Federal Register / Vol. 69, No. 232 / Friday, December 3, 2004 / Notices 70265

1. Type of Information Collection 

Request: Extension of currently 

approved collection. 

Title of Information Collection:

Hospice Cost Report and Supporting 

Regulations Contained in 42 CFR 413.20 

and 413.24. 

Use: The hospice cost report is the 

mechanism used to collect data from 

providers for rate evaluations for the 

Prospective Payment System (PPS). 

Once CMS obtains this information, we 

will update the PPS as mandated by 

Congress. 

Form Number: CMS–R–249 (OMB#: 

0938–0758). 

Frequency: Annually. 

Affected Public: Not-for-profit 

Institutions and Business or other forprofit. 

Number of Respondents: 1,720. 

Total Annual Responses: 1,720. 

Total Annual Hours: 302,720. 

2. Type of Information Collection 

Request: Extension of currently 

approved collection. 

Title of Information Collection:

Outpatient Rehabilitation Cost Report 

and Supporting Regulations Contained 

in 42 CFR 413.20 and 413.24. 

Use: This form is used by community 

mental health centers to report their 

health care costs to determine the 

amount of reimbursement for services 

furnished to Medicare beneficiaries. 

Form Number: CMS–2088–92 (OMB#: 

0938–0037). 

Frequency: Annually. 

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

Local or Tribal governments. 

Number of Respondents: 618. 

Total Annual Responses: 618. 

Total Annual Hours: 61,800. 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection. 

Title of Information Collection:

Hospital Conditions of Participation 

(COP) and Supporting Regulations in 42 

CFR 482.12, 482.13, 482.21, 482.22, 

482.27, 482.30, 482.41, 482.43, 482.45, 

482.53, 482.56, 482.57, 482.60, 482.61, 

482.62, 485.618 and 485.631. 

Use: Hospitals seeking to participate 

in the Medicare and Medicaid programs 

must meet the Conditions of 

Participation (COP) for Hospitals, 42 

CFR Part 482. The information 

collection requirements contained in 

this package are needed to implement 

the Medicare and Medicaid COP for 

hospitals and critical access hospitals 

(CAHs). 

Form Number: CMS–R–48 (OMB# 

0938–0328). 

Frequency: Annually. 

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

Federal Government, and State, Local or 

Tribal Gov. 

Number of Respondents: 6,085. 

Total Annual Responses: 6,085. 

Total Annual Hours: 5,511,544. 

4. Type of Information Collection 

Request: Revision of currently approved 

collection. 

Title of Information Collection: ESRD 

Beneficiary Selection and Supporting 

Regulations Contained in 42 CFR 

414.330. 

Use: ESRD facilities have each new 

home dialysis patient select one of two 

methods to handle Medicare 

reimbursement. The intermediaries pay 

for the beneficiaries selecting Method I 

and the carriers pay for the beneficiaries 

selecting Method II. This system was 

developed to avoid duplicate billing by 

both intermediaries and carriers. 

Form Number: CMS–382 (OMB#: 

0938–0372). 

Frequency: Other: One time only. 

Affected Public: Individuals or 

Households, Business or other for-profit, 

and Not-for profit Institutions. 

Number of Respondents: 7,400. 

Total Annual Responses: 7,400. 

Total Annual Hours: 617. 

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 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 18, 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. 04–26286 Filed 12–2–04; 8:45 am] 

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0114]

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Protection of Human Subjects; 

Recordkeeping Requirements for 

Institutional Review Boards

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Protection of Human Subjects; 

Recordkeeping Requirements for 

Institutional Review Boards’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Karen Nelson, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1482.

SUPPLEMENTARY INFORMATION: In the 

Federal Register of July 22, 2004, (69 FR 

43852) the agency announced that the 

proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0130. The 

approval expires on November 30, 2007. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: November 26, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26581 Filed 12–2–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing

AGENCY: National Institutes of Health, 

Public Health Service, DHHS.

ACTION: Notice.