[Federal Register: June 24, 2004 (Volume 69, Number 121)]
[Notices]
[Page 35369-35373]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn04-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Morbidity and Risk Behavior Surveillance
Announcement Type: New.
Funding Opportunity Number: 04155.
Catalog of Federal Domestic Assistance Number: 93.944.
Key Dates:
Application Deadline: July 26, 2004.
Executive Summary: HIV/AIDS surveillance programs function in all
U.S. states to collect a core set of information on the characteristics
of persons diagnosed with, living with, and dying from HIV infection
and AIDS. Supplemental surveillance projects have historically provided
complementary information about clinical outcomes of HIV infection, and
behaviors of persons with HIV infection with respect to care seeking
and utilization of care (which affect prevention of HIV-related
morbidity) and ongoing risk behaviors (which affect further
transmission of HIV).
Supplemental surveillance projects initiated in the 1990s were
funded at a time when the HIV epidemic was substantially more
concentrated in large cities, especially in the East and the West.
Currently, a much larger number of cities and states are heavily
impacted by the HIV epidemic. Supplemental surveillance data are thus
needed on a national basis (e.g., beyond the currently funded
supplemental surveillance sites) to understand the provision and impact
of treatments for HIV, health care utilization, ongoing HIV risk
behaviors, care seeking behaviors, quality of life for persons with HIV
infection, and acceptance of and adherence to prescribed antiretroviral
therapy. These data will be especially important as a means of
evaluation for new prevention initiatives (e.g., Advancing HIV
Prevention) which call for a focus on provision of prevention services
to persons living with HIV infection.
There is also a need for high-quality, population-based data on
quality of care and severity of need for care, prevention, and support
services on the local level to assist local planning groups (i.e.
Community Planning Groups and local planning councils) in determining
local allocation of CDC and Ryan White CARE Act funds.
In order to implement a supplemental surveillance system which will
address these data needs, CDC has developed a study design which will
rely on a national probability sample of persons with HIV infection to
generate nationally representative estimates of clinical outcomes and
HIV-related behaviors. The methodology has been demonstrated as
appropriate for this purpose by the Health Care Services and
Utilization Survey, conducted in the mid-1990s by the RAND Corporation.
CDC has contracted with the RAND Corporation to draw a nationally
representative sample of states using probability proportional to size
methods. Based on availability of resources, 20 states were selected by
RAND. Cities separately funded for HIV surveillance were deemed
eligible for funding if their state was selected for funding. This
resulted in 26 sites (20 states and 6 cities) being eligible for
funding.
In the 20 selected states, HIV care providers will be randomly
selected to participate in the study. For patients randomly selected
from these providers, data on HIV care will be abstracted from medical
records, and the patients will be offered participation in an
interview. CDC has piloted these methods for population-based patient
selection since 1998 in 12 sites in the Survey of HIV Disease and Care
(SHDC) project.
I. Funding Opportunity Description
Authority: This program is authorized under the Public Health
Service Act Sections 301 (42 U.S.C. 241); 318B (42 U.S.C. 247c-2),
as amended.
Purpose: The purpose of the program is to develop a supplemental
HIV/AIDS surveillance system which will produce population-based
estimates of characteristics of persons with HIV infection and the care
they receive. By using probability sampling, estimates developed will
be rigorously representative of the underlying populations diagnosed
with and in care for HIV infection in the United States and in the
participating project sites.
Measurable outcomes of the program will be in alignment with the
following goal for the National Center for HIV, STD and TB Prevention
(NCHSTP): Strengthen the capacity nationwide to monitor the epidemic,
develop and implement effective HIV prevention interventions and
evaluate prevention programs.
Activities: Awardee activities for this program are as follows:
Year 1 Activities (September 2004-May 2005--9 Months)
For sampled sites that have successfully conducted Supplement to
HIV/AIDS Surveillance (SHAS) and either Adult Spectrum of Disease (ASD)
or Survey of HIV Disease in Care (SHDC) in the past; or that are
currently conducting Survey of HIV Disease in Care-Plus (SHDC+)
(successful completion is defined as having transmitted abstraction or
interview data to CDC as of May 17, 2004) (see eligibility criteria):
Soon after receipt of funds, attend a principal
investigators meeting at CDC to review and finalize the project
protocol and data collection instruments.
Assist in the development and review of the required
protocols and data collection instruments.
Work with providers of HIV/AIDS care to educate them about
the surveillance project, determine potential barriers to provider
participation, and work to improve the likelihood of provider and
patient participation in this activity.
Work with CDC to develop a database and database
management capability for this project.
Develop a de-duplicated list of HIV/AIDS care providers in
the jurisdiction using data from the HIV/AIDS Reporting System (HARS).
Provide the list of providers (by unique identifier or
non-identifying code determined by CDC), to CDC and to a CDC contractor
for development of a sample of providers.
Approach selected providers to solicit the providers'
participation in the project. Work with selected providers to secure
human subjects review (if required).
Participate in required training activities: send
appropriate staff members to interviewer, abstractor, and data manager
training meetings before beginning data collection.
Abstract the medical records of sampled patients for
variables related to clinical care and outcomes as determined in
collaboration with CDC.
Work with sampled HIV/AIDS care providers to contact
sampled HIV-infected persons to conduct personal interviews. During the
interview, patients will be asked about care seeking and ongoing risk
behaviors as well as multiple sources of care during the surveillance
period. Consent for release of medical records will be obtained if
possible, and every effort will be made to contact all providers of
care named for each sampled participant during the surveillance
[[Page 35370]]
period and review and abstract medical records at those sites.
Maintain an electronic database of information linked to
interview and chart review data; periodically transmit this data to CDC
with patient unique identifier. No individual patient names will be
transmitted to CDC or to the CDC contractor.
Data security: Protect data in accordance with ``Appendix
C'' of CDC's ``Guidelines for HIV/AIDS Surveillance.'' Applicant must
ensure that the program requirements detailed in the Security Standards
are attained.
Participate in periodic conference calls and grantee
meetings with other funded sites and the CDC.
Disseminate findings jointly with CDC and other
participating sites.
Sampled sites that have successfully conducted either Adult
Spectrum of Disease (ASD) or Survey of HIV Disease in Care (SHDC), but
that have not conducted Supplement to HIV/AIDS Surveillance (SHAS) (see
eligibility criteria) will conduct all startup activities listed above
except the patient interview.
Sampled sites that have successfully conducted Supplement to HIV/
AIDS Surveillance (SHAS), but that have not conducted Survey of HIV
Disease in Care (SHDC) or Adult Spectrum of Disease (ASD) in the past
(see eligibility criteria) will conduct all startup activities listed
above in year 1 except the abstraction of medical records.
Sampled sites that have not conducted Adult/Adolescent Spectrum of
HIV Disease (ASD), or Supplement to HIV/AIDS Surveillance (SHAS), or
successfully conducted Survey of HIV Disease in Care (SHDC), will
conduct all startup activities listed above in year 1 except data
collection, participation in interviewer training, and participation in
abstractor training.
Year 2 Activities (June 2005-May 2006)
All funded sites will conduct medical record abstractions and
interviews during calendar year 2006 for care occurring during calendar
year 2005.
Participate in required training activities: send
appropriate staff members to interviewer, abstractor, and data manager
training meetings.
Continue to abstract medical records and interview
patients selected in year 1.
In preparation for data collection in year 3, sites will
develop a new de-duplicated list of HIV/AIDS care providers in the
jurisdiction, using data from the HIV/AIDS Reporting System (HARS).
Provide the list of providers (by unique identifier or
non-identifying code determined by CDC) to CDC and to a CDC contractor
for development of a sample of providers.
Approach selected providers to solicit participation in
the project. Work with selected providers to secure human subjects
review (if required).
Abstract the medical records of sampled patients for
variables related to clinical care and outcomes as determined in
collaboration with CDC.
Work with sampled HIV/AIDS care providers to contact
sampled HIV-infected persons to conduct personal interviews. During the
interview, patients will be asked about care seeking and ongoing risk
behaviors as well as multiple sources of care during the surveillance
period. Consent for release of medical records will be obtained if
possible, and every effort will be made to contact all providers of
care named for each sampled participant during the surveillance period
and review and abstract medical records at those sites.
Maintain a database of linked interview and chart review
data; periodically transmit this data to CDC with patient unique
identifier. No individual patient names will be transmitted to CDC or
to the CDC contractor.
Data security: Protect data in accordance with ``Appendix
C'' of CDC's ``Guidelines for HIV/AIDS Surveillance.'' Applicant must
ensure that the program requirements detailed in the Security Standards
are attained.
Participate in periodic conference calls and grantee
meetings with other funded sites and the CDC.
Disseminate findings jointly with CDC and other
participating sites.
Year 3 Activities (June 2006-May 2007)
Repeat cycle of chart abstractions and interviews for
persons in care for HIV infection.
Year 4 (June 2007-May 2008)
Repeat cycle of chart abstractions and interviews for
persons in care for HIV infection.
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:
Assist in the development and review of the core
components of protocols.
Participate in joint conference calls, grantee meetings,
and site visits.
Jointly disseminate findings.
Collaborate with the CDC-funded contractor to develop a
sample of HIV/AIDS care providers from the list of providers developed
by the grantee.
Collaborate with the CDC-funded contractor to develop a
sample of HIV-infected persons from the list of patients developed by
the sampled providers.
Provide training and technical support for data
abstractors and interviewers, including technical support for
electronic data collection and data transfer to CDC.
Provide training and technical support for data management
and data analysis.
II. Award Information
Type of Award: Cooperative Agreement.
CDC involvement in this program is listed in the Activities Section
above.
Fiscal Year Funds: 2004, 2005, 2006, 2007.
Approximate Total Funding: $41,000,000.
Approximate Number of Awards: 26 awards.
Approximate Average Award:
Year 1 (September 2004-May 2005, 9 Months)
Sampled sites that have successfully conducted Supplement to HIV/
AIDS Surveillance (SHAS) and either Adult Spectrum of Disease (ASD),
Survey of HIV Disease in Care (SHDC) in the past; or that are currently
conducting Survey of HIV Disease in Care-Plus (SHDC+) will receive
approximately $375,000 each in year 1.
Sampled sites that have successfully conducted either Adult
Spectrum of Disease (ASD), Survey of HIV Disease in Care (SHDC) but
that have not conducted Supplement to HIV/AIDS Surveillance (SHAS) will
receive approximately $200,000 each in year 1.
Sampled sites that have successfully conducted Supplement to HIV/
AIDS Surveillance (SHAS), but that have not conducted Survey of HIV
Disease in Care (SHDC) or Adult Spectrum of Disease (ASD) in the past
will receive approximately $270,000 each in year 1.
Sampled sites that have not conducted Adult/Adolescent Spectrum of
HIV Disease (ASD), or Supplement to HIV/AIDS Surveillance (SHAS), or
successfully conducted Survey of HIV Disease in Care (SHDC) will
receive approximately $140,000 each in year 1.
Years 2, 3 and 4
For all grantees, budgets for collecting chart abstraction data and
interviews for persons in care for HIV infection will be approximately
equal for years 2, 3 and 4. Average budgets will be as follows, based
on the number of matched medical record abstractions/interviews
allocated by random sampling:
[[Page 35371]]
1000 abstractions/interviews: $900,000-$1,100,000
800 abstractions/interviews: $700,000-$900,000
500 abstractions/interviews: $500,000-$700,000
400 abstractions/interviews: $450,000-$550,000
Less than or equal to 200 abstractions/interviews: $150,000-
$300,000
All eligible applicants that are technically acceptable will be
funded. Funding levels will be determined based on number of
abstractions and interviews to be performed, and site-specific
variations in cost. For the number of records to be collected, see
Appendix I, as posted on the CDC Web site.
Floor of Award Range: $100,000.
Ceiling of Award Range: $1,100,000.
Anticipated Award Date: September 1, 2004.
Budget Period Length: Year 1: 9 months; Year 2-4: 12 months.
Project Period Length: 3 years, 9 months.
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. If full funding is not available,
number of matched medical record abstractions/interviews allocated by
random sampling may be reduced.
III. Eligibility Information
Eligible Applicants
Eligible applicants are limited to those jurisdictions randomly
sampled by the RAND Corporation in a national probability sample.
Following are the jurisdictions sampled: California; Chicago, IL;
Delaware; Florida; Georgia; Houston, TX; Illinois; Indiana; Los
Angeles, CA; Maryland; Massachusetts; Michigan; Mississippi; New
Jersey; New York; New York City, NY; North Carolina; Oregon;
Pennsylvania; Philadelphia, PA; Puerto Rico; San Francisco, CA; South
Carolina; Texas; Virginia; and Washington.
Sampled sites that have successfully conducted Supplement to HIV/
AIDS Surveillance (SHAS) and either Adult Spectrum of Disease (ASD) or
Survey of HIV Disease in Care (SHDC), or are currently conducting
Survey of HIV Disease in Care-Plus (SHDC+) are: Georgia; Houston, TX;
Los Angeles, CA; Michigan; New Jersey; and Washington.
Sampled sites that have successfully conducted either Adult
Spectrum of Disease (ASD) or Survey of HIV Disease in Care (SHDC) but
that have not conducted Supplement to HIV/AIDS Surveillance (SHAS) are:
New York City, NY and Puerto Rico.
Sampled sites that have successfully conducted Supplement to HIV/
AIDS Surveillance (SHAS), but that have not conducted Survey of HIV
Disease in Care (SHDC) or Adult Spectrum of Disease (ASD) are:
Delaware; Florida; Illinois; Maryland; Philadelphia, PA; South
Carolina; and Texas.
Sampled sites that have not conducted Adult/Adolescent Spectrum of
HIV Disease (ASD), or Supplement to HIV/AIDS Surveillance (SHAS), or
successfully conducted Survey of HIV Disease in Care (SHDC) are:
California; Chicago, IL; Indiana; Massachusetts; Mississippi; North
Carolina; New York State; Oregon; Pennsylvania; San Francisco, CA; and
Virginia.
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other
CDC will accept and review applications with budgets greater than
the ceiling of the award range.
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.
IV. Application and Submission Information
IV.1. Address to Request Application Package
To apply for this funding opportunity use application form PHS
5161. Application forms and instructions are available on the CDC Web
site, at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm
.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to
you.
IV.2. Content and Form of Submission
Application: You must submit a project narrative with your
application forms. The narrative must be submitted in the following
format:
Maximum number of pages: 25. If your narrative exceeds the
page limit, only the first pages which are within the page limit will
be reviewed.
Font size: 12 point unreduced.
Double spaced.
Paper size: 8.5 by 11 inches.
Paper margin size: One inch.
Printed only on one side of page.
Held together only by rubber bands or metal clips; not
bound in any other way.
Your narrative plan should address activities to be conducted over
the entire project period, and must include the following items in the
order listed: Plan, Methods, Objectives, Timeline, Staff,
Understanding, Need, Performance Measures, Budget and Justification.
The budget justification will not be counted in the stated page limit.
Additional information may be included in the application
appendices. The appendices will not be counted toward the narrative
page limit.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. The DUNS number is a nine-digit
identification number, which uniquely identifies business entities.
Obtaining a DUNS number is easy and there is no charge. To obtain a
DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-5711.
For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm
.
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
IV.3. Submission Dates and Times
Application Deadline Date: July 26, 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.
[[Page 35372]]
This announcement is the definitive guide on application submission
address and deadline. It supersedes information provided in the
application instructions. If your application does not meet the
deadline above, it will not be eligible for review, and will be
discarded. You will be notified that your application did not meet the
submission requirements.
CDC will not notify you upon receipt of your application. If you
have a question about the receipt of your application, first contact
your courier. If you still have a question, contact the PGO-TIM staff
at: 770-488-2700. Before calling, please wait two to three days after
the application deadline. This will allow time for applications to be
processed and logged.
IV.4. Intergovernmental Review of Applications
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:
None
If you are requesting indirect costs in your budget, you must
include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement should be less than 12
months of age.
Awards will not allow reimbursement of pre-award costs.
IV.6. Other Submission Requirements
Application Submission Address: Submit the original and two hard
copies of your application by mail or express delivery service to:
Technical Information Management--PA04155, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Criteria
You are required to provide measures of effectiveness that will
demonstrate the accomplishment of the various identified objectives of
the cooperative agreement.
Measures of effectiveness must relate to the performance goals
stated in the ``Purpose'' section of this announcement. Measures must
be objective and quantitative, and must measure the intended outcome.
These measures of effectiveness must be submitted with the application
and will be an element of evaluation.
Note: All technically acceptable applications will be awarded
appropriate funds. Your application will be evaluated against the
following criteria:
1. Methods (40 points): The extent to which the proposed methods
are feasible, will accomplish program goals, addresses the required
follow-up activities and methods in a timely manner. Specific
methods for accomplishing the following technical activities should
be described.
2. Capacity (30 points): The extent to which the applicant has
the appropriate facilities and staff to conduct this research; the
extent to which the primary investigator is well qualified, by
education and experience, to lead the project team, hire and train
appropriate staff, and provide scientific oversight; the extent to
which job descriptions and curricula vitae for both the proposed and
current staff indicate the ability to carry out the purposes of the
program.
3. Objectives (20 points): The extent to which the objectives
are reasonable, time-phased and measurable. The extent to which the
applicant provides reasonable methods to evaluate their progress
toward the timely accomplishment of objectives.
4. Proposed data uses (10 points): The extent to which data
have, or will, assist in HIV prevention and care activities, so that
these data are used in formulating strategies and targeting
resources for improving quality of care for HIV infection and, if
applicable, getting HIV infected persons into care in a timely
manner.
5. Budget (not scored): The extent to which the budget is
reasonable, clearly itemized and justified, and consistent with the
intended use of funds.
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO) staff, and for responsiveness by the NCHSTP.
Incomplete applications and applications that are non-responsive to the
eligibility criteria will not advance through the review process.
Applicants will be notified that their application did not meet
submission requirements.
An objective review panel will evaluate complete and responsive
applications according to the criteria listed in the ``V.1. Criteria''
section above.
V.3. Anticipated Announcement and Award Dates
September 1, 2004.
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
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
.
[[Page 35373]]
VI.3. Reporting Requirements
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 Web site) no less than 90 days
before the end of the first 12 month 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 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 program technical assistance, contact: Patrick Sullivan, DVM,
PhD, Extramural Project Officer, 1600 Clifton Road, MS E-46, Atlanta,
Georgia 30333, Telephone: 404-639-2090, E-mail: msw6@CDC.GOV.
For financial, grants management, or budget assistance, contact:
Ann Cole, Grants Management Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-
2731, E-mail: zlr5@cdc.gov.
Dated: June 18, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-14310 Filed 6-23-04; 8:45 am]
BILLING CODE 4163-18-P