7268 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 

order, physician participants must 

participate in active and ongoing 

programs to evaluate and modify their 

clinical practice patterns in order to 

control costs and ensure the quality of 

services provided, and the arrangement 

must create a high degree of 

interdependence and cooperation 

among physicians. As with qualified 

risk-sharing arrangements, any 

agreement concerning price or other 

terms of dealing must be reasonably 

necessary to achieve the efficiency goals 

of the joint arrangement. 

Paragraph III, for three years, requires 

RFV to notify the Commission before it 

enters into any arrangements to act as a 

messenger or an agent on behalf of any 

physicians, with payers regarding 

contracts. Paragraph IV sets out the 

information necessary to make the 

notification complete. 

Paragraph V, for three years, requires 

RFV to notify the Commission before 

participating in contracting with health 

plans on behalf of either a qualified risksharing or a qualified clinicallyintegrated joint arrangement. Paragraph 

VI sets out the information necessary to 

satisfy the notification requirement. 

Paragraph VII imposes other 

notification obligations on RFV and 

requires the termination of certain 

contracts that were entered into 

illegally. Paragraph VII.A require RFV to 

distribute the complaint and order to (1) 

physicians who have participated in 

RFV since 2001; (2) to various past and 

current personnel of RFV; and (3) to 

payers with whom RFV has dealt since 

2001. Paragraph VII.B requires RFV, at 

any payer’s request and without 

penalty, to terminate its existing 

contracts with the payer for the 

provision of physician services. 

Paragraph VII.B allows certain contracts 

currently in effect to be extended at the 

written request of the payer no longer 

than one year from the date that the 

order becomes final. Paragraph VII.C 

requires RFV to distribute payer 

requests for contract termination to 

physicians who participate in the 

contract Paragraph VII.D requires RFV 

for three years, to provide new 

members, personnel, and payers not 

previously receiving a copy, a copy of 

the Order and the Complaint. Paragraph 

VII.D also requires RFV to publish 

annually a copy of the Order and the 

Complaint in its newsletter. 

Paragraphs VIII, IX, and X impose 

various obligations on RFV to report or 

provide access to information to the 

Commission to facilitate the monitoring 

of compliance with the order. Finally, 

Paragraph XI provides that the order 

will expire in 20 years. 

By direction of the Commission. 

Donald S. Clark 

Secretary. 

[FR Doc. 2010–3033 Filed 2–17–10: 7:19 am] 

BILLING CODE 6750–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–New] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of a 

proposed information collection request 

for public comment. Interested persons 

are invited to send comments regarding 

this burden estimate or any other aspect 

of this collection of information, 

including any of the following subjects: 

(1) The necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, e-mail your request, 

including your address, phone number, 

OMB number, and OS document 

identifier, to 

Sherette.funncoleman@hhs.gov, or call 

the Reports Clearance Office on (202) 

690–6162. Written comments and 

recommendations for the proposed 

information collections must be directed 

to the OS Paperwork Clearance Officer 

at the above e-mail address within 60- 

days. 

Proposed Project: Evaluation of 

Medicare Personal Health Records 

Choice Pilot—OMB No. 0990–NEW— 

Office of the Assistant Secretary for 

Planning and Evaluation. 

Abstract: Since 2003, HHS has 

worked toward the goal of establishing 

electronic, longitudinal health records 

for Americans that can be accessed 

safely, across the Internet, and anytime 

and anywhere by patients, doctors, and 

other health care providers. In addition 

to electronic health records (EHRs), 

where health information is created, 

stored and accessed mainly by health 

care organizations and practitioners, 

personal health records (PHRs), 

electronic, patient-centered applications 

and services, are gaining increasing 

recognition and momentum. Current 

PHR business models represent broad 

and varied uses, from disease 

management to health promotion, with 

sponsors consisting of commercial 

vendors, heath plans, employers, and 

health care providers. We know very 

little about why consumers, and 

specifically Medicare beneficiaries, elect 

to use PHRs and what functionality they 

want from a PHR. Understanding these 

needs will be critical if HHS and the 

Centers for Medicare & Medicaid 

Services (CMS) are to pursue PHRs as a 

tool to empower consumers to manage 

their health and have the capability to 

link to their provider’s EHR. 

In January 2009, CMS launched a new 

program in Arizona and Utah, the 

Medicare PHR Choice Pilot (PHRC). 

This pilot encourages Medicare fee-forservice (FFS) beneficiaries to take 

advantage of the newer, more robust 

Internet-based tools for tracking their 

health and health care services. This is 

the first pilot to offer a choice of PHRs 

to Medicare FFS beneficiaries, including 

PHRs with additional functionality and 

direct data linkages for the consumers. 

Pilot participants can choose among 

GoogleHealthTM, NoMoreClipboardTM, 

PassportMDTM, and HealthTrioTM, 

competitors in the open PHR market. 

HHS’ Office of the Assistant Secretary 

for Planning and Evaluation (ASPE) has 

contracted with Mathematica Policy 

Research to conduct an evaluation of 

this pilot program, including a PHR 

enrollee user satisfaction survey to 

assess barriers, facilitators, and 

satisfaction with the PHRs. A selfadministered paper-and-pencil 

instrument will be the primary data 

collection mode for the PHRC user 

satisfaction survey, with telephone 

followup for mail nonrespondents. The 

one-time data collection field period is 

expected to be 12 weeks in Fall 2010. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 7269 

ESTIMATED ANNUALIZED BURDEN TABLE

Forms 

(if necessary) 

Type of 

respondent 

Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Self-administered questionnaire ....... Medicare beneficiaries ..................... 500 1 25/60 208 

Total ........................................... 500 ........................ ........................ 208 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. 2010–3071 Filed 2–17–10; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0074] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Registration and 

Product Listing for Owners and 

Operators of Domestic Tobacco 

Product Establishments and Listing of 

Ingredients in Tobacco Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the proposed extension of an existing 

collection of information pertaining to 

registration and product listing for 

owners and operators of domestic 

tobacco product establishments and to 

listing of ingredients in tobacco 

products under the Family Smoking 

Prevention and Tobacco Control Act 

(the Tobacco Control Act). 

DATES: Submit written or electronic 

comments on the collection of 

information by April 19, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Registration and Product Listing for 

Owners and Operators of Domestic 

Tobacco Product Establishments and 

Listing of Ingredients in Tobacco 

Products (OMB Control Number 0910– 

0650)—Extension 

On June 22, 2009, the President 

signed the Tobacco Control Act (Public 

Law 111–31) into law. The Tobacco 

Control Act amended the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 301 et seq.) by, among other 

things, 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 905(b) of the act (21 U.S.C. 

395(b)), as amended by the Tobacco 

Control Act, requires that ‘‘every person 

who owns or operates any establishment 

in any State engaged in the 

manufacture, preparation, 

compounding, or processing of a 

tobacco product or tobacco products 

***’’ register with FDA the name, 

places of business, and all 

establishments owned or operated by 

that person. Every person must register 

by December 31 of each year. Section 

905(i)(1) of the act, as amended by the 

Tobacco Control Act, requires that all 

registrants ‘‘shall, at the time of 

registration under any such subsection, 

file with [FDA] a list of all tobacco 

products which are being manufactured, 

prepared, compounded, or processed by 

that person for commercial 

distribution,’’ along with certain 

accompanying consumer information, 

such as all labeling and a representative 

sampling of advertisements. Section 

904(a)(1) of the act, as amended by the 

Tobacco Control Act, requires each 

tobacco product manufacturer or 

importer, or agent thereof, to submit ‘‘a 

listing of all ingredients, including 

tobacco, substances, compounds, and 

additives that are * * * added by the 

manufacturer to the tobacco, paper, 

filter, or other part of each tobacco 

product by brand and by quantity in 

each brand and subbrand.’’ Since the 

Tobacco Control act was enacted on 

June 22, 2009, the information required 

under section 904(a)(1) must be 

submitted to FDA by December 22, 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES