2690 Federal Register / Vol. 76, No. 10 / Friday, January 14, 2011 / Notices 

for new technology services that were 

not covered by the transitional passthrough payments provisions authorized 

by the Balanced Budget Refinement Act 

(BBRA) of 1999. Both the New 

Technology APC provision and the 

transitional pass-through provisions 

provide ways for ensuring appropriate 

payment for new technologies for which 

the use and costs are not adequately 

represented in the base year claims data 

on which the outpatient PPS is 

constructed. 

CMS needs to keep pace with 

emerging new technologies and make 

them accessible to Medicare 

beneficiaries in a timely manner. It is 

necessary that we continue to collect 

appropriate information from interested 

parties such as hospitals, medical 

device manufacturers, pharmaceutical 

companies and others that bring to our 

attention specific services that they 

wish us to evaluate for New Technology 

APC payment. We are making no 

changes to the information that we 

collect. The information that we seek to 

continue to collect is necessary to 

determine whether certain new services 

are eligible for payment in New 

Technology APCs, to determine 

appropriate coding and to set an 

appropriate payment rate for the new 

technology service. The intent of these 

provisions is to ensure timely 

beneficiary access to new and 

appropriate technologies. Form Number: 

CMS–10054 (OMB#: 0938–0860); 

Frequency: Annually; Affected Public: 

Private sector business or other forprofits; Number of Respondents: 15; 

Total Annual Responses: 15; Total 

Annual Hours: 180. (For policy 

questions regarding this collection 

contact Christina Smith Ritter at 410– 

786–4636. For all other issues call 410– 

786–1326.) 

4. 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 

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.) 

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 February 14, 2011. OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–736 Filed 1–13–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–268 and 

CMS–10328] 

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: CMS Survey 

Tool for http://www.cms.gov and 

http://www.medicare.gov; Use: The 

purpose of this submission is to 

continue to collect information from 

Internet users as they exit from the Web 

sites Medicare.gov and CMS.gov. To 

ensure that we gather information about 

user reactions to the Web sites, we have 

developed a survey tool that users can 

complete when they exit either site or 

by accessing a link on the bottom bar on 

the page. The responses on this survey 

tool will help CMS to make appropriate 

changes to the Web sites in the future. 

The survey tool contains questions 

about the information that visitors are 

seeking from the sites, the degree to 

which either site was useful to them, the 

improvements that they would like to 

see in the sites, and their general 

comments. Form Number: CMS–R–268 

(OMB# 0938–0756); Frequency: Yearly; 

Affected Public: Individuals and 

households, Private sector—Business or 

other for-profit; Number of 

Respondents: 7,000; Total Annual 

Responses: 9,100; Total Annual Hours: 

1,167. (For policy questions regarding 

this collection contact Matthew Aiken at 

410–786–1029. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Revision of currently approved 

collection; Title of Information 

Collection: Medicare Self-Referral 

Disclosure Protocol; Use: Section 6409 

of the ACA requires the Secretary to 

establish and post information on the 

CMS’ public Internet Web site 

concerning a self-referral disclosure 

protocol (SRDP) that sets forth a process 

for providers of services and suppliers 

to self-disclose actual or potential 

violations of section 1877 of the Act. In 

addition, section 6409(b) of the ACA 

gives the Secretary authority to reduce 

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Federal Register / Vol. 76, No. 10 / Friday, January 14, 2011 / Notices 2691 

1FDA continues to monitor the occurrence of 

adverse events associated with both prescription 

and OTC acetaminophen products. Any action 

relating to additional safety measures for OTC 

acetaminophen products will be taken separately 

from this notice, through rulemaking as part of the 

ongoing OTC monograph proceeding for internal 

analgesic drug products. 

2The opioid ingredient propoxyphene has also 

been widely used in combination with 

acetaminophen under the brand name Darvocet as 

well as in many generic products. On November 19, 

2010, FDA announced that Darvocet was being 

voluntarily withdrawn from the market at FDA’s 

request due to significant safety concerns about 

propoxyphene. FDA also requested that makers of 

generic propoxyphene-acetaminophen combination 

products withdraw their products from the market. 

Additional information about the status of 

propoxyphene-containing drug products can be 

found on FDA’s Web site at http://www.fda.gov/

Drugs/DrugSafety/PostmarketDrugSafety

InformationforPatientsandProviders/

ucm233800.htm. 

the amounts due and owing for the 

violations. This information collection 

request is necessary in order to inform 

the public of the process and the types 

of information needed to participate in 

the SRDP. 

The SRDP is a voluntary selfdisclosure instrument that will allow 

providers of services and suppliers to 

disclose actual or potential violations of 

section 1877 of the Act. CMS will 

analyze the disclosed conduct to 

determine compliance with section 

1877 of the Act and the application of 

the exceptions to the physician selfreferral prohibition. In addition, the 

authority granted to the Secretary under 

section 6409(b) of the ACA, and 

subsequently delegated to CMS, may be 

used to reduce the amount due and 

owing for violations. Form Number: 

CMS–10328 (OMB#: 0938–1106; 

Frequency: Once; Affected Public: 

Private Sector, Business and other forprofit and not-for-profit institutions; 

Number of Respondents: 50; Total 

Annual Responses: 50; Total Annual 

Hours: 1,175. (For policy questions 

regarding this collection contact Ronke 

Fabayo at 410–786–4460. 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 March 15, 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: January 7, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–737 Filed 1–13–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0021] 

Prescription Drug Products Containing 

Acetaminophen; Actions To Reduce 

Liver Injury From Unintentional 

Overdose 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is taking steps to 

reduce the maximum dosage unit 

strength of acetaminophen in 

prescription drug products. This change 

will provide an increased margin of 

safety to help prevent liver damage due 

to acetaminophen overdosing, a serious 

public health problem. This notice 

explains the reasons for the reduction in 

dosage unit strength and describes how 

FDA is implementing it for approved 

prescription drug products that exceed 

the new maximum tablet or capsule 

strength. FDA is also requiring safety 

labeling changes, including a new boxed 

warning, for acetaminophen-containing 

prescription drug products to address 

new safety information about the risk of 

liver damage. 

DATES: Sponsors of approved 

prescription drug products containing 

more than 325 milligrams (mg) of 

acetaminophen have until January 14, 

2014 to request that FDA withdraw 

approval of the product’s application, 

after which they may be subject to 

action by FDA. 

FOR FURTHER INFORMATION CONTACT: 

Faith Dugan, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6182, Silver Spring, 

MD 20993–0002, 301–796–3446. 

SUPPLEMENTARY INFORMATION: 

I. Acetaminophen Drug Products and 

Liver Injury 

Acetaminophen is the generic name of 

a drug used in many over-the-counter 

(OTC) oral pain-relievers such as 

Tylenol, and in prescription 

combination drug products such as 

Vicodin and Percocet. Acetaminophen 

is one of the most widely used drugs in 

the United States in both prescription 

and OTC products. This notice applies 

only to acetaminophen-containing drug 

products that are labeled for 

prescription use and marketed under 

approved new drug applications (NDAs) 

or abbreviated new drug applications 

(ANDAs). OTC acetaminophen drug 

products are not affected by this notice.1

All acetaminophen-containing 

prescription products are combinations 

with other drug ingredients, primarily 

opioids in various strengths. These 

other drug ingredients include the 

opioids hydrocodone bitartrate (e.g., 

Vicodin), oxycodone hydrochloride 

(e.g., Percocet), codeine phosphate (e.g., 

Tylenol with Codeine), dihydrocodeine, 

tramadol hydrocholoride, and 

pentazocine hydrochloride, as well as 

butalbital (a barbiturate) and caffeine (a 

stimulant).2 General references to 

‘‘acetaminophen combinations’’ or 

‘‘acetaminophen combination products’’ 

in this notice refer to all such products. 

There are no prescription drug products 

that contain only acetaminophen. 

Prescription combination drugs 

account for approximately 20 percent of 

the total acetaminophen drug market, 

and include some of the most widely 

prescribed and sold prescription drug 

products in the United States. (The 

remaining 80 percent of the 

acetaminophen drug market consists of 

OTC products.) Acetaminophenhydrocodone combinations account for 

more than half of all prescriptions for 

acetaminophen combination drug 

products in the United States, and for 

many years, have also been the mostprescribed products in the U.S. retail 

market (Ref. 1). Unlike other drugs 

commonly used to reduce pain and 

fever (e.g., nonsteroidal antiinflammatory drugs (NSAIDS) such as 

aspirin, ibuprofen, and naproxen), at 

recommended doses acetaminophen 

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