[Federal Register: December 4, 2009 (Volume 74, Number 232)]
[Rules and Regulations]
[Page 63563-63565]
[DOCID:fr04de09-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1130; Directorate Identifier 2009-SW-40-AD;
Amendment 39-16130; AD 2009-25-10]
RIN 2120-AA64

Airworthiness Directives; Sikorsky Aircraft Corporation
(Sikorsky) Model S-92A Helicopters

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; request for comments.

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SUMMARY: This amendment adopts a new airworthiness directive (AD) for
the Sikorsky Model S-92A helicopters. This action requires a one-time
visual inspection of the main gearbox (MGB) lube system filter assembly
for oil filter damage. This action also requires if either the primary
or secondary oil filter is damaged, replacing both filters, all
packings, and the studs before further flight. This AD also requires
replacing the oil filter bowl within 30 days after replacing a damaged
filter and a daily leak inspection for an oil leak (no oil leaks
allowed) during that 30-day interim period. This amendment is prompted
by three reports of damaged oil filters or packings resulting from
installing the filter assembly with an oversized packing possibly
because of incorrect part numbers in the maintenance manual. Based on a
previous accident investigation, failure of the oil filter bowl or
mounting studs can result in sudden and complete loss of oil from the
MGB. The actions specified in this AD are intended to prevent complete
loss of oil from the MGB, failure of the MGB, and subsequent loss of
control of the helicopter.

DATES: Effective December 21, 2009.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of December 21, 2009.
    Comments for inclusion in the Rules Docket must be received on or
before February 2, 2010.

ADDRESSES: Use one of the following addresses to submit comments on
this AD:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-

30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue,
SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    You may get the service information identified in this AD from
Sikorsky Aircraft Corporation, Attn: Manager, Commercial Technical
Support, mailstop s581a, 6900 Main Street, Stratford, CT, telephone
(203) 383-4866, e-mail address<EMAIL_ADDRESS>or at http://
www.sikorsky.com.
    Examining the Docket: You may examine the docket that contains the
AD, any comments, and other information on the Internet at http://
www.regulations.gov, or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The Docket Operations office (telephone<PHONE_NUMBER>) is
located in Room W12-140 on the ground floor of the West Building at the
street address stated in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kirk Gustafson, Aviation Safety
Engineer, Boston Aircraft Certification Office, Engine and Propeller
Directorate, FAA, 12 New England Executive Park, Burlington, MA 01803,
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This amendment adopts a new AD for the
Sikorsky Model S-92A helicopters. This action requires a one-time
visual inspection of the MGB lube system filter assembly for oil filter
damage. This action also requires if either the primary or secondary
oil filter is damaged, replacing both filters, all packings, and the
studs before further flight. This action also requires replacing the
oil filter bowl within 30 days after replacing a damaged filter and a
daily inspection for an oil leak (no oil leaks allowed) during that 30-
day interim period. This amendment is prompted by three reports of
damaged oil filters or packings resulting from operating with an
oversized packing possibly because of incorrect part numbers in the
maintenance manual. Sikorsky has issued a temporary revision, T-Rev 63-
19, to the maintenance manual to correct any errors. Installing the
filter assembly with an oversized packing (also known as an O-ring) in
the oil filter double bypass valve can produce excessive assembly and
fatigue loads in the oil filter bowl or the mounting studs that secure
the oil filter bowl to the MGB. Based on rig testing, these conditions
can result in reduced fatigue life in the studs and the oil filter
bowl. Based on information from a previous accident investigation,
failure of the oil filter bowl or mounting studs can result in sudden
and complete loss of oil from the MGB. This condition, if not
corrected, could result in complete loss of oil from the MGB, failure
of the MGB, and subsequent loss of control of the helicopter.
    We have reviewed Sikorsky Alert Service Bulletin (ASB) No. 92-63-
018, dated July 1, 2009, and No. 92-63-019, dated July 14, 2009. ASB
No. 92-63-018 specifies a one-time visual inspection for a damaged oil
filter element. ASB No. 92-63-019 specifies replacing the MGB filter
bowl on those helicopters that have previously been found to have a
damaged MGB oil filter. ASB No. 92-63-019 also requires a daily visual
inspection of the MGB lube system filter assembly for oil leaks (no
leaks allowed) until the oil filter bowl is replaced.
    This unsafe condition is likely to exist or develop on other
helicopters of the same type design. Therefore, this AD is being issued
to prevent complete loss of oil from the MGB, failure of the MGB, and
subsequent loss of control of the helicopter. This AD requires visually
inspecting the oil filter for damage and replacing any filter,
packings, and mounting studs before further flight if the filter is
damaged. The AD also requires replacing the oil filter bowl within 30
days after a damaged filter has been replaced. Do the actions by
following specified portions of the service bulletin described
previously.
    The short compliance time involved is required because the
previously described critical unsafe condition can adversely affect the
controllability or structural integrity of the helicopter. Therefore, a
one-time visual inspection of the oil filter within 7 days is required.
If the visual inspection finds a damaged filter, replacing the damaged
filter, packings, and filter bowl mounting studs before further flight
are also required. Also, a one-time replacement of the oil filter bowl
is required within 30 days after replacing a damaged oil filter. All of
these are very short compliance times. Therefore, this AD must be
issued immediately.
    Since a situation exists that requires the immediate adoption of
this regulation, it is found that notice and opportunity for prior
public comment hereon are impracticable, and that good cause exists for
making this amendment effective in less than 30 days.
    We estimate that this AD will affect 44 helicopters. Assuming a
one-time inspection shows no damage to 39 of the helicopters, it will
take about 1.5 work hours to remove, inspect, and reinstall each oil
filter assembly and packing for 39 helicopters. Assuming oil filter
damage is discovered in 5 helicopters, the additional required actions
will take about:
     1.5 work hours to remove, inspect, and reinstall each
filter assembly and packing, and
     3 work hours to replace the mounting studs.

Assuming the bowl replacement is deferred on all 5 helicopters for 30
days, it will take about:

     15 work hours for 30 daily (.5 work hour each) inspections
for leakage, and
     1 work hour to replace the oil filter bowl.

The average labor rate is $80 per work hour. Required parts will cost
about $817 for the oil filter assembly, $81 for the filter bowl
mounting studs, and $4,568 for the filter bowl per helicopter. Based on
these figures, we estimate the total cost impact of the AD on U.S.
operators to be $40,210.

Comments Invited

    This AD is a final rule that involves requirements that affect
flight safety and was not preceded by notice and an opportunity for
public comment; however, we invite you to submit any written data,
views, or arguments regarding this AD. Send your comments to an address
listed under ADDRESSES. Include ``Docket No. FAA-2009-1130; Directorate
Identifier 2009-SW-40-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of the AD. We will consider all
comments received by the closing date and may amend the AD in light of
those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD. Using the search function of our
docket Web site, you can find and read the comments to any of our
dockets, including the name of the individual who sent the comment. You
may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477-78).

Regulatory Findings

    We have determined that this AD will not have federalism
implications under

Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
Government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD. See the AD docket to examine the economic evaluation.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration amends part 39 of
the Federal Aviation Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. Section 39.13 is amended by adding a new airworthiness directive to
read as follows:

2009-25-10 Sikorsky Aircraft Corp.: Amendment 39-16130. Docket No.
FAA-2009-1130; Directorate Identifier 2009-SW-40-AD.

    Applicability: Model S-92A helicopters, serial numbers 920006
through 920109, certificated in any category.
    Compliance: Required as indicated, unless done previously.
    To prevent complete loss of oil from the main gearbox (MGB),
failure of the MGB, and subsequent loss of control of the
helicopter, do the following:
    (a) Within 7 days, inspect the MGB lube system filter assembly
for damage to the primary and secondary oil filters by following the
Accomplishment Instructions, paragraphs 3.A.(4) and through 3.A.(6)
of Sikorsky Alert Service Bulletin (ASB) No. 92-63-018, dated July
1, 2009 (ASB No. 92-63-018). For purposes of this AD, ``damage'' is
the presence of those conditions described in paragraphs 3.A.(5) and
3.A.(8) of the Accomplishment Instructions of ASB No. 92-63-018.
    (b) If you find damage in the primary oil filter element (part
number (P/N) 70351-38801-102) as follows: ``wavy pleats'' as
depicted in Figure 1, internal buckling or a crack as depicted in
Figure 2, or indented dimples as depicted in Figure 3 of ASB No. 92-
63-018 or damage in the secondary oil filter element (P/N 70351-
38801-103) as follows: ``wavy pleats'' as depicted in Figure 4 or an
elongated cup as depicted in Figure 5 of ASB No. 92-63-018, replace
both the primary and secondary filters, packings, and filter bowl
mounting studs, service the transmission and perform a functional
test before further flight by following the Accomplishment
Instructions, paragraphs 3.C.(1) through 3.C.(23), of ASB No. 92-63-
018, except this AD does not require you to return removed studs to
HSI nor does it require you to contact the manufacturer. If you find
damage in the tapped holes or in the MGB housing lockring
counterbore, contact the Boston Aircraft Certification Office for an
approved repair.
    (c) If you find no damage in the primary or secondary oil filter
element, before further flight, replace the packings, service the
transmission, and perform a functional test by following the
Accomplishment Instructions, paragraphs 3.B.(1) through 3.B.(4) of
ASB No. 92-63-018.
    (d) For those helicopters on which the primary or secondary oil
filter element and filter bowl mounting studs were replaced as
required by paragraph (b) of this AD:
    (1) Before the first flight of each day until the oil filter
bowl, P/N AAC367-16D2A, is replaced, inspect the MGB lube system
filter assembly for any oil leak.
    (2) Before further flight after any oil leak is detected as
required by paragraph (d)(1) of this AD or within 30 days, whichever
is earlier, replace the oil filter bowl.

    Note:  Sikorsky ASB No. 92-63-019, dated July 1, 2009, pertains
to the subject of this AD.

    (e) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Contact the Manager, Boston Aircraft Certification Office, FAA,
ATTN: Kirk Gustafson, Aviation Safety Engineer, Engine and Propeller
Directorate, FAA, 12 New England Executive Park, Burlington, MA
01803, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, for information
about previously approved alternative methods of compliance.
    (f) The Joint Aircraft System/Component (JASC) Code is 6300:
Main Rotor System.
    (g) Inspecting and replacing the main gearbox lube system
assembly parts shall be done by following the specified portions of
Sikorsky Alert Service Bulletin (ASB) No. 92-63-018, dated July 1,
2009. The Director of the Federal Register approved this
incorporation by reference under 5 U.S.C. 552(a) and 1 CFR part 51.
Copies may be obtained from Sikorsky Aircraft Corporation, Attn:
Manager, Commercial Technical Support, mailstop s581a, 6900 Main
Street, Stratford, CT, telephone<PHONE_NUMBER>, e-mail address
<EMAIL_ADDRESS>or at http://www.sikorsky.com. Copies may
be inspected at the FAA, Office of the Regional Counsel, Southwest
Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.
    (h) This amendment becomes effective on December 21, 2009.

    Issued in Fort Worth, Texas, on November 25, 2009.
Lance T. Gant,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. E9-28863 Filed 12-3-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 121 (Monday, June 24, 2013)]
[Notices]
[Page 37820]
[FR Doc No: 2013-14930]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Nonprescription Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Nonprescription Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 31, 2013, from 8
a.m. to 5 p.m.
    Location: DoubleTree by Hilton Hotel Washington DC/Silver Spring,
The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel's
telephone number is<PHONE_NUMBER>.
    Contact Person: Glendolynn S. Johnson, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:
301-847-8533, email<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: The committee will discuss data submitted by sanofi-aventis
U.S., LLC to support a supplemental new drug application (sNDA) 20468/
S-035, for the switch from prescription to over-the-counter (OTC) of
triamcinolone acetonide nasal spray. The proposed OTC use is
``temporarily relieves these symptoms of hay fever or other upper
respiratory allergies: Nasal congestion, runny nose, sneezing, itchy
nose.'' The applicant proposes to label the product for OTC use in
adults and children. The data to be discussed will include studies
addressing the potential adverse effects, as well as a summary of the
postmarketing experience with the triamcinolone acetonide nasal spray
addressing the potential for both systemic and local effects. The
committee will be asked to consider whether the data support the
appropriate and safe use of triamcinolone acetonide nasal spray by OTC
consumers.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before July
25, 2013. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those individuals interested in making
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before July 23, 2013. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by July 24, 2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Glendolynn S.
Johnson at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: June 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-14930 Filed 6-21-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 200 (Thursday, October 15, 2020)]
[Notices]
[Pages 65412-65415]
[FR Doc No: 2020-22875]

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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 or Committees; Device Good Manufacturing Practice Advisory
Committee and the Medical Devices Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Device Good
Manufacturing Practice Advisory Committee (DGMPAC) and 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 December 14, 2020 will be
given first consideration for membership on the DGMPAC and Panels of
the MDAC. Nominations received after December 14, 2020 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:
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:
<EMAIL_ADDRESS>Aden S. Asefa, Office of Management,     Dental Products Panel,
 Center for Devices and Radiological      Immunology Devices Panel,
 Health, Food and Drug Administration,    Microbiology Devices Panel,
 10903 New Hampshire Ave., Bldg. 66,      Neurological Devices Panel,
 Rm. 5214, Silver Spring, MD 20993, 301-  Ophthalmic Devices Panel,
 796-0400, email:                         DGMPAC.
<EMAIL_ADDRESS>

CDR Patricio G. Garcia, Office of        Clinical Chemistry and Clinical
 Management, Center for Devices and       Toxicology Devices Panel,
 Radiological Health, Food and Drug       Gastroenterology and Urology
 Administration,10903 New Hampshire       Devices Panel, General and
 Ave., Bldg. 66, Rm. 5216, Silver         Plastic Surgery Devices Panel,
 Spring, MD 20993,<PHONE_NUMBER>, email:   Obstetrics and Gynecology
<EMAIL_ADDRESS>            Devices Panel, Orthopaedic and
                                          Rehabilitation Devices Panel.
James P. Swink, Office of Management,    Anesthesiology and Respiratory
 Center for Devices and Radiological      Therapy Devices Panel,
 Health, Food and Drug Administration,    Circulatory System Devices
 10903 New Hampshire Ave., Bldg. 66,      Panel, Ear, Nose and Throat
 Rm. 5211, Silver Spring, MD 20993, 301-  Devices Panel, Hematology and
 796-6313, email:                         Pathology Devices Panel,
<EMAIL_ADDRESS>                General Hospital and Personal
                                          Use Devices Panel, Molecular
                                          and Clinical Genetics Panel,
                                          Radiological Devices Panel.
------------------------------------------------------------------------

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

    Table 2--Expertise Needed, Vacancies, And Approximate Date Needed
------------------------------------------------------------------------
                                                      Approximate date
         Expertise needed              Vacancies           needed
------------------------------------------------------------------------
Device Good Manufacturing Practice               4  Immediately.
 Advisory Committee--Experts in                  1  General Public
 medical device quality management               2   Representative.
 system requirements/current Good                1  Health Professional
 Manufacturing Practices, with                       Representatives.
 experience in both 21 CFR part                     Government
 820 and International                               Representative.
 Organization for Standardization
 (ISO) 13485, are needed to
 provide cross-cutting scientific
 or clinical expertise concerning
 the particular issue in dispute.
 Vacancies include a
 representative of the interests
 of the general public,
 government, and representatives
 of the interests of physicians
 and other health professionals.
Anesthesiology and Respiratory                   2  Immediately.
 Therapy Devices 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                 1  July 1, 2021.
 of the Medical Devices Advisory
 Committee--Interventional
 cardiologists,
 electrophysiologists, invasive
 (vascular) radiologists, vascular
 and cardiothoracic surgeons, and
 cardiologists with special
 interest in congestive heart
 failure.
Clinical Chemistry and Clinical                  2  Immediately.
 Toxicology Panel of the Medical                 3  3/1/2021.
 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                     1  11/01/2020.
 Medical Devices 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                    3  11/01/2020.
 Panel of the Medical Devices
 Advisory Committee--Otologists,
 neurotologists, audiologists.
Gastroenterology and Urology                     2  Immediately.
 Devices Panel of the Medical                    3  1/1/2021.
 Devices Advisory Committee--
 Gastroenterologists, urologists,
 and nephrologists.
General and Plastic Surgery                      1  Immediately.
 Devices Panel of the Medical                    3  09/01/2021.
 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                1  Immediately.
 Devices Panel of the Medical
 Devices Advisory Committee--
 Internists, pediatricians,
 neonatologists, endocrinologists,
 gerontologists, nurses,
 biomedical engineers, human
 factors experts, or
 microbiologists/infection control
 practitioners or experts.
Hematology and Pathology Devices                 2  3/1/2021.
 Panel of the Medical Devices
 Advisory Committee--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; and devices utilizing
 artificial intelligence/machine
 learning.
Immunology Devices Panel of the                  5  Immediately.
 Medical Devices Advisory                        2  3/1/2021.
 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               1  10/1/2021.
 Panel of the Medical Devices
 Advisory Committee--Experts with
 cross-cutting scientific,
 clinical, analytical, or
 mediation skills.

Microbiology Devices Panel of the                2  Immediately.
 Medical Devices Advisory                        3  3/1/2021.
 Committee--Infectious disease
 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                  1  Immediately.
 Panel of the Medical Devices                    1  6/1/2021.
 Advisory Committee--Experts in
 human genetics, molecular
 diagnostics, and in the clinical
 management of patients with
 genetic disorders, e.g.,
 pediatricians, obstetricians, and
 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
 and medical ethics are also
 desired, and individuals with
 experience in ancillary fields of
 study will be considered.
Neurological Devices Panel of the                3  Immediately.
 Medical Devices Advisory                        3  12/1/2020.
 Committee--Neurosurgeons
 (cerebrovascular and pediatric),
 neurologists (stroke, pediatric,
 pain management, and movement
 disorders), interventional
 neuroradiologists, psychiatrists,
 and biostatisticians.
Obstetrics and Gynecology Devices                1  Immediately.
 Panel of the Medical Devices                    2  2/1/2021.
 Advisory Committee--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; and labor and delivery
 nursing.
Ophthalmic Devices Panel of the                  2  Immediately.
 Medical Devices Advisory                        2  11/01/2020.
 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                   2  9/1/2021.
 Devices Panel of the Medical
 Devices Advisory Committee--
 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; and radiologists
 specializing musculoskeletal
 imaging and analyses and
 biostatisticians.
Radiological Devices Panel of the                2  2/1/2021.
 Medical Devices Advisory
 Committee--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.
------------------------------------------------------------------------

I. General Description of the Committees Duties

A. DGMPAC

    The DGMPAC reviews regulations proposed for promulgation regarding
good manufacturing practices governing the methods used in, and the
facilities and controls used for, the manufacture, packing, storage and
installation of devices, and makes recommendations to the Commissioner
of Food and Drugs (the Commissioner) regarding the feasibility and
reasonableness of those proposed regulations. The DGMPAC also advises
the Commissioner on any petition submitted by a manufacturer for an
exemption or variance from good manufacturing practice regulations that
is referred to the committee.

B. MDAC

    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

A. DGMPAC

    The DGMPAC consists of a core of nine members including the Chair.
Members and the Chair are selected by the Secretary. Persons nominated
for membership as a health professional or officer or employee of any
Federal, State, or local government should have knowledge of or
expertise in any one or more of the following areas--quality assurance
concerning the design, manufacture, and use of medical devices in
accordance with 21 CFR part 820 and/or ISO 13485. To be eligible for
selection as a representative of the general public, nominees should
possess appropriate qualifications to understand and contribute to the
DGMPAC's work. Three of the members shall be officers or employees of
any State or local government or of the Federal Government; two shall
be representative of the interests of the device manufacturing
industry; two shall be representatives of the interests of physicians
and other health professionals; and two shall be representatives of the
interests of the general public. FDA is publishing a separate document
announcing the Request for Nominations Notification for Non-Voting
Representatives of the interests of the device manufacturing industry.
Almost all non-Federal members of this committee serve as Special
Government Employees. Members are invited to serve for overlapping
terms of 4 years. The current needs for the DGMPAC are listed in table
2.

B. Panels of the MDAC

    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 Non-Voting 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. 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 or
advisory committees. 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 committee(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: October 7, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22875 Filed 10-14-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 216 (Monday, November 9, 2015)]
[Notices]
[Pages 69204-69205]
[FR Doc No: 2015-28424]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL16-9-000]

Big Sandy Peaker Plant, LLC, Wolf Hills Energy, LLC, Crete Energy
Venture, LLC, Lincoln Generating Facility, LLC, Rolling Hills
Generating, L.L.C. v. PJM Interconnection, L.L.C.; Notice of Complaint

    Take notice that on November 3, 2015, pursuant to sections 206 and
306 of the Federal Power Act, 16 U.S.C. 824e and 825e (2012) and Rule
206 of the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.206 (2015), Big Sandy Peaker Plant,
LLC, Wolf Hills Energy, LLC, Crete Energy Venture, LLC, Lincoln
Generating Facility, LLC, and Rolling Hills Generating, L.L.C.,
(collectively Complainants) filed a complaint against PJM
Interconnection, L.L.C. (PJM or Respondent) alleging that PJM violated
its Open Access Transmission Tariff and acted in contravention of the
filed rate doctrine by finding that the generation units owned and
operated by the Complainants were not eligible to provide Tier 1
Synchronized Reserve effective retroactively to October 1, 2013, and by
invoicing the Complainants for adjustments to payments previously made
by PJM to the Complainants for providing Tier 1 Synchronized Reserve
during the period from October 1, 2013 to July 1, 2014, all as more
fully explained in the complaint.
    The Complainant certifies that copies of the complaint were served
on the contacts for the Respondent as listed on the Commission's list
of corporate officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must

be filed on or before the comment date. The Respondent's answer,
motions to intervene, and protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on December 3, 2015.

    Dated: November 3, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-28424 Filed 11-6-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 233 (Wednesday, December 6, 2017)]
[Rules and Regulations]
[Page 57541]
[FR Doc No: 2017-26203]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0295; Airspace Docket No. 16-AWP-2]

Establishment of Class E Airspace; Kaunakakai, HI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule, correction.

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SUMMARY: This action corrects a final rule published in the Federal
Register of October 11, 2017, that establishes Class E airspace and
amends Class D and E airspace at Molokai Airport, Kaunakakai, HI. The
airspace description for the airport in Class E airspace extending
upward from 700 feet above the surface contained the following wording
in error: ``That airspace extending upward from the surface . . .'' It
is removed and replaced by ``That airspace extending upward from 700
feet above the surface . . . .''

DATES: Effective date 0901 UTC December 7, 2017. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Tom Clark, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule in the Federal Register (82 FR
47104, October 11, 2017) Docket No. FAA-2017-0295 establishing Class E
airspace and amending Class D and Class E airspace at Molokai Airport,
Kaunakakai, HI. Subsequent to publication, the FAA identified a
clerical error in the legal description of the Class E airspace
extending upward from 700 feet or more above the surface at Molokai
Airport. This correction changes the words ``. . . from the surface . .
.'' to read ``. . . from 700 feet above the surface . . .''.

Correction to Final Rule

    Accordingly, pursuant to the authority delegated to me, in the
Federal Register of October 11, 2017 (82 FR 47104) FR Doc. FR Doc.
2017-21785, Establishment of Class E Airspace and Amendment of Class D
and Class E Airspace; Kaunakakai, HI, is corrected as follows:

Sec.  71.1   [Amended]

AWP HI E5 Kaunakakai, HI [Corrected]

0
On page 47105, column 3, lines 10 and 11, the words ``That airspace
extending upward from the surface'' are corrected to read ``That
airspace extending upward from 700 feet above the surface''.

    Issued in Seattle, Washington, on November 21, 2017.
Brian J. Johnson,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2017-26203 Filed 12-5-17; 8:45 am]
 BILLING CODE 4910-13-P