Notice of Closed Meeting, 44883 [2018-19077]
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Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
Notice of Closed Meeting
Physiologically Based
Pharmacokinetic Analyses—Format
and Content; Guidance for Industry;
Availability
[Docket No. FDA–2016–D–3969]
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)—
PAR 13–129, NIOSH Member Conflict
Special Emphasis Panel.
Date: October 25, 2018.
Time: 1:00 p.m.–5:00 p.m. EST.
Place: Teleconference.
Agenda: To review and evaluate grant
applications.
For Further Information Contact: Nina
Turner, Ph.D., Scientific Review Officer,
Office of Extramural Programs, 1095
Willowdale Road, Morgantown, WV
26506, (304) 285–5976; nxt2@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.
sradovich on DSK3GMQ082PROD with NOTICES
Sherri Berger,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2018–19077 Filed 8–31–18; 8:45 am]
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Physiologically Based Pharmacokinetic
Analyses—Format and Content.’’ This
guidance outlines the recommended
format and content for a sponsor or
applicant to submit physiologically
based pharmacokinetic (PBPK) analyses
to FDA to support applications
including, but not limited to,
investigational new drug applications
(INDs), new drug applications (NDAs),
biologics license applications (BLAs), or
abbreviated new drug applications
(ANDAs). This guidance does not
address methodological considerations
and best practices for the conduct of
PBPK modeling and simulation or the
appropriateness of PBPK analyses for a
particular drug or a drug product.
DATES: The announcement of the
guidance is published in the Federal
Register on September 4, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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
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.
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44883
• 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–D–3969 for ‘‘Physiologically
Based Pharmacokinetic Analyses—
Format and Content.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential 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 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/
E:\FR\FM\04SEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Page 44883]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19077]
[[Page 44883]]
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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)--PAR 13-129, NIOSH Member Conflict
Special Emphasis Panel.
Date: October 25, 2018.
Time: 1:00 p.m.-5:00 p.m. EST.
Place: Teleconference.
Agenda: To review and evaluate grant applications.
For Further Information Contact: Nina Turner, Ph.D., Scientific
Review Officer, Office of Extramural Programs, 1095 Willowdale Road,
Morgantown, WV 26506, (304) 285-5976; [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.
Sherri Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2018-19077 Filed 8-31-18; 8:45 am]
BILLING CODE 4163-18-P
