Federal Register / Vol. 60, No. 101 / Thursday, May 25, 1995 / Notices 27733

Dated: May 19, 1995.

Joseph R. Carter,

Acting Associate Director for Management,

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–12834 Filed 5–24–95; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 519]

Prevention of the Complications of

Hemophilia

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1995

funds for a cooperative agreement

program to conduct a trial of primary

prophylaxis therapy for the prevention

of joint disease and/or inhibitor

formation in children with hemophilia.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of Healthy People 2000, a

PHS-led national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to the priority area of Diabetes

and Chronic Disabling Conditions. (For

ordering a copy of Healthy People 2000,

see the section Where to Obtain

Additional Information.)

Authority

This program is authorized under

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

Public Health Service Act, as amended

[42 U.S.C. 241(a) and 247b(k)(2)].

Applicable program regulations are

found in 42 CFR Part 51b—Project

Grants for Preventive Health Services.

Smoke-Free Workplace

PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote nonuse of all

tobacco products, and Public Law 103–

227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicants

Because of the low prevalence of

hemophilia, competition is limited to

hemophilia treatment centers (HTCs)

that routinely access and administer

comprehensive health care to sufficient

numbers of previously untreated

patients with severe hemophilia each

year. Since HTCs are the only health

care facilities administering to the

numbers of hemophiliacs required for

this study, assistance will be provided

only to hemophilia treatment centers.

Availability of Funds

Approximately $500,000 is available

in FY 1995 to fund up to two awards.

It is expected that the award will begin

on or about September 30, 1995, and

will be made for a 12-month budget

period within a project period of up to

5 years. Funding estimates may vary

and are subject to change. Continuation

awards within the project period will be

made on the basis of satisfactory

programmatic progress and the

availability of funds.

Purpose

The purpose of this hemophilia

cooperative agreement program is to

assist recipients in the implementation

of and analysis of data from a

randomized, controlled trial of primary

prophylaxis in previously untreated

patients with severe hemophilia A and

no demonstrable factor VIII inhibitors.

Cost and efficacy of early intervention

should be determined in the treatment

group and should be compared to

similar data from appropriately treated,

control subjects. In addition to objective

measures of joint function and mobility,

the cumulative risk of factor VIII

inhibitor development should be

determined for each treatment group

and total costs and complication rates

ascertained. Molecular characterization

of factor VIII defects and detailed

molecular HLA typing should be

determined for all subjects in an effort

to predict which subjects will develop

inhibitors.

Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

shall be responsible for the activities

under A. below, and CDC shall be

responsible for conducting activities

under B. below:

A. Recipient Activities

1. Develop standardized study

protocols, data collection instruments,

interview questionnaires, progress

report forms, and amend previous

protocols with new activities or

procedures incorporating all changes

agreed to at assistance meetings.

2. Train study coordinators and

medical personnel in methods of data

collection and patient assessment in the

use of standard data abstraction

instruments, in techniques of reviewing

medical records, in interviewing

patients, and in other methods of data

collection as appropriate and provided

for in the study protocols. It is the

responsibility of the recipient to ensure

uniform training of study personnel at

all data collection sites and to ensure

that the data is collected in a uniform

manner at all locations.

3. Develop appropriate management

and evaluation systems to ensure that

study personnel use data collection and

interview instruments according to

standard study protocols.

4. Collect and edit all data from all

sites, including cost effectiveness data.

5. Obtain and transmit to CDC

sufficient clinical specimens for

specialized laboratory analysis and

genetic testing, including whole blood,

plasma, cell pellets or joint tissue/fluid,

to meet the requirements of the study.

6. Publish the results of the study

using a writing committee to determine

the inclusion and order of authors on all

publications.

B. CDC Activities

1. Provide consultation, and scientific

and technical assistance in planning

and implementing the study protocol.

This assistance will include the

development of standard study

protocols, data abstraction instruments,

interview questionnaires, consent and

progress report forms.

2. Participate in the planning,

coordination, and facilitation of initial

and periodic meetings with recipients to

exchange operational experiences, and

to provide consultation and assistance

in the modification of standard study

protocols as needed.

3. Provide the required software and

technical assistance in statistical and

epidemiologic methods to conduct data

analysis.

4. The coagulation research laboratory

at CDC will be responsible for

confirmation of factor VIII inhibitor

levels and will serve as the central

reference laboratory for molecular

analysis of all study participants. CDC

will be responsible for epitope typing of

all inhibitors and other specialized

immunological/genetic testing.

Evaluation Criteria

Applications will be reviewed and

evaluated according to the following

criteria: (Total 100 points)

A. Capacity

1. The capacity of the applicant to

accrue a minimum total of 40 boys with

severe factor VIII (<1%) who are 30

months old or less without a history of

joint hemorrhage from multiple HTCs to

each treatment arm of the protocol. Each

participating HTC must be able to enroll

a minimum of 5 previously untreated

patients who meet the above criteria. (20

points)

2. The capacity to accrue and

maintain patients on trials will be

measured by (a) the number of patients
27734 Federal Register / Vol. 60, No. 101 / Thursday, May 25, 1995 / Notices

eligible for randomization into the trial

that are seen annually at each HTC, (b)

the number of patients entered and

successfully followed in previous

similar trials and (c) the publication of

the results of other such trials in peer

reviewed journals. Such publications

should demonstrate that the applicant is

capable of enrolling and following

young hemophiliacs in a clinical trial.

(20 points)

3. Qualifications of proposed staff to

meet stated objectives and goals, and the

availability of facilities to be used

during the project period. (10 points)

B. Goals and Objectives

The extent to which the applicant’s

proposed goals and objectives meet the

required activities specified under

section A. ‘‘Recipient Activities’’ of this

announcement, and that are measurable,

specific, time-phased, and realistic. (10

points)

C. Methods and Activities

1. The quality of the applicant’s plan

for conducting program activities and

the extent to which the clinical trial

design proposed is: (a) appropriate to

accomplish stated goals and objectives;

(b) acceptable to the needs of the patient

population (e.g., likely to produce

compliance); (c) feasible within

programmatic and fiscal restrictions. (30

points)

2. The recipient should demonstrate a

basic knowledge of the methods of

randomized, clinical trials and describe

how they will implement a standardized

protocol at various HTCs; (a) develop

standardized progress report forms; (b)

collect, edit, and transmit appropriate

data to the CDC. (10 points)

D. Budget

The extent to which the budget is

reasonable and consistent with the

intended use of the cooperative

agreement funds. (not scored)

Funding Priorities

In order to maximize the probability

of developing meaningful conclusions

from this randomized trial in the

shortest possible time, funding priorities

will take into consideration the ability

of the HTC (including geographical

representation of all participating HTCs)

to accrue up to 40 previously untreated

hemophilia patients in each treatment

arm of the protocol.

Interested persons are invited to

comment on the proposed funding

priorities. All comments received on or

before June 26, 1995 will be considered

before the final funding priorities are

established.

Written comments should be

addressed to: Clara M. Jenkins, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–18, Atlanta, Georgia 30305.

Executive Order 12372 Review

This program is not subject to

Executive Order 12372 review.

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.283, Centers for

Disease Control and Prevention (CDC)—

Investigations and Technical Assistance.

Other Requirements

Paperwork Reduction Act

Projects that involve collection of

information from 10 or more individuals

and funded by the cooperative

agreements will be subject to review by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act.

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

which 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 evidence of

this assurance in accordance with the

appropriate guidelines and forms

provided in the application kit.

All information obtained in

connection with this prevention trial

shall not, without such individual’s

consent, be disclosed except as may be

necessary to provide services to him or

her or as may be required by a law of

a State or political subdivision of a

State. Information derived from any

such program may be disclosed: (1) in

summary, statistical, or other form, or

(2) for clinical or research proposed, but

only if the identity of the individuals

under such program is not disclosed.

Application Submission and Deadline

The original and five copies of the

application PHS Form 398 (OMB

Number 0925–0001) must be submitted

to Clara M. Jenkins, Grants Management

Officer, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E–18, Atlanta,

Georgia 30305, on or before July 7, 1995.

1. Deadline: Applications shall 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 objective review group. (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

which do not meet the criteria in 1.(a)

or 1.(b) above are considered late

applications. Late applications will not

be considered in the current

competition and will be returned to the

applicant.

Where To Obtain Additional

Information

A complete program description and

information on application procedures

are contained in the application

package. Business management

technical assistance may be obtained

from Locke Thompson, 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–18, Atlanta, Georgia 30305,

telephone (404) 842–6595.

Programmatic technical assistance may

be obtained from Bruce Evatt, M.D.,

Division of HIV/AIDS, National Center

for Infectious Diseases, Centers for

Disease Control and Prevention (CDC),

1600 Clifton Road, NE., Mailstop E–64,

Atlanta, Georgia 30333, telephone (404)

639–3925.

Please refer to Announcement

Number 519 when requesting

information and submitting an

application.

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, DC 20402–9325, telephone

(202) 512- 1800.
Federal Register / Vol. 60, No. 101 / Thursday, May 25, 1995 / Notices 27735

Dated: May 19, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–12835 Filed 5–24–95; 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,

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:

Fertility and Maternal Health Drugs

Advisory Committee With Generic

Drugs and Endocrinologic and

Metabolic Drugs Advisory Committee

Representation

Date, time, and place. July 27 and 28,

1995, 9 a.m., Parklawn Bldg., conference

rooms D and E, 5600 Fishers Lane,

Rockville, MD.

Type of meeting and contact person.

Open public hearing, July 27, 1995, 9

a.m. to 10 a.m., unless public

participation does not last that long;

open committee discussion, 10 a.m. to

5 p.m.; open committee discussion, July

28, 1995, 9 a.m. to 5 p.m.; Philip A.

Corfman, Center for Drug Evaluation

and Research (HFD–510), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

3510, or Kimberly Topper, Center for

Drug Evaluation and Research (HFD–9),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Hotline, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), Fertility and

Maternal Health Drugs Advisory

Committee, code 12537.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational human

drugs for use in the practice of obstetrics

and gynecology.

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 presentations should notify the

contact person before July 7, 1995, 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. The

committee will discuss the necessary

components of conjugated estrogens as

they relate to clinical efficacy of

conjugated estrogens and other estrogen

replacement drug products for approved

indications. Copies of the draft agenda

will be available June 1, 1995, from

CDER Executive Secretariat Staff (HFD–

8), Center for Drug Evaluation and

Research, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. The final agenda

will be available at the meeting.

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

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.