Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Notices 23031

B. Eligible Applicants

Assistance for this project will be

provided only to the Save a Life

Foundation. FY 2001 Federal

appropriations specifically directs CDC

to award funds to the Save a Life

Foundation. No other applications are

solicited.

Note: Title 2 of the United States Code,

chapter 26, section 1611 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $810,000 is available

in FY 2001 to fund one award. It is

expected that the award will begin on or

about September 1, 2001, and will be

made for a 12-month budget period

within a project period of one year.

Funding estimates may change.

D. Where to Obtain Additional

Information

For program technical assistance,

contact:

Paul Burlack, Centers for Disease

Control and Prevention, National Center

for Injury Prevention and Control, 4770

Buford Highway N.E., Mailstop F42,

Atlanta, GA 30341–3724, Telephone

(770) 488–4713, Email:

PBurlack@cdc.gov

To obtain business management

technical assistance, contact:

Angelia Hill, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office,

Announcement 01051, Centers for

Disease Control and Prevention (CDC),

2920 Brandywine Road, Suite 3000,

Mailstop E13, Atlanta, GA 30341–4146,

Telephone 770–488–2785, Email:

aph8@cdc.gov

Dated: May 1, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–11381 Filed 5–4–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Injury Research Grant Review

Committee; Meeting

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

the Federal Advisory Committee Act

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

Control and Prevention (CDC)

announces the following committee

meeting.

Name: Injury Research Grant Review

Committee (IRGRC).

Times and Dates: 6:30 p.m.–9 p.m.,

May 20, 2001. 8 a.m.–5:30 p.m., May 21,

2001.

Place: The Westin Atlanta Airport,

4736 Best Road, College Park, Georgia

30337.

Status: Open: 6:30 p.m.–7 p.m., May

20, 2001. Closed: 7 p.m.–9 p.m., May 20,

2001, through 5:30 p.m., May 21, 2001.

Purpose: This committee is charged

with advising the Secretary of Health

and Human Services, the Assistant

Secretary for Health, and the Director,

CDC, regarding the scientific merit and

technical feasibility of grant

applications received from academic

institutions and other public and private

profit and nonprofit organizations,

including State and local government

agencies, to conduct specific injury

research that focus on prevention and

control and to support injury prevention

research centers.

Matters To Be Discussed: Agenda

items include a budget update, recent

awards, future meeting dates, discussion

of the review process and panelists

responsibilities, and review of grant

applications. Beginning at 7 p.m., May

20, through 5:30 p.m., May 21, the

Committee will review individual

research grant applications submitted in

response to Program Announcements

01013, 01014, 01015, and 01016. This

portion of the meeting will be closed to

the public in accordance with

provisions set forth in section 552b(c)(4)

and (6), title 5 U.S.C., and the

Determination of the Deputy Director for

Program Management, CDC, pursuant to

Pub. L. 92–463.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Richard W. Sattin, M.D., Acting

Executive Secretary, IRGRC, National

Center for Injury Prevention and

Control, CDC, 4770 Buford Highway,

NE, M/S K58, Atlanta, Georgia 30341–

3724, telephone 770/488–4330.

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: April 25, 2001.

John Burckhardt,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention.

[FR Doc. 01–11378 Filed 5–4–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

National Vaccine Advisory Committee,

Subcommittee on Vaccine Safety and

Communication Meeting

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

the Federal Advisory Committee Act

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

Control and Prevention (CDC)

announces the following Federal

advisory Subcommittee meeting.

NAME: National Vaccine Advisory

Committee (NVAC) Subcommittee on

Vaccine Safety and Communications.

TIME AND DATE: 2 p.m.—5 p.m., June 5,

2001.

PLACE: Hubert H. Humphrey Building,

Room 800, 200 Independence Avenue,

SW, Washington, DC 20201.

STATUS: Open to the public, limited only

by the space available.

NOTICE: In the interest of security, the

Department has instituted stringent

procedures for entrance to the Hubert H.

Humphrey Building by non-government

employees. Thus, persons without a

government identification card should

plan to arrive at the building between

12:30 p.m. and 1 p.m. Entrance to the

meeting at other times during the day

cannot be assured.

STATUS: Open to the public, limited only

by the space available.

PURPOSE: This Subcommittee reviews

issues relevant to vaccine safety and

adverse reactions to vaccines.

MATTERS TO BE DISCUSSED: Review of the

agenda; review of National Infant

Immunization Week; discussion on

strengthening the vaccine supply;

follow-up to the ‘‘Workshop on Vaccine

Communications’; review of the

Institute of Medicine’s (IOM) report on

Measles-Mumps-Rubella Vaccine and

Autism, discussion of the process for

suggesting and selecting immunization

safety issues for review by the IOM in

2002; public comment on immunization

safety issues for review in 2002; and

committee discussion.

Special Note: The Subcommittee on

Vaccine Safety and Communications will

provide a forum for input from the public

regarding potential issues and topics for

23032 Federal Register / Vol. 66, No. 88 / Monday, May 7, 2001 / Notices

review in 2002 by the IOM’s Immunization

Safety Review Committee. This will be the

first opportunity for the public to provide

comments on the hypotheses that are being

considered for future review.

Agenda items are subject to change as

priorities dictate. A complete meeting

agenda of the Subcommittee on

VaccineSafety and Communications can

be found on the NationalVaccine

Program Office’s web site at

www.cdc.gov/od/nvpo/calendar.

CONTACT PERSON FOR MORE INFORMATION:

Ms. Shaunette Crawford, Associate

Director for Health Communications

and Legislation, NVPO, CDC, 1600

Clifton Road, NE, M/S D–66, Atlanta,

Georgia 30333, telephone 404/687–

6672.

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: May 1, 2001.

John Burckhardt,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention.

[FR Doc. 01–11371 Filed 5–4–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0530]

FDA Modernization Act of 1997:

Modifications to the List of Recognized

Standards, Recognition List Number:

005

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

publication containing modifications

the agency is making to the list of

standards FDA will recognize for use in

premarket reviews (FDA Recognized

Consensus Standards). This publication

entitled ‘‘Modifications to the List of

Recognized Standards, Recognition List

Number: 005’’ (Recognition List

Number: 005) will assist manufacturers

who elect to declare conformity with

consensus standards to meet certain

requirements for medical devices.

DATES: Submit written comments

concerning this document at any time.

See section VI of this document for the

effective date of the recognition of

standards announced in this document.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of

‘‘Modification to the List of Recognized

Standards, Recognition List Number:

005,’’ to the Division of Small

Manufacturers Assistance, Center for

Devices and Radiological Health (HFZ–

220), Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850.

Send two self-addressed adhesive labels

to assist that office in processing your

requests, or fax your request to 301–

443–8818. Submit written comments

concerning this document to the contact

person (address below). Comments

should be identified with the docket

number found in brackets in the

heading of this document. This

document may also be accessed on

FDA’s Internet site at http://

www.fda.gov/cdrh/fedregin.html. See

section V of this document for

electronic access to the searchable

database for the current list of ‘‘FDA

Recognized Consensus Standards,’’

including Recognition List Number: 005

modifications, and other standards

related information.

FOR FURTHER INFORMATION CONTACT: To

comment on this document and/or to

recommend additional standards for

recognition: Carol L. Herman, Center for

Devices and Radiological Health (HFZ–

84), Food and Drug Administration,

2094 Gaither Rd., Rockville, MD 20850,

301–594–4766, ext. 156.

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug

Administration Modernization Act of

1997 (FDAMA) (Public Law 105–115)

amended section 514 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360d). Amended section 514

allows FDA to recognize consensus

standards, developed by international

and national organizations, for use in

satisfying portions of device premarket

review submissions or other

requirements.

In a notice published in the Federal

Register of February 25, 1998 (63 FR

9561), FDA announced the availability

of the guidance entitled ‘‘Recognition

and Use of Consensus Standards.’’ This

notice described how FDA will

implement its standards program

recognizing the use of certain standards

and provided the initial list of

recognized standards.

In Federal Register notices published

on October 16, 1998 (63 FR 55617), July

12, 1999 (64 FR 37546), and November

15, 2000 (65 FR 69022), FDA modified

its initial list of recognized standards.

These notices described the addition,

withdrawal, and revision of certain

standards recognized by FDA. When

these notices were published, the

agency maintained ‘‘html’’ and ‘‘pdf’’

versions of the list of ‘‘FDA Recognized

Consensus Standards.’’ Both versions

were publicly accessible at the agency’s

Internet site. The agency maintains the

current list in a searchable database

accessible to the public. See section V

of this document for electronic access

information.

II. Discussion of Modifications to the

List of Recognized Standards,

Recognition List Number: 005

FDA is announcing the addition,

withdrawal, correction, and revision of

certain consensus standards the agency

will recognize for use in satisfying

premarket reviews for devices. FDA will

incorporate these modifications in the

list of ‘‘FDA Recognized Consensus

Standards’’ in the agency’s searchable

database. FDA will use the term

‘‘Recognition List Number: 005’’ to

identify: (1) Supplementary information

sheets for standards added to the list for

the first time, (2) standards added to

replace withdrawn standards, and (3)

still recognized standards for which

minor revisions are made to clarify the

application of the standards.

At the end of this notice, FDA lists

modifications the agency is making that

involve: (1) The initial addition of

standards not previously recognized by

FDA and (2) the addition of standards

in conjunction with the withdrawal of

other standards that are replaced by

these later, amended, or different

standards.

In this section, FDA describes

modifications that involve the

withdrawal of standards and their

replacement by others. In this notice, all

changes of this type are in the sterility

category of the complete list of

recognized standards.

1. ASTM–F1140:1996 is withdrawn

under previous item 59. ASTM–

F1140:2000 is added under current item

67.

2. ASTM–F1585:1995 is withdrawn

under previous item 61. ASTM

F1585:2000 is added under current item

68.

3. ASTM–1608:1995 is withdrawn

under previous item 62. ASTM

F1608:2000 is added under current item

69.

III. List of Recognized Standards

FDA maintains the agency’s current

list of ‘‘FDA Recognized Consensus

Standards’’ in a searchable database that

may be accessed directly at FDA’s

Intranet site at http://