Notice of Closed Meeting, 14859 [2018-07051]
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Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices
14859
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
[FR Doc. 2018–07016 Filed 4–5–18; 8:45 am]
Notice of Closed Meeting
Exposure-Response Analysis in Drug
Development and Regulatory Decision
Making; Establishment of a Public
Docket; Request for Comments
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Notice of Closed Meeting
daltland on DSKBBV9HB2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Management Analysis and
Services Office, CDC, pursuant to Public
Law 92–463. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)—RFA–CE–18–002,
Evaluation of Policies for the Primary
Prevention of Multiple Forms of Violence.
Dates: May 23, 2018 and May 24, 2018.
Time: 9:00 a.m.–5:00 p.m., EDT.
Place: DoubleTree by Hilton Hotel
Atlanta—Buckhead, 3342 Peachtree Road NE,
Atlanta, GA 30326.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Mikel L.
Walters, M.A., Ph.D., Scientific Review
Official, NCIPC, CDC, 4770 Buford Highway
NE, Mailstop F–63, Atlanta, Georgia 30341,
Telephone: (404)639–0913; Email: mwalters@
cdc.gov.
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 Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Management Analysis and
Services Office, CDC, pursuant to Public
Law 92–463. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Disease, Disability,
and Injury Prevention and Control Special
Emphasis Panel (SEP)—CK18–001,
Epicenters for the Prevention of HealthcareAssociated Infections (HAIs); Cycle II
Multicenter Program Studies and CK18–003,
Determining and Monitoring Health
Conditions Among US-Bound Refugees and
Other Globally Mobile Populations.
Date: May 9, 2018.
Time: 10:00 a.m.–3:00 p.m., EDT.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Gregory
Anderson, M.S., M.P.H., Scientific Review
Officer, CDC, 1600 Clifton Road NE, Mailstop
E60, Atlanta, Georgia 30329, (404) 718–8833,
gca5@cdc.gov.
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 Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2018–07053 Filed 4–5–18; 8:45 am]
BILLING CODE 4163–18–P
[FR Doc. 2018–07051 Filed 4–5–18; 8:45 am]
BILLING CODE 4163–18–P
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[Docket No. FDA–2018–N–0791]
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Prescription Drug User
Fee Act of 2017 (PDUFA VI), part of the
FDA Reauthorization Act of 2017
(FDARA, highlights the goal of
advancing model-informed drug
development (MIDD). Exposureresponse analysis is a MIDD strategy
that has been used in drug development
and regulatory decision making. The
Food and Drug Administration (FDA or
Agency) is opening a docket to receive
public comments on experience
leveraging exposure-response analysis
since publishing the guidance for
industry (GFI) entitled ‘‘ExposureResponse Relationships—Study Design,
Data Analysis, and Regulatory
Applications,’’ which was announced in
the Federal Register on May 6, 2003.
Specifically, the Agency wants to
identify areas of scientific policy that
may need further clarity or elaboration,
as well as any obstacles that prevent use
of exposure-response analyses in drug
development and regulatory review.
DATES: To ensure that the Agency
considers your input, submit either
electronic or written comments by July
5, 2018.
ADDRESSES: You may submit comments
as follows. Electronic comments must
be submitted on or before July 5, 2018.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
date service acceptance receipt is on or
before that date:
SUMMARY:
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
E:\FR\FM\06APN1.SGM
06APN1
Agencies
[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Page 14859]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07051]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended, and the Determination of the Director, Management
Analysis and Services Office, CDC, pursuant to Public Law 92-463. The
grant applications and the discussions could disclose confidential
trade secrets or commercial property such as patentable material, and
personal information concerning individuals associated with the grant
applications, the disclosure of which would constitute a clearly
unwarranted invasion of personal privacy.
Name of Committee: Disease, Disability, and Injury Prevention
and Control Special Emphasis Panel (SEP)--RFA-CE-18-002, Evaluation
of Policies for the Primary Prevention of Multiple Forms of
Violence.
Dates: May 23, 2018 and May 24, 2018.
Time: 9:00 a.m.-5:00 p.m., EDT.
Place: DoubleTree by Hilton Hotel Atlanta--Buckhead, 3342
Peachtree Road NE, Atlanta, GA 30326.
Agenda: To review and evaluate grant applications.
For Further Information Contact: Mikel L. Walters, M.A., Ph.D.,
Scientific Review Official, NCIPC, CDC, 4770 Buford Highway NE,
Mailstop F-63, Atlanta, Georgia 30341, Telephone: (404)639-0913;
Email: [email protected].
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 Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2018-07051 Filed 4-5-18; 8:45 am]
BILLING CODE 4163-18-P