Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Notices 27151

classification framework presumes that

the risk presented by a particular device

depends on its intended purpose and

the effectiveness of the risk management

techniques applied during the design,

manufacture, and use of that device.

The document also suggests that the

regulatory controls applied should be

proportional to the level of risk

associated with a medical device and

should increase with the associated

degree of risk presented by the medical

device. The GHTF document suggests

four global classifications of devices.

This document also presents a

decision tree logic that may help

regulatory authorities develop different

parameters that might be used to

classify specific devices.

When FDA discusses draft documents

with representatives of other countries,

we seek public comment on the

resulting documents. We believe that it

is important to publish draft documents

for comment at the same time as other

countries so we may review the public

comments and resume discussions in a

timely manner. Because other countries

do not follow our good guidance

practices (GGPs), we do not require draft

documents that result from international

discussions to comply with the format

requirements of our GGP regulation. The

GGP regulation does require that any

final FDA guidance that results from

international discussions will comply

with the GGP regulation.

II. Electronic Access

In order to receive ‘‘Medical Devices

Classification’’ via your fax machine,

call the CDRH Facts-On-Demand system

at 800–899–0381 or 301–827–0111 from

a touch-tone telephone. Press 1 to enter

the system. At the second voice prompt

press 1 to order a document. Enter the

document number (1327) followed by

the pound sign (#). Follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the draft document may also do so

using the Internet. CDRH maintains an

entry on the Internet for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with Internet access.

Updated on a regular basis, the CDRH

home page includes the civil money

penalty guidance documents package,

device safety alerts, Federal Register

reprints, information on premarket

submissions (including lists of approved

applications and manufacturers’

addresses), small manufacturers’

assistance, information on video

conferencing and electronic

submissions, Mammography Matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh.

III. Comments

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments regarding this draft guidance.

FDA must submit its written comments

to the GHTF by July 1, 2001. FDA will

consider any comments that it receives

in a timely manner, while preparing

those comments. FDA will consider any

public comments that it receives after

preparation of its comments to GHTF in

future discussions on this issue. Submit

two copies of any comments, 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

document and received comments may

be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: May 7, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–12226 Filed 5–15–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10041]

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: Long Term Care

Awareness Project; Form No.: HCFA–

10041 (OMB# 0938–NEW); Use: HCFA

needs to collect data to pilot test a

national campaign to educate current

and future Medicare beneficiaries and

their families about long term health

care needs, as requested in the Clinton

Fiscal Year 2000 Budget, to design and

implement a nationwide campaign.

Respondents will be from two groups:

55–70 year-olds and 18–64 years old

persons with disability; Frequency:

Quarterly; Affected Public: Individuals

or households; Number of Respondents:

7,800; Total Annual Responses: 3,900;

Total Annual Hours: 800.

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: Julie Brown, Attn. 10041,

Room N2–14–26, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: May 8, 2001.

Julie Brown,

Acting Reports Clearance Officer, Security

and Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–12342 Filed 5–15–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Center for Scientific Review; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

27152 Federal Register / Vol. 66, No. 95 / Wednesday, May 16, 2001 / Notices

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: Center for Scientific

Review Special Emphasis Panel.

Date: May 10, 2001.

Time: 3 p.m. to 4 p.m.

Agenda: To review and evaluate grant

applications.

Place: NIH, Rockledge 2, Bethesda, MD

20892, (Telephone Conference Call).

Contact Person: Jeanne N. Ketley, Ph.D,

Scientific Review Administrator, Center for

Scientific Review, National Institutes of

Health, 6701 Rockledge Drive, Room 4130,

MSC 7814, Bethesda, MD 20892, (301) 435–

1789.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.306, Comparative Medicine,

93.306; 93.333, Clinical Research, 93.333,

93.337, 93.393–93.396, 93.837–93.844,

93.846–93.878, 93.892, 93.893, National

Institutes of Health, HHS)

Dated: May 8, 2001.

Anna Snouffer,

Acting Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–12260 Filed 5–15–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

National Toxicology Program (NTP);

National Institute of Environmental

Health Sciences; NTP Announces the

Release of the NTP Final Report From

the Endocrine Disruptors Low-Dose

Peer Review for Public Comment

Summary

The National Toxicology Program

(NTP)/National Institute of

Environmental Health Sciences (NIEHS)

organized and conducted a scientific

peer review at the request of the US

Environmental Protection Agency (EPA)

to evaluate reported low-dose

reproductive and developmental effects

and dose-response relationships for

endocrine disrupting chemicals. The

NTP is soliciting public comment prior

to transmitting the final report to the US

EPA. Public comments received in

response to this solicitation will be

included in the final transmittal. The

final report is available on the NTP web

site at http://ntp-server.niehs.nih.gov or

by contacting the NTP Office of Liaison

and Scientific Review; 919–541–0530

(phone); 919–541–0295 (fax);

liaison@starbase.niehs.nih.gov; 111

T.W. Alexander Drive, P.O. Box 12233,

MD A3–01, Research Triangle Park, NC

27709.

Background

The NTP final report will be provided

to the US EPA to help guide the agency

in determining whether or not its

guidelines for reproductive and

developmental toxicity testing are

adequate for endocrine active

chemicals. For this meeting, ‘‘low-dose

effects’’ referred to biological changes

that occur in the range of human

exposures or at doses lower than those

typically used in the US EPA’s standard

testing paradigm for evaluating

reproductive and developmental

toxicity.

The peer review included plenary

sessions and several subpanel meetings.

The peer review panel was divided into

five subpanels: Bisphenol A, Other

Environmental Estrogens and Estradiol,

Androgens and Anti-Androgens,

Biological Factors and Study Design,

and Statistics and Dose-Response

Modeling. The Panel examined data

from major, selected studies (excluding

studies on phthalates and dioxin and

dioxin-like compounds) supporting the

presence or absence of low-dose effects

in laboratory animals that could be

relevant for human health assessments.

The Panel was also asked to evaluate the

shape of the dose-response curve for

endocrine active substances in the lowdose region. Prior to the peer review,

members of the Statistics and DoseResponse Modeling Subpanel analyzed

the raw data on selected parameters for

38 studies and provided its analyses to

the other subpanels. At the peer review,

members from this subpanel

participated in other subpanels.

Request for Public Comment on the

Final Report

Interested parties are encouraged to

submit written comments on the NTP

Endocrine Disruptors Low-Dose Peer

Review Final Report. Comments should

include name, affiliation, mailing

address, phone, fax, e-mail and

sponsoring organization (if any). The

NTP invites written public comment on

the final report through July 16, 2001.

Comments should be submitted to the

NTP Office of Liaison and Scientific

Review; 919–541–0530 (phone); 919–

541–0295 (fax);

liaison@starbase.niehs.nih.gov ; 111

T.W. Alexander Drive, P.O. Box 12233,

MD A3–01, Research Triangle Park, NC

27709.

Additional Information About the

Endocrine Disruptors Low-Dose Peer

Review

For additional information about the

Endocrine Disruptors Low-Dose Peer

Review including the peer review’s

program, list of participants, literature

reference lists, and Federal Register

notices, visit the NTP web site at:

http://ntp-server.niehs.nih.gov

Previously three Federal Register

notices were published about this peer

review: January 6, 2000, Volume 65,

Number 4, pages 784–787; April 17,

2000, Volume 65, Number 74, pages

20478–20479; September 27, 2000,

Volume 65, Number 188, pages 58097–

58099.

Dated: May 8, 2001.

Kenneth Olden,

Director, NIEHS, Director, NTP.

[FR Doc. 01–12261 Filed 5–15–01; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4655–N–13]

Notice of Proposed Information

Collection: Comment Request;

Hospital—Section 242, Application for

Project Mortgage Insurance

AGENCY: Office of the Assistant

Secretary for Housing, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments Due Date: July 16,

2001.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Wayne Eddins, Reports Management

Officer, Department of Housing and

Urban Development, 451 7th Street,

SW., L’Enfant Building, Room 8202,

Washington, DC 20410.

FOR FURTHER INFORMATION CONTACT:

Roger Miller, Director, Office of Insured

Health Care Facilities, U.S. Department

of Housing and Urban Development,

451 7th Street, SW., Washington, DC

20410, telephone number (202) 708–