Statement of Organization, Functions, and Delegations of Authority, 12821-12822 [2015-05552]
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Federal Register / Vol. 80, No. 47 / Wednesday, March 11, 2015 / Notices
•
•
HTAC Subcommittee Updates
Open Discussion Period
Public Participation: The meeting is
open to the public. Individuals who
would like to attend and/or to make oral
statements during the public comment
period must register no later than 5:00
p.m. on Wednesday, April 15, 2015, by
email at HTAC@nrel.gov. Entry to the
meeting room will be restricted to those
who have confirmed their attendance in
advance. Please provide your name,
organization, citizenship, and contact
information. Anyone attending the
meeting will be required to present
government-issued identification. Those
wishing to make a public comment are
required to register. The public
comment period will take place between
8:30 a.m. and 9:00 a.m. on April 21,
2015. Time allotted per speaker will
depend on the number who wish to
speak but will not exceed five minutes.
Those not able to attend the meeting or
have insufficient time to address the
committee are invited to send a written
statement by email to HTAC@nrel.gov.
Minutes: The minutes of the meeting
will be available within 45 days for
public review at https://
hydrogen.energy.gov/advisory_
htac.html.
Issued in Washington, DC in March 4,
2015.
LaTanya R. Butler,
Deputy Committee Management Officer.
[FR Doc. 2015–05531 Filed 3–10–15; 8:45 am]
BILLING CODE 6450–01–P
FEDERAL MINE SAFETY AND HEALTH
REVIEW COMMISSION
Sunshine Act Notice
March 9, 2015.
10:00 a.m., Tuesday,
March 17, 2015
PLACE: The Richard V. Backley Hearing
Room, Room 511N, 1331 Pennsylvania
Avenue NW., Washington, DC 20004
(enter from F Street entrance)
STATUS: Open
MATTERS TO BE CONSIDERED: The
Commission will consider and act upon
the following in open session:
Pocahontas Coal Co., LLC. v. Secretary
of Labor, Docket No. WEVA 2014–202–
R; and Pocahontas Coal Co., LLC v.
Secretary of Labor, Docket Nos. WEVA
2014–642–R, et al. (Issues include
whether the Administrative Law Judges
erred in ruling that they lacked
jurisdiction to review a Notice of Pattern
of Violations and a Notice of Safeguard,
respectively.)
Any person attending this meeting
who requires special accessibility
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TIME AND DATE:
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features and/or auxiliary aids, such as
sign language interpreters, must inform
the Commission in advance of those
needs. Subject to 29 CFR 2706.150(a)(3)
and 2706.160(d).
FOR FURTHER INFORMATION CONTACT:
Emogene Johnson (202) 434–9935/(202)
708–9300 for TDD Relay/1–800–877–
8339 for toll free.
Sarah Stewart,
Deputy General Counsel.
[FR Doc. 2015–05633 Filed 3–9–15; 4:15 pm]
BILLING CODE 6735–01–P
FEDERAL MINE SAFETY AND HEALTH
REVIEW COMMISSION
Sunshine Act Notice
March 9, 2015.
11:00 a.m., Tuesday,
March 17, 2015.
PLACE: The Richard V. Backley Hearing
Room, Room 511N, 1331 Pennsylvania
Avenue NW., Washington, DC 20004
(enter from F Street entrance).
STATUS: Open.
MATTERS TO BE CONSIDERED: The
Commission will consider and act upon
the following in open session: Secretary
of Labor v. Paramont Coal Company
Virginia, LLC, Docket Nos. VA 2010–
369–R, et al. (Issues include whether the
Administrative Law Judge erred in
ruling that a particular violation of the
standard governing conveyor belt
alignment was not ‘‘significant and
substantial.’’).
Any person attending this meeting
who requires special accessibility
features and/or auxiliary aids, such as
sign language interpreters, must inform
the Commission in advance of those
needs. Subject to 29 CFR 2706.150(a)(3)
and 2706.160(d).
FOR FURTHER INFORMATION CONTACT:
Emogene Johnson (202) 434–9935/(202)
708–9300 for TDD Relay/1–800–877–
8339 for toll free.
TIME AND DATE:
Sarah Stewart,
Deputy General Counsel.
[FR Doc. 2015–05637 Filed 3–9–15; 4:15 pm]
BILLING CODE 6735–01–P
FEDERAL MINE SAFETY AND HEALTH
REVIEW COMMISSION
Sunshine Act Notice: Cancellation of
Meeting Notice
March 6, 2015.
The following Commission meeting
has been cancelled. No earlier
announcement of the cancellation was
possible.
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12821
10:00 a.m., Thursday,
March 5, 2015
PLACE: The Richard V. Backley Hearing
Room, Room 511N, 1331 Pennsylvania
Avenue NW., Washington, DC 20004
(enter from F Street entrance)
STATUS: Open
MATTERS TO BE CONSIDERED: The
Commission will consider and act upon
the following in open session:
Pocahontas Coal Co., LLC. v. Secretary
of Labor, Docket No. WEVA 2014–202–
R; and Pocahontas Coal Co., LLC v.
Secretary of Labor, Docket Nos. WEVA
2014–642–R, et al. (Issues include
whether the Administrative Law Judges
erred in ruling that they lacked
jurisdiction to review a Notice of Pattern
of Violations and a Notice of Safeguard,
respectively.)
Any person attending this meeting
who requires special accessibility
features and/or auxiliary aids, such as
sign language interpreters, must inform
the Commission in advance of those
needs. Subject to 29 CFR 2706.150(a)(3)
and 2706.160(d).
CONTACT PERSON FOR MORE INFO:
Emogene Johnson (202) 434–9935/(202)
708–9300 for TDD Relay/1–800–877–
8339 for toll free.
TIME AND DATE:
Emogene Johnson,
Administrative Assistant.
[FR Doc. 2015–05589 Filed 3–9–15; 11:15 am]
BILLING CODE 6735–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority
Part C (Centers for Disease Control
and Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at 80 FR 14117–1419,
dated January 9, 2015) is amended to
establish the Western States Division
and Spokane Mining Research Division,
National Institute for Occupational
Safety and Health, Centers for Disease
Control and Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows:
After the title and functional
statement for the World Trade Center
Health Program (CCP), National
E:\FR\FM\11MRN1.SGM
11MRN1
12822
Federal Register / Vol. 80, No. 47 / Wednesday, March 11, 2015 / Notices
Institute for Occupational Safety and
Health (CC), insert the following:
Western States Division (CCQ). The
Western States Division (WSD) conducts
research and provides technical assistance
for the prevention of work-related illness,
injury, and death; these activities are
predominately focused on, but not limited to,
occupational safety and health (OS&H)
problems in the Western U.S., including
Alaska and Hawaii. WSD conducts specific
activities that provide actionable evidence to
reduce OS&H hazards. To accomplish its
mission, WSD: (1) Conducts prevention
research for at risk populations; (2) facilitates
the development of OS&H programs in states
and regions that have minimal or limited
OS&H public health program capacity and
state-supporting infrastructure; (3) serves as a
multi-regional resource to provide outreach,
expert advice, and technical assistance on
OS&H priority issues, including the
development, dissemination, and diffusion of
NIOSH research products; (4) enhances and
facilitates NIOSH initiatives and programs;
and (5) responds to requests for technical
assistance and conducts site evaluations to
support Division programs and priorities and
other NIOSH initiatives and programs,
including evaluating exposures to hazardous
chemical, biological, physical, and
radioactive agents and recommending
appropriate controls. Research includes the
development of viable strategies to evaluate
and prioritize hazards, communicate risk,
provide evidence for prevention
recommendations, and building state OS&H
(capacity or activities) through surveillance
data and stakeholder input. At risk
populations include, but are not limited to,
(a) high-risk industries such as oil and gas
extraction, fishing, and aviation; (b)
underserved groups such as American
Indian/Alaska Native and immigrant and
contingent workers; and (c) workers engaged
in particularly hazardous activities such as
hydraulic fracturing, wind and other
renewable energy development, wild land
firefighting; and water and air transportation.
Rmajette on DSK2VPTVN1PROD with NOTICES
After the title and functional
statement for the Office of Mine Safety
and Health Research (CCM), National
Institute for Occupational Safety and
Health (CC), insert the following:
Spokane Mining Research Division
(CCMG). (1) Provides leadership for
prevention of work-related illness, injury,
and death in the extractive industries with an
emphasis on the special needs of these
industries in western United States; (2)
develops numerical models and conducts
laboratory and field investigations to better
understand the causes of catastrophic failures
in underground metal/nonmetal mines that
may lead to multiple injuries and fatalities;
(3) develops new design practices and tools,
control technologies, and work practices to
reduce the risk of these global and local
ground failures in underground metal/
nonmetal mines; (4) conducts numerical
studies and field investigations to understand
the problems of ventilating deep and
multilevel underground mines, and develops
improved design approaches and engineering
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14:27 Mar 10, 2015
Jkt 235001
controls to reduce the concentration of toxic
substances in the mine air; (5) conducts
laboratory and field studies to help leverage
and support the Institute’s mining research
program; (6) develops and recommends
appropriate criteria for new standards,
NIOSH policy, documents, or testimony
related to health and safety in the extractive
industries.
James Seligman,
Acting Chief Operating Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2015–05552 Filed 3–10–15; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1999–D–1315 (formerly
1999–D–0296)]
Formal Meetings Between the Food
and Drug Administration and Sponsors
or Applicants of Prescription Drug
User Fee Act Products; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Formal Meetings
Between the FDA and Sponsors or
Applicants of Prescription Drug User
Fee Act (PDUFA) Products.’’ This draft
guidance provides recommendations to
industry on formal meetings between
FDA and sponsors or applicants relating
to the development and review of drug
or biological products (‘‘products’’).
This draft guidance revises the guidance
for industry entitled ‘‘Formal Meetings
Between the FDA and Sponsors or
Applicants’’ published May 19, 2009.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by June 9, 2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Bldg., 4th
Floor, Silver Spring, MD 20993–0002, or
the Office of Communication, Outreach,
and Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://www.
regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Rachel E. Hartford, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6312,
Silver Spring, MD 20993–0002, 301–
796–0319; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Formal Meetings Between the FDA and
Sponsors or Applicants of PDUFA
Products.’’ This draft guidance provides
recommendations to industry on formal
meetings between FDA and sponsors or
applicants relating to the development
and review of products regulated by the
Center for Drug Evaluation and Research
and the Center for Biologics Evaluation
and Research. This draft guidance does
not apply to abbreviated new drug
applications, applications for biosimilar
biological products, or submissions for
medical devices. For the purposes of
this draft guidance, ‘‘formal meeting’’
includes any meeting that is requested
by a sponsor or applicant following the
request procedures provided in this
guidance and includes meetings
conducted in any format (i.e., face to
face, teleconference, videoconference, or
written response).
This draft guidance discusses the
principles of good meeting management
practices and describes standardized
procedures for requesting, preparing for,
scheduling, conducting, and
documenting such formal meetings. The
general principles in this draft guidance
may be extended to other
nonapplication-related meetings with
external constituents, insofar as this is
possible.
This draft guidance revises the
guidance for industry entitled ‘‘Formal
Meetings Between the FDA and
Sponsors or Applicants’’ published May
19, 2009. This draft guidance is being
E:\FR\FM\11MRN1.SGM
11MRN1
]]>Agencies
[Federal Register Volume 80, Number 47 (Wednesday, March 11, 2015)]
[Notices]
[Pages 12821-12822]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05552]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Statement of Organization, Functions, and Delegations of
Authority
Part C (Centers for Disease Control and Prevention) of the
Statement of Organization, Functions, and Delegations of Authority of
the Department of Health and Human Services (45 FR 67772-76, dated
October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as
amended most recently at 80 FR 14117-1419, dated January 9, 2015) is
amended to establish the Western States Division and Spokane Mining
Research Division, National Institute for Occupational Safety and
Health, Centers for Disease Control and Prevention.
Section C-B, Organization and Functions, is hereby amended as
follows:
After the title and functional statement for the World Trade Center
Health Program (CCP), National
[[Page 12822]]
Institute for Occupational Safety and Health (CC), insert the
following:
Western States Division (CCQ). The Western States Division (WSD)
conducts research and provides technical assistance for the
prevention of work-related illness, injury, and death; these
activities are predominately focused on, but not limited to,
occupational safety and health (OS&H) problems in the Western U.S.,
including Alaska and Hawaii. WSD conducts specific activities that
provide actionable evidence to reduce OS&H hazards. To accomplish
its mission, WSD: (1) Conducts prevention research for at risk
populations; (2) facilitates the development of OS&H programs in
states and regions that have minimal or limited OS&H public health
program capacity and state-supporting infrastructure; (3) serves as
a multi-regional resource to provide outreach, expert advice, and
technical assistance on OS&H priority issues, including the
development, dissemination, and diffusion of NIOSH research
products; (4) enhances and facilitates NIOSH initiatives and
programs; and (5) responds to requests for technical assistance and
conducts site evaluations to support Division programs and
priorities and other NIOSH initiatives and programs, including
evaluating exposures to hazardous chemical, biological, physical,
and radioactive agents and recommending appropriate controls.
Research includes the development of viable strategies to evaluate
and prioritize hazards, communicate risk, provide evidence for
prevention recommendations, and building state OS&H (capacity or
activities) through surveillance data and stakeholder input. At risk
populations include, but are not limited to, (a) high-risk
industries such as oil and gas extraction, fishing, and aviation;
(b) underserved groups such as American Indian/Alaska Native and
immigrant and contingent workers; and (c) workers engaged in
particularly hazardous activities such as hydraulic fracturing, wind
and other renewable energy development, wild land firefighting; and
water and air transportation.
After the title and functional statement for the Office of Mine
Safety and Health Research (CCM), National Institute for Occupational
Safety and Health (CC), insert the following:
Spokane Mining Research Division (CCMG). (1) Provides leadership
for prevention of work-related illness, injury, and death in the
extractive industries with an emphasis on the special needs of these
industries in western United States; (2) develops numerical models
and conducts laboratory and field investigations to better
understand the causes of catastrophic failures in underground metal/
nonmetal mines that may lead to multiple injuries and fatalities;
(3) develops new design practices and tools, control technologies,
and work practices to reduce the risk of these global and local
ground failures in underground metal/nonmetal mines; (4) conducts
numerical studies and field investigations to understand the
problems of ventilating deep and multilevel underground mines, and
develops improved design approaches and engineering controls to
reduce the concentration of toxic substances in the mine air; (5)
conducts laboratory and field studies to help leverage and support
the Institute's mining research program; (6) develops and recommends
appropriate criteria for new standards, NIOSH policy, documents, or
testimony related to health and safety in the extractive industries.
James Seligman,
Acting Chief Operating Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2015-05552 Filed 3-10-15; 8:45 am]
BILLING CODE P
