[Federal Register Volume 68, Number 87 (Tuesday, May 6, 2003)]
[Notices]
[Pages 23994-23997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11138]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03101]


Active Surveillance for Pertussis--Surveillance for Vaccine 
Preventable Disease as a Foundation for Evaluating the Effectiveness 
and Impact of an Adolescent/Adult Pertussis Immunization Program; 
Notice of Availability of Funds

    Application Deadline: June 5, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 317 and 2102 of the 
Public Health Service Act, 42 U.S.C. 247b and 300aa-2. The Catalog of 
Federal Domestic Assistance number is 93.185.

B. Purpose

    The Centers for Disease Control and Prevention announces the 
availability of fiscal year (FY) 2003 funds to initiate a cooperative 
agreement for surveillance for pertussis in a defined geographic area 
to better characterize the epidemiology of pertussis disease across 
pediatric, adolescent, and adult age groups and to link disease 
surveillance with immunization registry data to evaluate vaccine 
effectiveness. Moreover, as licensure and recommendation of an 
adolescent/adult pertussis vaccine may occur in the United States in 
the near future, studies of the impact of this new recommendation could 
be conducted in this study site. The ``Healthy People 2010'' focus area 
is Objective 14: Immunization and Infectious Disease including 14.1 
(Reduce or eliminate indigenous cases of vaccine-preventable diseases) 
and 14.24 (Increase the

[[Page 23995]]

proportion of young children and adolescents who receive all vaccines 
that have been recommended for universal administration for at least 5 
years.)
    The specific goals of this project include:
    [sbull] Enhancing methods to evaluate the burden of pertussis 
disease across age groups.
    [sbull] Developing improved methods for pertussis surveillance that 
could be applied in other areas.
    [sbull] Evaluating the effectiveness of pertussis vaccination by 
linking disease surveillance with immunization registry data on 
vaccination coverage.
    [sbull] Developing a study site that could be used to assess the 
impact of an adolescent/adult pertussis vaccine program.
    Measurable outcomes of the program will be in alignment with the 
goals listed above.

Background

    The number of reported cases of pertussis in the United States has 
increased steadily from a historic low of 1,010 cases in 1976 to 7,867 
cases in 2000. Despite high vaccination coverage in infants and 
children, pertussis is the only vaccine-preventable disease that has a 
reported increase in overall cases and infant mortality in the United 
States over the past decade. Adolescents and adults suffer significant 
morbidity; 12 percent to greater than 30 percent of persons with cough 
illness of at least one to two weeks duration have evidence of 
pertussis infection. The mean duration of cough in adolescents and 
adults has been estimated to be approximately eight weeks. It has been 
hypothesized that the incidence of pertussis in adolescents and adults 
is increasing and that this age group is a reservoir for circulation of 
Bordetella pertussis and transmission to infants, who have the highest 
morbidity and mortality.
    The use of pertussis-containing vaccines has evolved since the 
first vaccine was licensed in the United States in 1914. Since becoming 
available in a combined vaccine with diphtheria and tetanus toxoids 
(DTP) in 1948, the vaccine has been widely used for routine childhood 
immunization. In 1991, acellular pertussis vaccine (DtaP) was 
introduced in the United States for the fourth and fifth booster dose. 
In 1997, DTaP was recommended for the entire five dose series (primary 
series plus booster doses) for children under six years of age. DTaP 
manufacturers and types have varied during their short history. 
Currently there are three different DTaP formulations (and one DTaP-
HepB-IPV) available in the United States. Many children receive more 
than one formulation of DTaP over the five dose vaccine series. Because 
the efficacy of products may differ, evaluating product specific 
vaccine efficacy requires good data on the specific vaccine 
administered; these data may be available in a vaccination registry.
    The current passive surveillance system for pertussis lacks 
sensitivity. Pertussis incidence is thought to be underestimated by at 
least one to two orders of magnitude in some age groups. Diagnostic 
criteria and reporting of pertussis vary significantly from state to 
state and from year to year. Outbreak investigations and the occurrence 
of periodic epidemic years can also markedly affect reporting. For 
example, among adolescents aged 15-19 years, the reported national 
incidence was 3.6 per 100,000 in 1999. By contrast, the reported 
incidence rate for adolescents aged 15-19 years in Massachusetts (which 
uses serologic testing for diagnosis in persons over the age of 11) was 
65.6 per 100,000 in 1999. In the epidemic year 1996, Massachusetts 
reported an incidence rate of 103 per 100,000 for adolescents in the 
same age group. Current data for pertussis in adults is even more 
limited. Thus, the variability in diagnostic testing and reporting 
makes the interpretation of the true incidence and trends in pertussis 
challenging.
    A better understanding of the age distribution, transmission, and 
disease burden is critical to implement and evaluate an adolescent/
adult immunization program in the United States. The ability to link 
immunization registry data to disease surveillance is also critical to 
evaluate vaccine efficacy and to assess trends in vaccine coverage and 
disease burden.

C. Eligible Applicants

    Applications may be submitted by public and non-profit private 
organizations and by governments and their agencies.

    Note: Title 2 of the United States Code Section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant, or loan.

D. Availability of Funds

    Approximately $325,000 is available in FY 2003 to fund one award. 
It is expected that the award will begin on or before September 15, 
2003 and will be made for a 12-month budget period. The overall project 
period is five years with funding in years two through five dependent 
on availability of funds and satisfactory progress achieving project 
goals.

Recipient Financial Participation

    Matching funds are not required for this program.

E. 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. The intention is for the Recipient and the CDC to 
work jointly and in collaboration in developing, executing and 
reporting on this project.

1. Recipient Activities

    The following section describes the expected activities of the 
recipient:
    a. Establish population-based active surveillance for pertussis in 
geographic area with a well-defined population of at least 200,000 
persons. Reporting sources should include all sites that provide 
inpatient and outpatient care to children, adolescents, and young 
adults. These include but are not necessarily limited to hospitals; 
emergency departments; pediatric, family practice, and internal 
medicine physician offices; public health clinics; urgent care centers; 
schools; and college health centers. Methods should be implemented to 
assure timely reporting of suspected pertussis cases, potentially 
including routine periodic contacts with reporting sources. Data should 
be collected from all suspected cases such that the descriptive 
epidemiology, risk factors, clinical course, therapy, and outcome of 
infection can be determined.
    b. Enhance availability and use of laboratory testing to confirm 
the diagnosis of pertussis.
    A range of laboratory tests should be available to confirm a 
pertussis diagnosis (e.g., culture, polymerase chain reaction (PCR), 
and serology). Strategies to facilitate widespread testing should be 
implemented. These may include educating reporting sources of the value 
and availability of testing, providing tests at no cost to the patient; 
facilitating transport of clinical specimens to the laboratory; and 
timely reporting of results.
    c. Enhance the quality and scope of immunization registries in the 
surveillance area.
    Activities to enhance quality include enrolling non-participating 
providers by facilitating ease of participation, and educating 
providers regarding the advantages of participation.
    d. The applicant is also invited to propose a methodology for a 
pertussis

[[Page 23996]]

vaccine efficacy study or a case-control study of risk factors for 
infection that could be implemented in conjunction with surveillance.
    If additional funding is identified, and at the discretion of CDC, 
epidemiological studies of risk factors or vaccine efficacy could be 
conducted as part of the scope of this project.

2. CDC Activities

    CDC staff will collaborate in the following activities:
    a. Collaborate in the development of surveillance strategies 
including consultation with staff experts on the clinical and 
laboratory diagnosis of pertussis.
    b. Perform confirmatory laboratory testing for a sample of positive 
or negative laboratory tests.
    c. Support registry evaluation and enhancement through consultation 
with staff experts on enhanced registry systems including immunizations 
registry computer programming experts.
    d. Collaborate in the development and implementation of research 
activities under this agreement.
    e. CDC staff experts on pertussis will provide educational training 
on the epidemiology, diagnosis, and treatment of pertussis as well as 
the limitations of the current national passive surveillance system.

F. Content

    The Program Announcement title and number must appear in the 
applications. Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Applications will be evaluated on the criteria 
listed, so it is important to address them when describing the program 
plan. The narrative should be no more than 20 single-spaced pages and 
be printed on one side, with one-inch margins and a 12-point unreduced 
font.
    The narrative should consist of, at a minimum, a Plan, Objectives, 
Methods, Evaluation, and Budget. The plan should address activities to 
be conducted over the entire five-year project period.

G. Submission and Deadline

Application Forms

    Submit the signed original and two copies of PHS 398 (OMB Number 
0925-0001). Adhere to the Errata Instruction Sheet (posted on the CDC 
web site) for PHS 398. Forms are available at the following Internet 
address: http://www.cdc.gov/od/pgo/forminfo.htm.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

    The application must be received by 4 p.m. Eastern Time June 5, 
2003. Submit the application to: Technical Information Management-
PA 03101, CDC Procurement and Grants Office, 2920 Brandywine 
Road, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.

CDC Acknowledgement of Application Receipt

    A postcard will be mailed by PGO-TIM, notifying you that CDC has 
received your application.

Deadline

    Letters of intent and applications shall be considered as meeting 
the deadline if they are received before 4 p.m. Eastern Time on the 
deadline date. Any applicant who sends their application by the United 
States Postal Service or commercial delivery services must ensure that 
the carrier will be able to guarantee delivery of the application by 
the closing date and time. If an application is received after closing 
due to (1) carrier error, when the carrier accepted the package with a 
guarantee for delivery by the closing date and time, or (2) significant 
weather delays or natural disasters, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline.
    Any application that does not meet the above criteria will not be 
eligible for competition, and will be discarded. The applicant will be 
notified of their failure to meet the submission requirements.

H. Evaluation Criteria

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the cooperative agreement. Measures of effectiveness must 
relate to the performance goals stated in section ``B. Purpose'' of 
this announcement. Measures must be objective and quantitative and must 
measure the intended outcome. These measures of effectiveness shall be 
submitted with the application and shall be an element of evaluation.
    Applications will be evaluated against the following criteria by a 
peer review group appointed by CDC:

1. Technical Approach to Implementing Surveillance (25 points)

    The extent to which applicant provides a clear description of how 
the tasks described in the recipient activities would be accomplished. 
Specifically: (a) Extent to which applicant identifies all potential 
reporting sites in the surveillance area and presents strategies to 
enlist broad participation; (b) extent to which applicant provides a 
quality strategy to assure timely reporting of suspected cases; and (c) 
extent to which applicant proposes a feasible plan to make laboratory 
testing services widely available and to assure their widespread use.

2. Previous Experience (20 points)

    The extent to which applicant provides information on the previous 
experience of the organization and project personnel that reflects an 
ability to complete the tasks listed in the recipient activities. 
Specifically, experience in disease surveillance; experience working 
with public and private medical care providers and hospitals in the 
surveillance area; and experience conducting culture, PCR, and 
serological laboratory tests. If applicant is not a State or local 
health department, experience working with the health department to 
conduct public health surveillance or other activities.

3. Quality of Diagnostic Laboratory Testing (15 points)

    The extent to which applicant provides information on the quality 
of culture, PCR and serological methods that would be used for 
pertussis diagnosis. If such testing is not done currently, extent to 
which applicant can document that the proposed method is sensitive and 
specific for pertussis infection.

4. Quality of Immunization Registry and of the Plan to Enhance It (15 
points)

    Extent to which applicant documents presence of a functional 
immunization registry and the completeness of that registry. Quality of 
plans to enhance participation, completeness, and data accuracy.

5. Personnel Qualifications and Management Plan (15 points)

    The extent to which applicant describes a staffing plan that 
demonstrates their understanding of the labor requirements to complete 
this scope of work and a management plan that describes their approach 
to managing this work, including subcontract management, if applicable. 
Includes identifying key staff, their roles

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and responsibilities, and their professional experience (curricula 
vitae should be supplied in appendices).

6. Understanding the Project Objectives (5 points)

    The extent to which the applicant demonstrates an understanding of 
the rationale of active surveillance for pertussis, the importance of 
laboratory testing to confirm diagnoses, and the role of immunization 
registries in assessing vaccine-specific coverage and facilitating 
epidemiological studies.

7. Objectives (5 points)

    The extent to which the applicant describes the surveillance area; 
documents a population of greater than 200,000 persons; and describes 
the demographic characteristics of the study population. The extent to 
which the surveillance population reflects that of the United States.

8. Human Subjects (Not Scored, However, an Application Can Be 
Disapproved if the Research Risks Are Sufficiently Serious and 
Protection Against Risks Is So Inadequate as to Make the Entire 
Application Unacceptable)

    The application should also adequately address the requirements of 
45 CFR part 46 for the protection of human subjects. This should 
include the provision of the FWA number from the Office of Human 
Research Projection (OHRP).

9. Budget (not scored)

    The applicant shall describe their proposed plan for managing the 
resources necessary to comply with the requirements specified in 
Section D. This shall include a description of the proposed person 
hours for each key individual.

I. Other Requirements

Technical Reporting Requirements

    The grantee will provide CDC with the original plus two copies of:
    1. Semi-annual progress reports. The results of the measures of 
effectiveness shall be a data requirement to be submitted with or 
incorporated into the progress report.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial report and performance report, 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.

Additional Requirements

    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment 1 of the 
announcement as posted on the CDC Web site.

AR-1--Human Subjects Requirements
AR-2--Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-10--Smoke-Free Workplace Requirements
AR-11--Healthy People 2010
AR-12--Lobbying Restrictions
AR-14--Accounting System Requirements
AR-21--Small, Minority, and Women-Owned Business
AR-22--Research Integrity

    Executive Order 12372 does not apply to this program.

J. Where To Obtain Additional Information

    This and other CDC announcements, the necessary applications, and 
associated forms can be found on the CDC home page Internet address--
http://www.cdc.gov.
    Click on ``Funding'' then ``Grants and Cooperative Agreements.''
    For general questions about this announcement, contact: Technical 
Information Management, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.
    For business management and budget assistance contact: Peaches 
Brown, Grants Management Specialist, Procurement and Grants Office, 
Centers for Disease Control and Prevention, 2920 Brandywine Road, 
Atlanta, GA 30341-4146, Telephone number: (770) 488-2738, E-mail 
address: [email protected].
    For program technical assistance, contact: Gregory S. Wallace, 
M.D., Epidemiology and Surveillance Division, National Immunization 
Program, Centers for Disease Control and Prevention, 1600 Clifton Road, 
NE, Mailstop E-61, Atlanta, GA 30333, Telephone number: (404) 639-8715, 
E-mail address: [email protected].

    Dated: April 30, 2003.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-11138 Filed 5-5-03; 8:45 am]
BILLING CODE 4163-18-P