Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nomination for Nonvoting Industry Representatives on the Vaccines and Related Biological Products Advisory Committee, 38634 [2019-16877]
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38634
Federal Register / Vol. 84, No. 152 / Wednesday, August 7, 2019 / Notices
Dated: August 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16889 Filed 8–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2832]
Request for Nominations From
Industry Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nomination for Nonvoting Industry
Representatives on the Vaccines and
Related Biological Products Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting that any industry
organizations interested in participating
in the selection of a nonvoting industry
representative to serve on the Vaccines
and Related Biological Products
Advisory Committee (VRBPAC) for the
Center for Biologics Evaluation and
Research (CBER) notify FDA in writing.
FDA is also requesting nominations for
a nonvoting industry representative(s) to
serve on the VRBPAC. A nominee may
either be self-nominated or nominated
by an organization to serve as a
nonvoting industry representative.
Nominations will be accepted for
current vacancies effective with this
notice.
SUMMARY:
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 September 6, 2019, (see sections
I and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by September 6,
2019.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative
nomination should be sent to Serina
Hunter-Thomas (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://
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DATES:
VerDate Sep<11>2014
16:49 Aug 06, 2019
Jkt 247001
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm.
Information about becoming a member
of an FDA advisory committee can also
be obtained by visiting FDA’s website:
https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Division of
Scientific Advisors and Consultants,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 6338, Silver Spring,
MD 20993–0002, 240–402–5771, Fax:
301–595–1307, Serina.Hunter-Thomas@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
I. CBER Advisory Committee
Vaccines and Related Biological
Products Advisory Committee
The committee reviews and evaluates
data concerning the safety,
effectiveness, and appropriate use of
vaccines and related biological products
which are intended for use in the
prevention, treatment, or diagnosis of
human diseases, and, as required, any
other products for which FDA has
regulatory responsibility. The
committee also considers the quality
and relevance of FDA’s research
program which provides scientific
support for the regulation of these
products and makes appropriate
recommendations to the Commissioner
of Food and Drugs (Commissioner).
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,
as well as a list of all nominees along
with their current resumes. 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,
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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, a 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, 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: July 31, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16877 Filed 8–6–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3369]
Evaluating the Clinical Pharmacology
of Oligonucleotide Therapeutics;
Establishment of a Public Docket;
Request for Information and
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for information
and comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
establishing a public docket to collect
comments on evaluating the clinical
pharmacology of oligonucleotide
therapeutics. There are many unique
clinical pharmacology considerations
concerning the development of
oligonucleotide therapeutics; however,
for the purposes of this request, the
Agency is specifically interested in
SUMMARY:
E:\FR\FM\07AUN1.SGM
07AUN1
]]>Agencies
[Federal Register Volume 84, Number 152 (Wednesday, August 7, 2019)]
[Notices]
[Page 38634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16877]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2832]
Request for Nominations From Industry Organizations Interested in
Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nomination for Nonvoting Industry
Representatives on the Vaccines and Related Biological Products
Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
that any industry organizations interested in participating in the
selection of a nonvoting industry representative to serve on the
Vaccines and Related Biological Products Advisory Committee (VRBPAC)
for the Center for Biologics Evaluation and Research (CBER) notify FDA
in writing. FDA is also requesting nominations for a nonvoting industry
representative(s) to serve on the VRBPAC. A nominee may either be self-
nominated or nominated by an organization to serve as a nonvoting
industry representative. Nominations will be accepted for current
vacancies effective with this notice.
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 September
6, 2019, (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by September 6, 2019.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative nomination should be sent to Serina Hunter-
Thomas (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.
Information about becoming a member of an FDA advisory committee can
also be obtained by visiting FDA's website: https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Division of
Scientific Advisors and Consultants, Center for Biologics Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6338, Silver Spring, MD 20993-0002, 240-402-5771, Fax:
301-595-1307, [email protected].
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
I. CBER Advisory Committee
Vaccines and Related Biological Products Advisory Committee
The committee reviews and evaluates data concerning the safety,
effectiveness, and appropriate use of vaccines and related biological
products which are intended for use in the prevention, treatment, or
diagnosis of human diseases, and, as required, any other products for
which FDA has regulatory responsibility. The committee also considers
the quality and relevance of FDA's research program which provides
scientific support for the regulation of these products and makes
appropriate recommendations to the Commissioner of Food and Drugs
(Commissioner).
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, as well as a list of all
nominees along with their current resumes. 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, a 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, 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: July 31, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16877 Filed 8-6-19; 8:45 am]
BILLING CODE 4164-01-P
