4564 Federal Register / Vol. 77, No. 19 / Monday, January 30, 2012 / Notices 

Desk Officer. Fax Number: (202) 395– 

6974. 

Email: 

OIRA_submission@omb.eop.gov. 

Dated: January 24, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division-B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–1945 Filed 1–27–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–855I and CMS– 

855R] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

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: Medicare 

Enrollment Application for Physician 

and Non-Physician Practitioners. Use: 

Health care practitioners who wish to 

enroll in the Medicare program must 

complete the CMS 855I enrollment 

application. It is submitted at the time 

the applicant first requests a Medicare 

billing number. The application is used 

by the Medicare Administrative 

Contractor (MAC), to collect data to 

assure the applicant has the necessary 

professional and/or business credentials 

to provide the health care services for 

which they intend to bill Medicare 

including information that allows the 

MAC to correctly price, process and pay 

the applicant’s claims. It also gathers 

information that allows the MAC to 

ensure that the practitioner is not 

sanctioned from the Medicare program, 

or debarred, suspended or excluded 

from any other Federal agency or 

program. Form Number: CMS–855I 

(OCN 0938–0685). Frequency: Once and 

Occasionally. Affected Public: Private 

Sector (Business or other for-profit and 

not-for-profit institutions). Number of 

Respondents: 345,000. Total Annual 

Responses: 345,000. Total Annual 

Hours: 824,000. (For policy questions 

regarding this collection contact 

Kimberly McPhillips at (410) 786–5374. 

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

2. Type of Information Collection 

Request: New collection. Title of 

Information Collection: Medicare 

Enrollment Application—Reassignment 

of Medicare Benefits. Use: Health care 

practitioners who wish to reassign their 

benefits in the Medicare program must 

complete the CMS 855R enrollment 

application. It is submitted at the time 

the physician or non-physician 

practitioner first requests reassignment 

of his/her Medicare benefits to a group 

practice, as well as any subsequent 

reassignments or terminations of 

established reassignments as requested 

by the physician or non-physician 

practitioner. The application is used by 

the Medicare Administrative Contractor 

(MAC) to collect data to assure the 

applicant has the necessary information 

that allows the MAC to correctly 

establish or terminate the reassignment. 

Form Number: CMS–855R (OCN 0938- 

New). Frequency: Occasionally. 

Affected Public: Private Sector (Business 

or other for-profit and not-for-profit 

institutions). Number of Respondents: 

100,000. Total Annual Responses: 

100,000. Total Annual Hours: 50,000. 

(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 at (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 30, 2012: 

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 llllRoom C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: January 24, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–1951 Filed 1–27–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9970–NC] 

Request for Information Regarding the 

Reinsurance Program Under the 

Affordable Care Act 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Request for information. 

SUMMARY: This notice is a request for 

information (RFI) to gain market 

information on entities that could 

administer a transitional reinsurance 

program. This RFI will inform one or 

more future Requests for Proposals 

(RFP). This RFI solicits information 

about entities that could function as a 

reinsurance entity for the transitional 

reinsurance program. CMS or one or 

more States may contract for services 

required to fulfill the statutory and 

regulatory requirements of the 

reinsurance entity. 

DATES: Submit written or electronic 

comments by February 29, 2012. 

ADDRESSES: In responding, please refer 

to file code CMS–9970–NC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit responses in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on this regulation 


emcdonald on DSK29S0YB1PROD with NOTICES
Federal Register / Vol. 77, No. 19 / Monday, January 30, 2012 / Notices 4565 

to http://www.regulations.gov. Follow 

the instructions under the ‘‘More Search 

Options’’ tab. 

2. By regular mail. You may mail 

written comments to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–9970–NC, P.O. Box 8016, 

Baltimore, MD 21244–8016. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments to the 

following address ONLY: Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–9970–NC, 

Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments before the close 

of the comment period to either of the 

following addresses: 

a. For delivery in Washington, DC— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Room 445–G, Hubert 

H. Humphrey Building, 200 

Independence Avenue SW., 

Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244– 

1850. 

If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

9994 in advance to schedule your 

arrival with one of our staff members. 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Milan Shah, (301) 492–4427. 

SUPPLEMENTARY INFORMATION: 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–(800) 743–3951. 

We note that responses to this RFI are 

not offers, and cannot be accepted by 

the Government to form a binding 

contract or to issue a grant. The purpose 

of this RFI is to inform one or more 

Requests for Proposals, not to gather 

public comments on the proposed rules 

for reinsurance, risk corridors, or risk 

adjustment under the Affordable Care 

Act. Those comments have been 

collected and are being evaluated 

separately. Information obtained in 

response to this RFI may be used by the 

Government for program planning and 

development, or other purposes with or 

without attribution. Do not include any 

information that might be considered 

proprietary or confidential. 

I. Background 

Section 1341 of the Patient Protection 

and Affordable Care Act (Pub. L. 111– 

148, enacted on March 23, 2010) (the 

Affordable Care Act), provides that each 

State must establish a transitional 

reinsurance program to help stabilize 

premiums for coverage in the individual 

market during the first three years of 

Exchange operation (2014–2016). The 

reinsurance program, which is a Statebased program, will reduce the 

uncertainty of insurance risk in the 

individual market by making payments 

for high-cost cases. This program will 

stabilize individual market rate 

increases that might otherwise occur 

because of the immediate enrollment of 

individuals with unknown health 

status, potentially including, at the 

State’s discretion, those currently in 

State high-risk pools. CMS published 

proposed rules for States and health 

insurance issuers for this reinsurance 

program on July 15, 2011 (76 FR 41930). 

The Affordable Care Act instructs 

each State to establish or contract with 

an entity to carry out the reinsurance 

program. Section 1321(c)(1) of the 

Affordable Care Act directs the 

Secretary to take such actions as are 

necessary to implement the reinsurance 

program in a State if a State has not 

taken action necessary to do so. The 

reinsurance entity, whether operating 

under contract with a State or CMS, 

must be a not-for-profit organization 

with a tax-exempt status. 

II. Request for Information 

This RFI seeks comment on the 

entities that could carry out the 

transitional reinsurance program. CMS 

may enter into one or more contracts to 

fulfill the statutory and regulatory 

requirements of the transitional 

reinsurance program established under 

section 1341 of the Affordable Care Act 

depending on the workload and number 

of States that would require assistance. 

In such a case, the contractor may be 

tasked with one or more of the following 

functions: 

• Collecting reinsurance 

contributions; 

• Accepting and validating requests 

for reinsurance payments; 

• Remitting reinsurance payments; 

• Reconciling and verifying 

reinsurance contributions and 

payments; 

• Maintaining records; and, 

• Providing customer support to 

issuers. 

CMS is seeking to engage formally, in 

a transparent and participatory manner, 

with entities that understand the 

reinsurance market, and would be able 

to perform the responsibilities of a 

reinsurance entity under the statute and 

associated regulations. In carrying out 

the transitional reinsurance program, 

CMS seeks to mitigate conflicts of 

interest (COIs) that may arise if potential 

market competitors operate the 

reinsurance program. As such, we 

request any information on potential 

COIs, and potential avenues for 

mitigation, from all stakeholders, 

including issuers and third-party 

administrators. 

Infrastructure 

1. Does your organization operate as 

a not-for-profit reinsurance entity in the 

State(s) in which you currently conduct 

business? 

2. If your organization operates as a 

reinsurance entity but does not function 

as a not-for-profit, what steps would 

have to be taken to convert the 

organization or the part of that 

organization responsible for reinsurance 

operations into a not-for-profit entity? 


emcdonald on DSK29S0YB1PROD with NOTICES
4566 Federal Register / Vol. 77, No. 19 / Monday, January 30, 2012 / Notices 

What other considerations should be 

taken into account in connection with 

such a conversion? 

3. What other steps must your 

organization take in order to be 

prepared to smoothly transition into a 

role as administrator of a new temporary 

reinsurance program? 

4. Does your organization operate 

nationally or in limited geographic 

areas? If the latter, what are the 

geographic areas? 

5. Would your organization be able 

and willing to contract with a State 

and/or the Federal government to 

operate a temporary reinsurance 

program? 

6. Are there any State and/or local 

licensing requirements that must be 

considered by an organization operating 

as such a reinsurance entity? 

7. What potential conflicts of interest 

(COIs) could arise if your organization 

were to operate such a reinsurance 

program as a not-for-profit entity? How 

might these COIs be mitigated? 

8. For organizations that do not 

currently have COI mitigation programs, 

what steps would have to be taken to 

develop and execute such a program? 

9. What is a reasonable amount of 

time for your organization to become 

fully operational (for example, have all 

systems in place to operate a 

reinsurance program) after the date of a 

contract award? What resources would 

be necessary? 

Collection and Disbursement of 

Reinsurance Funds 

10. Describe your organization’s 

ability to perform the following 

functions: 

• Collecting reinsurance 

contributions; 

• Accepting and validating requests 

for reinsurance payments; 

• Remitting reinsurance payments; 

and, 

• Reconciling and verifying 

reinsurance contributions and 

payments. 

11. What services related to the 

collection of reinsurance contributions, 

or disbursement of reinsurance 

payments to another entity would your 

organization need to subcontract due to 

a lack of capacity, expertise, or 

experience? 

12. What COIs could arise for such 

potential subcontractors? 

Data Collection 

13. Describe current data systems that 

are used by your organization, including 

any standards, security systems, and 

web-based interactive structure. Are 

your systems compliant or have the 

capability of being Section 508 

compliant (http://www.section508. 

gov/)? 

14. Do your organization’s current 

data systems have the capability to 

interface with external systems to accept 

data and reports? If yes, what types of 

interfaces are currently in place? 

15. What data are currently collected 

by your organization related to medical 

costs? 

16. What is your organization’s 

current capacity for collecting and 

verifying claims submissions from 

issuers? What processes does your 

organization have in place to ensure 

confidentiality and security protections 

of patient information? 

17. In what formats does your 

organization currently collect data? Can 

your organization support other 

formats? If so, which ones? 

18. Would your organization need to 

subcontract any services related to data 

collection? 

19. What COIs could arise for such 

subcontractors? 

Customer Support 

20. What telecommunication and 

technical support systems does your 

organization currently maintain for 

health insurance issuers or other 

commercial clients (for example, Web 

sites, 24-hour hotlines, helpdesk)? 

21. Are your support systems 

compliant or have the capability of 

being Section 508 compliant (http:// 

www.section508.gov/)? 

22. Would your organization need to 

subcontract any services related to data 

collection? 

23. What COIs could arise for such 

subcontractors? 

Evaluation 

24. Does your organization currently 

conduct evaluations of operations and 

activities? Do such evaluations include 

a financial assessment of your 

organization’s activities? 

25. What are your organization’s 

current financial and data reconciliation 

processes? 

Authority: Catalog of Federal Domestic 

Assistance Program No. 93.773, Medicare— 

Hospital Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program. 

Dated: January 20, 2012. 

Charles Littleton, 

Contracting Officer, Office of Acquisition and 

Grants Management, Centers for Medicare 

and Medicaid Services. 

[FR Doc. 2012–1944 Filed 1–27–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Pulmonary-Allergy Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: PulmonaryAllergy Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on February 23, 2012, from 8:30 

a.m. to 5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (rm. 

1503), Silver Spring MD 20993–0002. 

Information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You’’, click 

on ‘‘Public Meetings at the FDA White 

Oak Campus.’’ Please note that visitors 

to the White Oak Campus must enter 

through Building 1. 

Contact Person: Nicole Vesely, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, rm. 2417, 

Silver Spring, MD 20993–0002, (301) 

796–9001, Fax: (301) 847–8533, email: 

PADAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1-(800) 

741–8138 (301) 443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: The committee will discuss 

new drug application 202450, for 

aclidinium bromide, sponsored by 

Forest Laboratories, for the proposed 


emcdonald on DSK29S0YB1PROD with NOTICES