25266 Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by June 7, 2010 to: SAMHSA 

Desk Officer, Human Resources and 

Housing Branch, Office of Management 

and Budget, New Executive Office 

Building, Room 10235, Washington, DC 

20503; due to potential delays in OMB’s 

receipt and processing of mail sent 

through the U.S. Postal Service, 

respondents are encouraged to submit 

comments by fax to: 202–395–6974. 

Dated: April 28, 2010. 

Elaine Parry, 

Director, Office of Program Services. 

[FR Doc. 2010–10907 Filed 5–6–10; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–901A and 901D] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) 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 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. 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Federal 

Qualification Application (42 CFR 

417.140) and Medicare Health Care 

Prepayment Plan Application (42 CFR 

417.800); Use: The application is the 

collection form used to obtain 

information to determine if an applicant 

meets the regulatory requirements to 

enter into a contract with CMS as a 

Federal Qualified health maintenance 

organization (HMO) or to provide health 

benefits to Medicare beneficiaries as a 

Medicare Health Care Prepayment Plan 

contractor. Form Number: CMS–901A & 

901D (OMB#: 0938–0470); Frequency: 

Once; Affected Public: Business or other 

for-profits and Not-for-profit 

institutions; Number of Respondents: 

20; Total Annual Responses: 20; Total 

Annual Hours: 800 (For policy 

questions regarding this collection 

contact Heidi Arndt at 410–786–1607. 

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 

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. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by July 6, 2010: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–10623 Filed 5–6–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: CMS–10293] 

Centers for Medicare & Medicaid 

Services; Agency Information 

Collection Activities: Submission for 

OMB Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(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: New Collection; Title of 

Information Collection: Tribal 

Consultation State Plan Amendment 

Template; Use: Effective July 1, 2009, 

section 5006 of the American Recovery 

and Reinvestment Act of 2009 (Recovery 

Act) amended section 1902(a)(73) of the 

Act to require that certain States utilize 

a process for the State to seek advice on 

a regular, ongoing basis from designees 

of the Indian Health Service (IHS) and 

Urban Indian Organizations concerning 

Medicaid and Children’s Health 

Insurance Program (CHIP) matters 

having a direct effect on them. The 

consultation process is required for the 

37 States in which 1 or more Indian 

Health Programs or Urban Indian 

Organizations furnish health care 

services. The State Medicaid agency for 

each of these States will complete the 

template page and submit it for approval 

as part of a State plan amendment, to 

document how it meets the 

requirements for tribal consultation. 

Form Number: CMS–10293 (OMB#: 

0938–NEW); Frequency: Reporting— 

Once and occasionally; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 37; Total 

Annual Responses: 37; Total Annual 

Hours: 37. (For policy questions 

regarding this collection contact Lane 

Terwilliger at 410–786–2059. 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 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices 25267 

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 June 7, 2010. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–10622 Filed 5–6–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0074] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

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 June 7, 

2010. 

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 0910–0650. 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. 

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 Family Smoking Prevention 

and Tobacco Control Act (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) of the act must 

be submitted to FDA by December 22, 

2009, and include the ingredients added 

as of the date of submission. Section 

904(c) of the act also requires 

submission of information whenever 

additives, or the quantities of additives, 

are changed. 

FDA issued guidance documents on 

both (1) Registration and Product Listing 

for Owners and Operators of Domestic 

Tobacco Product Establishments 

(November 12, 2009, 74 FR 58298) and 

(2) Listing of Ingredients in Tobacco 

Products (December 1, 2009, 74 FR 

62795) to assist persons making such 

submissions to FDA under the Tobacco 

Control Act. While electronic 

submission of registration and product 

listing information and ingredient 

listing information are not required, 

FDA is strongly encouraging electronic 

submission to facilitate efficiency and 

timeliness of data management and 

collection. To that end, FDA designed 

the eSubmitter application to streamline 

the data entry process for registration 

and product listing and for ingredient 

listing. This tool allows for importation 

of large quantities of structured data, 

attachments of files (e.g., in portable 

document format (PDFs) and certain 

media files), and automatic 

acknowledgement of FDA’s receipt of 

submissions. FDA also developed paper 

forms (FDA Form 3742—Registration 

and Listing for Owners and Operators of 

Domestic Tobacco Product 

Establishments and FDA Form 3743— 

Listing of Ingredients in Tobacco 

Products) as an alternative submission 

tool. Both the eSubmitter application 

and the paper forms can be accessed at 

http://www.fda.gov/tobacco. 

In the Federal Register of September 

1, 2009 (74 FR 45219), FDA published 

a notice announcing that a proposed 

collection of information had been 

submitted to OMB for emergency 

processing under the PRA. In the 

Federal Register of September 15, 2009 

(74 FR 47257), FDA published a notice 

correcting the length of the comment 

period, keeping it open until October 1, 

2009. In the Federal Register of October 

13, 2009 (74 FR 52495), FDA published 

a notice reopening the comment period 

until October 26, 2009. Based on 

comments indicating that the burden 

estimates were too low, FDA has 

adjusted its original burden estimates. 

FDA has adjusted its burden estimate 

for registration and product listing for 

owners and operators of domestic 

establishments under section 905 of the 

act from 0.75 hours per response to 3.75 

hours per response. FDA has adjusted 

its burden estimate for listing of 

ingredients under section 904 of the act 

from 0.75 hours per response to 3.0 

hours per response. FDA also decreased 


jlentini on DSKJ8SOYB1PROD with NOTICES