[Federal Register Volume 69, Number 121 (Thursday, June 24, 2004)]
[Notices]
[Pages 35351-35356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14311]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Early Screening and Diagnosis of Duchenne Muscular Dystrophy

    Announcement Type: New.
    Funding Opportunity Number: PA 04216.
    Catalog of Federal Domestic Assistance Number: 93.283.
    Dates: Letter of Intent Deadline: July 14, 2004.
    Application Deadline: August 9, 2004.

I. Funding Opportunity Description

    Authority: This program is authorized under Sections 317 (k)(2)(42 
U.S.C. section 247b(k)(2)) and sections 311 and 317(C) of the Public 
Health Service Act [42 U.S.C. 241, 243, and 247b-4 as amended].
    Purpose and Research Objectives: The purpose of the program is to 
develop, implement and evaluate creatine kinase-based screening 
programs for the early detection of Duchenne Muscular Dystrophy (DMD) 
during the newborn period (part A) and during infancy (part B). This 
program addresses the ``Healthy People 2010'' focus area of Disability 
and Secondary Conditions. Measurable outcomes of the program will be in 
alignment with the following performance goal for the National Center 
on Birth Defects and Developmental Disabilities: To improve the health 
and quality of life of Americans with disabilities.
    DMD is the most common form of muscular dystrophy in children. It 
causes progressive muscle deterioration, leading to the inability to 
walk around the age of 12 years, and death in the teens or early 20s, 
most commonly due to severe respiratory or heart problems, or both. The 
gene for DMD is on the X chromosome so DMD affects males almost 
exclusively. In the absence of newborn screening, DMD is usually 
diagnosed when a child is three to six years of age. DMD does not meet 
the traditional criteria for inclusion in routine newborn screening 
panels in the United States, because there is insufficient evidence 
that early detection and intervention leads to an improved medical 
outcome for children with DMD. However, an earlier age of diagnosis has 
potential non-medical benefits to the family, including knowledge of 
recurrence risk, avoidance of a long diagnostic process, and more time 
for financial and other planning related to raising a child with a 
disabling condition. In addition, earlier age at diagnosis will offer 
more opportunity to study the potential medical benefits of earlier 
treatments. In several countries, families are offered newborn 
screening for DMD based on creatine kinase activity in dried 
bloodspots.
    Two approaches to screening have been employed; screening after 
birth and screening at 6-12 months of age. Sensitivity, specificity, 
and other characteristics of the screen are dependent on the age of 
screening, the particular assay utilized, and cut-off levels used. DMD 
screening offered to parents of male neonates, with informed consent 
and in conjunction with existing routine newborn screening systems, is 
one potential approach to decreasing the age of diagnosis in the United 
States. However, complications of this approach include the difficulty 
in obtaining uniform and informed consent (contingent on promoting 
complete understanding by parents of genetic and outcome factors) 
during the prenatal or immediate neonatal period, and the potential 
impact of test results on parent-infant bonding.
    A second potential approach is to offer screening to families of 
male infants (6 to 12 months) through pediatric health care services. 
This approach offers more time for informed consent, but a major 
complication is disparities in access to pediatric health care.
    Both approaches require well-planned protocols for follow-up of 
positive screening results. The purpose of this cooperative agreement 
is to develop, implement and evaluate early screening

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programs in both neonates (part A) and infants (part B) in order to: 
(a) Assess the feasibility of early screening for DMD; (b) identify 
challenges related to each approach; and (c) evaluate the risks and 
benefits of each approach.
    Activities: Applicants may apply for funding under part A and/or 
part B. Please note that if applicants choose to apply for both part A 
and part B, separate applications are required. There is no provision 
which allows the submission of consolidated applications addressing the 
requirements of both part A and part B under one application.
    Awardee activities for part A of this program are as follows:
     Develop, implement and evaluate laboratory protocols for 
DMD newborn screening based on creatine kinase activity levels in dried 
blood spots of male newborns. The evaluation component should include 
determination of sensitivity, specificity, negative predictive value 
and positive predictive value of the screening methodology in the 
newborn period.
     Develop, implement, and evaluate protocols for informed 
consent, follow-up of positive screening results, diagnostic testing, 
and referral to clinical care. The evaluation component should include 
assessments of (1) parental understanding of informed consent, (2) 
factors that influence the entire process for screening, (3) factors 
that influence loss to follow-up, (4) acceptability of screening to 
parents and health care providers, (5) impact of transient positive 
screening results on families, (6) attitudes of diagnosed families 
toward the screening and diagnostic process, (7) attitudes of transient 
positive and true negative families (both screen-negative and DMD not 
present) toward the screening process, (8) assessments of other 
potential risks and benefits of newborn screening for DMD, and (9) the 
overall economic costs of screening.
    Awardee activities for part B of this program are as follows:
     Develop, implement and evaluate laboratory protocols for 
DMD infant screening based on creatine kinase activity levels in dried 
blood spots or other suitable biologic specimens from male infants. The 
evaluation component should include determination of sensitivity, 
specificity, and positive predictive value of screening methodology in 
infancy (6-12 months).
     Develop, implement, and evaluate protocols for informed 
consent, follow-up of positive screening results, diagnostic testing, 
and referral to clinical care. The evaluation component should include 
assessments of (1) factors that influence access to and uptake of 
infant screening, (2) parental understanding of informed consent, (3) 
factors that influence loss to follow-up, (4) acceptability of 
screening to parents and health care professionals, (5) impact of 
transient positive screening results on families, (6) attitudes of 
diagnosed families toward the screening and diagnostic process, (7) 
attitudes of transient positive and true negative families toward the 
screening process, (8) assessments of other potential risks and 
benefits of infant screening for DMD, and (9) the overall economic 
costs of screening.
    CDC Responsibilities: In a cooperative agreement, CDC staff is 
substantially involved in the program activities, above and beyond 
routine grant monitoring. In this cooperative agreement, a CDC 
Scientist (Scientific Liaison) within the National Center on Birth 
Defects and Developmental Disabilities (NCBDDD) is an equal partner 
with scientific and programmatic involvement during the conduct of the 
project through technical assistance, advice, and coordination. The 
Scientific Liaison will:
    1. Participate in the development of the protocol.
    2. Participate in the analysis, interpretation, and reporting of 
findings in the scientific literature and other media to the community 
at large and the public policy community within the Federal government.
    3. Participate in data management, analysis of data, and 
interpretation and dissemination of findings.
    4. Provide scientific consultation and technical assistance in the 
design and conduct of the project, including protocol adherence, 
outcome measures, and analytical approaches in participation with the 
recipient organization.

CDC Scientific Program Administrator (SPA)

    The CDC NCBDDD will appoint an SPA, apart from the NCBDDD 
Scientific Liaison who will:
    1. Serve as the Program Official for the funded research 
institutions.
    2. Carry out continuous review of all scientific and administrative 
activities to ensure objectives are being met.
    3. Attend Coordination Committee meetings for purposes of assessing 
overall progress and for program evaluation purposes.
    4. Provide scientific consultation and technical assistance in the 
conduct of the project as requested.
    5. Conduct site visits to recipient institutions to determine the 
adequacy of the research and to monitor performance against approved 
project objectives.

Collaborative Responsibilities

    The planning and implementation of the cooperative aspects of the 
study will be effected by a Coordination Committee consisting of the 
Principal Investigator from the participating institution(s) and the 
CDC Scientific Liaison. This Coordinating Committee will formulate a 
plan for cooperative research.
    At periodic coordination committee meetings, the group will: (1) 
Make recommendations on the study protocol and data collection 
approaches; (2) discuss the target populations that have been or will 
be recruited; (3) identify and recommend solutions to unexpected study 
problems; and (4) discuss ways to efficiently coordinate study 
activities and best practices.

II. Award Information

Part A. DMD During the Newborn Period

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities section 
above.
    Fiscal Year Funds: 2004.
    Approximate Total Funding: $250,000.
    Approximate Number of Awards: One.
    Approximate Average Award: $250,000 (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: None.
    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.

Part B. DMD During the Infancy Period

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities section 
above.
    Fiscal Year Funds: 2004.
    Approximate Total Funding: $250,000.
    Approximate Number of Awards: One.
    Approximate Average Award: $250,000 (this amount is for the first 
12-month budget period, and includes both direct and indirect costs).

[[Page 35353]]

    Floor of Award Range: None.
    Ceiling of Award: None.
    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 non-profit 
organizations and by governments and their agencies, such as:
     Public non-profit organizations
     Private non-profit organizations
     Universities
     Colleges
     Non-profit Research Institutions and Hospitals
     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)
     Political subdivisions of States (in consultation with 
States)
    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 as documentation of your status. Place this documentation behind 
the first page of the application form.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    If your application is incomplete or non-responsive to the 
requirements listed below, it will not be entered into the review 
process. You will be notified that your application did not meet 
submission requirements.
    Applicants must document their present infrastructure, capacity, 
expertise, and experience (within organization or within organizations 
of collaborators) in conducting population-based newborn or infant 
screening and follow-up for genetic diseases.
    Applicants must provide specific evidence to substantiate this 
capacity, experience, and expertise. Through documentation of two pages 
in length, applicants must provide specific evidence that they can 
fully meet these eligibility criteria in order to be considered for 
formal review. This information must be included as part of the 
application and inserted immediately after the Face Page of the 
application.
    Individuals Eligible to Become Principal Investigators: Any 
individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to 
develop an application for support. Individuals from under-represented 
racial and ethnic groups as well as individuals with disabilities are 
always encouraged to apply for CDC programs.

    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 398 
(OMB number 0925-0001 rev. 5/2001). Forms and instructions are 
available in an interactive format on the CDC Web site, at the 
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
    Forms and instructions are also available in an interactive format 
on the National Institutes of Health (NIH) web site at the following 
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html.
    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 Application Submission

    Letter of Intent (LOI): The LOI must be written in the following 
format:
     Maximum number of pages: Two
     Font size: 12-point unreduced
     Paper size: 8.5 by 11 inches
     Page margin size: One-inch margins
     Printed only on one side of page
     Single-spaced
     Written in plain language; avoiding jargon
    The LOI must contain the following information: Name, address, and 
telephone number of the proposed Principal Investigator, number and 
title of this program announcement, intent to apply under part A or 
part B or both, names of other key personnel, designations of 
collaborating institutions and entities, and an outline of the proposed 
work, recruitment approach, and expected outcomes.
    Application: Follow the PHS 398 application instructions for 
content and formatting of your application. For further assistance with 
the PHS 398 application form, contact PGO-TIM staff at (770) 488-2700, 
or contact GrantsInfo, Telephone (301) 435-0714, e-mail: 
[email protected].
    You must submit a signed original and five copies of your 
application form. The PHS 398 grant application form requires the 
applicant to enter the project title on page 1 (Form AA, ``Face Page'') 
and the project description (abstract on page 2).
    The main body of the application should not exceed 25 single-spaced 
pages. This narrative research plan should address activities to be 
conducted over the entire project period.
    Additional information may be included in the application 
appendices. The appendices will not be counted toward the narrative 
page limit. This additional information may include curriculum vitae 
and resumes for key project staff, organizational charts, graphic 
workplan/time charts, letters of commitment, etc.; and should be 
limited to those items relevant to the requirements of this 
announcement.
    Applicants must include a graphic work plan (which may be placed in 
the appendices) that outlines major project goals and objectives with 
timelines established for each calendar quarter covering the entire 
project period.
    All material must be typewritten, with 10 characters per inch type 
(12 point) on 8\1/2\ by 11 inch white paper with one-inch margins, no 
headers or footers (except for applicant-produced forms such as 
organizational charts, c. vitae, graphs and tables, etc.). Applications 
must be held together only by rubber bands or metal clips, and not 
bound together in any way (including attachments/appendices).
    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. Your DUNS number must be entered 
on line 11 of the face page of the PHS 398 application form. The DUNS 
number is a nine-digit identification number, which uniquely

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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.
    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 Time

    Letter of Intent (LOI) Deadline Date: July 14, 2004.
    CDC requests that you send an LOI if you intend to apply for this 
program. Although the LOI is not required, not binding, and does not 
enter into the review of your subsequent application, the LOI will be 
used to gauge the level of interest in this program, and will allow CDC 
to plan the application review. LOI should include intent to apply 
under part A or part B or both.
    Application Deadline Date: August 9, 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 carrier's 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 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 not apply to this program.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are that project funds cannot be used to supplant other 
available applicant or collaborating agency funds for construction or 
for lease or purchase of facilities or space.
    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 must be less than 12 
months from the application due date.

IV.6. Other Submission Requirements

    LOI Submission Address: Lisa T. Garbarino, Public Health Analyst, 
National Center on Birth Defects and Developmental Disabilities, CDC, 
1600 Clifton Road, Mailstop E-87, Atlanta, Georgia 30333. E-mail 
address: [email protected].
    Application Submission Address: Submit the original and five copies 
of your application by mail or express delivery service to: Technical 
Information Management--PA 04216, CDC Procurement and Grants Office, 
2920 Brandywine Road, Atlanta, Georgia 30341. Applications may not be 
submitted by fax or e-mail at this time.

V. Application Review Information

V.1. Criteria

    You are required to provide measures of outcome and 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.
    The goals of CDC-supported research are to advance the 
understanding of biological, environmental, and human behavior systems; 
public health delivery/intervention systems; improvement of the control 
and prevention of disease and injury; and to enhance health. In the 
written comments, reviewers will be asked to evaluate the application 
in order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals. The scientific review 
group will address the applications' overall score, weighting them as 
appropriate for each application. The application does not have to be 
strong in all categories to be judged to have major scientific impact 
and thus deserve a high priority score.
    Under the evaluation criteria noted below, applicants must describe 
how they will address the program components as they relate to the 
Purpose and Research Objectives, and the Recipient/Awardee Activities 
as cited in this Announcement.
    Your application will be evaluated against the following criteria:
    1. Resources and Organizational Capacity:
     This includes applicant infrastructure, experience, and 
capacity within its organization and/or with partners in early 
screening and diagnosis programs for genetic conditions, including 
genetic counseling and other appropriate follow-up activities; and to 
access target populations for screening.
     This indicates that based on the organizational capacity 
and resources the proposed project goals and objectives will be 
relevant, specific, achievable, and measurable; and can be addressed 
through the proposed methods and within the established timelines.
    2. Methods and Activities:
     This includes that the proposed methods and activities 
convincingly and comprehensively meet the intent and purpose of the 
announcement.
     This considers that the overall process for planning, 
implementation, and evaluation is comprehensive and appropriate to 
accomplish the stated goals and objectives.
     This includes that: (a) The methods and activities are 
feasible within programmatic and fiscal restrictions; (b) the methods 
will produce accurate, valid and reliable data; (c) the potential 
capacity of the research design is adequate to generate meaningful 
results during the study period, the design can be replicated for 
future use; and (d) adequate and appropriate plans are in place for 
dissemination of findings and recommendations.
    3. Project Management and Staffing:
     This criteria includes whether the proposed personnel, 
staff qualifications and experience and project organization are 
sufficient to address the planning, operations, and management/analysis 
activities of the program.
     This includes the process by which the applicant will 
assemble an effective

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team and how the applicant presents specified tasks and 
responsibilities to be assigned for key personnel and positions.
     This includes how well the proposed approaches to meeting 
proposed goals and specific objectives are convincing and likely to 
achieve all objectives within the prescribed time frames.
    4. Evaluation Plan: This assesses that: (a) Evaluation components 
described in the announcement have been addressed in the proposal; (b) 
measurable time-phased goals and objectives are included in the 
proposal; and (c) the evaluation plan includes a process for evaluation 
of sub-components and the entire project, including the assignment of 
responsibility for ongoing review of specified components.
    5. Budget Description and Justification: This includes the 
comprehensiveness and adequacy of the proposed budget in relation to 
program operations, collaborations, and services; and the extent to 
which the budget is reasonable, clearly justified, accurate, and 
consistent with the purposes of this research.
    6. Protections: Does the application adequately address the 
requirements of title 45 CFR part 46 for the protection of human 
subjects? This criteria will not be 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. Inclusion: Does the application adequately address the CDC 
policy requirements regarding the inclusion of women, ethnic, and 
racial groups in the proposed research? This includes:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b. The proposed justification when representation is limited or 
absent.
    c. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    d. 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.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO), and for responsiveness by NCBDDD. 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 and will not receive further consideration.
    Applications, which are complete and responsive, will be subjected 
to a preliminary evaluation (triage) by a scientific review group 
(Special Emphasis Panel--SEP) composed of external (non-CDC) peer 
reviewers to determine if each application is of sufficient technical 
and scientific merit to warrant further review by the SEP. Applications 
that are determined to be non-competitive will not be considered. 
Subsequent to the review meeting CDC will notify the investigator/
program director and the official signing for the applicant 
organization of that determination.
    Applications determined to be competitive will then be reviewed and 
scored under the formal SEP peer review process. The review of these 
fully competitive applications will result in the determination of the 
score and ranking for those applications.
    Subsequent to the formal peer review of all competitive 
applications by the SEP a second level of review will be conducted by 
senior CDC program staff. This review will not revisit the scientific 
merit of the applications, but will evaluate the overall budget 
implications of the applications against funding ceilings and may not 
make recommendations as to the final ordering of the top ranked 
applications for part A and part B, they may not actually change the 
ranking order (or scores). It is possible that the second level of 
review may recommend funding the highest ranked proposal under part A 
(or part B) and also funding that same organization under its 
application for the other part of the announcement. That could occur in 
the event that an organization with the highest ranking in one part 
ranks among the highest three applicants in the other part. This would 
be done to take into account economies of scale and establish the 
capacity to conduct non-redundant programs to best meet the purposes of 
this announcement. In such a case, the total approved budget may be 
less than the sum of the two applications due to staff time commitment 
duplications and other considerations.

V.3. Anticipated Award Date

    September 1, 2004.

VI. Award Administration Information

VI.1. Award Notices

    If your application is to be funded, you 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 Parts 74 and 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-1 Human Subjects Requirements
     AR-2 Requirement 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 Systems Requirements
     AR-15 Proof of Non-Profit Status
     AR-22 Research Integrity
     AR-25 Release and Sharing of Data
    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 copies of the 
following reports:
    Interim progress report, (PHS 2590, OMB Number 0925-0001, rev. 5/
2001), on a date to be determined for your project for each subsequent 
budget year. The progress report will serve as your non-competing 
continuation application, and must contain the following elements:
    a. Current Budget Period Activities and Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activities and Objectives.
    d. Budget.
    e. Additional Requested Information.
    f. Measures of Effectiveness.
    2. Financial status report and annual 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

[[Page 35356]]

end of the project period. These reports must be sent to the Grants 
Management Specialist listed in the ``Agency Contacts'' section of this 
announcement.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section (PGO-TIM), CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, Georgia 30341, Telephone: (770) 
488-2700.
    For program technical assistance, contact: Lisa T. Garbarino, 
Public Health Analyst, National Center on Birth Defects and 
Developmental Disabilities, CDC, 1600 Clifton Road, Mailstop E-87, 
Atlanta, Georgia 30333. E-mail address: [email protected]. Telephone: (404) 
498-3979.
    For budget assistance, contact: Sylvia Dawson, Grants Management 
Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, 
Atlanta, Georgia 30341. Telephone: (770) 488-2771. E-mail: 
[email protected].

    Dated: June 18, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-14311 Filed 6-23-04; 8:45 am]
BILLING CODE 4163-18-P