Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 16793 

Dated: March 18, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–7099 Filed 3–24–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifier CMS–10320] 

Emergency Clearance: Public 

Information Collection Requirements 

Submitted to the Office of Management 

and Budget (OMB) 

AGENCY: Center for Medicare and 

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 and 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 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. 

We are, however, requesting an 

emergency review of the information 

collection referenced below. In 

compliance with the requirement of 

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

Reduction Act of 1995, we have 

submitted to the Office of Management 

and Budget (OMB) the following 

requirements for emergency review. We 

are requesting an emergency review 

because the collection of this 

information is needed before the 

expiration of the normal time limits 

under OMB’s regulations at 5 CFR Part 

1320(a)(2)(ii). This is necessary to 

ensure compliance with an initiative of 

the Administration. 

1. Type of Information Collection 

Request: Reinstatement of Previously 

Approved Collection; Title of 

Information Collection: Health Care 

Reform Insurance Web Portal 

Requirements 45 CFR part 159; Use: In 

accordance with sections 1103 and 

10102 of the Affordable Care Act, the 

U.S. Department of Health and Human 

Services created a Web site called 

healthcare.gov to meet these and other 

provisions of the law, and data 

collection was conducted for six months 

based upon an emergency information 

collection request. The interim final rule 

published on May 5, 2010 served as the 

emergency Federal Register Notice for 

the prior Information Collection Request 

(ICR). The Office of Management and 

Budget (OMB) reviewed this ICR under 

emergency processing and approved the 

ICR on April 30, 2010. CMS will be 

submitting a revised ICR to OMB for 

review and approval in accordance with 

the Paperwork Reduction Act of 1995. 

The proposed information collection is 

published to obtain comments from the 

public and affected agencies. 

As previously stated, this information 

collection is mandated by sections 1103 

and 10102 of the Affordable Care Act. 

Once all of the information is collected 

from insurance issuers of major medical 

health insurance hereon referred to as 

issuers, it will be processed for display 

at http://www.healthcare.gov. The 

information that is provided will help 

the general public make educated 

decisions about private health care 

insurance options. 

CMS is mandating the issuers verify 

and update their information for a June 

refresh of the Web site. In the event that 

an issuer has enhanced or modified its 

existing plans, created new plans, or 

deactivated plans, the organization 

would be required to update the 

information in the Web portal. States 

and High Risk Pool administrators are 

unaffected under this emergency PRA 

request. Form Number: CMS–10320 

(OMB#: 0938–1086); Frequency: 

Reporting—Annually/Monthly; Affected 

Public: For Profit Firms, States; Number 

of Respondents: 700; Total Annual 

Responses: 13,050; Total Annual Hours: 

101,960. (For policy questions regarding 

this collection contact Beth Liu at 301– 

492–4268. For all other issues call 410– 

786–1326.) 

CMS is requesting OMB review and 

approval of this collection by May 1, 

2011, with a 180-day approval period. 

Written comments and 

recommendations will be considered 

from the public if received by the 

individuals designated below by April 

25, 2011. 

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/ 

regulations/pra or E-mail 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. 

Interested persons are invited to send 

comments regarding the burden or any 

other aspect of these collections of 

information requirements. However, as 

noted above, comments on these 

information collection and 

recordkeeping requirements must be 

mailed and/or faxed to the designees 

referenced below by April 25, 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. 

3. By Facsimile or E-mail to OMB. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: March 18, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–7095 Filed 3–24–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[CMS–4154–FN] 

Medicare and Medicaid Programs; 

Renewal of Deeming Authority of the 

National Committee for Quality 

Assurance for Medicare Advantage 

Health Maintenance Organizations and 

Local Preferred Provider Organizations 

AGENCY: Centers for Medicare and 

Medicaid Services (CMS), HHS. 

ACTION: Final notice. 

SUMMARY: This final notice announces 

the decision to renew the Medicare 

Advantage Deeming Authority of the 

National Committee for Quality 

Assurance (NCQA) for Health 


erowe on DSK5CLS3C1PROD with NOTICES
16794 Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 

Maintenance Organizations and 

Preferred Provider Organizations for a 

term of 4 years. The new term of 

approval began October 19, 2010, and 

ends October 18, 2014. 

DATES: Effective Date: This notice is 

effective on April 25, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Caroline L. Baker, (410) 786–0116. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under the Medicare program, eligible 

beneficiaries may receive covered 

services through a Medicare Advantage 

(MA) organization that contracts with 

the Centers for Medicare & Medicaid 

Services (CMS) provided certain 

requirements are met under 42 CFR part 

422. Part C of Title XVIII of the Social 

Security Act (the Act), specifies the 

services that an MA organization must 

provide and the requirements that the 

organization must meet to be an MA 

contractor. Other relevant sections of 

the Act are Parts A and B of Title XVIII 

and Part A of Title XI of the Act 

pertaining to the provision of services 

by Medicare certified providers and 

suppliers. 

To assure compliance with certain 

Medicare requirements, an MA 

organization may chose to become 

accredited by a CMS approved 

accrediting organization (AO). By doing 

so, the MA organization may be 

‘‘deemed’’ compliant in one or more of 

6 requirements set forth in section 

1852(e)(4)(B) of the Act. In order for an 

AO to be able to ‘‘deem’’ an MA plan as 

compliant with these MA requirements, 

the AO must prove to CMS that its 

standards are at least as stringent as the 

Medicare requirements. MA 

organizations that are licensed as health 

maintenance organizations (HMOs) or 

preferred provider organizations (PPOs) 

and are accredited by an approved 

accrediting organization may receive, at 

their request, deemed status for CMS 

requirements in the following 6 MA 

survey areas: (1) Quality Improvement; 

(2) Antidiscrimination; (3) Access to 

Services; (4) Confidentiality and 

Accuracy of Enrollee Records; (5) 

Information on Advanced Directives; 

and (6) Provider Participation Rules. 

(See 42 CFR 422.156(b).) We note that 

at this time, deeming does not include 

the Part D areas of review listed in 

§ 422.156(b). 

Organizations that apply for MA 

deeming authority are generally 

recognized by the health care industry 

as entities that accredit HMOs and 

PPOs. As we specified in 

§ 422.157(b)(2), the term for which an 

AO may be approved by CMS may not 

exceed 6 years. For continuing approval, 

the AO must renew their application 

with CMS. 

II. Approval of Deeming Organizations 

Section 1852(e)(4)(C) of the Act 

provides a statutory timetable to ensure 

that our review of deeming applications 

in conducted in a timely manner. The 

Act provides us with 210 calendar days 

after the date of receipt of an application 

to complete our survey activities and 

application review process. At the end 

of the 210 day period, we must publish 

an approval or denial of the application 

in the Federal Register. 

III. Provisions of the Proposed Notice 

and Response to Comments 

On November 29, 2010, we published 

a proposed notice (75 FR 73087) in the 

Federal Register announcing reapproval of Medicare Advantage 

Deeming Authority of the National 

Committee for Quality Assurance 

(NCQA). In the proposed notice, we 

detailed our evaluation criteria. As set 

forth in section 1852(e)(4) of the Act and 

our regulations at § 422.158, the review 

and evaluation of NCQA’s accreditation 

program (including its standards and 

monitoring protocol) were compared to 

the requirements set forth in part 422 for 

the MA program. 

The review of NCQA’s application for 

approval of MA deeming authority 

included the following components: 

• The types of MA plans that it would 

review as part of its accreditation 

process. 

• A detailed comparison of the 

organization’s accreditation 

requirements and standards with the 

Medicare requirements (for example, a 

crosswalk). 

• Detailed information about the 

organization’s survey process, 

including— 

++ Frequency of surveys and whether 

surveys are announced or unannounced. 

++ Copies of survey forms, and 

guidelines and instructions to 

surveyors. 

++ Description of the survey review 

process and the accreditation status 

decision making process. 

++ The procedures used to notify 

accredited MA organizations of 

deficiencies and to monitor the 

correction of those deficiencies. 

++ The procedures used to enforce 

compliance with accreditation 

requirements. 

• Detailed information about the 

individuals who perform surveys for the 

accreditation organization, including— 

++ The size and composition of 

accreditation survey teams for each type 

of plan reviewed as part of the 

accreditation process. 

++ The education and experience 

requirements surveyors must meet. 

++ The content and frequency of the 

in-service training provided to survey 

personnel. 

++ The evaluation systems used to 

monitor the performance of individual 

surveyors and survey teams. 

• The organization’s policies and 

practice with respect to the 

participation, in surveys or in the 

accreditation decision process by an 

individual who is professionally or 

financially affiliated with the entity 

being surveyed. 

• A description of the organization’s 

data management and analysis system 

with respect to its surveys and 

accreditation decisions, including the 

kinds of reports, tables, and other 

displays generated by that system. 

• A description of the organization’s 

procedures for responding to and 

investigating complaints against 

accredited organizations, including 

policies and procedures regarding 

coordination of these activities with 

appropriate licensing bodies and 

ombudsmen programs. 

• A description of the organization’s 

policies and procedures with respect to 

the withholding or removal of 

accreditation for failure to meet the 

accreditation organization’s standards or 

requirements, and other actions the 

organization takes in response to 

noncompliance with its standards and 

requirements. 

• A description of all types (for 

example, full and partial) and categories 

(for example, provisional, conditional, 

and temporary) of accreditation offered 

by the organization, the duration of each 

type and category of accreditation, and 

a statement identifying the types and 

categories that would serve as a basis for 

accreditation if CMS approves the 

accreditation organization. 

• A list of all currently accredited MA 

organizations and the type, category, 

and expiration date of the accreditation 

held by each of them. 

• A list of all full and partial 

accreditation surveys scheduled to be 

performed by the accreditation 

organization as requested by CMS. 

• The name and address of each 

person with an ownership or control 

interest in the accreditation 

organization. 

• The NCQA’s past performance in 

the deeming program and results of 

recent deeming validation reviews, or 

look-behind audits conducted as part of 

continuing Federal oversight of the 

deeming program under § 422.157(d). 

No comments were received in 

response to the proposed notice 

published November 29, 2010. 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 76, No. 58 / Friday, March 25, 2011 / Notices 16795 

Therefore, based on the review and 

observations described in section III of 

this final notice, we have determined 

that NCQA’s requirements for HMOs 

and local PPOs continue to meet or 

exceed our requirements. We renew the 

MA deeming authority of the NCQA for 

HMOS and PPOs for a term of 4 years. 

The new term of approval began 

October 19, 2010, and ends October 18, 

2014. 

IV. Results of the Review Process 

Using the information listed in 

section III of this final notice, we 

determined that NCQA’s current 

accreditation program for HMO and 

PPO MA plans continues to be at least 

as stringent as the MA requirements 

contained in the 6 categories specified 

in section 1852(e)(4)(C) of the Act and 

our methods of evaluation for those 

areas. 

V. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). 

VI. Regulatory Impact Statement 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was not reviewed by the Office of 

Management and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 9, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–6222 Filed 3–24–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Voluntary Establishment of 

Paternity—NPRM. 

OMB No.: 0970–0175. 

Description: Section 466(a)(5)(C) of 

the Social Security Act requires States 

to pass laws ensuring a simple civil 

process for voluntarily acknowledging 

paternity under which the State must 

provide that the mother and putative 

father must be given notice, orally and 

in writing, of the benefits and legal 

responsibilities and consequences of 

acknowledging paternity. The 

information is to be used by hospitals, 

birth record agencies, and other entities 

participating in the voluntary paternity 

establishment program that collect 

information from the parents of children 

that are born out of wedlock. 

Respondents: 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Disclosure ........................................................................................................ 1,167,097 1 0.17 198,406.49 

Estimated Total Annual Burden 

Hours: 198,406.49. 

Additional Information: Copies of the 

proposed collection may be obtained 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. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: 202– 

395–7285, E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–7077 Filed 3–24–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0620] 

The National Antimicrobial Resistance 

Monitoring System Strategic Plan 

2011–2015; Request for Comments; 

Extension of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments; 

extension of comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending the 

comment period for the notice that 

appeared in the Federal Register of 

January 24, 2011 (76 FR 4120). In the 

notice, FDA requested comments on a 

document for the National 

Antimicrobial Resistance Monitoring 

System (NARMS) entitled ‘‘NARMS 

Strategic Plan 2011–2015.’’ The Agency 

is taking this action in response to 

requests for an extension to allow 

interested persons additional time to 

submit comments. Based on requests 

received, additional information is 

being placed in the docket related to the 

development of the Strategic Plan. This 

information can also be viewed at the 

Web sites listed in section III of this 

document. 

DATES: Submit either electronic or 

written comments by May 24, 2011. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit 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: 

Patrick McDermott, Center for 

Veterinary Medicine (HFV–530), Food 

and Drug Administration, 8401 

Muirkirk Rd., Laurel, MD 20708, 301– 

210–4213, e-mail: patrick.mcdermott@

fda.hhs.gov. 


erowe on DSK5CLS3C1PROD with NOTICES