Public Meeting of the Consumer Operated and Oriented Plan (CO-OP) Advisory Board, March 14, 2011, 11484-11485 [2011-4556]
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Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices
0070 (‘‘Dose Reconstruction During
Residual Radioactivity Periods at
Atomic Weapons Employer Facilities’’);
and a continuation of the commentresolution process for other dose
reconstruction procedures under review
by the Subcommittee.
The agenda is subject to change as
priorities dictate.
This meeting is open to the public,
but without a public comment period.
In the event an individual wishes to
provide comments, written comments
may be submitted. Any written
comments received will be provided at
the meeting and should be submitted to
the contact person below in advance of
the meeting.
Contact Person for More Information:
Theodore Katz, Executive Secretary,
NIOSH, CDC, 1600 Clifton Road,
Mailstop E–20, Atlanta, GA 30333,
Telephone (513) 533–6800, Toll Free 1
(800) CDC–INFO, E-mail dcas@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention, and the Agency for Toxic
Substances and Disease Registry.
Dated: February 24, 2011.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2011–4597 Filed 3–1–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–9978–N2]
Public Meeting of the Consumer
Operated and Oriented Plan (CO–OP)
Advisory Board, March 14, 2011
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
third meeting of an advisory committee
to the Center for Consumer Information
and Insurance Oversight (CCIIO) in
accordance with the Federal Advisory
Committee Act. The meeting is open to
the public. The purpose of the meeting
is to assist and advise the Secretary and
the Congress on the Department’s
strategy to foster the creation of
qualified nonprofit health insurance
issuers. Specifically, the Committee
emcdonald on DSK2BSOYB1PROD with NOTICES
SUMMARY:
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16:34 Mar 01, 2011
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shall advise the Secretary and the
Congress concerning the award of grants
and loans related to Section 1322 of the
Affordable Care Act, which provides for
a Federal program to assist
establishment and operation of
nonprofit, member run health insurance
issuers. In these matters, the Committee
shall consult with all components of the
Department, other federal entities, and
non-Federal organizations, as
appropriate; and examine relevant data
sources to assess the grant and loan
award strategy to provide
recommendations to CCIIO.
DATES: Meeting Date: March 14, 2011
from 8:30 a.m. to 5 p.m., Eastern
Standard Time (EST) Deadline for
Meeting Registration, Presentations and
Comments: March 10, 2011, 5 p.m.,
EST. Deadline for Requesting Special
Accommodations: March 10, 2011, 5
p.m., EST.
ADDRESSES: Meeting Location: Madison
Hotel, 1177 15th Street, NW.,
Washington, DC 20005.
Meeting Online Access: To participate
in this meeting via the Internet, go to
https://www.readyshow.com/ and enter
participant code 49888151. Note that
audio of the meeting will only be
broadcast through the conference phone
line.
Meeting Phone Access: To participate
in this meeting via phone, please dial
into the toll free phone number 1–888–
299–4099, and provide the following
code to the operator: VW38426.
Meeting Registration, Presentations,
and Written Comments: Anne Bollinger,
Center for Consumer Information and
Insurance Oversight, CMS, 200
Independence Avenue, SW.,
Washington, DC 20201, 301–492–395,
Fax: 301–492–4462, or contact by e-mail
at anne.bollinger@hhs.gov. Written
comments must be submitted in Word
format.
Registration: The meeting is open to
the public, but attendance is limited to
the space available. Persons wishing to
attend this meeting must register by
contacting the designated Federal
official at the address listed in the
ADDRESSES section of this notice or by
telephone at the number listed in the
FOR FURTHER INFORMATION CONTACT
section of this notice, by the date listed
in the DATES section of this notice.
FOR FURTHER INFORMATION CONTACT:
Anne Bollinger, 301–492–4395. Press
inquiries are handled through CCIIO’s
Press Office at (202) 690–6343.
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of the meeting is to assist
and advise the Secretary and the
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Congress on the Department’s strategy to
foster the creation of qualified nonprofit
health insurance issuers. Specifically,
the Committee shall advise the
Secretary and the Congress concerning
the award of grants and loans related to
section 1322 of the Affordable Care Act,
which provides for a Federal program to
assist establishment and operation of
nonprofit, member run health insurance
issuers. In these matters, the Committee
shall consult with all components of the
Department, other Federal entities, and
non-Federal organizations, as
appropriate; and examine relevant data
sources to assess the grant and loan
award strategy to provide
recommendations to CCIIO.
II. Meeting Agenda
The Committee will hear comments
from the public and then begin
deliberations on proposed
recommendations presented by the
work groups from the Committee. CCIIO
intends to make background material
available to the public no later than two
(2) business days prior to the meeting.
If CCIIO is unable to post the
background material on its Web site
prior to the meeting, it will be made
publicly available at the location of the
advisory committee meeting, and the
background material will be posted on
CCIIO’s Web site after the meeting, at
https://hhs.gov/CCIIO.
Oral comments from the public will
be scheduled between approximately
8:30 a.m.–9:30 a.m. Individuals or
organizations that wish to make a 3minute oral presentation on an agenda
topic should submit a written copy in
Word format of the oral presentation to
the designated federal official (DFO) at
the address listed in the ADDRESSES
section of this notice by the date listed
in the DATES section of this notice. The
number of oral presentations may be
limited by the time available. Persons
attending CCIIO’s advisory committee
meetings are advised that the agency is
not responsible for providing access to
electrical outlets. If the number of
speakers requesting to comment is
greater than can be reasonably
accommodated during the scheduled
open public comment session, CCIIO
will take written comments after the
meeting until close of business.
Individuals not wishing to make a
presentation may submit written
comments in Word format to the DFO at
the address listed in the ADDRESSES
section of this notice by the date listed
in the DATES section of this notice.
Individuals requiring sign language
interpretation or other special
accommodations must contact the DFO
via the contact information specified in
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Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices
the FOR FURTHER INFORMATION CONTACT
section of this notice by the date listed
in the DATES section of this notice.
CCIIO is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.hhs.gov/CCIIO for
procedures on public conduct during
advisory committee meetings.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
[FR Doc. 2011–4556 Filed 2–25–11; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0542]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Information
Request Regarding Dissolvable
Tobacco Products
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by April 1,
2011.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Information Request Regarding
Dissolvable Tobacco Products.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
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SUMMARY:
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In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Information Request Regarding
Dissolvable Tobacco Products—(OMB
Control Number 0910–NEW)
Dated: February 24, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare &
Medicaid Services.
AGENCY:
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (the Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) by adding a new chapter
granting FDA important new authority
to regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 917 of the Tobacco Control
Act (21 U.S.C. 387q) requires the
Secretary of Health and Human Services
(the Secretary) to establish a Tobacco
Products Scientific Advisory Committee
(TPSAC). Section 907(f) of the Tobacco
Control Act (21 U.S.C. 387g(f)) requires
the TPSAC to submit a report and
recommendations to the Secretary on
the impact of the use of dissolvable
tobacco products on the public health,
including such use among children. To
ensure a comprehensive review of this
issue, FDA is requesting tobacco
industry documents and information to
support the work of TPSAC. Under
section 907(f), TPSAC must submit its
report and recommendations to the
Secretary within 2 years after its
establishment, or March 22, 2012.
In order to provide TPSAC with the
information it needs to carry out its
statutory obligation, FDA is requesting
that tobacco companies submit
information under section 904(b) of the
Tobacco Control Act (21 U.S.C. 387d(b))
pertaining to documents and underlying
scientific and financial information
relating to research, and research
findings, conducted, supported, or
possessed by the manufacturer (or
agents thereof) on a specified set of
topics. For the purposes of this request,
‘‘research’’ may include, but is not
limited to, focus groups, surveys,
experimental clinical studies,
postmarketing surveillance,
toxicological and biochemical assays,
taste panels, and assessments of the
effectiveness of product marketing
practices. Topics for which information
relating to dissolvable tobacco products
is requested are marketing research;
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marketing practices; effectiveness of
marketing practices; and health,
toxicological, behavioral, and
physiological effects. FDA’s request for
documents related to dissolvable
tobacco products includes, but is not
limited to products for research,
investigational use, developmental
studies, test marketing, and/or
commercial marketing, and also to the
components, parts, or accessories of
such products.
In the Federal Register of October 25,
2010 (75 FR 65490), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received eight
comments from seven commenters; six
comments pertaining to the notice, and
two comments pertaining to the
information collection. Six comments
were beyond the scope of this
information request (e.g., tobacco is
dangerous, dissolvable tobacco products
are appealing to children, FDA should
let the market prevail, FDA reviewers
and TPSAC are not impartial).
Comments relevant to the information
request are addressed in this document.
One commenter suggested that they
would like to withhold proprietary
information or have FDA mark the
information received as ‘‘confidential
and proprietary’’, and would like FDA to
explicitly state in the letter that FDA
does not require nor accept publically
available information. The commenter
would like FDA to accept submission of
lists, summaries, and abstracts as a first
pass so FDA could then decide which
documents it really needs, and would
like FDA to better explain what it is
looking for with regard to internal
reports. The commenter would like FDA
to restrict submissions to primary
research data, and would like FDA to
provide specific instructions for the
citing of previously submitted
documents so they can be fully
referenced. FDA’s response is that, with
regard to confidential and proprietary
information, documents submitted
under section 904(b) of the FD&C Act
may include, but are not limited to a
company’s non-public, trade secret, or
confidential commercial information.
FDA also notes that several laws govern
maintaining the confidentiality of new
tobacco product information submitted
under section 904(b), including sections
301(j) and 906(c) of the FD&C Act
(21 U.S.C. 331(j) and 387f(c)), the Trade
Secrets Act (18 U.S.C. 1905), and the
Freedom of Information Act (FOIA)
(5 U.S.C. 552), as well as FDA’s
implementing regulations. FDA’s
general regulations concerning the
public availability of FDA’s records are
contained in 21 CFR part 20. With
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]]>Agencies
[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Notices]
[Pages 11484-11485]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4556]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-9978-N2]
Public Meeting of the Consumer Operated and Oriented Plan (CO-OP)
Advisory Board, March 14, 2011
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
SUMMARY: This notice announces the third meeting of an advisory
committee to the Center for Consumer Information and Insurance
Oversight (CCIIO) in accordance with the Federal Advisory Committee
Act. The meeting is open to the public. The purpose of the meeting is
to assist and advise the Secretary and the Congress on the Department's
strategy to foster the creation of qualified nonprofit health insurance
issuers. Specifically, the Committee shall advise the Secretary and the
Congress concerning the award of grants and loans related to Section
1322 of the Affordable Care Act, which provides for a Federal program
to assist establishment and operation of nonprofit, member run health
insurance issuers. In these matters, the Committee shall consult with
all components of the Department, other federal entities, and non-
Federal organizations, as appropriate; and examine relevant data
sources to assess the grant and loan award strategy to provide
recommendations to CCIIO.
DATES: Meeting Date: March 14, 2011 from 8:30 a.m. to 5 p.m., Eastern
Standard Time (EST) Deadline for Meeting Registration, Presentations
and Comments: March 10, 2011, 5 p.m., EST. Deadline for Requesting
Special Accommodations: March 10, 2011, 5 p.m., EST.
ADDRESSES: Meeting Location: Madison Hotel, 1177 15th Street, NW.,
Washington, DC 20005.
Meeting Online Access: To participate in this meeting via the
Internet, go to https://www.readyshow.com/ and enter participant code
49888151. Note that audio of the meeting will only be broadcast through
the conference phone line.
Meeting Phone Access: To participate in this meeting via phone,
please dial into the toll free phone number 1-888-299-4099, and provide
the following code to the operator: VW38426.
Meeting Registration, Presentations, and Written Comments: Anne
Bollinger, Center for Consumer Information and Insurance Oversight,
CMS, 200 Independence Avenue, SW., Washington, DC 20201, 301-492-395,
Fax: 301-492-4462, or contact by e-mail at anne.bollinger@hhs.gov.
Written comments must be submitted in Word format.
Registration: The meeting is open to the public, but attendance is
limited to the space available. Persons wishing to attend this meeting
must register by contacting the designated Federal official at the
address listed in the ADDRESSES section of this notice or by telephone
at the number listed in the FOR FURTHER INFORMATION CONTACT section of
this notice, by the date listed in the DATES section of this notice.
FOR FURTHER INFORMATION CONTACT: Anne Bollinger, 301-492-4395. Press
inquiries are handled through CCIIO's Press Office at (202) 690-6343.
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of the meeting is to assist and advise the Secretary
and the Congress on the Department's strategy to foster the creation of
qualified nonprofit health insurance issuers. Specifically, the
Committee shall advise the Secretary and the Congress concerning the
award of grants and loans related to section 1322 of the Affordable
Care Act, which provides for a Federal program to assist establishment
and operation of nonprofit, member run health insurance issuers. In
these matters, the Committee shall consult with all components of the
Department, other Federal entities, and non-Federal organizations, as
appropriate; and examine relevant data sources to assess the grant and
loan award strategy to provide recommendations to CCIIO.
II. Meeting Agenda
The Committee will hear comments from the public and then begin
deliberations on proposed recommendations presented by the work groups
from the Committee. CCIIO intends to make background material available
to the public no later than two (2) business days prior to the meeting.
If CCIIO is unable to post the background material on its Web site
prior to the meeting, it will be made publicly available at the
location of the advisory committee meeting, and the background material
will be posted on CCIIO's Web site after the meeting, at https://hhs.gov/CCIIO.
Oral comments from the public will be scheduled between
approximately 8:30 a.m.-9:30 a.m. Individuals or organizations that
wish to make a 3-minute oral presentation on an agenda topic should
submit a written copy in Word format of the oral presentation to the
designated federal official (DFO) at the address listed in the
ADDRESSES section of this notice by the date listed in the DATES
section of this notice. The number of oral presentations may be limited
by the time available. Persons attending CCIIO's advisory committee
meetings are advised that the agency is not responsible for providing
access to electrical outlets. If the number of speakers requesting to
comment is greater than can be reasonably accommodated during the
scheduled open public comment session, CCIIO will take written comments
after the meeting until close of business. Individuals not wishing to
make a presentation may submit written comments in Word format to the
DFO at the address listed in the ADDRESSES section of this notice by
the date listed in the DATES section of this notice.
Individuals requiring sign language interpretation or other special
accommodations must contact the DFO via the contact information
specified in
[[Page 11485]]
the FOR FURTHER INFORMATION CONTACT section of this notice by the date
listed in the DATES section of this notice.
CCIIO is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.hhs.gov/CCIIO for
procedures on public conduct during advisory committee meetings.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: February 24, 2011.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2011-4556 Filed 2-25-11; 11:15 am]
BILLING CODE 4120-01-P
