Notice of Meeting, 6403 [2019-03383]
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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in this draft guidance may also be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However, this draft guidance is not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written comments on the draft guidance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draft guidance before it begins work on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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6403
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BILLING CODE 4160–90–P
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
E:\FR\FM\27FEN1.SGM
27FEN1
]]>Agencies
[Federal Register Volume 84, Number 39 (Wednesday, February 27, 2019)]
[Notices]
[Page 6403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03383]
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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 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 non-confidential 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 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 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.
Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2019-03383 Filed 2-26-19; 8:45 am]
BILLING CODE 4160-90-P
