Request for Nominations for Voting Members on a Public Advisory Committee; Blood Products Advisory Committee, 43141-43142 [2019-17924]
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Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices
2. Toxicology studies including
Pharmacokinetic Concentrations
Domain (PC) and Pharmacokinetics
Parameters Domain (PP) domains.
3. Toxicology studies with study data
using controlled terminology (version
2018–03–30 or later) for:
a. Severity.
b. Non-neoplasm (NONNEO) using
codelist NONNEO and Microscopic
Domain (MI).
Please indicate in your request for
participation the extent to which your
submission will meet the above listed
criteria.
This pilot is intended to inform on the
readiness of the SEND 3.1 standard and
support improvements to the SENDIG
3.1 that will benefit FDA and
submitters. Pilot participants commit to
publicly share lessons learned with the
CDISC SEND team to ensure that the
CDISC SEND standard is improved for
the community. Participants may redact
any sensitive information as needed to
enable sharing FDA feedback with the
CDISC SEND team.
III. Requests for Participation
Requests to participate in the SENDIG
3.1 FFU pilot are to be identified with
the docket number found in brackets in
the heading of this document. Interested
persons should include the following
information in the request: Contact
name, contact phone number, email
address, name of the sponsor, address,
and license number, as well as the
description of criteria met, addressing
each of the items in the II. Project
Participation section.
Once requests for participation are
received, CDER will contact interested
sponsors to discuss the pilot project and
clarify requirements and expectations.
The elapsed time duration of the pilot
is expected to be approximately 6
months but may be extended as needed.
Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17877 Filed 8–19–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jbell on DSK3GLQ082PROD with NOTICES
[Docket No. FDA–2019–N–0573]
Request for Nominations for Voting
Members on a Public Advisory
Committee; Blood Products Advisory
Committee
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
20:49 Aug 19, 2019
Jkt 247001
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Blood Products Advisory
Committee (the Committee) in the
Center for Biologics Evaluation and
Research. Nominations will be accepted
for upcoming vacancies effective with
this notice. 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.
DATES: Nominations received on or
before October 21, 2019 will be given
first consideration for membership on
the Blood Products Advisory
Committee. Nominations received after
October 21, 2019 will be considered for
nomination to the committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be sent
electronically by logging into the FDA
Advisory Nomination Portal: https://
www.accessdata.fda.gov/scripts/
factrsportal/factrs/index.cfm.
Information about becoming a member
on an FDA advisory committee can also
be obtained by visiting FDA’s website at
https://www.fda.gov/advisorycommittees.
FOR FURTHER INFORMATION CONTACT:
Christina Vert, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6268,
Silver Spring, MD 20993–0002, 240–
402–8054, Fax: 301–595–1309, email:
Christina.Vert@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
requesting nominations for voting
members to fill upcoming vacancies on
the Blood Products Advisory
Committee.
I. General Description of the Committee
Duties
The Committee reviews and evaluates
available data concerning the safety,
effectiveness, and appropriate use of
blood, products derived from blood and
serum or biotechnology which are
intended for use in the diagnosis,
prevention, or treatment of human
diseases, and, as required, any other
product for which FDA has regulatory
responsibility, and advises the
Commissioner of Food and Drugs (the
Commissioner) of its findings regarding
screening and testing (to determine
eligibility) of donors and labeling of the
products, on clinical and laboratory
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
43141
studies involving such products, on the
affirmation or revocation of biological
products licenses, and on the quality
and relevance of FDA’s research
program which provides the scientific
support for regulating these agents. The
Committee will function at times as a
medical device panel under the Federal
Food, Drug, and Cosmetic Act Medical
Device Amendments of 1976. As such,
the Committee recommends
classification of devices subject to its
review into regulatory categories;
recommends the assignment of a
priority for the application of regulatory
requirements for devices classified in
the standards or premarket approval
category; advises on formulation of
product development protocols and
reviews premarket approval
applications for those devices to
recommend changes in classification as
appropriate; recommends exemption of
certain devices from the application of
portions of the Act; advises on the
necessity to ban a device; and responds
to requests from the Agency to review
and make recommendations on specific
issues or problems concerning the safety
and effectiveness of devices.
II. Criteria for Voting Members
The Committee consists of a core of
17 voting members including the Chair.
Members and the Chair are selected by
the Commissioner or designee from
among authorities knowledgeable in the
fields of clinical and administrative
medicine, hematology, immunology,
blood banking, surgery, internal
medicine, biochemistry, engineering,
biological and physical sciences,
biotechnology, computer technology,
statistics, epidemiology, sociology/
ethics, and other related professions.
Almost all non-Federal members of this
committee serve as Special Government
Employees. Members will be invited to
serve for terms of up to 4 years.
III. Nomination Procedures
Any interested person may nominate
one or more qualified persons for
membership on the advisory committee.
Self-nominations are also accepted.
Nominations must include a current,
complete re´sume´ or curriculum vitae for
each nominee, including current
business address, telephone number,
and email address if available and a
signed copy of the Acknowledgement
and Consent form available at the FDA
Advisory Nomination Portal (see
ADDRESSES). Nominations must specify
the advisory committee for which the
nominee is recommended. Nominations
must also acknowledge that the
nominee is aware of the nomination
unless self-nominated. FDA will ask
E:\FR\FM\20AUN1.SGM
20AUN1
43142
Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices
potential candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
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: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17924 Filed 8–19–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3613]
Antimicrobial 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.
jbell on DSK3GLQ082PROD with NOTICES
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Antimicrobial 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.
DATES: The meeting will be held on
October 16, 2019, from 8:00 a.m. to 4:30
p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2019–N–3613.
The docket will close on October 15,
2019. Submit either electronic or
written comments on this public
meeting by October 15, 2019. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
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before October 15, 2019. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
October 15, 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
October 1, 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:
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
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–
2019–N–3613 for ‘‘Antimicrobial Drugs
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Fmt 4703
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Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see the ADDRESSES section),
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.’’ FDA
will review this copy, including the
claimed confidential information, in its
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Dockets Management Staff.
If you do not wish your name and
contact information be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify the information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
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.
FOR FURTHER INFORMATION CONTACT:
Lauren Tesh Hotaki, 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:
AMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
E:\FR\FM\20AUN1.SGM
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Agencies
[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43141-43142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17924]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0573]
Request for Nominations for Voting Members on a Public Advisory
Committee; Blood Products Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Blood Products Advisory
Committee (the Committee) in the Center for Biologics Evaluation and
Research. Nominations will be accepted for upcoming vacancies effective
with this notice. 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.
DATES: Nominations received on or before October 21, 2019 will be given
first consideration for membership on the Blood Products Advisory
Committee. Nominations received after October 21, 2019 will be
considered for nomination to the committee as later vacancies occur.
ADDRESSES: All nominations for membership should be sent electronically
by logging into the FDA Advisory Nomination Portal: https://www.accessdata.fda.gov/scripts/factrsportal/factrs/index.cfm.
Information about becoming a member on an FDA advisory committee can
also be obtained by visiting FDA's website at https://www.fda.gov/advisory-committees.
FOR FURTHER INFORMATION CONTACT: Christina Vert, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD 20993-0002, 240-
402-8054, Fax: 301-595-1309, email: [email protected].
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members to fill upcoming vacancies on the Blood Products Advisory
Committee.
I. General Description of the Committee Duties
The Committee reviews and evaluates available data concerning the
safety, effectiveness, and appropriate use of blood, products derived
from blood and serum or biotechnology which are intended for use in the
diagnosis, prevention, or treatment of human diseases, and, as
required, any other product for which FDA has regulatory
responsibility, and advises the Commissioner of Food and Drugs (the
Commissioner) of its findings regarding screening and testing (to
determine eligibility) of donors and labeling of the products, on
clinical and laboratory studies involving such products, on the
affirmation or revocation of biological products licenses, and on the
quality and relevance of FDA's research program which provides the
scientific support for regulating these agents. The Committee will
function at times as a medical device panel under the Federal Food,
Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the
Committee recommends classification of devices subject to its review
into regulatory categories; recommends the assignment of a priority for
the application of regulatory requirements for devices classified in
the standards or premarket approval category; advises on formulation of
product development protocols and reviews premarket approval
applications for those devices to recommend changes in classification
as appropriate; recommends exemption of certain devices from the
application of portions of the Act; advises on the necessity to ban a
device; and responds to requests from the Agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices.
II. Criteria for Voting Members
The Committee consists of a core of 17 voting members including the
Chair. Members and the Chair are selected by the Commissioner or
designee from among authorities knowledgeable in the fields of clinical
and administrative medicine, hematology, immunology, blood banking,
surgery, internal medicine, biochemistry, engineering, biological and
physical sciences, biotechnology, computer technology, statistics,
epidemiology, sociology/ethics, and other related professions. Almost
all non-Federal members of this committee serve as Special Government
Employees. Members will be invited to serve for terms of up to 4 years.
III. Nomination Procedures
Any interested person may nominate one or more qualified persons
for membership on the advisory committee. Self-nominations are also
accepted. Nominations must include a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business address, telephone number, and email address if
available and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Nomination Portal (see ADDRESSES).
Nominations must specify the advisory committee for which the nominee
is recommended. Nominations must also acknowledge that the nominee is
aware of the nomination unless self-nominated. FDA will ask
[[Page 43142]]
potential candidates to provide detailed information concerning such
matters related to financial holdings, employment, and research grants
and/or contracts to permit evaluation of possible sources of conflicts
of interest.
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: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17924 Filed 8-19-19; 8:45 am]
BILLING CODE 4164-01-P