28916 Federal Register / Vol. 66, No. 102 / Friday, May 25, 2001 / Notices

such approach satisfies the

requirements of the applicable statutes

and regulations.

II. Comments

Interested persons may, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). Two copies of

any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. The guidance and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at either http:/

/www.fda.gov/cder/guidance/

index.htm, http://www.fda.gov/ohrms/

dockets/default.htm, or http://

www.fda.gov/cber/guidelines.htm.

Dated: May 17, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13249 Filed 5–24–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–216]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, DHHS.

In compliance with the requirement

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

Paperwork Reduction Act of 1995, 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.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Procedures for

Advisory Opinions Concerning

Physician Referrals and Supporting

Regulations in 42 CFR 411.370 through

411.389; Form No.: HCFA–R–216

(OMB# 0938–0714); Use: Section 4314

of Public Law 105–33, in establishing

section 1877(g)(6) of the Act, requires

the Department to provide advisory

opinions to the public regarding

whether a physician’s referrals for

certain designated health services are

prohibited under the other provisions in

section 1877 of the Act. These

regulations provide the procedures

under which members of the public may

request advisory opinions from HCFA.

Because all requests for advisory

opinions are purely voluntary,

respondents will only be required to

provide information to us that is

relevant to their individual requests.;

Frequency: On occasion; Affected

Public: Not-for-profit institutions,

Business or other for-profit, and

Individuals and Households; Number of

Respondents: 200; Total Annual

Responses: 200; Total Annual Hours:

2,000.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

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 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Dawn Willinghan,HCFA–R–

216, Room N2–14–26, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: May 17, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–13207 Filed 5–24–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–224]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, DHHS. In compliance

with the requirement of section

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

Reduction Act of 1995, 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.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Collection of

Managed Care Data Using the Uniform

Institutional Providers Form (HCFA–

1450/UB–92) and Supporting Statute

section 1853(a)(3) of the Balanced

budget Act of 1997; Form No.: HCFA–

R–224 (OMB No. 0938–0711); Use:

Section 1853(a)(3) of the Balanced

Budget Act (BBA) requires

Medicare+Choice organizations, as well

as eligible organizations with risksharing contracts under section 1876, to

submit encounter data. Data regarding

inpatient hospital services are required

for periods beginning on or after July 1,

1997. These data may be collected

starting January 1, 1998. Other data (as

the Secretary deems necessary) may be

required beginning July 1, 1998.

The BBA also requires the Secretary

to implement a risk adjustment

methodology that accounts for variation

in per capita costs based on health

status. This payment method must be

implemented no later than January 1,

2000. The encounter data are necessary

to implement a risk adjustment

methodology.

HCFA continues to require hospital

inpatient encounter data from

Medicare+Choice organizations to