11890 Federal Register / Vol. 75, No. 48 / Friday, March 12, 2010 / Notices 

all applicants. In addition, eliminating 

the error correction window will help 

NIH reduce the time needed to process 

applications and forward them through 

the peer review process. 

The error correction window was 

established at a time when an 

application could take multiple days to 

get processed by Grants.gov and NIH’s 

eRA systems. The lengthy processing 

time meant that applicants who applied 

on time might not receive feedback on 

the status of their submissions in time 

to address system identified errors/ 

warnings until after the due date, unless 

they applied well in advance. 

During the initial transition the error 

correction window also provided an 

opportunity for applicants to become 

familiar with the use of the new SF424 

(R&R) applications and the new way 

that long standing business rules would 

be enforced by electronic systems upon 

submission. 

Since 2005, combined system 

processing times have improved 

dramatically, with applications now 

taking minutes to process through both 

systems on average instead of days. This 

improvement provides applicants 

timely feedback on the status of their 

applications and allows them to address 

any system identified errors and 

warnings immediately, as the systems 

can process multiple submissions 

within a short period of time. NIH also 

has policies in place that do not rely on 

the error correction window to ensure 

that applicants are protected from 

possible eRA Commons or Grants.gov 

system issues that might keep an 

application from being received by the 

submission deadline. 

Additionally, elimination of the error 

correction window will not affect an 

applicant’s ability to submit late 

applications under the existing NIH 

Policy on Late Submission of Grant 

Applications (NOT–OD–06–086 

available at http://grants.nih.gov/grants/ 

guide/notice-files/NOT–OD–06– 

086.html) or for those who have 

provided substantial review service to 

NIH to take advantage of NIH’s 

continuous submission policy (http://

grants.nih.gov/grants/guide/notice-files/

NOT–OD–08–026.html). 

NIH is accepting comments from 

individuals and organizations on the 

impact of this change. We are also 

interested in feedback on possible 

timing of the change. Is there support 

for making the change in the next 3–6 

months, a year, or is more time needed 

to make the change should the agencies 

decide to move forward? 

Date: March 9, 2010. 

Sally J. Rockey, 

Acting Deputy Director for Extramural 

Research, National Institutes of Health. 

[FR Doc. 2010–5474 Filed 3–11–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10146] 

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: Notice of Denial 

of Medicare Prescription Drug Coverage: 

Use: Section 1860D–4(g)(1) of the Social 

Security Act requires Part D plan 

sponsors that deny prescription drug 

coverage to provide a written notice of 

the denial to the enrollee. The purpose 

of this notice is to provide information 

to enrollees when prescription drug 

coverage has been denied, in whole or 

in part, by their Part D plans. The notice 

must be readable, understandable, and 

state the specific reasons for the denial. 

The notice must also remind enrollees 

about their rights and protections 

related to requests for prescription drug 

coverage and include an explanation of 

both the standard and expedited 

redetermination processes and the rest 

of the appeal process. For a list of 

changes, refer to the summary of 

changes document. Form Number: 

CMS–10146 (OMB#: 0938–0976); 

Frequency: Daily; Affected Public: 

Business or other for-profits; Number of 

Respondents: 456; Total Annual 

Responses: 290,344; Total Annual 

Hours: 145,172. (For policy questions 

regarding this collection contact 

Kathryn M. Smith at 410–786–7623. 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 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 and recommendations must 

be submitted in one of the following 

ways by May 11, 2010: 

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: March 8, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–5429 Filed 3–11–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–2744, CMS– 

10304 and CMS–10282] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

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


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 48 / Friday, March 12, 2010 / Notices 11891 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & 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 function; 

(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: Reinstatement without change 

of a previously approved collection; 

Title of Information Collection: End 

Stage Renal Disease (ESRD) Medical 

Information Facility Survey; Form 

Number: CMS–2744 (OMB#: 0938– 

0447); Use: The End Stage Renal Disease 

(ESRD) Medical Information Facility 

Survey form (CMS–2744) is completed 

annually by Medicare-approved 

providers of dialysis and transplant 

services. The CMS–2744 is designed to 

collect information concerning 

treatment trends, utilization of services 

and patterns of practice in treating 

ESRD patients. The information is used 

to assess and evaluate the local, regional 

and national levels of medical and 

social impact of ESRD care and is used 

extensively by researchers and suppliers 

of services for trend analysis. The 

information is available on the CMS 

Dialysis Facility Compare Web site and 

will enable patients to make informed 

decisions about their care by comparing 

dialysis facilities in their area. 

Frequency: Yearly; Affected Public: 

Business or other for-profit, not-forprofit institutions; Number of 

Respondents: 5,465; Total Annual 

Responses: 5,465; Total Annual Hours: 

43,720. (For policy questions regarding 

this collection contact Connie Cole at 

410–786–0257. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Information 

Collection Requirements and 

Supporting Information for Chronic 

Kidney Disease Surveys under the 9th 

Scope of Work; Form Number: CMS– 

10304 (OMB#: 0938–New); Use: The 

Centers for Medicare & Medicaid 

Services (CMS) and the U.S. Department 

of Health and Human Services (DHHS) 

are requesting OMB clearance for the 

Chronic Kidney Disease (CKD) Partner 

Survey and the Chronic Kidney Disease 

(CKD) Provider Survey. The Prevention 

CKD Theme is a component of the 

Prevention Theme of the Quality 

Improvement Organization (QIO) 

Program’s 9th Scope of Work (SOW). 

The statutory authority for this scope of 

work is found in Part B of Title XI of 

the Social Security Act (the Act) as 

amended by the Peer Review 

Improvement Act of 1982. The Act 

established the Utilization and Quality 

Control Peer Review Organization 

Program, now known as the Quality 

Improvement Organization (QIO) 

Program. 

The goal of the Prevention CKD 

Theme is to detect the incidence, 

decrease the progression of CKD, and 

improve care among Medicare 

beneficiaries through provider adoption 

of timely and effective quality of care 

interventions; participation in quality 

incentive initiatives; beneficiary 

education; and key linkages and 

collaborations for system change at the 

state and local level. In addition to 

improving the quality of care for the 

elderly and frail-elderly, this Theme 

aims to reduce the rate of Medicare 

entitlement by disability through the 

delay and prevention of end-stage renal 

disease (ESRD); thus resulting in higher 

quality care and significant savings to 

the Medicare Trust Fund. 

The CKD Partner Survey constitutes a 

new information collection to be used 

by CMS to obtain information on how 

QIO collaboration with partners 

facilitates systems change within the 

QIO’s respective state. The CKD Partner 

Survey will be a census administered to 

350 collaborative partners in the 9th 

SOW. The CKD Partner Survey will be 

administered via telephone. Responses 

will be entered into a pre-programmed 

Computer-Assisted Telephone 

Interviewing (CATI) interface. The 

results of the survey shall be used for 

inpatient quality indicators (IQI) by the 

QIO. CMS will also use the results to 

assess how partner organizations and 

their perspective of the QIO’s role are 

implementing system change. 

Similarly, the CKD Provider Survey 

constitutes a new information collection 

to be used by CMS to obtain information 

on how QIO collaboration with 

physician practices facilitates systems 

change within the QIO’s respective 

state. The CKD Provider Survey will be 

administered via telephone and the 

Web. Responses collected by phone will 

be entered into a pre-programmed 

Computer-Assisted Telephone 

Interviewing (CATI) interface. 

Responses collected by Web will be 

housed on a secure server and database. 

The results of the survey shall be used 

for inpatient quality indicators (IQI) by 

the QIO. CMS will also use the results 

to assess how physicians’ practices and 

their perspective of the QIO’s role are 

implementing system change. 

Frequency: Yearly; Affected Public: 

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

Number of Respondents: 1,350; Total 

Annual Responses: 1,350; Total Annual 

Hours: 337.5. (For policy questions 

regarding this collection contact Robert 

Kambic at 410–786–1515. For all other 

issues call 410–786–1326.) 

3. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Conditions of 

Participation for Comprehensive 

Outpatient Rehabilitation Facilities 

(CORFs) and supporting regulations in 

485.50, 485.51, 485.54, 485.56, 485.58, 

485.60, 485.62, 485.64, 485.66, 485.70, 

and 485.74.; Form Number: CMS–10282 

(OMB#: 0938–New); Use: The 

Conditions of Participation (CoPs) and 

accompanying requirements specified in 

the regulations are used by our 

surveyors as a basis for determining 

whether a comprehensive outpatient 

rehabilitation facility (CORF) qualifies 

to be awarded a Medicare provider 

agreement. CMS believes the health care 

industry practice demonstrates that the 

patient clinical records and general 

content of records are necessary to 

ensure the well-being and safety of 

patients and that professional treatment 

and accountability are a normal part of 

industry practice. Frequency: Yearly; 

Affected Public: Business or other forprofit, not-for-profit institutions; 

Number of Respondents: 446; Total 

Annual Responses: 446; Total Annual 

Hours: 30,105. (For policy questions 

regarding this collection contact 

Monique Howard 410–786–3869. 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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on April 12, 2010: 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 


srobinson on DSKHWCL6B1PROD with NOTICES
11892 Federal Register / Vol. 75, No. 48 / Friday, March 12, 2010 / Notices 

Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov. 

Dated: March 8, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–5428 Filed 3–11–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer on (240) 276–1243. 

Proposed Project: Substance Abuse 

Prevention and Treatment Block Grant 

Synar Report Format, FFY 2011–2013— 

(OMB No. 0930–0222)—Revision 

Section 1926 of the Public Health 

Service Act [42 U.S.C. 300x–26] 

stipulates that funding Substance Abuse 

Prevention and Treatment (SAPT) Block 

Grant agreements for alcohol and drug 

abuse programs for fiscal year 1994 and 

subsequent fiscal years require States to 

have in effect a law providing that it is 

unlawful for any manufacturer, retailer, 

or distributor of tobacco products to sell 

or distribute any such product to any 

individual under the age of 18. This 

section further requires that States 

conduct annual, random, unannounced 

inspections to ensure compliance with 

the law; that the State submit annually 

a report describing the results of the 

inspections, describing the activities 

carried out by the State to enforce the 

required law, describing the success the 

State has achieved in reducing the 

availability of tobacco products to 

individuals under the age of 18, and 

describing the strategies to be utilized 

by the State for enforcing such law 

during the fiscal year for which the 

grant is sought. 

Before making an award to a State 

under the SAPT Block Grant, the 

Secretary must make a determination 

that the State has maintained 

compliance with these requirements. If 

a determination is made that the State 

is not in compliance, penalties shall be 

applied. Penalties ranged from 10 

percent of the Block Grant in applicable 

year 1 (FFY 1997 SAPT Block Grant 

Applications) to 40 percent in 

applicable year 4 (FFY 2000 SAPT 

Block Grant Applications) and 

subsequent years. Respondents include 

the 50 States, the District of Columbia, 

the Commonwealth of Puerto Rico, the 

U.S. Virgin Islands, Guam, American 

Samoa, the Commonwealth of the 

Northern Mariana Islands, Palau, 

Micronesia, and the Marshall Islands. 

Regulations that implement this 

legislation are at 45 CFR 96.130, are 

approved by OMB under control 

number 0930–0163, and require that 

each State submit an annual Synar 

report to the Secretary describing their 

progress in complying with section 1926 

of the PHS Act. The Synar report, due 

December 31 following the fiscal year 

for which the State is reporting, 

describes the results of the inspections 

and the activities carried out by the 

State to enforce the required law; the 

success the State has achieved in 

reducing the availability of tobacco 

products to individuals under the age of 

18; and the strategies to be utilized by 

the State for enforcing such law during 

the fiscal year for which the grant is 

sought. 

SAMHSA’s Center for Substance 

Abuse Prevention will request OMB 

approval of revisions to the current 

report format associated with Section 

1926 (42 U.S.C. 300x–26). The report 

format is minimally changing. Any 

changes in either formatting or content 

are being made to simplify the reporting 

process for the States and to clarify the 

information as the States report it; both 

outcomes will facilitate consistent, 

credible, and efficient monitoring of 

Synar compliance across the States and 

will reduce the reporting burden by the 

States. All of the information required 

in the new report format is already 

being collected by the States. Most of 

the specific revisions appear in Section 

I (Compliance Progress) of the report 

format and include clarifications to 

Questions 4a, 5b, 5e and 5f. 

Additionally, three new questions (5c, 

5d and 5g) have been added and two 

items have been added to Question 7b. 

Information on these additions appears 

below: 

Question 5c: Level of Enforcement— 

This question, which asks the State to 

select whether enforcement is 

conducted only at those outlets 

randomly selected for the Synar survey, 

only at a subset of outlets not randomly 

selected for the Synar survey, or a 

combination of the two, has been newly 

added to the ASR format. It has been 

added to provide additional information 

about State enforcement programs, 

which is frequently requested by partner 

agencies and can also be used to target 

technical assistance. 

Question 5d: Frequency of 

Enforcement—This question, which 

asks the State to select whether every 

tobacco outlet in the State did or did not 

receive at least one enforcement 

compliance check in the last year, has 

been newly added to the ASR format. It 

has been added to provide additional 

information about State enforcement 

programs, which is frequently requested 

by partner agencies and can also be used 

to target technical assistance. 

Question 5g. Relationship of State 

Synar Program to FDA-Funded 

Enforcement Program—This question, 

which asks the State to describe the 

relationship between the State’s Synar 

program and the Food and Drug 

Administration (FDA)-funded 

enforcement program, has been added to 

the ASR format. The Family Smoking 

Prevention and Tobacco Control Act, 

recently signed into law by President 

Obama, requires the FDA to reissue the 

1996 regulation aimed at reducing 

young people’s access to tobacco 

products and curbing the appeal of 

tobacco to the young. This regulation 

must be reissued by April 2010. As part 

of the implementation of this regulation, 

FDA will be contracting with States to 

enforce new Federal youth access 

provisions. This question asks the State 

to describe the relationship and 

coordination between its Synar program 

and the enforcement program funded by 

FDA. 

Question 7b. Synar Survey Results for 

States that Do Not Use the Synar Survey 

Estimation System (SSES)—Two items 

have been added to this question 

(accuracy rate and completion rate). 

These items were added to ensure that 

the same statistical parameters are asked 

of both States that do and do not use the 

SSES to analyze their Synar survey 

results. 

Additionally, in Appendix B (Synar 

Survey Sampling Methodology), the 

following changes are being made with 

respect to the Annual Synar Report: 

Question 10. Provide the following 

information about sample size 

calculation for the current FFY Synar 

survey. This question has been added to 

Appendix B and asks the State to 

provide information about the specific 

input values used to calculate the 

effective, target and original sample 

sizes for the current FFY Synar survey. 

This question will reduce the need for 

SAMHSA/CSAP to request additional 

clarifying information from the State 

when SAMHSA/CSAP is unable to 


srobinson on DSKHWCL6B1PROD with NOTICES