[Federal Register Volume 69, Number 71 (Tuesday, April 13, 2004)]
[Notices]
[Pages 19421-19425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8291]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Improving the Quality of Genetic Testing and Assuring Its 
Appropriate Integration Into Clinical and Public Health Practice

    Announcement Type: New.
    Funding Opportunity Number: 04137.
    Catalog of Federal Domestic Assistance Number: 93.064.
    Application Deadline: June 14, 2004.
    Executive Summary: The number of genetic tests available to the 
clinical and public health communities is increasing, as is the number 
of tests being ordered. For many genetic tests, significant concerns 
exist related to test ordering, analytical and clinical validation, 
quality control, result reporting, and use of test results in medical 
decision making. Surveys carried out previously have indicated 
variability and gaps in each of these areas with potentially 
significant implications for the delivery of genetic testing services 
to the public. Initially, to address these issues, the scope of work 
for this project will include a technology and practice assessment 
linked to development of a program to improve one, or more aspects of 
the genetic testing process.
    The goals of this program are (1) to conduct a technology and 
practice assessment within the scope of genetic testing laboratory 
services in the United States that will evaluate elements important for 
assuring the quality, appropriate use, and to what extent an 
understanding of benefits and limitations are applied; (2) to conduct a 
pilot study to test concepts potentially useful for improving the 
quality of the genetic testing process; and (3) to compare relevant 
international activities (those occurring outside the United States) to 
efforts undertaken in this project. The focus will be on one, or more 
health conditions and/or group of technologies that can provide 
insights into a broader spectrum of genetic testing issues. The target 
audiences for the assessment are laboratories performing genetic tests 
and users of genetic laboratory services (i.e. clinical and public 
health practitioners who order and use genetic tests and results). 
Important factors to consider include technologies employed, methods 
used for test validation and quality control, and pre- and post-
analytic factors pertinent to the collection and use of patient/
population-based information and the use of test results for health-
care

[[Page 19422]]

decision-making. This program is also expected to recognize 
international efforts that address similar issues and their potential 
impact on practices within the U.S. As such, a review of relevant 
international efforts will be undertaken as part of this project 
proposed.

I. Funding Opportunity Description

    Authority: This program is authorized under section 317(k)(2) of 
the Public Health Service Act, 42 U.S.C. section 247b(k)(2), as 
amended.

    Purpose: The purpose of the program is to improve the quality of 
laboratory genetic testing practices relevant to clinical and public 
health settings.
    This program will assess current practices and the impact of 
technology on the provision of genetic testing services within the U.S. 
The project will take a quality systems approach in which technical and 
management aspects of each component of the system is recognized as 
contributing to the overall quality of testing and its potential impact 
on clinical and public health decision making. The initial part of this 
project must include a U.S. technology and practice assessment. The 
proposed assessment can be undertaken in several formats. It may be 
general in nature with the intent to capture data covering a broad 
spectrum of topics or focused on a subset of health conditions and/or 
technologies that can serve as models reflective of broader genetic 
testing issues. The assessment will be used to document variability in 
practices and expected to be helpful in identifying opportunities to 
address shortcomings and improve the quality of genetic testing and 
laboratory practices. This assessment should not be duplicative of past 
efforts but build upon them, or be novel in the areas explored and 
approaches taken.
    Conclusions made from the assessment should be relevant to the 
broader community that performs genetic testing or uses genetic test 
results. Relevant issues can include test validation, quality 
assurance, quality control, proficiency testing, and the methods by 
which laboratories communicate with clinical and public health care 
providers, payers, policy makers, and others toward assuring 
appropriate use of their services. As such, it is also important to 
consider both the laboratories and users of their services (i.e. 
clinical/public health professionals) as target populations for the 
assessment and follow up efforts. The latter part of this program 
requires that the applicant propose a study or pilot program to test 
concepts that can potentially improve the quality of laboratory 
practice related to one or more of the issues documented during the 
assessment. Efforts can include developing and evaluating novel quality 
assurance practices, developing educational/training programs to 
improve the knowledge and competencies among laboratory and health care 
professionals (i.e., in the use and communication of genetic tests and 
results), or undertaking studies useful for informing professional 
groups and regulatory bodies toward the development, implementation, 
and evaluation of guidelines, standards, and/or regulatory 
requirements. As a final component to this program, a review of 
international efforts relevant to the work undertaken will be 
performed. The intent for this final requirement is to take a broader 
look at what is happening in other parts of the world relevant to the 
work undertaken in this program and comment upon opportunities that may 
benefit both U.S. practices as well as those in other countries. Less 
guidance is provided in addressing this part of the program since the 
nature of the work will depend on the direction the applicant proposes 
for earlier aims and their connectivity with the international 
community. This program addresses the ``Healthy People 2010'' focus 
area(s) of ``Access to Quality Health Services'' and ``Public Health 
Infrastructure.''
    Measurable outcomes of the program will be in alignment with the 
following performance goals for the Public Health Practice Program 
Office: Increase the number of frontline public health workers at the 
state and local level that are competent and prepared to respond to 
bioterrorism, other infectious disease outbreaks, and other public 
health threats and emergencies and prepare frontline state and local 
health departments and laboratories to respond to current and emergency 
health threats.
    Activities: This project requires several activities be undertaken 
and as such it is vital that the applicant clearly state what is 
intended to be accomplished each year, or part thereof, of the three-
year proposal. Funding for years two and three are dependent on the 
availability of funds and progress made.
    Awardee activities for this program are as follows:
    a. Develop and conduct assessments of laboratory practices which 
gather specific information related to technology assessment, test 
validation, quality assurance practices, personnel competencies, and 
ways in which tests are ordered and results are reported and used for 
medical and public health decision making. The recipient is expected to 
provide an analysis of the data that is potentially broadly applicable 
to genetic testing in clinical and/or public health practice settings.
    b. Conduct a pilot project to test and evaluate a process for 
improving the quality of laboratory testing that is based upon findings 
from the assessment described above.
    c. Where appropriate, educational efforts should be conducted for 
laboratory staff and/or health care professionals as a component of the 
research or pilot project proposed. An evaluation of the educational 
activity should be undertaken to assess its usefulness and broader 
applicability. Particular emphasis should be placed upon the clinical/
laboratory interface and/or public health laboratory setting.
    d. Develop and implement a comparative analysis between U.S. and 
non-U.S. practices and policies relevant to the project proposed.
    e. Convene advisory group(s) (comprised of knowledgeable and 
experienced persons), as appropriate, to develop recommendations useful 
for carrying out the work proposed.
    In a cooperative agreement, CDC staff is substantially involved in 
the program activities, above and beyond routine grant monitoring.
    CDC Activities for this program are as follows:
    a. Serve in an advisory capacity to the awardee in the development 
of data collection instruments and not otherwise be involved in the 
collection, use, or ownership of the data.
    b. Assist in collaborating with other organizations, government 
entities, CDC staff, and others in carrying out program activities.
    c. Assist in preparing training and education programs.
    d. Assist forming expert focus groups, which may be composed of 
national and international experts, to develop strategies and 
recommendations.

II. Award Information

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities Section 
above.
    Fiscal Year Funds: 2004.
    Approximate Total Funding: $225,000.
    Approximate Number of Awards: One.
    Approximate Average Award: $225,000 (This amount is for the first 
12-month budget period, and includes both direct and indirect costs).
    Floor of Award Range: None.
    Ceiling of Award Range: $225,000 (This ceiling is for the first 12-
month budget period.)

[[Page 19423]]

    Anticipated Award Date: September 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: Three years.
    Throughout the project period, CDC's commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal Government.

III. Eligibility Information

III.1. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies, such as:

     Public nonprofit organizations.
     Private nonprofit organizations.
     Universities.
     Colleges.
     Research institutions.
     Hospitals.
     Community-based organizations.
     State and local governments or their Bona Fide 
Agents (this includes the District of Columbia, the Commonwealth of 
Puerto Rico, the Virgin Islands, the Commonwealth of the Northern 
Marianna Islands, American Samoa, Guam, the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau).

    A Bona Fide Agent is an agency/organization identified by the state 
as eligible to submit an application under the state eligibility in 
lieu of a state application. If you are applying as a bona fide agent 
of a state or local government, you must provide a letter from the 
state or local government as documentation of your status. Place this 
documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    If you request a funding amount greater than the ceiling of the 
award range, your application will be considered non-responsive, and 
will not be entered into the review process. You will be notified that 
your application did not meet the submission requirements.


    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.

IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity use application form PHS 
5161. Application forms and instructions are available on the CDC Web 
site, 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) staff at: 770-488-2700. Application forms can be mailed to 
you.

IV.2. Content and Form of Submission

    Application: You must submit a project narrative with your 
application forms. The narrative must be submitted in the following 
format:
     Maximum number of pages: 25.
     If your narrative exceeds the page limit, only 
the first pages, which are within the page limit, will be reviewed.
     Font size: 12 point unreduced.
     Paper size: 8.5 by 11 inches.
     Page margin size: One inch.
     Printed only on one side of page.
     Held together only by rubber bands or metal 
clips; not bound in any other way.
     Single spaced.
    Your narrative should address activities to be conducted over the 
entire project period, and must include the following items in the 
order listed:
    The narrative should consist of goals and objectives, methods and 
technical approach, project management and staffing, evaluation plan, 
and proposed budget for carrying out the recipient activities 
consistent with the evaluation criteria listed section ``H''. The 
budget justification will be counted in the stated page limit. 
Additional information may be included in the application appendices. 
The appendices will not be counted toward the narrative page limit. 
This additional information includes:

 Curriculum Vitaes
 Letters of Support

    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. The DUNS number is a nine-digit 
identification number, which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge. To obtain a 
DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-
5711.
    For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
    If your application form does not have a DUNS number field, please 
write your DUNS number at the top of the first page of your 
application, and/or include your DUNS number in your application cover 
letter.
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

    Application Deadline Date: June 14, 2004.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office by 4 p.m. Eastern Time on the deadline 
date. If you send your application by the United States Postal Service 
or commercial delivery service, you must ensure that the carrier will 
be able to guarantee delivery of the application by the closing date 
and time. If CDC receives your application 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, you will be given the opportunity to 
submit documentation of the carriers guarantee. If the documentation 
verifies a carrier problem, CDC will consider the application as having 
been received by the deadline.
    This announcement is the definitive guide on application submission 
address and deadline. It supersedes information provided in the 
application instructions. If your application does not meet the 
deadline above, it will not be eligible for review, and will be 
discarded. You will be notified that your application did not meet the 
submission requirements.
    CDC will not notify you upon receipt of your application. If you 
have a question about the receipt of your application, first contact 
your courier. If you still have a question, contact the PGO-TIM staff 
at: 770-488-2700. Before calling, please wait two to three days after 
the application deadline. This will allow time for applications to be 
processed and logged.

IV.4. Intergovernmental Review of Applications

    Executive Order 12372 does apply to this program.

[[Page 19424]]

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:

 None.

    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement should be less than 12 
months of age.
    Awards will not allow reimbursement of pre-award costs.
    Guidance for completing your budget can be found on the CDC Web 
site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

IV.6. Other Submission Requirements

    Application Submission Address: Submit the original and two hard 
copies of your application by mail or express delivery service to: 
Technical Information Management-PA 04137, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    You 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 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.
    Your application will be evaluated against the following criteria:
1. Methods and Technical Approach (30 points)
    a. Does applicant clearly and succinctly describe the steps to be 
taken in the planning and implementation of the proposed cooperative 
agreement?
    b. Are the methods used to carry out the responsibilities of the 
proposed cooperative agreement must be feasible and explained in 
sufficient detail?
2. Project Management and Staffing (30 points)
    a. Does the applicant describe a project management and staffing 
plan, and must demonstrate sufficient knowledge, expertise, and other 
resources required to perform the responsibilities in this project?
    b. Does the applicant describe the staff qualifications and time 
allocations of key personnel to be assigned to this project, facilities 
and equipment, and other resources available for performance of this 
project?
3. Goals and Objectives (20 points)
    a. Does the applicant clearly describe an understanding of the 
objectives of this project and the relevance of the proposal to the 
stated objectives?
    b. Are the goals and objectives measurable, specific, and 
achievable?
4. Evaluation Plan (20 points)
    Does the applicant describe the schedule for accomplishing the 
activities to be carried out in this project and methods for evaluating 
the accomplishments?
5. Budget (Reviewed, but not Scored)
    The proposed budget must be reasonable, clearly justified, and 
consistent with the intended use of funds.
6. Performance Measures (Reviewed, but not Scored)
    The application should be consistent with the Government 
Performance and Results Act of 1993.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) staff, and for responsiveness by the PHPPO. 
Incomplete applications and applications that are non-responsive to the 
eligibility criteria will not advance through the review process. 
Applicants will be notified that their application did not meet 
submission requirements.
    An objective review panel will evaluate complete and responsive 
applications according to the criteria listed in the ``V.1. Criteria'' 
section above.
    In addition, the following factors may affect the funding decision:
    Preference may be given to organizations that routinely provide 
and/or utilize clinical or public health genetic testing laboratory 
services. Preference may also be given to organizations that have 
contributed to the development, or use of quality assurance programs 
for genetic testing, have engaged in research or assessment of new 
technologies and their implications for clinical and public health 
practice, have participated in activities relevant to the translation 
of research findings to clinical and public health applications, and/or 
participated in efforts to develop domestic and international genetic 
testing policies. Preferences may be given to organizations that have 
expertise in heritable human conditions of public health significance 
that can be applied to the efforts described in this program 
announcement in such a way that results will be broadly applicable to 
other areas of genetic testing. Lastly, preferences will be given to 
applications demonstrating collaboration among clinical and public 
health entities in developing and carrying out the work proposed. 
Entities can include clinical and public health academic departments, 
state and local public health organizations, professional organizations 
that focus on clinical and/or public health issues, and other such 
groups.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA) 
from the CDC Procurement and Grants Office. The NGA shall be the only 
binding, authorizing document between the recipient and CDC. The NGA 
will be signed by an authorized Grants Management Officer, and mailed 
to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:
     AR-10 Smoke-Free Workplace Requirements
     AR-11 Healthy People 2010
     AR-12 Lobbying Restrictions
     AR-15 Proof of Non-Profit Status
    Additional information on these requirements can be found on the 
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting Requirements

    You must provide CDC with an original, plus two hard copies of the 
following reports:
    1. Interim progress report, no less than 90 days before the end of 
the budget period. The progress report will serve as your non-competing 
continuation application, and must contain the following elements:

[[Page 19425]]

    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Additional Requested Information.
    f. Measures of Effectiveness.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    These reports must be mailed to the Grants Management or Contract 
Specialist listed in the ``Agency Contacts'' section of this 
announcement.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
    For program technical assistance, contact: Ira Lubin, Ph.D., 
Centers for Disease Control and Prevention, PHPPO, DLS, 4770 Buford 
HWY, MSG23, Telephone: 770-488-8070, Fax: 770-488-8278, E-mail: 
[email protected].
    For financial, grants management, or budget assistance, contact: 
Sharon Robertson, Grants Management Specialist, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-
488-2748, E-mail: [email protected].

VIII. Other Information

    For information about the Centers for Disease Control and 
Prevention see http://wwww.cdc.gov.
    For information about the genetic activities within the Division 
sponsoring this cooperative agreement, see http://www.phppo.cdc.gov/dls/genetics/default.asp.

    Dated: April 7, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-8291 Filed 4-12-04; 8:45 am]
BILLING CODE 4163-18-P