11248 Federal Register / Vol. 76, No. 40 / Tuesday, March 1, 2011 / Notices 

Board of Governors of the Federal Reserve 

System, February 24, 2011. 

Robert deV. Frierson, 

Deputy Secretary of the Board. 

[FR Doc. 2011–4487 Filed 2–28–11; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Secretary’s Advisory Committee on 

Human Research Protections; Notice 

of Meeting 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health, Office for Human Research 

Protections. 

ACTION: Notice. 

SUMMARY: Pursuant to Section 10(a) of 

the Federal Advisory Committee Act, 

Public Law 92–463, as amended (5 

U.S.C. App.), notice is hereby given that 

the Secretary’s Advisory Committee on 

Human Research Protections (SACHRP) 

will hold its twenty-fourth meeting. The 

meeting will be open to the public. 

Information about SACHRP and the 

meeting agenda will be posted on the 

SACHRP Web site at: http:// 

www.dhhs.gov/ohrp/sachrp/mtgings/ 

index.html. 

DATES: The meeting will be held on 

Tuesday, March 8, 2011 from 8:30 a.m. 

until 5 p.m. and Wednesday, March 9, 

2011 from 8:30 a.m. until 5 p.m. 

ADDRESSES: U.S. Department of Health 

and Human Services, 200 Independence 

Avenue, SW., Hubert H. Humphrey 

Building, Room 800, Washington, DC 

20201. 

FOR FURTHER INFORMATION CONTACT: Jerry 

Menikoff, M.D., J.D., Director, Office for 

Human Research Protections, or Julia 

Gorey, J.D., Executive Director, 

SACHRP; U.S. Department of Health 

and Human Services, 1101 Wootton 

Parkway, Suite 200, Rockville, 

Maryland 20852; 240–453–6900, fax: 

240–453–6909; e-mail address: 

Julia.Gorey@hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authority of 42 U.S.C. 217a, Section 222 

of the Public Health Service Act, as 

amended, SACHRP was established to 

provide expert advice and 

recommendations to the Secretary of 

Health and Human Services and the 

Assistant Secretary for Health on issues 

and topics pertaining to or associated 

with the protection of human research 

subjects. 

On March 8, 2011, SACHRP will hear 

a panel presentation on the work of the 

Federal Demonstration Partnership, 

followed by discussion. This will be 

followed by the report of the Subpart A 

Subcommittee (SAS), focusing on 

improvements to the informed consent 

process. SAS is charged with 

developing recommendations for 

consideration by SACHRP about the 

application of subpart A of 45 CFR part 

46 in the current research environment. 

This subcommittee was established by 

SACHRP at its October 2006 meeting. 

The afternoon will close with a panel 

presentation on the reporting and return 

of individual research results, including 

issues associated with the Clinical 

Laboratory Improvement Amendments. 

On March 9, 2011, the morning will 

open with a panel discussion on the 

reporting and return of aggregate 

research results, including a report on 

the status of ClinicalTrials.gov. The 

Subcommittee on Harmonization (SOH) 

will end the meeting with a report on 

their work to date. The SOH was 

established by SACHRP at its July 2009 

meeting, and is charged with identifying 

and prioritizing areas in which 

regulations and/or guidelines for human 

subjects research adopted by various 

agencies or offices within HHS would 

benefit from harmonization, 

consistency, clarity, simplification and/ 

or coordination. Public comment will be 

heard on both days. Public attendance at 

the meeting is limited to space 

available. Individuals who plan to 

attend the meeting and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

designated contact persons. Members of 

the public will have the opportunity to 

provide comments on both days of the 

meeting. Public comment will be 

limited to five minutes per speaker. Any 

members of the public who wish to have 

printed materials distributed to 

SACHRP members for this scheduled 

meeting should submit materials to the 

Executive Director, SACHRP, prior to 

the close of business on March 4, 2011. 

An unforeseen administrative matter 

delayed this notice being submitted to 

the Federal Register for publication. 

Dated: February 23, 2011. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections, Executive Secretary, Secretary’s 

Advisory Committee on Human Research 

Protections. 

[FR Doc. 2011–4473 Filed 2–28–11; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–185, CMS– 

10303 and CMS–10379] 

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 currently 

approved collection; Title of 

Information Collection: Granting and 

Withdrawal of Deeming Authority to 

Private Nonprofit Accreditation 

Organizations and of State Exemption 

Under State Laboratory Programs and 

Supporting Regulations; Form No.: 

CMS–R–185 (OMB#: 0938–0686); Use: 

The information required is necessary to 

determine whether a private 

accreditation organization/State 

licensure program standards and 

accreditation/licensure process is at 

least equal to or more stringent than 

those of the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA). If an accreditation organization 

is approved, the laboratories that it 

accredits are ‘‘deemed’’ to meet the CLIA 

requirements based on this 

accreditation. Similarly, if a State 

licensure program is determined to have 

requirements that are equal to or more 

stringent than those of CLIA, its 

laboratories are considered to be exempt 

from CLIA certification and 

requirements. The information collected 

will be used by HHS to: determine 

comparability/equivalency of the 

accreditation organization standards 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 40 / Tuesday, March 1, 2011 / Notices 11249 

and policies or State licensure program 

standards and policies to those of the 

CLIA program; to ensure the continued 

comparability/equivalency of the 

standards; and to fulfill certain statutory 

reporting requirements; Frequency: 

Occasionally; Affected Public: Private 

Sector: Business or other for-profits, 

Not-for-profit institutions; Number of 

Respondents: 8; Total Annual 

Responses: 96; Total Annual Hours: 

384. (For policy questions regarding this 

collection contact Minnie Christian at 

410–786–3339. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Revision of currently approved 

collection; Title of Information: 

Medicare Gainsharing Demonstration 

Evaluation: Physician Focus Groups; 

Use: The proposed physician focus 

groups are part of the evaluation of the 

Centers for Medicare and Medicaid 

Services (CMS)’s Medicare Physician 

Hospital Collaboration Demonstration. 

The Congress, under Section 646 of the 

Medicare Modernization Act (MMA) of 

2003 permitted CMS to conduct 

demonstrations to test methods for the 

provision of incentives for improving 

the quality and safety of care and 

achieving the efficient allocation of 

resources. The primary goal of the 

demonstration is to evaluate gainsharing 

as means to align physician and hospital 

incentives to improve quality and 

efficiency. This demonstration plans to 

use the physician focus group protocols 

approved by OMB for the DRA 5007 

Gainsharing Demonstration. Form 

Number: CMS–10303 (OMB#: 0938– 

1103); Frequency: Once; Affected 

Public: Private Sector, Business or other 

for profits; Number of Respondents: 288; 

Total Annual Responses: 144; Total 

Annual Hours: 144 (For policy 

questions regarding this collection 

contact William Buczko at 410–786– 

6593. For all other issues call 410–786– 

1326.) 

3. Type of Information Collection 

Request: New Collection; Title of 

Information Collection: Rate Increase 

Disclosure and Review Reporting 

Requirements (45 CFR Part 154) Use: 

Under the Section 1003 of the 

Affordable Care Act (Section 2794 of the 

Public Health Service Act), the 

Secretary, in conjunction with the 

States, is required to establish a process 

for the annual review, beginning with 

the 2010 plan year, of unreasonable 

increases in premiums for health 

insurance coverage. Section 2794 directs 

the Secretary to ensure the public 

disclosure of information of 

unreasonable rate increases and 

justification for those increases. 

General Information 

On December 23, 2010, HHS 

published a proposed regulation in the 

Federal Register defining the 

unreasonable rate review process and 

issuer reporting and disclosure 

requirements (Rate Increase Disclosure 

and Review Proposed Rule, 75 FR 

81004). The proposed regulation 

establishes the following reporting 

requirements: 

• The Preliminary Justification: This 

data collection is required of all health 

insurance issuers for all rate increases 

that exceed the ‘‘subject to review’’’ 

reporting threshold as defined in the 

proposed rule. This information will be 

posted on an HHS Web site. 

• Rate Review Final Determination: 

This data collection requires States with 

effective rate review programs and HHS 

to report their review findings and 

unreasonable rate increase 

determinations on all rate increases that 

are subject to review. This information 

will be posted on an HHS Web site. 

• The Final Justification for an 

Unreasonable Rate Increase: This data 

collection is required of health 

insurance issuers that elect to 

implement a rate increase that is 

determined to be unreasonable based on 

State or HHS review. This information 

will be posted on the Health Insurance 

Issuer’s Web site and on an HHS Web 

site. 

Preliminary Justification 

CCIIO is also requesting comments on 

the presentation and content of the 

consumer information contained in 

Parts I and II of the Preliminary 

Justification. Specifically, CCIIO would 

like comments on the usefulness and 

clarity of this information for 

consumers. Additionally, the 

Preliminary Justification is designed to 

limit burden on health insurance issuers 

by collecting data that most issuers 

should have readily available either 

through their State rate filing 

requirements or internal rate making 

analysis. CCIIO is requesting comments 

on the extent to which the data elements 

and definitions utilized in the 

Preliminary Justification align with 

current industry data collection and 

reporting standards. 

The Preliminary Justification consists 

of three parts, Part I: Rate Increase 

Summary, Part II: Written Explanation 

of the Rate Increase, and Part III: Rate 

Filing Documentation. Issuers must 

complete Parts I and II for all rate 

increases that exceed the reporting 

threshold as defined in the proposed 

rule. As described in the preamble of 

the proposed rule, this information 

would be collected to provide 

consumers with basic information on all 

rate increases that are subject to review 

under the rate review program. Under 

the proposed rule, ‘‘subject to review’’ 

rate increases would be reviewed by 

either States or HHS, depending on 

whether a State has an effective rate 

review program. Issuers would only be 

required to submit Part III of the 

Preliminary Justification when HHS is 

conducting the review of a ‘‘subject to 

review’’ rate increase. Accordingly, Part 

III requires health insurance issuers to 

provide detailed rate data that would be 

used for the purposes of conducting 

thorough actuarial reviews and for 

making determinations about whether 

rate increases are unreasonable. This 

Notice contains the following 

information about the Preliminary 

Justification: 

• Preliminary Justification Issuer 

Instructions: Health insurance issuer 

instructions for completing all three 

parts of the Preliminary Justification. 

• Part I Worksheet: A standardized 

Excel worksheet that must be used to 

complete Part I of the Preliminary 

Justification. 

• Sample internet display of the Rate 

Review Consumer Disclosure: 

Information provided in the Preliminary 

Justification would be posted on an 

HHS Web site. This sample display 

shows how the information contained in 

the Part I Worksheet would be displayed 

to consumers. 

Rate Review Final Determination 

Under the proposed rule States and 

HHS would have to provide a Rate 

Review Final Determination at the close 

of their review of all ‘‘subject to review’’ 

rate increases. The Rate Review Final 

Determination must provide the State’s 

or HHS’ determination on whether a 

rate increases is ‘unreasonable’. Section 

154.301(a)(3) of the proposed rule 

provides a list of actuarial review 

elements that must be taken into 

account as part of the rate review 

process. The Final Determination must 

provide a brief statement explaining 

how the review of elements set forth in 

§ 154.301(a)(3) caused the State or HHS 

to arrive at its determination that the 

rate is unreasonable. 

The Rate Review Final Determination 

will be entered into a data entry text box 

in the Rate Review Data Collection 

System. HHS is estimating that this 

statement would be approximately a 

paragraph in length. There is no specific 

form or set of instructions associated 

with this reporting requirement, apart 

from the reporting requirements 

provided in the proposed rule. The 

information provided in the Rate 


jlentini on DSKJ8SOYB1PROD with NOTICES
11250 Federal Register / Vol. 76, No. 40 / Tuesday, March 1, 2011 / Notices 

Review Final Determination will be 

posted as part of the rate review 

consumer disclosure information on an 

HHS Web site. 

Final Justification for an Unreasonable 

Rate Increase 

The proposed rule states that if a 

health insurance issuer implements a 

rate increase determined by HHS or a 

State to be unreasonable, the health 

insurance issuer must provide a Final 

Justification for an Unreasonable Rate 

Increase. In the Final Justification, 

issuers would have to provide a short 

statement about why they are electing to 

implement an unreasonable rate 

increase. This statement would be 

entered into a data entry text box in the 

Rate Review Data Collection System and 

would not need to be more than a 

paragraph or two in length. There is no 

form or instructions associated with this 

statement apart from the requirements 

provided in the proposed regulation. 

The Final Justification Statement will 

be posted on an HHS Web site in the 

same location as the Preliminary 

Justification and Rate Review Final 

Determination. Additionally, health 

insurance issuers implementing rate 

increases that were determined to be 

unreasonable, must post all of this 

information—the Preliminary 

Justification, the Rate Review Final 

Determination, and the Final 

Justification Statement on their Web 

sites for a period of 3 years. 

Form Number: CMS–10379; (OMB 

Control No. 0938–NEW) Frequency: 

Annually; Affected Public: Private 

Sector; Number of Respondents: 1,543 

Number of Responses: 1,546; Total 

Annual Hours: 8,418. (For policy 

questions regarding this collection, 

contact Sally McCarty at (301) 492–4489 

or RateReview@hhs.gov. 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 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 May 2, 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: February 23, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–4552 Filed 2–25–11; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Child Care and Development 

Fund Tribal Plan Preprint—ACF–118– 

A. 

OMB No.: 0970–0198. 

Description: The Child Care and 

Development Fund (CCDF) Plan (the 

Plan) for Tribes (Indian Tribes, Tribal 

consortia and Tribal organizations) is 

required from each CCDF Lead agency 

in accordance with Section 658E of the 

Child Care and Development Block 

Grant Act of 1990, as amended (Pub. L. 

101–508, Pub. L. 104–193, and 42 U.S.C. 

9858). The implementing regulations for 

the statutorily required Plan are set forth 

at 45 CFR 98.10 through 98.18. The 

Plan, submitted on the ACF 118–A, is 

required biennially, and remains in 

effect for two years. The Plan provides 

ACF and the public with a description 

of, and assurance about, the Tribal child 

care program. The ACF 118–A is 

currently approved through September 

30, 2011, making it available to Tribes 

needing to submit Plan Amendments 

through the end of the FY 2011 Plan 

Period. However, on July 1, 2011, Tribes 

will be required to submit their FY 

2012–2013 Plans for approval by 

September 30, 2011. Consistent with the 

statute and regulations, ACF requests 

revision of the ACF 118–A with minor 

corrections and modifications. 

The Office of Child Care(OCC) has 

given thoughtful consideration to the 

comments received from the 1st Public 

Notice. OCC has revised the document 

to reflect some of the changes made to 

minimize the burden of the collection of 

information on respondents. The 

revised document contains revisions to 

improve the accuracy and clarity of 

questions in order to improve the 

quality of information that is collected. 

This second Public Comment Period 

provides an opportunity for the public 

to submit comments to the Office of 

Management and Budget (OMB). 

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. 

Respondents: 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

CCDF Tribal Plan ............................................................................ 257 0.5 120 15,420 

Estimated Total Annual Burden 

Hours: 15,420. 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES