Cooperative Agreement To Provide Information Concerning the Diagnosis, Prevention and Treatment of Viral Hepatitis-Related Liver Disease

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement Number 781]

Cooperative Agreement To Provide Information Concerning the

Diagnosis, Prevention and Treatment of Viral Hepatitis-Related Liver

Disease

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of funds beginning in fiscal year (FY) 1997 for a

cooperative agreement program with one or more national organizations

to develop and distribute materials to educate the general public,

affected patients, risk groups, physicians, and other health care

providers about the prevention, diagnosis and medical management of

acute and chronic liver disease due to all types of viral hepatitis,

with initial emphasis on hepatitis C.

CDC is committed to achieving the health promotion and disease

prevention objectives of ``Healthy People 2000,'' a national activity

to reduce morbidity and mortality and improve the quality of life. This

announcement is related to the priority area of Immunization and

Infectious Diseases. (To order a copy of Healthy People 2000, see WHERE

TO OBTAIN ADDITIONAL INFORMATION.)

Authority

This program is authorized under sections 301 (42 U.S.C. 241) and

317(k)(2) (42 U.S.C. 247b(k)(2)) of the Public Health Service Act, as

amended.

Smoke-Free Workplace

CDC strongly encourages all grant recipients to provide a smoke-

free workplace and promote the 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

Eligible applicants are limited to national nonprofit organizations

which devote a major portion of their activities to educating the

public, patients, and health care providers about the diagnosis,

prevention, and medical management of viral hepatitis-related liver

disease. Eligible applicants must also have established collaboration

with diverse national organizations and groups that represent health

care professionals, minority populations, volunteers, consumers,

patients, community organizations, groups at risk of infection with

hepatitis viruses, government entities, and others.

Organizations that meet these eligibility requirements are the most

appropriate applicants because:

1. They have the expertise and experience needed to produce

effective health education materials and messages and develop

strategies to maximize health care professionals and public awareness

and education about the risk factors, preventive measures, and

treatment options for viral hepatitis, including hepatitis C.

2. They have demonstrated interest in providing accurate, pertinent

information on viral hepatitis-related liver disease to the public,

populations at risk of infection, patients, and health care

professionals.

3. They have the ability to collaborate with health professional

schools (medical, dental, public health, nursing, allied health),

medical and health professional societies, blood banks, health care

facilities, community organizations, at-risk populations, and local,

State, and Federal government agencies to increase awareness of how

viral hepatitis, in general, and hepatitis C virus (HCV) infections

specifically, can be identified, treated, and prevented.

4. They can conduct formative research, pilot test potential

messages and materials, and evaluate their effectiveness in increasing

knowledge and motivating behavior change.

Availability of Funds

Approximately $250,000 is available in FY 1997 to fund up to two

cooperative agreements. It is expected that the awards will begin on or

about September 1, 1997, for a 12-month budget period within a project

period of up to three years. Continuation awards within the project

period will be made on the basis of satisfactory progress and the

availability of funds. Funding estimates may vary and are subject to

change.

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Use of Funds

Restrictions on Lobbying

Applicants should be aware of restrictions on the use of Department

of Health and Human Services (HHS) funds for lobbying of Federal or

State legislative bodies. Under the provisions of 31 U.S.C. Section

1352 (which has been in effect since December 23, 1989), recipients

(and their subtier contractors) are prohibited from using appropriated

Federal funds (other than profits from a Federal contract) for lobbying

Congress or any Federal agency in connection with the award of a

particular contract, grant, cooperative agreement, or loan. This

includes grants/cooperative agreements that, in whole or in part,

involve conferences for which Federal funds cannot be used directly or

indirectly to encourage participants to lobby or to instruct

participants on how to lobby.

In addition, the FY 1997 Departments of Labor, HHS, and Education,

and Related Agencies Appropriations Act, which became effective October

1, 1996, expressly prohibits the use of 1997 appropriated funds for

indirect or ``grass roots'' lobbying efforts that are designed to

support or defeat legislation pending before State legislatures.

Section 503 of this new law, as enacted by the Omnibus Consolidated

Appropriations Act, 1997, Division A, Title I, Section 101(e), Pub. L.

No. 104-208 (September 30, 1966), provides as follows:

Sec. 503(a) No part of any appropriation contained in this Act

shall be used, other than for normal and recognized executive-

legislative relationships, for publicity or propaganda purposes, for

the preparation, distribution, or use of any kit, pamphlet, booklet,

publication, radio, television, or video presentation designed to

support or defeat legislation pending before the Congress, * * *

except in presentation to the Congress or any State legislative body

itself.

(b) No part of any appropriation contained in this Act shall be

used to pay the salary or expenses of any grant or contract

recipient, or agent acting for such recipient, related to any

activity designed to influence legislation or appropriations pending

before the Congress or any State legislature.

Background

Hepatitis C virus (HCV) is an important cause of acute and chronic

hepatitis in the United States. The CDC estimates 30,000 persons were

infected with HCV in 1995, with most infections occurring among young

adults with high-risk behaviors or lifestyles. The most efficient mode

of transmission of HCV is through direct percutaneous exposures, such

as from sharing of contaminated needles among injection drug users or

from blood transfusion. Exposures associated with acquiring HCV

infection include blood transfusion prior to 1990, receipt of clotting

factor concentrates that were not virally inactivated, injection drug

use, snorting cocaine, hemodialysis, health care work involving

frequent exposure to blood (in particular, accidental needle sticks),

sexual contact with a partner infected with HCV, multiple sex partners

(heterosexual or homosexual), and birth to a HCV-infected woman.

Currently, most HCV infections are acquired by high-risk drug use (60

percent) and sexual behaviors (20 percent). There is no evidence that

transmission of HCV is associated with commercial use of equipment for

tattooing, body piercing, hair cutting (razors), or manicures.

The most important feature of hepatitis C is the high rate of

progression to chronic infection, even in the absence of active liver

disease. About 70 percent of HCV infected persons develop chronic

hepatitis that can progress to cirrhosis and hepatocellular carcinoma,

with an estimated 8-10,000 HCV-related chronic liver disease deaths

each year. A national survey conducted in the U.S. from 1988 to 1994

found that 1.8 percent of a representative sample of the civilian

population had antibody to HCV, corresponding to 3.9 million HCV-

infected Americans. Infection rates were higher in males than in

females, and higher in African Americans than in Caucasians. The

highest rates of HCV infection were found in adults aged 30-49 years.

Because of the large degree of confusion and lack of accurate

information about hepatitis C, educational materials are necessary for

both health care providers and the general public about the risks of

acquiring HCV infection, indications for serological testing and other

diagnostic methods, treatment issues, and means to prevent the spread

of infection. Prevention strategies to identify, treat and counsel

persons with chronic infection and measures to reduce transmission in

high-risk groups are needed. For health care providers, these should

include information on identifying patients with a history of high-risk

exposures, interpretation of diagnostic test results, discussion of

treatment options, guidelines for counseling patients, and the

importance of appropriate disease reporting.

Hepatitis A virus (HAV) infection is a major cause of acute

hepatitis in the United States (U.S.). At least 150,000 persons are

newly infected each year with 75,000 developing clinical illness

associated with substantial morbidity and medical and work-loss costs.

Up to 20 percent of persons with hepatitis A are hospitalized with an

average 27 days of work loss. Direct and indirect costs were estimated

to be more than $200 million in 1991. Most cases of hepatitis A occur

by person-to-person transmission in community-wide outbreaks. The

highest rates of disease occur in children, adolescents and young

adults, and among American Indians/Alaska Natives and Hispanics.

Children may be the major reservoir for transmission of HAV; nearly 30

percent of reported cases occur among children less than 15 years of

age, and many more children probably have unrecognized or asymptomatic

infection that is not recognized until transmission to older household

contacts occurs.

Hepatitis A vaccines are licensed for persons over two years of

age, with virtually 100 percent of children, adolescents, and adults

developing protective levels of antibody after the vaccine series.

While the most effective means of achieving control of HAV infection

would be to include routine hepatitis A vaccination in the childhood

vaccination schedule, the vaccine is not licensed, as yet, for children

under two years of age. Current recommendations are for pre-exposure

vaccination of groups at increased risk for HAV infection (e.g.,

persons traveling to countries with high rates of HAV infection, men

who have sex with men, drug users) and routine vaccination of children

and adults in communities with high or intermediate rates of HAV

infection.

Acute and chronic hepatitis B virus (HBV) infections are a major

cause of morbidity and mortality in the United States, consuming a

large amount of health care resources. Approximately 60,000 new

infections with HBV continue to occur each year in spite of the

availability of an effective vaccine. The existing pool of 1.25 million

persons with chronic HBV infection are potentially infectious to others

and are at risk of long-term sequelae that include chronic active

hepatitis, cirrhosis and primary hepatocellular carcinoma.

Approximately 6,000 deaths occur annually from HBV-related chronic

liver disease. Antiviral therapy is moderately effective in eliminating

chronic HBV infection. However, most chronically infected persons are

not being identified, counseled, or treated. Patients with chronic HBV

infection need to be counseled about treatment options and health care

interventions that can be used to prevent HBV transmission to others.

The most effective means of preventing new HBV infections and HBV-

related acute and chronic liver

[[Page 38543]]

disease is by immunizing susceptible persons with hepatitis B vaccine.

A comprehensive strategy to eliminate HBV transmission in the U.S. has

been developed and includes prevention of perinatal HBV infection,

routine vaccination of infants, catch-up vaccination of young children

at high risk of HBV infection, routine vaccination of adolescents, and

vaccination of adolescents or adults at high risk of infection.

Currently, routine maternal screening to prevent perinatal HBV

infection and routine vaccination of infants and adolescents have been

widely implemented throughout the U.S. However, high levels of

vaccination coverage have not been achieved for childhood populations

at high risk of infection and for adults and adolescents in groups at

high risk of infection.

Purpose

The purpose of this cooperative agreement program is to assist

national organizations in fulfilling their goals of developing and

disseminating accurate information on viral hepatitis to target

audiences that include health care providers, at-risk populations,

patients, and the general public. Specifically, the objectives are to:

(1) improve health care provider knowledge about the diagnosis,

prevention, health consequences, and medical management of viral

hepatitis (with initial emphasis on hepatitis C), and (2) improve

community, risk group, and patient awareness of the importance of and

the means for the prevention of viral hepatitis (with initial emphasis

on hepatitis C) by collecting, developing, and disseminating

information and educational materials.

Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient will be responsible for the activities described under A.

below, and CDC will be responsible for the activities described under

B. below:

A. Recipient Activities

1. Review existing available educational information on the

diagnosis, prevention, health consequences, and medical management of

viral hepatitis. Such materials may be available from the recipient and

others (e.g., nonprofit organizations, pharmaceutical and vaccine

manufacturers, provider organizations, Federal and State governments,

etc.). Determine gaps and in information and efforts to effectively

reach groups targeted by these available materials. For example, review

the materials for accuracy, completeness, and appropriateness for

target audiences which include various professional groups (i.e.,

physician, nursing, dental), at-risk groups, and racial/ethnic groups

with high rates of the various types of viral hepatitis.

2. Develop and evaluate new educational materials that will fill

identified gaps through collaboration with organizations and groups

that represent the target audiences. Use formative research to develop

various types of health education materials (e.g., fact sheets,

brochures, pamphlets, videos, public service announcements, letters to

the editor, posters, articles for the lay press) that will fill the

identified gaps in health education materials needed for the various

disease-specific target audiences. Such materials should target both

the general public and at-risk populations. Messages for at-risk groups

should be appropriate for the specific diseases (HAV, HBV, HCV) and

risk groups should include men who have sex with men and injection drug

users where appropriate. Evaluation of the effectiveness of newly

developed materials should employ methods such as:

a. Focus groups and/or intercept interviews with the public and

specific at-risk populations to determine acceptance and clarity of

messages.

b. Pilot testing messages with representative audiences for appeal,

effectiveness in increasing knowledge, and motivating behavior change.

3. Evaluate various methods used to disseminate health education

materials/messages to determine the most effective methods for the

target audiences.

4. Disseminate existing and newly developed materials to target

audiences which include individuals at risk for or infected with HCV,

health care providers, and the general public. Recipient may network

with other organizations or groups (professional, voluntary,

governmental, community-based) that represent minority populations with

high rates of viral hepatitis or groups/populations at high risk of

specific types of viral hepatitis, e.g., National Institute for Drug

Abuse (NIDA), American Social Health Association (ASHA).

B. CDC Activities

1. Provide scientific and public health consultation and assistance

in the development of materials and activities related to the

cooperative agreement.

2. Provide scientific collaboration for appropriate aspects of the

activities, including information on disease impact, vaccination

coverage levels, and prevention strategies.

3. Assist in reporting and validating relevant information

concerning viral hepatitis made available to Federal, State, local

health agencies, health care providers, and volunteer organizations.

Technical Reporting Requirements

Narrative progress reports are required semiannually. The first

semiannual report is required with each year's noncompeting

continuation application and should cover program activities from date

of the previous report (or date of award for reporting in the first

year of the project). The second semiannual report is due 90 days after

the end of each budget period and should cover activities from the date

of previous report. Progress reports should address the status of all

recipient activities above, including: (1) A comparison of actual

accomplishments to the objectives established for the funding period;

(2) The reasons for failing to meet any established objectives; (3)

Description and explanation of any modifications of program activities

and protocols; and (4) Other pertinent information such as key staffing

changes or reasons for unexpectedly high or low costs for performance.

An original and two copies of a financial status report are

required no later than 90 days after the end of each budget period. A

final performance report and financial status report are due no later

than 90 days after the end of the project period.

All reports are submitted to the Grants Management Branch, Centers

for Disease Control and Prevention (CDC), Attention: Sharron P. Orum,

Grants Management Officer, Procurement and Grants Office, 255 East

Paces Ferry Road, NE., Mailstop E-18, Room 300, Atlanta, Georgia 30305.

Application Content

All applicants must develop their applications in accordance with

PHS Form 5161-1 (OMB Number 0937-0189) information contained in this

Program Announcement, and the instructions regarding typing, mailing,

and format outlined below.

Typing and Mailing

An original and two copies of the application must be submitted.

Pages must be clearly numbered, and a complete index to the application

and its appendixes must be included. Please begin each separate section

on a new page. The original and each copy of the application must be

submitted unstapled and unbound. All materials must be typewritten,

single-spaced, with unreduced type on 8-\1/2\'' by 11'' paper,

[[Page 38544]]

with at least 1'' margins headers and footers, and printed on one side

only. The application narrative must not exceed 10 single-spaced pages

(excluding budget and appendices). Unless indicated otherwise, all

information requested below must appear in the narrative. Materials or

information that should be part of the narrative will not be accepted

if placed in the appendices.

Format

The application narrative must contain the following sections in

the order presented below:

1. Introduction

Clearly demonstrate that applicant satisfies the eligibility

requirements under Eligible Applicants section above. Briefly provide a

thorough description of the need or problem(s) to be addressed and the

specific and unique contributions that applicant can make in the

development and dissemination of health education materials about viral

hepatitis with initial emphasis on hepatitis C.

2. Capacity and Personnel

Describe applicant's ability to develop health education materials

and to conduct education and awareness campaigns for specific

audiences, including populations at risk for specific types of viral

hepatitis. Describe applicant's resources, facilities, and professional

personnel that will be involved in conducting the activities. Include

in an appendix curriculum vitae for all professional personnel involved

with the project. Describe plans for administration of the project and

identify administrative resources/personnel that will be assigned to

the project. Provide in an appendix letters of support from all key

participating non-applicant organizations which clearly indicate their

commitment to participate as described in the operational plan.

3. Objectives and Technical Approach

Present specific objectives for the proposed project which are

measurable, time-phased, and clearly address the Purpose and Recipient

Activities for this program. Present a detailed operational plan for

initiating and conducting the project which clearly and adequately

addresses these objectives (if proposing a multi-year project, provide

a detailed description of first-year activities and a brief overview of

subsequent-year activities). Clearly identify specific assigned

responsibilities for all key professional personnel and their time

commitment. Include a clear description of applicant's technical

approach/methods which are directly relevant to the above objectives.

Describe the nature and extent of collaboration with CDC and others

during various phases of the project. Describe in detail a plan for

evaluating the effectiveness of newly developed educational materials

in increasing target audience knowledge and facilitating changes in

their behavior, including assessing the impact of strategies on

professional practice behaviors. Describe plans to evaluate overall

progress toward achieving project objectives.

4. Budget

Provide a line-item budget and accompanying detailed, line-by-line

justification that demonstrates the request is consistent with the

purpose and objectives of this program. If requesting funds for any

contracts, provide the following information for each proposed

contract: (1) Name of proposed contractor, (2) breakdown and

justification for estimated costs, (3) description and scope of

activities to be performed by contractor, (4) period of performance,

and (5) method of contractor selection (e.g., sole-source or

competitive solicitation).

5. Human Subjects

Whether or not exempt from DHHS regulations, if the proposed

project involves human subjects, describe (in an appendix) adequate

procedures for the protection of human subjects. Ensure that women,

racial, and ethnic minority populations are appropriately represented

in applications for research involving human subjects (see the section

OTHER REQUIREMENTS for additional information). A copy of CDC policy is

included in the application kit.

Evaluation Criteria (Total 100 points)

Applications will be reviewed and evaluated according to the

following criteria:

1. Understanding (25 points)

Extent to which the application responds to the objectives of this

cooperative agreement program including: (a) Applicant's understanding

of the objectives of the cooperative agreement, and (b) relevance of

the applicant's plan to the stated objectives.

2. Capacity (25 points)

Extent to which applicant describes adequate resources and

facilities (both technical and administrative) for conducting the

project. Extent to which applicant documents that professional

personnel involved in the project are qualified and have past

experience and achievements related to the proposed activities. Extent

to which applicant includes letters of support from appropriate non-

applicant organizations, individuals, etc., needed to carry out

proposed activities and the extent to which such letters clearly

indicate the author's commitment to participate as described in the

operational plan.

3. Objectives and Technical Approach (45 points total)

a. Extent to which applicant describes objectives of the proposed

project which are consistent with the purpose of this cooperative

agreement program and which are measurable and time-phased. (15 points)

b. Extent to which applicant presents a detailed operational plan

for initiating and conducting the project which clearly and

appropriately addresses all Recipient Activities. Extent to which

applicant clearly identifies specific assigned responsibilities and

time commitment of all key professional personnel. Extent to which the

plan clearly describes applicant's technical approach/methods for

conducting the proposed studies and extent to which the approach/

methods are appropriate and adequate to accomplish the objectives.

Extent to which applicant describes collaboration with CDC and/or

others during various phases of the project. (15 points)

c. Extent to which applicant provides a detailed and adequate plan

for evaluating effectiveness of newly developed educational materials

in increasing target audience knowledge and facilitating changes in

their behavior, including assessing the impact of strategies on

professional practice behaviors. Extent to which applicant describes

plans to evaluate progress toward achieving project objectives. (15

points)

4. Budget (not Scored)

Extent to which the proposed budget is reasonable, clearly

justifiable, and consistent with the intended use of grant/cooperative

agreement funds.

5. Human Subjects (5 Points)

If the proposed project involves human subjects, whether or not

exempt from the Department of Health and Human Services (DHHS)

regulations, the extent to which adequate procedures are described for

the protection of human subjects. Note: Objective Review Group (ORG)

recommendations on the adequacy of protections include: (1) Protections

appear adequate and there are no comments to make or concerns to raise,

(2) protections appear adequate,

[[Page 38545]]

but there are comments regarding the protocol, (3) protections appear

inadequate and the ORG has concerns related to human subjects, (4)

disapproval of the application is recommended because the research

risks are sufficiently serious and protection against the risks are

inadequate as to make the entire application unacceptable, and (5)

protections appear adequate that women, racial and ethnic minority

populations are appropriately represented in applications involving

human research.

Executive Order 12372 Review

This program is not subject to the Executive Order 12372 review.

Public Health System Reporting Requirement

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 92.283.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of information from 10 or more

individuals and funded by the cooperative agreement 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 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

form provided in the application kit. Should human subjects review be

required, the proposed work plan should incorporate time lines for such

development and review activities.

Women, Racial and Ethnic Minorities

It is the policy of the Centers for Disease Control and Prevention

(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR)

to ensure that individuals of both sexes and the various racial and

ethnic groups will be included in CDC/ATSDR-supported research projects

involving human subjects, whenever feasible and appropriate. Racial and

ethnic groups are those defined in OMB Directive NO. 15 and include

American Indian, Alaskan Native, Asian, Pacific Islander, Black and

Hispanic. Applicants shall ensure that women, racial and ethnic

minority populations are appropriately represented in applications for

research involving human subjects. Where clear and compelling rationale

exist that inclusion is inappropriate or not feasible, this situation

must be explained as part of the application. This policy does not

apply to research studies when the investigator cannot control the

race, ethnicity and/or sex of subjects. Further guidance to this policy

is contained in the Federal Register, Vol. 60, No. 179, pages 47947-

47951, dated Friday, September 15, 1995.

Application Submission and Deadline

The original and two copies of the application Form PHS-5161-1 (OMB

Number 0937-0189) must be submitted to Sharron P. Orum, Grants

Management Officer, Grants Management Branch, Procurement and Grants

Office, Centers for Disease Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 305, Mailstop E-18, Atlanta, Georgia 30305,

on or before August 19, 1997.

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.)

Late applications: Applications which do not meet the criteria in

(a) or (b) above are considered late applications. Late applications

will not be considered 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 Bernice A. Moore,

Grants Management Specialist, Grants Management Branch, Procurement and

Grants Office, Centers for Disease Control and Prevention (CDC), 255

East Paces Ferry Road, NE., Room 305 Mailstop E-18, Atlanta, Georgia

30305, telephone (404) 842-6802, fax (404) 842-6513, or Internet or CDC

WONDER electronic mail at [email protected].

Programmatic technical assistance may be obtained from Louise S.

Barden, Health Educator, Hepatitis Branch, National Center for

Infectious Diseases, Centers for Disease Control and Prevention (CDC),

1600 Clifton Road, Mailstop G-37, Atlanta, Georgia 30333, telephone

(404) 639-2709, (fax) 404-639-1538, or Internet or CDC Wonder

electronic mail [email protected].

To receive an application kit, please call (404) 332-4561. You will

be asked to leave your name, mailing address, and telephone number.

Please reference Announcement Number 781 when requesting information

and submitting your application. You may also obtain this announcement

and other CDC announcements from one of two Internet sites: CDC's

homepage at http://www.cdc.gov or the Government Printing Office

homepage (including free on-line access to the Federal Register at

http://www.access.gpo.gov).

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.

Dated: July 14, 1997.

Joseph R. Carter,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97-18948 Filed 7-17-97; 8:45 am]

BILLING CODE 4163-18-P