18658 Federal Register / Vol. 72, No. 71 / Friday, April 13, 2007 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

[Document Identifier: OS–4040–0005] [30- 

Day Notice] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Office of the Secretary, HHS. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of a 

proposed collection 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. 

Type of Information Collection 

Request: Revision. 

Title of Information Collection: SF–

424 Individual. 

Form/OMB No.: OS–4040–0005. 

Use: The SF–424 (individual) is a 

simplified, alternative government-wide 

data set and application cover page for 

use by Federal grant-making agencies 

that award grants to individuals. The 

form will include one change to one 

field—the Social Security Number 

(SSN). The SSN field will remain 

optional. The SSN field will be changed 

to pre-populate the first five digits with 

‘‘000–00–’’ The applicant will only 

enter the last four digits of the SSN. 

This change ensures the entire SSN will 

not be collected or stored. This change 

will not increase the collection burden 

to the applicant. 

Frequency: Recordkeeping on 

Occasion. 

Affected Public: Individuals or 

Households. 

Annual Number of Respondents: 

5827. 

Total Annual Responses: 6949. 

Average Burden per Response: 25 

minutes. 

Total Annual Hours: 2895. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, e-mail your request, 

including your address, phone number, 

OMB number, and OS document 

identifier, to 

Sherette.funncoleman@hhs.gov , or call 

the Reports Clearance Office on (202) 

690–6162. Written comments and 

recommendations for the proposed 

information collections must be 

received within 30 days of this notice 

directly to the Desk Officer at the 

address below: 

OMB Desk Officer: John Kraemer, 

OMB Human Resources and Housing 

Branch, Attention: (OMB #4040–0005), 

New Executive Office Building, Room 

10235, Washington, DC 20503. 

Dated: April 5, 2007. 

Mary Oliver-Anderson, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. E7–7004 Filed 4–12–07; 8:45 am] 

BILLING CODE 4150–17–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10227, CMS–

1561 and 1561A, CMS–2728, CMS–10221, 

CMS–R–290, and CMS–R–26] 

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: Existing collection in use 

without an OMB Control Number; Title 

of Information Collection: PACE State 

Plan Amendment Pre-print; Form 

Number: CMS–10227 (OMB#: 0938–

New); Use: The Balanced Budget Act of 

1997 created section 1934 of the Social 

Security Act that established the 

Program for the All-Inclusive Care for 

the Elderly (PACE). The legislation 

established the PACE program as a 

Medicaid State plan option serving the 

frail and elderly in the home and 

community. In accordance with the rule 

published in the November 24, 1999 

Federal Register (64 FR 66271), if a 

State elects to offer PACE as an optional 

Medicaid benefit, it must complete a 

State Plan Amendment described as 

Enclosures #3, 4, 5, 6 and 7. In State 

Medicaid Director letters dated March 

23, 1998 and November 9, 2000, CMS 

advised States that it had provided a 

suggested pre-print and supplemental 

pages for a State to express its intention 

to elect PACE as an option to its State 

plans. As pre-print packet Enclosures 

#3–7 were suggested and not required, 

CMS did not believe at the time that a 

suggested form required clearance from 

OMB. The PACE regulation 42 CFR part 

460 was first published in the Federal 

Register as an interim final rule on 

November 24, 1999. The final PACE rule 

was published on December 8, 2006. 

CMS is seeking OMB approval to use 

Enclosures #3, 4, 5, 6 and 7. The 

information is used by CMS to affirm 

that the State elects to offer PACE an 

optional State plan service and the 

specifications of eligibility, payment 

and enrollment for the program; 

Frequency: Reporting—Once; Affected 

Public: State, Local or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 56 possible 

responses but we have only received 20 

thus far; Total Annual Hours: 1,120. 

2. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Health 

Insurance Benefit Agreement and 

Supporting Regulations at 42 CFR 489; 

Form Numbers: CMS–1561 and 1561A 

(OMB#: 0938–0832); Use: Applicants to 

the Medicare program are required to 

agree to provide services in accordance 

with Federal requirements. The CMS–

1561 and 1561A are essential for CMS 

to ensure that applicants are in 

compliance with the requirements. 

Applicants will be required to sign the 

completed form and provide operational 

information to CMS to assure that they 

continue to meet the requirements after 

approval; Frequency: Reporting—Other: 

all new applicants must complete; 

Affected Public: State, Local or Tribal 

Governments, Business or Other for 

profit and Not-for-profit institutions; 

Number of Respondents: 3300; Total 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 71 / Friday, April 13, 2007 / Notices 18659 

Annual Responses: 3300; Total Annual 

Hours: 275. 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: End Stage Renal 

Disease Medical Evidence Report 

Medicare Entitlement and/or Patient 

Registration; Form Number: CMS–2728 

(OMB#: 0938–0046); Use: The End Stage 

Renal Disease Medical Evidence (CMS–

2728) is completed for all ESRD patients 

either by the first treatment facility or by 

a Medicare-approved ESRD facility 

when it is determined by a physician 

that the patient’s condition has reached 

that stage of renal impairment that a 

regular course of kidney dialysis or a 

kidney transplant is necessary to 

maintain life. 

The data reported on the CMS–2728 

is used by the Federal Government, 

ESRD Networks, treatment facilities, 

researchers and others to monitor and 

assess the quality and type of care 

provided to end stage renal 

beneficiaries. The data collection 

captures the specific medical 

information required to determine the 

Medicare medical eligibility of End 

Stage Renal Disease claimants. It also 

collects data for research and policy on 

this population. Frequency: Reporting—

Once; Affected Public: Individuals or 

households, Business or other-for-profit, 

Not-for-profit institutions; Number of 

Respondents: 100,000; Total Annual 

Responses: 100,000; Total Annual 

Hours: 75,000. 

4. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Worksheet for 

Recording Results of Medicare Site 

Visits of Independent Diagnostic Testing 

Facilities (IDTFs) Form; Form Number: 

CMS–10221 (OMB#: 0938–New); Use: 

Prior to enrolling in Medicare, 

independent diagnostic testing facilities 

(IDTFs) must undergo a site visit as 

required under 42 CFR 410.33. The 

purpose of the site visit is to ensure that 

the IDTF is in compliance with the 

provisions of 42 CFR 410.33, as well as 

all other applicable Federal, State and 

local laws and regulations. It is also 

used to verify the information the IDTF 

furnished on its CMS–855B enrollment 

application. 

Section 410.33 contains a significant 

number of standards that IDTFs must 

meet in order to enroll in Medicare. 

Compliance with the standards further 

ensures that only qualified and 

legitimate IDTFs can bill Medicare. This 

is especially important in light of 

concerns about recent fraudulent 

activity by some IDTFs. We are 

submitting the ‘‘Worksheet for 

Recording Results of Medicare Site 

Visits of Independent Diagnostic Testing 

Facilities (IDTFs),’’ for OMB approval. 

The purpose of this document is to 

ensure that the individuals performing 

IDTF site visits take into account both 

new and existing IDTF standards in a 

consistent fashion. Frequency: 

Reporting—On occasion; Affected 

Public: Business or other-for-profit, Notfor-profit institutions; Number of 

Respondents: 2,000; Total Annual 

Responses: 2,000; Total Annual Hours: 

4,000. 

5. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare 

Program: Process for Making National 

Coverage Determinations; Form 

Number: CMS–R–290 (OMB#: 0938–

0776); Use: On September 26, 2003 (68 

FR 55634), we published a notice that 

described how we revised the process 

we use to make Medicare coverage 

decisions including decisions regarding 

whether new technology and services 

can be covered. In accordance with 

section IV.B of the aforementioned 

notice, CMS’ Revised Process for 

Making National Coverage 

Determinations, we require an 

individual or entity to make a formal 

request for a national coverage 

determination. Upon receipt of a formal 

request and adequate supporting 

documentation, we will make a 

determination based on the evidence 

presented, to cover the device or service 

or not to cover the device or service 

where it is not supported by the medical 

evidence. We are resubmitting this 

information collection request (ICR) to 

the Office of Management and Budget as 

an extension of the currently approved 

collection. We have not made any 

material modifications to the ICR since 

the last submission. Frequency: 

Recordkeeping and Reporting—On 

occasion; Affected Public: Business or 

other-for-profit, Not-for-profit 

institutions; Number of Respondents: 

200; Total Annual Responses: 200; Total 

Annual Hours: 8,000. 

6. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Information 

Collection Requirements (ICRs) 

Contained in the Clinical Laboratory 

Improvement Amendments (CLIA) 

Regulations 42 CFR part 493.801, 

493.803, 493.1232, 493.1233, 493.1234, 

493.1235, 493.1236, 493.1239, 493.1241, 

493.1242, 493.1249, 493.1251, 493.1252, 

439.1253, 493.1254, 493.1255, 493.1256, 

493.1261, 493.1262, 493.1263, 493.1269, 

493.1273, 493.1274, 493.1278, 493.1283, 

493.1289, 493.1291, and 493.1299; Form 

Numbers: CMS–R–26 (OMB#: 0938–

0612); Use: The ICRs referenced in 42 

CFR part 493 outline the requirements 

necessary to determine an entity’s 

complicance with CLIA. CLIA requires 

laboratories that perform testing on 

human beings to meet performance 

requirements (quality standards) in 

order to be certified by the Department 

of Health and Human Services (HHS). 

HHS conducts inspections to determine 

a laboratory’s compliance with CLIA 

requirements. CLIA implements the 

certificate, laboratory standards and 

inspection requirements; Frequency: 

Reporting—As needed; Affected Public: 

State, Local or Tribal Governments, 

Federal Government, Business or Other 

for profit and Not-for-profit institutions; 

Number of Respondents: 168,688; Total 

Annual Responses: 756,241; Total 

Annual Hours: 11,363,680. 

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 

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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received at the address below, no 

later than 5 p.m. on June 12, 2007. 

CMS, Office of Strategic Operations 

and Regulatory Affairs, Division of 

Regulations Development—A, 

Attention: Melissa Musotto, Room C4–

26–05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Dated: April 6, 2007. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E7–6990 Filed 4–12–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0015] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Adoption of the 

Food and Drug Administration Food 

Code by Local, State, and Tribal 

Governments 

AGENCY: Food and Drug Administration, 

HHS. 


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