Blood Establishment Computer Software: Understanding What to Include in a 510(k) Submission; Public Workshop, 44374-44375 [E9-20781]
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Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Notices
Committee. The list of research topics to
be discussed at the meeting will be
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prior to the meeting: https://
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21:38 Aug 27, 2009
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(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: August 24, 2009.
Barry M. Straube,
Chief Medical Officer and Director, Office
of Clinical Standards and Quality, Centers
for Medicare & Medicaid Services.
[FR Doc. E9–20844 Filed 8–27–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Blood Establishment Computer
Software: Understanding What to
Include in a 510(k) Submission; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Blood Establishment
Computer Software: Understanding
What to Include in a 510(k)
Submission.’’ The purpose of the public
workshop is to educate industry on the
laws and regulations for medical
devices that are applicable to Blood
Establishment Computer Software
(BECS), including requirements for the
content of a 510(k) submission. The
public workshop will feature
presentations and panel discussions led
by FDA and other experts in software
quality engineering.
Date and Time: The public workshop
will be held on November 4, 2009, from
PO 00000
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8:30 a.m. to 5 p.m. and November 5,
2009, from 8:30 a.m. to 12 noon.
Location: The public workshop will
be held at The Universities at Shady
Grove Conference Center, Bldg. II,
multipurpose room, 9630 Gudelsky Dr.,
Rockville, MD 20850.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research (HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 550N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or e-mail your
registration information (including
name, title, firm name, address,
telephone, and fax numbers) to the
contact person by October 16, 2009.
There is no registration fee for the
public workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 7:30
a.m.
If you need special accommodations
due to a disability, please contact
Rhonda Dawson (see Contact Person) at
least 7 days in advance.
SUPPLEMENTARY INFORMATION: BECS is a
device used in the prevention of disease
in humans, by identifying unsuitable
donors and preventing the release of
infectious or otherwise harmful blood
and blood components for transfusion
or for further manufacturing use.
Facilities that manufacture and
distribute BECS are subject to device
provisions of the Federal Food, Drug,
and Cosmetic Act (the act), including
premarket notification under section
510(k) of the act (21 U.S.C. 360(k)) and
applicable regulations at 21 CFR 807,
subpart E. The public workshop will
consist of a series of presentations,
question-and-answer sessions, and a
panel discussion on the following
topics:
• The history and legal framework of
BECS regulation in the United States;
• Content of 510(k) submissions,
applicable regulations, and guidance;
• Common challenges in obtaining
510(k) clearance;
• FDA-recognized software standards;
• General software quality
engineering;
• Transfusion safety management
systems (blood administration software);
• Virtualization; and
• Wireless technology.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
E:\FR\FM\28AUN1.SGM
28AUN1
Federal Register / Vol. 74, No. 166 / Friday, August 28, 2009 / Notices
44375
approximately 15 working days after the
public workshop at a cost of 10 cents
per page. A transcript of the public
workshop will be available on the
Internet at https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
TranscriptsMinutes/default.htm.
Dated: August 21, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–20775 Filed 8–27–09; 8:45 am]
DEPARTMENT OF HOMELAND
SECURITY
BILLING CODE 4140–01–P
Dated: August 21, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20781 Filed 8–27–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities: Form I–485 and
Supplements A and E, Revision of a
Currently Approved Information
Collection; Comment Request
BILLING CODE 4160–01–S
National Cancer Institute; Notice of
Closed Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
hsrobinson on DSK69SOYB1PROD with NOTICES
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: National Heart, Lung,
and Blood Institute Special Emphasis Panel.
Cardiopulmonary and Hematology Grant
Opportunities (ARRA).
Date: September 2, 2009.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Telephone Conference Call)
Contact Person: Robert Blaine Moore, PhD,
Scientific Review Officer, Review Branch/
DERA, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Room 7213,
Bethesda, MD 20892. 301–594–8394.
mooreb@nhlbi.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research; 93.701, ARRA
Related Biomedical Research and Research
Support Awards., National Institutes of
Health, HHS)
VerDate Nov<24>2008
21:38 Aug 27, 2009
Jkt 217001
National Institutes of Health
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: National Cancer
Institute Initial Review Group; Subcommittee
J—Population and Patient-Oriented Training.
Date: October 28, 2009.
Time: 7:45 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Monaco Alexandria, 480 King
Street, Alexandria, VA.
Contact Person: Ilda M. Mckenna, PhD,
Scientific Review Officer, Research Training
Review Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Boulevard, Room 8111, Bethesda,
MD 20892, 301–496–7481,
mckennai@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: August 21, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–20782 Filed 8–27–09; 8:45 am]
BILLING CODE 4140–01–P
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U.S. Citizenship and Immigration
Services
ACTION: 30-Day Notice of Information
Collection Under Review: Form I–485
and Supplements A and E, Application
to Register Permanent Residence or
Adjust Status; OMB Control No. 1615–
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The Department of Homeland
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review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection was
previously published in the Federal
Register on June 11, 2009, at 74 FR
27811, allowing for a 60-day public
comment period. USCIS did not receive
any comments for this information
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The purpose of this notice is to allow
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Written comments and/or suggestions
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estimated public burden and associated
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and Regulatory Affairs, Office of
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submitted to: USCIS, Chief, Regulatory
Products Division, Clearance Office, 111
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20529–2210. Comments may also be
submitted to DHS via facsimile to 202–
272–8352 or via e-mail at
rfs.regs@dhs.gov, and to OMB USCIS
Desk Officer via facsimile at 202–395–
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When submitting comments by e-mail
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E:\FR\FM\28AUN1.SGM
28AUN1
]]>Agencies
[Federal Register Volume 74, Number 166 (Friday, August 28, 2009)]
[Notices]
[Pages 44374-44375]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20781]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Blood Establishment Computer Software: Understanding What to
Include in a 510(k) Submission; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Blood Establishment Computer Software:
Understanding What to Include in a 510(k) Submission.'' The purpose of
the public workshop is to educate industry on the laws and regulations
for medical devices that are applicable to Blood Establishment Computer
Software (BECS), including requirements for the content of a 510(k)
submission. The public workshop will feature presentations and panel
discussions led by FDA and other experts in software quality
engineering.
Date and Time: The public workshop will be held on November 4,
2009, from 8:30 a.m. to 5 p.m. and November 5, 2009, from 8:30 a.m. to
12 noon.
Location: The public workshop will be held at The Universities at
Shady Grove Conference Center, Bldg. II, multipurpose room, 9630
Gudelsky Dr., Rockville, MD 20850.
Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 550N, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843,
e-mail: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or e-mail your registration information
(including name, title, firm name, address, telephone, and fax numbers)
to the contact person by October 16, 2009. There is no registration fee
for the public workshop. Early registration is recommended because
seating is limited. Registration on the day of the public workshop will
be provided on a space available basis beginning at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Rhonda Dawson (see Contact Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: BECS is a device used in the prevention of
disease in humans, by identifying unsuitable donors and preventing the
release of infectious or otherwise harmful blood and blood components
for transfusion or for further manufacturing use. Facilities that
manufacture and distribute BECS are subject to device provisions of the
Federal Food, Drug, and Cosmetic Act (the act), including premarket
notification under section 510(k) of the act (21 U.S.C. 360(k)) and
applicable regulations at 21 CFR 807, subpart E. The public workshop
will consist of a series of presentations, question-and-answer
sessions, and a panel discussion on the following topics:
The history and legal framework of BECS regulation in the
United States;
Content of 510(k) submissions, applicable regulations, and
guidance;
Common challenges in obtaining 510(k) clearance;
FDA-recognized software standards;
General software quality engineering;
Transfusion safety management systems (blood
administration software);
Virtualization; and
Wireless technology.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
[[Page 44375]]
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/TranscriptsMinutes/default.htm.
Dated: August 21, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20781 Filed 8-27-09; 8:45 am]
BILLING CODE 4160-01-S
