[Federal Register Volume 69, Number 163 (Tuesday, August 24, 2004)]
[Notices]
[Pages 52012-52017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19310]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Reproductive Health Research

    Announcement Type: New.
    Funding Opportunity Number: RFA DP05-010.
    Catalog of Federal Domestic Assistance Number: 93.946.
    Key Dates:
    Letter of Intent Deadline: September 23, 2004.
    Application Deadline: November 8, 2004.
    Executive Summary: The Division of Reproductive Health has four 
priority areas addressed by this announcement: (1) Maternal health, (2) 
infant health, (3) unintended and teen pregnancy prevention, and (4) 
women's reproductive health. This announcement seeks proposals for 
etiologic or interventional research that one or more of these four 
priority areas, especially as they relate to the problems of 
disparities in risk, prediction of risk, and prevention of preterm 
birth or unintended pregnancy. This program addresses the ``Healthy 
People 2010'' focus areas of Maternal, Infant, and Child Health and 
Family Planning.

I. Funding Opportunity Description

    Authority: This program is authorized under Sections 301 (a) and 
317 (k)(2) [42 U.S.C. 241 (a) and 247b (k)(2)] of the Public Health 
Service Act, as amended.
    Purpose: The purpose of the program is to generate new knowledge to 
further the health of United States families and to eliminate 
disparities related to contraception, pregnancy, preterm delivery, and 
human reproduction.
    Measurable outcomes of the program will be in alignment with one or 
more of the following performance goals (1) reduce maternal morbidity 
and mortality; or (2) identify biological and behavioral risk factors 
influencing prematurity; (3) increase the proportion of pregnancies 
that are intended; (4) reduce pregnancies among adolescent females; or 
(5) increase the proportion of adolescents who abstain from sexual 
intercourse or use condoms if currently sexually active.
    Research Objectives:
    (1) To gain a better understanding of the susceptibility to preterm 
delivery, in a public health framework, through research that explores:
     The social, behavioral, community, genetic, historical, 
and biologic determinants of preterm birth.
     The effect of gene variation within and between groups on 
the risk of preterm birth, and how the environment modifies that risk.
     The potential to predict the risk of preterm birth using 
combinations of social, behavioral, community, genetic, historical, and 
biologic determinants of preterm birth.
     To gain a better understanding of the clinical use of 17-
alpha hydroxyprogesterone for the prevention of preterm delivery, 
evaluate barriers to its use, and develop capacity for future expanded 
studies of therapeutic effectiveness in the context of routine 
obstetrical care.
    (2) To prevent unintended and teen pregnancy and to improve 
reproductive health among U.S. teens through innovative intervention 
research, non-intervention research, and research with Latino youth. 
Latinos are now the number one minority adolescent population and will 
continue to grow given the population demographics of such a young U.S. 
Latino population. Much of the data for Latinos are not disaggregated 
by ethnic subgroups or by first or subsequent generation and, 
therefore, preclude a discussion of differing risk factors and sexual 
health outcomes specific to each subgroup. Latinos have the highest 
teen pregnancy rate and over half of teenaged Latinos are sexually 
active. They are among the

[[Page 52013]]

least likely to use contraceptives at first intercourse. Latino youth 
are also disproportionately at risk for contracting sexually 
transmitted infections, including HIV. Such data suggest that they are 
an important target group for pregnancy prevention programs. However, 
very few programs have been evaluated that are directed specifically 
towards Latino teens.
    (3) The principal objective of this research is the development of 
knowledge to support public health prevention programs and policies, 
including those that promote abstinence, reduce sexual risk taking, 
improve contraceptive use including STD prevention, and improve the 
delivery of reproductive health services. Proposals may include 
epidemiologic, behavioral, clinical, ethnographic, contextual-level, 
ecologic, and other research, both qualitative and quantitative. 
(Research that focuses primarily on school-based curriculum approaches 
will not be supported under this announcement.)
    Activities:
    Recipient activities for this program are as follows:
    (1) Preterm Delivery:
     Using existing standardized assays, or creating new 
standard assays where standards do not exist, track the natural history 
of inflammatory biomarkers for preterm delivery through the course of 
pregnancy in an ethnically and racially diverse cohort of pregnant 
women in the United States. Biomarkers should include, but are not 
limited to, mediators of inflammation (cytokines, chemokines). Stored 
biologic specimens for women (blood, cervical swabs, vaginal swabs) and 
infant (cord blood, buccal swabs) dyads in this cohort will facilitate 
further analyses such as exploring the gene polymorphisms associated 
with variation in the inflammatory response. In addition to serial 
biological specimens, a broad range of social, behavioral, community, 
historical, and biologic determinants of preterm birth, and obstetrical 
data as well as pregnancy outcomes must be collected so that we might 
better understand the factors associated with an increased 
susceptibility to preterm delivery.
     Perform studies to explore the association between the 
presence of potential genetic markers for up-regulating or down-
regulating inflammatory mediators and preterm birth in an ethnically 
and racially diverse cohort of U.S. women and their infants. The nature 
and design of these studies necessitate an existing cohort about which 
exists a broad range of social, behavioral, community, historical, and 
biologic determinants of preterm birth, and obstetrical data, stored 
biological samples for women and infant dyads, and pregnancy and 
neonatal outcomes.
     Describe the use of 17-alpha hydroxyprogesterone in the 
setting of routine clinical practice in representative sample of health 
care providers treating socially and racially diverse populations. 
Evaluate provider and patient acceptance of progesterone therapy. 
Examine patient compliance with weekly clinic visits and injections, 
according to obstetrical history, risk factors, social, behavioral, 
community, historical, and biologic determinants of preterm birth. 
Evaluate barriers to patient adherence and potential novel solutions. 
Develop capacity for possible future expanded assessments of 
therapeutic effectiveness of progesterone preparations in the context 
of routine clinical care.
    (2) Unintended and Teen Pregnancy Prevention:
     Intervention Research Objective: To gain a better 
understanding of factors associated with successful programs to prevent 
unintended and teen pregnancy through rigorous, innovative intervention 
research. Potential projects could include:
    [cir] Youth development or parent interventions which incorporate 
reproductive health promotion;
    [cir] Innovative approaches to providing clinical services which 
incorporate behavior change interventions into clinical settings;
    [cir] Programmatic ways to improve contraceptive practice and 
contraceptive adherence;
    [cir] Intervention research tailored to the cultural circumstances 
of specific communities;
    [cir] Culturally appropriate adaptations to teen pregnancy 
prevention programs to address the needs for culturally diverse youth;
    [cir] Community-level interventions, such as use of radio drama or 
community outreach workers, to prevent unintended pregnancy and to 
promote reproductive health;
    [cir] Interventions that target health care providers and youth 
service workers to better meet needs of clients in diverse populations.
     Non-Intervention Research Objective: To increase knowledge 
of factors associated with risk of unintended and teen pregnancy and 
related health consequences through innovative research. Potential 
projects could include:
    [cir] Delayed initiation of first intercourse among teens or 
promotion of abstinence among sexually experienced teens;
    [cir] Social and cultural forces that shape pregnancy intentions 
and reproductive decision-making including contraceptive use, 
childbearing, and HIV/STD prevention;
    [cir] Sensitivity and appropriateness of unintended pregnancy 
measures in diverse and disempowered populations;
    [cir] Determinants of incorrect or inconsistent use of 
contraception and factors associated with highly effective use;
    [cir] Issues of gender and male involvement in sexual behavior and 
decision making, abstinence, contraceptive use, and pregnancy outcome;
    [cir] Risks for unintended pregnancy and STDs among gay, lesbian, 
bisexual, transgender, and questioning youth;
    [cir] Differences between racial and ethnic subgroups in adolescent 
pregnancy rates, antecedents, and associated factors;
    [cir] Efforts to improve the measurement of pregnancy intentions 
and factors related to teen pregnancy and unintended pregnancy;
    [cir] Methodological research designed to improve research 
approaches and public health surveillance for teen and unintended 
pregnancy;
    [cir] Migration and acculturation processes as they relate to 
reproductive health outcomes and wantedness and intendedness of 
pregnancy;
    [cir] Social and cultural influences, including gender dynamics, on 
abstinence, sexual risk behavior, and contraceptive use;
    [cir] Longitudinal research projects examining sexual development, 
life planning, and pregnancy-related intentions and behaviors in 
diverse populations.
     Latino Youth Objective: To gain a better understanding of 
the risk for unintended and teen pregnancy and associated health 
outcomes among Latino youth through research. Potential projects could 
include:
    [cir] Social and cultural determinants of pregnancy intentions, 
contraceptive use, and HIV/STD prevention among diverse Latino ethnic 
subgroups and in diverse settings, e.g., along the U.S.-Mexico border;
    [cir] Sensitivity and appropriateness of unintended pregnancy 
measures in Latino populations;
    [cir] Ways that migration and acculturation interact with 
reproductive health behaviors and outcomes;
    [cir] The meaning and measurement of acculturation processes as 
they relate to reproductive health outcomes and wantedness and 
intendedness of pregnancy among Latina youth;

[[Page 52014]]

    [cir] Issues of gender and male involvement in sexual behavior and 
decision making, abstinence, contraceptive use, and pregnancy outcome;
    [cir] Longitudinal research projects.
    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:
    (1) Assist in development of the research protocol by providing 
scientific consultation and technical assistance.
    (2) Facilitate movement of the initial research protocol through 
CDC IRB as well as keeping CDC IRB abreast of protocol amendments and 
facilitating annual reviews.
    (3) Assist in data analyses and interpretation and the presentation 
and publication of findings.
    (4) Conduct site visits to recipient institution to determine the 
progress of the research and to monitor performance against approved 
project objectives.
    (5) Establish agreements for sharing data and access to biological 
specimens.
    (6) Facilitate distribution and dissemination of research findings, 
especially to state and local health departments and other grantees.

II. Award Information

    Type of Award: Cooperative Agreement. CDC involvement in this 
program is listed in the Activities Section above.
    Fiscal Year Funds: Fiscal Year 2005.
    Approximate Total Funding: $4,500,000.
    $1,500,000 for preterm delivery.
    $3,000,000 for unintended and teen pregnancy prevention. (The 
estimated funding amount is pending availability of FY 2005 funds, and 
is subject to change.)
    Approximate Number of Awards: At least six total, including a 
minimum of one for each of the three activities under preterm delivery 
and one for each of the three objectives under unintended and teen 
pregnancy prevention activities.
    Approximate Average Award: $500,000 (This amount is for the first 
12-month budget period, and includes both direct and indirect costs) 
for the preterm delivery and teen and unintended pregnancy intervention 
projects; and $300,000 for the teen and unintended pregnancy non-
intervention and Latino projects.
    Floor of Award Range: None.
    Ceiling of Award Range: $600,000 for preterm delivery and teen and 
unintended pregnancy intervention projects; $350,000 for non-
intervention and Latino projects.
    Anticipated Award Date: January 15, 2005.
    Budget Period Length: 12 months.
    Project Period Length: Up to five 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 and 
for profit organizations and by governments and their agencies, such 
as:
     Public nonprofit organizations.
     Private nonprofit organizations.
     For profit organizations.
     Small, minority, women-owned businesses.
     Universities.
     Colleges.
     Research institutions.
     Hospitals.
     Community-based organizations.
     Faith-based organizations.
     Federally recognized Indian tribal governments.
     Indian tribes.
     Indian tribal 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).
     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 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.
    If your application is incomplete or non-responsive to the 
requirements listed in this section, it will not be entered into the 
review process. You will be notified that your application did not meet 
submission requirements.
    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 underrepresented 
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): Your LOI must be written in the following 
format:
     Maximum number of pages: Two.
     Font size: 12-point unreduced.
     Single spaced.
     Paper size: 8.5 by 11 inches.
     Page margin size: One inch.
     Printed only on one side of page.
     Written in plain language, avoid jargon.
    Your LOI must contain the following information:

[[Page 52015]]

     Descriptive title of the proposed research.
     Name, address, E-mail address, and telephone number of the 
Principal Investigator.
     Names of other key personnel.
     Participating institutions.
     Number and title of this Program Announcement (PA).
    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].
    Your research plan should address activities to be conducted over 
the entire project period.
    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 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.
    This PA uses just-in-time concepts. It also uses the modular 
budgeting as well as non-modular budgeting formats. See: http://grants.nih.gov/grants/funding/modular/modular.htm for additional 
guidance on modular budgets. Specifically, if you are submitting an 
application with direct costs in each year of $250,000 or less, use the 
modular budget format. Otherwise, follow the instructions for non-
modular budget research grant applications.
    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

    LOI Deadline Date: September 23, 2004.
    CDC requests that you send a 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 to allow CDC 
to plan the application review.
    Application Deadline Date: November 8, 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 LOI and application 
content, 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

    Your application is subject to Intergovernmental Review of Federal 
Programs, as governed by Executive Order (EO) 12372. This order sets up 
a system for state and local governmental review of proposed federal 
assistance applications. You should contact your state single point of 
contact (SPOC) as early as possible to alert the SPOC to prospective 
applications, and to receive instructions on your state's process. 
Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.

IV.5. Funding Restrictions

     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.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or E-mail to: Brenda Colley-Gilbert, Scientific Review 
Administrator, CDC, NCCDPHP, 4770 Buford Highway, NE.,Mail Stop 
K22,Atlanta, GA 30341-3717,Telephone: 770-488-6295,Fax: 770-488-7291,E-
mail: [email protected].
    Application Submission Address: Submit the original and three hard 
copies of your application by mail or express delivery service 
to:Technical Information Management-RFA DP05-010, CDC 
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-
3717.
    At the time of submission, two additional copies of the application 
must be sent to: Brenda Colley-Gilbert, Scientific Review 
Administrator, CDC, NCCDPHP, 4770 Buford Highway, NE.,Mail Stop 
K22,Atlanta, GA 30341-3717,Telephone: 770-488-6295,Fax: 770-488-7291,E-
mail: [email protected].
    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.
    The goals of CDC-supported research are to advance the 
understanding of biological systems, improve the control and prevention 
of disease and injury, and 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 and consider each of the 
following criteria in assigning the application's overall score, 
weighting them as appropriate for each application. The application 
does not need to be strong in all categories to be judged likely to 
have major scientific impact and thus deserve a high priority score. 
For example, an investigator may propose to carry out important work 
that by its nature is not innovative, but is essential to move a field 
forward.

[[Page 52016]]

    The criteria are as follows:
    Significance: Does this study address an important problem? If the 
aims of the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of these studies on the concepts or 
methods that drive this field?
    Approach: Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project? Does the applicant acknowledge potential problem 
areas and consider alternative tactics?
    [cir] For preterm delivery only: It is critical to the design of 
this project that the study population be of sufficient ethnic and 
racial diversity to study differences in risk factors, biomarkers, and 
gene-environment interactions for white and black race and Hispanic 
ethnicity.
    Innovation: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?
    Investigator: Is the investigator appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers?
    [cir] For preterm delivery only: The principal investigator or the 
co-principal investigator must have a history of conducting 
competitively funded peer reviewed research directed at exploring the 
etiology or determinants of preterm delivery or directed at 
understanding the susceptibility of preterm delivery. The results of 
this research must have been published in peer reviewed journals within 
the last five years.
    [cir] For preterm delivery only: In addition, the applicant's 
project team must include significant expertise in research on the 
relationships between infection and inflammation and preterm birth. For 
genetic studies, the team must include expertise in the area of the 
genetic regulation of the production of inflammatory mediators. At 
least one member of the project team must have laboratory experience in 
developing assays for inflammatory mediators (e.g. chemokines, 
cytokines), stress hormones (e.g. corticotrophin releasing hormone), 
and in the case of genetic studies, determination of polymorphism 
status (e.g. single and multiplex polymerase chain reaction).
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support?
    [cir] For preterm delivery only: For studies involving 
prospectively-collected information, the applicant must document the 
existence of the appropriate institutional research infrastructure to 
carry out a large, complex project as well as the facilities to handle, 
store, and analyze biological samples for activities that require 
collection, storage, and analysis of such samples. There must be 
demonstrated ability to recruit women early in pregnancy and retain 
them throughout the course of their pregnancy.
    Protection of Human Subjects from Research Risks: Does the 
application adequately address the requirements of Title 45 CFR part 46 
for the protection of human subjects? This 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.
    Inclusion of Women and Minorities in Research: 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; and (4) a statement as 
to whether the plans for recruitment and outreach for study 
participants include the process of establishing partnerships with 
communities and recognition of mutual benefits.
    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) and for responsiveness by the National Center 
for Chronic Disease Prevention and Heath Promotion (NCCDPHP). 
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.
    Applications that are complete and responsive to the PA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group or charter study section convened by NCCDPHP in accordance 
with the review criteria listed above. As part of the initial merit 
review, all applications may:
     Undergo a process in which only those applications deemed 
to have the highest scientific merit, generally the top half of the 
applications under review, will be discussed and assigned a priority 
score.
     Receive a written critique.
     Receive a second level review by the NCCDPHP Extramural 
Research Review Group.
    Award Criteria: Criteria that will be used to make award decisions 
include:
     Scientific merit (as determined by peer review).
     Availability of funds.
     Programmatic priorities.

V.3. Anticipated Award Date

    CDC expects to make awards on or about January 15, 2005.

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-1 Human Subjects Requirements.
     AR-2 Requirements for Inclusion of Women and Racial and 
Ethnic Minorities in Research.
     AR-4 HIV/AIDS Confidentiality Provisions.
     AR-5 HIV Program Review Panel Requirements.
     AR-6 Patient Care.
     AR-7 Executive Order 12372.
     AR-8 Public Health System Reporting Requirements.
     AR-9 Paperwork Reduction Act Requirements.

[[Page 52017]]

     AR-10 Smoke-Free Workplace Requirements.
     AR-11 Healthy People 2010.
     AR-12 Lobbying Restrictions.
     AR-14 Accounting System Requirements.
     AR-15 Proof of Non-Profit Status.
     AR-21 Small, Minority, and Women-Owned Business.
     AR-22 Research Integrity.
     AR-23 States and Faith-Based Organizations.
     AR-24 Health Insurance Portability and Accountability Act 
Requirements.
     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

    You must provide CDC with an original, plus two hard copies of the 
following reports:
    1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC website) 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:
    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 and annual progress 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 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 scientific/research issues, contact: Brenda Colley Gilbert, 
Extramural Project Officer, NCCDPHP/Deputy Associate Director for 
Extramural Research (DADER), 4770 Buford Highway, NE., Mail Stop K20, 
Atlanta, GA 30341-3717, Telephone: 770-488-6295, E-mail: 
[email protected].
    For questions about peer review, contact: Brenda Colley Gilbert, 
Scientific Review Administrator, 4770 Buford Highway, NE., Mail Stop 
K20, Atlanta, GA 30341-3717, Telephone: 770-488-6295, E-mail: 
[email protected].
    For financial, grants management, or budget assistance, contact: 
Tracey Sims, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-
2739, E-mail: [email protected].

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
on the CDC Web site, Internet address: http://www.cdc.gov. Click on 
``Funding'' then ``Grants and Cooperative Agreements.''

    Dated: August 17, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-19310 Filed 8-23-04; 8:45 am]
BILLING CODE 4163-18-P