[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Notices]
[Page 55440]
[FR Doc No: 2021-21010]

Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 /
Notices

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0212]

Applications for Premarket Review of New Tobacco Products; Draft
Guidance for Industry; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
withdrawal of a draft guidance for industry entitled ``Applications for
Premarket Review of New Tobacco Products.'' We are withdrawing this
guidance because the topics discussed in the draft guidance are
addressed in the final rule entitled ``Premarket Tobacco Product
Applications and Recordkeeping Requirements.''

DATES: The draft guidance is withdrawn as of October 5, 2021.

FOR FURTHER INFORMATION CONTACT: Paul Hart, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is announcing the withdrawal of a draft
guidance for industry entitled ``Applications for Premarket Review of
New Tobacco Products,'' the notice of availability for which appeared
in the Federal Register of September 28, 2011 (76 FR 60055). The draft
guidance was intended to assist persons submitting premarket tobacco
product applications (PMTAs) for new tobacco products under section
910(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 387j(b)(1)). The draft guidance discussed, among other things,
when and how to submit PMTAs, what information the FD&C Act requires a
PMTA to contain, and what information FDA recommends that applicants
submit to demonstrate its new tobacco product should receive a
marketing granted order. We are withdrawing this draft guidance and not
finalizing it because the final rule entitled ``Premarket Tobacco
Product Applications and Recordkeeping Requirements'' covers the topics
described in the draft guidance.

    Dated: September 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21010 Filed 10-4-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 168 (Tuesday, August 30, 2016)]
[Notices]
[Pages 59621-59622]
[FR Doc No: 2016-20851]

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 ENVIRONMENTAL PROTECTION AGENCY

[FRL-9951-65-OA]

Request for Nominations of Experts To Augment the Science
Advisory Board Ecological Processes and Effects Committee To Provide
Advice on Methods for Deriving Water Quality Criteria for the
Protection of Aquatic Life

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA), SAB Staff Office is
requesting public nominations of scientific experts to augment the SAB
Ecological Processes and Effects Committee (EPEC) for review of a draft
EPA document entitled ``Scope and Approach for Revising USEPA's
Guidelines for Deriving National Water Quality Criteria to Protect
Aquatic Life.''

DATES: Nominations should be submitted by September 20, 2016 per the
instructions below.

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

SUPPLEMENTARY INFORMATION:
    Background: The SAB (42 U.S.C. 4365) is a chartered Federal
Advisory Committee that provides independent scientific and technical
peer review, advice, consultation, and recommendations to the EPA
Administrator on the technical basis for EPA actions. As a Federal
Advisory Committee, the SAB conducts business in accordance with the
Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and related
regulations. The SAB Ecological Process and Effects Committee (EPEC) is
a subcommittee of the SAB that provides advice through the chartered
SAB on technical issues related to EPA environmental programs and the
supporting science and research to protect, sustain, and restore the
health of ecosystems. The SAB and the EPEC, augmented with additional
experts, will comply with the provisions of FACA and all appropriate
SAB Staff Office procedural policies. The augmented EPEC will provide
advice through the chartered SAB on scientific and technical issues
related to the Agency's proposed methods for revising and updating
water quality criteria, as described in the Agency's draft scoping
document, entitled ``Scope and Approach for Revising USEPA's Guidelines
for Deriving National Water Quality Criteria to Protect Aquatic Life.''
This draft document provides an overview of the framework EPA proposes
to use for the phased revision of the 1985 Guidelines for Deriving
Numerical Water Quality Criteria for the Protection of Aquatic
Organisms and Their Uses by outlining the planned scope and approach of
the Guidelines revision process and introducing new and alternative
methods to be considered for deriving aquatic life criteria based on
the latest and most appropriate science available.
    EPA's Office of Water (OW) requested an SAB consultation (i.e.,
early advice) on their draft approach for updating and revising the
EPA's 1985 methodology for deriving national Ambient Water Quality
Criteria to protect aquatic life, as described in the draft scoping
document. The SAB Staff Office is seeking experts to augment the SAB
EPEC for this advisory activity. EPA's OW has also requested reviews of
two subsequent and related draft documents: ``Draft Expedited
Methodologies for Deriving Water Quality Criteria for the Protection of
Aquatic Life'' and ``Draft Revised USEPA Guidelines for Deriving
Numeric Water Quality Criteria for the Protection of Aquatic Life.''
These draft documents are currently scheduled for completion as drafts
in late 2017 and mid-2019.
    Technical Contact for EPA's Draft Report: For information
concerning the draft EPA report, ``Scope and Approach for Revising
USEPA's Guidelines for Deriving National Water Quality Criteria to
Protect Aquatic Life,'' please contact Mike Elias, Ecological Risk
Assessment Branch, Health and Ecological Criteria Division, Office of
Water, U.S. EPA, 1200 Pennsylvania Ave. NW., Washington, DC 20460,
phone<PHONE_NUMBER> or via email at<EMAIL_ADDRESS>    Request for Nominations: The SAB Staff Office is seeking
nominations of nationally and internationally recognized scientists
with demonstrated expertise and research to augment the EPEC for the
consultation and subsequent reviews of methods for revising Water
Quality Criteria. For this effort, the SAB Staff Office seeks experts
in one or more of the following areas: Aquatic toxicology;
ecotoxicology; aquatic ecology; ecological risk assessment; ecological
effects modeling; and statistics, especially as applied to developing
robust computational methods for estimating acute and chronic effects
of water pollutants on aquatic life and aquatic-dependent wildlife.
Additional information about this advisory activity is available on the
SAB Web site at http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/1985%20WQ%20Criteria%20Guidelines%20Revision?OpenDocument. Questions
regarding this advisory activity should be directed to Iris Goodman,
Designated Federal Officer (DFO), SAB Staff Office, by telephone/voice
mail at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, or via email at
<EMAIL_ADDRESS>    Process and Deadline for Submitting Nominations: Any interested
person or organization may nominate qualified individuals in the areas
of expertise described above for possible service on the augmented EPEC
panel described above. Nominations should be submitted in electronic
format (preferred over hard copy) using the online nomination form
under the ``Nomination of Experts'' category at the bottom of the SAB
home page at http://www.epa.gov/sab. To receive full consideration,
nominations should include all of the information requested below.
EPA's SAB Staff Office requests contact information about the person
making the nomination; contact information about the nominee; the
disciplinary and specific areas of expertise of the nominee; the
nominee's resume or curriculum vitae; sources of recent grant and/or
contract support; and a biographical sketch of the nominee indicating
current position, educational background, research activities, and
recent service on other national advisory committees or national
professional organizations.
    Persons having questions about the nomination procedures, or who
are unable to submit nominations through the SAB Web site, should
contact Iris Goodman as indicated above in this notice. Nominations
should be

submitted in time to arrive no later than September 20, 2016. EPA
values and welcomes diversity. In an effort to obtain nominations of
diverse candidates, EPA encourages nominations of women and men of all
racial and ethnic groups.
    The EPA SAB Staff Office will acknowledge receipt of nominations.
The names and biosketches of qualified nominees identified by
respondents to this Federal Register notice, and additional experts
identified by the SAB Staff, will be posted in a List of Candidates for
the EPEC Augmented for Review of Aquatic Life Water Quality Criteria
Methods on the SAB Web site at http://www.epa.gov/sab (see links under
``Public Input on Membership'' at the bottom of the SAB home page).
Public comments on the List of Candidates will be accepted for 21 days.
The public will be requested to provide relevant information or other
documentation on nominees that the SAB Staff Office should consider in
evaluating candidates.
    For the EPA SAB Staff Office a balanced review panel includes
candidates who possess the necessary domains of knowledge, the relevant
scientific perspectives (which, among other factors, can be influenced
by work history and affiliation), and the collective breadth of
experience to adequately address the charge. In forming the augmented
EPEC, the SAB Staff Office will consider public comments on the List of
Candidates, information provided by the candidates themselves, and
background information independently gathered by the SAB Staff Office.
Selection criteria to be used for panel membership include: (a)
Scientific and/or technical expertise, knowledge, and experience
(primary factors); (b) availability and willingness to serve; (c)
absence of financial conflicts of interest; (d) absence of an
appearance of a loss of impartiality; (e) skills working in committees,
subcommittees and advisory panels; and, (f) for the panel as a whole,
diversity of expertise and scientific points of view.
    The SAB Staff Office's evaluation of an absence of financial
conflicts of interest will include a review of the ``Confidential
Financial Disclosure Form for Environmental Protection Agency Special
Government Employees'' (EPA Form 3110-48). This confidential form
allows government officials to determine whether there is a statutory
conflict between a person's public responsibilities (which include
membership on an EPA federal advisory committee) and private interests
and activities, or the appearance of a loss of impartiality, as defined
by federal regulation. The form may be viewed and downloaded from the
following URL address http://yosemite.epa.gov/sab/sabproduct.nsf/Web/ethics?OpenDocument.
    The approved policy under which the EPA SAB Office selects members
for subcommittees and review panels is described in the following
document: Overview of the Panel Formation Process at the Environmental
Protection Agency Science Advisory Board (EPA-SAB-EC-02-010), which is
posted on the SAB Web site at http://www.epa.gov/sab/pdf/ec02010.pdf.

    Dated: August 24, 2016.
Christopher S. Zarba,
Director, EPA Science Advisory Board Staff Office.
[FR Doc. 2016-20851 Filed 8-29-16; 8:45 am]
BILLING CODE 6560-50-P


Insert for New Section IX.B.1.c. Immediately following 1.b.
IX.
B.
1.
c. Definition of gas well
Comment: Several commenters mentioned that the proposed definition of "gas well" was unclear due to the term "principal production" used in describing what the well produces. One commenter requests that the definition of gas well be modified to include each respective state's definition of gas well. The commenter states that by doing this, the EPA would eliminate any confusion associated with having to apply different criteria (NSPS versus state regulations) for how to define a well-type in assessing the applicability of the rule.
Response:
      In response to comments requesting further clarity in the definition, the EPA has revised the definition.  The proposed definition was "Gas well means an onshore well, the principal production of which at the mouth of the well is gas."  In the final rule, in response to the comments we received, the EPA has revised the definition to exclude the term "at the mouth of the well."
      EPA's intent in setting standards for completion of hydraulically fractured gas wells is to require reduced emissions completions for wells where infrastructure is generally present to get recovered natural gas to market. We believe that the final rule will result in control of hydraulically fractured gas wells drilled in the four formation types generally accepted as gas-producing formations: (1) high-permeability gas, (2) shale gas, (3) other tight reservoir rock, or (4) coal seam. We believe that the wording changes made to the definition of "gas well" clarify the intent so that implementing agencies and industry will not be burdened with complex applicability determinations.
      With respect to using state gas well definitions, basing applicability on different definitions from state to state could introduce inconsistencies that are counter to the goal of nationwide regulation. We believe the NSPS, being a national rule, should contain a single definition applicable nationwide.
Comment:  One commenter states that based on the EPA's discussion in Section 4 of the Technical Support Document, it appears the EPA's intent is to require reduced emissions completions only for natural gas wells. The commenter supports that the EPA applied reduced emissions completions only to natural gas wellhead facilities and excluded oil wellhead facilities and other types of gas wells which have little or no VOC emissions. The commenter states that, as shown on page 4-13 on Table 4.4 "Nationwide Baseline Emissions from Uncontrolled Oil and Gas Well Completions and Recompletions" of the Technical Support Document, there are only 134 TPY of VOCs emissions from oil well completions and recompletions for the entire U.S., which is not worth regulating.
    One commenter recommends the following revision: "Gas well means a well, the principal production of which at the mouth of the well is [add: hydrocarbon gas, not CO2]. . .Well means an oil or gas well, a hole drilled for the purpose of producing oil or gas, or a well into which fluids are injected." One commenter proposes the following revision: "Gas well means a well, [DELETE the principal production of which at the mouth of the well is gas] completed for production of natural gas from one or more gas zones or reservoirs. Such wells contain no completions for the production of crude oil. The commenter also proposes the following revision: Gas well means a well [STRIKETHROUGH: the principal production of which at the mouth of the well is gas.] [ADD TEXT: completed for production of natural gas from one or more gas zones or reservoirs. Such wells contain no completions for the production of crude oil.]"
Response:  Although some wells drilled in crude oil formations may produce associated gas along with the oil, the EPA does not have sufficient data on VOC emissions during completion of hydraulically fractured oil wells to set standards for these operations at this time. As a result, the final rule will not apply to completion of oil wells.


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[Federal Register Volume 83, Number 227 (Monday, November 26, 2018)]
[Notices]
[Page 60556]
[FR Doc No: 2018-25823]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Sunshine Act Meetings; Unified Carrier Registration Plan Board of
Directors

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of Unified Carrier Registration Plan Audit Subcommittee
meeting.

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TIME AND DATE: The meeting will occur on December 19, 2018, from 2 p.m.
until 4 p.m. Eastern Standard Time.

PLACE: This meeting will be open to the public via conference call. Any
interested person may call 1-866-210-1669, passcode 5253902#, to listen
and participate in this meeting.

STATUS: Open to the public.

MATTERS TO BE CONSIDERED: The Unified Carrier Registration Plan Audit
Subcommittee will continue its work in developing and implementing the
Unified Carrier Registration Plan and Agreement. An agenda for this
meeting will be available no later than 5:00 p.m. Eastern Standard
Time, December 7, 2018, at: https://ucrplan.org.

FOR FURTHER INFORMATION CONTACT: Mr. Avelino Gutierrez, Chair, Unified
Carrier Registration Board of Directors, at<PHONE_NUMBER>.

    Issued on: November 20, 2018.
Larry W. Minor,
Associate Administrator for Policy, Federal Motor Carrier Safety
Administration.
[FR Doc. 2018-25823 Filed 11-21-18; 4:15 pm]
 BILLING CODE 4910-EX-P


[Federal Register Volume 85, Number 116 (Tuesday, June 16, 2020)]
[Proposed Rules]
[Pages 36368-36372]
[FR Doc No: 2020-12692]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-2012-0063; FRL-10009-34-Region 4]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Deletion of the Fairfax St. Wood Treaters
Superfund Site

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; Notice of Intent.

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SUMMARY: The Environmental Protection Agency (EPA) Region 4 is issuing
a Notice of Intent to Delete Fairfax St. Wood Treaters Superfund Site
(Site) located in Jacksonville, Florida, from the National Priorities
List (NPL) and requests public comments on this proposed action. The
NPL, promulgated pursuant to section 105 of the Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA) of
1980, as amended, is an appendix of the National Oil and Hazardous
Substances Pollution Contingency Plan (NCP). The EPA and the State of
Florida, through the Florida Department of Environmental Protection
(FDEP), have determined that all appropriate response actions under

CERCLA, have been completed. However, this deletion does not preclude
future actions under Superfund.

DATES: Comments must be received by July 16, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
SFUND-2012-0063, by one of the following methods:
     https://www.regulations.gov. Follow the online
instructions for submitting comments.
    Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include a
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e. on the web, cloud, or other file sharing system). For
additional submission methods, the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
     Following Centers for Disease Control and Prevention (CDC)
and Office of Policy Management (OPM) guidance and specific state
guidelines impacting our regional offices, EPA's workforce has been
authorized to telework to help prevent transmission of the coronavirus
[COVID-19]. As a result there is a temporary shutdown of EPA's Docket
Center and EPA Regional Records Centers. While in this workforce
telework status, there are practical limitations on the ability of
staff to collect, and for Agency personnel to respond to, ``hard copy''
mailed queries sent directly to Agency office locations. Therefore,
until the workforce is able to return to office locations, EPA
recommends that, to the extent feasible, any correspondence mailed to
the Agency should also be sent via email.
     For questions on this document and submission of comments
please contact--Leigh Lattimore, Remedial Project Manager, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW--
MS9T25, Atlanta, GA 30303,<PHONE_NUMBER><EMAIL_ADDRESS>or
Ron Tolliver at<EMAIL_ADDRESS>    Instructions: Direct your comments to Docket ID No. EPA-HQ-SFUND-
2012-0063. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
https://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 https://www.regulations.gov or email. The https://www.regulations.gov website
is an ``anonymous access'' system, which means the EPA will not know
your identity or contact information unless you provide it in the body
of your comment. If you send an email comment directly to the EPA
without going through https://www.regulations.gov, your email address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the internet. If
you submit an electronic comment, the 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 the EPA cannot read your comment
due to technical difficulties and cannot contact you for clarification,
the 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 https://www.regulations.gov index. 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, will be publicly available only in hardcopy.
Publicly available docket materials are available electronically in
https://www.regulations.gov.
    The EPA is temporarily suspending its Docket Center and Regional
Records Centers for public visitors to reduce the risk of transmitting
COVID-19. In addition, many site information repositories are closed
and information in these repositories, including the deletion docket,
has not been updated with hardcopy or electronic media. For further
information and updates on EPA Docket Center services, please visit us
online at https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the Centers for Disease Control and Prevention (CDC), local area
health departments, and our Federal partners so that we can respond
rapidly as conditions change regarding COVID.

FOR FURTHER INFORMATION CONTACT: Leigh Lattimore, Remedial Project
Manager, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW--MS9T25, Atlanta, GA 30303,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. NPL Deletion Criteria
III. Deletion Procedures
IV. Basis for Site Deletion

I. Introduction

    EPA Region 4 announces its intent to delete the Fairfax St. Wood
Treaters Superfund Site from the National Priorities List (NPL) and
requests public comment on this proposed action. The NPL constitutes
appendix B of 40 CFR part 300 which is the National Oil and Hazardous
Substances Pollution Contingency Plan (NCP), which the EPA promulgated
pursuant to section 105 of the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA) of 1980, as amended. The EPA
maintains the NPL as the list of sites that appear to present a
significant risk to public health, welfare, or the environment. Sites
on the NPL may be the subject of remedial actions financed by the
Hazardous Substance Superfund (Fund). As described in 40 CFR
300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible
for Fund-financed remedial actions if future conditions warrant such
actions.
    The EPA will accept comments on the proposal to delete this site
for thirty (30) days after publication of this document in the Federal
Register.
    Section II of this document explains the criteria for deleting
sites from the NPL. Section III of this document discusses procedures
that the EPA is using for this action. Section IV of this document
discusses where to access and review the information that demonstrates
how the deletion criteria have been met at the Fairfax St. Wood
Treaters Superfund Site and demonstrates how it meets the deletion
criteria.

II. NPL Deletion Criteria

    The NCP establishes the criteria that the EPA uses to delete sites
from the NPL. In accordance with 40 CFR 300.425(e), sites may be
deleted from

the NPL where no further response is appropriate. In making such a
determination pursuant to 40 CFR 300.425(e), the EPA will consider, in
consultation with the State, whether any of the following criteria have
been met:
    i. Responsible parties or other persons have implemented all
appropriate response actions required;
    ii. All appropriate Fund-financed response under CERCLA has been
implemented, and no further response action by responsible parties is
appropriate; or
    iii. The remedial investigation has shown that the release poses no
significant threat to public health or the environment and, therefore,
the taking of remedial measures is not appropriate.
    Pursuant to CERCLA section 121(c) and the NCP, the EPA conducts
five-year reviews to ensure the continued protectiveness of remedial
actions where hazardous substances, pollutants, or contaminants remain
at a site above levels that allow for unlimited use and unrestricted
exposure. The EPA conducts such five-year reviews even if a site is
deleted from the NPL. The EPA may initiate further action to ensure
continued protectiveness at a deleted site if new information becomes
available that indicates it is appropriate. Whenever there is a
significant release from a site deleted from the NPL, the deleted site
may be restored to the NPL without application of the hazard ranking
system.

III. Deletion Procedures

    The following procedures apply to deletion of the Site:
    (1) The EPA consulted with the State before developing this Notice
of Intent to Delete.
    (2) The EPA has provided the state 30 working days for review of
this document prior to publication of it today.
    (3) In accordance with the criteria discussed above, the EPA has
determined that no further response is appropriate;
    (4) The State of Florida, through the Florida Department of
Environmental Protection, has concurred with deletion of the Site from
the NPL.
    (5) Concurrently with the publication of this Notice of Intent to
Delete in the Federal Register, a notice is being published in a major
local newspaper, The Florida Times-Union. The newspaper notice
announces the 30-day public comment period concerning the Notice of
Intent to Delete the site from the NPL.
    (6) The EPA placed copies of documents supporting the proposed
deletion in the deletion docket and made these items available for
public inspection and copying at the Site information repositories
identified above.
    If comments are received within the 30-day public comment period on
this document, the EPA will evaluate and respond appropriately to the
comments before making a final decision to delete. If necessary, the
EPA will prepare a Responsiveness Summary to address any significant
public comments received. After the public comment period, if the EPA
determines it is still appropriate to delete the Site, the Regional
Administrator will publish a final Notice of Deletion in the Federal
Register. Public notices, public submissions and copies of the
Responsiveness Summary, if prepared, will be made available to
interested parties and in the site information repositories listed
above.
    Deletion of a site from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. Deletion of a site from
the NPL does not in any way alter EPA's right to take enforcement
actions, as appropriate. The NPL is designed primarily for
informational purposes and to assist EPA management. Section
300.425(e)(3) of the NCP states that the deletion of a site from the
NPL does not preclude eligibility for future response actions, should
future conditions warrant such actions.

IV. Basis for Site Deletion

    The following information provides EPA's rationale for deleting the
Site from the NPL:

Site Background and History

    The Fairfax St. Wood Treaters (FSWT) (CERCLIS ID: FLD000623041)
Superfund site encompasses 12.5 acres and is located at 2610 Fairfax
Street, in a predominantly residential area of Jacksonville, Duval
County, Florida. Features of the FSWT facility included a burned
building, parking lot, drip pad, former tank farm, and retention pond.
FSWT is bordered to the north by St. Johns/CSX railroad tracks, to the
east by Fairfax Street and residential properties beyond, to the south
by West 14th Street and residential properties beyond, and to the west
by Susie E. Tolbert and R.V. Daniels Elementary Schools (STES) and by
residential properties on Pullman Court. Moncrief Creek is located
about 1,000 feet west of the FSWT property. Overflow from the FSWT
retention pond flows into Moncrief Creek via a city drainage pipe,
which collects stormwater from the general area.
    From 1980 to 2010, Wood Treaters, LLC operated a wood treating
facility that pressure-treated utility poles, pilings, heavy timber
items, and plywood lumber products using the wood treating preservative
chromated copper arsenate (CCA). CCA is characterized by a bright green
color and is composed of waterborne oxides, or salts, of chromium,
copper, and arsenic.
    As a result of the wood treating operations and EPA's understanding
of the process at the facility, some of the contaminated soil is
contaminated with Resource Conservation and Recovery Act (RCRA) Listed
Hazardous Waste (F035). Under 40 CFR 261.31, F035 Listed hazardous
waste is defined as ``Wastewater (except those that have not come into
contact with process contaminants), process residuals, preservative
drippage, and spent formulations from wood preserving processes
generated at plants that use inorganic preservatives containing arsenic
or chromium.'' Under EPA's ``contained-in'' policy, contaminated media
(e.g., groundwater, soil, or sediments) is considered to contain RCRA
hazardous waste: (1) When media is contaminated with characteristic
hazardous waste and exhibits a characteristic of hazardous waste; or
(2) when the media is contaminated with hazardous constituents from
RCRA Listed Hazardous Waste. (63 FR 28617, May 26, 1998). For F035, the
RCRA hazardous constituents are arsenic and chromium. If contaminated
media (e.g. soil) contain Listed Hazardous Waste, then once generated
(i.e., excavated from the ground) they are with limited exceptions,
subject to all applicable RCRA hazardous waste requirements until EPA
(or an authorized State) determine the media no longer contains
hazardous waste. These RCRA requirements were identified in the ROD as
``applicable or relevant and appropriate requirements'' (ARARs)
consistent with CERCLA Section 121(d)(2) and the National Contingency
Plan (NCP) as well as EPA guidance. In addition, due to the elevated
concentrations of arsenic and chromium in soil and residual waste in
the former process area, there is a possibility that this soil/waste
could be determined by the Toxicity Characteristic Leaching Procedure
(TCLP) to be RCRA Toxicity characteristic waste under 40 CFR 261.24
[D004 and D007]. Residual waste material in pipes and drains are
classified as a RCRA Listed hazardous waste [F035]. Building and other
man-made debris that is contaminated with this Listed hazardous waste
may be hazardous debris under RCRA regulations.

    Between 1980 and 1990, there was no stormwater management system on
the facility. The topography of the FSWT property and the surrounding
area is generally flat; therefore, stormwater was either directed to
the STES retention pond or flowed overland across the FSWT property.
Uncontrolled stormwater contaminated with CCA from the wood treating
process is believed to have overflowed onto neighboring properties
during this time, resulting in CCA contaminated soil. In 1990, FSWT
installed a stormwater collection and retention system, including site
grading and paving for drainage, stormwater collection swales,
diversion berms, and a polyethylene-lined retention pond.
    After 1990, stormwater that collected in the treated wood storage
yard and areas other than the drip pad was diverted to ditches located
along the northern, southern, and western property boundaries. These
ditches drained into the retention pond at the northwestern corner of
the property. An overflow pipe is located in the retention pond so that
water overflows into the pipe and discharges into nearby Moncrief
Creek, a tributary of the Trout River.
    Wood Treaters, LLC filed for bankruptcy in July 2010. In August
2010, after Wood Treaters, LLC, abandoned the facility, the EPA, at the
request of the FDEP, conducted emergency response (ER) activities at
the facility that included pumping out the water contained in the
secondary containment area and retention pond, removing product in
tanks, and collecting soil, surface water, sediment, and residual waste
material samples. Upon arrival, the EPA plugged the overflow pipe in
the on-site retention pond to prevent contaminated water in the pond
from flowing into Moncrief Creek. Once the on-site retention pond was
stabilized, the plug was removed.
    In January 2011, the EPA conducted a removal investigation at the
FSWT property. During the removal investigation, soil samples were
collected from 17 residential properties, the STES and RVDES
properties, and the FSWT property. Arsenic, chromium, and copper were
detected in surface and subsurface soil samples collected from the FSWT
property.
    In July 2011, the EPA conducted a removal confirmation and
residential sampling event at the FSWT property. Removal activities
included excavation of gravel and soil down to 1.5 feet below land
surface (bls) along the northern, western, and southern portions of the
property. Between March and October 2011, the EPA conducted removal
activities at the FSWT property and the adjacent STES and RVDES shared
playground.
    In May 2011, the EPA conducted a site assessment investigation at
the FSWT property. During the investigation, soil samples were
collected along the northern and western portions of the FSWT property,
along the southern FSWT property boundary, beneath the concrete that
covered the majority of the FSWT property, and from nearby residential
properties. Groundwater samples were also collected from monitoring
wells installed by Wood Treaters, LLC throughout the property and
around the STES retention pond.
    The site was proposed to be on the National Priorities List (NPL)
on March 15, 2012 (77 FR 15344), and was finalized on September 18,
2012 (77 FR 57495).

Remedial Investigation and Feasibility Study (RI/FS)

    Between 2012 and 2013, the EPA conducted a remedial investigation
(RI) and risk assessment to fully characterize site contaminants, fate
and transport, and receptors for all exposure routes on and off-site.
Based on the Human Health Risk Assessment (HHRA) and the Screening-
Level Ecological Risk Assessment (SLERA), unacceptable risks were
estimated for non-residential and residential exposures to arsenic,
copper, chromium, and polycyclic aromatic hydrocarbons (PAHs) on site.
For off-site residential soils, the EPA believed that soils immediately
adjacent to the FSWT property and nearby residential yards were
contaminated by former wood treating operations conducted at the site.
The HHRA determined that several residential yards exceed EPA's
acceptable risk range. It was determined that the site-related
contamination migrated due to stormwater runoff and spray from the
tires of the trucks leaving the site from the south, east, and west.
The EPA and FDEP decided to address all residential parcels that were
impacted by site-related contamination and where arsenic concentrations
are above the background concentration of 2.36 ppm.
    The SLERA also identified a risk for an avian receptor that may use
the on-site retention pond as a primary food source and the sediments
warrant a response action. Within Moncrief Creek, the major area of
sediment contamination is located about 1,800 feet downstream of the
discharge point of stormwater from the FSWT site to the creek. However,
further investigation of stream sediments in Moncrief Creek located
off-site was needed to determine if a response action is warranted to
protect the environment. It was determined that if a response action
was warranted, a focused feasibility study will be completed and the
additional contaminated areas will be remediated as a second operable
unit under the FSWT site.
    The Feasibility Study evaluated excavation and off-site disposal
and with different treatment options for soils considered RCRA
hazardous. The future anticipated land use is residential. Cleanup
concentrations were developed to be protective of human health and are
based on future anticipated land use.

Selected Remedy

    EPA chose excavation and off-site treatment and disposal as the
best option for the remedial action at the site. The Record of Decision
(ROD) was signed on August 22, 2017. The major components of the remedy
included excavation of the 12.5 area parcel, sediment in the on-site
retention pond, and off-site properties. In addition to excavation, the
remedy included temporary storage of generated waste, off-site disposal
at EPA approved landfills, backfilling and restoration activities. The
Remedial Action Objectives were: (1) Prevent human exposure (direct
contact and ingestion) to on-site soil with concentrations of COCs
above levels protective of residential use; (2) Prevent migration of
contaminated stormwater runoff from the FSWT site to adjacent
properties and Moncrief Creek; (3) Prevent unacceptable risk to
ecological receptors (benthic organisms and avian) from contaminated
sediments and surface water in the on-site retention pond; (4) Prevent
direct contact with residual waste material and contaminated building
structures located on the site, including the drip pad and process
containment areas; and (5) Prevent off-site residential human exposure
(direct contact and ingestion) to soil with concentrations of arsenic
above levels protective of residential use.

Response Actions

    In accordance with the ROD, a pre-design field investigation was
performed to fill data gaps at the school property and at residential
properties east of the FSWT Site for arsenic concentrations and to
provide additional site-specific information needed to develop the RD.
    Three residential properties were sampled consistent with the RI
sampling. Two of the properties exceeded the arsenic cleanup level.
    STES delineation soil samples were collected on March 20, 2018 and
June

12 through June 14, 2018. Arsenic concentrations exceeded the cleanup
level. The EPA and FDEP recognized the potential concern of the parents
and community and worked together to address the impacted soil as soon
as possible. Since the EPA did not have RA funding, FDEP mobilized,
removed, and disposed of offsite the impacted soil during the summer
break when students were not present. This facilitated a component of
the selected remedy.
    Starting on July 9, 2018, the FDEP, started collecting additional
soil samples for delineation of the area needing removal on the STES.
Excavation activities occurred from July 16, 2018 through August 12,
2018, and were completed in 25 days. Approximately 3,360 tons of soil
was removed from the school property during the excavation activities.
The excavated area was backfilled and restored.
    The Remedial Action began in February 2019 and construction
activities were completed in October 2019. The 51 residential
properties, the 12.5-acre property, and the on-site retention pond were
remediated and restored. The EPA contractor excavated, stockpiled, and
disposed of roughly 67,000 tons of excavated soils and sediments at EPA
approved RCRA facilities. The EPA also collected confirmation samples
from the floors and sidewalls of excavation areas and continued
excavating soil if confirmation samples exceeded cleanup levels.
    In July 2019, the EPA collected sediment samples, fish, insects,
and crayfish along Moncrief Creek to address uncertainties raised in
the SERLA. The analyses of the data concluded that site-related
contaminants (arsenic, copper, chromium) are not likely to be
appreciable contributors to the toxicity levels observed in the
sediment toxicity tests from sediment samples from the retention basin
and that site-related metals contamination in the Moncrief Creek
retention basin is not likely to cause appreciable or unacceptable
risks to ecological receptors that may feed at the Moncrief Creek
retention basin. Therefore, it was determined the EPA would not take a
response action on Moncrief Creek.
    The completion of Remedial Action was documented in the Final
Remedial Action Report and documented in a Superfund Remedial Action
Completion memorandum signed on March 11, 2020 (Superfund Enterprise
Management System (SEMS) document identification number 11143607). The
reports and the memorandum are available in the deletion docket and
they describe the cleanup techniques, cleanup concentrations for COCs,
confirmation testing results, and QA/QC methodologies.

Cleanup Levels

    Except for arsenic, the cleanup levels for the on-site and off-site
contaminated surface soils are based on FDEP's SCTLs for direct
exposure and residential use (Florida Administrative Code [F.A.C.] 62-
777 Table II). These SCTLs are identified as chemical-specific ARARs.
Neither EPA (as a policy matter) nor Florida set cleanup levels for an
individual contaminant that is more stringent than the site-specific
background concentration for that contaminant, provided that the
background level is protective of human health and the environment.
Therefore, the EPA used the site-specific background level of 2.36 ppm
for arsenic instead of the FDEP SCTL. The cleanup levels for sediments
are based on Florida's sediment quality assessment guidelines for the
protection of sediment-dwelling organisms. The cleanup levels can be
found in the Record of Decision (SEMS 11054367)

Operation and Maintenance

    Since the RA cleanup levels achieved unlimited use and unrestricted
exposure (UU/UE), there is no need for Operation and Maintenance (O&M).
However, the owner of the property should employ good housing keeping
practices to ensure proper drainage of stormwater from the site and
should include routine inspection of all site areas for evidence of
positive drainage towards the site ditches and retention pond, routine
mowing of site grass, routine removal of debris and vegetation other
than grass from the ditches and retention pond, and routine inspection
and removal of any debris, vegetation or other obstruction from the
pond inlet structures and pipes.

Five-Year Review

    Hazardous substances, pollutants, or contaminants will not remain
at the Site above levels that allow for UU/UE after completion of all
remedial action construction. Therefore, a statutory five-year review
under CERCLA Section 121(c) will not be required for this remedial
action.

Community Involvement

    The EPA held numerous community meetings before and during the
residential cleanup. The EPA issued fact sheets and maintained a public
website during remedial construction. After the cleanup was complete,
the EPA released final fact sheets and held a final availability
session to highlight the accomplishment and answer any questions and
concerns.
    All EPA documents are on the site's public website. A notice is
being published in a major local newspaper, the Florida Times-Union and
postcards have been sent out notifying the pubic of the deletion.

Determination That the Site Meets the Criteria for Deletion in the NCP

    The EPA has followed all procedures required by 40 CFR 300.425(e),
Deletion from the NPL. The EPA consulted with the State of Florida
prior to developing this document. The EPA determined that both the EPA
and FDEP have conducted all appropriate response actions required and
that no further response action for this portion of the Site is
appropriate. The EPA is publishing a notice in a major local newspaper,
The Florida Times-Union, of its intent to partially delete the Site and
how to submit comments. The EPA placed copies of documents supporting
the proposed partial deletion in the Site information repository; these
documents are available for public inspection and copying.
    The implemented remedy achieved the degree of cleanup and
protection specified in the ROD. The selected remedial action
objectives and associated cleanup levels for the surface soil are
consistent with agency policy and guidance. Based on information
currently available to the EPA, no further Superfund response in the
area proposed for deletion is needed to protect human health and the
environment.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Authority: 33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626,
77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3
CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp.,
p. 193.

    Dated: June 4, 2020.
Mary S. Walker,
Regional Administrator, Region 4.
[FR Doc. 2020-12692 Filed 6-15-20; 8:45 am]
BILLING CODE 6560-50-P


Office of Nonprescription Products

Center for Drug Evaluation and Research ( Food and Drug Administration

Silver Spring ( MD 20993

CONDITION 	Sodium Shale Oil Sulfonate (SSOS)

	PHARMACOLOGICAL CLASS	Anti-dandruff

	MONOGRAPH	OTC Drug Products for the Control of Dandruff, Seborrheic
Dermatitis, and Psoriasis (21 CFR part 358 subpart H)

	APPLICANT	Dow Pharmaceutical Sciences

	1330A Redwood Way

	Petaluma, CA  94954-1169

	SUBMISSION DATE	November 30, 2007

	REVIEW DATE	February 5, 2008

	REVIEWER	Michael Chasey

	TEAM LEADER	Matthew R. Holman, Ph.D.

BACKGROUND

The applicant requests addition of sodium shale oil sulfonate (SSOS) to
the dandruff, seborrheic dermatitis, and psoriasis monograph (21 CFR
part 358 subpart H), in concentrations of:

0.5–2.0% for dandruff leave-on formulations

4.0% for psoriasis leave-on formulations

0.5–2.0% for dandruff rinse-off formulations

2.0% for psoriasis rinse-off formulations

The applicant does not request any other changes (e.g., labeling,
testing) to the dandruff, seborrheic dermatitis, and psoriasis monograph
other than addition of SSOS.

REVIEWER’S COMMENTS

The applicant provides basic information about SSOS, including a
detailed chemical description as required in 21 CFR 330.14(c)(1)(i), as
well as a detailed description of the method of synthesis and
purification.  A monograph for SSOS has been developed, but is not yet
part of any official pharmacopoeia (USP-NF).  The applicant does note
that the monograph is part of the quality documentation that was
approved by the German Federal Institute for Drugs and Medical Devices
(BfArM) in the scope of registration of OTC drugs containing SSOS as an
active ingredient.

The applicant indicates that SSOS is or has been marketed in 34
countries.  Of these countries, SSOS has been marketed for at least five
continuous years in 26 of them.  The applicant has designated Austria,
France, Germany, Italy and Spain as “selected countries,” in
accordance with 21 CFR 330.14(c)(4).  SSOS has been marketed for over 11
years in each of the “selected countries.”

As indicated in 21 CFR 330.14(b)(2), extent of marketing is determined
by the extent to which sales meets the requirements outlined in 21 CFR
330.14(c)(2)(ii), (c)(2)(iii), and (c)(2)(iv).  These paragraphs
collectively address the adequacy of the markets and marketing to reveal
“infrequent but serious ADEs” (adverse drug events) that may occur
in the U.S. population if FDA finds the condition generally recognized
as safe and effective (67 FR 3060 at 3065).  The applicant is only aware
of 5 reported adverse events for SSOS.  They are only minor skin
irritations.  Because they are not serious, they do not prevent the
ingredient from being eligible for the OTC drug monograph system.

As specified in 21 CFR 330.14(c)(2)(ii), the applicant provides the
“cumulative total number of dosage units . . . sold for each dosage
form of the condition.”  In this case, the applicant reports that
approximately 21 million dosage units of products containing SSOS have
been sold worldwide.  The total dosage units sold worldwide was
calculated using the equation in 21 CFR 330.14(c)(2)(ii)(B), where the
largest package size marketed is reported to be 300 g, and the average
concentration of SSOS in all products marketed is reported to be 1.25%.
Although the highest concentration (i.e., 2%) is typically used in the
calculation, the applicant includes data demonstrating that using the
average concentration is more accurate in this case.  The applicant
calculated the number of dosage units sold for 13 products from a
leading German finished drug product manufacturer.  The calculation used
the amount of SSOS sold to the finished drug product manufacturer and
the actual (not estimated) volume and concentration of the products.
Approximately 20 million of these 13 products were sold.  Therefore, it
seems that 21 million is a valid estimate, if not an underestimate, of
the dosage units sold.

The applicant notes that the five “selected countries” market
approximately 85% of all SSOS-containing products.  In addition, the
applicant estimates that rinse-off treatments for dandruff comprise
80-90% of the SSOS marketplace.  Because the rinse-off formulations for
dandruff treatment comprise such a large portion of the marketplace,
there is very little marketing experience with dandruff treatment
leave-on formulations or psoriasis treatment leave-on or rinse-off
formulations.

The applicant notes that in Europe, dandruff products are considered
cosmetics while psoriasis products are considered drugs.  The applicant
describes how cosmetics and drugs are regulated in Europe.  All five of
the applicant’s “selected countries” are members of the European
Union and, as such, are listed in Section 802(b)(1)(A) of the Federal
Food, Drug, and Cosmetic Act (the Act).  Inclusion in this section of
the Act has been interpreted to indicate that the regulatory systems in
these countries are of comparable sophistication to that in the United
States (64 FR 71062 at 71068).

The applicant provides specific demographic information about the
population in each of the five “selected countries.”  This
information complies with 21 CFR 330.14(c)(2)(iii), which requires a
description of population demographics “to ensure that the
condition’s use(s) can be reasonably extrapolated to the U.S.
population.”  The demographics of the 5 selected countries represent a
diverse population of persons that seems to reflect the diversity of the
U.S. population.

The applicant does not specifically provide an explanation of the “use
pattern,” as required by 21 CFR 330.14(c)(2)(iv).  Use pattern is
defined as how often the product is used (according to the label) and
for how long.  The labeling submitted, however, for currently marketed
products overseas is similar to the labeling currently required in the
dandruff, seborrheic dermatitis, and psoriasis monograph (21 CFR part
358 subpart H).   Therefore, it is assumed that the applicant does not
request any change to the monograph specific for SSOS-containing
products.

RECOMMENDATION

I recommend that sodium shale oil sulfonate (SSOS), 0.5–2.0% in
rinse-off formulations for dandruff treatment, be considered eligible
for review as an active ingredient in the OTC dandruff, seborrheic
dermatitis, and psoriasis monograph (21 CFR part 358 subpart H).  To be
considered eligible for review under the TEA process, a product must
meet the criteria of marketing for a material time and to a material
extent as set forth in 21 CFR 330.14(b)(2).  SSOS meets the requirement
for the material time criteria because SSOS-containing products have
been marketed directly to consumers for over five continuous years in 26
countries.  In addition, ecamsule meets the criteria for marketing to a
material extent because it has been marketed in 34 countries with an
estimated 21 million dosage units sold, of which approximately 80-90%
were sold as rinse-off formulations for dandruff treatment.

TEA 	Sodium Shale Oil Sulfonate (SSOS)	  PAGE  4

 PAGE   1

Time and Extent Application (TEA) Review for Sodium Shale Oil Sulfonate
(SSOS)


[Federal Register Volume 87, Number 126 (Friday, July 1, 2022)]
[Notices]
[Pages 39526-39531]
[FR Doc No: 2022-14135]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0008]

Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
that any consumer organizations interested in participating in the
selection of voting and/or nonvoting consumer representatives to serve
on its advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory

committees and/or panels for which vacancies currently exist or are
expected to occur in the near future. Nominees recommended to serve as
a voting or nonvoting consumer representative may be self-nominated or
may be nominated by a consumer organization. FDA seeks to include the
views of individuals on its advisory committee regardless of their
gender identification, religious affiliation, racial and ethnic
identification, or disability status and, therefore, encourages
nominations of appropriately qualified candidates from all groups.

DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by August
15, 2022, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by August 15, 2022. Nominations will be accepted for current
vacancies and for those that will or may occur through December 31,
2023.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be
submitted electronically to [email protected] or by mail to
Advisory Committee Oversight and Management Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002.
    Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002. Additional information about becoming a member
of an FDA advisory committee can also be obtained by visiting FDA's
website at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>, [email protected].
    For questions relating to specific advisory committees or panels,
contact the appropriate contact person listed in table 1.

                  Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
               Contact person                      Committee/panel
------------------------------------------------------------------------
Rakesh Raghuwanshi, Office of the Chief      FDA Science Board Advisory
 Scientist, Food and Drug Administration,     Committee.
 10903 New Hampshire Ave., Bldg. 1, Rm.
 3309, Silver Spring, MD 20993-0002, 301-
 796-4769, [email protected].
Prabhakara Atreya, Center for Biologics      Allergenics Products
 Evaluation and Research, Food and Drug       Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 71, Rm. 1226, Silver Spring, MD
 20993-0002,<PHONE_NUMBER>,
 [email protected].
Moon Hee Choi, Center for Drugs Evaluation   Anesthetic and Analgesic
 and Research, Food and Drug                  Drug Advisory Committee,
 Administration, 10903 New Hampshire Ave.,    Non-Prescription Drugs
 Bldg. 31, Rm. 2434, Silver Spring, MD        Advisory Committee.
 20993-0002,<PHONE_NUMBER>,
 [email protected].
She-Chia Chen, Center for Dugs Evaluation    Antimicrobial Drugs
 and Research, Food and Drug                  Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31 Rm. 2438, Silver Spring, MD 20993-
 0002,<PHONE_NUMBER>, [email protected].
Jessica Seo, Center for Drugs Evaluation     Arthritis Drugs Advisory
 and Research, Food and Drug                  Committee, Peripheral and
 Administration, 10903 New Hampshire Ave.,    Central Nervous System
 Bldg. 31, Rm. 2412, Silver Spring, MD        Drugs Advisory Committee.
 20993-0002,<PHONE_NUMBER>,
 [email protected].
Joyce Yu, Center for Drugs Evaluation        Cardiovascular Drugs
 Research, Food and Drug Administration,      Advisory Committee,
 10903 New Hampshire Ave., Bldg. 31, Rm.      Medical Imaging Drugs
 2438, Silver Spring, MD 20993-0002, 301-     Advisory Committee.
 837-7126, [email protected].
LaToya Bonner, Center for Drugs Evaluation   Endocrinologic and
 and Research, Food and Drug                  Metabolic Drugs Advisory
 Administration, 10903 New Hampshire Ave.,    Committee.
 Bldg. 31, Rm. 2428, Silver Spring, MD
 20993-0002,<PHONE_NUMBER>,
 [email protected].
Takyiah Stevenson, Center for Drugs          Pharmacy Compounding Drugs
 Evaluation Research, Food and Drug           Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31, Rm. 2406, Silver Spring, MD
 20993-0002,<PHONE_NUMBER>,
 [email protected].
Joyce Frimpong, Center for Drugs Evaluation  Psychopharmacologic Drugs
 and Research, Food and Drug                  Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31, Rm. 2462, Silver Spring, MD
 20993-0002,<PHONE_NUMBER>,
 [email protected].
Candace Nalls, Center for Devices and        Anesthesiology and
 Radiological Health, Food and Drug           Respiratory Therapy
 Administration, 10903 New Hampshire Ave.,    Devices Panel, Clinical
 Bldg. 66, Rm. 5211, Silver Spring, MD        Chemistry and Clinical
 20993-0002,<PHONE_NUMBER>,                    Toxicology Devices Panel,
 [email protected].                   Ear, Nose and Throat
                                              Devices Panel,
                                              Gastroenterology and
                                              Urology Devices Panel,
                                              General and Plastic
                                              Surgery Devices Panel.
James Swink, Center for Devices and          Circulatory System Devices
 Radiological Health, Food and Drug           Panel, Immunology Devices
 Administration, 10903 New Hampshire Ave.,    Panel, Microbiology
 Bldg. 66, Rm. 5211, Silver Spring, MD        Devices Panel.
 20993-0002,<PHONE_NUMBER>,
 [email protected].
Akinola Awojope, Center for Devices and      Dental Products Devices
 Radiological Health, Food and Drug           Panel, Obstetrics and
 Administration, 10903 New Hampshire Ave.,    Gynecology Devices Panel,
 Bldg. 66, Rm. 5216, Silver Spring, MD        Orthopaedic and
 20993-0002,<PHONE_NUMBER>,                    Rehabilitation Devices
 [email protected].                 Panel.
Jarrod Collier, Center for Devices and       General Hospital and
 Radiological Health, Food and Drug           Personal Use Devices
 Administration, 10903 New Hampshire Ave.,    Panel, Hematology and
 Bldg. 66, Rm. 5211, Silver Spring, MD        Pathology Devices Panel,
 20993-0002,<PHONE_NUMBER>,                    Molecular and Clinical
 [email protected].                  Genetics Devices Panel,
                                              Ophthalmic Devices Panel,
                                              Radiology Devices Panel.

James Swink, Center for Devices and          National Mammography
 Radiological Health, Food and Drug           Quality Assurance Advisory
 Administration, 10903 New Hampshire Ave.,    Committee.
 Bldg. 66, Rm. 5211, Silver Spring, MD
 20993-0002,<PHONE_NUMBER>,
 [email protected].
------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
table 2:

    Table 2--Committee Descriptions, Type of Consumer Representative
                  Vacancy, and Approximate Date Needed
------------------------------------------------------------------------
     Committee/panel/areas of                           Approximate date
         expertise needed            Type of vacancy         needed
------------------------------------------------------------------------
FDA Science Board Advisory         1--Voting.........  Immediately.
 Committee--The Science Board
 provides advice to the
 Commissioner of Food and Drugs
 Administration (Commissioner)
 and other appropriate officials
 on specific complex scientific
 and technical issues important
 to FDA and its mission,
 including emerging issues within
 the scientific community.
 Additionally, the Science Board
 provides advice that supports
 the Agency in keeping pace with
 technical and scientific
 developments, including in
 regulatory science; and input
 into the Agency's research
 agenda, and on upgrading its
 scientific and research
 facilities and training
 opportunities. It also provides,
 where requested, expert review
 of Agency-sponsored intramural
 and extramural scientific
 research programs.
Allergenics Products Advisory      1--Voting.........  Immediately.
 Committee--Knowledgeable in the
 fields of allergy, immunology,
 pediatrics, internal medicine,
 biochemistry, and related
 specialties.
Anesthetic and Analgesic Drug      1--Voting.........  April 1, 2023.
 Products Advisory Committee--
 Knowledgeable in the fields of
 anesthesiology, surgery,
 epidemiology or statistics, and
 related specialties.
Non-Prescription Drugs Advisory    1--Voting.........  Immediately.
 Committee--Knowledgeable in the
 fields of internal medicine,
 family practice, clinical
 toxicology, clinical
 pharmacology, pharmacy,
 dentistry, and related
 specialties.
Antimicrobial Drugs Advisory       1--Voting.........  May 1, 2023.
 Committee--Knowledgeable in the
 fields of infectious disease,
 internal medicine, microbiology,
 pediatrics, epidemiology or
 statistics, and related
 specialties.
Arthritis Drugs Advisory           1--Voting.........  December 1, 2023.
 Committee--Knowledgeable in the
 fields of arthritis,
 rheumatology, orthopedics,
 epidemiology or statistics,
 analgesics, and related
 specialties.
Peripheral and Central Nervous     1--Voting.........  February 1, 2023.
 Systems Drugs Advisory
 Committee--Knowledgeable in the
 fields of neurology,
 neuropharmacology,
 neuropathology, otolaryngology,
 epidemiology or statistics, and
 related specialties.
Cardiovascular Drugs Advisory      1--Voting.........  July 1, 2023.
 Committee--Knowledgeable in the
 fields of cardiology,
 hypertension, arrhythmia,
 angina, congestive heart
 failure, diuresis, and
 biostatistics.
Medical Imaging Drugs Advisory     1--Voting.........  Immediately.
 Committee--Knowledgeable in the
 fields of nuclear medicine,
 radiology, epidemiology,
 statistics, and related
 specialties.
Endocrinologic and Metabolic       1--Voting.........  July 1, 2022.
 Drugs Advisory Committee--
 Knowledgeable in the fields of
 endocrinology, metabolism,
 epidemiology or statistics, and
 related specialties.
Pharmacy Compounding Drugs         1--Voting.........  October 1, 2023.
 Advisory Committee--
 Knowledgeable in the fields of
 pharmaceutical compounding,
 pharmaceutical manufacturing,
 pharmacy, medicine, and other
 related specialties.
Psychopharmacologic Drugs          1--Voting.........  July 1, 2022.
 Advisory Committee--
 Knowledgeable in the fields of
 psychopharmacology, psychiatry,
 epidemiology or statistics, and
 related specialties.
Anesthesiology and Respiratory     1--Nonvoting......  Immediately.
 Therapy Devices Panel--
 Anesthesiologists, pulmonary
 medicine specialists, or other
 experts who have specialized
 interests in ventilator support,
 pharmacology, physiology, or the
 effects and complications of
 anesthesia.
Clinical Chemistry and Clinical    1--Nonvoting......  Immediately.
 Toxicology Devices Panel--Doctor
 of Medicine or Philosophy with
 experience in clinical chemistry
 (e.g., cardiac markers),
 clinical toxicology, clinical
 pathology, clinical laboratory
 medicine, and endocrinology.
Ear, Nose and Throat Devices       1--Nonvoting......  November 1, 2023.
 Panel--Otologists,
 neurotologists, audiologists.
Gastroenterology and Urology       1--Nonvoting......  Immediately.
 Devices Panel--
 Gastroenterologists, urologists,
 and nephrologists.
General and Plastic Surgery        1--Nonvoting......  Immediately.
 Devices Panel--Surgeons
 (general, plastic,
 reconstructive, pediatric,
 thoracic, abdominal, pelvic and
 endoscopic); dermatologists;
 experts in biomaterials, lasers,
 wound healing, and quality of
 life; and biostatisticians.
Circulatory System Devices Panel-- 1--Nonvoting......  Immediately.
 Interventional cardiologists,
 electrophysiologists, invasive
 (vascular) radiologists,
 vascular and cardiothoracic
 surgeons, and cardiologists with
 special interest in congestive
 heart failure.

Immunology Devices Panel--Persons  1--Nonvoting......  Immediately.
 with experience in medical,
 surgical, or clinical oncology,
 internal medicine, clinical
 immunology, allergy, molecular
 diagnostics, or clinical
 laboratory medicine.
Microbiology Devices Panel--       1--Nonvoting......  Immediately.
 Clinicians with an expertise in
 infectious disease, e.g.,
 pulmonary disease specialists,
 sexually transmitted disease
 specialists, pediatric
 infectious disease specialists,
 experts in tropical medicine and
 emerging infectious diseases,
 mycologists; clinical
 microbiologists and virologists;
 clinical virology and
 microbiology laboratory
 directors, with expertise in
 clinical diagnosis and in vitro
 diagnostic assays, e.g.,
 hepatologists; molecular
 biologists.
Dental Products Devices Panel--    1--Nonvoting......  Immediately.
 Dentists, engineers and
 scientists who have expertise in
 the areas of dental implants,
 dental materials,
 periodontology, tissue
 engineering, and dental anatomy.
Obstetrics and Gynecology Devices  1--Nonvoting......  Immediately.
 Panel--Experts in perinatology,
 embryology, reproductive
 endocrinology, pediatric
 gynecology, gynecological
 oncology, operative
 hysteroscopy, pelviscopy,
 electrosurgery, laser surgery,
 assisted reproductive
 technologies, contraception,
 postoperative adhesions, and
 cervical cancer and colposcopy;
 biostatisticians and engineers
 with experience in obstetrics/
 gynecology devices;
 urogynecologists; experts in
 breast care; experts in
 gynecology in the older patient;
 experts in diagnostic (optical)
 spectroscopy; experts in
 midwifery; labor and delivery
 nursing.
Orthopaedic and Rehabilitation     1--Nonvoting......  Immediately.
 Devices Panel--Orthopedic
 surgeons (joint spine, trauma,
 and pediatric); rheumatologists;
 engineers (biomedical,
 biomaterials, and
 biomechanical); experts in
 rehabilitation medicine, sports
 medicine, and connective tissue
 engineering; and
 biostatisticians.
General Hospital and Personal Use  1--Nonvoting......  Immediately.
 Devices Panel--Internists,
 pediatricians, neonatologists,
 endocrinologists,
 gerontologists, nurses,
 biomedical engineers, or
 microbiologists/infection
 control practitioners or experts.
Hematology and Pathology Devices   1--Nonvoting......  Immediately.
 Panel--Hematologists (benign and/
 or malignant hematology),
 hematopathologists (general and
 special hematology, coagulation
 and hemostasis, and
 hematological oncology),
 gynecologists with special
 interests in gynecological
 oncology, cytopathologists, and
 molecular pathologists with
 special interests in development
 of predictive biomarkers.
Molecular and Clinical Genetics    1--Nonvoting......  Immediately.
 Devices Panel--Experts in human
 genetics and in the clinical
 management of patients with
 genetic disorders, e.g.,
 pediatricians, obstetricians,
 neonatologists. The Agency is
 also interested in considering
 candidates with training in
 inborn errors of metabolism,
 biochemical and/or molecular
 genetics, population genetics,
 epidemiology, and related
 statistical training.
 Additionally, individuals with
 experience in genetic
 counseling, medical ethics, as
 well as ancillary fields of
 study will be considered.
Ophthalmic Devices Panel--         1--Nonvoting......  Immediately.
 Ophthalmologists with expertise
 in corneal-external disease,
 vitreo-retinal surgery,
 glaucoma, ocular immunology,
 ocular pathology; optometrists;
 vision scientists; and
 ophthalmic professionals with
 expertise in clinical trial
 design, quality of life
 assessment, electrophysiology,
 low vision rehabilitation, and
 biostatistics.
Radiological Devices Panel--       1--Nonvoting......  Immediately.
 Physicians with experience in
 general radiology, mammography,
 ultrasound, magnetic resonance,
 computed tomography, other
 radiological subspecialties, and
 radiation oncology; scientists
 with experience in diagnostic
 devices, radiation physics,
 statistical analysis, digital
 imaging, and image analysis.
National Mammography Quality       3--Voting.........  Immediately.
 Assurance Advisory Committee--
 Physician, practitioner, or
 other health professional whose
 clinical practice, research
 specialization, or professional
 expertise includes a significant
 focus on mammography.
------------------------------------------------------------------------

I. Functions and General Description of the Committee Duties

A. FDA Science Board Advisory Committee

    The Science Board Advisory Committee (Science Board) provides
advice to the Commissioner of Food and Drugs (Commissioner) and other
appropriate officials on specific complex scientific and technical
issues important to FDA and its mission, including emerging issues
within the scientific community. Additionally, the Science Board
provides advice that supports the Agency in keeping pace with technical
and scientific developments, including in regulatory science, and input
into the Agency's research agenda and on upgrading its scientific and
research facilities and training opportunities. It also provides, where
requested, expert review of Agency-sponsored intramural and extramural
scientific research programs.

B. Allergenics Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety,
effectiveness, and adequacy of labeling of marketed and investigational
allergenic biological products or materials that are administered to
humans for the diagnosis, prevention, or treatment of allergies and
allergic disease, as well as the affirmation or revocation of
biological product licenses, on the safety, effectiveness, and labeling
of the

products, on clinical and laboratory studies of such products, on
amendments or revisions to regulations governing the manufacture,
testing and licensing of allergenic biological products, and on the
quality and relevance of FDA's research programs.

C. Anesthetic and Analgesic Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in anesthesiology and surgery.

D. Nonprescription Drugs Advisory Committee

    Review and evaluate available data concerning the safety and
effectiveness of over-the-counter (nonprescription) human drug
products, or any other FDA-regulated product, for use in the treatment
of a broad spectrum of human symptoms and diseases and advise the
Commissioner either on the promulgation of monographs establishing
conditions under which these drugs are generally recognized as safe and
effective and not misbranded or on the approval of new drug
applications for such drugs. The Committee will serve as a forum for
the exchange of views regarding the prescription and nonprescription
status, including switches from one status to another, of these various
drug products and combinations thereof. The Committee may also conduct
peer review of Agency-sponsored intramural and extramural scientific
biomedical programs in support of FDA's mission and regulatory
responsibilities.

E. Antimicrobial Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of infectious diseases and disorders.

F. Arthritis Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of arthritis, rheumatism, and related diseases.

G. Peripheral and Central Nervous System Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of neurologic diseases.

H. Cardiovascular Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of cardiovascular and renal disorders.

I. Medical Imaging Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in
diagnostic and therapeutic procedures using radioactive pharmaceuticals
and contrast media used in diagnostic radiology.

J. Endocrinologic and Metabolic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of endocrine and metabolic disorders.

K. Pharmacy Compounding

    Provides advice on scientific, technical, and medical issues
concerning drug compounding by pharmacists and licensed practitioners.

L. Psychopharmacologic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
practice of psychiatry and related fields.

M. Medical Devices Panels

    The Medical Devices Advisory Committee has established certain
panels to review and evaluate data on the safety and effectiveness of
marketed and investigational devices and make recommendations for their
regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area: (1)
advises on the classification or reclassification of devices into one
of three regulatory categories and advises on any possible risks to
health associated with the use of devices; (2) advises on formulation
of product development protocols; (3) reviews premarket approval
applications for medical devices; (4) reviews guidelines and guidance
documents; (5) recommends exemption of certain devices from the
application of portions of the Federal Food, Drug, and Cosmetic Act;
(6) advises on the necessity to ban a device; and (7) responds to
requests from the Agency to review and make recommendations on specific
issues or problems concerning the safety and effectiveness of devices.
Except for the Medical Devices Dispute Resolution Panel, each panel,
according to its specialty area, may also make appropriate
recommendations to the Commissioner on issues relating to the design of
clinical studies regarding the safety and effectiveness of marketed and
investigational devices.
    The Dental Products Devices Panel also functions at times as a
dental drug panel. The functions of the dental drug panel are to
evaluate and recommend whether various prescription drug products
should be changed to over-the-counter status and to evaluate data and
make recommendations concerning the approval of new dental drug
products for human use.
    The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The Panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.

N. National Mammography Quality Assurance Advisory Committee

    Advise the Agency on the following: development of appropriate
quality standards and regulations for mammography facilities; standards
and regulations for bodies accrediting mammography facilities under
this program; regulations with respect to sanctions; procedures for
monitoring compliance with standards; establishing a mechanism to
investigate consumer complaints; and reporting new developments
concerning breast imaging that should be considered in the oversight of
mammography facilities. The Committee also advises on determining
whether there exists a shortage of mammography facilities in rural and
health professional shortage areas and determining the effects of
personnel on access to the services of such facilities in such areas;
determining whether there will exist enough medical physicists after
October 1, 1999; and determining the costs and benefits of compliance
with these requirements.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
demonstrate an

affiliation with and/or active participation in consumer or community-
based organizations, (2) be able to analyze technical data, (3)
understand research design, (4) discuss benefits and risks, and (5)
evaluate the safety and efficacy of products under review. The consumer
representative should be able to represent the consumer perspective on
issues and actions before the advisory committee; serve as a liaison
between the committee and interested consumers, associations,
coalitions, and consumer organizations; and facilitate dialogue with
the advisory committees on scientific issues that affect consumers.

III. Selection Procedures

    Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
    Within the subsequent 45 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA
within 30 days. The nominee receiving the highest number of votes
ordinarily will be selected to serve as the member representing
consumer interests for that particular advisory committee or panel.

IV. Nomination Procedures

    Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations must include a current, complete r[eacute]sum[eacute] or
curriculum vitae for each nominee and a signed copy of the
Acknowledgement and Consent form available at the FDA Advisory
Nomination Portal (see ADDRESSES section of this document), and a list
of consumer or community-based organizations for which the candidate
can demonstrate active participation.
    Nominations must also specify the advisory committee(s) or panel(s)
for which the nominee is recommended. In addition, nominations must
also acknowledge that the nominee is aware of the nomination unless
self-nominated. FDA will ask potential candidates to provide detailed
information concerning such matters as financial holdings, employment,
and research grants and/or contracts to permit evaluation of possible
sources of conflicts of interest. Members will be invited to serve for
terms of up to 4 years.
    FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
After selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: June 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14135 Filed 6-30-22; 8:45 am]
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