Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices 2079 

and support systems. CMS currently 

requires grantees to report on a 

quarterly, semi-annual, and or annual 

basis depending upon the grant type. 

CMS requires the information obtained 

through web-based grantee reporting for 

two reasons: (1) In order to effectively 

monitor the grants; and, (2) To report to 

Congress and other interested 

stakeholders the progress and obstacles 

experienced by the grantees. The 

grantees are the respondents to the webbased reporting system. Form Number: 

CMS–10161 (OMB# 0938–0979); 

Frequency: annually, semi-annually, 

and quarterly; Affected Public: State, 

Local or Tribal Governments; Number of 

Respondents: 171; Total Annual 

Responses: 428; Total Annual Hours: 

3,764. 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Request for 

Certification as a Supplier of Portable Xray Services and Portable X-ray Survey 

Report Form under the Medicare/ 

Medicaid Program and Supporting 

Regulations in 42 CFR 486.100–486.110; 

Use: The Medicare program requires 

portable X-ray suppliers to be surveyed 

for health and safety standards. The 

CMS–1882 is the survey form that 

records survey results. The CMS–1880 

is used by the surveyor to determine if 

a portable X-ray applicant meets the 

eligibility requirements. Form Numbers: 

CMS–1880/1882 (OMB# 0938–0027); 

Frequency: Occasionally; Affected 

Public: State, Local or Tribal 

Governments; Number of Respondents: 

544; Total Annual Responses: 68; Total 

Annual Hours: 4,760. 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Rehabilitation 

Hospital Criteria Worksheet and 

Rehabilitation Hospital Criteria 

Worksheet; Use: The rehabilitation 

hospital and rehabilitation unit criteria 

worksheets are necessary to verify that 

these facilities/units comply and remain 

in compliance with the exclusion 

criteria for the Medicare prospective 

payment system. Form Number: CMS– 

437A and 437B (OMB# 0938–0986); 

Frequency: Annually; Affected Public: 

Business or other for-profit; Number of 

Respondents: 1,227; Total Annual 

Responses: 1,227; Total Annual Hours: 

307. 

4. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Survey Report 

Form for Clinical Laboratory 

Improvement Amendments (CLIA) and 

Supporting Regulations in 42 CFR 

493.1–493.2001; Use: This form is used 

by the State to determine a laboratory’s 

compliance with CLIA. This 

information is needed for a laboratory’s 

CLIA certification and recertification. 

Form Number: CMS–1557 (OMB# 0938– 

0544); Frequency: Biennially; Affected 

Public: Business or other for-profit, Notfor-profit institutions, State, Local or 

Tribal Governments and Federal 

Government; Number of Respondents: 

21,000; Total Annual Responses: 

10,500; Total Annual Hours: 5,248. 

5. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Inpatient 

Rehabilitation Facility Patient 

Assessment Instrument (IRF–PAI) data 

and Supporting Regulations in 42 CFR 

412 Subpart P; Use: This instrument 

with its supporting manual is needed to 

permit the Secretary of Health and 

Human Services, and CMS, to 

implement Section 1886(j) of the Social 

Security Act. The statute requires the 

Secretary to develop a prospective 

payment system for inpatient 

rehabilitation facility services for the 

Medicare program. This payment 

system is to cover both operating and 

capital costs for inpatient rehabilitation 

facility services. It applies to inpatient 

rehabilitation hospitals as well as 

rehabilitation units of acute care 

hospitals. CMS implemented the 

inpatient rehabilitation facility 

prospective payment system for cost 

reporting periods beginning on or after 

January 1, 2002. 

Form Number: CMS–10036 (OMB# 

0938–0842); Frequency: Annually; 

Affected Public: Business or other forprofit, Not-for-profit institutions, State, 

Local or Tribal Governments and 

Federal Government; Number of 

Respondents: 1,202; Total Annual 

Responses: 396,660; Total Annual 

Hours: 337,161. 

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 February 13, 2009: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, New 

Executive Office Building, Room 10235, 

Washington, DC 20503, Fax Number: 

(202) 395–6974. 

Dated: January 8, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–687 Filed 1–13–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0544] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Record Retention 

Requirements for the Soy Protein and 

Risk of Coronary Heart Disease Health 

Claim 

AGENCY: Food and Drug Administration, 

HHS. 

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 February 

13, 2009. 

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, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0428. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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. 


sroberts on PROD1PC70 with NOTICES
2080 Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices 

Record Retention Requirements for the 

Soy Protein and Risk of Coronary Heart 

Disease Health Claim—(OMB Control 

Number 0910–0428—Extension) 

Section 403(r)(3)(A)(i) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

343(r)(3)(A)(i)) provides for the use of 

food label statements characterizing a 

relationship of any nutrient of the type 

required to be in the label or labeling of 

the food to a disease or a health-related 

condition only where that statement 

meets the requirements of the 

regulations issued by the Secretary of 

Health and Human Services to authorize 

the use of such a health claim. Section 

101.82 (§ 101.82) of FDA’s regulations 

authorizes a health claim for food labels 

about soy protein and the risk of 

coronary heart disease. To bear the soy 

protein/coronary heart disease health 

claim, foods must contain at least 6.25 

grams of soy protein per reference 

amount customarily consumed. 

Analytical methods for measuring total 

protein can be used to quantify the 

amount of soy protein in foods that 

contain soy as the sole source of protein. 

However, at the present time there is no 

validated analytical methodology 

available to quantify the amount of soy 

protein in foods that contain other 

sources of protein. For these latter 

foods, FDA must rely on information 

known only to the manufacturer to 

assess compliance with the requirement 

that the foods contain the qualifying 

amount of soy protein. Thus, FDA 

requires manufacturers to have and keep 

records to substantiate the amount of 

soy protein in a food that bears the 

health claim and contains sources of 

protein other than soy, and to make 

such records available to appropriate 

regulatory officials upon written 

request. The information collected 

includes nutrient databases or analyses, 

recipes or formulations, purchase orders 

for ingredients, or any other information 

that reasonably substantiates the ratio of 

soy protein to total protein. 

In the Federal Register of October 23, 

2008 (73 FR 63157), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

101.82(c)(2)(ii)(B) 25 1 25 1 25 

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

Based upon the agency’s experience 

with the use of health claims, FDA 

estimates that only about 25 firms 

would be likely to market products 

bearing a soy protein/coronary heart 

disease health claim and that only, 

perhaps, one of each firm’s products 

might contain non-soy sources of 

protein along with soy protein. The 

records required to be retained by 

§ 101.82(c)(2)(ii)(B) are the records, e.g., 

the formulation or recipe, that a 

manufacturer has and maintains as a 

normal course of its doing business. 

Thus, the burden to the food 

manufacturer is that involved in 

assembling and providing the records to 

appropriate regulatory officials for 

review or copying. 

Dated: January 7, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–573 Filed 1–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0653] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Filing Objections 

and Requests for a Hearing on a 

Regulation or Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements for filing objections and 

requests for a hearing on a regulation or 

order. 

DATES: Submit written or electronic 

comments on the collection of 

information by March 16, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 


sroberts on PROD1PC70 with NOTICES