Federal Register / Vol. 65, No. 109 / Tuesday, June 6, 2000 / Notices 35943

4. Project Management and Staffing (15

points)

The extent to which the applicant

identifies staff that have the

responsibility, capability, and authority

to carry out each activity, as evidenced

by job descriptions, curriculum vitae,

and organizational charts.

5. Sharing Experiences and Resources (5

points)

The extent to which the applicant

describes plans to share effective

materials and activities with appropriate

audiences.

6. Collaboration (5 points)

The extent to which the applicant

describes plans to collaborate with

agencies such as state and local health

and education departments,

postsecondary institutions, and other

national organizations and provides

letters of specific intentions from

collaborating agencies.

7. Evaluation (10 points)

The quality of the plans for both

process and outcome evaluations, to

include specification of indicators of

program success, methods of obtaining

data, ways of reporting results, use of

results for programmatic decisions, and

timing and staff responsibility.

8. Budget (Not Scored)

The extent to which the applicant

provides a detailed and clear budget

narrative consistent with the stated

objectives, planned activities, and goals

of the project.

H. Other Requirements

1. Technical Reporting Requirements

Provide Center for Disease Control

with original plus two copies of:

a. Annual progress reports, no more

than 90 days after the end of each

budget period;

b. Financial status reports, no more

than 90 days after the end of the budget

period; and

c. Final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in

section J, ‘‘Where to Obtain Additional

Information’’.

2. Research Activities Restricted

Activities funded under this program

announcement are intended to build the

capacity of postsecondary institutions to

promote HIV, other STDs, and

unintended pregnancy prevention and

to prevent other serious health problems

among youth and young adults as

described in the two priority areas.

Research activities will not be

supported under this announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment III in the

application kit.

AR–5—HIV Program Review Panel

Requirements

AR–7—Executive Order 12372 Review

AR–8—Public Health System Reporting

Requirements

AR–9—Paperwork Reduction Act

Requirements

AR–10—Smoke-Free Workplace

Requirements

AR–11—Healthy People 2010

AR–12—Lobbying Restrictions

AR–15—Proof of Non-profit Status

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301(a), 317(k)(2) and 1706 [42

U.S.C. 241(a), 247b(k)(2) and 300u–5] of

the Public Health Service Act, as

amended. The Catalog of Federal

Domestic Assistance number is 93.938.

J. Where to Obtain Additional

Information

This and other Center for Disease

Control announcements can be found on

the Center for Disease Control home

page <www.cdc.gov>. Click on Funding

then click on Grants and Cooperative

Agreements. To receive additional

written information and to request an

application kit, call (1–888–472–6874).

You will be asked to leave your name

and address and will be instructed to

identify the announcement of interest.

If you have questions after reviewing

the contents of all documents, business

management assistance may be obtained

from: Van A. King, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office,

Announcement 00081, Centers for

Disease Control and Prevention, 2920

Brandywine Road, Room 3000, Atlanta,

GA 30341–4146; Telephone Number

(770) 488–2751; Email address

vbk5@cdc.gov.

For program technical assistance,

contact: Mary Vernon-Smiley, Chief,

Special Populations Program Section,

Division of Adolescent and School

Health, National Center for Chronic

Disease Prevention and Health

Promotion, Centers for Disease Control

and Prevention, 4770 Buford Highway,

MS K–31, Atlanta, Georgia 30341–4146;

Telephone Number (770) 488–325–

8004; Email address mev0@cdc.gov.

Dated: May 31, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–14098 Filed 6–5–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Arthritis Advisory Committee; Notice

of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Arthritis

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 12, 2000, 8 a.m. to 5 p.m.

Location: Gaithersburg Holiday Inn,

Walker and Whetstone Rooms, Two

Montgomery Village Ave., Gaithersburg,

MD.

Contact Person: Kathleen R. Reedy or

LaNise S. Giles, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, (for express delivery, 5630

Fishers Lane, rm. 1093) Rockville, MD

20857, 301–827–7001, or e-mail:

reedyk@cder.fda.gov, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12532.

Please call the Information Line for upto-date information on this meeting.

Agenda: The Committee will discuss

biologics license application (BLA) 99–

1234, RemicadeTM (infliximab,

Centocor) for the treatment of

rheumatoid arthritis, prevention of

radiographic progression and

prevention of physical disability. The

Committee will also discuss general

issues regarding claims based on

radiographic data in patients with

rheumatoid arthritis.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 6, 2000. Oral

presentations from the public will be

scheduled between approximately 11

35944 Federal Register / Vol. 65, No. 109 / Tuesday, June 6, 2000 / Notices

a.m. and 12 noon. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 6, 2000, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 31, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–14213 Filed 6–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0965]

‘‘Guidance for Industry: Recognition

and Use of a Standard for the Uniform

Labeling of Blood and Blood

Components;’’ Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document

entitled ‘‘Guidance for Industry:

Recognition and Use of a Standard for

the Uniform Labeling of Blood and

Blood Components.’’ The guidance

document describes a system for the

uniform labeling of blood and blood

components for transfusion, Source

Plasma, and other components for use

in further manufacturing. The guidance

will assist manufacturers in complying

with the labeling requirements under

FDA’s regulations.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies of the guidance entitled

‘‘Guidance for Industry: Recognition

and Use of a Standard for the Uniform

Labeling of Blood and Blood

Components’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

the office in processing your requests.

The document may also be obtained by

mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by fax by calling

the FAX Information System at 1–888–

CBER–FAX or 301–827–3844. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the guidance

document.

Submit written comments on the

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: For

information about this notice: Sharon A.

Carayiannis, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210.

For technical information: Kenneth A.

Zemann, Center for Biologics Evaluation

and Research (HFM–375), Food and

Drug Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448, 301–

827–3543, or FAX 301–827–3534.

SUPPLEMENTARY INFORMATION:

I. Background

The International Council for

Commonality in Blood Banking

Automation (ICCBBA) prepared and

submitted to FDA a draft document

entitled ‘‘United States Industry

Consensus Standard for the Uniform

Labeling of Blood and Blood

Components Using ISBT 128,’’ Version

1.2.0 (draft Standard). The ICCBBA

requested that ISBT 128 replace the

current ‘‘ABC Codabar’’ system as an

approved machine readable barcode for

labeling blood and blood components.

On November 21, 1998, FDA made the

draft Standard available on its website

for public comment. In the Federal

Register of November 27, 1998 (63 FR

65600), FDA announced the availability

of the draft Standard and requested

public comment on both the use of ISBT

128 and timeframes for implementation.

The ICCBBA revised the draft Standard

in response to public comment and

submitted to FDA the revised document

entitled ‘‘United States Industry

Consensus Standard for the Uniform

Labeling of Blood and Blood

Components Using ISBT 128,’’ Version

1.2.0, dated November 1999 (the

Version 1.2.0 Standard).

FDA has reviewed the draft Standard,

the comments received, and the Version

1.2.0 Standard. FDA believes that

conformance to the Version 1.2.0

Standard, prepared and revised by

ICCBBA, will help facilitate the use of

a uniform container label for blood and

blood components. FDA is announcing

the availability of a guidance entitled

‘‘Guidance for Industry: Recognition

and Use of a Standard for the Uniform

Labeling of Blood and Blood

Components’’ that recognizes as

acceptable the Version 1.2.0 Standard

prepared by ICCBBA, and the

implementation of the ISBT 128

uniform labeling system, except where

inconsistent with FDA’s regulations

under 21 CFR 606.121. Although FDA

finds use of the Version 1.2.0 Standard

acceptable, FDA has identified

inconsistencies between the Version

1.2.0 Standard and Federal regulations.

FDA intends to revise the regulations to

remove these inconsistencies. The

guidance provides recommendations to

follow where discrepancies exist

between the Version 1.2.0 Standard and

the current regulations, pending

completion of rulemaking to remove

these discrepancies.

This guidance document represents

the agency’s current thinking with

regard to use of the Version 1.2.0

Standard for use in labeling blood,

blood components for transfusion,

Source Plasma, and other components

for further manufacturing use. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirement of the

applicable statute, regulations, or both.

As with other guidance documents,

FDA does not intend this document to

be all-inclusive and cautions that not all

information may be applicable to all

situations. The document is intended to

provide information and does not set

forth requirements.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

guidance document at any time. Two

copies of any comments are to be

submitted, except individuals may

submit one copy. Comments should be

identified with the docket number

found in the brackets in the heading of

this document. A copy of the document

and received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Paperwork Reduction Act of 1995

The labeling regulations on which the

guidance is based are reported under the

Office of Management and Budget

(OMB) control number 0910–0116. FDA

tentatively concludes that this guidance

contains no new collections of

information. Therefore, clearance by

OMB under the Paperwork Reduction

Act of 1995 is not required.