Blood Products Advisory Committee; Notice of Meeting, 39814-39815 [E7-14088]
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mstockstill on PROD1PC66 with NOTICES
39814
Federal Register / Vol. 72, No. 139 / Friday, July 20, 2007 / Notices
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: The Medicare
and Medicaid Programs: Programs of
All-inclusive Care for the Elderly
(PACE); Form Number: CMS–R–244
(OMB#: 0938–0790); Use: PACE
organizations must demonstrate their
ability to provide quality communitybased care for the frail elderly who meet
their State’s nursing home eligibility
standards using capitated payments
from Medicare and the State. PACE
programs must provide all Medicare and
Medicaid covered services including
hospital, nursing home, home health,
and other specialized services. This
collection is necessary to ensure that
only appropriate organizations are
selected to become PACE organizations
and that CMS has the information
necessary to monitor the care they
provide; Frequency: Reporting—Once
and on occasion; Affected Public: Notfor-profit institutions and State, Local,
or Tribal Governments; Number of
Respondents: 54; Total Annual
Responses: 108; Total Annual Hours:
44131.50.
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Application for
Hospital Insurance Benefits; Form
Number: CMS–18F5 (OMB#: 0938–
0251); Use: The CMS–18F5 form is used
to establish entitlement to and
enrollment in Part A of Medicare for
beneficiaries who are not automatically
entitled to Medicare Part A under Title
XVIII of the Social Security Act and
must file an application. Sections
226(a), 227 and 1818A of the Social
Security Act and sections 42 CFR
406.10, 406.11 and 406.20 outline the
requirements for entitlement to
Medicare hospital insurance (Part A).
Section 42 CFR 406.6 provides
information about who needs to file an
application for Part A and who does not.
Section 42 CFR 406.7 lists the CMS–
18F5 form as the application to be used
by individuals applying for Part A of
Medicare. The CMS–18F5 form was
designed to capture all the information
needed to make a determination of an
individual’s entitlement to hospital
insurance (Part A); Frequency:
Reporting—once; Affected Public:
Individuals or households; Number of
Respondents: 50,000; Total Annual
Responses: 50,000; Total Annual Hours:
12,495.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
VerDate Aug<31>2005
16:19 Jul 19, 2007
Jkt 211001
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
Written comments and
recommendations for the proposed
information collections must be mailed
or faxed within 30 days of this notice
directly to the OMB desk officer: OMB
Human Resources and Housing Branch,
Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
Dated: July 12, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–13905 Filed 7–19–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Blood Products
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on August 16, 2007, from 8 a.m. to
5 p.m.
Location: Doubletree Hotel and
Executive Meeting Center, 8120
Wisconsin Ave., Bethesda, MD 20814.
Contact Person: Donald W. Jehn or
Pearline K. Muckelvene, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike (HFM–71), Rockville, MD
20852, 301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014519516. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
PO 00000
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Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On August 16, 2007, the
Committee will hear updates on the
following topics: (1) Summary of the
May 10 through 11, 2007, and the
August 6 through 7, 2007, meetings of
the Department of Health and Human
Services Advisory Committee on Blood
Safety and Availability; (2) summary of
the April 25 through 26, 2007, FDA
Workshop on Immune Globulins for
Primary Immune Deficiency Diseases:
Antibody Specificity, Potency and
Testing; and (3) summary of the August
15, 2007, FDA Workshop on Licensure
of Apheresis Blood Products. The
Committee will then hear informational
presentations relating to World Health
Organization (WHO) biological
standards on the following topics: (1)
Summary of the January 29 through 30,
2007, WHO meeting with WHO
collaborating centers for biological
standards and standardization to
support the development of WHO
biological reference preparations for
high risk blood safety-related in vitro
diagnostics; (2) potency and safety
standards for plasma derivatives; and (3)
joint FDA/WHO minimum potency
standards for certain blood grouping
reagents. The Committee will hear the
response of the Office of Blood Research
and Review to their office level site visit
of July 22, 2005. In the afternoon the
Committee will discuss measles
antibody levels in U.S. Immune
Globulin products.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 8, 2007. Oral
presentations from the public will be
E:\FR\FM\20JYN1.SGM
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Federal Register / Vol. 72, No. 139 / Friday, July 20, 2007 / Notices
scheduled between approximately 11:15
a.m. and 11:45 p.m. and between
approximately 3:30 p.m. and 4 p.m. on
August 16, 2007. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before July 31, 2007. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 1, 2007.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Donald W.
Jehn or Pearline K. Muckelvene at least
7 days in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 16, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–14088 Filed 7–19–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Cardiovascular
and Renal Drugs Advisory Committee
and the Drug Safety and Risk
Management Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committees: Cardiovascular
and Renal Drugs Advisory Committee
VerDate Aug<31>2005
16:19 Jul 19, 2007
Jkt 211001
and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 11, 2007, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD, 301–
977–8900.
Contact Person: Mimi Phan, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail:
Mimi.Phan@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code 3014512533
or 3014512535. Please call the
Information Line for up-to-date
information on this meeting. A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
agency’s Web site and call the
appropriate advisory committee hot
line/phone line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
updated information on the risks and
benefits of erythropoeisis-stimulating
agents (ARANESP, Amgen, Inc.,
EPOGEN, Amgen, Inc., and PROCRIT,
Amgen, Inc.) when used in the
treatment of anemia due to chronic
renal failure. This discussion follows a
March 9, 2007, FDA Public Health
Advisory regarding the use of these
agents (https://www.fda.gov/cder/drug/
advisory/RHE2007.htm).
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
PO 00000
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Fmt 4703
Sfmt 4703
39815
submissions may be made to the contact
person on or before August 27, 2007.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 17, 2007. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by August 20, 2007.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Mimi Phan at
301–827–7001, at least 7 days in
advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 16, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–14086 Filed 7–19–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0277]
Food Labeling: Use of Symbols to
Communicate Nutrition Information,
Consideration of Consumer Studies
and Nutritional Criteria; Public
Hearing; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is announcing a
public hearing concerning the use of
symbols to communicate nutrition
E:\FR\FM\20JYN1.SGM
20JYN1
]]>Agencies
[Federal Register Volume 72, Number 139 (Friday, July 20, 2007)]
[Notices]
[Pages 39814-39815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14088]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Blood Products Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Blood Products Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on August 16, 2007, from 8
a.m. to 5 p.m.
Location: Doubletree Hotel and Executive Meeting Center, 8120
Wisconsin Ave., Bethesda, MD 20814.
Contact Person: Donald W. Jehn or Pearline K. Muckelvene, Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike (HFM-71), Rockville, MD 20852, 301-827-0314, or FDA
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in
the Washington, DC area), code 3014519516. Please call the Information
Line for up-to-date information on this meeting. A notice in the
Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On August 16, 2007, the Committee will hear updates on the
following topics: (1) Summary of the May 10 through 11, 2007, and the
August 6 through 7, 2007, meetings of the Department of Health and
Human Services Advisory Committee on Blood Safety and Availability; (2)
summary of the April 25 through 26, 2007, FDA Workshop on Immune
Globulins for Primary Immune Deficiency Diseases: Antibody Specificity,
Potency and Testing; and (3) summary of the August 15, 2007, FDA
Workshop on Licensure of Apheresis Blood Products. The Committee will
then hear informational presentations relating to World Health
Organization (WHO) biological standards on the following topics: (1)
Summary of the January 29 through 30, 2007, WHO meeting with WHO
collaborating centers for biological standards and standardization to
support the development of WHO biological reference preparations for
high risk blood safety-related in vitro diagnostics; (2) potency and
safety standards for plasma derivatives; and (3) joint FDA/WHO minimum
potency standards for certain blood grouping reagents. The Committee
will hear the response of the Office of Blood Research and Review to
their office level site visit of July 22, 2005. In the afternoon the
Committee will discuss measles antibody levels in U.S. Immune Globulin
products.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and scroll down to the appropriate advisory committee
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
August 8, 2007. Oral presentations from the public will be
[[Page 39815]]
scheduled between approximately 11:15 a.m. and 11:45 p.m. and between
approximately 3:30 p.m. and 4 p.m. on August 16, 2007. Those desiring
to make formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before July 31, 2007. Time allotted for
each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by August 1, 2007.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Donald W. Jehn or
Pearline K. Muckelvene at least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 16, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-14088 Filed 7-19-07; 8:45 am]
BILLING CODE 4160-01-S
