[Federal Register Volume 67, Number 177 (Thursday, September 12, 2002)]
[Notices]
[Pages 57822-57825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03006]


Immunization and Vaccines for Children Grants; Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2003 funds for a grant program for 
Preventive Health Services, Immunization and the Vaccines for Children 
(VFC) program. Both programs address the ``Healthy People 2010'' 
priority area under Immunization and Infectious Diseases.
    The purpose of this grant program is to support efforts to plan, 
develop, and maintain a public health infrastructure, which assures an 
effective national immunization system. As a part of this system, the 
purpose of the VFC program is to increase access to vaccines for 
eligible children by supplying Federal government-purchased pediatric 
vaccines to public and private health care providers registered with 
the program. Eligible children include newborns through those 18 years 
of age who are Medicaid-eligible, not insured, American Indian/Alaska 
Natives, and children not insured with respect to the vaccine who are 
served by a Federally-Qualified Health Center or a Rural Health Clinic.
    Measurable outcomes of the program will be in alignment with one or 
more of the following performance goals for the National Immunization 
Program:
    1. Reduce the number of indigenous cases of vaccine-preventable 
diseases.
    2. Ensure that two year-olds are appropriately vaccinated.
    3. Improve vaccine safety surveillance.
    4. Increase routine vaccination coverage levels for adolescents.
    5. Increase the proportion of adults who are vaccinated annually 
against influenza and who have ever been vaccinated against 
pneumococcal diseases.

B. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 317 of the Public Health 
Service Act, [42 U.S.C. 247b], as amended. The Catalog of Federal 
Domestic Assistance number is 93.268. The VFC Program is authorized 
under Section 1902(a)(62), of the Social Security Act, 42 U.S.C. 
section 1396a(a)(62). The VFC Program was established under the 
authority of Section 1928(a) of the Social Security Act, 42 U.S.C. 
1396s)(a).

C. Eligible Applicants

Limited Competition

    Assistance will be provided only to the 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, the Federated 
States of Micronesia, the Republic of the Marshall Islands, and the 
Republic of Palau. In consultation with States, assistance may be 
provided to political subdivisions of States. The Federated States of 
Micronesia, the Republic of Palau and the Republic of the Marshall 
Islands are not eligible for funding through the VFC Program. 
Competition is limited to these entities because they have the primary 
responsibility for carrying out the public health assurance functions 
required to achieve the desired outcomes and performance goals 
established by CDC.

    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. Funds

Availability of Funds

Section 317
    Approximately $180,000,000 in Section 317 funds is available in FY 
2003 to fund 64 awards for program operations. It is expected that the 
average Section 317 award for program operations will be $2.8 million, 
ranging from $62,000 to $16,000,000.
    In addition, approximately $208,000,000 in Section 317 funds is 
available in FY 2003 to fund 64 Section 317 awards for vaccine 
purchases. It is expected that the average Section 317 award for 
vaccine purchase will be $3,250,000, ranging from $6,000 to 
$25,000,000.
VFC
    Approximately $65,000,000 in VFC funds is available in FY 2003 to 
fund 61 awards for program operations. It is expected that the average 
VFC award for program operations will be $1,000,000, ranging from 
$99,000 to $7,000,000.
    In addition, approximately $704,000,000 in VFC funds is available 
in FY 2003 to fund 61 VFC awards for vaccine purchase. It is expected 
that the average VFC award for vaccine purchase will be $11,555,000, 
ranging from $298,000 to $121,000,000.
    All applicants eligible for VFC funding are expected to apply for 
both Section 317 and VFC funds.
    It is expected that the awards will begin on or about January 1, 
2003 and will be made for a 12-month budget period within a project 
period of up to five years. Funding estimates may change. All awards 
are subject to availability of funds.
    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.

Direct Assistance

    You may request Federal personnel and vaccines for which CDC has 
established purchase contracts as Direct Assistance (DA) in lieu of a 
portion of financial assistance. Grantees may also access Federal 
contracts for equipment, supplies, and services needed for immunization 
registry development by requesting these costs as DA.

Use of Funds

    Funding requests not directly related to immunization activities 
are outside the scope of these grant programs and will not be funded.
    Immunization grant funds are intended to supplement and may not be 
used to supplant state and local resources.
    Grant funds awarded for vaccine may be used only for purchasing 
vaccines. Vaccines obtained through the VFC Program may be administered 
only to VFC-eligible persons in risk groups recommended by the Advisory 
Committee on Immunization Practices (ACIP). Vaccines and related 
products acquired with 317 funds [with the exception of Td/DT toxoids 
and hepatitis B immune globulin (HBIG)] are not to be administered to 
persons eligible for the VFC Program. Additional information about 
limitations on the use of VFC funds for program operations is provided 
in the CDC document entitled ``VFC Operations Guide'' which is 
available from CDC upon request. (See section J. Where to Obtain 
Additional Information).
    Based on the availability of appropriated 317 funds, Section 317

[[Page 57823]]

grant funds may also be used to implement programs to ensure 
vaccination of adolescents and adults. Also based upon the availability 
of grant funds, vaccines may be purchased for adults not covered by 
Medicare, including hepatitis B vaccine for persons at high risk, 
influenza vaccine for persons 50 years of age and older, and any other 
vaccines recommended by the ACIP for adults.
    The amount of grant funds used for shipping vaccine to providers 
should be within the per-dose cost standards established by CDC through 
on-going cost studies.
    Grant funds may not be used to purchase or lease vehicles or for 
administrative overhead such as rent and utilities. Costs associated 
with purchasing or leasing vehicles will be denied except in cases 
where the application provides strong evidence of exceptional need 
directly related to the implementation of the program. Requests for 
funds to support administrative overhead covered by the indirect cost 
agreement will also be denied. Applications that include requests for 
funding to support administrative overhead should include a copy of the 
grantee's indirect cost rate agreement.

Recipient Financial Participation

    Documentation of recipient financial participation is required for 
this program in accordance with this Program Announcement. Although CDC 
does not require grantees to match funding for immunization activities, 
CDC wishes to fully document grantee financial participation in 
immunization programs as recommended by the Institute of Medicine 
(``Calling The Shots, Immunization Finance Policies and Practices'', 
National Academy of Sciences, 2000). Therefore, grantees should fully 
and comprehensively document all support by grantee and sub-grantee 
agencies, including in-kind support, for immunization program 
activities and vaccine purchases.

Funding Priority

    As funding levels permit, funds will be awarded for the program 
activities listed in the ``2002 VFC Operations Guide'' and the 
``Immunization Program Operations Manual'' (available from CDC upon 
request: See section J. Where to Obtain Additional Information); 
including screening and referral of children enrolled in the Special 
Supplemental Nutrition Program for Women, Infants and Children (WIC) in 
areas where evidence suggests that WIC enrollees are significantly 
under-immunized.
    Priority will be given to funding activities proven to be effective 
in raising immunization coverage. These activities are described in the 
``Community Guide to Preventive Health Services'' published by CDC and 
available through the following Web site: www.thecommunityguide.org.
    Priority will also be given to funding activities that: (1) 
Identify areas where immunization coverage is low relative to the over-
all population; (2) identify the under-immunized individuals in these 
areas; and (3) implement proven strategies to ensure that these 
individuals are fully vaccinated.

Funding Preferences

    Funding preference will be given to current recipients.

E. Program Requirements

    In conducting activities to achieve the purposes of these programs, 
the recipient will be responsible for the following activities:
1. Program Management
    a.Identify areas where immunization coverage is low and implement 
strategies to ensure that under-immunized individuals in these areas 
are identified and receive ACIP-recommended vaccines.
    b. Build and participate in community-based and program-wide 
coalitions to promote specific activities or projects intended to 
assure immunization of all age groups.
    c. Coordinate educational and other activities with state and local 
WIC programs, to assure that children participating in WIC are screened 
and referred for immunizations using a documented immunization history 
in accordance with policy of the United States Department of 
Agriculture.
    d. Coordinate program planning and implementation with the Indian 
Health Service, Tribal/638 health clinics and other entities that 
provide medical services to Native populations to assure consistent and 
immediate access to all VFC vaccines by American Indian and Alaska 
Native populations.
2. Vaccine Management
    a. Establish a cost-effective system for distributing federally-
purchased vaccine to private and public health care providers.
    b. Estimate 317 and VFC vaccine needs, based on ACIP 
recommendations, populations to be served, anticipated vaccine uptake 
and wastage rates, state/local vaccine supply policies and existing 
vaccine inventories.
    c. Follow a CDC-approved purchasing plan for VFC vaccine to ensure 
that total annual VFC vaccine purchases do not exceed the amount needed 
for VFC eligible children and are consistent with the number of VFC-
eligible children reported to and certified by CDC.
    d. Provide vaccines to VFC enrolled providers in sufficient 
quantities to immunize VFC-eligible children in accordance with ACIP 
resolutions.
    e. Update (annually) and maintain VFC program records on all 
participating providers.
    f. Establish a system to document wasted and unaccounted for 
vaccines purchased with 317 and VFC funds.
    g. Implement a program with immunization providers and vaccine 
depots to minimize and report vaccine wastage.
    h. Submit claims for rebate of excise tax for vaccines that cannot 
be administered because of shelf-life expiration or improper storage 
and handling.
    i. Maintain a system for detecting, responding to, and reporting 
suspected cases of fraud and abuse involving Federally-purchased 
vaccine.
3. Immunization Registries
    Develop, update, and/or implement a plan to reach the Healthy 
People 2010 goal of enrolling at least 95 percent of children under six 
years of age in a fully operational registry.
4. Provider Quality Assurance
    a. Work with health insurance companies, managed care organizations 
(MCOs) and the State Medicaid agency to ensure that local health 
departments are appropriately reimbursed for vaccines and vaccine 
administration costs that are covered benefits.
    b. Work with private health care providers to reduce referrals to 
public clinics and remove the barriers to immunization that drain 
limited 317 vaccine resources in public clinics.
    c. Provide educational opportunities for public and private 
providers concerning the standards for pediatric and adult immunization 
practices, reporting of suspected vaccine preventable diseases (VPDs), 
and provider responsibilities under the National Childhood Vaccine 
Injury Act (sections 2125 and 2126 of the Public Health Service Act, 42 
U.S.C. sections 300aa-25 and 300aa-26); including recordkeeping, 
reporting and use of Vaccine Information Statements.
    d. Conduct site visits to VFC provider offices to evaluate vaccine 
management, ensure compliance with VFC program requirements, assess 
immunization

[[Page 57824]]

practices and make recommendations for improvement.
5. Service Delivery
    a. Coordinate with local public health agencies and clinics to make 
immunization services and ACIP-recommended vaccines available for 
underserved populations of all age groups in every county and major 
city.
    b. Enroll health care providers who serve children into the VFC 
program in accordance with Section 1902(a)(62), of the Social Security 
Act and Section 1928 (42 U.S.C. 1396s) (a) of the Social Security Act.
    c. Assess completeness of prenatal hepatitis B surface antigen 
(HbsAg) screening and appropriate vaccination of infants at high risk 
of perinatally-acquired hepatitis B infection.
    d. Conduct and coordinate case management of infants at high risk 
of perinatally-acquired hepatitis B infection to ensure completion of 
the hepatitis B vaccination series.
    e. Work with child care facilities, schools, state, and local 
agencies, to identify and provide appropriate vaccinations to under-
immunized infants and children entering day care and school.
6. Consumer Information
    a. Undertake appropriate efforts to inform, influence, and motivate 
the public about the importance and safety of immunizations.
    b. Distribute Vaccine Information Statements (VIS) and CDC's 
instructions for their use to ensure proper use of VIS in accordance 
with the National Childhood Vaccine Injury Act (section 2126 of the 
Public Health Service Act, 42 U.S.C. 300aa-26.
7. Surveillance
    a. Investigate and document suspected VPD cases in accordance with 
CDC's ``Manual for Surveillance of Vaccine Preventable Diseases''.
    b. Submit timely case reports to CDC on cases of VPD designated as 
reportable by the Council of State and Territorial Epidemiologists.
    c. Coordinate and monitor the Vaccine Adverse Events Surveillance 
System mandated by the National Childhood Vaccine Injury Act of 1986.
    d. Follow up on all reports of serious adverse events (e.g., death, 
life-threatening illness, hospitalization and permanent disability) 
following immunization.
8. Population Assessment
    a. Identify and monitor pockets of under-immunized children and 
adults by using immunization coverage estimates (e.g., cluster surveys, 
immunization registries, Medicare billing data, retrospective analysis 
of school immunization surveys, provider coverage assessments and 
Behavioral Risk Factor Sample Survey).
    b. Estimate immunization coverage and exemption rates among 
children in day care and kindergarten.
    c. Use existing coverage data to monitor and analyze uptake of new 
and recently introduced vaccines.

F. Content

Applications

    The Program Announcement title and number must appear in the 
application. Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out the program 
plan. The narrative should be no more than 80 pages, double-spaced, 
printed on one side, with one-inch margins, and 12 point Courier font.
    The application should consist of, at minimum, a description of 
Program Need, Objectives, Methods, Evaluation, Budget, Budget 
Justification, Applicant Resources, and Management Plan. All 
applications must clearly differentiate 317 and VFC funding streams to 
enable CDC and grantee financial offices to track these funds 
separately. CDC will provide instructions and a budget template for 
this purpose in a Grant Guidance document. Requests for VFC funds must 
be justified based on the number and proportion of the population 
eligible for VFC vaccines.
Direct Assistance
    To request new direct-assistance assignees, include:
    a. Number of assignees requested.
    b. Description of the position and proposed duties.
    c. Ability or inability to hire locally with financial assistance.
    d. Justification for request.
    e. Organizational chart and name of intended supervisor.
    f. Opportunities for training, education, and work experiences for 
assignees.
    g. Description of assignee's access to computer equipment for 
communication with CDC (e.g., personal computer at home, personal 
computer at workstation, shared computer at workstation on site, shared 
computer at a central office).

G. Submission and Deadline

    Submit the original and two copies of PHS 5161-1 (OMB Number 0920-
0428). Forms are available at the following internet address: 
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 
at: 770-488-2700. Application forms can be mailed to you.
    The application must be received by 5 p.m. Eastern Time October 28, 
2002. Submit the application to: Technical Information Management-
PA03006, Procurement and Grants Office, Center for Disease Control and 
Prevention, 2920 Brandywine Rd, Room 3000, Atlanta, GA 30341-4146. 
Forms may not be submitted electronically.
    Deadline: Applications shall be considered as meeting the deadline 
if they are received before 5 P.M. Eastern Time on the deadline date. 
Applicants sending applications 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 close due to (1) carrier error, 
when the carrier accepted the package with a guarantee for delivery of 
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.
    Applications which do not meet the above criteria will be returned 
to the applicant. Applicants will be notified of their failure to meet 
the submission requirements.

H. Evaluation Criteria

Application

    Applicants are required to provide Measures of Effectiveness that 
will demonstrate the accomplishment of various identified objectives of 
the grant. Measures of Effectiveness must relate to the performance 
goals as stated in section ``A. Purpose'' of this announcement. They 
should be expressed as: (1) A stated percentage increase in coverage 
for individual vaccines or maintenance of coverage at the national goal 
of 90 percent, and (2) objectives related to specific programmatic 
areas for which a need for additional programmatic emphasis has been 
identified. 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.
    Each application will be evaluated individually against the 
following

[[Page 57825]]

criteria by an independent review group appointed by CDC:
1. Methods (30 points)
    Are the proposed activities and interventions potentially effective 
in directly impacting immunization coverage and disease reduction, 
(especially in under-immunized geographical areas and sub-populations)? 
Is the management plan likely to ensure that grant-funded activities 
will be implemented in a timely fashion?
2. Program Plan (25 points)
    Does the application propose effort for required activities in all 
program components outlined in section ``D. Program Requirements'' and 
for populations of all ages (infants, children, adolescents and 
adults)?
3. Objectives (25 points)
    Does the program objectives focus on specific activities that 
potentially impact program need?
4. Evaluation (20 points)
    Are quantified performance measures that will demonstrate program 
effectiveness as indicated by achievement of program objectives and 
intended outcomes clearly stated?
5. Budget (not scored)
    Are the budget and budget justification thorough in explaining the 
purpose for which each line item is requested, and how the amounts were 
derived? Are the budget items apportioned across the program 
components? Are the 317 and VFC funds clearly differentiated?

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Semiannual progress reports. The progress report will include a 
data element that demonstrates measures of effectiveness. The first 
report will cover the period January 1 to June 30, and the second 
report (which serves as the continuation application) will cover the 
period July 1 to December 30. A copy of the progress report due on July 
30 must be submitted via computer-based systems and formats developed 
by CDC that specify required data elements related to measures of 
effectiveness (the original and two copies are to be mailed).
    2. Ad hoc reports, i.e., VPD case reports and ongoing purchase and 
inventory reports for all vaccines purchased with public funds, via 
forms, templates, and computer-based systems developed by CDC should be 
submitted as information is collected or as requested by CDC.
    3. Financial Status Report, with an attachment that delineates 
separate VFC and 317 expenditures and obligations by object class 
category, no more than 90 days after the end of the budget period.
    4. Final financial and performance report, with an attachment that 
delineates separate VFC and 317 expenditures and obligations by object 
class category, 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.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I in the 
application kit.

AR-1 Human Subjects Requirements
AR-7 Executive Order 12372 Review
AR-8 Public Health System Reporting Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-14 Accounting System Requirements

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: 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 Rd. Room 3000, 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, Room 
3000, Atlanta, GA 30341-4146, Telephone number: (770) 488-2738, E-mail 
address: [email protected].
    For program technical assistance, contact: Glen Koops, Acting 
Chief, Program Operations Branch, ISD, National Immunization Program, 
Mailstop E-52, 1600 Clifton Rd., Atlanta, GA 30333, Telephone number: 
(404) 639-8215, E-mail address: [email protected].

    Dated: September 6, 2002.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 02-23187 Filed 9-11-02; 8:45 am]
BILLING CODE 4163-18-P