11484 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 

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 

http://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 

http://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 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 41 / Wednesday, March 2, 2011 / Notices 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 

http://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 

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 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: 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 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, 

Jonnalynn.Capezzuto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Information Request Regarding 

Dissolvable Tobacco Products—(OMB 

Control Number 0910–NEW) 

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; 

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 


emcdonald on DSK2BSOYB1PROD with NOTICES