33552 Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Notices

projects as well as key professional

personnel from other participating or

collaborating institutions, agencies,

organizations outside of the applicant’s

agency that will be assigned to PE

activities (provide curriculum vitae for

each in an appendix). Clear

identification of applicants’ respective

roles in the management and operation

of the Prevention Epicenter and in

individual projects. Descriptions of

participants’ experience in conducting

work similar to that proposed in this

announcement.

h. Description of all support staff and

services to be assigned to the Prevention

Epicenter.

i. The degree to which the applicant

has met the CDC Policy requirements

regarding the inclusion of women,

ethnic, and racial groups in the

proposed research. This includes (a) the

proposed plan for the inclusion of both

sexes and racial and ethnic minority

populations for appropriate

representation, (b) the proposed

justification when representation is

limited or absent, (c) a statement as to

whether the design of the study is

adequate to measure differences when

warranted and (d) a statement as to

whether the plans for recruitment and

outreach for study participants include

the process of establishing partnerships

with community(ies) and recognition of

mutual benefits.

5. Evaluation (5 points)

a. Quality of plan for monitoring and

evaluating scientific and operational

accomplishments of the Prevention

Epicenter and of individual Center

projects.

b. Quality of plan for monitoring and

evaluating progress in achieving the

purpose and overall goals of this

cooperative agreement program.

6. Budget (not scored)

Extent to which the line-item budget

is detailed, clearly justified, and

consistent with the purpose and

objectives of this program.

7. Human Subjects (not scored)

Does the application adequately

address the requirements of Title 45

CFR part 46 for the protection of human

subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of

1. progress reports (semiannual);

2. financial status report, no more

than 90 days after the end of the budget

period; and

3. final financial status 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 the

‘‘Where To Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application kit.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–7 Executive Order 12372 Review

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

section 301(a) and 317(k)(2) of the

Public Health Service Act, [42 U.S.C.

sections 241(a) and 247b(k)(2)], as

amended. The Catalog of Federal

Domestic Assistance number is 93.283.

J. Where to Obtain Additional

Information

For this and other CDC

announcements, please see the CDC

home page on the Internet: http://

www.cdc.gov (click on ‘‘Funding’’). To

receive additional written information

and to request an application kit, call 1–

888-GRANTS4 (1–888 472–6874). You

will be asked to leave your name and

address and will be instructed to

identify the Announcement number of

interest.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from: Gladys

Gissentanna, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

2920 Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone

number 770–488–2753, Email address

gcg4@cdc.gov

For program technical assistance,

contact: Steve Solomon, M.D., Hospital

Infections Program, National Center for

Infectious Diseases, Centers for Disease

Control and Prevention, 1600 Clifton

Road, N.E. Mailstop A–07, Atlanta, GA

30333, Telephone number 404–639–

6476, Email address sls1@cdc.gov

Dated: May 18, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–13028 Filed 5–23–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00093]

States Helping States Through The

Association of Food And Drug

Officials; Notice of Availability of

Funds

A. Purpose

The Centers for Disease Control and

Prevention, (CDC) announces the

availability of fiscal year (FY) 2000

funds for a cooperative agreement

program for States Helping States

Through the Association of Food and

Drug Officials.

B. Eligible Applicant

Assistance will be provided only to

the Association of Food and Drug

Officials (AFDO). No other applications

are solicited.

AFDO is the only organization

qualified to conduct this work because:

1. AFDO is the only organization that

represents the state and local food

protection regulatory agencies. Regular

members are official heads of State or

local regulatory agencies or personnel

under their supervision. The

Association’s principle purpose is to act

as a leader and resource to state and

local regulatory agencies in developing

strategies to resolve and promote public

health and consumer protection related

to the regulation of foods as well as

drugs, medical devices and consumer

products.

2. AFDO focuses on the

administration of the nation’s food

safety component of public health

programs. AFDO has unique perspective

on the infrastructure, capacity, strengths

and needs of state and local food safety

programs.

3. AFDO has experience in carrying

out national training efforts that focus

on the needs of state and local

regulatory agencies.

C. Availability of Funds

Approximately $102,000 is available

in FY 2000 to fund this Cooperative

Agreement. It is expected that the award

will begin on or about September 1,

2000, and will be made for a 12-month

Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Notices 33553

budget period within a project period of

up to 5 years.

D. Where To Obtain Additional

Information

Program technical assistance may be

obtained from: Chuck Higgins, Senior

Environmental Health Officer,

Environmental Health Services Branch,

Centers for Disease Control and

Prevention, 4770 Buford Highway, NE,

Atlanta, GA 30341–3724, Telephone

number: (770) 488–4180, Email address:

cth4@cdc.gov

Business management technical

assistance may be obtained from: Sonia

V. Rowell, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

Room 3000, 2920 Brandywine Road,

Atlanta, GA 30341–4146, Telephone

number: (770) 488–2724, Email address:

svp1@cdc.gov

Dated: May 18, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–13029 Filed 5–23–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0046]

Quarterly List of Guidance Documents

at the Food and Drug Administration

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

quarterly update of all guidance

documents issued and withdrawn since

we compiled the last quarterly list of

guidance documents that published on

March 14, 2000. FDA committed to

publishing quarterly updates in our

February 1997 ‘‘Good Guidance

Practices’’ (GGP’s) document, which set

forth the agency’s policies and

procedures for developing, issuing, and

using guidance documents. This list is

intended to inform the public of the

existence and availability of guidance

documents issued since the annual

comprehensive list was compiled.

DATES: General comments on this list

and on agency guidance documents are

welcome at any time.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. For

information on where to obtain single

copies of guidance documents listed

here, see the specific center’s list of

guidance documents.

FOR FURTHER INFORMATION CONTACT:

LaJuana D. Caldwell, Office of Policy

(HF–27), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7010.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of February

27, 1997 (62 FR 8961), FDA published

a notice announcing its ‘‘Good Guidance

Practices’’ (GGP’s), which set forth our

policies and procedures for developing,

issuing, and using guidance documents.

We adopted the GGP’s to ensure public

involvement in the development of

guidance documents and to enhance

public understanding of the availability,

nature, and legal effect of our guidance

documents.

As part of FDA’s effort to ensure

meaningful interaction with the public

regarding guidance documents, we

committed to publishing an annual

comprehensive list of guidance

documents and quarterly Federal

Register notices that list all guidance

documents that were issued and

withdrawn during that quarter,

including ‘‘Level 2’’ guidance

documents. The following list of

guidance documents represents all

guidances that we issued or withdrew

since we published the last quarterly list

on March 14, 2000 (65 FR 13771). The

guidance documents are organized by

the issuing center or office within FDA,

and are further grouped by the intended

users or relevant regulatory activities.

Dates provided in the following list refer

to the date the guidance was issued or,

where applicable, the last date the

document was revised. We provided

document numbers where available.

II. Guidance Document Issued by the

Center for Biologics Evaluation and

Research (CBER)

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

How to Obtain a Hard Copy of the Document

(Name and Address, Phone, FAX, E-mail or

Internet)

Draft guidance entitled ‘‘International Conference on Harmonsation of Technical Requirements for Registration of Pharmaceuticals for Human Use M4: Common

Technical Document’’

February 11, 2000 FDA Regulated IndustryOffice of Communication, Training, and Manufacturers Assistance (HFM–40), Center

for Biologics Evaluation and Research

(CBER), Food and Drug Administration,

1401 Rockville Pike, Rockville, MD 20852–

1448, 1–800–835–4709 or 301–827–1800,

FAX Information System: 1–888–CBER–FAX

(within U.S.)or 301–827–3844 (outside

U.S. and local to Rockville, MD).

Internet access: http://www.fda.gov/cber

Draft Guidance for Industry: Special Protocol

Assessment

December 1999 Do Do

Draft Guidance for Reviewers: Potency Limits

for Standardized Dust Mite and Grass Allergen Vaccines: A Revised Protocol

February 2000 FDA Personnel Do