76988 Federal Register / Vol. 75, No. 237 / Friday, December 10, 2010 / Notices 

easy use by beneficiaries who file their 

own claims. The form can be obtained 

from any Social Security office or 

Medicare carrier. Frequency: 

Reporting—On occasion; Affected 

Public: State, Local, or Tribal 

Government, Business or other-forprofit, Not-for-profit institutions; 

Number of Respondents: 1,048,243; 

Total Annual Responses: 991,160,925; 

Total Annual Hours: 23,815,541. (For 

policy questions regarding this 

collection contact Brian Reitz at 410– 

786–5001. 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 January 10, 2011. 

OMB, Office of Information and 

Regulatory Affairs. 

Attention: CMS Desk Officer. 

Fax Number: (202) 395–6974. 

E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: December 6, 2010. 

Michelle Shortt, 

Director, Regulations Development Group 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–31075 Filed 12–9–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–21 and CMS– 

21B, CMS–37, CMS–64, CMS–10120, CMS– 

10224, CMS–10098, CMS–10292 and CMS– 

10220] 

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 without change of a 

currently approved collection; Title of 

Information Collection: CMS–21 

(Quarterly Children’s Health Insurance 

Program (CHIP) Statement of 

Expenditures for the Title XXI Program) 

and CMS–21B (State Children’s Health 

Insurance Program Budget Report for 

the Title XXI Program State Plan 

Expenditures); Use: Forms CMS–21 and 

–21B provide CMS with the information 

necessary to issue quarterly grant 

awards, monitor current year 

expenditure levels, determine the 

allowability of State claims for 

reimbursement, develop CHIP financial 

management information, provide for 

State reporting of waiver expenditures, 

and ensure that the Federally 

established allotment is not exceeded. 

Further, these forms are necessary in the 

redistribution and reallocation of 

unspent funds over the Federally 

mandated timeframes; Form Numbers: 

CMS–21 and CMS–21B (OMB#: 0938– 

0731); Frequency: Quarterly; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 448; Total 

Annual Hours: 7,840. (For policy 

questions regarding this collection 

contact Jonas Eberly at 410–786–6232. 

For all other issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Medicaid 

Program Budget Report; Use: Form 

CMS–37 is prepared and submitted to 

the Centers for Medicare & Medicaid 

Services (CMS) by State Medicaid 

agencies. Form CMS–37 is the primary 

document used by CMS in developing 

the national Medicaid budget estimates 

that are submitted to the Office of 

Management and Budget and the 

Congress; Form Number: CMS–37 

(OMB#: 0938–0101); Frequency: 

Quarterly; Affected Public: State, Local, 

or Tribal Governments; Number of 

Respondents: 56; Total Annual 

Responses: 224; Total Annual Hours: 

7,616. (For policy questions regarding 

this collection contact Jonas Eberly at 

410–786–6232. For all other issues call 

410–786–1326.) 

3. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Quarterly 

Medicaid Statement of Expenditures for 

the Medical Assistance Program; Use: 

Form CMS–64 has been used since 

January 1980 by the Medicaid State 

Agencies to report their actual program 

benefit costs and administrative 

expenses to CMS. CMS uses this 

information to compute the Federal 

financial participation (FFP) for the 

State’s Medicaid Program costs. Certain 

schedules of the CMS–64 form are used 

by States to report budget, expenditure 

and related statistical information 

required for implementation of the 

Medicaid portion of the State Children’s 

Health Insurance Programs; Form 

Number: CMS–64 (OMB#: 0938–0067); 

Frequency: Quarterly; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 56; Total 

Annual Responses: 224; Total Annual 

Hours: 16,464. (For policy questions 

regarding this collection contact Jonas 

Eberly at 410–786–6232. For all other 

issues call 410–786–1326.) 

4. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: 1932 State Plan 

Amendment Template; Use: Section 

1932(a)(1)(A) of the Social Security Act 

(the Act) grants states the authority to 

enroll Medicaid beneficiaries on a 

mandatory basis into managed care 

entities, managed care organizations 

(MCOs) and primary care case managers 

(PCCMs). Under this authority, a state 

can amend its Medicaid state plan to 

require certain categories of Medicaid 

beneficiaries to enroll in managed care 

entities without being out of 

compliance. This template may be used 

by states to easily modify their state 

plans if they choose to implement the 

provisions of section 1932(a)(1)(A). 

The State Medicaid Agencies will 

complete the template. CMS will review 

the information to determine if the state 

has met all the requirements of section 

1932(a)(1)(A) and 42 CFR 438.50. If the 

requirements are met, CMS will approve 

the amendment to the state’s title XIX 

plan giving the state the authority to 

enroll Medicaid beneficiaries on a 

mandatory basis into managed care 

entities MCOs and PCCMs. For a state 

to receive Medicaid funding, there must 

be an approved title XIX state plan; 

Form Number: CMS–10120 (OMB#: 

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Federal Register / Vol. 75, No. 237 / Friday, December 10, 2010 / Notices 76989 

0938–0933); Frequency: Occasionally; 

Affected Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 10; Total 

Annual Hours: 100. (For policy 

questions regarding this collection 

contact Camille Dobson at 410–786– 

7065. For all other issues call 410–786– 

1326.) 

5. Type of Information Collection 

Request: Revision of currently approved 

collection; Title of Information 

Collection: Healthcare Common 

Procedure Coding System (HCPCS); Use: 

In October 2003, the Secretary of Health 

and Human Services delegated the 

Center for Medicare and Medicaid 

Services (CMS) authority to maintain 

and distribute HCPCS Level II Codes. As 

a result, the National Panel was 

delineated and CMS continued with the 

decision-making process under its 

current structure, the CMS HCPCS 

Workgroup (herein referred to as ‘‘the 

Workgroup’’. CMS’ HCPCS Workgroup 

is an internal workgroup comprised of 

representatives of the major components 

of CMS, and private insurers, as well as 

other consultants from pertinent Federal 

agencies. Currently the application 

intake is paper-based. However, the 

process has grown and the HCPCS staff 

is exploring electronic processes for the 

collection and storage of applications. 

We have received feedback on the 

nature of the application; and have 

streamlined the form into a userfriendly application. The content of the 

material is the same, but the questions 

have been refined in accordance with 

comments received from industry 

members; and the level of necessity of 

the information required to render 

quality coding decision as determined 

by the CMS workgroup. The information 

on the form is used to update the 

HCPCS code set. All information is 

received and distributed to CMS’ 

HCPCS workgroup and is reviewed and 

discussed at workgroup meetings. In 

turn, CMS’ HCPCS workgroup reaches a 

decision as to whether a change should 

be made to codes in the HCPCS code 

set. The respondent who submits the 

application form can be anyone who has 

an interest in obtaining a code or 

modifying an existing code. However, 

respondents are usually manufacturers 

of products, or consultants on behalf of 

the manufacturer. Form Number: CMS– 

10224 (OMB#: 0938–1042; Frequency: 

Occasionally; Affected Public: Private 

Sector, Business and other for-profit and 

not-for-profit institutions; Number of 

Respondents: 300; Total Annual 

Responses: 300; Total Annual Hours: 

3300. (For policy questions regarding 

this collection contact Felicia Eggleston 

at 410–786–9287 or Lori Anderson at 

410–786–6190. For all other issues call 

410–786–1326.) 

6. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Beneficiary 

Satisfaction Survey; Use: The 

Beneficiary Satisfaction survey is 

performed to insure that the CMS 

1–800–MEDICARE Helpline contractor 

is delivering satisfactory service to the 

Medicare beneficiaries. It gathers data 

on several Helpline operations such as 

print fulfillment and websites tool 

hosted on http://www.medicare.gov. 

Respondents to the survey are Medicare 

beneficiaries that have contacted 1–800– 

MEDICARE for information on benefits 

and services. CMS is seeking approval 

for additional questions to be added to 

the original collection entitled 800- 

Medicare Beneficiary Satisfaction 

survey. The original set of questions was 

used when placing outbound calls to 

callers regarding the service they 

received when they called the 800 

Medicare Helpline with a Medicare 

question. The new expanded collection 

will include multiple survey methods to 

measure customer satisfaction not only 

with the Beneficiary Contact Center’s 

(BCC’s) handling of issues via 

telephone, but also the service provided 

to beneficiaries when they write a letter 

regarding their Medicare issue or use 

the e-mail and/or web chat services 

provided by the BCC. The use of 

Customer Satisfaction Surveys is critical 

to the CMS mission to provide service 

to beneficiaries that is convenient, 

accessible, accurate, courteous, 

professional and responsive to the needs 

of diverse groups. Form Number: CMS– 

10098 (OMB#: 0938–0919); Frequency: 

Weekly, Monthly, and Yearly; Affected 

Public: Individuals and Households; 

Number of Respondents: 36,144; Total 

Annual Responses: 36,144; Total 

Annual Hours: 6033. (For policy 

questions regarding this collection 

contact Mark Broccolino at 410–786– 

6128. For all other issues call 410–786– 

1326.) 

7. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: State Medicaid 

Health Information Technology Plan, 

Planning-Advance Planning Document 

and Update, Implementation Advance 

Planning Document and Update, and 

Annual Implementation of Advance 

Planning Document to Implement 

Section 4201 of the American 

Reinvestment and Recovery Act of 2009; 

Use: Section 4201 of Recovery Act 

establishes 100 percent Federal 

Financial Participation (FFP) as 

reimbursement to States for making 

incentive payments to providers for 

meaningful use of certified electronic 

health record technology and 90 percent 

FFP for administering these payments. 

Additionally, States are required to 

conduct oversight of this program and 

ensure no duplicate payments; thus, 

CMS is requiring States to submit 

information to CMS for prior approval 

before drawing down funding. These 

documents, if States choose to 

implement these flexibilities, will 

require a collection of information to 

effectuate these changes. 

The State Medicaid agencies will 

complete the templates. CMS will 

review the information to determine if 

the State has met all of the requirements 

of the Recovery Act provisions the 

States choose to implement. If the 

requirements are met, CMS will approve 

the amendments giving the State the 

authority to implement their Health 

Information Technology (HIT) strategy 

and implementation plans. For a State 

to receive Medicaid Title XIX funding, 

there must be an approved State 

Medicaid HIT Plan, Planning Advance 

Planning Document and 

Implementation Advance Planning 

Document; Form Number: CMS–10292 

(OMB#: 0938–1088); Frequency: Yearly, 

Once, Occasionally; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 56; Total 

Annual Responses: 56; Total Annual 

Hours: 56. (For policy questions 

regarding this collection contact Sherry 

Armstead at 410–786–4342. For all 

other issues call 410–786–1326.) 

8. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Provider 

Enrollment, Chain and Ownership 

System (PECOS) Security Consent Form; 

Use: The primary function of the 

Medicare enrollment application is to 

obtain information about the provider or 

supplier and whether the provider or 

supplier meets Federal and/or State 

qualifications to participate in the 

Medicare program. In addition, the 

Medicare enrollment application gathers 

information regarding the provider or 

supplier’s practice location, the identity 

of the owners of the enrolling 

organization, and information necessary 

to establish the correct claims payment. 

In establishing a Web based application 

process, we allow providers and 

suppliers the ability to enroll in the 

Medicare program via the Internet. For 

these applicants, no security consent 

form is needed to enroll or make a 

change in their Medicare enrollment 

information. These applicants receive 

complete access to their own 

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76990 Federal Register / Vol. 75, No. 237 / Friday, December 10, 2010 / Notices 

enrollments through Internet-based 

Provider Enrollment, Chain and 

Ownership System (PECOS). 

In order to allow a provider or 

supplier to delegate the Medicare 

credentialing process to another 

individual or organization, it is 

necessary to establish a Security 

Consent Form for those providers and 

suppliers who choose to have another 

individual or organization access their 

enrollment information and complete 

enrollments on their behalf. These users 

could consist of administrative staff, 

independent contractors, or 

credentialing departments and are 

represented as Employer Organizations. 

Employer Organizations and its 

members must request access to 

enrollment data through a Security 

Consent Form. The security consent 

form replicates business service 

agreements between Medicare 

applicants and organizations providing 

enrollment services. 

We are proposing two different 

versions of the Security Consent Form. 

The form, once signed, mailed and 

approved, grants an employer 

organization or its members access to all 

current and future enrollment data for 

the Medicare provider. Form Number: 

CMS–10220 (OMB#: 0938–1035); 

Frequency: Occasionally; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

197,500; Total Annual Responses: 

197,500; Total Annual Hours: 49,375. 

(For policy questions regarding this 

collection contact Alisha Banks at 410– 

786–0671. 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 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. 

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 February 8, 2011: 

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. 

Dated: December 6, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–31071 Filed 12–9–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0510] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; COARTEM 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

COARTEM and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human drug product. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of Patents and Trademarks may 

award (for example, half the testing 

phase must be subtracted as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a human drug product will 

include all of the testing phase and 

approval phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product COARTEM 

(artemether/lumefantrine). COARTEM is 

indicated for treatment of acute, 

uncomplicated malaria infections due to 

Plasmodium falciparum in patients of 5 

kilograms bodyweight and above. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

COARTEM (U.S. Patent No. 5,677,331) 

from Novartis AG, and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated February 17, 2010, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of COARTEM 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the Patent and 

Trademark Office requested that FDA 

determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

COARTEM is 285 days. Of this time, 

zero days occurred during the testing 

phase of the regulatory review period, 

while 285 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C act) (21 

U.S.C. 355(i)) became effective: not 

applicable. FDA has verified the 

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