Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Cellular, Tissue, and Gene Therapies Advisory Committee, 27782-27783 [2019-12565]
Download as PDF
<![CDATA[
27782
Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002 or the
Office of Policy, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist the
office in processing your requests. The
draft guidance may also be obtained by
mail by calling CBER at 1–800–835–
4709 or 240–402–8010. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
jbell on DSK3GLQ082PROD with NOTICES
Shruti Modi, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
17:04 Jun 13, 2019
Jkt 247001
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 809 have
been approved under OMB control
number 0901–0485.
III. Electronic Access
I. Background
FDA is announcing the availability of
a draft document entitled ‘‘Testing for
Biotin Interference in In Vitro
Diagnostic Devices.’’ The draft guidance
document provides FDA’s
recommendations on the testing for
interference by biotin on the
performance of IVDs. The draft guidance
is intended to help device developers
and clinicians understand how FDA
recommends that biotin interference
testing be performed and how the
results of the testing should be
communicated to end users, including
VerDate Sep<11>2014
clinical laboratories and clinicians. FDA
also recommends that manufacturers of
currently marketed devices consider
these draft recommendations. The
recommendations apply to IVDs, as well
as devices that are licensed under
section 351 of the Public Health Service
Act (42 U.S.C. 262) and used in donor
screening, that use biotin technology.
Biotin, also known as vitamin B7, is
a water-soluble vitamin often found in
multivitamins, prenatal vitamins, and
dietary supplements marketed for hair,
skin, and nail growth. FDA has become
aware of potential biotin interference
with IVDs that use biotin/avidin
interactions as part of the device
technology. Biotin in patient samples
can cause falsely high or falsely low
results, depending on the test.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on testing for biotin interference in in
vitro diagnostic devices. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
MedicalDevices/DeviceRegulation
andGuidance/GuidanceDocuments/
default.htm, or https://
www.regulations.gov.
Dated: June 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12564 Filed 6–13–19; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2272]
Request for Nominations From
Industry Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on the Cellular,
Tissue, and Gene Therapies Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of a
nonvoting industry representative to
serve on the Cellular, Tissue, and Gene
Therapies Advisory Committee for the
Center for Biologics Evaluation and
Research (CBER) notify FDA in writing.
FDA is also requesting nominations for
a non-voting industry representative(s)
to serve on the Cellular, Tissue, and
Gene Therapies Advisory Committee
Blood Products Advisory Committee. 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 non-voting
member to represent industry interests
must send a letter stating that interest to
FDA by July 15, 2019 (see sections I and
II of this document for further details).
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by July 15, 2019.
ADDRESSES: All statements of interest
from industry organizations interested
in participating in the selection process
of nonvoting industry representative(s)
should be sent to Prabhakara Atreya and
Jeannette Devine (see FOR FURTHER
INFORMATION CONTACT). All nominations
for nonvoting industry representatives
may be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal at:
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 at https://www.fda.gov/
AdvisoryCommittees/default.htm.
SUMMARY:
E:\FR\FM\14JNN1.SGM
14JNN1
Federal Register / Vol. 84, No. 115 / Friday, June 14, 2019 / Notices
FOR FURTHER INFORMATION CONTACT:
Prabhakara Atreya, Division of
Scientific Advisors and Consultants,
Center for Biologics Evaluation and
Research, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6306, Silver Spring, MD
20993–0002, 240–402–8006, Fax: 301–
595–1307, email: Prabhakara.Atreya@
fda.hhs.gov; and Jeannette Devine,
Division of Scientific Advisors and
Consultants, Center for Biologics
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6334,
Silver Spring, MD 20993–0002, 240–
402–0403, Fax: 301–595–1307,
Jeannette.Devine@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
jbell on DSK3GLQ082PROD with NOTICES
I. CBER Cellular, Tissue, and Gene
Therapies Advisory Committee
The Cellular, Tissue, and Gene
Therapies Advisory Committee (the
Committee) reviews and evaluates
available data relating to the safety,
effectiveness, and appropriate use of
human cells, human tissues, gene
transfer therapies and
xenotransplantation products which are
intended for transplantation,
implantation, infusion and transfer in
the prevention and treatment of a broad
spectrum of human diseases and in the
reconstruction, repair or replacement of
tissues for various conditions. 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.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate non-voting 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 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
VerDate Sep<11>2014
17:04 Jun 13, 2019
Jkt 247001
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
non-voting 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: June 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–12565 Filed 6–13–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2396]
Psychopharmacologic Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Psychopharmacologic
Drugs Advisory Committee. The general
function of the committee is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
27783
The meeting will be held on July
31, 2019, from 8 a.m. to 5 p.m.
ADDRESSES: Tommy Douglas Conference
Center, The Ballroom, 10000 New
Hampshire Ave., Silver Spring, MD
20903. The conference center’s
telephone number is 240–645–4000 and
the website address is https://
www.tommydouglascenter.com/.
Answers to commonly asked questions
about FDA Advisory Committee
meetings may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2019–N–2396.
The docket will close on July 30, 2019.
Submit either electronic or written
comments on this public meeting by
July 30, 2019. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 30, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 30, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Comments received on or before July
17, 2019, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA.
You may submit comments 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
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
E:\FR\FM\14JNN1.SGM
14JNN1
]]>Agencies
[Federal Register Volume 84, Number 115 (Friday, June 14, 2019)]
[Notices]
[Pages 27782-27783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12565]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2272]
Request for Nominations From Industry Organizations Interested in
Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on the Cellular, Tissue, and Gene Therapies Advisory
Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
a nonvoting industry representative to serve on the Cellular, Tissue,
and Gene Therapies Advisory Committee for the Center for Biologics
Evaluation and Research (CBER) notify FDA in writing. FDA is also
requesting nominations for a non-voting industry representative(s) to
serve on the Cellular, Tissue, and Gene Therapies Advisory Committee
Blood Products Advisory Committee. 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 non-voting member to represent industry
interests must send a letter stating that interest to FDA by July 15,
2019 (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by July 15, 2019.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of nonvoting
industry representative(s) should be sent to Prabhakara Atreya and
Jeannette Devine (see FOR FURTHER INFORMATION CONTACT). All nominations
for nonvoting industry representatives may be submitted electronically
by accessing the FDA Advisory Committee Membership Nomination Portal
at: 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 at https://www.fda.gov/AdvisoryCommittees/default.htm.
[[Page 27783]]
FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Division of
Scientific Advisors and Consultants, Center for Biologics Evaluation
and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 6306, Silver
Spring, MD 20993-0002, 240-402-8006, Fax: 301-595-1307, email:
[email protected]; and Jeannette Devine, Division of
Scientific Advisors and Consultants, Center for Biologics Evaluation
and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 6334, Silver
Spring, MD 20993-0002, 240-402-0403, 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 Cellular, Tissue, and Gene Therapies Advisory Committee
The Cellular, Tissue, and Gene Therapies Advisory Committee (the
Committee) reviews and evaluates available data relating to the safety,
effectiveness, and appropriate use of human cells, human tissues, gene
transfer therapies and xenotransplantation products which are intended
for transplantation, implantation, infusion and transfer in the
prevention and treatment of a broad spectrum of human diseases and in
the reconstruction, repair or replacement of tissues for various
conditions. 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.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate non-voting 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 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 non-voting 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: June 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12565 Filed 6-13-19; 8:45 am]
BILLING CODE 4164-01-P
