Federal Register / Vol. 65, No. 195 / Friday, October 6, 2000 / Notices 59857

(See, e.g., Heckler v. Chaney, 470 U.S.

821 (1985); Schering v. Heckler, 779

F.2d 683 (D.C. Cir. 1985).) It is also

consistent with the Pearson decision,

which described several circumstances

in which FDA might be justified in

banning certain health claims outright

—e.g., where consumer health and

safety are threatened, or where FDA can

demonstrate that a health claim would

be misleading even if qualified (see

Pearson, 164 F.3d at 650, 657–60). For

example, the court said that FDA could

prohibit a health claim where the

evidence in support of the claim is

outweighed by evidence against the

claim, either quantitatively or

qualitatively (164 F.3d at 659 & n.10).

The agency is adopting this modified

process on an interim basis to minimize

any burden on speech pending

consumer research and rulemaking to

complete the implementation of the

Pearson decision.

3. Timing of FDA’s Decisions on Health

Claims for Dietary Supplements

FDA will complete its reconsideration

of the four Pearson claims and issue a

final decision on each of the claims

within 190 days after the close of the

comment period seeking scientific data

on the claims, i.e., by October 10, 2000.

For new health claim petitions for

dietary supplements, FDA will continue

to follow the applicable deadlines in

§ 101.70(j), as with past health claim

petitions.

Dated: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–25702 Filed 10–3–00; 4:29 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10011]

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: New Collection;

Title of Information Collection: Stages

of Change Survey for Informed Choice

in the Medicare Population;

Form No.: HCFA–10011 (OMB# 0938–

NEW);

Use: This is a survey of Medicare

beneficiaries in the first step in the

application the Transtheoretical Model

(the ‘‘stage model’’) to informed choice

in the Medicare population. The

Transtheoretical Model has been

applied and proven effective in

facilitating behavior change in a wide

range of health behaviors including

smoking cessation, mammography

screening, and safe sex. This work will

yield psychometrically sound and

externally valid measures of

beneficiaries’ readiness to make

informed choices about health plans,

and provide information to HCFA to

assist with its national educational

campaign to inform beneficiaries about

their choices. Stages of Change

measures will be administered to 560

Medicare beneficiaries and initial

enrollees. This survey research will

yield psychometrically sound measures

of beneficiaries’ readiness to make

informed choices about health plans,

and provide information to guide

HCFA’s National Medicare Education

Program (NMEP);

Frequency: Other: One-time survey;

Affected Public: Individuals or

Households;

Number of Respondents: 560;

Total Annual Responses: 560;

Total Annual Hours: 327.

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: Melissa Musotto, HCFA–

10011, Room N2–14–26, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: September 26, 2000.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–25761 Filed 10–5–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–9044]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, OHHS.

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: Provider

Reimbursement Manual, Part 1—

Chapter 27, Section 2721, 2722 and

2725, Request for Exception to ESRD

Composite Rates and Supporting

Regulations in 42 CFR 413.170 and

413.184; Form No.: HCFA–9044 (OMB#

0938–0296); Use: Sections 2721, 2722

and 2525 of the Provider

Reimbursement Manual describe the

information ESRD facilities must submit