Federal Register / Vol. 76, No. 190 / Friday, September 30, 2011 / Notices 60845 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: September 27, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–25271 Filed 9–29–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10241, CMS– 

10412, CMS–R–263, CMS–R–262, CMS– 

10142 and CMS–855(O)] 

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: Revision of a currently 

approved collection; Title of 

Information Collection: Survey of Retail 

Prices: Payment and Utilization Rates, 

and Performance Rankings; Use: CMS 

will develop a National Average Drug 

Acquisition Cost (NADAC) for States to 

consider when developing 

reimbursement methodology. The 

NADAC is a new pricing benchmark 

that will be based on the national 

average costs that pharmacies pay to 

acquire Medicaid covered outpatient 

drugs. It is intended to provide States 

with a more accurate reference price to 

base reimbursement for prescription 

drugs and will be based on drug 

acquisition costs collected directly from 

pharmacies through a nationwide 

survey process. This survey will be 

conducted on a monthly basis to ensure 

that the NADAC reference file remains 

current and up-to-date. A NADAC 

Survey Request for Information has been 

developed to send to random 

pharmacies for voluntary completion. 

CMS proposes to add the survey to an 

existing collection, ‘‘Annual State 

Report and Annual State Performance 

Rankings.’’ The requirements and 

burden associated with the annual 

report/rankings are unaffected by this 

proposed action; Form Number: CMS– 

10241 (OCN: 0938–1041); Frequency: 

Biennially, Once; Affected Public: 

Private Sector; Business or other forprofits; Number of Respondents: 30,000; 

Total Annual Responses: 30,000; Total 

Annual Hours: 15,000. (For policy 

questions regarding this collection 

contact Lisa Ferrandi at 410–786–5445. 

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

2. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Section 1115 

Demonstration: Long Term Services and 

Supports and Other Service Models for 

Individuals with Disabilities and 

Chronic Conditions; Use: Section 1115 

of the Social Security Act provides the 

Secretary of Health and Human Services 

broad authority to authorize 

experimental, pilot, or demonstration 

projects likely to assist in promoting the 

objectives of the Medicaid statute. 

Flexibility under Section 1115 is 

sufficiently broad to allow states to test 

substantially new ideas of policy merit. 

States seeking interventions for 

individuals needing LTSS to lower 

costs, improve care and improve health 

can utilize the 1115 demonstration to 

test and deliver innovative services and 

approaches to better and more 

efficiently meet the needs of this 

population. Section 1115 

demonstrations provide a vehicle for 

innovations in both care delivery and 

payment methodologies. 

Demonstrations must be ‘‘budget 

neutral’’ over the life of the project, 

meaning they cannot be expected to cost 

the Federal government more than it 

would cost without the waiver. State 

Medicaid agencies are responsible for 

developing section 1115 demonstration 

applications and submitting them to 

CMS; Form Number: CMS–10412 (OCN: 

0938–New); Frequency: Once; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 56; Total 

Annual Hours: 2,240. (For policy 

questions regarding this collection 

contact Adrienne Delozer at 410–786– 

0278. For all other issues call 410–786– 

1326.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Site 

Investigation for Durable Medical 

Equipment (DME) Suppliers; Use: CMS 

is mandated to identify and implement 

measures to prevent fraud and abuse in 

the Medicare program. To meet this 

challenge, CMS has moved forward to 

improve the quality of the process for 

enrolling suppliers into the Medicare 

program by establishing a uniform 

application for enumerating suppliers of 

durable medical equipment, prosthetics, 

orthotics, and supplies (DMEPOS). 

Implementation of enhanced procedures 

for verifying the enrollment information 

has also improved the enrollment 

process. As part of this process, 

verification of compliance with supplier 

standards is necessary. The site 

investigation form has been used in the 

past to aid the Medicare contractor (the 

National Supplier Clearinghouse and/or 

its subcontractors) in verifying 

compliance with the required supplier 

standards found in 42 CFR 424.57(c). 

The primary function of the site 

investigation form is to provide a 

standardized, uniform tool to gather 

information from a DMEPOS supplier 

that tells us whether it meets certain 

qualifications to be a DMEPOS supplier 

(as found in 42 CFR 424.57(c)) and 

where it practices or renders its 

services. 

This site investigation form collects 

the same information as its predecessor, 

with the exception of one new yes/no 

question under the ‘‘Records and 

Telephone’’ section (question 11(a)) 

used to verify if the DMEPOS supplier 

maintains physician ordering/referring 

records for the supplies and/or services 

it renders to Medicare beneficiaries (if 

applicable). This information is required 

by Section 1833(q) of the Social Security 

Act which states that all physicians and 

non-physician practitioners that meet 

the definitions at section 1861(r) and 

1842(b)(18)(C) be uniquely identified for 

all claims for services that are ordered 

or referred. Other information collected 

on this site investigation remains 

unchanged, but has been reformatted for 

greater functionality. Form Number: 

CMS–R–263 (OCN: 0938–0749); 

Frequency: Once; Affected Public: 

Private Sector—Business or other forprofits and not-for-profit institutions; 

Number of Respondents: 30,000; Total 

Annual Responses: 30,000; Total 

Annual Hours: 15,000. (For policy 

questions regarding this collection 

contact Kimberly McPhillips at 410– 

mstockstill on DSK4VPTVN1PROD with NOTICES

60846 Federal Register / Vol. 76, No. 190 / Friday, September 30, 2011 / Notices 

786–5374. For all other issues call 410– 

786–1326.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Plan Benefit 

Package (PBP) and Formulary 

Submission for Medicare Advantage 

(MA) Plans and Prescription Drug Plans 

(PDP); Use: Under the Medicare 

Modernization Act (MMA), Medicare 

Advantage (MA) and Prescription Drug 

Plan (PDP) organizations are required to 

submit plan benefit packages for all 

Medicare beneficiaries residing in their 

service area. The plan benefit package 

submission consists of the Plan Benefit 

Package (PBP) software, formulary file, 

and supporting documentation, as 

necessary. MA and PDP organizations 

use the PBP software to describe their 

organization’s plan benefit packages, 

including information on premiums, 

cost sharing, authorization rules, and 

supplemental benefits. They also 

generate a formulary to describe their 

list of drugs, including information on 

prior authorization, step therapy, 

tiering, and quantity limits. 

Additionally, CMS uses the PBP and 

formulary data to review and approve 

the plan benefit packages proposed by 

each MA and PDP organization. 

CMS requires that MA and PDP 

organizations submit a completed PBP 

and formulary as part of the annual 

bidding process. During this process, 

organizations prepare their proposed 

plan benefit packages for the upcoming 

contract year and submit them to CMS 

for review and approval. 

CMS is requesting to continue its use 

of the PBP software and formulary 

submission for the collection of benefits 

and related information for CY 2013 

through CY 2015. CMS estimates that 

571 MA organizations and 64 PDP 

organizations will be required to submit 

the plan benefit package information in 

CY 2013. Based on operational changes 

and policy clarifications to the Medicare 

program and continued input and 

feedback by the industry, CMS has 

made the necessary changes to the plan 

benefit package submission. Form 

Number: CMS–R–262 (OCN: 0938– 

0763); Frequency: Yearly; Affected 

Public: Private Sector—Business or 

other for-profits and not-for-profit 

institutions; Number of Respondents: 

635; Total Annual Responses: 6,015; 

Total Annual Hours: 53,291. (For policy 

questions regarding this collection 

contact Kristy Holtje at 410–786–2209. 

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

5. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Bid Pricing Tool 

(BPT) for Medicare Advantage (MA) 

Plans and Prescription Drug Plans 

(PDP); Use: Under the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA), and 

implementing regulations at 42 CFR, 

Medicare Advantage organizations 

(MAO) and Prescription Drug Plans 

(PDP) are required to submit an 

actuarial pricing ‘‘bid’’ for each plan 

offered to Medicare beneficiaries for 

approval by the Centers for Medicare & 

Medicaid Services (CMS). 

MAOs and PDPs use the Bid Pricing 

Tool (BPT) software to develop their 

actuarial pricing bid. The information 

provided in the BPT is the basis for the 

plan’s enrollee premiums and CMS 

payments for each contract year. The 

tool collects data such as medical 

expense development (from claims data 

and/or manual rating), administrative 

expenses, profit levels, and projected 

plan enrollment information. By statute, 

completed BPTs are due to CMS by the 

first Monday of June each year. 

CMS reviews and analyzes the 

information provided on the Bid Pricing 

Tool. Ultimately, CMS decides whether 

to approve the plan pricing (i.e., 

payment and premium) proposed by 

each organization. CMS is requesting to 

continue its use of the BPT for the 

collection of information for CY2013 

through CY2015. Form Number: CMS– 

10142 (OCN: 0938–0944); Frequency: 

Yearly; Affected Public: Private Sector— 

Business or other for-profits and not-forprofit institutions; Number of 

Respondents: 530; Total Annual 

Responses: 4,770; Total Annual Hours: 

143,100. (For policy questions regarding 

this collection contact Diane Spitalnic at 

410–786–5745. For all other issues call 

410–786–1326.) 

6. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare 

Registration Application; Use: The CMS 

855O allows a physician to receive a 

Medicare identification number 

(without being approved for billing 

privileges) for the sole purpose of 

ordering and referring Medicare 

beneficiaries to Medicare approved 

providers and suppliers. This new 

Medicare registration application form 

allows physicians who do not provide 

services to Medicare beneficiaries to be 

given a Medicare identification number 

without having to supply all the data 

required for the submission of Medicare 

claims. It also allows the Medicare 

program to identify ordering and 

referring physicians without having to 

validate the amount of data necessary to 

determine claims payment eligibility 

(such as banking information), while 

continuing to identify the physician’s 

credentials as valid for ordering and 

referring purposes. Since the physicians 

and non-physician practitioners 

submitting this application are not 

enrolling in Medicare to submit claims 

but are only registering with Medicare 

as eligible to order and refer, CMS 

believes changing the title from 

Medicare Enrollment Application to 

Medicare Registration Application 

better captures the actual purpose of 

this form. 

Where appropriate, CMS has changed 

all references to enrollment or enrolling 

to registration and registering and 

Medicare billing number to National 

Provider Identifier. CMS also added a 

check box to allow physicians and nonphysician practitioners to withdraw 

from the ordering and referring registry. 

A section to collect information on 

professional certifications was added for 

those practitioners who are not 

professionally licensed. Editorial and 

formatting corrections were made in 

response to prior comments received 

during the approval of the current 

version of this application. Other minor 

editorial and formatting corrections 

were made to better clarify the purpose 

of this application. Form Number: 

CMS–855(O) (OCN: 0938–1135); 

Frequency: Occasionally; Affected 

Public: Individuals; Number of 

Respondents: 48,500; Total Annual 

Responses: 48,500; Total Annual Hours: 

24,125. (For policy questions regarding 

this collection contact Kimberly 

McPhillips at 410–786–5374. 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 

November 29, 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 76, No. 190 / Friday, September 30, 2011 / Notices 60847 

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 27, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–25274 Filed 9–29–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Refugee Data Submission 

System for Allocation of Formula 

Funds. 

OMB No.: 0970–0043. 

Description: The Refugee Data 

Submission System for Allocation of 

Formula Funds is designed to satisfy the 

statutory requirements of the 

Immigration and Naturalization Act 

(INA). Section 412(a)(3)of the Act 

requires that the Director of the Office 

of Refugee Resettlement (ORR) make a 

periodic assessment of the needs of 

refugees for assistance and services and 

the resources available to meet those 

needs. This assessment includes 

compiling and maintaining data on 

secondary migration of refugees within 

the United States after arrival. Further, 

INA 412(c)(1)(B)states that formula 

funds shall be allocated based on the 

total number of refugees in each State, 

taking into account secondary 

migration. 

In order to meet these statutory 

requirements, ORR requires each State 

to submit disaggregated individual 

records containing certain data elements 

for eligible populations. ORR uses the 

information collected through the Web 

site to determine secondary migration 

for the purposes of formula funds 

allocation to States. 

The submission of individual records 

via the Refugee Data Submission System 

for Allocation of Formula Funds is a 

reliable and secure process for 

collecting data for the purposes of 

tracking secondary migration and 

allocating formula funds. Data 

submitted by the States via the Web site 

are also compiled and analyzed for 

inclusion in ORR’s Annual Report to 

Congress. 

Respondents: States, Wilson/Fish 

Alternative Projects, and the District of 

Columbia. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

Refugee Data Submission for Formula Funds Allocations ........... 50 1 20 1,000 

Estimated Total Annual Burden 

Hours: 1,000. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects and Families is 

soliciting public comment on the 

specific aspects of the information 

collection described above. Copies of 

the proposed collection of information 

can be obtained and comments may be 

forwarded by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: infocollection@

acf.hhs.gov. All requests should be 

identified by the title of the information 

collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–25210 Filed 9–29–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0691] 

Draft Guidance on Media Fills for 

Validation of Aseptic Preparations for 

Positron Emission Tomography Drugs; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘Media Fills for Validation of Aseptic 

Preparations for Positron Emission 

Tomography (PET) Drugs.’’ This draft 

guidance is intended to help 

manufacturers of PET drugs meet the 

requirements for the Agency’s current 

good manufacturing practice regulations 

for PET drugs. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

mstockstill on DSK4VPTVN1PROD with NOTICES