES).

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients

    (1) Of all the symptoms that you/your child experiences because of
the condition, which 1-3 symptoms have the most significant impact on
your/your child's life? (Examples may include behavioral symptoms,
difficulty with motor coordination, difficulty sleeping, difficulty
concentrating, seizures, etc.)
    (2) Are there specific activities that are important to you/your
child but that you/your child cannot do at all or as fully as you would
like because of these symptoms? (Examples of activities may include
sleeping through the night, daily hygiene, eating, dressing,
participation in sports or social activities, etc.)
    (a) How do these symptoms and their negative impacts affect daily
life on the best days? On the worst days?
    (3) How has your/your child's condition and its symptoms changed
over time?
    (4) What worries you/your child most about your/your child's
condition?

Topic 2: Patients' Perspectives on Current Approaches to Treating

    (1) What are you/your child currently doing to help treat the
condition or its symptoms? (Examples may include prescription
medicines, over-the-counter products, and other therapies including
non-drug therapies such as behavioral interventions)
    (a) How has your/your child's treatment regimen changed over time,
and why?
    (2) How well does your/your child's current treatment regimen treat
the most significant symptoms of the condition?
    (a) How well do your/your child's treatments address specific
activities that are important to you/your child's daily life?
    (b) How well have these treatments worked for you/your child as the
condition has changed over time? Which symptoms are not addressed as
well?
    (3) What are the most significant downsides to your/your child's
current treatments, and how do they affect your daily life? (Examples
of downsides may include bothersome side effects, interacts with other
medications, time devoted to treatment, etc.)
    (4) What specific things would you look for in an ideal treatment
for your/your child's condition?
    (a) What would you consider to be a meaningful improvement (for
example symptom improvements or functional improvements) in your/your
child's condition that a treatment could provide?
    (5) What factors do you/your child take into account when making
decisions about selecting a course of treatment?
    (a) What information on potential benefits of these treatments
factors most into your/your child's decision?

    (b) How do you/your child weigh the potential benefits of these
treatments versus the common side effects of the treatments? (Common
side effects could include headache, nausea, fatigue, weight gain)
    (c) How do you/your child weigh potential benefits of these
treatments versus the less common but serious risks associated with the
treatments? (Examples of less common but serious risks are infections,
organ damage or failure, suicidal thoughts)

III. Meeting Attendance and Participation

    If you wish to attend this meeting, visit https://autismpfdd.eventbrite.com. Persons interested in attending this public
meeting must register by April 24, 2017. If you are unable to attend
the meeting in person, you can register to view a live Webcast of the
meeting. You will be asked to indicate in your registration if you plan
to attend in person or via the Webcast. Registration is free and based
on space availability, with priority given to early registrants. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation once they have been accepted.
Onsite registration on the day of the meeting will be based on space
availability. If you need special accommodations because of a
disability, please contact Shanon Woodward (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the meeting.
    Patients and patient representatives who are interested in
presenting comments as part of the initial panel discussions will be
asked to indicate in their registration which topic(s) they wish to
address. These patients and patient representatives also must send to
<EMAIL_ADDRESS>a brief summary of responses to the topic
questions by April 17, 2017. Panelists will be notified of their
selection approximately 7 days before the public meeting. We will try
to accommodate all patients and patient representatives who wish to
speak, either through the panel discussion or audience participation;
however, the duration of comments may be limited by time constraints.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see ADDRESSES). A link
to the transcript will also be available on the Internet at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm529043.htm.

    Dated February 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04229 Filed 3-3-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 21, 2009 (Volume 74, Number 202)]
[Notices]
[Page 54118-54119]
[DOCID:fr21oc09-119]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2009-0168]

Technical Report on Fatalities in Frontal Crashes Despite Seat
Belts and Air Bags

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for comments on technical report.

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SUMMARY: This notice announces NHTSA's publication of a Technical
Report reviewing and evaluating the performance in frontal crashes of
air-bag-equipped, late-model passenger cars, pickup trucks, SUVs and
vans and the protection they offer to drivers and front-seat passengers
who wear seat belts. The report's title is: Fatalities in Frontal
Crashes Despite Seat Belts and Air Bags.

DATES: Comments must be received no later than February 18, 2010.

ADDRESSES: Report: The technical report is available on the Internet
for viewing on line in PDF format at http://www-nrd.nhtsa.dot.gov/Pubs/
811102.PDF. You may obtain a copy of the report free of charge by
sending a self-addressed mailing label to Charles J. Kahane (NVS-431),
National Highway Traffic Safety Administration, 1200 New Jersey Avenue,
SE., Washington, DC 20590.
    Comments: You may submit comments [identified by Docket Number
NHTSA-2009-0168] by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., between 9 am and 5 pm Eastern Time, Monday
through Friday, except Federal holidays.
    You may call Docket Management at<PHONE_NUMBER>.
    Instructions: For detailed instructions on submitting comments, see
the Procedural Matters section of this document. Note that all comments
received will be posted without change to http://www.regulations.gov,
including any personal information provided.

FOR FURTHER INFORMATION CONTACT: Charles J. Kahane, Chief, Evaluation

Division, NVS-431, National Center for Statistics and Analysis,
National Highway Traffic Safety Administration, Room W53-312, 1200 New
Jersey Avenue, SE., Washington, DC 20590. Telephone:<PHONE_NUMBER>. E-
mail<EMAIL_ADDRESS>    For information about NHTSA's evaluations of the effectiveness of
existing regulations and programs: You may see a list of published
evaluation reports at http://www-nrd.nhtsa.dot.gov/cats/
listpublications.aspx?Id=226&ShowBy=Category and if you click on any
report you will be able to view it in PDF format.

SUPPLEMENTARY INFORMATION: Why are people still dying in frontal
crashes despite seat belt use, air bags, and the crashworthy structures
of late-model vehicles? Statistical analyses show the combination of
seat belt use and air bags is highly effective, reducing fatality risk
by 61 percent compared to an unbelted occupant of a vehicle not
equipped with air bags--but 61 percent is not 100 percent. To address
the question, an interdisciplinary NHTSA team reviewed every case of a
frontal fatality to a belted driver or right-front passenger in a model
year 2000 or newer vehicle in the Crashworthiness Data System (CDS) of
the National Automotive Sampling System through calendar year 2007.
Aside from a substantial proportion of these 122 crashes that are just
exceedingly severe, the main reason people are still dying is because
so many crashes involve poor structural engagement between the vehicle
and its collision partner: corner impacts, oblique crashes, impacts
with narrow objects, and underrides. By contrast, few if any of these
122 fatal crashes were full-frontal or offset-frontal impacts with good
structural engagement, unless the crashes were of extreme severity or
the occupants exceptionally vulnerable.

Procedural Matters

How Can I Influence NHTSA's Thinking on This Subject?

    NHTSA welcomes public review of the evaluation plan and invites the
reviewers to comment about the selection, priority, and schedule of the
regulations to be evaluated. The agency is interested in learning of
any additional data that may be useful in the evaluations. NHTSA will
submit to the Docket a response to the comments and, if appropriate,
will supplement or revise the evaluation plan.

How Do I Prepare and Submit Comments?

    Your comments must be written and in English. To ensure that your
comments are correctly filed in the Docket, please include the Docket
number of this document (NHTSA-2009-0168) in your comments.
    Your primary comments must not be more than 15 pages long (49 CFR
553.21). However, you may attach additional documents to your primary
comments. There is no limit on the length of the attachments.
    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477) or you may visit http://regulations.gov.
    Please send two paper copies of your comments to Docket Management,
fax them, or use the Federal eRulemaking Portal. The mailing address is
U.S. Department of Transportation, Docket Management Facility, M-30,
West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590. The fax number is 1-202-493-2251. To use the
Federal eRulemaking Portal, go to http://www.regulations.gov and follow
the online instructions for submitting comments.
    We also request, but do not require you to send a copy to Charles
J. Kahane, Chief, Evaluation Division, NVS-431, National Highway
Traffic Safety Administration, Room W53-312, 1200 New Jersey Avenue,
SE., Washington, DC 20590 (or e-mail them to chuck.kahane@dot.gov). He
can check if your comments have been received at the Docket and he can
expedite their review by NHTSA.

How Can I Be Sure that My Comments Were Received?

    If you wish Docket Management to notify you upon its receipt of
your comments, enclose a self-addressed, stamped postcard in the
envelope containing your comments. Upon receiving your comments, Docket
Management will return the postcard by mail.

How Do I Submit Confidential Business Information?

    If you wish to submit any information under a claim of
confidentiality, send three copies of your complete submission,
including the information you claim to be confidential business
information, to the Chief Counsel, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590.
Include a cover letter supplying the information specified in our
confidential business information regulation (49 CFR Part 512).
    In addition, send two copies from which you have deleted the
claimed confidential business information to U. S. Department of
Transportation, Docket Management Facility, M-30, West Building, Ground
Floor, Rm. W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590,
or submit them via the Federal eRulemaking Portal.

Will the Agency Consider Late Comments?

    In our response, we will consider all comments that Docket
Management receives before the close of business on the comment closing
date indicated above under DATES. To the extent possible, we will also
consider comments that Docket Management receives after that date.
    Please note that even after the comment closing date, we will
continue to file relevant information in the Docket as it becomes
available. Further, some people may submit late comments. Accordingly,
we recommend that you periodically check the Docket for new material.

How Can I Read the Comments Submitted by Other People?

    You may read the materials placed in the docket for this document
(e.g., the comments submitted in response to this document by other
interested persons) at any time by going to http://www.regulations.gov.
Follow the online instructions for accessing the dockets. You may also
read the materials at the Docket Management Facility by going to the
street address given above under ADDRESSES. The Docket Management
Facility is open between 9 a.m. and 5 p.m. Eastern Time, Monday through
Friday, except Federal holidays.

    Authority: 49 U.S.C. 30111, 30168; delegation of authority at 49
CFR 1.50 and 501.8.

James F. Simons,
Director, Office of Regulatory Analysis and Evaluation.
[FR Doc. E9-25271 Filed 10-20-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 82, Number 206 (Thursday, October 26, 2017)]
[Notices]
[Pages 49647-49649]
[FR Doc No: 2017-23230]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2017-0002; Internal Agency Docket No. FEMA-B-1756]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR). The LOMR will be used by
insurance agents and others to calculate appropriate flood insurance
premium rates for new buildings and the contents of those buildings.
For rating purposes, the currently effective community number is shown
in the table below and must be used for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these

changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at www.msc.fema.gov for comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at www.msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: October 13, 2017.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

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                                                                 Chief executive  officer of                                        Online location of                                Community
          State and county            Location and  case No.              community                Community map  repository      letter  of map revision    Date of  modification       No.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Alaska: Anchorage..................  Municipality of          The Honorable Ethan Berkowitz,    City Hall, 632 West 6th Avenue,  http://www.msc.fema.gov/  Jan. 12, 2018...........       020005
                                      Anchorage (17-10-        Mayor, Municipality of            Anchorage, AK 99501.             lomc.
                                      0709P).                  Anchorage, 632 West 6th Avenue,
                                                               Suite 840, Anchorage, AK 99501.
California:
    Riverside......................  City of Corona (17-09-   The Honorable Dick Haley, Mayor,  City Hall, 400 South Vicentia    http://www.msc.fema.gov/  Jan. 19, 2018...........       060250
                                      0805P).                  City of Corona, 400 South         Avenue, Corona, CA 92882.        lomc.
                                                               Vicentia Avenue, Corona, CA
                                                               92882.
    Riverside......................  Unincorporated Areas of  The Honorable John F.             Riverside County Flood and       http://www.msc.fema.gov/  Jan. 19, 2018...........       060245
                                      Riverside County (17-    Tavaglione, Chairman, Board of    Water Conservation District,     lomc.
                                      09-0805P).               Supervisors, Riverside County,    1995 Market Street, Riverside,
                                                               4080 Lemon Street, 5th Floor,     CA 92502.
                                                               Riverside, CA 92501.
    Sacramento.....................  Unincorporated Areas of  The Honorable Don Nottoli,        Sacramento County, Department    http://www.msc.fema.gov/  Jan. 10, 2018...........       060262
                                      Sacramento County (16-   Chairman, Board of Supervisors,   of Water Resources, 827 7th      lomc.
                                      09-2857P).               Sacramento County, 700 H          Street, Suite 301, Sacramento,
                                                               Street, Suite 2450, Sacramento,   CA 95814.
                                                               CA 95814.
    San Benito.....................  City of Hollister (17-   The Honorable Ignacio Velazquez,  Planning Department, 420 Hill    http://www.msc.fema.gov/  Jan. 8, 2018............       060268
                                      09-1234P).               Mayor, City of Hollister, 375     Street, Building A, Hollister,   lomc.
                                                               5th Street, Hollister, CA         CA 95023.
                                                               95023.
    San Benito.....................  Unincorporated Areas of  The Honorable Jaime De La Cruz,   San Benito County Department of  http://www.msc.fema.gov/  Jan. 8, 2018............       060267
                                      San Benito County (17-   Chairman, Board of Supervisors,   Public Works, 3220 Southside     lomc.
                                      09-1234P).               San Benito County, 481 4th        Road, Hollister, CA 95023.
                                                               Street, 1st Floor, Hollister,
                                                               CA 95023.

    San Luis Obispo................  Unincorporated Areas of  The Honorable John Peschong,      San Luis Obispo County Public    http://www.msc.fema.gov/  Jan. 11, 2018...........       060304
                                      San Luis Obispo County   Chairman, Board of Supervisors,   Works Department, 976 Osos       lomc.
                                      (16-09-3181P).           San Luis Obispo County, 1055      Street, Room 207, San Luis
                                                               Monterey Street, Suite D430,      Obispo, CA 93401.
                                                               San Luis Obispo, CA 93408.
    Santa Clara....................  City of San Jose (16-09- The Honorable Sam Liccardo,       Department of Public Works, 200  http://www.msc.fema.gov/  Jan. 5, 2018............       060349
                                      3074P).                  Mayor, City of San Jose, 200      East Santa Clara Street, 5th     lomc.
                                                               East Santa Clara Street, 18th     Floor, San Jose, CA 95113.
                                                               Floor, San Jose, CA 95113.
Florida: St. Johns.................  Unincorporated Areas of  The Honorable James K. Johns,     St. Johns County Administration  http://www.msc.fema.gov/  Jan. 12, 2018...........       125147
                                      St. Johns County (17-    Chairman, St. Johns County        Building, 4020 Lewis Speedway,   lomc.
                                      04-4604P).               Board of Commissioners, 500 San   St. Augustine, FL 32084.
                                                               Sebastian View, St. Augustine,
                                                               FL 32084.
Idaho:
    Ada............................  City of Eagle (17-10-    The Honorable Stan Ridgeway,      City Hall, 660 East Civic        http://www.msc.fema.gov/  Jan. 16, 2018...........       160003
                                      1535P).                  Mayor, City of Eagle, City        Street, Eagle, ID 83616.         lomc.
                                                               Hall, 660 East Civic Lane,
                                                               Eagle, ID 83616.
    Ada............................  Unincorporated Areas of  The Honorable David L. Case,      Ada County Courthouse, 200       http://www.msc.fema.gov/  Jan. 16, 2018...........       160001
                                      Ada County (17-10-       Chairman, Ada County Board of     Front West Street, Boise, ID     lomc.
                                      1535P).                  Commissioners, 200 West Front     83702.
                                                               Street, 3rd Floor, Boise, ID
                                                               83702.
Kansas: Johnson....................  City of Overland Park    The Honorable Carl Gerlach,       City Hall, 8500 Santa Fe Drive,  http://www.msc.fema.gov/  Jan. 5, 2018............       200174
                                      (17-07-1247P).           Mayor, City of Overland Park,     Overland Park, KS 66212.         lomc.
                                                               City Hall, 8500 Santa Fe Drive,
                                                               Overland Park, KS 66212.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-23230 Filed 10-25-17; 8:45 am]
 BILLING CODE 9110-12-P


TABLE 2a AVERAGE ANNUAL EPA RESOURCE REQUIREMENT NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS ( NESHAPS)

SUBPART NNN  WOOL FIBERGLASS MANUFACTURING  YEAR 1*

REPORTING/ RECORDKEEPING REQUIREMENT EPA Hours/

Occurence ( A) Occurences/

Plant/ Year ( B) EPA Hours/

Year ( C= A* B)

( C) Plants/

Year ( D) Technical Hours/ Year ( E) Management Hours/ Year ( E* 0.05) Admin.

Hours/ Year ( E* 0.1) EPA Hours/ Year ( E= C* D)

( F)

INITIAL PERFORMANCE TESTS New or Modified Facility 40 1 40 9 360 18 36 414 REPEAT PERFORMANCE TEST New or Modified Facility 40 0.2 8 1.8 14.4 0.72 1.44 17 REPORT REVIEW New or Modified Facility Notification of Applicability** 2 1 2 0 0 0 0 0 Notification of Construction/

Reconstruction 2 1 2 0 0 0 0 0 Notification of Anticipated Startup 2 1 2 0 0 0 0 0 Notification of Actual Startup 2 1 2 0 0 0 0 0 Notification of Special Compliance Requirements 1 1 1 1 1 0.05 0.1 1 Notification of Initial Performance Test 2 1 2 9 18 0.9 1.8 21 Notification of Compliance Status 2 1 2 9 18 0.9 1.8 21 Adjustments to Time Periods, and 2 1 2 1 2 0.1 0.2 2 Quality Improvement Plan 40 1 40 1.8 72 3.6 7.2 83 Operations Maintenance and Monitoring Plan 40 1 40 9 360 18 36 414 Startup, Shutdown, and Malfunction Plan 40 1 40 9 360 18 36 414 Report of Performance Test 40 1 40 9 360 18 36 414 Excess Emissions Reports 20 2 40 1.6 64 3.2 6.4 74 Report of No Excess Emissions 2 2 4 6.4 25.6 1.28 2.56 29 Startup, Shutdown, and Malfunction Reports 20 2 40 1 40 2 4 46 TOTAL ANNUAL HOURS 1,949 ANNUAL TRAVEL EXPENSES $ 3,600.00 ( 1 person x 9 plants/ yr. x 3 days/ plant x $ 50 per diem) + ($ 250 round trip/ plant x 9 plants/ yr.) =

SALARY BURDEN ( per year) $ 67,619.48 1 person x $ 34.69/ hr x 943 hrs/ yr.

TOTAL ANNUAL BURDEN $ 71,219.48 TABLE 2b AVERAGE ANNUAL EPA RESOURCE REQUIREMENT NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS ( NESHAPS)

SUBPART NNN  WOOL FIBERGLASS MANUFACTURING  YEAR 2 REPORTING/ RECORDKEEPING REQUIREMENT EPA Hours/

Occurence ( A) Occurences/

Plant/ Year ( B) EPA Hours/

Year ( C= A* B)

( C) Plants/

Year ( D) Technical Hours/ Year ( E) Management Hours/ Year ( E* 0.05) Admin.

Hours/ Year ( E* 0.1) EPA Hours/ Year ( E= C* D)

( F)

INITIAL PERFORMANCE TESTS New or Modified Facility 40 1 40 9 360 18 36 414 REPEAT PERFORMANCE TEST New or Modified Facility 40 0.2 8 1.8 14.4 0.72 1.44 17 REPORT REVIEW New or Modified Facility Notification of Applicability 2 1 2 0 0 0 0 0 Notification of Construction/

Reconstruction 2 1 2 0 0 0 0 0 Notification of Anticipated Startup 2 1 2 0 0 0 0 0 Notification of Actual Startup 2 1 2 0 0 0 0 0 Notification of Special Compliance Requirements 1 1 1 1 1 0.05 0.1 1 Notification of Initial Performance Test 2 1 2 9 18 0.9 1.8 21 Notification of Compliance Status 2 1 2 9 18 0.9 1.8 21 Request for Extension of Compliance,

Adjustments to Time Periods, and Changes in Information 2 1 2 1 2 0.1 0.2 2 Quality Improvement Plan 40 1 40 1.8 72 3.6 7.2 83 Operations Maintenance and Monitoring Plan 40 1 40 9 360 18 36 414 Startup, Shutdown, and Malfunction Plan 40 1 40 9 360 18 36 414 Report of Performance Test 40 1 40 9 360 18 36 414 Excess Emissions Reports 20 2 40 3.4 136 6.8 13.6 156 Report of No Excess Emissions 2 2 4 13.6 54.4 2.72 5.44 63 Startup, Shutdown, and Malfunction Reports 20 2 40 1 40 2 4 46 TOTAL ANNUAL HOURS 2,065 ANNUAL TRAVEL EXPENSES $ 3,600.00 ( 1 person x 9 plants/ yr. x 3 days/ plant x $ 50 per diem) + ($ 250 round trip/ plant x 9 plants/ yr.) =

SALARY BURDEN ( per year) $ 71,640.75 1 person x $ 34.69/ hr x 943 hrs/ yr.

TOTAL ANNUAL BURDEN $ 75,240.75 TABLE 2c AVERAGE ANNUAL EPA RESOURCE REQUIREMENT NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS ( NESHAPS)

SUBPART NNN  WOOL FIBERGLASS MANUFACTURING  YEAR 3 REPORTING/ RECORDKEEPING REQUIREMENT EPA Hours/

Occurence ( A) Occurences/

Plant/ Year ( B) EPA Hours/

Year ( C= A* B)

( C) Plants/

Year ( D) Technical Hours/ Year ( E) Management Hours/ Year ( E* 0.05) Admin.

Hours/ Year ( E* 0.1) EPA Hours/ Year ( E= C* D)

( F)

INITIAL PERFORMANCE TESTS New or Modified Facility 40 1 40 0 0 0 0 0 REPEAT PERFORMANCE TEST New or Modified Facility 40 0.2 8 0 0 0 0 0 REPORT REVIEW New or Modified Facility Notification of Applicability 2 1 2 0 0 0 0 0 Notification of Construction/

Reconstruction 2 1 2 0 0 0 0 0 Notification of Anticipated Startup 2 1 2 0 0 0 0 0 Notification of Actual Startup 2 1 2 0 0 0 0 0 Notification of Special Compliance Requirements 1 1 1 1 1 0.05 0.1 1 Notification of Initial Performance Test 2 1 2 0 0 0 0 0 Notification of Compliance Status 2 1 2 0 0 0 0 0 Request for Extension of Compliance,

Adjustments to Time Periods, and Changes in Information 2 1 2 1 2 0.1 0.2 2 Quality Improvement Plan 40 1 40 0 0 0 0 0 Operations Maintenance and Monitoring Plan 40 1 40 0 0 0 0 0 Startup, Shutdown, and Malfunction Plan 40 1 40 0 0 0 0 0 Report of Performance Test 40 1 40 0 0 0 0 0 Excess Emissions Reports 20 2 40 5.2 208 10.4 20.8 239 Report of No Excess Emissions 2 2 4 20.8 83.2 4.16 8.32 96 Startup, Shutdown, and Malfunction Reports 20 2 40 1 40 2 4 46 TOTAL ANNUAL HOURS 384 ANNUAL TRAVEL EXPENSES $ 0.00 ( 1 person x 0 plants/ yr. x 3 days/ plant x $ 50 per diem) + ($ 250 round trip/ plant x 0 plants/ yr.) =

SALARY BURDEN ( per year) $ 13,332.41 1 person x $ 34.69/ hr x 943 hrs/ yr.

TOTAL ANNUAL BURDEN $ 13,332.41 Assumptions Number of new plants 0 Rate of failed performance tests 20%

Time required to participate with performance test ( per plant) 40 Time require to review notifications ( hours) 2 Time required to review plans ( hours) 40 Time required to review performance test results ( hours) 40 Time required to review reports ( e. g.,

excess emissions, startup, shutdown,

and malfunctions) ( hours) 20 Number of startup, shutdowns, and malfunctions ( per year) 2 Percent of facilities required to prepare excess emissions reports 20%

Percent of facilities required to prepare no excess emissions reports 80%

Estimated number of plants that will be required to submit startup, shutdown,

and malfunction reports 1 Estimated number of extensions,

adjustments to time periods, etc. ( per year) 1 EPA labor rate $ 34.69 Percentage of new plant visits 100%

* We are assuming that nine existing facilities will come into compliance each year during the first two years of this ICR. In addition, we are assuming that all exisiting facilities will be in compliance before the third year since the compliance deadline falls within the second year of this ICR. The remaining 8 facilities came into compliance during the previous ICR.

** All notifications of applicability for existing facilities were submitted within 180 days of the effective date ( 12/ 14/ 99)


[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Notices]
[Pages 45634-45635]
[FR Doc No: 2020-16417]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2955-011]

City of Watervliet; Notice of Application Accepted for Filing and
Soliciting Motions To Intervene and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Subsequent Minor License.
    b. Project No.: 2955-011.
    c. Date Filed: February 28, 2020.
    d. Applicant: City of Watervliet, New York.
    e. Name of Project: Normanskill Hydroelectric Project.
    f. Location: The project is located on the Normans Kill in
Guilderland, Albany County, New York. The project does not occupy any
federal land.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825 (r).
    h. Applicant Contact: Michele E. Stottler, Gomez and Sullivan
Engineers, DPC, 399 Albany Shaker Road, Suite 203, Loudonville, NY
12211;<PHONE_NUMBER>; [email protected] or Joseph
LaCivita, General Manager, The City of Watervliet, 2 Fifteenth Street,
Watervliet, NY 12189;<PHONE_NUMBER>; [email protected]
    i. FERC Contact: Woohee Choi at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    The Commission strongly encourages electronic filing. Please file
motions to intervene and protests using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please
contact FERC Online Support at<EMAIL_ADDRESS>(866) 208-
3676 (toll free), or<PHONE_NUMBER> (TTY). In lieu of electronic
filing, you may submit a paper copy. Submissions sent via the U.S.
Postal Service must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE, Room 1A,
Washington, DC 20426. Submissions sent via any other carrier must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. The first
page of any filing should include docket number P-2955-011.
    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.
    k. This application has been accepted but is not ready for
environmental analysis at this time.
    l. The Normanskill Project consists of the following existing
facilities: (1) A 380-foot-long reinforced concrete Ambursen-type dam
with a 306-foot-long overflow section having a crest elevation of 259
feet National Geodetic Vertical Datum of 1929 (NGVD29) surmounted by 3-
foot-high flashboards; (2) a 380-acre reservoir with a gross volume of
3,600 acre-feet at the normal maximum pool elevation of 262 feet
NGVD29; (3) an intake structure and sluiceway; (4) a 700-foot-long, 6-
foot-diameter, concrete-encased steel, buried penstock; (5) a
reinforced concrete underground powerhouse containing a single 1,250-
kilowatt tube-type generating unit; (6) a 600-foot-long, 2.4-kilovolt
(kV) transmission line; (7) a 2.4/13.2-kV transformer bank; and (8)
appurtenant facilities.
    The Normanskill Project is operated in a run-of-river mode with an
average annual generation of 2,863 megawatt-hours between 2010 and
2019.
    m. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested individuals an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (www.ferc.gov) using the
``eLibrary'' link. At this time, the Commission has suspended access to
the Commission's Public Access 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 FERC
at<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, .211, and .214. In determining the appropriate action to
take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
protests or motions to intervene must be received on or before the
specified comment date for the particular application.
    All filings must: (1) Bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE;'' (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 protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application.
    o. Procedural schedule and final amendments: The application will
be processed according to the following preliminary schedule. Revisions
to the schedule will be made as appropriate.

Issue Scoping Document 1 for comments.  August 2020.
Request Additional Information (if      October 2020.
 necessary).
Issue Scoping Document 2 (if            November 2020.
 necessary).
Issue notice of ready for               November 2020.
 environmental analysis.
Commission issues EA..................  May 2021.
Comments on EA........................  June 2021.

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

    Dated: July 23, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-16417 Filed 7-28-20; 8:45 am]
BILLING CODE 6717-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C., 20460 ENVIRONMENTAL FATE AND EFFECTS DIVISION OFFICE OF PESTICIDE PROGRAMS March 18, 2003 SUBJECT: Response to BASF's comments on the RED fo sodium acifluorfen ( PC Code 114402 / Company: 007969 BASF Corporation) for uses on soybeans, peanuts and rice.

FROM: James J. Goodyear, Ph. D. Biologist ( 7507C) Kevin Costello, Geologist Environmental Risk Branch 3, EFED THRU: Ben Smith, Branch Chief ( 7507C) Environmental Risk Branch 3, EFED TO: Betty Shackleford, Branch Chief ( 7508C) Christina Scheltema, Chemical Review Manager Reregistration Branch 3, SRRD EFED has review BASF's second set of comments on EFED's portion of the RED for acifluorfen. Our responses are below.

BASF Comments.

" 1. Comment no. 1 Evaluation of chronic risk to birds." " BASF respectfully requests that EFED further refine the assessment to consider the effects of three other conservative factors."

The assumption that a breeding bird will take 100% of its diet exclusively from a treated field.

EFED Response:

As EFED has stated previously that the current risk assessment method for terrestrial organisms was designed to account for uncertainties. Because of the uncertainty, the method includes some conservative assumptions. In some aspects, conservative assumptions are made that will tend to over estimate exposure. 2 However, in many other aspects, assumptions are made and factors are overlooked that may cause the risk to be underestimated. For example, all routes of exposure other than ingestion of contaminated food are ignored, and animals in the wild are assumed to consume food at a rate no greater than those kept in captivity. Overall, EFED does not believe that the risk assessment is inappropriately conservative. EFED is working on developing risk assessment methods that will address some of these factors. EFED is open to receiving data from BASF that further explore consumption patterns of terrestrial organisms in the wild. Until these studies are submitted and approved, EFED must analyze the study reports based upon the models that it has on hand.

The use of the maximum residue values of 240 ppm per lb a. i./ A for short grass and 58 ppm lb a. i./ A for broadleaves and insects instead of BASF's calculated value of 125 ppm for short grass and 33 ppm for broadleaf plants and insects over the entire assessment.

EFED Response:

The above answer applies to this comment as well. In addition, EFED did not use 240/ 58 ppm a. i./ A for calculating risk. That value is calculated from ( as BASF states) the application of 1 lb. a. i./ A. EFED used the label rates ( e. g., 0.25 lb a. i./ A) to calculate the EECs. On page 35 [ the page numbers are from the document that EFED sent to SRRD; SRRD should change the numbers to the ones for the document that they sent to the registrant, JG], in Chapter 7 under EXPOSURE the table Estimated Environmental Concentrations is:

Estimated Environmental Concentrations ( EECs) on avian and mammalian food items ( ppm) immediately following the second of two applications of 0.25 lb ai/ A.

Food Items EEC ( ppm) Predicted Maximum Residue EEC ( ppm) Predicted Mean Residue Short grass 120 43 Tall grass 55 18 Broadleaf plants / Insects1 68 23 Seeds 8 4 Page 36 ( 3rd paragraph) states, " The duration of the chronic risk will be for three days after the first application and more than 15 days after the second application." 3 The nature of the effect observed in the Northern bobwhite reproduction study and the use of 20 ppm as the NOEAC.

EFED Response:

In performing avian chronic toxicity studies, the Agency encourages registrants to perform studies at numerous levels in order to better refine their estimates of LOAECs and NOAECs, but does not typically consider studies based on less than five treatment levels. In this case, BASF only provided information on two levels. Rather than requiring new studies, the Agency agreed to consider the information in its risk assessment process. Unfortunately, by selecting such an approach, BASF has limited the Agency's ability to draw conclusions about intermediary doses. There is no basis for imputing an effect at intermediate doses of acifluorfen, as it cannot even be established that the effect would be linear in this range. Furthermore, having incomplete information, it would inappropriate for the Agency to pick the least conservative conclusion based on a LOAEC. Should BASF desire consideration of intermediate points for the NOAEC, they have the option to perform studies at those levels to demonstrate its accuracy. Lacking such information, the Agency must continue to use 20 ppm as the NOAEC.

BASF Comments: " 2. Comment no. 2. Discussion of uncertainty of chronic risk to freshwater and estuarine animals." " BASF argues that the preponderance of the evidence leads to the conclusion that acifluorfen does not pose a chronic risk to aquatic organisms. Acifluorfen has a fairly short photolytic half life in water ( 3.8 days), is not acutely toxic, and, even with a theoretical 20 fold increase in toxicity, the chronic RQs for all crops are well below LOCs. BASF does not believe an additional study ( aquatic phototoxicity) is necessary to address aquatic chronic toxicity."

" BASF argues that the preponderance of the evidence leads to the conclusion that acifluorfen does not pose a chronic risk to aquatic organisms. Acifluorfen has a fairly short photolytic half life in water, is not acutely toxic, and, even with a theoretical 20 fold increase in toxicity, the chronic RQs for all crops are well below LOCs. BASF does not believe an additional study ( aquatic phototoxicity) is necessary to address aquatic chronic toxicity." The Agency disagrees with BASF on both of its conclusions. Clearly establishing that there is no chronic effect requires an evaluation that includes studies at proper conditions and demonstration of a NOAEC. BASF has provided neither. They acknowledge they have not provided data at a clear NOAEC. The sole effect observed at 1.5 mg/ L was on weight. BASF did not provide additional information on behavior or blood chemistry that would have enabled the Agency further to refine its evaluation of the importance of this effect. Consequently, we are left with the presumption that the NOAEC is some level less than 1.5 mg/ L. 4 As stated in the draft RED, the Agency has good reason to expect an increase in toxicity similar to that observed in the study of carfentrazone ethyl ( 20 fold). Taken together, these points suggest a chronic level of concern considerably below 75 g/ L. How far below 75 g/ L the level of concern is can only be addressed by a properly conducted study of phototoxicity. BASF also asserts that acifluorfen's short half life in water makes it unlikely that it would persist in shallow, clear bodies of water where photolytic activity could generate increased phototoxicity. Consequently, BASF believes it is unlikely that a 60 day EEC of 20 g/ L associated with soybeans would be likely to occur. The Agency disagrees, as normal water body mixing should be more than adequate to maintain long term concentrations estimated by PRZM/ EXAMS. Counterbalancing BSAF's concern is the inherent inability of chronic toxicity studies to account for the impact of higher initial concentration " shock" levels on organisms that can amplify chronic effects in the natural environment. While the Agency acknowledges that, without phototoxicity, a 14 fold safety factor of safety would not pose a chronic concern for aquatic life. This statement is consistent with the fact that one must consider phototoxicity as a possible mechanism of concern for acifluorfen. When such phototoxicity is considered, the quotient is not fourteen, but approximately three. This narrow margin, coupled with the shortcomings of the provided study ( which failed to establish an NOAEC), leads the Agency to conclude the requested study is still necessary.

BASF Comments:

" 3. Comment no. 3. Nontarget terrestrial plant testing. BASF is willing to work with the Agency to further define the risk."

EFED Response: The registrant acknowledges that additional studies are needed. EFED looks forward to seeing BASF's new studies or to discussing their new protocol.


[Federal Register Volume 88, Number 138 (Thursday, July 20, 2023)]
[Notices]
[Pages 46792-46793]
[FR Doc No: 2023-15428]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-504-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on June 27, 2023, Columbia Gas Transmission
(Columbia), 700 Louisiana Street, Suite 1300, Houston, Texas 77002-
2700, filed in the above referenced docket, a prior notice request
pursuant to sections 157.205 and 157.216(b) of the Commission's
regulations under the Natural Gas Act (NGA), and Columbia's blanket
certificate issued in Docket No. CP83-76-000, for authorization to
abandon one injection/withdrawal well, connecting pipe, and appurtenant
facilities. All of the above facilities are located in the Wellington
Storage Field in Lorain County, Ohio. The project will allow Columbia
to protect the integrity of the Wellington Storage Field as well as
Columbia's certificated facilities and services and thereby safeguard
the interests of Columbia's customers, affected landowners, and the
environment. The estimated cost for the project is $550,000, all as
more fully set forth in the request 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 (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. At this time,
the Commission has suspended access to the Commission's Public
Reference Room. For assistance, contact the Federal Energy Regulatory
Commission at [email protected] or call toll-free, (886) 208-
3676 or TTY<PHONE_NUMBER>.
    Any questions concerning this request should be directed to David
A. Alonzo, Manager, Project Authorizations, Columbia Gas Transmission,
LLC, 700 Louisiana Street, Suite 1300, Houston, Texas 77002-2700, at
(832) 320-5477 or [email protected].

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 September 12,
2023. How to file protests, motions to intervene, and comments is
explained below.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\1\ any person \2\ 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.
---------------------------------------------------------------------------

    \1\ 18 CFR 157.205.
    \2\ 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,\3\ and must be submitted by
the protest deadline, which is September 12, 2023. A protest may also
serve as a motion to intervene so long as the protestor states it also
seeks to be an intervenor.
---------------------------------------------------------------------------

    \3\ 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 \4\ and the regulations under the NGA \5\ by the
intervention deadline for the project, which is September 12, 2023. 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.
---------------------------------------------------------------------------

    \4\ 18 CFR 385.214.
    \5\ 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 September 12, 2023. 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
CP23-504-000 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 \6\
---------------------------------------------------------------------------

    \6\ 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 CP23-504-000.

To file via USPS: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426
To file via any other method: 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: David A.
Alonzo, Manager, Project Authorizations, Columbia Gas Transmission,
LLC, 700 Louisiana Street, Suite 1300, Houston, TX 77002-2700, or by
[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
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: July 14, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-15428 Filed 7-19-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 17, 2008 (Volume 73, Number 138)]
[Notices]
[Page 41087-41088]
[DOCID:fr17jy08-83]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0208] (formerly Docket No. 2005D-0438)

Guidance for Industry: Safety, Efficacy, and Pharmacokinetic
Studies to Support Marketing of Immune Globulin Intravenous (Human)
as Replacement Therapy for Primary Humoral Immunodeficiency;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry: Safety,
Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune
Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral
Immunodeficiency,'' dated June 2008. The guidance document provides
recommendations for the design of clinical trials to assess the safety,
efficacy, and pharmacokinetics of immune globulin intravenous (human)
(IGIV) products as replacement therapy in primary humoral
immunodeficiency. The guidance announced in this notice finalizes the
draft guidance of the same title dated November 2005.

DATES:  Submit written or electronic comments on agency guidances at
any time. Submit written requests for single copies of the guidance to
the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448. Send one self-addressed adhesive label to assist the office
in processing your requests. The guidance may also be obtained by mail
by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.

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

FOR FURTHER INFORMATION CONTACT: Denise S[aacute]nchez, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies
to Support Marketing of Immune Globulin Intravenous (Human) as
Replacement Therapy for Primary Humoral Immunodeficiency,'' dated June
2008. This guidance provides investigational new drug application (IND)
and biologics license application (BLA) sponsors with recommendations
for the design of clinical trials to assess the safety, efficacy, and
pharmacokinetics of investigational IGIV products when used as
replacement therapy in primary humoral immunodeficiency. This

guidance is intended to assist sponsors in the preparation of the
clinical/biostatistical and human pharmacokinetic sections of a BLA.
This guidance does not address additional sections of a BLA, such as
chemistry, manufacturing, and controls and pre-clinical toxicology, for
an IGIV product for this indication.
    In the Federal Register of December 1, 2005 (70 FR 72124), FDA
announced the availability of the draft guidance of the same title
dated November 2005. FDA received several comments on the draft
guidance and those comments were considered as the guidance was
finalized. A summary of changes includes: Recommendations for
compliance with the Pediatric Research Equity Act of 2007, refinements
to the criteria for diagnosing serious infections, refinements to the
recommended safety analyses of adverse experiences temporally related
to infusions, and additional guidance on the methodology of
pharmacokinetic studies. The guidance announced in this notice
finalizes the draft guidance dated November 2005.
    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information regarding BLAs (21 CFR part 601) have been
approved under OMB control number 0910-0338.

III. Comments

    Interested persons may, at any time, submit to the Division of
Dockets Management (see ADDRESSES) written or electronic comments
regarding the guidance. Submit a single copy of electronic comments or
two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. A copy of the
guidance and received comments are available for public examination in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/cber/guidelines.htm or http://
www.regulations.gov.

    Dated: July 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16395 Filed 7-16-08; 8:45 am]

BILLING CODE 4160-01-S