Request for Nomination From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Committees, 2875-2876 [2019-01555]
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Federal Register / Vol. 84, No. 27 / Friday, February 8, 2019 / Notices
795–7334. Email: allison.cruz@
acl.hhs.gov
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Dated: February 4, 2018.
Julie Hocker,
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(AoD).
[FR Doc. 2019–01698 Filed 2–7–19; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
amozie on DSK3GDR082PROD with NOTICES1
[Docket No. FDA–2018–N–3918]
Request for Nomination From Industry
Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on Public Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
SUMMARY:
VerDate Sep<11>2014
17:18 Feb 07, 2019
requesting that any industry
organizations interested in participating
in the selection of nonvoting industry
representatives to serve on its public
advisory committees for the Center for
Drug Evaluation and Research (CDER)
notify FDA in writing. FDA is also
requesting nominations for nonvoting
industry representatives to serve on
CDER’s public advisory committees. A
nominee may either be self-nominated
or nominated by an organization to
serve as a nonvoting industry
representative. Nominations will be
accepted for vacancies which become
available on November 1, 2019, for the
4-year term of November 1, 2019 to
October 31, 2023.
I. CDER Advisory Committees
Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by March 11, 2019, (see sections I
and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by March 11,
2019.
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of arthritis, rheumatism, and related
diseases.
DATES:
All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nominations should be sent to Cicely
Reese (see FOR FURTHER INFORMATION
CONTACT). All nominations for
nonvoting industry representatives may
be submitted electronically by accessing
the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to: Division of Advisory Committee
and Consultant Management, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002.
Information about becoming a member
of an FDA advisory committee can also
be obtained by visiting FDA’s website
at: https://www.fda.gov/Advisory
Committees/default.htm.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Cicely Reese, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, Fax:
301–847–8533, email: Cicely.Reese@
fda.hhs.gov.
The
Agency intends to add a nonvoting
industry representative to the following
advisory committees:
SUPPLEMENTARY INFORMATION:
Notice.
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A. Anesthetic and Analgesic Drug
Products Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in anesthesiology
and surgery.
B. Antimicrobial Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of infectious diseases and disorders.
C. Arthritis Advisory Committee
D. Bone, Reproductive, and Urologic
Drugs Advisory Committee
Reviews and evaluates available data
on the safety and effectiveness of
marketed and investigational human
drugs for use in the practice of
obstetrics, gynecology, urology, and
related specialties.
E. Cardiovascular and Renal Drugs
Advisory Committee
Reviews and evaluates available data
on the safety and effectiveness of
marketed and investigational human
drug products for use in the treatment
of cardiovascular and renal disorders.
F. Dermatologic and Ophthalmic Drugs
Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of dermatologic and ophthalmic
disorders.
G. Drug Safety and Risk Management
Advisory Committee
Reviews and evaluates information on
risk management, risk communication,
and quantitative evaluation of
spontaneous reports for drugs for
human use.
H. Endocrinologic and Metabolic Drugs
Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of endocrine and metabolic disorders.
E:\FR\FM\08FEN1.SGM
08FEN1
2876
Federal Register / Vol. 84, No. 27 / Friday, February 8, 2019 / Notices
I. Gastrointestinal Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of gastrointestinal diseases.
of marketed and investigational human
drug products for use in the treatment
of pulmonary disease and diseases with
allergic and/or immunologic
mechanisms.
J. Medical Imaging Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in diagnostic and
therapeutic procedures using
radioactive pharmaceuticals and
contrast media used in diagnostic
radiology.
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resume`s. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
K. Nonprescription Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of over-the-counter (nonprescription)
human drug products for use in the
treatment of a broad spectrum of human
symptoms and diseases.
L. Oncologic Drugs Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of cancer.
M. Peripheral and Central Nervous
System Drugs Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of neurologic diseases.
N. Pharmaceutical Science and Clinical
Pharmacology Advisory Committee
Reviews and evaluates scientific,
clinical, and technical issues related to
the safety and effectiveness of drug
products for use in the treatment of a
broad spectrum of human diseases.
O. Pharmacy Compounding Advisory
Committee
Provides advice on scientific,
technical, and medical issues
concerning drug compounding.
amozie on DSK3GDR082PROD with NOTICES1
P. Psychopharmacologic Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the practice of
psychiatry and related fields.
Q. Pulmonary-Allergy Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
VerDate Sep<11>2014
17:18 Feb 07, 2019
Jkt 247001
Dated: February 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–01555 Filed 2–7–19; 8:45 am]
BILLING CODE 4164–01–P
II. Selection Procedure
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process.)
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–3548]
Public Warning and Notification of
Recalls; Guidance for Industry and
FDA Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a final
guidance for industry and FDA staff
entitled ‘‘Public Warning and
Notification of Recalls.’’ The guidance
establishes guidance for industry and
FDA staff regarding the use, content,
and circumstances for issuance of
public warnings and public notification
of recalls under federal regulations. The
intent of the guidance is to increase and
expedite the appropriate and accurate
use of public warnings and public
notification and to increase public
health protection by better informing
the public about violative products
being recalled. The guidance clarifies
and supplements existing policy for
industry and FDA staff regarding the use
of public warnings and public
notification.
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on February 8, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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
E:\FR\FM\08FEN1.SGM
08FEN1
]]>Agencies
[Federal Register Volume 84, Number 27 (Friday, February 8, 2019)]
[Notices]
[Pages 2875-2876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01555]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3918]
Request for Nomination From Industry Organizations Interested in
Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on Public Advisory Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
requesting that any industry organizations interested in participating
in the selection of nonvoting industry representatives to serve on its
public advisory committees for the Center for Drug Evaluation and
Research (CDER) notify FDA in writing. FDA is also requesting
nominations for nonvoting industry representatives to serve on CDER's
public advisory committees. A nominee may either be self-nominated or
nominated by an organization to serve as a nonvoting industry
representative. Nominations will be accepted for vacancies which become
available on November 1, 2019, for the 4-year term of November 1, 2019
to October 31, 2023.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to FDA by March 11,
2019, (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by March 11, 2019.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nominations should be sent to Cicely Reese (see
FOR FURTHER INFORMATION CONTACT). All nominations for nonvoting
industry representatives may be submitted electronically by accessing
the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail
to: Division of Advisory Committee and Consultant Management, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993-0002. Information about becoming a member of an
FDA advisory committee can also be obtained by visiting FDA's website
at: https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Cicely Reese, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax: 301-847-8533, email: Cicely.Reese@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative to the following advisory committees:
I. CDER Advisory Committees
A. Anesthetic and Analgesic Drug Products Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in anesthesiology and surgery.
B. Antimicrobial Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of infectious diseases and disorders.
C. Arthritis Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of arthritis, rheumatism, and related diseases.
D. Bone, Reproductive, and Urologic Drugs Advisory Committee
Reviews and evaluates available data on the safety and
effectiveness of marketed and investigational human drugs for use in
the practice of obstetrics, gynecology, urology, and related
specialties.
E. Cardiovascular and Renal Drugs Advisory Committee
Reviews and evaluates available data on the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of cardiovascular and renal disorders.
F. Dermatologic and Ophthalmic Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of dermatologic and ophthalmic disorders.
G. Drug Safety and Risk Management Advisory Committee
Reviews and evaluates information on risk management, risk
communication, and quantitative evaluation of spontaneous reports for
drugs for human use.
H. Endocrinologic and Metabolic Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of endocrine and metabolic disorders.
[[Page 2876]]
I. Gastrointestinal Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of gastrointestinal diseases.
J. Medical Imaging Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in diagnostic and therapeutic procedures using radioactive
pharmaceuticals and contrast media used in diagnostic radiology.
K. Nonprescription Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of over-the-counter (nonprescription) human drug products
for use in the treatment of a broad spectrum of human symptoms and
diseases.
L. Oncologic Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of cancer.
M. Peripheral and Central Nervous System Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of neurologic diseases.
N. Pharmaceutical Science and Clinical Pharmacology Advisory Committee
Reviews and evaluates scientific, clinical, and technical issues
related to the safety and effectiveness of drug products for use in the
treatment of a broad spectrum of human diseases.
O. Pharmacy Compounding Advisory Committee
Provides advice on scientific, technical, and medical issues
concerning drug compounding.
P. Psychopharmacologic Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the practice of psychiatry and related fields.
Q. Pulmonary-Allergy Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of pulmonary disease and diseases with allergic
and/or immunologic mechanisms.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations; and a list of all nominees
along with their current resum[egrave]s. The letter will also state
that it is the responsibility of the interested organizations to confer
with one another and to select a candidate, within 60 days after the
receipt of the FDA letter, to serve as the nonvoting member to
represent industry interests for the committee. The interested
organizations are not bound by the list of nominees in selecting a
candidate. However, if no individual is selected within 60 days, the
Commissioner will select the nonvoting member to represent industry
interests.
III. Application Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, current curriculum vitae, and the
name of the committee of interest should be sent to the FDA Advisory
Committee Membership Nomination Portal (see ADDRESSES) within 30 days
of publication of this document (see DATES). FDA will forward all
nominations to the organizations expressing interest in participating
in the selection process for the committee. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process.)
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: February 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01555 Filed 2-7-19; 8:45 am]
BILLING CODE 4164-01-P
