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. 


pwalker on PROD1PC71 with NOTICES
18660 Federal Register / Vol. 72, No. 71 / Friday, April 13, 2007 / Notices 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 14, 

2007. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Adoption of the Food and Drug 

Administration Food Code by Local, 

State, and Tribal Governments (OMB 

Control Number 0910–0448)—Extension 

FDA has developed its model Food 

Code to assist and promote consistent 

implementation of national food safety 

regulatory policy among the local, State, 

and tribal governmental agencies that 

have primary responsibility for the 

regulation or oversight of retail level 

food operations. The FDA Food Code 

provides a scientifically sound technical 

and legal basis for regulating the retail 

segment of the food industry. Authority 

for providing such assistance is derived 

from section 311(a) of the Public Health 

Service Act (42 U.S.C. 243(a)). Under 31 

U.S.C. 1535, FDA provides assistance to 

other Federal agencies such as the 

Indian Health Service. 

Nationwide adoption of the model 

FDA Food Code is an important step 

toward the agency’s goal for consistent, 

scientifically sound, and risk-based food 

safety standards and practices. A 

current, comprehensive, and accurate 

inventory of food code adoptions by 

States and U.S. territories, local, and 

tribal governments is necessary to 

determine the status of up-to-date 

protection of the U.S. population and to 

identify areas where assistance to these 

governments may promote the adoption 

of regulations based on the FDA Food 

Code. 

This collection effort, which began in 

2001, has had remarkable success with 

97 percent participation from State and 

territorial governmental agencies. FDA 

contracted with the Association of Food 

and Drug Officials (AFDO) to conduct 

the initial survey using the OMB 

approved survey form. The rulemaking 

process that local, State, territorial, and 

tribal governmental agencies must 

follow to adopt the model FDA Food 

Code is often a long and complicated 

process that can extend for several 

years. For this reason, many agencies 

have reported that they are still in the 

rulemaking process to adopt or update 

their food codes. Thus, FDA believes 

that extension of OMB approval of the 

survey is needed in order to keep the 

current database accurate and up-todate. AFDO will collect the information 

electronically and/or telephonically and 

will be able to provide respondents with 

previous survey responses already in 

the database. 

Description of Respondents: States 

and U.S. territories, local, and tribal 

governmental agencies. 

In the Federal Register of January 26, 

2007 (72 FR 3862), FDA published a 60- 

day notice requesting public comment 

on the information collection 

provisions. We received one comment, 

which was non-responsive to our 

request for comments on the proposed 

information collection. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Food Code Survey No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Respondents 75 4 300 1 300 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

This estimate is based on FDA’s 

experience and the number of updates 

received in the past 3 years. FDA has 

reduced the estimated number of annual 

respondents from 150 to 75. FDA 

estimates that 75 respondents will 

provide four quarterly updates each, 

resulting in an estimated 300 total 

annual responses. The agency estimates 

that each quarterly update will take 

about 1 hour. Of the 75 respondents, 

those who amend their regulations with 

changes unrelated to the risk factors and 

interventions, and those who are not 

adopting model FDA Food Code 

provisions, but are incorporating certain 

Conference for Food Protection 

recommendations only, will likely need 

only annual contact. 

Dated: April 9, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6983 Filed 4–12–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0525] 

Supplements and Other Changes to an 

Approved Application; Public Meeting; 

Reopening of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

May 18, 2007, the comment period for 

a notice of public meeting that 

published in the Federal Register of 

January 5, 2007 (72 FR 574). In the 

notice, FDA announced a February 7, 

2007, meeting to solicit input on issues 

that the agency should consider if it 

decides to propose revisions to its 

regulations regarding chemistry, 

manufacturing, and controls (CMC) 

supplements and other changes to 

approved marketing applications for 

human drugs. FDA is reopening the 

comment period in light of continued 

public interest in this topic. 

DATES: Submit written or electronic 

comments by May 18, 2007. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 


pwalker on PROD1PC71 with NOTICES