[Federal Register: February 1, 2010 (Volume 75, Number 20)]
[Notices]
[Page 5069]
[DOCID:fr01fe10-42]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2157-190]

Public Utility District No. 1 of Snohomish County, WA; City of
Everett, WA; Notice of Application To Amend Recreation Plan and
Soliciting Comments, Motions To Intervene, and Protests

January 22, 2010.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Amendment of License.
    b. Project No: 2157-190.
    c. Date Filed: December 7, 2009.
    d. Applicant: Public Utility District No. 1 of Snohomish County,
Washington and City of Everett, Washington.
    e. Name of Project: Henry M. Jackson Hydroelectric Project.
    f. Location: The project is located on Sulton River, in Snohomish
County, Washington. This project occupies approximately 1,939 acres of
Federal lands administered by the U.S. Forest Service.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Anne Spangler, Public Utility District No. 1
of Snohomish County, Washington, 2320 California Street, P.O. Box 1107,
Everett, WA 98206,<PHONE_NUMBER>.
    i. FERC Contact: Any questions on this notice should be addressed
to Jade Alvey at<PHONE_NUMBER>, or by e-mail<EMAIL_ADDRESS>    j. Deadline for filing comments and/or motions: February 22, 2010.
    All documents (original and eight copies) should be filed with: The
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Please include the project number (P-2157-190) on
any comments or motions filed.
    The Commission's Rules of Practice require all interveners 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
intervener 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. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    k. Description of Proposal: Public Utility District No. 1 of
Snohomish County, Washington (PUD), with the support from the City of
Everett, Washington, filed an application to amend the recreation plan
(plan) for the Henry M. Jackson Hydroelectric Project. The amendment
request pertains to changes and improvements to the Nighthawk and Bear
Creek recreation sites at the project, currently being contemplated as
part of the relicensing process. Due to the scheduled 2011 closure of
3.1 miles of South Shore Road by the Washington Department of Natural
Resources, PUD is requesting an amendment to the plan in order to
complete construction work at these sites prior to the closure.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3372 or e-mail
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.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 comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Any filings must bear in all capital letters the title
``COMMENTS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as applicable,
and the Project Number of the particular application to which the
filing refers.
    p. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov
under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-1986 Filed 1-29-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)]
[Notices]
[Pages 5259-5260]
[FR Doc No: 2018-02330]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9974-01-Region 2]

Proposed CERCLA Cost Recovery Settlement for the Frankfort
Asbestos Superfund Site, Village of Frankfort, Herkimer County, New
York

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for public comment.

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

SUMMARY: In accordance with the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980, as amended (``CERCLA''),
notice is hereby given by the U.S. Environmental Protection Agency
(``EPA''), Region 2, of a proposed cost recovery settlement agreement
pursuant to CERCLA, with City Recycling, Inc. (``Settling Party'') for
the Frankfort Asbestos Superfund Site (``Site''), located in the
Village of Frankfort, Herkimer County, New York.

DATES: Comments must be submitted on or before March 8, 2018.

ADDRESSES: The proposed settlement is available for public inspection
at EPA Region 2 offices at 290 Broadway, New York, New York 10007-1866.
Comments should reference the Frankfort Asbestos Superfund Site,
Frankfort, Herkimer County, New York, Index No. CERCLA-02-2018-2008. To
request a copy of the proposed settlement agreement, please contact the
EPA employee identified below.

FOR FURTHER INFORMATION CONTACT: Jocelyn Scott, Attorney, Office of
Regional Counsel, New York/Caribbean Superfund Branch, U.S.
Environmental Protection Agency, 290 Broadway, 17th Floor, New York, NY
10007-1866. email: [email protected]. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Settling Party agrees to pay EPA
$100,000.00 in reimbursement of EPA's past response costs paid at or in
connection with the Site, plus an additional sum for interest from the
date of execution by EPA through the date of payment.
    The settlement includes a covenant by EPA not to sue or to take
administrative

action against the Settling Party pursuant to Section 107(a) of CERCLA,
42 U.S.C. 9607(a), with regard to the response costs related to the
work at the Site enumerated in the settlement agreement. For thirty
(30) days following the date of publication of this notice, EPA will
receive written comments relating to the settlement. EPA will consider
all comments received and may modify or withdraw its consent to the
settlement if comments received disclose facts or considerations that
indicate that the proposed settlement is inappropriate, improper, or
inadequate. EPA's response to any comments received will be available
for public inspection at EPA Region 2, 290 Broadway, New York, New York
10007-1866.

    Date: January 18, 2018.
Walter Mugdan,
Director, Emergency and Remedial Response Division, U.S. Environmental
Protection Agency, Region 2.
[FR Doc. 2018-02330 Filed 2-5-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71643-71646]
[FR Doc No: 2021-27376]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3926]

Request for Nominations for Voting Members on Public Advisory
Panels of the Medical Devices Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Medical Devices Advisory
Committee (MDAC) device panels in the Center for Devices and
Radiological Health. This annual notice is also in accordance with the
21st Century Cures Act, which requires the Secretary of Health and
Human Services (the Secretary) to provide an annual opportunity for
patients, representatives of patients, and sponsors of medical devices
that may be specifically the subject of a review by a classification
panel to provide recommendations for individuals with appropriate
expertise to fill voting member positions on classification panels. FDA
seeks to include the views of women and men, members of all racial and
ethnic groups, and individuals with and without disabilities on its
advisory committees, and therefore, encourages nominations of
appropriately qualified candidates from these groups.

DATES: Nominations received on or before February 15, 2022, will be
given first consideration for membership on the Panels of the MDAC.
Nominations received after February 15, 2022, will be considered for
nomination to the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be submitted
electronically by logging into the FDA Advisory Nomination Portal at
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member on 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: Regarding all nomination questions for
membership, contact the following persons listed in table 1:

             Table 1--Primary Contact and Committee or Panel
------------------------------------------------------------------------
         Primary contact person                 Committee or panel
------------------------------------------------------------------------
Joannie Adams-White, Office of the       Medical Devices Dispute
 Center Director, Center for Devices      Resolution Panel.
 and Radiological Health, Food and Drug
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5561, Silver
 Spring, MD 20993,<PHONE_NUMBER>,
 [email protected].
James P. Swink, Office of Management,    Circulatory System Devices
 Center for Devices and Radiological      Panel, Immunology Devices
 Health, Food and Drug Administration,    Panel, Microbiology Devices
 10903 New Hampshire Ave., Bldg. 66 Rm.   Panel,Ophthalmic Devices
 5211, Silver Spring, MD 20993, 301-796-  Panel.
 6313, [email protected].
Akinola Awojope, Office of Management,   Dental Products Panel,
 Center for Devices and Radiological      Neurological Devices Panel,
 Health, Food and Drug                    Obstetrics and Gynecology
 Administration,10903 New Hampshire       Devices Panel Orthopaedic and
 Ave., Bldg. 66, Rm. 5216, Silver         Rehabilitation Devices Panel.
 Spring, MD 20993,<PHONE_NUMBER>,
 [email protected].
Jarrod Collier, Office of Management,    Ear, Nose and Throat Devices
 Center for Devices and Radiological      Panel, General Hospital and
 Health, Food and Drug                    Personal Use Devices Panel,
 Administration,10903 New Hampshire       Hematology and Pathology
 Ave., Bldg. 66, Rm. 5216, Silver         Devices Panel, Molecular and
 Spring, MD 20993,<PHONE_NUMBER>,          Clinical Genetics Panel,
 [email protected].              Radiological Devices Panel.
Candace Nalls, Office of Management,     Anesthesiology and Respiratory
 Center for Devices and Radiological      Therapy Devices Panel,
 Health, Food and Drug                    Clinical Chemistry and
 Administration,10903 New Hampshire       Clinical Toxicology Devices
 Ave., Bldg. 66, Rm. 5214, Silver         Panel, General and Plastic
 Spring, MD 20993,<PHONE_NUMBER>,          Surgery Devices Panel.
 [email protected].
------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for vacancies listed in table 2:

                       Table 2-- Expertise Needed, Vacancies, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
                Expertise needed                    Vacancies                Approximate date needed
----------------------------------------------------------------------------------------------------------------
Anesthesiology and Respiratory Therapy Devices                3  Immediately.
 Panel of the Medical Devices Advisory
 Committee--Anesthesiologists, pulmonary
 medicine specialists, or other experts who
 have specialized interests in ventilator
 support, sleep medicine, pharmacology,
 physiology, or the effects and complications
 of anesthesia. FDA is also seeking applicants
 with pediatric expertise in these areas.
Circulatory System Devices Panel of the Medical               1  Immediately.
 Devices Advisory Committee--Interventional                   1  July 1, 2022.
 cardiologists, electrophysiologists, invasive
 (vascular) radiologists, vascular and
 cardiothoracic surgeons, and cardiologists
 with special interest in congestive heart
 failure.
Clinical Chemistry and Clinical Toxicology                    1  March 1, 2022.
 Panel of the Medical Devices Advisory
 Committee--Doctors of medicine or philosophy
 with experience in clinical chemistry (e.g.,
 cardiac markers), clinical toxicology,
 clinical pathology, clinical laboratory
 medicine, and endocrinology.
Dental Products Panel of the Medical Devices                  3  Immediately.
 Advisory Committee--Dentists, engineers, and
 scientists who have expertise in the areas of
 dental implants, dental materials, oral and
 maxillofacial surgery, endodontics,
 periodontology, tissue engineering, snoring/
 sleep therapy, and dental anatomy.
Ear, Nose, and Throat Devices Panel of the                    4  Immediately.
 Medical Devices Advisory Committee--
 Otologists, neurotologists, and audiologists.
General and Plastic Surgery Devices Panel of                  4  Immediately.
 the Medical Devices Advisory Committee--
 Surgeons (general, plastic, reconstructive,
 pediatric, thoracic, abdominal, pelvic, and
 endoscopic); dermatologists; experts in
 biomaterials, lasers, wound healing, and
 quality of life; and biostatisticians.
General Hospital and Personal Use Devices Panel               2  Immediately.
 of the Medical Devices Advisory Committee--                  1  January 1, 2022.
 Internists, pediatricians, neonatologists,
 endocrinologists, gerontologists, nurses,
 biomedical engineers, human factors experts,
 or microbiologists/infection control
 practitioners or experts.
Hematology and Pathology Devices Panel of the                 3  Immediately.
 Medical Devices Advisory Committee--                         1  March 1, 2022.
 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 and prognostic
 biomarkers, molecular oncology, cancer
 screening, cancer risk, digital pathology,
 whole slide imaging; devices utilizing
 artificial intelligence/machine learning.
Immunology Devices Panel of the Medical Devices               7  Immediately.
 Advisory Committee--Persons with experience in
 medical, surgical, or clinical oncology,
 internal medicine, clinical immunology,
 allergy, molecular diagnostics, or clinical
 laboratory medicine.
Medical Devices Dispute Resolution Panel of the               1  October 1, 2022.
 Medical Devices Advisory Committee--Experts
 with cross-cutting scientific, clinical,
 analytical or mediation skills.

Microbiology Devices Panel of the Medical                     5  Immediately.
 Devices Advisory Committee--Infectious disease               2  March 1, 2022.
 clinicians (e.g., pulmonary disease
 specialists, sexually transmitted disease
 specialists, pediatric ID specialists,
 tropical diseases specialists) and clinical
 microbiologists experienced in emerging
 infectious diseases; clinical microbiology
 laboratory directors; molecular biologists
 with experience in in vitro diagnostic device
 testing; virologists; hepatologists; or
 clinical oncologists experienced with tumor
 resistance and susceptibility.
Molecular and Clinical Genetics Panel of the                  2  Immediately.
 Medical Devices Advisory Committee--Experts in               2  June 1, 2022.
 human genetics, molecular diagnostics, and in
 the clinical management of patients with
 genetic disorders, and (e.g., pediatricians,
 obstetricians, neonatologists). Individuals
 with training in inborn errors of metabolism,
 biochemical and/or molecular genetics,
 population genetics, epidemiology and related
 statistical training, bioinformatics,
 computational genetics/genomics, variant
 classification, cancer genetics/genomics,
 molecular oncology, radiation biology, and
 clinical molecular genetics testing, (e.g.,
 sequencing, whole exome sequencing, whole
 genome sequencing, non-invasive prenatal
 testing, cancer screening, circulating cell
 free/circulating tumor nucleic acid testing,
 digital PCR, genotyping, array CGH, etc.).
 Individuals with experience in genetics
 counseling, medical ethics are also desired,
 and individuals with experience in ancillary
 fields of study will be considered.
Neurological Devices Panel of the Medical                     2  Immediately.
 Devices Advisory Committee--Neurosurgeons
 (cerebrovascular and pediatric), neurologists
 (stroke, pediatric, pain management, and
 movement disorders), interventional
 neuroradiologists, psychiatrists, and
 biostatisticians.
Obstetrics and Gynecology Devices Panel of the                4  Immediately.
 Medical Devices Advisory Committee--Experts in               1  February 1, 2022.
 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.
Ophthalmic Devices Panel of the Medical Devices               4  Immediately.
 Advisory Committee--Ophthalmologists
 specializing in cataract and refractive
 surgery and vitreo-retinal surgery, in
 addition to vision scientists, optometrists,
 and biostatisticians practiced in ophthalmic
 clinical trials.
Orthopaedic and Rehabilitation Devices Panel of               2  Immediately.
 the Medical Devices Advisory Committee--                     2  September 1, 2022.
 Orthopaedic surgeons (joint, spine, trauma,
 reconstruction, sports medicine, hand, foot
 and ankle, and pediatric orthopaedic
 surgeons); rheumatologists; engineers
 (biomedical, biomaterials, and biomechanical);
 experts in rehabilitation medicine, and
 musculoskeletal engineering; radiologists
 specializing musculoskeletal imaging and
 analyses and biostatisticians.
Radiological Devices Panel of the Medical                     3  Immediately.
 Devices Advisory Committee--Physicians with                  4  February 1, 2022.
 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.
----------------------------------------------------------------------------------------------------------------

I. General Description of the Committee Duties

    The MDAC reviews and evaluates data on the safety and effectiveness
of marketed and investigational devices and makes recommendations for
their regulation. The panels engage in many activities to fulfill the
functions the Federal Food, Drug, and Cosmetic Act (FD&C Act) envisions
for device advisory panels. With the exception of the Medical Devices
Dispute Resolution Panel, each panel, according to its specialty area,
performs the following duties: (1) Advises the Commissioner regarding
recommended classification or reclassification of devices into one of
three regulatory categories, (2) advises on any possible risks to
health associated with the use of devices, (3) advises on formulation
of product development protocols, (4) reviews premarket approval
applications for medical devices, (5) reviews guidelines and guidance
documents, (6) recommends exemption of certain devices from the
application of portions of the FD&C Act, (7) advises on the necessity
to ban a device, and (8) responds to requests from the Agency to review
and make recommendations on specific issues or problems concerning the
safety and effectiveness of devices. With the exception of 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 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.

II. Criteria for Voting Members

    The MDAC with its 18 panels shall consist of a maximum of 159
standing members. Members are selected by the Commissioner or designee
from among authorities in clinical and administrative medicine,
engineering, biological and physical sciences, and other related
professions. Almost all non-Federal members of this committee serve as
Special Government Employees. A maximum of 122 members shall be
standing voting

members and 37 shall be nonvoting members who serve as representatives
of consumer interests and of industry interests. FDA is publishing
separate documents announcing the Request for Nominations Notification
for Nonvoting Representatives on certain panels of the MDAC. Persons
nominated for membership on the panels should have adequately
diversified experience appropriate to the work of the panel in such
fields as clinical and administrative medicine, engineering, biological
and physical sciences, statistics, and other related professions. The
nature of specialized training and experience necessary to qualify the
nominee as an expert suitable for appointment may include experience in
medical practice, teaching, and/or research relevant to the field of
activity of the panel. The current needs for each panel are listed in
table 2. Members will be invited to serve for terms of up to 4 years.

III. Nomination Procedures

    Any interested person may nominate one or more qualified
individuals for membership on one or more of the advisory panels. Self-
nominations are also accepted. Nominations must include a current,
complete r[eacute]sum[eacute] or curriculum vitae for each nominee,
including current business address, telephone number, and email address
if available and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Nomination Portal (see ADDRESSES).
Nominations must also specify the advisory panel(s) for which the
nominee is recommended. 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 related to financial holdings, employment, and research grants
and/or contracts to permit evaluation of possible sources of conflict
of interest.
    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: December 13, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27376 Filed 12-16-21; 8:45 am]
BILLING CODE 4164-01-P