2078 Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices 

locations to be determined. This draft 

Plan will serve as the basis for the 

development of the updated National 

Vaccine Plan and based on this range of 

input, indicators of measurable 

outcomes will be determined and 

priorities will be presented. In addition, 

an implementation plan will be drafted 

that identifies specific actions that will 

be undertaken by government and other 

vaccine and immunization enterprise 

stakeholders to achieve the objectives 

and strategies in the plan and 

milestones will be established that will 

allow progress to be measured. The draft 

Plan has a ten-year horizon, and thereby 

balances a strategic vision, which 

requires development and 

implementation of new initiatives, with 

the recognition that changing 

circumstances and new opportunities 

and challenges will occur over the next 

decade. The ten-year horizon also 

allows incorporation of the 

HealthyPeople 2020 objectives once 

those are established by the Department 

of Health and Human Services (see 

http://www.healthypeople.gov). Annual 

monitoring of progress and a mid-course 

review will promote both accountability 

and flexibility. The updated National 

Vaccine Plan is expected to be 

completed by early 2010. 

Through this Request for Information, 

HHS is seeking broad comment from 

stakeholders and the general public. 

Comments received will be available for 

public viewing and will be summarized 

in an open meeting on February 6, 2009, 

to the NVAC in Washington, DC. If you 

wish to attend the meeting in person or 

by audioconference, please reply to 

nvpo@hhs.gov, or to 202–690–5566. 

II. Information Request 

NVPO, on behalf of the NVAC 

requests information in four broad areas. 

Responders may address one or more of 

the areas below. 

(1) Comments on priorities for the 

National Vaccine Plan for a ten-year 

period: What do you recommend be the 

top priorities for vaccines and the 

immunization enterprise in the United 

States and globally? Why are those 

priorities most important to you? 

[Provide up to 3 pages for an answer to 

these questions]. 

(2) Comments on the goals, objectives, 

and strategies for the National Vaccine 

Plan for a ten-year period: Please 

comment on the existing goals, 

objectives, and strategies in the draft 

Plan, and suggest specific goals, 

objectives, or strategies to be added to 

it, if the existing ones do not address 

your concerns. Are there any goals, 

objectives or strategies in the draft 

strategic Plan that should be discarded 

or revised? Which ones, and why? 

[Provide up to 3 pages for an answer to 

these questions]. 

(3) Comments on the indicators for 

the National Vaccine Plan for a ten-year 

period: Please comment on the existing 

indicators in the draft Plan, and suggest 

target estimates for them. Please suggest 

new indicators to be added to it, if the 

existing ones do not address your 

concerns. Are there any indicators in 

the draft strategic Plan that should be 

discarded or revised? Which ones, and 

why? [Provide up to 3 pages for an 

answer to these questions]. 

(4) Comments on stakeholders’ roles 

in the National Vaccine Plan: Please 

identify which stakeholders you believe 

should have responsibility for enacting 

the objectives and strategies listed in the 

draft Plan, as well as for any new 

objectives and strategies you suggest. 

Specifically identify roles your 

organization can play in the Plan. 

[Provide up to 3 pages for an answer to 

these questions]. 

III. Potential Responders 

HHS invites input from a broad range 

of individuals and organizations that 

have interests in vaccines and the 

immunization enterprise. Some 

examples of these organizations include, 

but are not limited to, the following: 

• General public. 

• Advocacy groups and public 

interest organizations. 

• State, local, and tribal governments 

and public health agencies. 

• State and local public health 

departments. 

• Vaccine manufacturing industry, 

distributors, investors, and other 

businesses. 

• Health care professional societies 

and organizations. 

• Academic researchers and groups. 

• Health care payers and plans. 

• International organizations. 

• Non-governmental organizations. 

• Philanthropic organizations. 

• Travel industry. 

The submission of written materials 

in response to the RFI should not 

exceed 12 pages (3 pages for each of the 

four broad topics), not including 

appendices and supplemental 

documents. Responders may submit 

other forms of electronic materials to 

demonstrate or exhibit concepts of their 

written responses. Any information you 

submit will be made public. 

Consequently, do not send proprietary, 

commercial, financial, business 

confidential, trade secret, or personal 

information that you do not wish to be 

made public. Information and 

comments will not be considered nor 

made publicly available, if it is not 

signed by, or attributed to, an 

individual, or an individual 

representing an organization. 

Public Access: Responses to this RFI 

will be available to the public on the 

NVPO Web site at http://www.hhs.gov/ 

nvpo/vacc_plan/. You may access 

public comments received from this RFI 

by going to the above Web site. 

Dated: January 7, 2009. 

Bruce Gellin, 

Deputy Assistant Secretary for Health, 

Director, National Vaccine Program Office, 

U.S. Department of Health and Human 

Services. 

[FR Doc. E9–495 Filed 1–13–09; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10161, CMS– 

1882, CMS–437A and B, CMS–1557 and 

CMS–10036] 

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 

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: Extension of a currently 

approved collection; Title of 

Information Collection: New Freedom 

Initiative—Web-based Reporting System 

for Grantees; Use: CMS currently awards 

competitive grants to States and other 

eligible entities for the purpose of 

designing and implementing effective 

and enduring improvements in 

community-based long-term services 


sroberts on PROD1PC70 with NOTICES
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