[Federal Register Volume 68, Number 112 (Wednesday, June 11, 2003)]
[Notices]
[Pages 34972-34976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-14671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03121]


Standards Development and Maintenance for Cancer Surveillance; 
Notice of Availability of Funds

A. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301 and 317(k)(2) of the 
Public Health Service (PHS) Act, (42 U.S.C. sections 241 and 
247b(k)(2)), as amended. The Catalog of Federal Domestic Assistance 
number is 93.283.

B. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2003 funds for a cooperative agreement 
program for Standards Development and Maintenance for Cancer 
Surveillance. This program addresses the ``Healthy People 2010'' focus 
area of Cancer.
    This program will promote the development and maintenance of 
standards, which can be utilized by the National Program of Cancer 
Registries (NPCR) network of hospitals, free-standing pathology 
laboratories, central

[[Page 34973]]

cancer registries, and software developers, to collect, edit, and 
transmit data.
    This program consists of 2 parts:
    Part I--Standard-setting activities related to the operation of 
population-based cancer registries.
    The purpose of Part I is to support efforts to improve the quality 
of population-based central cancer registry data and operations through 
data item and transmittal standards, to facilitate coordination and 
communication from health care facilities to (and among) central cancer 
registries, and to promote the use of cancer incidence data for cancer 
control such as health care interventions planning, resource 
allocation, program evaluation, and research.
    Part II--Standardized reporting and Encoding of surgical pathology 
reports.
    The purpose of Part II is to support and promote the development of 
a controlled medical vocabulary for: encoding pathology data elements, 
indexing the entire medical vocabulary, and establishing guidelines for 
standardizing the reporting of surgical specimens.
    This program announcement addresses the National Center for Chronic 
Disease Prevention and Health Promotion performance goal to improve the 
quality of state-based cancer registries.

C. Eligible Applicants

    Part I--Eligible applicants for Part I are non-profit, non-
governmental organizations with a nationwide organizational 
infrastructure and the capacity to bring together cancer registry 
standard-setting organizations, central cancer registries, hospital 
cancer registries, and software developers in order to attain consensus 
on data item definitions, codes, format, transmission record layouts, 
and time line for implementation of new standards.
    Applicants ideally should have local, state, or regional 
constituencies representing all states and territories, but at minimum 
representing 25 states/territories.
    Part 2--Eligible applicants for Part 2 are non-profit, non-
governmental organizations with a nationwide organizational 
infrastructure and the capacity to develop standardized medical 
vocabularies and structures for encoding the content of pathology 
reports; to obtain consensus from the clinical and anatomic pathology 
community; and to provide education and technical assistance to promote 
and encourage consistent pathology reporting throughout the United 
States.
    Applicants ideally should have local, state, or regional 
constituencies representing all states and territories, but at minimum 
representing 25 states/territories.

D. Funding

Availability of Funds

    Approximately $900,000 is available in FY 2003 to fund the 
following categories:
    Part I--Standard-setting activities related to the operation of 
population-based cancer registries: Approximately $600,000 is available 
in FY 2003 to fund a single award.
    Part II--Standardized reporting and encoding of surgical pathology 
reports: Approximately $300,000 is available in FY 2003 to fund a 
single award.
    Applicants may apply for Part I, Part II, or both based on 
eligibility. It is expected that awards will begin on or about 
September 15, 2003 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, 
program progress, and the availability of funds.

Recipient Financial Participation

    Matching funds are not required.

E. Program Requirements

    In conducting activities to achieve the purposes of Parts I and/or 
II, 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
Part I
    a. Develop and provide infrastructure and management to address 
cancer registration issues including standards for completeness, 
timeliness, and quality (CTQ) for central cancer registries in the 
collection and processing of cancer incidence data. Performance will be 
measured by the extent to which the applicant develops, maintains, and 
promotes such standards.
    b. Develop and provide infrastructure for the development of 
educational materials, guidance, and forums that promote the use of 
cancer registry data for the purposes of cancer control and prevention. 
Performance will be measured by the extent to which the applicant 
participates in or develops forums to either gain information or to 
educate constituents in cancer registry data use.
    c. Coordinate and facilitate regional and national meetings of 
central cancer registry staff and related partners for consensus 
building, model development, and guidance development in the areas of 
central cancer registry operations, standard data item definitions, 
formats for the electronic transmittal of data, use of mortality data, 
cancer incidence and mortality rates, and mechanisms to share cancer 
reports with the community.
    Performance will be measured by the extent to which the applicant 
participates in or coordinates such regional and national meetings to 
gain information; facilitate consensus; develop models and guidance; 
and to educate constituents in the accomplishment of program goals and 
objectives.
    d. Participate in CDC-sponsored meetings and events. Performance 
will be measured by the extent to which the applicant attends and 
participates in NPCR-CDC conferences.
    e. Participate in a post-award meeting (to occur no later than 45 
days after the notice of award) to share information, clarify 
expectations, and establish regular conference call and face-to-face 
meetings (to occur at a minimum of every two months) to discuss issues 
and report progress.
Part II
    a. Facilitate and promote the development, enhancement, and use of 
a controlled medical vocabulary to allow the encoding of information in 
a pathology report, typically a key component of a cancer patient's 
medical record, from a synoptic checklist as opposed to the traditional 
narrative-style report. Performance will be measured by the extent to 
which the applicant develops, enhances, and promotes the use of 
controlled medical vocabulary and site-specific synoptic checklists.
    b. Monitor and evaluate the use of vocabulary among pathologists, 
registries, and pathology laboratory software vendors to identify 
inconsistent uses and new pathological trends in order to adjust and 
update the controlled medical vocabulary. Performance will be measured 
by the extent to which the applicant identifies inconsistencies and new 
trends and updates the controlled medical vocabularies.
    c. Work to enhance the ability to reflect cancer protocols, as 
identified by committees of pathologists representing the United 
States, in the controlled medical vocabularies and the site-specific 
synoptic checklist. Performance

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will be measured by the extent to which the applicant's controlled 
medical vocabularies and site-specific synoptic checklist reflect 
nationally recognized cancer protocols.
    d. Identify, attend, and facilitate educational meetings and 
provide technical assistance to promote the use of controlled medical 
vocabularies and site-specific synoptic checklists in the pathologist 
community. Performance will be measured by the extent to which the 
applicant attends and facilitates educational meetings and provides 
technical assistance to promote the use of controlled medical 
vocabularies and site-specific synoptic checklists.
    e. Participate in CDC-sponsored meetings and events. Performance 
will be measured by the extent to which the applicant attends and 
participates in NPCR-CDC conferences.
    f. Participate in a post-award meeting (to occur no later than 45 
days after the notice of award) to share information, clarify 
expectations, and establish regular conference call and face-to-face 
meetings (to occur at a minimum of every two months) to discuss issues 
and report progress.
2. CDC Activities
Part I
    a. Participate in a post-award meeting (to occur no later than 45 
days after the notice of award) to share information, clarify 
expectations, and establish regular conference calls and face-to-face 
meetings (to occur at a minimum of every two months) to discuss issues 
and report progress.
    b. Enhance standards for completeness, timeliness, and quality 
(CTQ) for central cancer registries in the collection and process of 
cancer incidence data to ensure that CDC funded cancer registries 
continue to meet program standards.
    c. Develop educational materials that promote the use of cancer 
registry data for the purposes of cancer control and prevention to 
ensure that CDC funded cancer registries continue to meet program 
standards.
    d. Attend and participate in regional and national meetings of 
central cancer registry staff and related partners for consensus 
building, model development, and guidance development.
    e. Monitor attendance of applicant at NPCR-CDC meetings and events.
Part II
    a. Participate in a post-award meeting to share information, 
clarify expectations, and establish routine meetings to discuss issues 
and report progress.
    b. Develop controlled medical vocabulary and site-specific synoptic 
checklists to promote the use of electronic data submissions from 
pathology laboratories to CDC funded cancer registries.
    c. Monitor the development, publication, and use of controlled 
medical vocabulary and site-specific synoptic checklists to promote the 
use of electronic data submissions from pathology laboratories to CDC 
funded cancer registries.
    d. Monitor and attend educational conferences and meetings where 
controlled medical vocabularies and site-specific synoptic checklists 
are promoted.

F. Content

Letter of Intent (LOI)

    A LOI is requested from potential applicants. The non-binding LOI 
will be used to determine the level of interest for this program 
announcement. The narrative should be no more than two, single-spaced 
pages, printed on one side, with one-inch margins, and unreduced 12-
point font. Your letter should include the following information: 
Program announcement number, name of the principal investigator, and 
specifically which Part(s) the applicant plans to apply for.

Pre-Application Conference Call

    A Pre-application conference call is scheduled for [Fill in after 
HHS review]. Eligible applicants are invited to participate in this 
conference call. The purpose of the conference call will be to 
communicate the specifics of the application process and to respond to 
any questions applicants may have regarding this announcement. 
Participation in this conference call is optional. A summary of the 
questions and answers will be made available for those unable to 
participate. Information for this conference call will be sent to all 
eligible applicants that have submitted an LOI by [Fill in after HHS 
review].

Applications

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections for Parts I-II to 
develop the application content. Your application will be evaluated on 
the criteria listed, so it is important to follow them in laying out 
your program plan. The narrative for Part I and Part II should be no 
more than 30 double-spaced pages, printed on one side, with one inch 
margins, and unreduced 12-point font. The original and each copy of the 
application must be submitted unstapled and unbound. Pages should be 
clearly numbered and a complete index to the application and any 
appendices should be included.
    Applicants may apply for support under one or both of the Parts. 
Only one application should be submitted. For each Part applied for, 
include a separate and complete narrative, a separate budget, and a 
separate budget justification that can stand alone as an application 
for review purposes.
    Include funding for staff for Parts I and II to attend the 
following meetings: (1) A 1-day, post-award meeting in Atlanta; and (2) 
an additional 2-day meeting in a city to be determined later.
    The narrative should consist of, at a minimum, a Plan, Objectives, 
Methods, Evaluation and Budget. The program Plan should address 
activities to be conducted over the entire five-year project period.

G. Submission and Deadline

Letter of Intent (LOI) Submission

    On or before June 25, 2003, submit the LOI to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.

Application Form

    Submit the signed original and two copies of PHS 5161 (OMB 0348-
0043). 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 July 28, 
2003. Submit the application to: Technical Information Management--
PA03121, CDC Procurement and Grants Office, 2920 Brandywine 
Road, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.

CDC Acknowledgment 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.

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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 date 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

Application

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified objective 
of the cooperative agreement. Measures of effectiveness must relate to 
the performance goals stated in the purpose section of this 
announcement. Measures must be objective and quantitative and must 
measure the intended outcome. These measures of effectiveness must be 
submitted with the application and will be an element of evaluation.
    An independent review group appointed by CDC will evaluate each 
application individually against the following criteria.
    Specific evaluation criteria for each part are as follows:
Part I--Evaluation Criteria
    1. Methods (31 points total)--
    a. The extent to which the applicant adequately describes the 
methods that will be used to accomplish the objectives of the project. 
(20 points)
    b. The extent to which the timetable incorporates project 
activities and milestones and is specific, measurable and realistic (11 
points)
    2. Program Need (24 points total)--
    a. The extent to which the applicant demonstrates the ability to 
provide infrastructure and management to address cancer registration 
issues including standards for completeness, timeliness, and quality 
for cancer incidence data. (6 points)
    b. The extent to which the applicant demonstrates the ability to 
participate in activities that promote States' accessibility and use of 
cancer registry data for cancer control activities. (6 points)
    c. The extent to which the applicant demonstrates the ability to 
convene regional and national meetings of central cancer registry staff 
and partner organizations for consensus building, model development, 
and guidance development in the areas of central cancer registry 
operations, standard data item definitions, formats for the electronic 
transmittal of data, use of mortality data, cancer incidence and 
mortality rates, and mechanism to share cancer reports with the 
community. ( 6 points)
    d. The extent to which the applicant demonstrates the ability to 
participate in NPCR-CDC sponsored meetings and events. (6 points)
    3. Objectives (20 points)--The extent to which the applicant 
demonstrates that the proposed program objectives are measurable, 
specific, time-phased, and related to the recipient activities, program 
purpose, and program need.
    4. Evaluation (15 points)--The extent to which the applicant 
describes adequate plans for providing on-going communication including 
feedback and quality control suggestions for improvement and 
implementation of project objectives.
    5. Program Management and Staffing Plan (10 points)--The extent to 
which proposed staffing and management is adequate as defined by:
    a. Job descriptions for existing and proposed positions.
    b. Descriptions of background, experience and qualification for the 
proposed responsibilities; education, experience and licensure 
requirements, and curriculum vitae for each staff member.
    c. An organizational chart that identifies lines of communication, 
accountability and reporting authority.
    6. Human Subjects (not scored)--Does the application adequately 
address the requirements of Title 45 CFR part 46 for the protection of 
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.
    7. Requirements concerning the inclusion of women, racial, and 
ethnic groups (not scored)--Does the application adequately address the 
CDC Policy requirements regarding the inclusion of women, ethnic, and 
racial groups in the proposed research. This includes:
    1. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    2. The proposed justification when representation is limited or 
absent.
    3. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    4. A statement as to whether the plans for recruitment and outreach 
for study participants include the process of establishing partnerships 
with community (ies) and recognition of mutual benefits.
    8. Budget (not scored)--The extent to which the budget is 
reasonable, clearly justified, consistent with the demonstrated need 
and proposed activities, and likely to lead to program success.
Part II--Evaluation Criteria
    1. Methods (31 points total)--
    a. The extent to which the applicant adequately describes the 
methods that will be used to accomplish the objectives of the project. 
(20 points)
    b. The extent to which the timetable incorporates project 
activities and milestones and is specific, measurable, and realistic. 
(11 points)
    2. Program Need (24 points total)--
    a. The extent to which the applicant demonstrates an ability to 
facilitate and foster development, revision, and enhancement of 
controlled medical vocabulary to encode the information in a pathology 
checklist report, which constitutes an essential part of a cancer 
patient's medical record. (6 points)
    b. The extent to which the applicant describes a need to monitor 
the use of the vocabulary by clinical groups members, pathology 
laboratories, registries, and laboratory information system vendors to 
detect problems and address needs in implementation of a medical 
vocabulary. (6 points)
    c. The extent to which the applicant describes a need to facilitate 
and foster the development, revision, and enhancement of cancer 
protocols by pathology laboratories, including automation of data 
entry, coding, and storage. (6 points)
    d. The need to target appropriate educational and technical 
assistance interventions and workshops that would increase the use of 
encoded pathology reports and other data, including standardized 
reports that use cancer protocols. (6 points)
    3. Objectives (20 points)--The extent to which the applicant 
demonstrates that the proposed program objectives are measurable, 
specific, time-phased, and related to the recipient activities, program 
purpose, and program need.
    4. Evaluation (15 points)--The extent to which the applicant 
describes adequate plans for providing on-going communication including 
feedback and quality control suggestions for

[[Page 34976]]

improvement and implementation of project objectives.
    5. Project Management and Staffing Plan (10 points)--The extent to 
which proposed staffing and management is adequate as defined by:
    a. Job descriptions for existing and proposed positions.
    b. Descriptions of background, experience and qualification for the 
proposed responsibilities; education, experience and licensure 
requirements, and curriculum vita for each staff member.
    c. An organizational chart that identifies lines of communication, 
accountability, and reporting authority.
    6. Human Subjects (not scored)--Does the application adequately 
address the requirements of Title 45 CFR part 46 for the protection of 
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.)
    7. Requirements concerning the inclusion of women, racial, and 
ethnic groups (not scored)--Does the application adequately address the 
CDC Policy requirements regarding the inclusion of women, ethnic, and 
racial groups in the proposed research. This includes:
    1. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    2. The proposed justification when representation is limited or 
absent.
    3. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    4. A statement as to whether the plans for recruitment and outreach 
for study participants include the process of establishing partnerships 
with community (ies) and recognition of mutual benefits.
    8. Budget (not scored)--The extent to which the budget is 
reasonable, clearly justified, consistent with the demonstrated need 
and proposed activities, and likely to lead to program success.

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. An interim progress report. The interim progress report will be 
due on the 15th of March each year through 2008. This interim progress 
report will serve as your non-competing continuation application. A 
second report is due 90 days after the end of each budget period. These 
reports must include the following elements:
    a. A succinct description of the program accomplishments and 
progress made in meeting each Current Budget Period Activities 
Objectives during the previous six months of the budget period.
    b. A succinct description of the program accomplishments/narrative 
and progress made in meeting each Current Budget Period Activities 
Objectives during the previous six months of the budget period.
    c. The reason(s) for not meeting established program objectives and 
strategies to be implemented to achieve unmet objectives.
    d. Current Budget Period Financial Progress.
    e. New Budget Period Proposed Activities and Objectives.
    f. Detailed Line-Item Budget and Justification.
    g. For all proposed contracts, provide the name of contractor, 
method of selection, period of performance, scope of work, and itemized 
budget and budget justification. If the information is not available, 
please indicate ``To Be Determined'' until the information becomes 
available; it should be submitted to CDC Procurement and Grants 
Management Office contact identified in this program announcement.
    2. Financial status report, no more than 90 days after the end of 
the budget period. The financial status report should include an 
attachment that identifies unspent balances for each program component.
    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.

Additional Requirements

    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
announcement.

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-8 Public Health System Reporting Requirements
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-22 Research Integrity

J. Where To Obtain Additional Information

    This and other CDC announcements 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.
    To obtain business management and budget assistance, contact:
    Glynnis Taylor, Grants Management Specialist, Centers for Disease 
Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, 
Telephone number: (770) 488-2752, E-mail address: [email protected].
    For business management and budget assistance in the territories, 
contact:
    Charlotte Flitcraft, Centers for Disease Control and Prevention, 
2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone number: (770) 
488-2632, E-mail address: [email protected].
    For program technical assistance, contact:
Part I
    Faye Floyd, Cancer Surveillance Branch, Division of Cancer 
Prevention and Control, National Center for Chronic Disease Prevention, 
and Health Promotion, Centers for Disease Control and Prevention, 4770 
Buford Hwy., NE, MS-K53, Atlanta, GA 30341-3717, Telephone number: 
(770) 488-4518, E-mail address: [email protected].
Part II
    Ken Gerlach, Cancer Surveillance Branch, Division of Cancer 
Prevention and Control, National Center for Chronic Disease Prevention 
and Health Promotion, Centers for Disease Control and Prevention, 4770 
Buford Hwy., NE, MS-K53, Atlanta, GA 30341-3717, Telephone number: 
(770) 488-3008, E-mail address: [email protected].

    Dated: June 3, 2003.
Sandra Manning,
Director, Procurement and Grants Office, Center for Disease Control and 
Prevention.
[FR Doc. 03-14671 Filed 6-10-03; 8:45 am]
BILLING CODE 4163-18-P