25736 Federal Register / Vol. 65, No. 86 / Wednesday, May 3, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0430]

Nalco Chemical Co.; Withdrawal of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 8A4598) proposing that the food

additive regulations be amended to

provide for the safe use of sodium

acrylate/sulfonated styrene copolymer

for use as an antiscalant boiler treatment

where steam from treated boilers may

contact food.

FOR FURTHER INFORMATION CONTACT:

Parvin M. Yasaei, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3023.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

June 30, 1998 (63 FR 35603), FDA

announced that a food additive petition

(FAP 8A4598) had been filed by Nalco

Chemical Co., One Nalco Center,

Naperville, IL 60563. The petition

proposed to amend the food additive

regulations in § 173.310 Boiler water

additives (21 CFR 173.310) to provide

for the safe use of sodium acrylate/

sulfonated styrene copolymer for use as

an antiscalant boiler treatment where

steam from treated boilers may contact

food. Nalco Chemical Co. has now

withdrawn the petition without

prejudice to a future filing (21 CFR

171.7).

Dated: April 5, 2000.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 00–10931 Filed 5–2–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–313]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration.

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: New Collection;

Title of Information Collection:

Medicare DMEPOS Competitive Bidding

Demonstration: Follow-up to Original

Survey;

Form No.: HCFA–R–313;

Use: This collection is the ‘‘followup’’ or ‘‘second round’’ to the original

Competitive Bidding Demonstration

collection to compare the results of the

two surveys to make inferences about

the impact of the competitive bidding

demonstration on issues measured by

the survey (i.e., access and quality, and

goods and services).

Section 4319 of the Balanced Budget

Act (BBA) mandates HCFA to

implement demonstration projects

under which competitive acquisition

areas are established for contract award

purposes for the furnishing of Part B

items and services, except for

physician’s services. The first of these

demonstration projects implements

competitive bidding of categories of

durable medical equipment, prosthetics,

orthotics, and supplies (DMEPOS).

Under the law, suppliers can receive

payments from Medicare for items and

services covered by the demonstration

only if their bids are competitive in

terms of quality and price. Each

demonstration project may be

conducted in up to three metropolitan

areas for a three year period. Authority

for the demonstration expires on

December 31, 2002. The schedule for

the demonstration anticipates about a

six month period required between

mailing the bidding forms to potential

bidders and the start of payments for

DMEPOS under the demonstration.

HCFA intended to operate the

demonstration in two rounds, the first of

two years, and the second of one year.

HCFA has operated its first

demonstration in Polk County, Florida,

which is the Lakeland-Winter Haven

Metropolitan Area. This ‘‘second

round’’ evaluation is necessary to

determine whether access to care,

quality of care, and diversity of product

selection are affected by the competitive

bidding demonstration. Although

secondary data will be used wherever

possible in the evaluation, primary data

from beneficiaries themselves is

required in order to gain an

understanding of changes in their level

of satisfaction and in the quality and

selection of the medical equipment.

The follow-up beneficiary surveys

will take place July to September 2000.

We will sample beneficiaries from

claimant lists provided by the durable

medical equipment regional carrier

(DMERC). The sample will be stratified

into two groups: beneficiaries who use

oxygen and beneficiaries who are nonoxygen users, i.e., users of the other four

product categories covered by the

demonstration (hospital beds, enteral

nutrition, urological supplies, and

surgical dressings) but not oxygen. To

draw a comparison, we will sample in

both the demonstration site (Polk

County, Florida) and a comparison site

(Brevard County, Florida) that matches

Polk County on characteristics such as

number of Medicare beneficiaries and

DME/POS utilization. Information

collected in the beneficiary survey will

be used by the University of WisconsinMadison (UW–M), Research Triangle

Institute (RTI), and Northwestern

University (NU) to evaluate the

Competitive Bidding Demonstration for

DME and POS. Results of the evaluation

will be used by HCFA and the Congress

in formulating future Medicare policy

on Part B competitive bidding.

The research questions to be

addressed by the surveys focus on

access, quality, and product selection.

Our collection process includes fielding

a survey for oxygen users and a survey

for non-oxygen users before the

demonstration begins and again after the

new demonstration prices were put into

effect. The baseline beneficiary survey

was conducted between March and May

1999. The same data collection process

will be followed in the comparison site

(Brevard County). In the analysis of the

data, we will also control for

socioeconomic factors. This will allow

us to separate the effects of the

demonstration from beneficiary or sitespecific effects. In the survey, we will

also ask beneficiaries about the types of

equipment that they use. This will allow

us to determine if certain users are

affected while others are not. For

example, we will be able to evaluate

whether oxygen users experience a