59004 Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Notices

Respondents Number of

respondents

Number of

responses/

respondent

Average

burden of

response

(in hrs.)

Total burden

(in hrs.)

Health Care Providers ..................................................................................... 1800 1 D20/60 600

Office Managers .............................................................................................. 1800 1 20/60 600

Totals ........................................................................................................ ........................ ........................ ........................ 1200

Dated: September 27, 2000.

Nancy Cheal,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 00–25321 Filed 10–2–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Availability of Government-Owned

Trademark for Licensing

AGENCY: National Institute of

Occupational Safety and Health

(NIOSH), Centers for Disease Control

and Prevention (CDC), Department of

Health and Human Services (DHHS).

TITLE: Availability of a Governmentowned Trademark for Licensing: The

Registry of Toxic Effects of Chemical

Substances (RTECS).

ACTION: Notice and request for

proposals. NIOSH is requesting

proposals for the purpose of establishing

a licensing agreement for the

continuation of a trademarked product:

RTECS. (The NIOSH Trademark

named in this notice is owned by the

United States Government and is

available or licensing in the United

States (U.S.), in accordance with 35

U.S.C. 207 to achieve expeditious

commercialization of results of federally

funded research and development.)

SUMMARY: From the 1971 initial release

of the mandated Toxic Substances List,

the National Institute for Occupational

Safety and Health (NIOSH) has been

systematically building and updating

the Registry of Toxic Effects of Chemical

Substances (RTECS). RTECS was

originally published in book format,

later a microfiche version was

developed. Currently, RTECS is

available in a digital format for

electronic delivery. RTECS is

recognized as the world’s most

extensive collection of numerical

toxicological data. Because RTECS

identifies specific toxicological

endpoints, it has a unique status among

databases that provide toxicology

information. RTECS is used not only

by the occupational safety and health

community; it serves as a standard

reference for life-science scientists and

regulatory groups from all parts of the

world. Both its content and design have

contributed to its wild spread use, thus

making RTECS a commercially viable

product. NIOSH is now soliciting

proposals from organizations interested

in assuming the responsibility for the

continued operation and funding of

RTECS. This include the ongoing

review of toxicological documents,

extraction and updating of appropriate

information as well as the marketing

and distribution of the RTECS database

through a trademark licensing

agreement.

DATES: Written licensing proposals can

be sent to Thomas E. O’Toole, M.P.H.,

Deputy Director, Technology Transfer

Office, Centers for Disease Control and

Prevention (CDC), Mailstop E–67, 1600

Clifton Road, Atlanta, Georgia 30333 on

or before December 4, 2000.

FOR FURTHER INFORMATION CONTACT:

Doris Sweet, Education and Information

Division, Information Resources Branch,

NIOSH, CDC 4676 Columbia Parkway,

Mailstop C–18, Cincinnati, Ohio 45226,

telephone 513–533–8359, e-mail

address: dvs1@cdc.gov.

SUPPLEMENTARY INFORMATION:

RTECS Trademark License Proposal

1. Exclusive use of the RTECS name

for the production and marketing of the

database. The Licensee will have

unlimited right to the use of the

RTECS name for product identification

and promotion as related to selling and

marketing the production of the

Database.

2. Control of the current RTECS

Master File. The Licensee will provided

with a copy of the last NIOSH-produced

RTECS Master File and the CODEN

File. The Licensee may reformat the

data, provided the six toxicity fields

remain intact. New fields may be added

for the enhancement of the Database

(e.g. physical and chemical properties,

structural formulas, author names).

Selected fields may be deleted if the

worth or power of the Database is not

diminished (e.g., Wiswesser Line

Notation).

3. Authority and responsibility for

vendor agreements. Upon execution of

this agreement, the National Technical

Information Service (NTIS), currently

serving as broker for NIOSH, will notify

all current vendors that existing vendor

agreements will terminate after ninety

(90) days. Thereafter, vendor agreements

become the responsibility of the

Licensee, who may decide to extend

existing agreements until the expiration

date, or to negotiate new agreements

with all vendors. The Licensee will not

be bound by any previous agreements

with NTIS, unless they chose to

negotiate with that organization.

4. Access to comprehensive

documentation. NIOSH will provide

access to the collection of all source

references cited in RTECS. These are

an essential tool in accessing the

original documentation cited in the

Database. In order to assure full

historical information, NIOSH will also

provide access to a complete collection

of printed editions of RTECS, from

1971 to 1985–86, and annual microfiche

editions beyond 1987.

5. NIOSH consultation services.

NIOSH will provide support to the

Licensee through participation on any

established Board/Committee

empowered to modify the Database.

NIOSH Requirements To Be Addressed

in the Proposal

1. Maintenance of RTECS as a viable

toxicological database. The Licensee

must maintain the quality of the

Database, making only such changes

that will enhance its value and power,

and those mandated by changing

technologies. The adoption of alternate

test methods will require an altered

approach. The proposal should address

plans for coverage of current

toxicological literature on an

international scale.

2. Preservation of international

literature coverage. The proposal shall

address the manner in which the

continued coverage of international

literature will be accomplished. Because

much of the current data now originates

from outside the United States,

especially in the Orient and Eastern

Europe, access to linguistic skills is

vital.

Federal Register / Vol. 65, No. 192 / Tuesday, October 3, 2000 / Notices 59005

3. Continued accessibility of RTECS

to the international scientific

community. The Licensee must make

RTECS continuously available worldwide and market the Database in a

variety of formats including, but not

limited to on-line, CD–ROM, and the

Internet.

4. Multiple point and free access to

NIOSH of all RTECS products. The

Licensee will provide NIOSH research

and information staff with multiple

point and free access to RTECS to

accommodate NIOSH users at six

NIOSH sites, maximum usage not to

exceed 25 users.

5. NIOSH representation on editorial

or policy board or committee. A NIOSH

representative will be designated to

serve on any editorial or policy board

established for the Database to ensure

that the interests of the Institute are

considered. This representative will

serve in a consultative capacity without

decision-making authority.

General Terms

1. Ownership of the RTECS

trademark will be retained by NIOSH.

2. The licensing agreement can be

terminated by either party.

3. Ownership of data files, microfiche,

and other files. NIOSH will retain

ownership of the last RTECS Master

File produced with NIOSH funds. The

Licensee will retain ownership of all

new data generated and indexed under

this agreement. NIOSH will also retain

ownership of the microfiche collection

of the bibliographical references. The

full hard copy collection of the same

references will be delivered to the

Licensee, along with the annual

microfiche editions produced after

1987. In the event of a termination of

the Licensing Agreement, the hard copy

collection and annual microfiche

additions will be returned to NIOSH.

4. Duration of agreement will be

negotiated in the license.

5. In submitted proposals, each

requirement shall be addressed

individually.

Linda Rosenstock,

Director, National Institute for Occupational

Safety and Health, Centers for Disease Control

and Prevention.

[FR Doc. 00–25429 Filed 10–02–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Advisory Council for the Elimination of

Tuberculosis: Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(P.L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following council

meeting.

Name: Advisory Council for the

Elimination of Tuberculosis (ACET).

Times and Dates: 8:30 a.m.–5 p.m.,

October 18, 2000; 8:30 a.m.–12 p.m., October

19, 2000.

Place: Corporate Square, Building 8, 1st

Floor Conference Room, Atlanta, Georgia

30333.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 100 people.

Purpose: This council advises and makes

recommendations to the Secretary of Health

and Human Services, the Assistant Secretary

for Health, and the Director, CDC, regarding

the elimination of tuberculosis. Specifically,

the Council makes recommendations

regarding policies, strategies, objectives, and

priorities; addresses the development and

application of new technologies; and reviews

the extent to which progress has been made

toward eliminating tuberculosis.

Matters To Be Discussed: Agenda items

include issues pertaining to the IOM Report

on TB Elimination in the U.S. and other TB

related topics.

Contact Person for More Information:

Paulette Ford, National Center for HIV, STD,

and TB Prevention, 1600 Clifton Road, NE,

M/S E–07, Atlanta, Georgia 30333, telephone

404/639–8008.

The Director, Management Analysis

and Services Office, has been delegated

the authority to sign Federal Register

Notices pertaining to announcements of

meetings and other committee

management activities, for both the

Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: September 27, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 00–25322 Filed 10–2–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1224]

Agency Information Collection

Activities; Announcement of OMB

Approval; Submitting and Reviewing

Complete Responses to Clinical Holds;

Guidance for Industry

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Submitting and Reviewing Complete

Responses to Clinical Holds; Guidance

for Industry’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In the

Federal Register of April, 13, 2000 (65

FR 19910), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0445. The

approval expires on September 12,

2003. A copy of the supporting

statement for this information collection

is available on the Internet at http://

www.fda.gov/ohrms/dockets.

Dated: September 26, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–25283 Filed 10–2–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Cardiovascular and Renal Drugs

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.