36448 Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Notices

program. For a complete description of

each, see Addendum I in the application

kit.

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

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301 and 317 of the Public

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

241 and 247b, as amended. The Catalog

of Federal Domestic Assistance number

is 93.283.

J. Where To Obtain Additional

Information

This and other CDC announcements

may be downloaded through the CDC

Home Page on the Internet at <http://

www.cdc.gov> (click on Funding).

Please refer to Program Announcement

Number 00127 when requesting

information. 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: Mattie

B. Jackson, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention, E–

13, Room 3000, 2920 Brandywine Road,

Atlanta, GA 30341–4146, Telephone

number: 770–488–2718, Email address:

mij3@cdc.gov

For program technical assistance,

contact: Marta Gwinn, MD, MPH, Senior

Medical Epidemiologist, Office of

Genetics and Disease Prevention,

National Center for Environmental

Health Centers for Disease Control and

Prevention, K–28, 4770 Buford

Highway, NE, Atlanta, GA 30341–3724,

Telephone number: 770–488–3235,

Email address: mlg1@cdc.gov

Dated: June 2, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Conrol and Prevention

(CDC).

[FR Doc. 00–14424 Filed 6–7–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement Number 00141]

Notice of Availability of Funds;

Surveillance of Intimate Partner

Violence (IPV)

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 Surveillance of Intimate

Partner Violence (IPV). The purpose(s)

of the program announcement are (1) to

improve state injury surveillance

capacity through the implementation of

the Consensus Recommendations For

Injury Surveillance In State Health

Departments, September 1999 Report,

for a copy of this report, visit the

Internet site: (http://

www.injuryprevention.org/stipda/spubs) and (2) to support the integration

of population-based IPV surveillance

systems into existing injury surveillance

systems that will help determine the

magnitude of IPV in population

subgroups, and continued revision and

testing of uniform definitions and

recommended data elements. This

program addresses ‘‘Healthy People

2010,’’ a national activity to reduce

morbidity and mortality and improve

health. This announcement is related to

the focus area of Injury and Violence

Prevention. For the conference copy of

‘‘Healthy People 2010’’, visit the

Internet site: http://www.health.gov/

healthypeople.

B. Eligible Applicants

Assistance will be provided only to

the official public health departments of

States or their bona fide agents,

including the District of Columbia, the

Commonwealth of Puerto Rico, the

Virgin Islands, the Commonwealth of

the Northern Mariana Islands, American

Samoa, Guam, federally recognized

Indian tribal governments, the

Federated States of Micronesia, the

Republic of the Marshall Islands, and

the Republic of Palau. States previously

funded under announcement number

94483 ‘‘State Injury Prevention

Programs’’ are eligible to apply

(Massachusetts, Michigan and Rhode

Island). States previously funded under

announcement number 99134 ‘‘State

Injury Prevention Programs’’ are not

eligible to apply (Kentucky and

Oklahoma).

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 which

engages in lobbying activities shall not be

eligible to receive Federal funds constituting

an award, grant cooperative agreement

contract, loan, or any other form.

C. Availability of Funds

Approximately $1.2 million is

available to fund up to four awards. It

is expected that the average award will

be $300,000. It is expected that the

awards will begin on or about

September 30, 2000 and will be made

for a 12-month budget period within a

project period of up to five years.

Funding estimates may change.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress, as

evidenced by required reports, and the

availability of funds.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under (1) Recipient Activities, and CDC

will be responsible for the activities

listed under (2) CDC Activities.

1. Recipient Activities

a. Enhance existing injury

surveillance activities to support

Intimate Partner Violence (IPV)

surveillance to identify victims and

occurrences of IPV, including data

describing the magnitude of the problem

and the extent of injuries (i.e., who is

affected, areas and persons at greatest

risk, and the type and source of the

information used).

b. Enhance an existing injury

surveillance system, capable of linking

with one or more health-related data

sources to determine intimate partner

violence incidence and prevalence in

the targeted area (e.g., linkage of

emergency department injury

surveillance data or hospital discharge

data with health-care based IPV

surveillance data).

c. Enhance the capacity for general

injury surveillance by incorporating the

IPV surveillance system into other

existing injury surveillance systems.

d. Using the Uniform Definitions for

IPV Surveillance, assess the feasibility

of enhancing existing injury

surveillance and integrating a subset of

the fifty recommended data elements:

Uniform Definitions and Recommended

Data Elements, 1999; http://

www.cdc.gov/ncipc/pub-res/

intimate.html into an existing healthcare related injury surveillance system.

Explain decisions made in selecting the

subset of 50 data elements.

Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Notices 36449

e. Establish and maintain cooperative

partnerships with key personnel of

potential data source agencies (e.g.,

hospitals, emergency departments, etc.).

f. Monitor quality, representativeness

and completeness of IPV surveillance

data.

g. Collect and analyze surveillance

data.

h. Produce and distribute periodic,

progress reports to appropriate state and

local agencies, and develop replication

guidelines for future use by other states

and localities.

i. Establish an advisory committee to

exchange information and increase the

likelihood of integrated injury

surveillance systems.

In addition to the above, applicants

should have well-developed

surveillance capacity that includes the

ability to: (See Consensus

Recommendations for Injury

Surveillance in State Health

Departments—September 1999 Report.)

a. Access the 11 core data sets

recommended for injury surveillance.

The 11 data sets are vital records (VR),

hospital discharge data (HDD), Fatality

Analysis Reporting System (FARS), the

Behavioral Risk Factor Surveillance

System (BRFSS), the Youth Risk

Behavioral Surveillance System

(YRBSS), emergency department data

(ED), medical examiner data and

coroner data (ME), child death review

data (CDR), the National Occupant

Protection System (OPU), Uniform

Crime Reporting System (UCR), and

emergency medical services data (EMS).

b. Assess the completeness and

validity of the 11 core data sets and

evaluate the surveillance systems that

generated these data using standard

evaluation criteria.

c. Link data sets.

d. Ensure that each injury event is

counted only once when using patient

records.

e. Conduct special analyses.

f. Identify and measure interim

program outcomes.

g. Evaluate state injury prevention

program.

h. Use surveillance to support applied

research.

i. Produce routine reports based on

core data to support the five

components of a model state injury

prevention program: data collection and

analysis; program design,

implementation, and evaluation;

coordination and collaboration;

technical support and training; and

public policy.

j. Develop and implement a

surveillance system for additional major

injury problems (e.g., nonfatal

interpersonal violence including

intimate partner violence, sexual

assault, and child abuse).

k. Develop unique surveillance

systems to meet the state’s individual

data needs.

2. CDC Activities

a. If needed, provide technical

assistance in the design of all phases of

the IPV surveillance programs,

including consultation on data

collection instruments and procedures.

b. Provide technical assistance in

developing a standardized approach to

surveillance and related evaluation

activities.

c. Provide consultation and assistance

in problem assessment and target

population identification, the evaluation

of coverage, cost, and impact of

surveillance activities, and design of

scientific protocols.

d. Collaborate in the analysis and

dissemination of IPV surveillance data.

e. Provide up-to-date scientific

information about intimate partner

violence and coordinate with related

activities at CDC’s National Center for

Injury Prevention and Control.

f. Assist in the transfer of information

and methods developed in this program

to other geographical areas.

E. Application Content

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. The application

will be evaluated on the Evaluation

Criteria listed, so it is important to

follow them in laying out the program

plan. The narrative should be no more

than 45 double-spaced pages, printed on

one side, with one inch margins, no

smaller than 12 point Courier Font.

Number each page consecutively and

provide a complete Table of Contents.

The total number of pages should not

exceed 60 pages including the

appendix. No bound booklets, etc.

should be attached.

In developing the application, the

applicant must also include a two-page,

double-spaced abstract. In following the

format shown below, the applicant

should also provide a detailed

description of the first year activities

and briefly describe future-year

objectives and activities.

Format

1. Abstract.

2. Background and Need.

3. Goals.

4. Objectives.

5. Methodology.

6. Evaluation.

7. Coordination and Collaboration.

8. Project Management and Staffing.

9. Budget.

10. Human Subjects.

11. Other Requirements and

Attachments.

F. Submission and Deadline

Application: Submit the original and

two copies of PHS 5161–1 (OMB

Number 0937–0189). Forms are in the

application kit. On or before August 8,

2000, submit the application to the

Grants Management Specialist

identified in the ‘‘Where to Obtain

Additional Information’’ section of this

announcement.

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 independent 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.)

Late Applications: Applications

which do not meet the criteria in (a) or

(b) above are considered late

applications, will not be considered,

and will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Abstract (Not To Exceed Two Pages)

(Not Scored)

The extent to which the applicant

summarizes the existing injury

surveillance system, the proposed IPV

surveillance system, and the proposed

integration of the IPV system into the

injury surveillance system.

2. Background and Need (15 Points)

a. The extent to which the applicant

documents the magnitude of the

intimate partner violence problem in the

applicant’s targeted area, and provides a

profile of the persons and groups at

greatest risk.

b. The extent to which the applicant

documents its current activities and

previous experiences in injury

surveillance, intimate partner violence

surveillance, evaluation, and

coordination with other agencies and

potential partners.

c. The extent to which the applicant

documents the current capacity and

demonstrates the existence of a welldeveloped injury surveillance system to

36450 Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Notices

collect and link health related data;

what information is collected and what

data sources are used, e.g. Hospital

discharge data, emergency department

data, and emergency services data, etc.

3. Goals (10 Points)

a. The extent to which the applicant

states specific goals that indicate where

the applicant anticipates the integration

of intimate partner violence into the

existing injury surveillance system will

be at the end of the five-year project

period.

b. The extent to which the applicant

describes and provides evidence of its

willingness and ability to undertake

related projects to expand the capacity

of the IPV surveillance system should

additional funds become available.

4. Objectives (15 Points)

a. The extent to which the applicant

states specific, time-phased, measurable

and achievable objectives.

b. The extent to which the applicant

relates the objectives directly to the

project goals and the use of various

health-related information sources,

effort to achieve representativeness,

surveillance system evaluation,

collaboration, and demonstrates the

utility of the surveillance system in

replication efforts.

5. Methodology (20 Points)

a. The extent to which the applicant

documents the capacity of the existing

injury surveillance system; the proposed

IPV surveillance system; and the

proposed integration of the intimate

partner violence surveillance system

into the injury surveillance system.

b. The extent to which the applicant

describes specific activities that are

proposed to achieve each of the program

objectives during the budget period.

c. The extent to which the applicant

provides a time-line which indicates

when each activity and preparations for

activities will occur.

d. The extent to which the applicant

provides evidence of an organizational

chart that represents the actual structure

of the integrated IPV injury surveillance

system operating organization and its

placement within the organizational

units with existing jurisdiction and

authority over other injury surveillance

systems.

e. The extent to which the applicant

provides evidence it has met the CDC

Policy requirements regarding the

inclusion of women, ethnic, and racial

groups in the proposed research.

6. Evaluation (15 Points)

a. The extent to which the applicant

describes the methods and design to be

used to evaluate the integrated subset of

the IPV surveillance system into the

injury surveillance system, including

what will be evaluated, data to be used,

who will perform the evaluation and the

time it will take (timeline) to do the

evaluation.

b. The extent to which the applicant

provides evidence of staff availability,

expertise, and capacity to evaluate

surveillance activities.

7. Coordination and Collaboration (10

Points)

a. The extent to which the applicant

describes the relationship between the

program and other organizations,

agencies, and health department units

that will relate to the program or which

conduct related activities.

b. The extent to which applicant

provides evidence of collaboration with

academic institutions, public safety

officials, or with other agencies. In

addition, the extent to which the

applicant describes responsibilities and

composition of the surveillance

advisory committee.

8. Project Management and Staffing (15

Points)

a. The extent to which the applicant

documents the experience in the

management of intimate partner

violence surveillance, and describes the

roles and responsibilities of the project

director, epidemiologist, and each staff

member, including a description of staff

with appreciable experience in other

injury surveillance systems expected to

work in the integrated surveillance

system.

b. The extent to which the applicant

describes the allocation of staff to the

activities outlined in the Methodology

section.

c. The extent to which the applicant

includes letters in the appendix from

each collaborating consultant or outside

agency stating their willingness and

ability to fulfill the proposed

responsibilities.

9. Budget (Not Scored)

The extent to which the budget

request is clearly explained, adequately

justified, reasonable, sufficient, and

consistent with the stated objectives and

planned activities.

10. Human Subject (Not Scored)

a. The extent to which the applicant

describes the degree to which human

subjects may be at risk.

b. The extent to which the applicant

describes assurances that all activities

will conform to the requirements of 45

CFR part 46.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Semi-annual progress reports.

2. Financial status report, no more

than 90 days after the end of the budget

period.

3. 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 the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

Projects that involve the collection of

information from 10 or more individuals

and funded by a resulting cooperative

agreement will be subject to review by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Addendum in the application

package.

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–13 Prohibition on Use of CDC

Funds for Certain Gun Control

Activities

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301(a), 317(k)(2), and 391–

394A [42 U.S.C. 241(a), 247b(k)(2), and

280b–280b–3] of the Public Health

Service Act as amended.

J. Where To Obtain Additional

Information

This and other CDC announcements

are available through the CDC homepage

on the Internet at: http://www.cdc.gov.

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 program

announcement number (00141).

If you have questions after reviewing

the contents of all the documents,

business management assistance may be

obtained from: Joanne Wojcik, Lead,

Grants Management Specialist,

Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Notices 36451

Announcement #00141, 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)

488–2717.

For program technical assistance,

contact: John D. Hemphill, National

Center for Injury Prevention and Control

Centers for Disease Control and

Prevention, 4770 Buford Highway, NE,

Mailstop K60, Atlanta, GA 30341,

Telephone (770) 488–1285, Email

address: jdh2@cdc.gov, FAX (770) 488–

1011

Dated: June 2, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–14425 Filed 6–7–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement Number 00066]

Using Private Provider Partnerships To

Strengthen the Immunization Message;

Notice of Availability of Funds;

Amendment

A notice announcing the availability

of Fiscal Year 2000 funds to fund a

cooperative agreement program with

national private provider organizations

which was published in the Federal

Register on May 1, 2000, [Vol. 65, No.

84, Pages 25334–25336]. The notice is

amended as follows:

On page 25335, Third Column, under

Section F. Submission and Deadline, the

submission due date is revised to read

on or before July 18, 2000.

Dated: June 2, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–14426 Filed 6–7–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Dermatologic and Ophthalmic Drugs

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). At least one portion of the

meeting will be closed to the public.

Name of Committee: Dermatologic

and Ophthalmic Drugs 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 June 29, 2000, from 8:30 a.m.

to 5:30 p.m. and on June 30, 2000, from

8:30 a.m. to 5:30 p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact: Tracy K. Riley or Angie

Whitacre, Center for Drug Evaluation

and Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7001, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12534. Please call the Information Line

for up-to-date information on this

meeting. Current information may also

be accessed on the Internet at the FDA

Website, www.FDA.GOV.

Agenda: On June 29, 2000, during the

initial open session, the committee will

discuss new drug application (NDA) 20–

010, LotrisoneTM Lotion (clotrimazole/

betamethasone diproprionate),

Schering-Plough, Inc., for treatment of

tinea pedis, tinea cruris, and tinea

corporis; and NDA 20–996, Dermex IITM

Ointment (zinc oxinate), Dermex

Pharmaceuticals, Limited Liability

Corp., for treatment of actinic keratosis,

basal cell carcinoma, and squamous cell

carcinoma. On June 30, 2000, the

committee will discuss NDA 21–026,

(miconazole nitrate, USP 0.25%)

ointment, Johnson & Johnson Consumer

Companies, Inc., for treatment of diaper

dermatitis.

Procedure: On June 29, 2000, from 10

a.m. to 5:30 p.m. and on June 30, 2000,

from 8:30 a.m. to 5:30 p.m., the meeting

is open to the public. 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 June 21, 2000. Oral

presentations from the public will be

scheduled between approximately 10

a.m. and 10:30 a.m. on June 29, 2000,

and between approximately 8:30 a.m.

and 9:30 a.m. on June 30, 2000. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before June 21, 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.

Closed Committee Deliberations: On

June 29, 2000, from 8:30 a.m. to 10 a.m.,

the meeting will be closed to permit

discussion and review of trade secret

and/or confidential information

regarding pending investigational new

drug applications issues (5 U.S.C.

552b(c)(4)).

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. 00–14461 Filed 6–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Gastroenterology and Urology Devices

Panel of the Medical Devices 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: Gastroenterology

and Urology Devices Panel of the

Medical Devices 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 June 19, 2000, 10 a.m. to 5 p.m.

Location: Hilton, Salons D and E, 620

Perry Pkwy., Gaithersburg, MD.

Contact Person: Mary J. Cornelius,

Center for Devices and Radiological

Health (HFZ–470), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–2194,

ext. 118, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12523. Please call the

information Line for up-to-date

information on this meeting.

Agenda: The committee will discuss,

make recommendations, and vote on a

premarket approval application for a

device for the treatment of obesity.

Procedure: Interested persons may

present data, information, or views,