55330 Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices 

achieving its participation goal and to 

respond to inquiries. Respondents are 

State Medicaid Agencies. The data is 

due April 1 of every year so States need 

to have the form and instructions as 

soon as possible in order to report 

timely. Frequency: Yearly; Affected 

Public: State, Tribal and Local 

governments; Number of Respondents: 

56; Total Annual Responses: 112; Total 

Annual Hours: 1,568. (For policy 

questions regarding this collection 

contact Cindy Ruff at 410–786–5916. 

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 12, 2010. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

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

Dated: September 3, 2010. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–22592 Filed 9–9–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifier: CMS–10207, CMS– 

10244, CMS–10343 and CMS–R–131] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare and 

Medicaid Services. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare and 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: Physician SelfReferral Exceptions for Electronic 

Prescribing and Electronic Health 

Records; Use: Section 101 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) directed the Secretary to 

create an exception to the physician 

self-referral prohibition in section 1877 

of the Social Security Act for certain 

arrangements in which a physician 

receives compensation in the form of 

items or services (not including cash or 

cash equivalents) (‘‘nonmonetary 

remuneration’’) that is necessary and 

used solely to receive and transmit 

electronic prescription information. 

Also, CMS created a separate regulatory 

exception for certain arrangements 

involving the provision of nonmonetary 

remuneration in the form of electronic 

health records software or information 

technology and training services 

necessary and used predominantly to 

create, maintain, transmit, or receive 

electronic health records. 

The conditions for both exceptions 

require that arrangements for the items 

and services provided must be set forth 

in a written agreement, be signed by the 

parties involved, specify the items or 

services being provided and the cost of 

those items or services, and cover all of 

the electronic prescribing and/or 

electronic health records technology to 

be provided by the donating entity. CMS 

would use the collected information for 

enforcement purposes; specifically, if 

we were investigating the financial 

relationships between the donors and 

the physicians to determine whether the 

provisions in the exceptions were met. 

Form Number: CMS–10207 (OMB#: 

0938–1009); Frequency: Occasionally; 

Affected Public: Private Sector: Business 

or other for-profits and Not-for-profit 

institutions; Number of Respondents: 

9,796; Total Annual Responses: 38,959; 

Total Annual Hours: 12,451.5. (For 

policy questions regarding this 

collection contact Kristin Bohl at 410– 

786–8680. For all other issues call 410– 

786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicaid State 

Program Integrity Assessment (SPIA); 

Use: Under the provisions of the Deficit 

Reduction Act (DRA) of 2005, the 

Congress directed CMS to establish the 

Medicaid Integrity Program (MIP), CMS’ 

first national strategy to combat 

Medicaid fraud, waste, and abuse. CMS 

has two broad responsibilities under the 

MIP: (1) Reviewing the actions of 

individuals or entities providing 

services or furnishing items under 

Medicaid; conducting audits of claims 

submitted for payment; identifying 

overpayments; and educating providers 

and others on payment integrity and 

quality of care; and (2) Providing 

effective support and assistance to 

States to combat Medicaid fraud, waste, 

and abuse. 

In order to fulfill the second of these 

requirements, CMS developed SPIA. 

CMS uses SPIA to collect data on State 

Medicaid program integrity activities, 

develop reports for each State based on 

these data, determine areas to provide 

States with technical support and 

assistance, and develop measures to 

assess States’ performance. Form 

Number: CMS–10244 (OMB#: 0938– 

1033); Frequency: Annually; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 1,400. (For policy 

questions regarding this collection 

contact Mary Jo Cook at 410–786–3231. 

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

3. Type of Information Collection 

Request: New collection; Title of 

Information Collection: State Plan 

Preprint for Medicaid Recovery Audit 

Contractors (RACs); Use: Under section 

1902(a)(42)(B)(i) of the Social Security 

Act, States are required to establish 

programs to contract with one or more 

Medicaid RACs for the purpose of 

identifying underpayments and 

recouping overpayments under the State 

plan and any waiver of the State plan 

with respect to all services for which 

payment is made to any entity under 

such plan or waiver. Further, the statute 

requires States to establish programs to 

contract with Medicaid RACs in a 

manner consistent with State law, and 

generally in the same manner as the 

Secretary contracts with Medicare 

RACs. 

State programs contracted with 

Medicaid RACs are not required to be 

fully operational until after December 

31, 2010. States may submit, to CMS, a 

State Plan Amendment (SPA) attesting 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices 55331 

that they will establish a Medicaid RAC 

program. States have broad discretion 

regarding the Medicaid RAC program 

design and the number of entities with 

which they elect to contract. Many 

States already have experience utilizing 

contingency-fee-based Third Party 

Liability recovery contractors. Form 

Number: CMS–10343 (OMB#: 0938– 

NEW); Frequency: Once; 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 Mary Jo 

Cook at 410–786–3231 or Eva Tetteyfio 

at 410–786–3653. For all other issues 

call 410–786–1326.) 

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Advance 

Beneficiary Notice of Noncoverage 

(ABN); Use: Under section 1879 of the 

Social Security Act, a physician, 

provider, practitioner, or supplier of 

items or services participating in the 

Medicare program, or taking a claim on 

assignment, may bill a Medicare 

beneficiary for items or services usually 

covered under Medicare, but denied in 

an individual case under one of the 

several statutory exclusions, if they 

inform the beneficiary, prior to 

furnishing the service, that Medicare is 

likely to deny payment. Sections 42 CFR 

411.404(b) and (c), and 411.408(d)(2) 

and (f), require written notice be 

provided to inform beneficiaries in 

advance of potential liability for 

payment. Form Number: CMS–R–131 

(OMB#: 0938–0566); Frequency: 

Reporting: Weekly, Monthly, Yearly, 

Biennially and Occasionally; Affected 

Public: Private Sector: Business or other 

for-profits and Not-for-profit 

institutions; Number of Respondents: 

1,326,282 ; Total Annual Responses: 

43,725,850; Total Annual Hours: 

5,099,309. (For policy questions 

regarding this collection contact Evelyn 

Blaemire at 410–786–1803. 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 November 9, 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. 

Dated: September 3, 2010. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–22593 Filed 9–9–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–E–0041] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; SAPHRIS 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

SAPHRIS 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 (Public Law 98– 

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 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 SAPHRIS 

(asenapine). SAPHRIS is an atypical 

antipsychotic indicated for acute 

treatment of schizophrenia in adults and 

acute treatment of manic or mixed 

episodes associated with bipolar I 

disorder in adults. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for SAPHRIS (U.S. Patent 

No. 5,763,476) from NV Organon, and 

the Patent and Trademark Office 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

March 3, 2010, FDA advised the Patent 

and Trademark Office that this human 

drug product had undergone a 

regulatory review period and that the 

approval of SAPHRIS 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. 


srobinson on DSKHWCL6B1PROD with NOTICES