67744 Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 

• AR–2 Requirements for Inclusion of 

Women and Racial and Ethnic 

Minorities in Research. 

• AR–7 Executive Order 12372. 

• AR–9 Paperwork Reduction Act 

Requirements. 

• AR–10 Smoke-Free Workplace 

Requirements. 

• AR–11 Healthy People 2010. 

• AR–12 Lobbying Restrictions. 

• AR–13 Prohibition on Use of CDC 

Funds for Certain Gun Control 

Activities. 

• AR–14 Accounting System 

Requirements. 

• AR–22 Research Integrity. 

• AR–23 States and Faith-Based 

Organizations. 

• AR–24 Health Insurance Portability 

and Accountability Act Requirements 

(HIPAA).

Additional information on AR–1 

through AR–24 can be found on the 

CDC Web site at the following Internet 

address: http://www.cdc.gov/od/pgo/

funding/ARs.htm.

• AR–25 Release and Sharing of Data.

Starting with the December 1, 2004, 

receipt date, all ‘‘Requests for 

Applications (RFA)/Program 

Announcements (PA)’’ soliciting 

proposals for individual research 

projects of $500,000 or more in total 

(direct and indirect) costs per year 

require the applicant to include a plan 

describing how the final research data 

will be shared/released or explain why 

data sharing is not possible. Details on 

data sharing and release, including 

information on the timeliness of the 

data and the name of the project data 

steward, should be included in a brief 

paragraph immediately following the 

Research Plan Section of the PHS 398 

form. References to data sharing and 

release may also be appropriate in other 

sections of the application (e.g.

background and significance, or human 

subjects requirements). The content of 

the data sharing and release plan will 

vary, depending on the data being 

collected and how the investigator is 

planning to share the data. The data 

sharing and release plan will not count 

towards the application page limit and 

will not factor into the determining 

scientific merit or the priority scoring. 

Investigators should seek guidance from 

their institutions on issues related to 

institutional policies, and local IRB 

rules, as well as local, State and Federal 

laws and regulations, including the 

Privacy Rule. 

Further detail on the requirements for 

addressing data sharing in applications 

for NCIPC funding may be obtained by 

contacting NCIPC program staff or by 

visiting the NCIPC Internet Web site at: 

http://www.cdc.gov/ncipc/osp/

sharing_policy.htm.

VI.3. Reporting 

You must provide CDC with an 

original, plus two hard copies of the 

following reports: 

1. Interim progress report, (use form 

PHS 2590, OMB Number 0925–0001, 

rev. 5/2001 as posted on the CDC Web 

site) no less than 90 days before the end 

of the budget period. The progress 

report will serve as your non-competing 

continuation application, and must 

contain the following elements: 

a. Current Budget Period Activities 

Objectives. 

b. Current Budget Period Financial 

Progress. 

c. New Budget Period Program 

Proposed Activity Objectives. 

d. Budget. 

e. Measures of Effectiveness. 

f. Dissemination activities. 

g. Additional Requested Information. 

2. Financial status report, no more 

than 90 days after the end of the budget 

period. 

3. Final financial and performance 

reports, no more than 90 days after the 

end of the project period.

These reports must be mailed to the 

Grants Management Specialist listed in 

the ‘‘Agency Contacts’’ section of this 

announcement. 

VII. Agency Contacts 

We encourage inquiries concerning 

this announcement. 

For general questions, contact: 

Technical Information Management 

Section, CDC Procurement and Grants 

Office, 2920 Brandywine Road, Atlanta, 

GA 30341; Telephone: 770/488–2700. 

For scientific/research issues, contact: 

L.J. David Wallace, MS, Injury 

Prevention Specialist, National Center 

for Injury Prevention and Control, 

Centers for Disease Control and 

Prevention (CDC), 4770 Buford 

Highway, NE., Mailstop K–02, Atlanta, 

GA 30341; Telephone: 770/488–4712, Email: Dwallace2@cdc.gov.

For questions about peer review, 

contact: Gwendolyn Cattledge, PhD., 

Scientific Review Administrator, 

Associate Director for Extramural 

Research, National Center for Injury 

Prevention and Control, Centers for 

Disease Control and Prevention (CDC), 

4770 Buford Highway, NE., Mailstop K–

02; Atlanta, GA 30341; Telephone: 770/

488–1430, E-mail: gxc8@cdc.gov.

For financial, grants management, or 

budget assistance, contact: James 

Masone, Grants Management Specialist, 

CDC Procurement and Grants Office, 

2920 Brandywine Road, Atlanta, GA 

30341; Telephone: 770/488–2736, Email: ZFT2@cdc.gov.

VIII. Other Information 

This and other CDC funding 

opportunity announcements can be 

found on the CDC Web site, Internet 

address: http://www.cdc.gov. Click on 

‘‘Funding’’ then ‘‘Grants and 

Cooperative Agreements.’’

Dated: November 10, 2004. 

William P. Nichols, 

Acting Director, Procurement and Grants 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–25672 Filed 11–18–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifier: CMS–10052 and CMS–

370, 377, 378, R–54] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request

AGENCY: Centers for Medicare and 

Medicaid Services. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare and Medicaid 

Services (CMS) (formerly known as the 

Health Care Financing Administration 

(HCFA), 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 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: Extension of currently 

approved collection; Title of 

Information Collection: Recognition of 

Pass-Through Payment for Additional 

(new) Categories of Devices under the 

Outpatient Prospective Payment System 

and Supporting Regulations in 42 CFR 

part 419; Use: Information is necessary 

to determine eligibility of medical 

devices for establishment of additional 

device categories for payment under 

Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 67745

transitional pass-through payment 

provisions as required by section 

1833(t)(6) of the Social Security Act. 

Form Number: CMS–10052 (OMB#: 

0938–0857); Frequency: On occasion; 

Affected Public: Business or other forprofit; Number of Respondents: 12; 

Total Annual Responses: 12; Total 

Annual Hours: 192. 

2. Type of Information Collection 

Request: Revision of currently approved 

collection; Title of Information 

Collection: Ambulatory Surgical Center 

(ASC) Health Insurance Benefit 

Agreement, ASC Request for 

Certification, ASC Survey Report and 

Supporting Regulations in 42 CFR 

416.41, 416.43, 416.47, and 416.48; Use:

The ASC Health Insurance Benefits 

Agreement form is utilized for the 

purpose of establishing eligibility for 

payment under Title XVIII of the Social 

Security Act. The ASC Request for 

Certification form is utilized as an 

application for facilities wishing to 

participate in the Medicare program as 

an ASC. This form initiates the process 

of obtaining a decision as to whether the 

conditions of coverage are met. It also 

promotes data retrieval from the Online 

Data Input Edit (ODIE system, a 

subsystem of the Online Survey 

Certification and Report (OSCAR) 

system by the Centers for Medicare and 

Medicaid Services (CMS) Regional 

Offices (RO)). The ASC Report Form is 

an instrument used by the State survey 

agency to record data collection in order 

to determine supplier compliance with 

individual conditions of coverage and to 

report it to the Federal government. The 

form is primarily a coding worksheet 

designed to facilitate data reduction and 

retrieval into the ODIE/OSCAR system 

at the CMS ROs. This form includes 

basic information on compliance (i.e., 

met, not met and explanatory 

statements) and does not require any 

descriptive information regarding the 

survey activity itself; Form Number:

CMS–370, 377, 378, R–54 (OMB#: 0938–

0266); Frequency: Annually and Other: 

once; Affected Public: State, Local or 

Tribal Government; Number of 

Respondents: 4,312; Total Annual 

Responses: 4,312; Total Annual Hours:

2,241. 

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/

regulations/pra/, or E-mail your request, 

including your address, phone number, 

OMB number, and CMS document 

identifier, to Paperwork@hcfa.gov, or 

call the Reports Clearance Office on 

(410) 786–1326. Written comments and 

recommendations for the proposed 

information collections must be mailed 

within 30 days of this notice directly to 

the OMB desk officer: OMB Human 

Resources and Housing Branch, 

Attention: Christopher Martin, New 

Executive Office Building, Room 10235, 

Washington, DC 20503.

Dated: November 10, 2004. 

John P. Burke, III, 

Paperwork Reduction Act Team Leader, CMS 

Reports Clearance Officer, Office of Strategic 

Operations and Regulatory Affairs, Division 

of Regulations Development and Issuances.

[FR Doc. 04–25720 Filed 11–18–04; 8:45 am] 

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifier: CMS–10102] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request

AGENCY: Centers for Medicare and 

Medicaid Services. 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995, the 

Centers for Medicare and Medicaid 

Services (CMS) (formerly known as the 

Health Care Financing Administration 

(HCFA)), 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 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: New Collection; Title of 

Information Collection: National 

Implementation of the Hospital CAHPS 

Survey; Form No.: CMS–10102 (OMB# 

0938–NEW); Use: Hospital CAHPS, part 

of the Hospital Quality Alliance, is an 

effort to provide comparative 

performance information on hospitals to 

the public. HCAHPS includes a 

standardized survey instrument and 

data collection protocol allowing for 

flexibility in the mode of 

administration. The goals of the 

HCAHPS are to offer consumers choice 

and create incentives for hospitals to 

improve performance in areas that are 

important to patients. The current 

version of the questionnaire and 

implementation strategy has been tested 

and modified to reflect public input. 

CMS will begin training and 

implementation for HCAHPS following 

National Quality Forum endorsement 

and the Office of Management and 

Budget approval.; Frequency: Monthly; 

Affected Public: Individuals or 

households; Number of Respondents:

2,855,250; Total Annual Responses:

2,855,250; Total Annual Hours: 285,525. 

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/

regulations/pra/, 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. 

Written comments and 

recommendations for the proposed 

information collections must be mailed 

within 60 days of this notice directly to 

the CMS Paperwork Clearance Officer 

designated at the following address: 

CMS, Office of Strategic Operations and 

Regulatory Affairs, Division of 

Regulations Development and 

Issuances, Attention: Melissa Musotto, 

Room C5–14–03, 7500 Security 

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: November 10, 2004. 

John P. Burke, III, 

Paperwork Reduction Act Team Leader, 

Office of Strategic Operations and Strategic 

Affairs, Division of Regulations Development 

and Issuances.

[FR Doc. 04–25721 Filed 11–18–04; 8:45 am] 

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D–0229]

Guidance for Industry on Continuous 

Marketing Applications: Pilot 2—

Scientific Feedback and Interactions 

During Development of Fast Track 

Products Under the Prescription Drug 

User Fee Act of 1992; Extension of 

Application Deadline

AGENCY: Food and Drug Administration, 

HHS.