Request for Nominations for Board of Governors of the Patient-Centered Outcomes Research Institute (PCORI), 14642 [2018-06999]
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Federal Register / Vol. 83, No. 66 / Thursday, April 5, 2018 / Notices
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Board of Governors of the Federal Reserve
System, April 2, 2018.
Ann Misback,
Secretary of the Board.
[FR Doc. 2018–06948 Filed 4–4–18; 8:45 am]
Nominations, 441 G Street NW,
Washington, DC 20548.
FOR FURTHER INFORMATION CONTACT:
Rashmi Agarwal at (202) 512–4077 or
agarwalr@gao.gov if you do not receive
an acknowledgement or need additional
information. For general information,
contact GAO’s Office of Public Affairs,
(202) 512–4800.
Authority: [Sec. 6301 and Sec. 10602, Pub.
L. 111–148].
Gene L. Dodaro,
Comptroller General of the United States.
[FR Doc. 2018–06999 Filed 4–4–18; 8:45 am]
BILLING CODE 6210–01–P
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GOVERNMENT ACCOUNTABILITY
OFFICE
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Nominations for Board of
Governors of the Patient-Centered
Outcomes Research Institute (PCORI)
Food and Drug Administration
Government Accountability
Office (GAO).
ACTION: Request for letters of
nomination and resumes.
Liposome Drug Products: Chemistry,
Manufacturing, and Controls; Human
Pharmacokinetics and Bioavailability;
and Labeling Documentation;
Guidance for Industry; Availability
AGENCY:
The Patient Protection and
Affordable Care Act gave the
Comptroller General of the United
States responsibility for appointing 19
members to the Board of Governors of
the Patient-Centered Outcomes Research
Institute. In addition, the Directors of
the Agency for Healthcare Research and
Quality and the National Institutes of
Health, or their designees, are members
of the Board. As the result of terms
ending in September 2018, GAO is
accepting nominations in the following
categories required in statute: A
physician, a nurse, a representative of
patients and health care consumers, a
representative of private payers, a
representative of a state or a federal
health program or agency, and a
representative of pharmaceutical,
device, or diagnostic manufacturers or
developers. Nominations should be sent
to the email or mailing address listed
below. Acknowledgement of
submissions will be provided within a
week of submission.
DATES: Letters of nomination and
resumes should be submitted no later
than May 4, 2018, to ensure adequate
opportunity for review and
consideration of nominees prior to
appointment.
amozie on DSK30RV082PROD with NOTICES
SUMMARY:
Submit letters of
nomination and resumes by either of the
following methods: Email: PCORI@
gao.gov. Include PCORI Nominations in
the subject line of the message, or Mail:
U.S. GAO, Attn: PCORI Board
ADDRESSES:
VerDate Sep<11>2014
18:33 Apr 04, 2018
Jkt 244001
[Docket No. FDA–2002–D–0093]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Liposome Drug Products: Chemistry,
Manufacturing, and Controls; Human
Pharmacokinetics and Bioavailability;
and Labeling Documentation.’’ This
guidance document finalizes the revised
draft of the same name that published
on October 30, 2015. This guidance
provides recommendations to
applicants on the chemistry,
manufacturing, and controls (CMC);
pharmacokinetics and bioavailability;
and labeling documentation for
liposome drug products submitted in
new drug applications (NDAs) and
abbreviated new drug applications
(ANDAs), reviewed by the Center for
Drug Evaluation and Research (CDER).
DATES: The announcement of the
guidance is published in the Federal
Register on April 5, 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
PO 00000
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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–
2002–D–0093 (formerly 2002D–0337)
for ‘‘Liposome Drug Products:
Chemistry, Manufacturing, and
Controls; Human Pharmacokinetics and
Bioavailability; and Labeling
Documentation.’’ 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
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[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Notices]
[Page 14642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06999]
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GOVERNMENT ACCOUNTABILITY OFFICE
Request for Nominations for Board of Governors of the Patient-
Centered Outcomes Research Institute (PCORI)
AGENCY: Government Accountability Office (GAO).
ACTION: Request for letters of nomination and resumes.
-----------------------------------------------------------------------
SUMMARY: The Patient Protection and Affordable Care Act gave the
Comptroller General of the United States responsibility for appointing
19 members to the Board of Governors of the Patient-Centered Outcomes
Research Institute. In addition, the Directors of the Agency for
Healthcare Research and Quality and the National Institutes of Health,
or their designees, are members of the Board. As the result of terms
ending in September 2018, GAO is accepting nominations in the following
categories required in statute: A physician, a nurse, a representative
of patients and health care consumers, a representative of private
payers, a representative of a state or a federal health program or
agency, and a representative of pharmaceutical, device, or diagnostic
manufacturers or developers. Nominations should be sent to the email or
mailing address listed below. Acknowledgement of submissions will be
provided within a week of submission.
DATES: Letters of nomination and resumes should be submitted no later
than May 4, 2018, to ensure adequate opportunity for review and
consideration of nominees prior to appointment.
ADDRESSES: Submit letters of nomination and resumes by either of the
following methods: Email: [email protected]. Include PCORI Nominations in
the subject line of the message, or Mail: U.S. GAO, Attn: PCORI Board
Nominations, 441 G Street NW, Washington, DC 20548.
FOR FURTHER INFORMATION CONTACT: Rashmi Agarwal at (202) 512-4077 or
[email protected] if you do not receive an acknowledgement or need
additional information. For general information, contact GAO's Office
of Public Affairs, (202) 512-4800.
Authority: [Sec. 6301 and Sec. 10602, Pub. L. 111-148].
Gene L. Dodaro,
Comptroller General of the United States.
[FR Doc. 2018-06999 Filed 4-4-18; 8:45 am]
BILLING CODE 1610-02-P
