Federal Register / Vol. 75, No. 190 / Friday, October 1, 2010 / Notices 60759 

OMB No. 0930–0106). However, a 

separate OMB approval will be 

requested for the OTP survey. 

The OTP survey will use the same 

point prevalence date as the N–SSATS 

and will offer the same response options 

(paper questionnaire, online via the 

Internet, or by telephone with an 

interviewer). The information collected 

will include detailed information on 

OTP client characteristics and OTP 

facility operations, information that is 

not currently obtained by the N–SSATS 

or other federally-sponsored surveys. 

The findings will supplement 

information collected by the annual 

N–SSATS and will be published by 

SAMHSA in a separate report on Opioid 

Treatment Programs. Survey data will 

also be used to update SAMHSA’s 

‘‘Medication-Assisted Treatment for 

Opioid Addiction State Profiles.’’ These 

publications will be used by the Federal 

government, State and local 

governments, the U.S. Congress, 

researchers, and other health care 

professionals. The following Table 

summarizes the estimated response 

burden for the survey. 

ESTIMATED TOTAL RESPONSE BURDEN FOR THE 2011 OTP SURVEY

Number of 

respondents 

Responses per 

respondent 

Average hours 

per response 

Total hour 

burden 

Certified OTP Facilities—2011 Survey .................................................... 1,200 1 .83 996 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 8–1099, One Choke Cherry Road, 

Rockville, MD 20857 AND e-mail a copy 

to summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Dated: September 23, 2010. 

Elaine Parry, 

Director, Office of Management, Technology, 

and Operations. 

[FR Doc. 2010–24505 Filed 9–30–10; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–367] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506I(2)(A) of the Paperwork 

Reduction Act of 1995, the Centers for 

Medicare & Medicaid Services (CMS), 

Department of Health and Human 

Services is publishing the following 

summary of proposed collections 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 function; 

(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. 

1. Type of Information Collection 

Request: Revision of a currently 

approval collection; Title of Information 

Collection: Medicaid Drug Program 

Monthly and Quarterly Drug Reporting 

Format; Use: In order for payment to be 

made under Medicaid, the drug labeler 

must complete and sign a drug rebate 

agreement and fill in the information on 

the related documents. The Patient 

Protection and Affordable Care Act of 

2010 added two new data elements to 

potentially be reported by 

manufacturers. In addition, the Food 

and Drug Administration has informed 

us that ‘‘DESI’’ is now obsolete; 

therefore, we are replacing it with a 

more appropriate ‘‘rebate eligibility 

code’’ that will more accurately describe 

how a product is eligible for coverage 

under the drug rebate program. Form 

Number: CMS–367 (OMB#: 0938–0578); 

Frequency: Monthly and Quarterly; 

Affected Public: Private Sector: Business 

or other for-profits; Number of 

Respondents: 580; Total Annual 

Responses: 9,280; Total Annual Hours: 

137,344 (For policy questions regarding 

this collection contact Gail Sexton at 

410–786–4583. For all other issues call 

410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

e-mail 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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on November 1, 2010. OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: September 24, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–24477 Filed 9–30–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0488] 

Enforcement Action Plan for 

Promotion and Advertising 

Restrictions; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Enforcement Action Plan for Promotion 

and Advertising Restrictions’’ 

(Enforcement Action Plan), which 

describes FDA’s plan to enforce the 

restrictions on promotion and 

advertising of menthol and other 

cigarettes to youth and other 

requirements relating to tobacco product 

promotion and advertising established 

by the Family Smoking Prevention and 

Tobacco Control Act (Tobacco Control 

Act). As described in the Enforcement 

Action Plan, FDA intends to use a 

multipronged approach that includes 

surveillance, inspections, enforcement 

actions, and education to enforce and 

facilitate compliance with these 

restrictions and requirements. The 

Enforcement Action Plan includes 


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