Federal Register / Vol. 63, No. 123 / Friday, June 26, 1998 / Notices 34903

document for industry will be on

display in the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday. A copy of the draft guidance

document will also be available on the

Internet at ‘‘http://www.fda.gov/cder/

guidance/index.htm’’.

On July 29, 1998, the committee will

discuss effectiveness testing for final

formulations of health-care antiseptic

drug products relative to performance

expectations for these OTC drug

products. In the Federal Register of June

17, 1994 (59 FR 31402 through 31452),

the agency published a proposed rule

for OTC health-care antiseptic drug

products, i.e., patient preoperative skin

preparations, surgical hand scrubs, and

health-care personnel and antiseptic

handwashes. Included in the proposed

rule are key characteristics for each drug

product class of health-care antiseptic

drug products (i.e., definitions), a

requirement for final formulation

testing, effectiveness standards, and

labeling of each of the drug product

categories. In response to the proposed

rule, the agency received comments to

consider six drug product categories

(preoperative skin preparation, surgical

hand scrub, health-care personnel

handwash, food handler handwash,

antimicrobial handwash, and

antimicrobial bodywash). Comments

also proposed alternate: (1) Testing

requirements, (2) key characteristics,

and (3) labeling for each of the

categories. FDA is seeking the

recommendations of the committee and

experts on appropriate performance

expectations for OTC health-care

antiseptic drug products and how these

final formulations should be tested.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 21, 1998. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 2 p.m. on July 28 and 29, 1998.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before July 21, 1998,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 18, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–17074 Filed 6–25–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–R–224]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

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.

Hospital data from the period, July 1,

1997–June 30, 1998, will serve as the

basis for plan-level estimates of risk

adjusted payments. These estimates will

be provided to plans by March, 1999.

Encounter data collected from

subsequent time periods will serve as

the basis for actual payments to plans

for CY 2000 and beyond.

In implementing the requirements of

the BBA, hospitals will submit data to

the managed care plan for enrollees who

have a hospital discharge using the

HCFA–1450 (UB–92), Uniform

Institutional Provider Claim Form.

Encounter data for hospital discharges

occurring on or after July 1, 1997 are

required. While submission from the

hospital to the plan is required, plans

are provided with an alternate

submission route for the start-up year.

Special procedures have been

identified to ensure that hospital

encounter data are submitted for

discharges occurring between July 1,

1997 and June 30, 1998, the start-up

year. HCFA has identified three

alternatives for the submission of

hospital encounter data for discharges

during the star-up year, including the

following:

Option 1: The Plan will have a hospital

submit UB–92s or Medicare Part A

ANSI ASC X12 837 (ANSI 837)

records using the traditional HMO

‘‘No Pay’’ bill method.

Option 2: The Plan can currently

produce a complete UB–92/ANSI 837

and will hold the data until the fiscal

intermediary (FI) can accept it.

Option 3: The Plan will submit an

abbreviated UB–92 data set via an

alternative route.

During the start up year, the plan is

expected to establish an electronic data

linkage to a FI to be determined by

HCFA. HCFA will assist Plans in

initiating discussions with their FI. By

July 15, 1998, the Plan is expected to

have completed this linkage, including

testing of the linkage, and to be capable

of transmitting hospital encounter data

to a FI. Data for the start-up year must

be transmitted to the plan’s FI by

September, 18, 1998. All data with

discharge dates after July 1, 1998 will be

transmitted using this linkage. (See

Appendix III for additional information

on the transmission of data to HCFA.)

Each plan and/or contract will use a

single FI. HCFA will establish a series

of interim deadlines to ensure that plans

are making sufficient progress toward
34904 Federal Register / Vol. 63, No. 123 / Friday, June 26, 1998 / Notices

accomplishing this linkage no later than

July 15, 1998.

After plans have established linkages

to a FI, hospitals will submit HCFA–

1450 (UB–92) forms to the managed care

plan. The HCFA–1450 (UB–92) form is

identical to the one used by hospitals in

billing for Medicare fee-for-service

claims. After receiving the pseudo claim

from the hospital, the plan attaches the

plan identifier, which is the HCFA

assigned managed care organization

(MCO) Contract Number, and submits

the pseudo-claim electronically to the

fiscal intermediary (FI). The data

processing flow by the FI is very similar

to current claims processing for the feefor-service system, except that no

payment is authorized to the plan.

Pseudo claims will flow though the FI

to our Common Working File (CWF) and

will be retained by HCFA.; Frequency:

On occasion; Affected Public: Business

or other for-profit, Not-for-profit

institutions, and Federal government;

Number of Respondents: 1.9 million;

Total Annual Responses: 1.9 million;

Total Annual Hours: 32,833.

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: Louis Blank, Room C2–26–

17, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: June 16, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 98–16989 Filed 6–25–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–243]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

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 the 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: New Collection; Title of

Information Collection: Medicare

Agreement Application, Health Care

Prepayment Plan; Form No.: HCFA–R–

243; Use: An organization must meet

certain requirements to be a Health Care

Prepayment Plan that is eligible for a

Medicare 1833 agreement. The

application is the collection form used

to obtain information from an

organization that would allow HCFA

staff to determine compliance with the

regulations. This form includes requests

for information about: the management

of the applicant organization;

arrangements for providing health care

to beneficiaries; meeting Medicare

requirements for appeals, hearings,

advance directives, health benefits; risk

sharing with other entities; the fiscal

soundness of the applicant; the cost

budget, which forms the basis for HCFA

payment; prevention of duplicate

payment; and the applicant’s marketing

strategy. Frequency: One time ; Affected

Public: Business or other for-profit

institutions, Not-for-profit institutions,

and State, Local or Tribal Governments.;

Number of Respondents: 15; Total

Annual Responses: 15; Total Annual

Hours: 1,125.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or any

related forms, E-mail your request,

including your address and phone

number, 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,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: June 18, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Health Care

Financing Administration.

[FR Doc. 98–16999 Filed 6–25–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995, Pub.

L. 104–13), the Health Resources and

Services Administration (HRSA) will

publish periodic summaries of proposed

projects being developed for submission

to OMB under the Paperwork Reduction

Act of 1995. To request more

information on the proposed project or

to obtain a copy of the data collection

plans and draft instruments, call the

HRSA Reports Clearance Officer on

(301) 443–1891.

Comments are invited on: (a) whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.