70008 Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices 

oral conditions, as well as leading to 

nicotine addiction and dependence. 

Furthermore, SLT use is not a safe 

substitute for cigarette smoking. 

Adolescents who use smokeless tobacco 

are more likely to become cigarette 

smokers. 

The Centers for Disease Control and 

Prevention (CDC), Office on Smoking 

and Health (OSH), has primary 

responsibility for the Department of 

Health and Human Services (HHS) 

smoking and health program. HHS’s 

overall goal is to reduce death and 

disability resulting from the use of 

smokeless tobacco products and other 

forms of tobacco through programs of 

information, education and research. 

The Comprehensive Smokeless 

Tobacco Health Education Act of 1986 

(CSTHEA, 15 U.S.C. 4401 et seq., Pub. 

L. 99–252) requires each person who 

manufactures, packages, or imports 

smokeless tobacco products to provide 

the Secretary of Health and Human 

Services (HHS) with a list of ingredients 

added to tobacco in the manufacture of 

smokeless tobacco products. CSTHEA 

further requires submission of the 

quantity of nicotine contained in each 

smokeless tobacco product. Finally, the 

legislation authorizes HHS to undertake 

research, and to report to Congress (as 

deemed appropriate) discussing the 

health effects of these ingredients. 

HHS has delegated responsibility for 

implementing the required information 

collection to CDC’s Office on Smoking 

and Health. Respondents are not 

required to submit specific forms; 

however, they are required to meet 

reporting guidelines and to submit the 

ingredient report by chemical name and 

Chemical Abstract Service (CAS) 

Registration Number, consistent with 

accepted reporting practices for other 

companies that are required to report 

ingredients added to other consumer 

products. Typically, respondents submit 

a summary report to CDC with the 

ingredient information for multiple 

products, or a statement that there are 

no changes to their previously 

submitted ingredient report. 

Respondents may submit the required 

information to CDC through a 

designated representative. 

Ingredient reports for new SLT 

products are due at the time of first 

importation. Thereafter, ingredient 

reports are due annually on March 31. 

Information is submitted to OSH by 

mailing a written report on the 

respondent’s letterhead, by CD, threeinch floppy disk, or thumb drive. 

Electronic mail submissions are not 

accepted. Upon receipt and verification 

of the annual nicotine and ingredient 

report, OSH issues a Certificate of 

Compliance to the respondent. 

There are no costs to respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Smokeless Tobacco Manufacturers, Packagers, and Importers.SLT Nicotine and Ingredient 

and Report.

11 1 1,713 18,843 

Dated: November 9, 2010. 

Carol E. Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–28786 Filed 11–15–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Office of Community Services 

(OCS) Community Economic 

Development (CED) and Job 

Opportunities for Low-Income 

Individuals (JOLI) Standard Reporting 

Format. 

OMB No.: New Collection. 

Description: The Office of Community 

Services (OCS) is collecting key 

information about projects funded 

through the Community Economic 

Development (CED) and Job 

Opportunities for Low-Income 

Individuals (JOLI) programs. The 

legislative requirement for these two 

programs is in Title IV of the 

Community Opportunities, 

Accountability and Training and 

Educational Services Act (COATS 

Human Services Reauthorization Act) of 

October 27, 1998, Public Law 105–285, 

section 680(b) as amended. The 

Performance Progress Report (PPR) is a 

new proposed reporting format that will 

collect information concerning the 

outcomes and management of CED and 

JOLI projects. OCS will use the data to 

critically review the overall design and 

effectiveness of each program. 

The PPR will be administered to all 

active grantees of the CED and JOLI 

programs. Grantees will be required to 

use this reporting tool for their 

semiannual reports. The majority of the 

questions in this tool were adapted from 

a previously approved questionnaire, 

Office of Management and Budget 

(OMB) Control Number: 0970–0317. 

Questions were also adapted to the 

OMB-approved reporting format of the 

PPR, specifically forms SF–PPR, SF– 

PPR–A, SF–PPR–B, and SF–PPR–E. 

Additional changes were made to 

improve the clarity and quality of the 

data and to eliminate unnecessary 

questions. The PPR will replace both the 

annual questionnaire and the current 

semi-annual reporting format, which 

will result in an overall reduction in 

burden for the grantees while 

significantly improving the quality of 

the data collected by OCS. 

Respondents: Current CED and JOLI 

grantees. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

Questionnaire for current OCS–JOLI grantees ............................................... 40 2 1.50 120 

Questionnaire for current OCS–CED grantees ............................................... 170 2 1.50 510 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices 70009 

Estimated Total Annual Burden 

Hours: 630. 

Additional Information: 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: 202– 

395–7285, E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: November 10, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–28855 Filed 11–15–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Development of Health Risk 

Assessment Guidance 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Request for Information. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) located 

within the Department of Health and 

Human Services (HHS) is seeking public 

comment on the development of 

guidance concerning Health Risk 

Assessment (HRAs). Section 4103 of the 

Affordable Care Act (ACA) (Pub. L. 111– 

148) requires that a health risk 

assessment be included in the annual 

wellness visit benefit authorized for 

Medicare beneficiaries under the ACA. 

CDC is collaborating with the Centers 

for Medicare and Medicaid Services 

(CMS), also located within HHS, in the 

development of guidance for this type of 

assessment. This guidance is also 

intended to be useful for HRAs 

conducted in other patient populations 

such as privately insured populations, 

including those persons covered by 

employer healthcare plans. Comments 

received from this request for 

information will be used to inform the 

HRA guidance development process. 

DATES: Written comments must be 

received on or before January 3, 2011. 

Comments received after January 3, 

2011 will be considered to the extent 

possible. 

ADDRESSES: You may submit written 

comments to the following address: 

Office of Prevention through Healthcare, 

Office of the Associate Director for 

Policy, Centers for Disease Control and 

Prevention, 1600 Clifton Road, NE., 

Mailstop D–28, Atlanta, Georgia, 30333, 

ATTN: Health Risk Assessment 

Guidance. 

You may also submit written 

comments via e-mail to: OPTH@cdc.gov. 

Please use ‘‘Health Risk Assessment 

Guidance’’ for the subject line. 

Submitted comments will be available 

for public review from Monday through 

Friday, except for legal holidays, from 9 

a.m. until 5 p.m. Eastern Standard Time, 

at 1600 Clifton Road NE., Atlanta, 

Georgia 30333. Please call ahead to 1– 

404–639–0210 and ask for a 

representative in the Office of 

Prevention through Healthcare to 

schedule your visit. Comments will also 

be available for viewing at the following 

Internet address: http://www.cdc.gov/ 

policy/opth/. 

CDC will make all comments it 

receives available to the public without 

change, including personal information 

you may provide, which includes the 

name of the person submitting the 

comment or signing the comment on 

behalf of an organization, business, or 

any such entity. If anyone does not wish 

to have this information published, then 

that information should not be included 

when submitting the comment. 

FOR FURTHER INFORMATION CONTACT: 

Paula Staley, Office of Prevention 

through Healthcare, Associate Director 

for Policy, Centers for Disease Control 

and Prevention, 1600 Clifton Road, NE., 

Mailstop D–28, Atlanta, Georgia, 30333, 

telephone: (404) 639–0210. 

SUPPLEMENTARY INFORMATION: 

Section 4103 of the Affordable Care 

Act (ACA) requires that a health risk 

assessment be included in the annual 

wellness visit benefit authorized for 

Medicare beneficiaries under the ACA. 

CDC is collaborating with CMS to 

develop guidance for this type of 

assessment. This guidance is also 

intended to be useful for HRAs 

conducted in other patient populations 

such as privately insured populations, 

including those persons covered by 

employer healthcare plans. 

Currently there is considerable 

variation in available HRAs, with the 

majority of assessments created to 

support employer-based health and 

wellness programs. Several instruments 

have been created for use in research 

and are not available in the marketplace; 

and the scientific rigor of HRA tools is 

not always evident. Therefore, the 

development of HRA guidance is 

essential for effective implementation of 

this part of the Medicare wellness visit 

and to support broader HRA use within 

primary care. 

Although comments on any aspect of 

the guidance development process will 

be accepted, comments are especially 

solicited about these areas of emphasis: 

Content and Design 

• Risk assessment domains—What 

are generic elements of any HRA and 

what elements must be tailored to 

specific populations, particularly those 

stratified by age? 

• How should literacy and other 

cultural appropriateness factors be 

factored into the design? 

• How should the HRA instrument 

support shared decision-making by 

provider and patient? 

Mode of Administration 

• How will individuals access the 

HRA (e.g., via kiosk or some other 

means in the physician’s office, Internet, 

mail-in paper form, other nontraditional healthcare locations, such as, 

kiosk in a pharmacy)? 

• What are the cultural 

appropriateness factors in patient HRA 

access? 

Primary Care Office Capacity 

• What primary care office capacity 

(personnel, Information Technology 

(IT), etc) is required to utilize HRA data 

effectively in support of personalized 

prevention planning? 

• Are training and technical 

assistance necessary for effective 

practice utilization of an HRA? What 

entity should provide this technical 

assistance? 

• What are potential or demonstrated 

community care transition linkages— 

follow-up outside the office by other 

providers—that help patients and 

providers manage priority risks 

identified by the HRA? 

• What is the current practice of HRA 

in medical practices of various sizes, 

particularly those with five or fewer 

physicians? 

mstockstill on DSKH9S0YB1PROD with NOTICES