Notice of Closed Meeting, 60402 [2017-27324]
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60402
Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / Notices
be sent electronically to
Comments.applications@stls.frb.org:
1. David Armbrust, Salem, Illinois; to
acquire voting shares of Iuka
Bancshares, Inc., Salem, Illinois, and
thereby indirectly acquire shares of Iuka
State Bank, Iuka, Illinois.
B. Federal Reserve Bank of Kansas
City (Dennis Denney, Assistant Vice
President) 1 Memorial Drive, Kansas
City, Missouri 64198–0001:
1. David Riordan, Abilene, Kansas;
Robert Riordan, Solomon, Kansas;
Dennis Riordan, Salina, Kansas;
Michael Riordan, St. Charles, Missouri;
and Kirk Berneking, Salina, Kansas; to
retain voting shares of Solomon
Bancshares, Inc., Solomon, Kansas, and
thereby indirectly retain shares of
Solomon State Bank, Solomon, Kansas.
Board of Governors of the Federal Reserve
System, December 15, 2017.
Ann E. Misback,
Secretary of the Board.
[FR Doc. 2017–27408 Filed 12–19–17; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6380]
ACTION:
In accordance with the Federal
Advisory Committee Act, the Centers for
Disease Control and Prevention (CDC)
announces the following meeting.
The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title
5 U.S.C., and the Determination of the
Director, Management Analysis and
Services Office, CDC, pursuant to Public
Law 92–463.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)–
PAR15–303, Occupational Safety and
Health Education Research Centers
(ERC).
Date: February 21–23, 2018.
Time: 8:30 a.m.–6:00 p.m., EST.
Place: The Alexandrian Hotel, 480
King Street Alexandria, VA 22314, 703–
549–6080.
Agenda: The meeting will include the
initial review, discussion, and
evaluation of applications received in
response to PAR15–303, Occupational
Safety and Health Education Research
Centers (ERC).
FOR FURTHER INFORMATION CONTACT:
Michael Goldcamp, Ph.D., Scientific
Review Officer/CDC, 1095 Willowdale
Road, Mailstop H1808, Morgantown,
Jkt 244001
Food and Drug Administration,
HHS.
Notice of Closed Meeting
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2017–27324 Filed 12–19–17; 8:45 am]
AGENCY:
Centers for Disease Control and
Prevention
21:36 Dec 19, 2017
Elaine L. Baker,
Director, Management Analysis and Services
Office; Centers for Disease Control and
Prevention.
Clarification of Orphan Designation of
Drugs and Biologics for Pediatric
Subpopulations of Common Diseases;
Draft Guidance for Industry;
Availability
BILLING CODE 6210–01–P
VerDate Sep<11>2014
West Virginia, 26505, (304) 285–5951;
mgoldcamp@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.
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Clarification of Orphan Designation of
Drugs and Biologics for Pediatric
Subpopulations of Common Diseases.’’
FDA intends to no longer grant orphan
drug designation to drugs for pediatric
subpopulations of common diseases
(i.e., diseases or conditions with an
overall prevalence of over 200,000 in
the United States), unless the use of the
drug in the pediatric subpopulation
meets the regulatory criteria for an
orphan subset, or unless the disease in
the pediatric subpopulation is
considered a different disease from the
disease in the adult population. This
will help resolve an unintended
loophole in the Pediatric Research
Equity Act (PREA) orphan exemption
process where a sponsor holding a
pediatric-subpopulation designation can
submit a marketing application for use
of its drug in the non-orphan adult
population of that disease, get a
pediatric-subpopulation designation for
the pediatric subset of the disease, and,
due to this designation, be exempt from
conducting the pediatric studies
normally required under PREA when
seeking approval of the adult indication.
SUMMARY:
PO 00000
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Submit either electronic or
written comments on the draft guidance
by January 19, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
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–
2017–D–6380 for ‘‘Clarification of
Orphan Designation of Drugs and
Biologics for Pediatric Subpopulations
of Common Diseases.’’ 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.
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[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Notices]
[Page 60402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27324]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Notice of Closed Meeting
In accordance with the Federal Advisory Committee Act, the Centers
for Disease Control and Prevention (CDC) announces the following
meeting.
The meeting will be closed to the public in accordance with
provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and
the Determination of the Director, Management Analysis and Services
Office, CDC, pursuant to Public Law 92-463.
Name of Committee: Disease, Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)-PAR15-303, Occupational Safety and
Health Education Research Centers (ERC).
Date: February 21-23, 2018.
Time: 8:30 a.m.-6:00 p.m., EST.
Place: The Alexandrian Hotel, 480 King Street Alexandria, VA 22314,
703-549-6080.
Agenda: The meeting will include the initial review, discussion,
and evaluation of applications received in response to PAR15-303,
Occupational Safety and Health Education Research Centers (ERC).
FOR FURTHER INFORMATION CONTACT: Michael Goldcamp, Ph.D., Scientific
Review Officer/CDC, 1095 Willowdale Road, Mailstop H1808, Morgantown,
West Virginia, 26505, (304) 285-5951; [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 L. Baker,
Director, Management Analysis and Services Office; Centers for Disease
Control and Prevention.
[FR Doc. 2017-27324 Filed 12-19-17; 8:45 am]
BILLING CODE 4163-18-P
