Notice of Meeting, 6402-6403 [2019-03382]
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Federal Register / Vol. 84, No. 39 / Wednesday, February 27, 2019 / Notices
having made a prohibited off-the-record
communication shall serve the
document on all parties listed on the
official service list for the applicable
proceeding in accordance with Rule
2010, 18 CFR 385.2010.
Exempt off-the-record
communications are included in the
decisional record of the proceeding,
unless the communication was with a
cooperating agency as described by 40
CFR 1501.6, made under 18 CFR
385.2201(e) (1) (v).
The following is a list of off-therecord communications recently
received by the Secretary of the
Commission. The communications
listed are grouped by docket numbers in
ascending order. These filings are
available for electronic review at the
Commission in the Public Reference
Room or may be viewed on the
Docket No.
File date
Presenter or requester
Prohibited:
1. CP18–5 .................................................................................................................................
2/11/19
Cabot Oil & Gas Corporation.
ER19–570
2. EL19–9–000 ..........................................................................................................................
2/8/19
Congress Member Frank
Pallone, Jr.
Exempt:
1. P–2413 ..................................................................................................................................
2/7/19
Congress Member Jody
Hice.
Dated: February 21, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
FEDERAL RESERVE SYSTEM
B. Federal Reserve Bank of San
Francisco (Gerald C. Tsai, Director,
Applications and Enforcement) 101
Market Street, San Francisco, California
94105–1579:
1. Ivo A. Tjan, North Tustin,
California; to retain voting shares of
CommerceWest Bank, Irvine, California.
Change in Bank Control Notices;
Acquisitions of Shares of a Bank or
Bank Holding Company
Board of Governors of the Federal Reserve
System, February 22, 2019.
Yao-Chin Chao,
Assistant Secretary of the Board.
[FR Doc. 2019–03399 Filed 2–26–19; 8:45 am]
BILLING CODE 6717–01–P
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Commission’s website at https://
www.ferc.gov using the eLibrary link.
Enter the docket number, excluding the
last three digits, in the docket number
field to access the document. For
assistance, please contact FERC Online
Support at FERCOnlineSupport@
ferc.gov or toll free at (866) 208–3676, or
for TTY, contact (202)502–8659.
The notificants listed below have
applied under the Change in Bank
Control Act (‘‘Act’’) (12 U.S.C. 1817(j))
and § 225.41 of the Board’s Regulation
Y (12 CFR 225.41) to acquire shares of
a bank or bank holding company. The
factors that are considered in acting on
the notices are set forth in paragraph 7
of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for
immediate inspection at the Federal
Reserve Bank indicated. The notices
also will be available for inspection at
the offices of the Board of Governors.
Interested persons may express their
views in writing to the Reserve Bank
indicated for that notice or to the offices
of the Board of Governors. Comments
must be received not later than March
14, 2019.
A. Federal Reserve Bank of
Minneapolis (Mark A. Rauzi, Vice
President), 90 Hennepin Avenue,
Minneapolis, Minnesota 55480–0291:
1. Scott Koop, Galesville, Wisconsin,
individually and acting in concert with
Steve Koop, LaCrosse, Wisconsin, and
Mark Kopp, Galesville, Wisconsin; all to
retain shares of Gale Bank Holding
Company, Inc., and thereby indirectly
retain shares of Bluff View Bank, both
of Galesville, Wisconsin.
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[FR Doc. 2019–03364 Filed 2–26–19; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Notice of Meeting
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is
announcing a Special Emphasis Panel
(SEP) meeting on AHRQ–HS–18–002,
‘‘Screening and Management of
Unhealthy Alcohol Use in Primary Care:
Dissemination and Implementation of
PCOR Evidence (R18).’’
DATES: April 1, 2019 (Open on April 1st
from 8:30 a.m. to 8:45 a.m. and closed
for the remainder of the meeting).
ADDRESSES: Bethesda North Marriott
Hotel & Conference Center, 5701
Marinelli Rd., Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Anyone wishing to obtain a roster of
SUMMARY:
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members, agenda or minutes of the nonconfidential portions of this meeting
should contact: Mrs. Heather Phelps,
Acting Committee Management Officer,
Office of Extramural Research,
Education and Priority Populations,
AHRQ, 5600 Fishers Lane, Rockville,
Maryland 20850, Telephone: (301)427–
1128.
Agenda items for this meeting are
subject to change as priorities dictate.
SUPPLEMENTARY INFORMATION: A SEP is a
group of experts in fields related to
health care research who are invited by
AHRQ, and agree to be available, to
conduct on an as needed basis,
scientific reviews of applications for
AHRQ support. Individual members of
the SEP do not attend regularlyscheduled meetings and do not serve for
fixed terms or a long period of time.
Rather, they are asked to participate in
particular review meetings which
require their type of expertise.
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act (5
U.S.C. App. 2), announcement is made
of an AHRQ SEP meeting on AHRQ–
HS–18–002, ‘‘Screening and
Management of Unhealthy Alcohol Use
in Primary Care: Dissemination and
Implementation of PCOR Evidence
(R18).’’
Each SEP meeting will commence in
open session before closing to the public
for the duration of the meeting. The SEP
meeting referenced above will be closed
to the public in accordance with the
provisions set forth in 5 U.S.C. App. 2,
section 10(d), 5 U.S.C. 552b(c)(4), and 5
U.S.C. 552b(c)(6). Grant applications for
AHRQ–HS–18–002, ‘‘Screening and
Management of Unhealthy Alcohol Use
in Primary Care: Dissemination and
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Federal Register / Vol. 84, No. 39 / Wednesday, February 27, 2019 / Notices
Agency for Healthcare Research and
Quality
U.S.C. App. 2), announcement is made
of an AHRQ SEP meeting on Conference
Grants (R13).
Each SEP meeting will commence in
open session before closing to the public
for the duration of the meeting. The SEP
meeting referenced above will be closed
to the public in accordance with the
provisions set forth in 5 U.S.C. App. 2,
section 10(d), 5 U.S.C. 552b(c)(4), and 5
U.S.C. 552b(c)(6). Grant applications for
Conference Grants (R13) are to be
reviewed and discussed at this meeting.
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.
all finished dosage forms where
appropriate, including those submitted
in NDAs, ANDAs, drug master files,
biologics license applications (BLAs),
and nonapplication over the counter
products. Scientific principles described
in this draft guidance may also be
applicable to continuous manufacturing
technologies used for these drugs.
However, this draft guidance is not
intended to provide recommendations
specific to continuous manufacturing
technologies used for biological
products under a BLA.
DATES: Submit either electronic or
written comments on the draft guidance
by May 28, 2019 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:
Notice of Meeting
Francis D. Chesley, Jr.,
Acting Deputy Director.
Electronic Submissions
Implementation of PCOR Evidence
(R18)’’ are to be reviewed and discussed
at this meeting. 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.
Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2019–03382 Filed 2–26–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
[FR Doc. 2019–03383 Filed 2–26–19; 8:45 am]
The Agency for Healthcare
Research and Quality (AHRQ) is
announcing a Special Emphasis Panel
(SEP) meeting on Conference Grants
(R13).
DATES: April 4, 2019 (Open on April 4th
from 10:00 a.m. to 10:15 a.m. and closed
for the remainder of the meeting).
ADDRESSES: Agency for Healthcare
Research and Quality (AHRQ), 5600
Fishers Lane, Rockville, MD 20850.
FOR FURTHER INFORMATION CONTACT:
Anyone wishing to obtain a roster of
members, agenda or minutes of the nonconfidential portions of this meeting
should contact: Heather Phelps, Acting
Committee Management Officer, Office
of Extramural Research, Education and
Priority Populations, AHRQ, 5600
Fishers Lane, Rockville, Maryland
20850, Telephone: (301) 427–1128.
Agenda items for this meeting are
subject to change as priorities dictate.
SUPPLEMENTARY INFORMATION: An SEP is
a group of experts in fields related to
health care research who are invited by
the Agency for Healthcare Research and
Quality (AHRQ), and agree to be
available, to conduct on an as needed
basis, scientific reviews of applications
for AHRQ support. Individual members
of the Panel do not attend regularlyscheduled meetings and do not serve for
fixed terms or a long period of time.
Rather, they are asked to participate in
particular review meetings which
require their type of expertise.
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act (5
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
SUMMARY:
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Food and Drug Administration
[Docket No. FDA–2019–D–0298]
Quality Considerations for Continuous
Manufacturing; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Quality
Considerations for Continuous
Manufacturing.’’ This draft guidance
provides information regarding FDA’s
current thinking on the quality
considerations for continuous
manufacturing of small molecule, solid
oral drug products that are regulated by
the Center for Drug Evaluation and
Research (CDER). The draft guidance
describes several key quality
considerations and provides
recommendations for how applicants
should address these considerations in
new drug applications (NDAs),
abbreviated new drug applications
(ANDAs), and supplemental NDAs and
ANDAs, for small molecule, solid oral
drug products that are produced via a
continuous manufacturing process. FDA
supports the development and
implementation of continuous
manufacturing for drug substances and
SUMMARY:
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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
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Agencies
[Federal Register Volume 84, Number 39 (Wednesday, February 27, 2019)]
[Notices]
[Pages 6402-6403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03382]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Notice of Meeting
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
announcing a Special Emphasis Panel (SEP) meeting on AHRQ-HS-18-002,
``Screening and Management of Unhealthy Alcohol Use in Primary Care:
Dissemination and Implementation of PCOR Evidence (R18).''
DATES: April 1, 2019 (Open on April 1st from 8:30 a.m. to 8:45 a.m. and
closed for the remainder of the meeting).
ADDRESSES: Bethesda North Marriott Hotel & Conference Center, 5701
Marinelli Rd., Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Anyone wishing to obtain a roster of
members, agenda or minutes of the non-confidential portions of this
meeting should contact: Mrs. Heather Phelps, Acting Committee
Management Officer, Office of Extramural Research, Education and
Priority Populations, AHRQ, 5600 Fishers Lane, Rockville, Maryland
20850, Telephone: (301)427-1128.
Agenda items for this meeting are subject to change as priorities
dictate.
SUPPLEMENTARY INFORMATION: A SEP is a group of experts in fields
related to health care research who are invited by AHRQ, and agree to
be available, to conduct on an as needed basis, scientific reviews of
applications for AHRQ support. Individual members of the SEP do not
attend regularly-scheduled meetings and do not serve for fixed terms or
a long period of time. Rather, they are asked to participate in
particular review meetings which require their type of expertise.
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (5 U.S.C. App. 2), announcement is made of an AHRQ SEP
meeting on AHRQ-HS-18-002, ``Screening and Management of Unhealthy
Alcohol Use in Primary Care: Dissemination and Implementation of PCOR
Evidence (R18).''
Each SEP meeting will commence in open session before closing to
the public for the duration of the meeting. The SEP meeting referenced
above will be closed to the public in accordance with the provisions
set forth in 5 U.S.C. App. 2, section 10(d), 5 U.S.C. 552b(c)(4), and 5
U.S.C. 552b(c)(6). Grant applications for AHRQ-HS-18-002, ``Screening
and Management of Unhealthy Alcohol Use in Primary Care: Dissemination
and
[[Page 6403]]
Implementation of PCOR Evidence (R18)'' are to be reviewed and
discussed at this meeting. 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.
Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2019-03382 Filed 2-26-19; 8:45 am]
BILLING CODE 4160-90-P