Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices 48973 

mechanisms for providing specific 

information on a timely basis to current 

and prospective enrollees upon request. 

These mechanisms include, Internet 

Web site that includes information on 

part D plan description. MA 

organizations (formerly M+C 

organizations) and Prescription Drug 

Plan Sponsors use the information to 

comply with the eligibility requirements 

and the MA and part D contract 

requirements. CMS will use this 

information to ensure that correct 

information is disclosed to Medicare 

beneficiaries, both potential enrollees 

and enrollees. Form Number: CMS– 

10260 (OMB#: 0938–1051); Frequency: 

Reporting—Yearly; Affected Public: 

Business or other for-profits; Number of 

Respondents: 740; Total Annual 

Responses: 740; Total Annual Hours: 

8,880. (For policy questions regarding 

this collection contact Camille Brown at 

410–786–0274. For all other issues call 

410–786–1326.) 

5. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicaid and 

Children’s Health Insurance (CHIP) 

Managed Care; Use: The Payment Error 

Rate Measurement (PERM) program 

measures improper payments for 

Medicaid and the State Children’s 

Health Insurance Program (SCHIP). The 

program was designed to comply with 

the Improper Payments Information Act 

(IPIA) of 2002 and the Office of 

Management and Budget (OMB) 

guidance. Although OMB guidance 

requires error rate measurement for 

SCHIP, 2009 SCHIP legislation 

temporarily suspended PERM 

measurement for this program and 

changed to Children’s Health Insurance 

Program (CHIP) effective April 01, 2009. 

See Children’s Health Insurance 

Program Reauthorization Act of 2009 

(CHIPRA) Public Law 111–3 for more 

details. 

There are two phases of the PERM 

program, the measurement phase and 

the corrective action phase. PERM 

measures improper payments in 

Medicaid and CHIP and produces State 

and national-level error rates for each 

program. The error rates are based on 

reviews of Medicaid and CHIP fee-forservice (FFS) and managed care 

payments made in the Federal fiscal 

year under review. States conduct 

eligibility reviews and report eligibility 

related payment error rates also used in 

the national error rate calculation. CMS 

created a 17 State rotation cycle so that 

each State will participate in PERM 

once every three years. 

The information collected from the 

selected States will be used by Federal 

contractors to conduct Medicaid and 

CHIP managed care data processing 

reviews on which State-specific error 

rates will be calculated. The quarterly 

capitation payments will provide the 

contractor with the actual claims to be 

sampled. The managed care contracts, 

rate schedules, and updates to both, will 

be used by the federal contractor when 

conducting the managed care claims 

reviews. Form Number: CMS–10178 

(OMB#: 0938–0994); Frequency: 

Reporting—Occasionally; Affected 

Public: State, Local, or Tribal 

governments; Number of Respondents: 

34; Total Annual Responses: 2,040; 

Total Annual Hours: 28,050. (For policy 

questions regarding this collection 

contact Nicole Perry at 410–786–8786. 

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 email 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 October 26, 2009. 

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 18, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–23124 Filed 9–24–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection: Comment 

Request; 0MB No. 0925–0601/exp. 2/28/ 

2010, ‘‘Request for Human Embryonic 

Stem Cell Line To Be Approved for Use 

in NIH Funded Research’’ 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

Office of Extramural Research, the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (0MB) for 

review and approval. 

Proposed Collection: Title: Request for 

Human Embryonic Stem Cell Line to be 

Approved for Use in NIH Funded 

Research. Type of Information 

Collection Request: Extension, 0MB 

0925–0601, Expiration Date 2/28/2010. 

Form Number: 2890. The form is used 

by applicants to request that human 

embryonic stem cell lines be approved 

for use in NIH funded research. 

Applicants may submit applications at 

any time; this request is a one-time 

submission. Affected Public: Business 

or other for-profit; Not-for-profit 

institutions; Federal Government; and 

State, Local or Tribal Government. Type 

of Respondents: Adult scientific 

professionals. The annual reporting 

burden is as follows: 

Estimated Number of Respondents: 

100; Estimated Number of Responses 

per Respondent: 1; Average Burden 

Hours Per Response: 3; and Estimated 

Total Annual Burden Hours Requested: 

300. The estimated annualized cost to 

respondents is $10,500. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’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 those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Ms. Mikia Currie, 

Division of Grants Policy, Office of 

Policy for Extramural Research 

Administration, NIH, Rockledge 1 

Building, Room 3505, 6705 Rockledge 

Drive, Bethesda, MD 20892–7974, or 

call non-toll-free number 301–435– 

0941, or E-mail your request, including 

your address to: [curriem@od.nih.gov]. 

Comments Due Date: Comments 

regarding this information collection are 


jlentini on DSKJ8SOYB1PROD with NOTICES
48974 Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices 

best assured of having their full effect if 

received within 60-days of the date of 

this publication. 

Dated: September 17, 2009. 

Joe Ellis, 

Director, OPERA, OER, National Institutes of 

Health. 

[FR Doc. E9–23078 Filed 9–24–09; 8:45 am] 

BILLING CODE 4140–10–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0449] 

Enforcement of General Tobacco 

Standard Special Rule for Cigarettes 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Federal Food, Drug, and 

Cosmetic Act (the act), as amended by 

the Family Smoking Prevention and 

Tobacco Control Act (FSPTCA), 

establishes a tobacco standard special 

rule for cigarettes. This special rule for 

cigarettes prohibits a cigarette or any of 

its component parts (including the 

tobacco, filter, or paper) from 

containing, as a constituent (including a 

smoke constituent) or additive, an 

artificial or natural flavor (other than 

tobacco or menthol) or an herb or spice, 

including strawberry, grape, orange, 

clove, cinnamon, pineapple, vanilla, 

coconut, licorice, cocoa, chocolate, 

cherry, or coffee, that is a characterizing 

flavor of the tobacco product or tobacco 

smoke. The Food and Drug 

Administration (FDA) is providing this 

notice to remind regulated industry that 

as of the effective date identified in the 

FSPTCA, cigarettes that contain certain 

characterizing flavors are considered 

adulterated under the act. FDA is also 

providing in this notice contact 

information to which individuals who 

observe violative products after the 

effective date of the tobacco standard 

special rule may report their 

observations to FDA. 

DATES: Effective September 22, 2009. 

ADDRESSES: To report tobacco products 

that fail to comply with section 

907(a)(1)(A) of the act after September 

22, 2009, please contact the Center for 

Tobacco Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229, 877–287– 

1373 or http://www.fda.gov/flavored

tobacco. 

FOR FURTHER INFORMATION CONTACT: 

Michele Mital, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850–3229, 877–287– 

1373, Michele.Mital@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Smoking 

is the leading preventable cause of death 

in the United States. An important way 

to reduce the death and disease caused 

by smoking is to prevent children and 

adolescents from starting to smoke. 

Congress has stated that flavors make 

cigarettes more appealing to youth and 

often result in exposure to additional 

carcinogens and other toxic 

constituents. The removal from the 

market of cigarettes that contain certain 

characterizing flavors is an important 

step in FDA’s efforts to reduce the 

burden of illness and death caused by 

tobacco products. 

The FSPTCA provides FDA with 

regulatory authority over the 

manufacture, marketing, and 

distribution of tobacco products. 

Specifically, section 907(a)(1)(A) of the 

act, as amended by the FSPTCA, 

establishes a tobacco product standard 

special rule for cigarettes that states in 

part: ‘‘* * * a cigarette or any of its 

component parts (including the tobacco, 

filter, or paper) shall not contain, as a 

constituent (including a smoke 

constituent) or additive, an artificial or 

natural flavor (other than tobacco or 

menthol) or an herb or spice, including 

strawberry, grape, orange, clove, 

cinnamon, pineapple, vanilla, coconut, 

licorice, cocoa, chocolate, cherry, or 

coffee, that is a characterizing flavor of 

the tobacco product or tobacco smoke.’’ 

This standard applies to all tobacco 

products that meet the definition of a 

‘‘cigarette’’ in section 900(3) of the act, 

as amended, even if they are not labeled 

as ‘‘cigarettes’’ or are labeled as cigars or 

as some other product. 

As of the September 22, 2009, 

effective date, cigarettes and their 

component parts that fail to comply 

with the special rule established under 

section 907 of the act, as amended, are 

deemed adulterated under section 902 

of the act, as amended. Under the act, 

adulterated products sold or held for 

sale in the United States may be subject 

to seizure under section 304 of the act 

(21 U.S.C. 334). In addition, 

manufacturers, distributors, and 

retailers may be subject to injunction 

actions, civil money penalties, and/or 

criminal prosecution for violating the 

requirements of the act (sections 301, 

302, and 303 of the act (21 U.S.C. 331, 

332, and 333, respectively)). FDA 

intends to use the full range of 

enforcement tools within the agency’s 

authority to ensure compliance with the 

new requirement. 

FDA encourages individuals who 

observe violative products after 

September 22, 2009, to report their 

observations to FDA. This collection of 

information was approved under OMB 

control number 0910–0647 and expires 

on March 31, 2010. Individuals may 

report products in violation of this 

standard to FDA through the contact 

information provided in the ADDRESSES

section of this document. 

Dated: September 21, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23144 Filed 9–22–09; 11:15 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2487–FN] 

Medicare and Medicaid Programs; 

Application by the American 

Osteopathic Association for Continued 

Deeming Authority for Ambulatory 

Surgical Centers 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

our decision to approve the American 

Osteopathic Association (AOA) for 

continued recognition as a national 

accreditation program for ambulatory 

surgical centers (ASCs) seeking to 

participate in the Medicare or Medicaid 

programs. 

DATES: Effective Date: This final notice 

is effective on October 23, 2009 through 

October 23, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Cindy Melanson, (410) 786–0310. 

Patricia Chmielewski, (410) 786–6899. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services in an ambulatory surgical 

center (ASC) provided certain 

requirements are met. Sections 

1832(a)(2)(F)(i) of the Social Security 

Act (the Act) establishes distinct criteria 

for facilities seeking designation as an 

ASC. Under this authority, the 

minimum requirements that an ASC 

must meet to participate in Medicare are 

set forth in regulations at 42 CFR part 

416, which determine the basis and 

scope of ASC covered services, and the 

conditions for Medicare payment for 

facility services. Regulations concerning 

provider agreements are at 42 CFR part 

489 and those pertaining to activities 


jlentini on DSKJ8SOYB1PROD with NOTICES