Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices 62413 

per respondent will be received on an 

annual basis. 

The Report of Identification of Select 

Agent or Toxin form 42 CFR 73.5(a)(b) 

and 73.6(a)(b)) will be used by clinical 

and diagnostic laboratories to notify 

CDC that select agents or toxins 

identified as the result of diagnostic or 

proficiency testing have been disposed 

of in a proper manner. In addition, the 

form will be used by Federal law 

enforcement agencies to report the 

seizure and final disposition of select 

agents and toxins. CDC in conjunction 

with APHIS has revised the Report of 

Identification of Select Agent or Toxin 

form to ensure duplicate reports are not 

submitted by requesting the entity 

making the final identification report 

the select agents or toxins identified as 

the result of diagnostic or verification 

testing. Estimated average time to 

complete this form is 1 hour. Based on 

data regarding the reports received since 

the last submission, CDC estimates that 

9 reports per respondent will be 

received on an annual basis. 

There is no cost to the respondents 

other than their time. The total 

estimated annualized burden hours are 

8,878, which is a reduction of 778.5 

hours from the previously approved 

ICR. 

ESTIMATED ANNUALIZED BURDEN HOURS

CFR Form name Number of 

respondents 

Number responses per 

respondent 

Average burden 

per response 

73.3(d) ................................... Application for Registration ................................................... 5 1 4 .5 

73.7(h)(1) ............................... Amendment to Registration Application ................................ 320 8 1 

73.16 ...................................... Request to Transfer Select Agents or Toxins ....................... 320 1 1 .5 

73.19(a)(b) ............................. Notification of Theft, Loss or Release ................................... 180 1 1 

73.5 & 73.6(a)(b) ................... Report of Identification of Select Agent ................................ 320 9 1 

73.5 & 73.6(d–e) .................... Request of Exemption ........................................................... 3 1 1 

73.3 & 73.4(e)(1) ................... Request for Exclusions/Restricted ........................................ 71 1 1 

73.10(e) ................................. Request for Expedited Review .............................................. 1 1 1 

73.20 ...................................... Administrative Review ........................................................... 30 1 4 

73.18 ...................................... Inspections ............................................................................. 320 1 8 

Dated: September 30, 2011. 

Daniel Holcomb, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2011–26008 Filed 10–6–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10268 and CMS– 

1696] 

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: Consolidated 

Renal Operations in a Web Enabled 

Network (CROWNWeb) Third-party 

Submission Authorization Form; Use: 

The Consolidated Renal Operations in a 

Web Enabled Network (CROWNWeb) 

Third-Party Submission Authorization 

form is to be completed by ‘‘Facility 

Administrators’’ (administrators of 

CMS-certified dialysis facilities) if they 

intend to authorize a third party (a 

business with which the facility is 

associated, or an independent vendor) 

to submit data to CMS to comply with 

the recently-revised Conditions for 

Coverage of dialysis facilities. The 

CROWNWeb system is the system used 

as the collection point of data necessary 

for entitlement of ESRD patients to 

Medicare benefits and for Federal 

Government monitoring and assessing 

of the quality and types of care provided 

to renal patients. The information 

collected through the CWTPSA form 

will allow CMS and its contractors to 

receive data from authorized parties 

acting on behalf of CMS-certified 

dialysis facilities. Since February 2009, 

CMS has received 4,160 CWTPSA forms 

and anticipates that they will continue 

to receive no more than 400 new 

CWTPSA forms annually to address the 

creation of new facilities under the 

current participating ‘‘third party 

submitters.’’ Form Number: CMS–10268 

(OCN: 0938–1052); Frequency: 

Occasionally; Affected Public: Private 

Sector; Business or other for-profits and 

Not-for-profit institutions; Number of 

Respondents: 400; Total Annual 

Responses: 400; Total Annual Hours: 

34. (For policy questions regarding this 

collection contact Michelle Tucker at 

410–786–0736. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Appointment of 

Representative; Use: This information 

collection requests re-approval of an 

information collection associated with 

regulations that permit individuals or 

entities to appoint representatives to 

exercise their rights to appeal an initial 

determination. The Appointment of 

Representative form will be completed 

by beneficiaries, providers and 

suppliers who wish to appoint 

representatives to assist them with 

obtaining initial determinations and 

filing appeals. The appointment of 

representative form must be signed by 

the party making the appointment and 

the individual agreeing to accept the 

appointment. Form Number: CMS–1696 

(OCN: 0938–0950); Frequency: 

Occasionally; Affected Public: 

Individuals or households and Business 

or other for-profits; Number of 

Respondents: 265,481; Total Annual 

Responses: 265,481; Total Annual 


jlentini on DSK4TPTVN1PROD with NOTICES
62414 Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices 

Hours: 66,370. (For policy questions 

regarding this collection contact 

Katherine Hosna at 410–786–4993. 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. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments must be received by 

December 6, 2011, and submitted in one 

of the following ways: 

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: October 4, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–26034 Filed 10–6–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10340, CMS– 

10237, CMS–10137, and CMS–265–11 and 

CMS–265–94] 

Agency Information Collection 

Activities: Submission for OMB 

Review; 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), 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: Collection of 

Encounter Data from Medicare 

Advantage Organizations; Use: The 

Centers for Medicare and Medicaid 

Services (CMS) intends to collect 

encounter data, or data on each item or 

service delivered to an enrollee, from 

Medicare Advantage Organizations. 

Medicare Advantage organizations will 

obtain this data from providers. CMS 

would collect the data electronically 

from Medicare Advantage Organizations 

via the Health Insurance Portability and 

Accountability Act (HIPAA) compliant 

standard Health Care Claims 

transactions for professional data and 

institutional data. The information is 

used to submit health care claims or 

equivalent health encounter 

information, carry out health plan 

enrollments and disenrollments, 

determine health plan eligibility, send 

and receive health care payment and 

remittance advices, transmit health plan 

premium payments, determine health 

care claim status, provide referral 

certifications and authorizations, and 

coordinate the benefits for individuals 

who have more than one health plan. 

Form Number: CMS–10340 (OMB#: 

0938–New); Frequency: Weekly; 

Affected Public: Private Sector; 

Businesses or other for-profits; Number 

of Respondents: 827; Total Annual 

Responses: 517,793,438; Total Annual 

Hours: 34,520. (For policy questions 

regarding this collection contact Sean 

Creighton at 410–786–9302 or Deondra 

Moseley at 410–786–4577. For all other 

issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; 

Title of Information Collection: Part C 

Medicare Advantage and 1876 Cost Plan 

Expansion Application; Use: Collection 

of this information is mandated in Part 

C of the Medicare Prescription Drug, 

Improvement and Modernization Act of 

2003 (MMA) in Subpart K of 42 CFR 

part 422 entitled Contracts with 

Medicare Advantage Organizations. In 

addition, the Medicare Improvements 

for Patients and Providers Act of 2008 

(MIPPA) amended titles XVII and XIX of 

the Social Security Act to improve the 

Medicare program. 

In general, coverage for the 

prescription drug benefit is provided 

through prescription drug plans (PDPs) 

that offer drug-only coverage or through 

Medicare Advantage (MA) organizations 

that offer integrated prescription drug 

and health care products (MA–PD 

plans). PDPs must offer a basic drug 

benefit. Medicare Advantage 

Coordinated Care Plans (MA–CCPs) 

either must offer a basic benefit or may 

offer broader coverage for no additional 

cost. Medicare Advantage Private Fee 

for Service Plans (MA–PFFS) may 

choose to offer enrollees a Part D 

benefit. Employer Group Plans may also 

provide Part D benefits. If any of the 

contracting organizations meet basic 

requirements, they may also offer 

supplemental benefits through 

enhanced alternative coverage for an 

additional premium. 

Organizations wishing to provide 

healthcare services under MA and/or 

MA–PD plans must complete an 

application, file a bid, and receive final 

approval from CMS. Existing MA plans 

may request to expand their contracted 

service area by completing the Service 

Area Expansion (SAE) application. 

Applicants may offer a local MA plan in 

a county, a portion of a county (i.e., a 

partial county) or multiple counties. 

Applicants may offer a MA regional 

plan in one or more of the 26 MA 

regions. 

This clearance request is for the 

information collected to ensure 

applicant compliance with CMS 

requirements and to gather data used to 

support determination of contract 

awards. The information will be 

collected under the solicitation of Part 

C application from MA, EGWP Plan, 

and Cost Plan applicants. The collection 

information will be used by CMS to: (1) 

Ensure that applicants meet CMS 

requirements, (2) support the 

determination of contract awards. 

Participation in all Programs is 

voluntary in nature. Only organizations 

that are interested in participating in the 

program will respond to the solicitation. 

MA–PDs that voluntarily participate in 

the Part C program must submit a Part 

D application and successful bid. Form 

Number: CMS–10237 (OMB # 0938– 

0935); Frequency: Yearly; Affected 

Public: Private Sector; Number of 

Respondents: 378; Total Annual 

Responses: 378; Total Annual Hours: 


jlentini on DSK4TPTVN1PROD with NOTICES