Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices 20831

following information must be

provided:

A. A copy of the face page of the

application (SF 424).

B. A summary of the project that

should be titled ‘‘Public Health System

Impact Statement’’ (PHSIS), not to

exceed one page, and include the

following:

1. A description of the population to

be served;

2. A summary of the services to be

provided; and

3. A description of the coordination

plans with the appropriate State and/or

local health agencies.

If the State and/or local health official

should desire a copy of the entire

application, it may be obtained from the

State Single Point of Contact (SPOC) or

directly from the applicant.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.268.

Other Requirements

Human Subjects

If the proposed project involves

research on human subjects, the

applicant must comply with the

Department of Health and Human

Services Regulations, 45 CFR Part 46,

regarding the protection of human

subjects. Assurance must be provided to

demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and forms provided in the

application kit.

Application Submission and Deadline

A. Preapplication Letter of Intent

Although not a prerequisite of

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. The letter should

be submitted to the Grants Management

Specialist (whose address is reflected in

section B, ‘‘Applications’’). It should be

postmarked no later than one month

prior to the planned submission

deadline, (e.g., June 12 for a July 12

submission). The letter should identify

the announcement number, the name of

the applicant AMC or CHN and its

Project Collaborators, as defined in this

announcement, and the geographic type

(urban or rural) of program which the

intended application will address. The

letter of intent does not influence

review or funding decisions, but it will

enable CDC to plan the review more

efficiently and thereby potentially

benefit all applicants.

B. Application

The application should be carefully

completed, following the directions

provided in this program

announcement. The original and two

copies of the application PHS Form

5161–1 must be submitted to Lisa G.

Tamaroff, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, Room

300, Mailstop E–13, Atlanta, Georgia

30305, on or before July 12, 1996.

1. Deadline

Applications will be considered as

meeting the deadline if they are either:

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the triage process, if it is employed, or

the objective review process if it is not.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing.)

2. Late Applications

Applications that do not meet the

criteria in 1.a. or 1.b. above are

considered late applications. Late

applications will not be considered and

will be returned to the applicant.

Where To Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address, and phone number and will

need to refer to Announcement #612.

You will receive a complete program

description. The program

announcement is also available on

through the CDC homepage on the

Internet. The address for the CDC

homepage is http://www.cdc.gov. CDC

will not send program announcements

by facsimile or express mail. If you have

any questions after reviewing the

contents of all the documents, business

management technical assistance may

be obtained from Lisa Tamaroff, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–13, Atlanta, Georgia 30305,

telephone (404) 842–6796, Internet

address: lgt1@opspgo1.em.cdc.gov.

Programmatic technical assistance

may be obtained from Russ Havlak,

Immunization Services Division,

National Immunization Program,

Centers for Disease Control and

Prevention (CDC), Building 12,

Corporate Square Boulevard, Mailstop

E–52, Atlanta, Georgia 30329, telephone

(404) 639–8569, Internet address:

grh1@cpstb1.em.cdc.gov.

Please refer to Announcement

Number 612 when requesting

information and submitting an

application.

There may be delays in mail delivery

as well as difficulty in reaching the CDC

Atlanta offices during the 1996 Summer

Olympics (July 19–August 4). Therefore,

CDC suggests the following to get more

timely responses to any questions: using

internet/email, following all

instructions in this announcement, and

leaving messages on the contact

person’s voice mail.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) referenced

in the Introduction through the

Superintendent of Documents,

Government Printing Office,

Washington, D.C. 20402–9325,

telephone: 202–512–1800.

Dated: May 2, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–11443 Filed 5–7–96; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,
20832 Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETING: The following advisory

committee meeting is announced:

Veterinary Medicine Advisory

Committee

Date, time, and place. May 29, 1996,

8:30 a.m., Holiday Inn—Gaithersburg,

Goshen Room, Two Montgomery Village

Ave., Gaithersburg, MD.

Type of meeting and contact person.

Open committee discussion, 8:30 a.m. to

10:30 a.m.; open public hearing, 10:30

a.m. to 11:30 a.m., unless public

participation does not last that long;

open committee discussion, 11:30 a.m.

to 2:30 p.m.; open public hearing, 2:30

p.m. to 3:30 p.m., unless public

participation does not last that long;

Joanne M. Kla, Center for Veterinary

Medicine (HFV–244), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1765, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Veterinary Medicine Advisory

Committee, code 12546. Please call the

hotline for information concerning any

possible changes.

General function of the committee.

The committee reviews and evaluates

available data concerning safety and

effectiveness of marketed and

investigational new animal drugs, feeds,

and devices for use in the treatment and

prevention of animal disease and

increased animal production.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentation should notify the

contact person before May 22, 1996, 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

required to make their comments.

Open committee discussion. FDA

relies on States and the milk industry

for much of the routine drug residue

monitoring, and in conjunction with the

National Conference on Interstate Milk

Shipments (NCIMS), uses its limited

resources in the training of a wide range

of State and industry personnel,

provides testing for the accreditation of

State laboratories, and conducts a

limited number of assays. The General

Accounting Office (GAO) recently

recommended that FDA develop a

comprehensive strategy to address

animal drug residues in milk. The first

topic to be addressed by the committee

will be a draft document entitled ‘‘FDA

Strategy To Address Animal Drug

Residues In Milk.’’ During the

afternoon, the committee will discuss

the status of the sometribove PostApproval Monitoring Program (PAMP).

FDA approved sometribove, a

recombinant bovine somatotropin (bST)

on November 12, 1993 (58 FR 55946),

and the product, Posilac, began

commercial distribution on February 4,

1994. Steps have been taken to monitor

sometribove in commercial use. The

Monsanto Co. is conducting a PAMP

that includes the following elements:

• A study of animal health effects

including mastitis, animal drug use and

resulting loss of milk associated with

bST use in a minimum of 24

commercial dairy herds. The in-life

portion of this study were recently

completed. The committee will hear a

brief status report on May 29, 1996, and

will consider the report in detail during

the fall of 1996 after the quality

assurance and statistical treatments of

the data are complete.

• A 2-year tracking system of milk

production and drug residues in key

dairy States that represent over 50

percent of the total U.S. milk production

to compare the amount of milk

discarded due to drug residues before

and after bST approval.

• A 12-month comparison of the

proportion of milk discarded due to

possible drug residues between bST

treated and untreated herds.

• A reporting system to monitor bST use

and reports of adverse drug experiences.

The committee will also consider the 2-

year tracking system to compare mild

discarded pre- versus post-bST approval

and adverse experience reports filed

with FDA during the first 2 years of

sometribove commercial use.

FDA public advisory committee

meetings may have as many as four

separable portions: (1) An open public

hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. There are no closed portions

for the meetings announced in this

notice. The dates and times reserved for

the open portions of each committee

meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday
Federal Register / Vol. 61, No. 90 / Wednesday, May 8, 1996 / Notices 20833

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

This notice is issued under section

10(a)(1) and (2) of the Federal Advisory

Committee Act (5 U.S.C. app. 2), and

FDA’s regulations (21 CFR part 14) on

advisory committees.

Dated: April 29, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96–11436 Filed 5–7–96; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[HCFA–319]

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposals for the

collection of information. Interested

persons are invited to send comments

regarding this burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) The necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

1. Type of Request: Reinstatement,

without change, of a previously

approved collection for which approval

has expired; Title of Information

Collection: State Medicaid Eligibility

Quality Control (MEQC) Sample

Selection Lists; Form No.: HCFA–319;

Use: The State MEQC sample selection

list is necessary for regional offices to

control and track State MEQC reviews.

The sample selection lists contain

identifying information on Medicaid

beneficiaries; Frequency: Monthly;

Affected Public: State, local, or tribal

government; Number of Respondents:

55; Total Annual Responses: 12; Total

Annual Hours: 5,280.

To request copies of the proposed

paperwork collection referenced above,

E-mail your request, including your

address, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections should be sent

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Financial and Human

Resources, Management Planning and

Analysis Staff, Attention: Linda

Mansfield, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: April 29, 1996.

Kathleen B. Larson,

Director, Management Planning and Analysis

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 96–11384 Filed 5–7–96; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

Notice of Receipt of Applications for

Permit

The following applicants have

applied for a permit to conduct certain

activities with endangered species. This

notice is provided pursuant to Section

10(c) of the Endangered Species Act of

1973, as amended (16 U.S.C. 1531, et

seq.):

PRT–814546

Applicant: James Spotila, Drexel University,

Philadelphia, PA

The applicant requests a permit to

import blood and tissue samples from

leatherback sea turtle (Dermochelys

coriacea), green sea turtle (Chelonia

mydas agassizi) and olive ridley sea

turtle (Lepidochelys olivacea) from

Costa Rica and India for the purpose of

scientific research that will benefit the

species in the wild. This notice covers

activities conducted by the applicant

over a five year period.

Written data or comments should be

submitted to the Director, U.S. Fish and

Wildlife Service, Office of Management

Authority, 4401 North Fairfax Drive,

Room 430, Arlington, Virginia 22203

and must be received by the Director

within 30 days of the date of this

publication.

Documents and other information

submitted with these applications are

available for review, subject to the

requirements of the Privacy Act and

Freedom of Information Act, by any

party who submits a written request for

a copy of such documents to the

following office within 30 days of the

date of publication of this notice: U.S.

Fish and Wildlife Service, Office of

Management Authority, 4401 North

Fairfax Drive, Room 430, Arlington,

Virginia 22203. Phone: (703/358–2104);

FAX: (703/358–2281).

Dated: May 3, 1996.

Caroline Anderson,

Acting Chief Branch of Permits, Office of

Management Authority.

[FR Doc. 96–11490 Filed 5–7–96; 8:45 am]

BILLING CODE 4310–55–P

Bureau of Land Management

[WO–300–1310–00]

Green River Basin Advisory

Committee, Colorado and Wyoming

AGENCY: Bureau of Land Management,

Interior.

ACTION: Notice of Meeting of the Green

River Basin Advisory Committee.

SUMMARY: This notice sets forth the time

schedule and agenda for the third

meeting of the Green River Basin

Advisory Committee (GRBAC).

DATES: Wednesday, May 22, 1996, from

8:00 a.m. until 7:00 p.m., and Thursday,

May 23, 1996, from 8:00 a.m., until 4:00

p.m.

ADDRESSES: Moffat County Fairgrounds

Pavilion, junction of Bellaire and 4th

Street, Craig, CO 81625.

FOR FURTHER INFORMATION CONTACT:

Terri Trevino, GRBAC Coordinator,

Bureau of Land Management, P.O. Box

1828, Cheyenne, WY 82003, telephone

(307) 775–6020; or Frank Salwerowicz,

Bureau of Land Management, 2850

Youngfield St., Lakewood, CO 80215,

telephone number (303) 239–3745.

SUPPLEMENTARY INFORMATION: The topics

for the meeting will include:

1. Sub-group reports;

2. Dissemination of GRBAC

information requests; and

3. Public comment.

This meeting is open to the public.

Persons interested in making oral

comments to the GRBAC or filing

written statements for the GRBAC’s

consideration should notify the GRBAC

Coordinator at the above address by

May 14, 1996. Oral comments will be

heard from 5:00 p.m., to 7:00 p.m., on

Wednesday, May 22. The GRBAC may

establish a time limit for oral

statements.

Dated: April 29, 1996.

Mike Dombeck,

Acting Director, Bureau of Land Management.

[FR Doc. 96–11433 Filed 5–7–96; 8:45 am]

BILLING CODE 4310–84–M