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documents issued and withdrawn since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

33554 Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Notices

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 for Industry: IND Meetings for

Human Drugs and Biologics: Chemistry,

Manufacturing, and Controls Information

February 2000 FDA Regulated IndustryDo

Guidance for Industry: Formal Meetings With

Sponsors and Applicants for PDUFA Products

February 2000 Do Do

Guidance for Industry: Formal Dispute Resolution: Appeals Above the Division LevelFebruary 2000 Do Do

Guidance for Industry: Gamma Irradiation of

Blood and Blood Components: A Pilot Program for Licensing

February 2000 Do Do

Draft Guidance for Industry: Information Program on Clinical Trials for Serious or LifeThreatening Diseases: Establishment of a

Data Bank

March 2000 Do Do

III. Guidance Documents Issued by the

Center for Devices and Radiological

Health (CDRH)

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

Date Withdrawn

Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices

Reprocessed by Third Parties and Hospitals,

Draft Guidance-Not for Implementation

February 8, 2000 Office of Compliance

(OC)

Division of Small Manufacturers Assistance;

1–800–638–2041 or 301–827–0111 or

FAX Facts-on-Demand 1–800–899–0381

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

Guidance for FDA Staff; Compliance Program

Guidance Manual; Field Compliance Testing

of Diagnostic (Medical) X-ray Equipment

March 15, 2000 OC/Division of Enforcement I (DOE1)Do

Guidance for Industry and FDA; Guidance for

Indwelling Blood Gas Analyzer 510(k) Submissions

February 21, 2000 Office of Device Evaluation (ODE )Do

Guidance on the Use of Standards in Substantial Equivalence DeterminationMarch 12, 2000 Do Do

Guidance Document for Premarket Notification

Submission for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer

January 24, 2000 ODE/Division of Cardiovascular, Respiratory & Neurological Devices

(DCRND)

Do

Guidance for Extracorporeal Blood Circuit

Defoamer 510(k) Submissions

February 16, 2000 ODE/DCRND Do

Guidance for Cardiopulmonary Bypass Arterial

Line Blood Filter 510(k) Submissions

February 21, 2000 Do Do

Guidance Document for the Preparation of

IDEs for Spinal Systems (Replaces: Guidance Document for the Preparation of IDEs

for Spinal Systems 8/26/98)

January 13, 2000 ODE/Division of General & Restorative

Devices (DGRD)

Do

Guidance for the Arrangement and Content of

a Premarket Approval (PMA Application for

an Endosseous Implant

May 16, 1989 ODE/Division of Dental, Infection Control

and General Hospital Devices

(DDIGD)

Do

Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Notices 33555

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

Date Withdrawn

Guidance for Industry and FDA Reviewers: Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme (Replaces: Reprocessing and Reuse of SingleUse-Devices: Risk Categorization Scheme;

Draft Guidance 12/9/99)

February 8, 2000 Do Do

Guidance for Industry and for FDA Reviewers/

Staff; Guidance for the Content of Premarket

Notifications for Penile Rigidity Implants (Replaced: Draft Guidance for the Content of

Premarket Notifications for Penile Rigidity Implants 5/30/95)

January 16, 2000 ODE/Division of Reproductive Abdominal, ENT and Radiological Devices

(DRAERD)

Do

Guidance for Manufacturers Seeking Marketing

Clearance of Ear, Nose, and Throat Endoscope Sheaths Used as Protective Barriers

(Replaces: Guidance for the Content of Premarket Notification for Disposable, Sterile,

Ear, Nose and Throat Endoscope Sheaths

with Protective Barrier Claims 10/21/96)

March 12, 2000 ODE/Division of Ophthalmic and Ear,

Nose, Throat Devices (DOED)

Do

Draft Guidance for Industry; Guidance on Medical Device Patient LabelingMarch 3, 2000 Office of Health and

Industry Programs

(OHIP)/Division of

Device User Programs and Systems

Anaylsis (DDUPSA)

Do

The FDA Export Reform and Enhancement Act

of 1996/Export Certification Package including ‘‘Instructions for Requests for Certificate

to Foreign Governments’’ (Replaces: The

FDA Export Reform and Enhancement Act of

1996/Export Certification Package including

‘‘Instructions for Requests for Certificate to

Foreign Governments’’ 6/22/99)

February 7, 2000 OHIP/Division of

Small Manufacturers Assistance

(DSMA)

Do

Compliance Guidance: The Mammography

Quality Standards Act Final Regulations Document #2

February 25, 2000 OHIP/Division of

Mammography

Quality and Radiation Programs

(DMQRP)

Do

Guidance for Industry on the Testing of Metallic

Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of

Postmarket (Replaces: Guidance for Industry

on the Testing of Metallic Plasma Sprayed

Coatings on Orthopedic Implants to Support

Reconsideration of Postmarket Surveillance

Requirements 2/22/99)

February 2, 2000 Office of Surveillance

and Biometrics

(OSB)/Division of

Postmarket Surveillance (DPS)

Do

WITHDRAWALS

Name of Document Date of Issuance Grouped by Intended

User or Regulatory

Activity

Date Withdrawn

Guidance on Medical Device Tracking

[FDAMA] Replaced by Guidance for Industry

and FDA Staff-Guidance on Medical Device

Tracking [FDAMA]

February 19, 1998 OC January 24, 2000

Guideline for Preparing Notices of Availability

of Investigational Medical Devices (Replaced

by: Preparing Notices of Availability of Investigational Medical Devices and for Recruiting

Study Subjects 3/19/99)

November 1, 1985 OC/BIMO February 14, 2000

33556 Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Notices

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

Date Withdrawn

Review Proposal for Reagents and Analyzer

Systems

March 14, 1995 ODE February 17, 2000

Implantable Pacemaker Lead Testing Guidance

for the Submission of a Section 510(k) Notification (Replaced by: Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and

for Pacemaker Lead Adaptor 510(k) Submissions 1/14/00)

September 1, 1989 ODE/DCRND January 21, 2000

Determining Equivalence of Intraaortic Balloon

Catheters Under the 510(k) Regulations

December 12, 1989 Do April 7, 2000

510(k) Guidance for Screw Type Endosseous

Implants for Prosthetic Attachment

August 11, 1992 ODE/DDIGD April 5, 2000

Addendum to Guidance on the Content and

Format of Premarket Notification [510(k)]

Submissions for General Purpose Disinfectants

March 9, 1994 Do February 15, 2000

Reprocessing and Reuse of Single-Use-Devices: Risk Categorization Scheme; Draft

Guidance (Replaced by: Guidance for Industry and FDA Reviewers: Reprocessing and

Reuse of Single-Use Devices: Review

Prioritization Scheme Draft 2/8/00

December 9, 1999 Do February 9, 2000

Draft Guidance on the Content and Format of

Premarket Approval Application (PMA) for

Sharps Needle Destruction Devices

February 11, 1997 Do April 10, 2000

Sunglass Package; including Certification

Statement for the Impact-Resistance Test of

Lenses in Eyeglasses and Sunglasses

March 19, 1998 ODE/DOD February 8, 2000

Guidance for Submission of a 510(k) Premarket Notification for an Air Conduction

Hearing Aid

April 1, 1991 ODE/DRAERD April 7, 2000

Draft Guidance for the Content of Premarket

Notifications for Penile Rigidity Implants (Replaced by: Guidance for Industry and for

FDA Reviewer/Staff; Guidance for the Content of Premarket Notifications for Penile Rigidity Implants 1/16/00)

May 30, 1995 Do March 20, 2000

Guidance for the Content of Premarket Notification for Disposable, Sterile, Ear, Nose and

Throat Endoscope Sheaths with Protective

Barrier Claims (Replaced by: Guidance for

the Content of Premarket Notification for Disposable, Sterile, Ear, Nose and Throat Endoscope Sheaths with Protective Barrier Claims

3/12/00)

November 21, 1996 Do March 22, 2000

Draft Guidance to Hearing Aid Manufacturers

for Substantiation of Claims

August 5, 1994 Do April 14, 2000

Medical Device Reporting for Distributors April 1, 1996 OHIP/DSMA February 16, 2000

Compliance Guidance: The Mammography

Quality Standards Act Final Regulations Document #2 (Replaced by Compliance Guidance: The Mammography Quality Standards

Act Final Regulations Document #2 2/25/00)

March 5, 1999 OHIP/DMQRP January 21, 2000

Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Notices 33557

Name of Document Date of Issuance

Grouped by Intended

User or Regulatory

Activity

Date Withdrawn

The FDA Export Reform and Enhancement Act

of 1996/Export Certification Package including ‘‘Instructions for Requests for Certificate

to Foreign Governments’’

June 22, 1999 Do February 14, 2000

Import of Medical Devices—A Workshop Manual (FDA 93–4228)March 1, 1993 Do February 8, 2000

Guidance for Medical Gloves—A Workshop

Manual FDA 97–4257 (Replaced by Guidance for Industry and FDA–Medical Glove

Guidance Manual Draft FDA 99–4257)

September 1, 1997 Do Do

Part I—FDA Structure and Functions Part II—

Center for Devices and Radiological Health

(CDRH) Structure and Functions/International

Manual (Replaced by: U.S. FDA–Regulation

of Medical Devices; Background Information

for International Officials 4/14/99)

April 14, 1999 OHIP/DSMA February 15, 2000

Part III—FDA’s Regulation of Medical Devices/

International Manual (Replaced by: U.S. FDA

Regulation of Medical Devices; Background

Information for International Officials 4/14/99)

April 14, 1999 OHIP/DSMA Do

Part IV—Electronic Access to FDA Guidance

Documents and Information/International

Manual (Replaced by: U.S. FDA–Regulation

of Medical Devices; Background Information

for International Officials 4/14/99)

April 14, 1999 OHIP/DSMA Do

MDR Documents Access Information for CDRH

Facts-On-Demand (FOD)

February 29, 1996 OSB Do

MDR Documents Access Information for Industry OrganizationsMay 8, 1996 OSB Do

Guidance for Industry on the Testing of Metallic

Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of

Postmarket Surveillance Requirements

February 22, 1999 OSB/DPS January 17, 2000

CORRECTIONS

Name of Document Date of Issuance Grouped by Intended

User or Regulatory

Group

How to Obtain a Hard Copy of the Document

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

or Internet)

Guidance on Premarket Notification [510(k)]

Submissions for Automated Endoscope

Washers, Washer/Disinfectors, and

Disinfectors Intended for Use in Health Care

Facilities (This document was mistakenly listed as ‘‘withdrawn’’ in the March 14, 2000

FEDERAL REGISTER

August 1, 1993 ODE/Division of General & Restorative

Devices (DGRD)

Do

IV. Guidance Documents Issued by the

Center for Drug Evaluation and

Research (CDER)

33558 Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Notices

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)

Skin Irritation and Sensitization Testing of Generic Transdermal Drug ProductsFebruary 3, 2000 Generic Drug Office of Training and Communication, Drug

Information Branch, Food and Drug Administration, 5600 Fishers Lane, Rockville,

MD 20857,

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

guidance/index.htm

IND Meetings for Human Drugs and Biologics;

Chemistry, Manufacturing, and Controls information

February 4, 2000 Chemistry Draft Do

Special Protocol Assessment February 9, 2000 Modernization Act

Draft

Do

Draft guidance entitled ‘‘M4 Common Technical

Document: Request for Comments on Initial

Components’’

February 11, 2000 ICH Draft—Joint Safety/EfficacyDo

NDAs: Impurities in Drug Substances February 25, 2000 Chemistry Do

Formal Meetings With Sponsors and Applicants

For PDUFA Products

March 7, 2000 Modernization Act Do

Formal Dispute Resolution: Appeals Above the

Division Level

March 7, 2000 Do Do

OTC Treatment of Herpes Labialis with

Antiviral Agents

March 8, 2000 Clinical/Medical Draft Do

Conjugated Estrogens, USP: LC–MS Method

for Both Qualitative chemical characterization

and Documentation of Qualitative Pharmaceutical Equivalence

March 9, 2000 Biopharmaceutic Draft Do

Content and Format of New Drug Applications

and Abbreviated New Drug Applications for

Certain Positron Emission Tomography Drug

Products

March 10, 2000 Modernization Act

Draft

Do

Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Establishment of a Data Bank: AvailabilityMarch 29, 2000 Do Do

Court Decisions, ANDA Approvals, and 180-

Day Exclusivity Under the Hatch-Waxman

Amendments to the Federal Food, Drug, and

Cosmetic Act

March 30, 2000 Procedural Do

Draft guidance entitled ‘‘E11: Clinical Investigation of Medicinal Products in the Pediatric

Population’’

April 12, 2000 ICH Draft—Efficacy Do

V. Guidance Documents Issued by the

Center for Veterinary Medicine (CVM)

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)

Guidance for Industry: Development of Supplemental Applications for Approved New Animal Drugs—Draft GuidanceJanuary 2000 Animal Drug Industry Communications Staff (HFV–12), FDA/CVM,

7500 Standish Pl., Rockville, MD 20855,

301–594–1755,

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

FAX 301–594–1831

Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Notices 33559

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)

Guidance for Industry: Stability Testing for

Medicated Premixes Guidance

March 2000 Do Do

VI. Guidance Documents Issued by the

Office of Regulatory Affairs (ORA)

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 for Institutional Review Baords,

Clinical Investigators, and Sponsors: Exception from Informed Consent Requirements for

Emergency Research.

March 30, 2000 Regulated Industry Division of Compliance Policy (HFC–230),

Office of Enforcement, Food and Drug Administration, 5600 Fishers Lane, Rockville,

MD 20857, 301–857–0420 or

Internet access at http://www.fda.gov/ora/

compliance—ref/bimolerr—guide.htm

Compliance Policy Guide, Chapter 2,

Sec.252.110, NEW: Volume Limits for Automated collection of Source Plasma

March 6, 2000 FDA Staff Do

Internet access at http://www.fda.gov/ora/

compliance—ref/cpg/cpgbio/

cpg252.110.htm

Compliance Policy Guide, Chapter 2, Sec.

257.100, REVISED: Deferral of source Plasma Donors Due to Red Cell Loss During collection of Source Plasma by Automated Plasmapheresis

March 22, 2000 Do Do—Internet at http://www.fda.gov/ora/ compliance—ref/cpg/cpgbio/ cpg257.100.htm

Regulatory Procedures Manual, UPDATE/ REVISION: Chapter 4, Subchapter/ Warning

Letters

March 21, 2000 Do Do—Internet at http://www.fda.gov/ora/compliance—ref/rpm—new2/ch4.html

Investigations Operation Manual 2000 March 2000 Do Division of Emergency and Investigational

Operations (HFC–130) Office of Regional

Operations, Food and Drug Administration,

5600 Fishers Lane, Rockville, MD 20857,

301–827–5636

Memorandum to Import Program Managers—

Surveillance and Post Reconditioning Sampling of Bulk Spices for Pathogens

February 11, 2000 Do Division of Import Operations and Policy

(HFC–170), Office of Regional Operations,

Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 301–443–6553

Import Alerts Continuously Do Freedom of Information staff (HFI–35), Food

and Drug Administration, 5600 Fishers

Lane, Rockville MD

Internet at http:www.fda.gov/ora/fiars/ ora—

import—alerts.html

WITHDRAWALS

Name of Document Date of Issuance Grouped by Intended

User or Regulatory

Activity

Date Withdrawn

Compliance Policy Guide, Chapter 2, Sec.

215.100 (CPG 7134.07), IND Filings; Completion of Applicable Portions Prior to Final

Action on License Applications or License

Amendments

July 19, 1976 FDA Staff March 28, 2000

33560 Federal Register / Vol. 65, No. 101 / Wednesday, May 24, 2000 / Notices

Dated: May 17, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–12989 Filed 5–23–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

AIDS Education and Training Centers’

National HIV/AIDS Clinical

Consultation Center Grant

AGENCY: Health Resources and Services

Administration.

ACTION: Notice of availability of funds.

SUMMARY: The Health Resources and

Services Administration’s (HRSA) HIV/

AIDS Bureau (HAB) announces that

applications will be accepted for fiscal

year (FY) 2000 grants for a discretionary

grant to support an AIDS Education and

Training Centers’ National Clinical

Consultation Center. The Center will be

responsible for assisting medical

providers in the treatment of persons

with HIV infection and in management

of health care workers who may have

sustained occupational exposure to HIV

and other blood borne pathogens

commonly occurring in persons living

with HIV infection (including Hepatitis

B and C) through prompt,

individualized, expert consultation. The

Center will also link service users to

education and training opportunities

available through regional AIDS

Education and Training Centers and

provide technical assistance to these

regional centers. The authority for this

program is 2692 (a) of the Public Health

Service Act as amended by Public Law

104–146, the Ryan White

Comprehensive AIDS Resources

Emergency Act Amendments of 1996.

Availability of Funds

It is anticipated that a single recipient

will be selected for the National HIV/

AIDS Clinical Consultation Center and

the award is expected to be $1,500,000

of the initial budget period. Funding

will be made available for 12 months,

with a project period of up to three

years. Continuation awards within the

approved project period will be made

on the basis of satisfactory progress and

the availability of funds.

Eligible Applicants

Eligible applicants are public and

nonprofit entities and schools and

academic health science centers.

DATES: A letter of intent to submit an

application is requested by June 14,

2000. Applications for this announced

grant must be received in the HRSA

Grants Application Center by the close

of business July 10, 2000, to be

considered for competition.

Applications shall be considered as

meeting the deadline if they are: (1)

Received on or before the deadline date,

or (2) postmarked on or before the

deadline date and received in time for

orderly processing and submission to

the review committee. (Applicants

should request a legibly dated receipt

from a commercial carrier or U.S. Postal

Service postmark. Private metered

postmarks shall not be acceptable as

proof of timely mailing.) Applications

received after the deadline will be

returned to the applicant.

ADDRESSES: Letters of intent to apply for

funding should be mailed to Dr. Laura

Cheever, HIV Education Branch, HRSA,

5600 Fishers Lane, Parklawn Building,

Rm 7–16, Rockville, Maryland 20857.

All applications should be mailed or

delivered to: Grants Management

Officer, HRSA Grants Application

Center, 1815 N. Fort Meyer Drive, Suite

300, Arlington, VA 22209. Grant

applications sent to any address other

than that above are subject to being

returned. Federal Register notices and

application guidance for the HIV/AIDS

Bureau program are available on the

World Wide Web via the Internet. The

web site for the HIV/AIDS Bureau is:

http://www.hrsa.gov/hab/. Federal grant

application kits are available at the

following Internet address: http://

forms.psc.gov/phsforms.htm. For those

applicants who are unable to access

application materials electronically, a

hard copy of the official grant

application kit (SF 5161) must be

obtained from the HRSA Grants

Application Center. The Center may be

contacted by (telephone, 1–877–477–

2123) FAX: (703–477–2345) e-mail:

hrsagac@hrsa.gov.

FOR FURTHER INFORMATION CONTACT:

Additional information may be obtained

from Dr. Laura W. Cheever, Chief, HIV

Education Branch, Division of Training

and Technical Assistance, HIV/AIDS

Bureau, Health Resources and Services

Administration, 5600 Fishers Lane,

Room 7–16, Rockville, Maryland 20857.

Telephone number (301) 443–6364 and

the FAX: (301) 443–9887.

Dated: May 17, 2000.

Claude Earl Fox,

Administrator.

[FR Doc. 00–12990 Filed 5–23–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

‘‘Low-Income’’ Levels for Health

Professions and Nursing Programs

Health Resources and Services

Administration (HRSA) is updating

income levels used to identify a ‘‘lowincome family’’ for the purpose of

providing training in the various health

professions and nursing programs

included in titles VII and VIII of the

Public Health Service Act (the Act).

The Department periodically

publishes in the Federal Register lowincome levels used for grants and

cooperative agreements to institutions

providing training for (1) disadvantaged

individuals, (2) individuals from a

disadvantaged background, or (3)

individuals from low-income families.

The program under the Act that may

use ‘‘low-income levels’’ as one of the

factors in determining a disadvantaged

or low-income status are:

Advanced Education Nursing (section

811)

Allied Health Special Projects (section

755)

Basic Nurse Education and Practice

(section 831)

Dental Public Health (section 768)

Faculty Loan Repayment and

Fellowships Program (section 738)

General and Pediatric Dentistry (section

747)

Health Administration Traineeships and

Special Projects (section 769)

Health Careers Opportunity Program

(section 739)

Loans to Disadvantaged Students

(section 724)

Physician Assistant Training (section

747)

Primary Care Residency Training

(section 747)

Public Health Traineeships (section 767)

Quentin N. Burdick Program for Rural

Interdisciplinary Training (section

754)

Residency Training in Preventive

Medicine (section 768)

Scholarships for Disadvantaged

Students (section 737)

Public Health Training Centers (section

766)

Nursing Workforce Diversity (section

821)

These programs generally award

grants to accredited schools of

medicine, osteopathic medicine, public

health, dentistry, veterinary medicine,

optometry, pharmacy, allied health,

Pediatric medicine, nursing,

chiropractic, public or nonprofit private