Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting, 47714-47715 [2013-18825]
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Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices
TABLE 1—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued
Recognition
No.
Title of standard 1
13–61 .............
Industrial communication networks—Network and system security—Part 2–1: Establishing an industrial automation and control system security program.
Industrial communication networks—Network and system security—Part 3–1: Security technologies for industrial automation and control systems.
13–62 .............
1 All
IEC 62443–2–1 Edition 1.0 2010–11
IEC/TR 62443–3–1 Edition 1.0 2009–07
standard titles in this table conform to the style requirements of the respective organizations.
IV. List of Recognized Standards
FDA maintains the Agency’s current
list of FDA recognized consensus
standards in a searchable database that
may be accessed directly at FDA’s
Internet site at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA
will incorporate the modifications and
revisions described into the database
and, upon publication in the Federal
Register, this recognition of consensus
standards will be effective. FDA will
announce additional modifications and
revisions to the list of recognized
consensus standards, as needed, in the
Federal Register once a year, or more
often, if necessary. Beginning with
Recognition List Number: 033, FDA will
no longer be announcing minor
revisions to the list of recognized
consensus standards such as technical
contact person, relevant guidance,
processes affected, CFR citations, and
product codes.
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Reference No. and date
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the
FD&C Act by submitting such
recommendations, with reasons for the
recommendation, to the contact person
(see FOR FURTHER INFORMATION CONTACT).
To be properly considered, such
recommendations should contain, at a
minimum, the following information:
(1) Title of the standard; (2) any
reference number and date; (3) name
and address of the national or
international standards development
organization; (4) a proposed list of
devices for which a declaration of
conformity to this standard should
routinely apply; and (5) a brief
identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
VI. Electronic Access
You may obtain a copy of ‘‘Guidance
on the Recognition and Use of
Consensus Standards’’ by using the
Internet. The Center for Devices and
Radiological Health (CDRH) maintains a
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site on the Internet for easy access to
information including text, graphics,
and files that you may download to a
personal computer with access to the
Internet. Updated on a regular basis, the
CDRH home page includes the guidance
as well as the current list of recognized
standards and other standards-related
documents. After publication in the
Federal Register, this notice
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 032’’ will be available on the
CDRH home page. You may access the
CDRH home page at https://www.fda.gov/
MedicalDevices.
You may access ‘‘Guidance on the
Recognition and Use of Consensus
Standards,’’ and the searchable database
for ‘‘FDA Recognized Consensus
Standards’’ at https://www.fda.gov/
MedicalDevices/
DeviceRegulationandGuidance/
Standards.
This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm.
VII. Submission of Comments and
Effective Date
Interested persons may submit to the
contact person (see FOR FURTHER
INFORMATION CONTACT) either electronic
or written comments regarding this
document. It is only necessary to send
one set of comments. Comments are to
be identified with the docket number
found in brackets in the heading of this
document. FDA will consider any
comments received in determining
whether to amend the current listing of
modifications to the list of recognized
standards, Recognition List Number:
032. These modifications to the list of
recognized standards are effective upon
publication of this notice in the Federal
Register.
Dated: July 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Council on Blood Stem Cell
Transplantation; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Council on Blood
Stem Cell Transplantation.
Date and Time: September 13, 2013,
10:00 a.m. to 4:00 p.m. (Eastern
Standard Time).
Place: The meeting will be via audio
conference call and Adobe Connect Pro.
Status: The meeting will be open to
the public.
Purpose: Pursuant to Public Law 109–
129, 42 U.S.C. 274k (section 379 of the
Public Health Service Act, as amended),
the Advisory Council on Blood Stem
Cell Transplantation (ACBSCT) advises
the Secretary of the Department of
Health and Human Services and the
Administrator, Health Resources and
Services Administration on matters
related to the activities of the C.W. Bill
Young Cell Transplantation Program
(Program) and the National Cord Blood
Inventory Program.
Agenda: The Council will hear reports
from ACBSCT Work Groups including:
Cord Blood Thawing and Washing;
Access to Transplantation; and
Advancing Hematopoietic Stem Cell
Transplantation for
Hemoglobinopathies. The Council also
will hear presentations and discussions
on topics including: Accreditation;
Adverse Event Reporting; and Unmet
Need. Agenda items are subject to
change as priorities indicate.
After Council discussions, members
of the public will have an opportunity
to provide comments. Because of the
Council’s full agenda and the time frame
in which to cover the agenda topics,
public comment will be limited. All
public comments will be included in
the record of the ACBSCT meeting.
Meeting summary notes will be posted
on the HRSA’s Program Web site at
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tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 151 / Tuesday, August 6, 2013 / Notices
https://bloodcell.transplant.hrsa.gov/
ABOUT/Advisory_Council/.
The draft meeting agenda will be
posted on https://
www.acbsctmeeting.com. Those
participating in this meeting should
register by visiting https://
www.acbsctmeeting.com. The deadline
to register for this meeting is
Wednesday, September 11, 2013. For all
logistical questions and concerns, please
contact Deborah Jones, Meeting Planner,
by calling (301) 585–1261 or by sending
an email to Deborah.Jones@luxcg.com.
The public can join the meeting by:
1. (Audio Portion) Calling the
conference number at 800–857–9638
and providing the Participant Code
75841, AND
2. (Visual Portion) Connecting to the
ACBSCT Adobe Connect Pro Meeting
using the following URL and entering as
GUEST: https://
hrsa.connectsolutions.com/
acbsct_advisory/ (copy and paste the
link into your browser if it does not
work directly, and enter as a guest).
Participants should call and connect
15 minutes prior to the meeting in order
for logistics to be set up. If you have
never attended an Adobe Connect
meeting, please test your connection
using the following URL: https://
hrsa.connectsolutions.com/common/
help/en/support/meeting_test.htm and
get a quick overview by following URL:
https://www.adobe.com/go/
connectpro_overview.
Call (301) 443–0437 or send an email
to ptongele@hrsa.gov if you are having
trouble connecting to the meeting site.
Public Comment: It is preferred that
persons interested in providing an oral
presentation submit a written request,
along with a copy of their presentation
to: Passy Tongele, MBA, Division of
Transplantation, Healthcare Systems
Bureau, Health Resources and Services
Administration, Room 12C–06, 5600
Fishers Lane, Rockville, Maryland
20857 or email at ptongele@hrsa.gov.
Requests should contain the name,
address, telephone number, email
address, and any business or
professional affiliation of the person
desiring to make an oral presentation.
Groups having similar interests are
requested to combine their comments
and present them through a single
representative.
The allocation of time may be
adjusted to accommodate the level of
expressed interest. Persons who do not
file an advance request for a
presentation, but desire to make an oral
statement, may request it at the time of
the public comment period. Public
participation and ability to comment
will be limited to time as it permits.
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For Further Information Contact:
Patricia Stroup, MBA, MPA, Executive
Secretary, Healthcare Systems Bureau,
Health Resources and Services
Administration, 5600 Fishers Lane,
Room 12C–06, Rockville, Maryland
20857; telephone (301) 443–1127.
Dated: July 30, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–18825 Filed 8–5–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Inherited
Disease Research Access Committee
Date: September 12, 2013.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
509, 5635 Fishers Lane, Bethesda, MD 20892.
Contact Person: Camilla E. Day, Ph.D.,
Scientific Review Officer, CIDR, National
Human Genome Research Institute, National
Institutes of Health, 5635 Fishers Lane, Suite
4075, Bethesda, MD 20892, 301–402–8837,
camilla.day@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research,
National Institutes of Health, HHS)
Dated: July 31, 2013.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–18896 Filed 8–5–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the Environmental
Health Sciences Review Committee, July
24, 2013, 08:00 a.m. to July 26, 2013,
02:00 p.m., Double Tree by Hilton, 4810
Page Creek Lane, Ball Room, Durham,
NC, 27703 which was published in the
Federal Register on July 02, 2013, 2013–
15770.
The date of this meeting changed from
July 24–26, 2013 to September 18–19,
2013. The meeting is closed to the
public.
Dated: July 31, 2013.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–18895 Filed 8–5–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Council for Human
Genome Research.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council for Human Genome Research.
Date: September 9–10, 2013.
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]]>Agencies
[Federal Register Volume 78, Number 151 (Tuesday, August 6, 2013)]
[Notices]
[Pages 47714-47715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18825]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Council on Blood Stem Cell Transplantation; Notice of
Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
Name: Advisory Council on Blood Stem Cell Transplantation.
Date and Time: September 13, 2013, 10:00 a.m. to 4:00 p.m. (Eastern
Standard Time).
Place: The meeting will be via audio conference call and Adobe
Connect Pro.
Status: The meeting will be open to the public.
Purpose: Pursuant to Public Law 109-129, 42 U.S.C. 274k (section
379 of the Public Health Service Act, as amended), the Advisory Council
on Blood Stem Cell Transplantation (ACBSCT) advises the Secretary of
the Department of Health and Human Services and the Administrator,
Health Resources and Services Administration on matters related to the
activities of the C.W. Bill Young Cell Transplantation Program
(Program) and the National Cord Blood Inventory Program.
Agenda: The Council will hear reports from ACBSCT Work Groups
including: Cord Blood Thawing and Washing; Access to Transplantation;
and Advancing Hematopoietic Stem Cell Transplantation for
Hemoglobinopathies. The Council also will hear presentations and
discussions on topics including: Accreditation; Adverse Event
Reporting; and Unmet Need. Agenda items are subject to change as
priorities indicate.
After Council discussions, members of the public will have an
opportunity to provide comments. Because of the Council's full agenda
and the time frame in which to cover the agenda topics, public comment
will be limited. All public comments will be included in the record of
the ACBSCT meeting. Meeting summary notes will be posted on the HRSA's
Program Web site at
[[Page 47715]]
https://bloodcell.transplant.hrsa.gov/ABOUT/Advisory_Council/.
The draft meeting agenda will be posted on https://www.acbsctmeeting.com. Those participating in this meeting should
register by visiting https://www.acbsctmeeting.com. The deadline to
register for this meeting is Wednesday, September 11, 2013. For all
logistical questions and concerns, please contact Deborah Jones,
Meeting Planner, by calling (301) 585-1261 or by sending an email to
Deborah.Jones@luxcg.com.
The public can join the meeting by:
1. (Audio Portion) Calling the conference number at 800-857-9638
and providing the Participant Code 75841, AND
2. (Visual Portion) Connecting to the ACBSCT Adobe Connect Pro
Meeting using the following URL and entering as GUEST: https://hrsa.connectsolutions.com/acbsct_advisory/ (copy and paste the link
into your browser if it does not work directly, and enter as a guest).
Participants should call and connect 15 minutes prior to the
meeting in order for logistics to be set up. If you have never attended
an Adobe Connect meeting, please test your connection using the
following URL: https://hrsa.connectsolutions.com/common/help/en/support/meeting_test.htm and get a quick overview by following URL:
https://www.adobe.com/go/connectpro_overview.
Call (301) 443-0437 or send an email to ptongele@hrsa.gov if you
are having trouble connecting to the meeting site.
Public Comment: It is preferred that persons interested in
providing an oral presentation submit a written request, along with a
copy of their presentation to: Passy Tongele, MBA, Division of
Transplantation, Healthcare Systems Bureau, Health Resources and
Services Administration, Room 12C-06, 5600 Fishers Lane, Rockville,
Maryland 20857 or email at ptongele@hrsa.gov. Requests should contain
the name, address, telephone number, email address, and any business or
professional affiliation of the person desiring to make an oral
presentation. Groups having similar interests are requested to combine
their comments and present them through a single representative.
The allocation of time may be adjusted to accommodate the level of
expressed interest. Persons who do not file an advance request for a
presentation, but desire to make an oral statement, may request it at
the time of the public comment period. Public participation and ability
to comment will be limited to time as it permits.
For Further Information Contact: Patricia Stroup, MBA, MPA,
Executive Secretary, Healthcare Systems Bureau, Health Resources and
Services Administration, 5600 Fishers Lane, Room 12C-06, Rockville,
Maryland 20857; telephone (301) 443-1127.
Dated: July 30, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-18825 Filed 8-5-13; 8:45 am]
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