Mine Safety and Health Research Advisory Committee (MSHRAC), 46495-46496 [2017-21423]
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Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices
Federal Communications Commission.
Marlene H. Dortch,
Secretary, Office of the Secretary.
[FR Doc. 2017–21482 Filed 10–4–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry (BSC, NCEH/
ATSDR)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
Centers for Disease Control and
Prevention (CDC), announces the
following meeting for the Board of
Scientific Counselors, National Center
for Environmental Health/Agency for
Toxic Substances and Disease Registry
(BSC, NCEH/ATSDR). This meeting is
open to the public, limited in the room
by 60 people and 75 lines over the
phone. The public is also welcome to
listen to the meeting by 1–888–790–
2009, passcode: 7865774, with 75 lines.
The deadline for notification of
attendance is November 10, 2017. The
public comment period is scheduled on
Wednesday, November 15, 2017 from
2:00 p.m. until 2:15 p.m.; and from 3:25
p.m. until 3:40 p.m. EST, and on
Thursday, November 16, 2017 from
10:10 a.m. until 10:25 a.m. EST.
Individuals wishing to make a comment
during Public Comment period, please
email your name, organization, and
phone number by November 6, 2017 to
William Cibulas at wic1@cdc.gov.
DATES: The meeting will be held on
November 15, 2017, 8:30 a.m. to 4:30
p.m., EST and November 16, 2017, 8:30
a.m. to noon, EST.
ADDRESSES: CDC, 4770 Buford Hwy.,
Atlanta, Georgia 30341, Building 107,
Room 1A or by phone: 1–888–790–2009
FOR FURTHER INFORMATION CONTACT:
Shirley Little, Program Analyst, NCEH/
ATSDR, CDC, 4770 Buford Hwy., Mail
Stop F–45, Atlanta, Georgia 30341,
telephone (770) 488–0577; snl7@
cdc.gov.
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SUMMARY:
SUPPLEMENTARY INFORMATION:
Purpose: The Secretary, Department
of Health and Human Services (HHS)
and by delegation, the Director, CDC
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and Administrator, NCEH/ATSDR, are
authorized under Section 301 (42 U.S.C.
241) and Section 311 (42 U.S.C. 243) of
the Public Health Service Act, as
amended, to: (1) Conduct, encourage,
cooperate with, and assist other
appropriate public authorities, scientific
institutions, and scientists in the
conduct of research, investigations,
experiments, demonstrations, and
studies relating to the causes, diagnosis,
treatment, control, and prevention of
physical and mental diseases and other
impairments; (2) assist states and their
political subdivisions in the prevention
of infectious diseases and other
preventable conditions and in the
promotion of health and wellbeing; and
(3) train state and local personnel in
health work. The BSC, NCEH/ATSDR
provides advice and guidance to the
Secretary, HHS; the Director, CDC and
Administrator, ATSDR; and the
Director, NCEH/ATSDR, regarding
program goals, objectives, strategies, and
priorities in fulfillment of the agency’s
mission to protect and promote people’s
health. The board provides advice and
guidance that will assist NCEH/ATSDR
in ensuring scientific quality,
timeliness, utility, and dissemination of
results. The board also provides
guidance to help NCEH/ATSDR work
more efficiently and effectively with its
various constituents and to fulfill its
mission in protecting America’s health.
Matters To Be Considered: The agenda
will include discussions on NCEH/
ATSDR Director Updates; NoiseInduced Hearing Loss; NCEH/ATSDR
Program Responses to BSC Guidance
and Action Items; CDC’s Hurricane
Season Response; Lead Poisoning
Prevention Program Updates; Flint
Registry; Revision of blood lead level
reference value (status); Discussion of
Legislative Requirements of new Lead
Exposure Poisoning Federal Advisory
Committee; Amyotrophic Lateral
Sclerosis (ALS) Program Update;
Environmental Health Tracking Program
update; updates from the National
Institute of Environmental Health
Sciences, the National Institute for
Occupational Safety and Health, the
U.S. Department of Energy and the U.S.
Environmental Protection Agency.
Agenda items are subject to change as
priorities dictate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
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46495
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2017–21422 Filed 10–4–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Mine Safety and Health Research
Advisory Committee (MSHRAC)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
Centers for Disease Control and
Prevention (CDC), National Institute for
Occupational Safety and Health
(NIOSH), announces the following
meeting for the Mine Safety and Health
Research Advisory Committee
(MSHRAC). This meeting is open to the
public, limited only by the limited only
by the space available. The meeting
room accommodates approximately 50
people. If you wish to attend in person
or by phone, please contact Marie
Chovanec by email at MChovanec@
cdc.gov or by phone at least 5 business
days in advance of the meeting.
DATES: The meeting will be held on
November 15, 2017, 8:00 a.m.–3:00
p.m., Mountain Time.
ADDRESSES: Sheraton Denver West
Hotel, 360 Union Boulevard, Lakewood,
CO 80228 or call 412–386–5302.
FOR FURTHER INFORMATION CONTACT:
Jeffrey H. Welsh, Designated Federal
Officer, MSHRAC, NIOSH, CDC, 626
Cochrans Mill Road, Pittsburgh, PA
15236, telephone 412–386–4040, fax
412–386–6614.
SUPPLEMENTARY INFORMATION:
Purpose: This committee is charged
with providing advice to the Secretary,
Department of Health and Human
Services; the Director, CDC; and the
Director, NIOSH, on priorities in mine
safety and health research, including
grants and contracts for such research,
30 U.S.C. 812(b)(2), Section 102(b)(2).
Matters To Be Considered: The
meeting will focus on mining safety and
health research projects and outcomes,
including built-in-place refuge
alternatives, explosion protection,
domestic and international
SUMMARY:
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Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices
collaborations, fatigue management
systems, mitigating dynamic failure in
western underground coal mines,
mining strategic planning, and mining
innovations research initiative. Agenda
items are subject to change as priorities
dictate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2017–21423 Filed 10–4–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–2479]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; KOVALTRY
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for KOVALTRY and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological product.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by December 4, 2017.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
April 3, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
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SUMMARY:
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considered. Electronic comments must
be submitted on or before December 4,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of December 4, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–E–2479 for ’’Determination of
Regulatory Review Period for Purposes
of Patent Extension; KOVALTRY.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
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Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
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[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46495-46496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21423]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Mine Safety and Health Research Advisory Committee (MSHRAC)
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, the
Centers for Disease Control and Prevention (CDC), National Institute
for Occupational Safety and Health (NIOSH), announces the following
meeting for the Mine Safety and Health Research Advisory Committee
(MSHRAC). This meeting is open to the public, limited only by the
limited only by the space available. The meeting room accommodates
approximately 50 people. If you wish to attend in person or by phone,
please contact Marie Chovanec by email at MChovanec@cdc.gov or by phone
at least 5 business days in advance of the meeting.
DATES: The meeting will be held on November 15, 2017, 8:00 a.m.-3:00
p.m., Mountain Time.
ADDRESSES: Sheraton Denver West Hotel, 360 Union Boulevard, Lakewood,
CO 80228 or call 412-386-5302.
FOR FURTHER INFORMATION CONTACT: Jeffrey H. Welsh, Designated Federal
Officer, MSHRAC, NIOSH, CDC, 626 Cochrans Mill Road, Pittsburgh, PA
15236, telephone 412-386-4040, fax 412-386-6614.
SUPPLEMENTARY INFORMATION:
Purpose: This committee is charged with providing advice to the
Secretary, Department of Health and Human Services; the Director, CDC;
and the Director, NIOSH, on priorities in mine safety and health
research, including grants and contracts for such research, 30 U.S.C.
812(b)(2), Section 102(b)(2).
Matters To Be Considered: The meeting will focus on mining safety
and health research projects and outcomes, including built-in-place
refuge alternatives, explosion protection, domestic and international
[[Page 46496]]
collaborations, fatigue management systems, mitigating dynamic failure
in western underground coal mines, mining strategic planning, and
mining innovations research initiative. Agenda items are subject to
change as priorities dictate.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities,
for both the Centers for Disease Control and Prevention and the Agency
for Toxic Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2017-21423 Filed 10-4-17; 8:45 am]
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