[Federal Register Volume 70, Number 90 (Wednesday, May 11, 2005)]
[Notices]
[Pages 24797-24801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9373]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry


Applied Research for Populations Around Hazardous Waste Sites

    Announcement Type: New.
    Funding Opportunity Number: RFA TS05-110.
    Catalog of Federal Domestic Assistance Number: 93.161.
    Key Dates: Letter of Intent Deadline: June 10, 2005.
    Application Deadline: June 27, 2005.

I. Funding Opportunity Description

    Authority: This program is authorized in sections 104(i) (1)(E), 
(7), (9), and (15) of the Comprehensive Environmental Response, 
Compensation, and Liability Act (CERCLA) as amended by the Superfund 
Amendments and Reauthorization Act (SARA) [42 U.S.C. 9604(i)(1)(E), 
(7), (9), and (15)].

Background

    Agency for Toxic Substances and Disease Registry (ATSDR) has the 
responsibility under Comprehensive Environmental Response, 
Compensation, and Liability Act (CERCLA), as amended, to evaluate the 
relationship between exposures to hazardous substances and adverse 
human health effects. However, this relationship between exposures to 
hazardous substances and adverse health effects is complicated and 
difficult to evaluate. Many factors can generate the appearance or hide 
the presence of a relationship between exposure to hazardous substances 
and adverse health effects. The presence of environmental contamination 
and an adverse health effect does not automatically demonstrate 
evidence of a causal relationship. Beginning in 1992, ATSDR developed a 
research agenda to address some of these questions. Research under this 
agenda continues to be conducted, but additional research is needed. 
Therefore, projects conducted under this program announcement will 
focus on those questions that have the greatest relevance toward 
determining the relationship of adverse health effects among persons 
exposed to hazardous substances.
    Examples of relevant ATSDR activities are presented below:

Evaluation of Persons Exposed to Tremolite Asbestos Contaminated 
Vermiculite

    Asbestos contaminated vermiculite ore was mined and processed in 
Libby, Montana, from the early 1920s until 1990. ATSDR has completed a 
medical screening program, a mortality review and a Public Health 
assessment in Libby. Based on these studies and additional evaluation 
conducted by ATSDR, EPA and the State of Montana, people who worked in 
the Libby mine or processing facilities and people who lived in the 
Libby community were exposed to asbestos-contaminated vermiculite. 
Nearly eighteen percent of medical screening participants had 
radiographic pleural abnormalities consistent with asbestos exposure. 
Mortality due to lung cancer and asbestosis was also found to be 
elevated in Libby. ATSDR has also implemented a Tremolite Asbestos 
Registry (TAR) of exposed persons and has funded the State of Montana 
to conduct additional periodic medical surveillance for eligible 
persons.
    Additionally, records indicate that the vermiculite ore from Libby 
was shipped to over 200 locations around the U.S. for handling and/or 
processing into various commercial and consumer products. Twenty-eight 
``Phase 1 Sites'' have been identified based on a variety of factors 
such as tonnage of ore received, population density, numbers of 
workers, etc. Health statistics reviews (to evaluate mortality and 
cancer registry data) are currently being completed in sixteen states 
and mesothelioma surveillance has been initiated in three states (New 
York, Wisconsin and New Jersey). In addition, ATSDR has funded a 
comprehensive community exposure assessment project in a community 
receiving the ore. This work addresses the priority health conditions 
of lung and respiratory disease.

Exposure to Contaminants From Collapse of World Trade Center Towers on 
September 11, 2001

    The World Trade Center Health Registry is a joint effort of ATSDR 
and the New York City Department of Health and Mental Hygiene 
(NYCDOHMH). It was designed to track the health of people who were most 
directly exposed to the disaster on September 11, 2001 and in the 
months that followed. Registrants will be followed to attempt to 
determine if their exposure to smoke, dust, and airborne substances 
from the collapse of the towers and subsequent fires has a long term 
impact on their health. Questions regarding their physical and mental 
health were asked

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in a structured interview of approximately 30 minutes. Data collection 
was completed over approximately 15 months and over 71,000 people 
enrolled in the registry. Environmental monitoring information 
indicates that possible exposure to asbestos, particulate matter, 
manmade vitrious fibers, silica, Polycyclic Aromatic Hydrocarbons 
(PAHs), and other caustic material may have occurred. Several of these 
materials are associated with short- and long-term health effects. Some 
preliminary follow-up studies of people in lower Manhattan have found 
some associations between those exposures and respiratory health 
problems. Additional research is needed to better clarify the exposure 
and dose relationship. In addition, research is needed to determine the 
possible future occurrence of adverse health effects. This work 
addresses the priority health conditions of lung and respiratory 
disease.
    Purpose: The purpose of this program is to fill gaps in knowledge 
by conducting applied research studies related to human exposure to 
hazardous substances at hazardous waste sites and adverse health 
outcomes, including health outcomes as prioritized by ATSDR. This 
program addresses the ``Healthy People 2010'' focus areas of 
Environmental Health and Public Health Infrastructure.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the ATSDR:
     Determine human health effects associated with exposures 
from hazardous waste sites to Superfund-related priority hazardous 
substances.
    Hazardous substances, as applies to this announcement, are those as 
defined by the Comprehensive Environmental, Response, Compensation, and 
Liability Act (CERCLA).
    The list of priority hazardous substances found at CERCLA sites can 
be found at http://www.atsdr.cdc.gov/clist.html.
    Research Objectives: Studies may be conducted in the following 
areas:
     Identification, validation, and development of biomarkers 
of exposure, susceptibility, and effect;
     Further evaluation of the link or lack of linkage between 
specific chemicals and specific health effects and
     Development of research projects to further investigate 
outcomes found in data previously collected by ATSDR or its grantees.
    Activities: Awardee activities for this program are as follows:
    Applications must propose studies which will address one or more of 
the following ATSDR Priority Health Conditions: (in alphabetic order)
     Birth defects and reproductive disorders;
     Cancers (selected anatomic sites);
     Immune function disorders;
     Kidney dysfunction;
     Liver dysfunction
     Lung and respiratory diseases; and
     Neurotoxic disorders.
    Applicants must propose studies/projects in one or more of any of 
the following areas of investigation:
     Identify risk factors for adverse health effects in 
populations that have either potential or known exposures to hazardous 
substances (as defined by CERCLA) from hazardous waste sites and 
releases.
     Evaluate potentially impacted populations exposed to the 
events of the collapse of the World Trade Center Towers on 9/11 and/or 
exposed to ore from the Libby, MT mine to identify linkages between 
exposure and adverse health effects and those risk factors which may be 
impacted by prevention actions. See summaries of these ATSDR activities 
under the Background section of this RFA.
     Develop methods to identify adverse health effects in 
populations that are potentially exposed to hazardous substances from 
hazardous waste sites in their environment. This includes medical 
research to evaluate currently available biological tests (biomarkers) 
and disease occurrence in potentially impacted populations such as 
individuals exposed to vermiculite contaminated with asbestos from the 
Libby, MT mine. See summary of this ATSDR activity under the Background 
section of this RFA.
     Disseminate research findings upon satisfactory completion 
of peer and public review. Findings should be disseminated through 
presentations at scientific meetings, participation in stakeholder or 
state sponsored meetings, and/or journal publications.

II. Award Information

    Type of Award: Grant.
    Mechanism of Support: R01.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $500,000. (This amount is an estimate, 
and is subject to availability of funds.)
    Approximate Number of Awards: One.
    Approximate Average Award: $500,000. (This amount is for the first 
12-month budget period.)
    Floor of Award Range: None.
    Ceiling of Award Range: $500,000. (This ceiling is for the first 
12-month budget period.)
    Anticipated Award Date: August 31, 2005.
    Budget Period Length: 12 Months.
    Project Period Length: Three (3) 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

    Assistance will be provided only to state supported United States 
Schools of Public Health who are currently accredited by the Council on 
Education of Public Health that are associated with or have access to 
programs in environmental epidemiology, environmental sciences, 
clinical medicine, and medical informatics. Applicants must 
affirmatively establish that they meet their respective State's 
legislative definition of a State entity or political subdivision to be 
considered an eligible applicant. Eligibility is limited to these 
applicants because they provide (1) the technical expertise in the wide 
range of disciplines needed to further develop the theoretical and 
scientific base necessary for this research and to develop and test for 
new methodology essential to support state and local programs; and (2) 
a training ground for the nation's future environmental public health 
workforce. This range of disciplines and expertise is often unavailable 
or difficult to access by state or local public health agencies.

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.
    Special 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.
     Late applications will be considered non-responsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
     Note: Title 2 of the United States Code Section 1611 
states that an

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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.
    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.

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. 9/2004). 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
     Double 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:
     Descriptive title of the proposed research
     Name, address, E-mail address, telephone number, and FAX 
number of the Principal Investigator
     Names of other key personnel
     Participating institutions
     Number and title of this Announcement
    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 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 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 announcement 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: June 10, 2005.
    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: June 27, 2005.
    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 submit your application by the United States Postal 
Service or commercial delivery service, you must ensure that the 
carrier will be able to guarantee delivery by the closing date and 
time. If CDC receives your submission 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 submission 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 you did not meet the submission 
requirements.
    CDC will not notify you upon receipt of your submission. If you 
have a question about the receipt of your LOI or application, first 
contact your courier. If you still have a question about your 
application, contact the PGO-TIM staff at: 770-488-2700. If you still 
have a question about your LOI, contact OPHR staff at: 404-371-5253. 
Before calling, please wait two to three days after the submission 
deadline. This will allow time for submissions 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

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
     Funds relating to the conduct of research will not be 
released until the appropriate assurances and Institutional Review 
Board approvals are in place.
     Reimbursement of pre-award costs is not allowed.
     Funds may not be used for projects in the area of asthma-
related research.
    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.

[[Page 24800]]

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or E-mail to: Mary Lerchen, DrPH, Scientific Review 
Administrator, CDC/Office of Public Health Research, One West Court 
Square, Suite 7000, Mailstop D-72, Decatur, GA 30030. Telephone Number: 
404-371-5277. Fax: 404-371-5215. E-mail address: [email protected].
    Application Submission Address: Submit the original and one copy of 
your application by mail or express delivery service to: Technical 
Information Management-RFA TS05-110, CDC Procurement and Grants Office, 
2920 Brandywine Road, Atlanta, GA 30341.
    At the time of submission, four additional copies of the 
applications, and all appendices must be sent to: Mary Lerchen, DrPH, 
Scientific Review Administrator, CDC/Office of Public Health Research, 
One West Court Square, Suite 7000, Mailstop D-72, Decatur, GA 30030.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the grant. 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/ATSDR 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 equally 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.
    The review 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? The study should include the rationale for selecting a 
community and population to be the subject of the proposed 
investigation and the relevance to exposures to hazardous substances at 
hazardous waste sites and adverse health outcomes.
    Approach: Does the applicant provide a sound rationale for the 
specific approach and scientific method to conduct the study? 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? Is there (a) an adequate rationale for the design 
of the proposed study; (b) identification of a target (exposed/
diseased) population; (c) identification of an appropriate comparison 
group (if warranted); (d) consideration of sample size; (e) a plan for 
linking environmental exposure to hazardous substances and health 
outcome data; and (f) detailed plan for analysis of the data included.
    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 
(if any)?
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Do the proposed 
studies take advantage of unique features of the scientific environment 
or employ useful collaborative arrangements? Is there evidence of 
adequate institutional support? Are there letters of support, if 
appropriate?
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
    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? The involvement of human subjects 
and protections from research risk relating to their participation in 
the proposed research will be assessed.
    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 
community(ies) 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 Office of Public 
Health Research. 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 announcement 
will be evaluated for scientific and technical merit by an appropriate 
peer review group or charter study section convened by ATSDR 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 by the review group, generally the 
top half of the applications under review, will be discussed and 
assigned a priority score.
     Receive a written critique.
     Receive a second programmatic level review conducted by 
the Scientific Program Administrator in the Office of the Associate 
Director for Science.
    Award Criteria: Criteria that will be used to make award decisions 
during the programmatic review include:
     Scientific merit (as determined by peer review)
     Availability of funds
     Programmatic priorities

V.3. Anticipated Announcement and Award Dates

    The anticipated award date will be on or before August 31, 2005.

[[Page 24801]]

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Award (NoA) from the 
CDC Procurement and Grants Office. The NoA shall be the only binding, 
authorizing document between the recipient and CDC. The NoA 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-7 Executive Order 12372
 AR-9 Paperwork Reduction Act Requirements
 AR-10 Smoke-Free Workplace Requirements
 AR-11 Healthy People 2010
 AR-12 Lobbying Restrictions
 AR-14 Accounting System Requirements
 AR-17 Peer and Technical Reviews of Final Reports of Health 
Studies--ATSDR
 AR-18 Cost Recovery--ATSDR
 AR-19 Third Party Agreements--ATSDR
 AR-22 Research Integrity

    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 ATSDR with an original, plus two hard copies of 
the following reports:
    1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 9/2004 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 additional elements:
    a. Progress toward Measures of Effectiveness.
    b. Additional Information Requested by Program.
    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. Final performance reports should 
include a scientific report that summarizes the complete project, the 
analyses and the final results, and/or a manuscript suitable for 
publication in a peer review journal. Additionally, the Program office 
requests that all data sets generated under this project be provided to 
ATSDR in electronic format.
    These reports must be mailed to the Grants Management Specialist 
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    We encourage inquiries concerning this announcement. For general 
questions, 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: Mildred Williams-Johnson, 
Ph.D., Scientific Program Administrator, CDC/ATSDR, 1600 Clifton Road, 
NE, MailStop E17, Atlanta, GA 30333. Telephone: 404 498-0639. E-mail: 
[email protected]; or Sharon Campolucci, RN, MSN, Scientific 
Collaborator, CDC/ATSDR, 1600 Clifton Road, NE, MailStop E31, Atlanta, 
GA 30333. Telephone: 404-498-0105. E-mail: [email protected].
    For questions about peer review, contact: Mary Lerchen, DrPH, 
Scientific Review Administrator, CDC/Office of Public Health Research, 
One West Court Square, Suite 7000, Mailstop D-72, Atlanta, GA 30030. 
Telephone: 404-498-5277. E-mail: [email protected].
    For financial, grants management, or budget assistance, contact: 
Edna Green, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770 488-
2743. 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: May 5, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 05-9373 Filed 5-10-05; 8:45 am]
BILLING CODE 4163-70-P