80058 Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Notices 

application form. To qualify, programs 

must meet the minimum eligibility 

requirements set forth in CDC’s ‘‘DPRP 

Draft Recognition Standards and 

Operating Procedures.’’ Criteria for 

recognition include, but are not limited 

to: (1) Following an evidence-based 

curriculum that has been proven 

effective in research and demonstration 

projects, and (2) submitting deidentified participant process and 

outcome data to CDC every six months. 

CDC will use the process and outcome 

data to monitor and evaluate program 

effectiveness and to provide targeted 

technical assistance to applicant 

organizations. Three levels of 

recognition will be provided: Pending 

recognition for new applicants that have 

submitted an application and meet 

eligibility criteria defined by DPRP 

standards and operating procedures; 

Full recognition for programs that have 

demonstrated effectiveness according to 

DPRP standards; and Probationary 

recognition for programs that are 

working towards full attainment of the 

standards. 

Each organization that seeks 

recognition through the DPRP will 

submit an initial, online application 

form to CDC. There is no application 

deadline. The de-identified process and 

outcome data necessary for assessing 

program performance will be submitted 

to CDC electronically twice per year. 

The due dates for these submissions 

will be determined by the date of the 

organization’s initial application. CDC 

estimates that burden to respondents 

will be modest since the information 

requested for DPRP recognition is 

routinely collected by organizations that 

deliver lifestyle programs. To further 

minimize burden to respondents, CDC 

will accept process and outcome data 

submitted using any electronic format, 

software or method that meets the 

requirements established by DPRP 

standards and operating procedures. 

OMB approval is requested for three 

years. CDC anticipates seeking 

continued OMB approval throughout 

the lifetime of the DPRP. Respondents 

will be organizational entities that offer 

diabetes prevention services. 

Participation in the DPRP is voluntary, 

and there are no costs to respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

per response 

(in hr) 

Total 

burden 

(in hr) 

Applicants for Recognition through 

the DPRP.

Application Form .............................. 67 1 3/60 3 

Process and Outcome Data ............. 67 2 5/60 11 

Total ........................................... ........................................................... ........................ ........................ ........................ 14 

Thelma Sims, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–31978 Filed 12–20–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Notice of Hearing: Reconsideration of 

Disapproval of California State Plan 

Amendments (SPAs) 08–009A; 08– 

009B1; 08–009B2; 08–009D; and 08– 

019 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of hearing. 

SUMMARY: This notice announces an 

administrative hearing to be held on 

February 10, 2011, at the CMS San 

Francisco Regional Office, 90 7th Street, 

#5–300 (5W), San Francisco, California 

94103 to reconsider CMS’ decision to 

disapprove California SPAs 08–009A; 

08–009B1; 08–009B2; 08–009D; and 08– 

019. 

CLOSING DATE: Requests to participate in 

the hearing as a party must be received 

by the presiding officer by January 5, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Benjamin Cohen, Presiding Officer, 

CMS, 2520 Lord Baltimore Drive, Suite 

L, Baltimore, Maryland 21244. 

Telephone: (410) 786–3169. 

SUPPLEMENTARY INFORMATION: This 

notice announces an administrative 

hearing to reconsider the decision of the 

Centers for Medicare & Medicaid 

Services (CMS) to disapprove California 

State plan amendments (SPAs) 08– 

009A; 08–009B1; 08–009B2; 08–009D; 

and 08–019 which were submitted on 

December 31, 2008, and disapproved on 

November 18, 2010. The SPAs proposed 

to reduce the reimbursement rates for 

certain services furnished under the 

approved State plan. 

In the initial determination, CMS 

determined, after consulting with the 

Secretary, that it is unable to approve 

these SPAs because California has not 

demonstrated that it would meet the 

conditions set out in section 

1902(a)(30)(A) of the Social Security Act 

(Act). 

Section 1902(a)(30)(A) of the Act 

requires that State plans assure that 

‘‘payments [to providers] * * * are 

sufficient to enlist enough providers so 

that care and services are available 

under the [State’s Medicaid] plan [to 

recipients] at least to the extent that 

such care and services are available to 

the general population in the geographic 

area.’’ 

When the SPAs were initially 

submitted, the State did not provide 

information concerning the impact of 

the proposed reimbursement reductions 

on beneficiary access to services, even 

though available national data indicate 

that this may be an issue for California. 

In the Requests for Additional 

Information (RAI) for SPAs TN 08– 

009A, TN 08–009B–1, TN 08–009D, 

(sent to the State in December 2008), 

and 08–019 (sent to the State in March, 

2009), CMS requested information about 

beneficiary access to services, but 

California did not respond. As indicated 

in a January 2, 2001, letter to State 

Medicaid Directors, to the extent that 

responses to such RAIs are not received 

within 90 days, CMS may initiate 

disapproval action. In this instance, in 

addition, CMS had concerns that, given 

the time that has elapsed since these 

SPAs were submitted but not 

implemented, the cumulative effect of a 

retroactively effective approval of these 

reimbursement reductions would only 

serve to exacerbate beneficiary access 

concerns. 

For these reasons, and after consulting 

with the Secretary as required by 

Federal regulations at 42 CFR 

430.15(c)(2), these SPAs were 

disapproved. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 244 / Tuesday, December 21, 2010 / Notices 80059 

The issues to be considered at the 

hearing are: 

• Whether California has 

demonstrated that the proposed 

payments to providers were sufficient to 

enlist enough providers so that care and 

services were available under the State’s 

Medicaid plan at least to the extent that 

such care and services are available to 

the general population in the geographic 

area as required by section 

1902(a)(30)(A) of the Social Security 

Act. 

• Whether the application of the 

payment rates under the SPAs 

retroactively, based on the proposed 

effective date, would be consistent with 

that requirement under section 

1902(a)(30)(A) of the Act. 

Section 1116 of the Act and Federal 

regulations at 42 CFR part 430, establish 

Department procedures that provide an 

administrative hearing for 

reconsideration of a disapproval of a 

State plan or plan amendment. CMS is 

required to publish a copy of the notice 

to a State Medicaid agency that informs 

the agency of the time and place of the 

hearing, and the issues to be considered. 

If we subsequently notify the agency of 

additional issues that will be considered 

at the hearing, we will also publish that 

notice. 

Any individual or group that wants to 

participate in the hearing as a party 

must petition the presiding officer 

within 15 days after publication of this 

notice, in accordance with the 

requirements contained at 42 CFR 

430.76(b)(2). Any interested person or 

organization that wants to participate as 

amicus curiae must petition the 

presiding officer before the hearing 

begins in accordance with the 

requirements contained at 42 CFR 

430.76(c). If the hearing is later 

rescheduled, the presiding officer will 

notify all participants. 

The notice to California announcing 

an administrative hearing to reconsider 

the disapproval of its SPAs reads as 

follows: 

Mr. Toby Douglas, Chief Deputy 

Director 

Health Care Programs 

Department of Health Care Services 

1501 Capitol Avenue, 6th Floor 

MS 0002 

Sacramento, CA 95814 

Dear Mr. Douglas: 

I am responding to your request for 

reconsideration of the decision to 

disapprove the California State Plan 

Amendments (SPAs) 08–009A; 08– 

009B1; 08–009B2; 08–009D which were 

submitted on September 30, 2008, and 

08–019 which was submitted on 

December 31, 2009, and disapproved on 

November 18, 2010. The SPAs proposed 

to reduce the reimbursement rates for 

certain services furnished under the 

approved State plan. 

The issues to be considered at the 

hearing are: 

• Whether California has 

demonstrated that the SPAs assured that 

the proposed payments to providers 

would be sufficient to enlist enough 

providers so that care and services were 

available under the State’s Medicaid 

plan at least to the extent that such care 

and services are available to the general 

population in the geographic area as 

required by section 1902(a)(30)(A) of the 

Social Security Act. 

• Whether the application of the 

payment rates under the SPAs 

retroactively, based on the proposed 

effective date, would be consistent with 

that requirement under section 

1902(a)(30)(A) of the Act. 

In reviewing this issue, we note that, 

when the SPAs were initially submitted, 

the State did not provide any 

information concerning the impact of 

the proposed reimbursement reductions 

on beneficiary access to services, even 

though available national data indicated 

that this may be an issue for California. 

In Requests for Additional 

Information (RAI) for SPAs TN 08– 

009A, TN 08–009B1, TN 08–009D (sent 

to the State in December 2008) and 08– 

019 (sent to the State in March 2009), 

CMS requested information about 

beneficiary access to services, but 

California never responded. As 

indicated in a January 2, 2001, letter to 

State Medicaid Directors, to the extent 

that responses to such RAIs are not 

received within 90 days, CMS may 

initiate disapproval action. In this 

instance, in addition, CMS was 

concerned that, given the time that had 

elapsed since these SPAs had been 

submitted but were not implemented, 

the cumulative effect of a retroactively 

effective approval of these 

reimbursement reductions exacerbate 

beneficiary access concerns. 

I am scheduling a hearing on your 

request for reconsideration to be held on 

February 10, 2011, at the CMS San 

Francisco Regional Office, 90 7th Street, 

#5–300 (5W), San Francisco, California 

94103–6706, in order to reconsider the 

decision to disapprove SPAs 08–009A; 

08–009B1; 08–009B2; 08–009D; and 08– 

019. If this date is not acceptable, we 

would be glad to set another date that 

is mutually agreeable to the parties. The 

hearing will be governed by the 

procedures prescribed by Federal 

regulations at 42 CFR Part 430. 

I am designating Mr. Benjamin Cohen 

as the presiding officer. If these 

arrangements are not acceptable, please 

contact the presiding officer at (410) 

786–3169. To facilitate any 

communication which may be necessary 

between the parties to the hearing, 

please notify the presiding officer to 

indicate acceptability of the hearing 

date that has been scheduled, and to 

provide names of the individuals who 

will represent the State at the hearing. 

Sincerely, 

Donald M. Berwick, M.D. 

Section 1116 of the Social Security Act 

(42 U.S.C. section 1316; 42 CFR section 

430.18) 

(Catalog of Federal Domestic Assistance 

program No. 13.714, Medicaid Assistance 

Program.) 

Dated: December 15, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2010–32007 Filed 12–20–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Advisory Committees; Tentative 

Schedule of Meetings for 2011 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

tentative schedule of forthcoming 

meetings of its public advisory 

committees for 2011. During 1991, at the 

request of the Commissioner of Food 

and Drugs (the Commissioner), the 

Institute of Medicine (the IOM) 

conducted a study of the use of FDA’s 

advisory committees. In its final report, 

one of the IOM’s recommendations was 

for the Agency to publish an annual 

tentative schedule of its meetings in the 

Federal Register. This publication 

implements the IOM’s recommendation. 

FOR FURTHER INFORMATION CONTACT: 

Teresa L. Hays, Advisory Committee 

Oversight and Management Staff (HF– 

4), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

Rm. 5290, Silver Spring, MD 20993– 

0002, 301–796–8220. 

SUPPLEMENTARY INFORMATION: The IOM, 

at the request of the Commissioner, 

undertook a study of the use of FDA’s 

advisory committees. In its final report 

in 1992, one of the IOM’s 

recommendations was for FDA to adopt 

a policy of publishing an advance yearly 

schedule of its upcoming public 


srobinson on DSKHWCL6B1PROD with NOTICES