Implementation of Multi-Disciplinary HIV Care for Sexually Abused Children in Zambia, as Part of the President's Emergency Plan for AIDS Relief, 49648-49654 [05-16838]
Download as PDF
49648
Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices
While U.S.-based organizations are
eligible to apply, we will give
preference to existing national/
Ethiopian organizations. It is possible
for one organization to apply as lead
grantee with a plan that includes
partnering with other organizations,
preferably local. Although matching
funds are not required, preference will
be go to organizations that can leverage
additional funds to contribute to
program goals.
Applications will be funded in order
by score and rank determined by the
review panel. HHS/CDC will provide
justification for any decision to fund out
of rank order.
V.3. Anticipated Announcement and
Award Dates
September 23, 2005.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a
Notice of Award (NoA) from the HHS/
CDC Procurement and Grants Office.
The NoA shall be the only binding,
authorizing document between the
recipient and HHS/CDC. An authorized
Grants Management Officer will sign the
NoA, and mail it 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
For more information on the Code of
Federal Regulations, see the National
Archives and Records Administration at
the following Internet address: https://
www.access.gpo.gov/nara/cfr/cfr-tablesearch.html.
The following additional
requirements apply to this project:
• AR–4 HIV/AIDS Confidentiality
Provisions
• AR–8 Public Health System
Reporting Requirements
• AR–10 Smoke-Free Workplace
Requirements
• AR–12 Lobbying Restrictions
• AR–14 Accounting System
Requirements
Applicants can find additional
information on these requirements on
the HHS/CDC Web site at the following
Internet address: https://www.cdc.gov/
od/pgo/funding/ARs.htm.
You need to include an additional
Certifications form from the PHS5161–
1 application in the Grants.gov
electronic submission only. Please refer
to https://www.cdc.gov/od/pgo/funding/
PHS5161-1-Certificates.pdf. Once you
15:23 Aug 23, 2005
Jkt 205001
VI.3. Reporting Requirements
You must provide HHS/CDC with an
original, plus two hard copies of the
following reports:
1. Interim progress report, due 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. Measures of Effectiveness.
f. Additional Requested Information.
2. Annual progress report, due 90
days after the end of the budget period.
3. Financial status report, no more
than 90 days after the end of the budget
period.
4. 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
45 CFR Part 74 and Part 92
VerDate jul<14>2003
have filled out the form, attach it to the
Grants.gov submission as Other
Attachments Form.
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 program technical assistance,
contact: Tadesse Wuhib, MD, MPH,
Country Director, CDC-Ethiopia, PO Box
1014, Entoto Road, Addis Ababa,
Telephone: (Office) 251–1–66–95–33;
(Cell) 251–9–228543, E-mail address:
wuhibt@etcdc.com.
For financial, grants management, or
budget assistance, contact: Shirley
Wynn, Grants Management Specialist,
CDC Procurement and Grants Office,
2920 Brandywine Road, Atlanta, GA
30341, Telephone: 770–488–1515, Email: SWynn@cdc.gov.
VIII. Other Information
This and other CDC funding
opportunity announcements can be
found on the CDC Web site, Internet
address: www.cdc.gov. Click on
‘‘Funding’’, then ‘‘Grants and
Cooperative Agreements.’’
PO 00000
Frm 00095
Fmt 4703
Sfmt 4703
Dated: August 17, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention.
[FR Doc. 05–16832 Filed 8–23–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Implementation of Multi-Disciplinary
HIV Care for Sexually Abused Children
in Zambia, as Part of the President’s
Emergency Plan for AIDS Relief
Announcement Type: New.
Funding Opportunity Number: CDC–
RFA–AA172.
Catalog of Federal Domestic
Assistance Number: 93.067.
Key Dates: Application Deadline:
September 19, 2005.
I. Funding Opportunity Description
Authority: This program is authorized
under Sections 301(a) and 307 of the
Public Health Service Act [42 U.S.C. 241
and 242l], as amended, and under
Public Law 108–25 (United States
Leadership Against HIV/AIDS,
Tuberculosis and Malaria Act of 2003)
[U.S.C. 7601].
Background: President Bush’s
Emergency Plan for AIDS Relief has
called for immediate, comprehensive
and evidence-based action to turn the
tide of global HIV/AIDS. The initiative
aims to treat more than two million
HIV-infected people with effective
combination anti-retroviral therapy by
2008; care for ten million HIV-infected
and affected persons, including those
orphaned by HIV/AIDS, by 2008; and
prevent seven million infections by
2010, with focus on 15 priority
countries, including 12 in sub-Saharan
Africa. The five-year strategy for the
Emergency Plan is available at the
following Internet address: https://
www.state.gov/s/gac/rl/or/c11652.htm.
Over the same time period, as part of
a collective national response, the
Emergency Plan goals specific to
Zambia are to treat at least 120,000 HIVinfected individuals and care for
600,000 HIV-affected individuals,
including orphans.
Under the leadership of the U.S.
Global AIDS Coordinator, as part of the
President’s Emergency Plan, the U.S.
Department of Health and Human
Services (HHS) works with host
countries and other key partners to
assess the needs of each country and
design a customized program of
E:\FR\FM\24AUN1.SGM
24AUN1
Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices
assistance that fits within the host
nation’s strategic plan.
HHS focuses on two or three major
program areas in each country. Goals
and priorities include the following:
• Achieving primary prevention of
HIV infection through activities such as
expanding confidential counseling and
testing programs, building programs to
reduce mother-to-child transmission,
and strengthening programs to reduce
transmission via blood transfusion and
medical injections.
• Improving the care and treatment of
HIV/AIDS, sexually transmitted diseases
(STDs) and related opportunistic
infections by improving STD
management; enhancing care and
treatment of opportunistic infections,
including tuberculosis (TB); and
initiating programs to provide antiretroviral therapy (ART).
• Strengthening the capacity of
countries to collect and use surveillance
data and manage national HIV/AIDS
programs by expanding HIV/STD/TB
surveillance programs and
strengthening laboratory support for
surveillance, diagnosis, treatment,
disease-monitoring and HIV screening
for blood safety.
To carry out its activities in these
countries, HHS works in a collaborative
manner with national governments and
other agencies to develop programs of
assistance to address the HIV/AIDS
epidemic. In particular, HHS’ mission in
Zambia is to work with the Ministry of
Health, and its partners, to develop and
apply effective interventions to prevent
and treat HIV infection and associated
illness and death from AIDS.
Purpose: The Demographic and
Health Survey (2001-2002) from Zambia
indicates that in the age group 15 to 19
the HIV prevalence among women is 6.6
percent, compared to a prevalence of 1.9
percent in men of the same age. Reports
from South Africa indicate that death
rates among girls between 15 to 19 years
have increased by over 50 percent in the
last ten years. In the last few years, there
has been a disturbing rise in the number
of cases of child rape and sexual abuse
reported in the media. In some subSaharan African countries, including
Zambia, there are myths surrounding
HIV, such as that sex with a virgin can
cure a man of HIV. In addition, older
men seek sex with very young partners
in the belief the young are free from
HIV. These practices expose young
children to HIV infection, and have
consequences on the child’s physical,
psychological and social development.
The actual extent of this problem is
often unclear, because the perpetrators
are sometimes close family members.
VerDate jul<14>2003
15:23 Aug 23, 2005
Jkt 205001
The University Teaching Hospital
(UTH) is the main referral hospital for
pediatric care in Zambia. Cases of
sexual abuse reported to the hospital are
seen first at the Police Post based there.
In 2003, a total of 659 cases of child
sexual abuse were reported at the Police
Post. Currently, 15 to 20 sexually
abused children are seen in the clinic
each week. However, many other cases
might be missed because of a lack of
awareness of attending clinicians of
evidence of sexual abuse, or reluctance
to discuss such issues with parents and
guardians. This leads to lost
opportunities to provide post-exposure
prophylaxis and psychological support
to the child, and increases the
possibility of HIV infection.
The Zambian UTH Department of
Pediatrics, the National AIDS Council
Technical Group on Orphans and
Vulnerable Children and the Zambian
Society for the Prevention of Child
Abuse and Neglect (ZSPCAN), in
collaboration with international
partners, has instituted various
activities on child sexual abuse, and the
purpose of the program is to strengthen
the human capacity in Zambia to
provide a child-friendly and parent
sensitive environment in which to
provide counseling and support; clinical
care; and ongoing care including postexposure prophylaxis and anti-retroviral
treatment (ART), as required, to
children who have suffered sexual
abuse.
Measurable outcomes of the program
will be in alignment with the numerical
goals of the President’s Emergency Plan
for AIDS Relief and one (or more) of the
following performance goal(s) for the
National Center for HIV, Sexually
Transmitted Diseases and Tuberculosis
Prevention (NCHSTP) of the Centers for
Disease Control and Prevention (CDC)
within HHS: Increase the proportion of
HIV-infected people who are linked to
appropriate prevention, care and
treatment services and to strengthen the
capacity nationwide to monitor the
epidemic, develop and implement
effective HIV prevention interventions
and evaluate prevention programs.
This announcement is only for nonresearch activities supported by HHS,
including CDC. If research is proposed,
the application will not be reviewed.
For the definition of ‘‘research,’’ please
see the HHS/CDC Web site at the
following Internet address: https://
www.cdc.gov/od/ads/opspoll1.htm.
Activities: The recipient of these
funds is responsible for activities in
multiple program areas designed to
target underserved populations in
Zambia. Either the awardee will
implement activities directly or will
PO 00000
Frm 00096
Fmt 4703
Sfmt 4703
49649
implement them through its subgrantees
and/or subcontractors; the awardee will
retain overall financial and
programmatic management under the
oversight of HHS/CDC and the strategic
direction of the Office of the U.S. Global
AIDS Coordinator. The awardee must
show a measurable, progressive
reinforcement of the capacity of
indigenous organizations and local
communities to respond to the national
HIV epidemic, as well as, progress
towards the sustainability of activities.
Applications should describe
activities in detail as part of a four-year
action plan (U.S. Government Fiscal
Years 2005–2008 inclusive) that reflects
the policies and goals outlined in the
five-year strategy for the President’s
Emergency Plan.
The grantee will produce an annual
operational plan in the context of this
four-year plan, which the U.S.
Government Emergency Plan team on
the ground in Zambia will review as
part of an annual Emergency Plan for
AIDS Relief Country Operational Plan
review and approval process managed
by the Office of the U.S. Global AIDS
Coordinator. The grantee may work on
some of the activities listed below in the
first year and in subsequent years, and
then progressively add others from the
list to achieve all of the Emergency Plan
performance goals, as cited in the
previous section. HHS/CDC, under the
guidance of the U.S. Global AIDS
Coordinator, will approve funds for
activities on an annual basis, based on
documented performance towards
achieving Emergency Plan goals, as part
of the annual Emergency Plan for AIDS
Relief Country Operational Plan review
and approval process.
Awardee activities for this program
are as follows:
1. Train health workers in the Zambia
UTH Departments of Pediatrics and
Obstetrics and Gynecology to recognize
and care for child sexual abuse.
2. Train health care workers to
provide post-exposure prophylaxis and
ART, in general, for pediatric HIV care.
3. Provide culturally and ageappropriate psycho-social support in
local languages to sexually abused
children and their families.
4. Develop a system to record
accurately cases of child sexual abuse,
and to follow up such cases in the
community.
5. Strengthen links with the Zambian
Society for Child Abuse and Neglect,
and design activities to increase
community awareness.
6. Develop a multi-disciplinary team
to provide pediatric HIV care.
Administration: The winning
applicant must comply with all HHS
E:\FR\FM\24AUN1.SGM
24AUN1
49650
Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices
management requirements for meeting
participation and progress and financial
reporting for this cooperative agreement
(See HHS Activities and Reporting
sections below for details), and comply
with all policy directives established by
the Office of the U.S. Global AIDS
Coordinator.
In a cooperative agreement, HHS staff
is substantially involved in the program
activities, above and beyond routine
grant monitoring.
HHS/CDC activities for this program
are as follows:
1. Provide scientific and technical
assistance in developing the awardee’s
operational plan.
2. Provide ongoing technical
assistance in program implementation.
3. Assist the awardee in assessments
of the program’s operations to determine
the overall effectiveness of the program,
including developing a monitoring and
evaluation tool for the activities in the
program.
4. Design the program activities in
conjunction with the UTH Department
of Pediatrics and other partners.
5. Participate in training of health
staff.
6. Provide technical assistance from
HHS-headquarters and the in-country
HHS office in Zambia to assure other
related U.S. Government activities are
well-coordinated with the national
program.
7. Organize an orientation meeting
with the grantee to brief it on applicable
U.S. Government, HHS, and Emergency
Plan expectations, regulations and key
management requirements, as well as
report formats and contents. The
orientation could include meetings with
staff from HHS agencies and the Office
of the U.S. Global AIDS Coordinator.
8. Review and approve the process
used by the grantee to select key
personnel and/or post-award
subcontractors and/or subgrantees to be
involved in the activities performed
under this agreement, as part of the
Emergency Plan for AIDS Relief Country
Operational Plan review and approval
process, managed by the Office of the
U.S. Global AIDS Coordinator.
9. Review and approve grantee’s
annual work plan and detailed budget,
as part of the Emergency Plan for AIDS
Relief Country Operational Plan review
and approval process, managed by the
Office of the U.S. Global AIDS
Coordinator.
10. Review and approve grantee’s
monitoring and evaluation plan,
including for compliance with the
strategic information guidance
established by the Office of the U.S.
Global AIDS Coordinator.
VerDate jul<14>2003
15:23 Aug 23, 2005
Jkt 205001
11. Meet on a monthly basis with
grantee to assess monthly expenditures
in relation to approved work plan and
modify plans as necessary.
12. Meet on a quarterly basis with
grantee to assess quarterly technical and
financial progress reports and modify
plans as necessary.
13. Meet on an annual basis with
grantee to review annual progress report
for each U.S. Government Fiscal Year,
and to review annual work plans and
budgets for subsequent year, as part of
the Emergency Plan for AIDS Relief
review and approval process for
Country Operational Plans, managed by
the Office of the U.S. Global AIDS
Coordinator.
14. Provide technical assistance, as
mutually agreed upon, and revise
annually during validation of the first
and subsequent annual work plans. This
could include expert technical
assistance and targeted training
activities in specialized areas, such as
strategic information, project
management, confidential counseling
and testing, palliative care, treatment
literacy, and adult learning techniques.
15. Provide in-country administrative
support to help grantee meet U.S.
Government financial and reporting
requirements.
II. Award Information
Type of Award: Cooperative
Agreement.
HHS involvement in this program is
listed in the Activities Section above.
Fiscal Year Funds: 2005.
Approximate Total Funding:
$225,000. (This amount is an estimate,
and is subject to availability of funds.)
Approximate Number of Awards:
One.
Approximate Average Award:
$75,000. (This amount is for the first 12month budget period, and includes
direct costs.)
Floor of Award Range: None.
Ceiling of Award Range: $95,000.
(This ceiling is for the first 12-month
budget period.)
Anticipated Award Date: September
23, 2005.
Budget Period Length: 12 months.
Project Period Length: Three years.
Throughout the project period, HHS’
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, through the
annual Country Operational Plan review
and approval process, managed by the
Office of the U.S. Global AIDS
Coordinator.
PO 00000
Frm 00097
Fmt 4703
Sfmt 4703
III. Eligibility Information
III.1. Eligible Applicants
We will provide assistance only to
university teaching hospitals that are
referral hospitals and provide a full
range of care, including pediatric care,
and have a mandate and specialty in
caring for sexually abused children.
Eligible applicants must already have
established activities to monitor cases of
child sexual abuse by working with the
local police post, to which all such
cases, are initially referred.
III.2. Cost-Sharing or Matching Funds
Matching funds are not required for
this program. Although matching funds
are not required, preference will go to
organizations that can leverage
additional funds to contribute to
program goals.
III.3. Other
If you request a funding amount
greater than the ceiling of the award
range, we will consider your application
non-responsive, and it will not enter
into the review process. We will notify
you that your application did not meet
the submission requirements.
Special Requirements: If your
application is incomplete or nonresponsive to the special requirements
listed in this section, it will not enter
into the review process. We will notify
you that your application did not meet
the submission requirements.
• HHS/CDC will consider late
applications 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
organization described in Section
501(c)(4) of the Internal Revenue Code
that engages in lobbying activities is not
eligible to receive Federal funds
constituting an award, grant, or loan.
IV. Application and Submission
Information
IV.1. Address to Request Application
Package
To apply for this funding opportunity
use application form PHS 5161–1.
HHS strongly encourages you to
submit your application electronically
by using the forms and instructions
posted for this announcement on
https://www.grants.gov.
Application forms and instructions
are available on the HHS/CDC Web site,
at the following Internet address:
https://www.cdc.gov/od/pgo/
forminfo.htm.
If you do not have access to the
Internet, or if you have difficulty
E:\FR\FM\24AUN1.SGM
24AUN1
Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices
accessing the forms on-line, you may
contact the HHS/CDC Procurement and
Grants Office Technical Information
Management Section (PGO-TIM) staff at
770–488–2700. We can mail application
forms to you.
IV.2. Content and Form of Submission
Application: You must submit a
project narrative with your application
forms. You must submit the narrative in
the following format:
• Maximum number of pages: 25. If
your narrative exceeds the page limit,
we will only review the first pages
within the page limit.
• 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.
• Held together only by rubber bands
or metal clips; not bound in any other
way.
• Application must be written in
English.
Your narrative should address
activities to be conducted over the
entire project period, and must include
the following items in the order listed:
• Justification for program.
• Eligibility and organizational
capacity.
• Proposed program plan, including
goals, objectives and plan of operation.
• Program Management, staffing,
collaborations, and infrastructure.
• Evaluation plan.
• Budget and 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. This
additional information includes:
• Curriculum Vitae.
• Organizational Charts.
• Letters of support.
• Applicants must document
eligibility by submitting verification of
their Zambian registration status.
• Job descriptions of proposed key
positions to be created for the activity.
• Quality-Assurance, Monitoringand-Evaluation, and StrategicInformation Forms.
• Applicant’s Corporate Capability
Statement.
• Evidence of Legal Organizational
Structure.
You must 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
VerDate jul<14>2003
15:23 Aug 23, 2005
Jkt 205001
49651
number, access https://
www.dunandbradstreet.com or call
1–866–705–5711.
For more information, see the HHS/
CDC Web site at: https://www.cdc.gov/
od/pgo/funding/grantmain.htm. If your
application form does not have a DUNS
number field, please write your DUNS
number at the top of the first page of
your application, and/or include your
DUNS number in your application cover
letter.
Additional requirements that could
require you to submit additional
documentation with your application
are listed in section ‘‘VI.2.
Administrative and National Policy
Requirements.’’
a question about the receipt of your
application, first contact your carrier. 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 submission deadline. This will
allow time for us to process and log
submissions.
This announcement is the definitive
guide on application content,
submission address, and deadline. It
supersedes information provided in the
application instructions. If your
submission does not meet the deadline
above, it will not be eligible for review,
and we will discard it. We will notify
you that you did not meet the
submission requirements.
IV.3. Submission Dates and Times
Application Deadline Date:
September 19, 2005.
Explanation of Deadlines:
Applications must be received in the
HHS/CDC Procurement and Grants
Office by 4 p.m. eastern time on the
deadline date.
You may submit your application
electronically at https://www.grants.gov.
We consider applications completed online through Grants.gov as formally
submitted when the applicant
organization’s Authorizing Official
electronically submits the application to
https://www.grants.gov. We will consider
electronic applications as having met
the deadline if the applicant
organization’s Authorizing Official has
submitted the application electronically
to Grants.gov on or before the deadline
date and time.
If you submit your application
electronically through Grants.gov, your
application will be electronically time/
date stamped, which will serve as
receipt of submission. You will receive
an e-mail notice of receipt when HHS/
CDC receives the application.
If you submit your application by the
United States Postal Service or
commercial delivery service, you must
ensure the carrier will be able to
guarantee delivery by the closing date
and time. If HHS/CDC receives your
submission after the closing date
because: (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
have the opportunity to submit
documentation of the carrier’s
guarantee. If the documentation verifies
a carrier problem, HHS/CDC will
consider the submission as received by
the deadline.
If you submit a hard copy application,
HHS/CDC will not notify you upon
receipt of your submission. If you have
IV.4. Intergovernmental Review of
Applications
Executive Order 12372 does not apply
to this program.
PO 00000
Frm 00098
Fmt 4703
Sfmt 4703
IV.5. Funding Restrictions
Restrictions, which you must take
into account while writing your budget,
are as follows:
• Funds may not be used for research.
• Reimbursement of pre-award costs
is not allowed.
• Needle Exchange—No funds
appropriated under this Act shall be
used to carry out any program of
distributing sterile needles or syringes
for the hypodermic injection of any
illegal drug.
• Funds may be spent for reasonable
program purposes, including personnel,
travel, supplies, and services.
Equipment may be purchased if deemed
necessary to accomplish program
objectives; however, prior approval by
HHS/CDC officials must be requested in
writing.
• All requests for funds contained in
the budget shall be stated in U.S.
dollars. Once an award is made, HHS/
CDC will not compensate foreign
grantees for currency exchange
fluctuations through the issuance of
supplemental awards.
• The costs that are generally
allowable in grants to domestic
organizations are allowable to foreign
institutions and international
organizations, with the following
exception: With the exception of the
American University, Beirut, and the
World Health Organization, Indirect
Costs will not be paid (either directly or
through sub-award) to organizations
located outside the territorial limits of
the U.S. or to international
organizations, regardless of their
location.
• The applicant may contract with
other organizations under this program;
however the applicant must perform a
E:\FR\FM\24AUN1.SGM
24AUN1
49652
Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices
substantial portion of the activities
(including program management and
operations, and delivery of prevention
services for which funds are required).
• You must obtain an annual audit of
these HHS/CDC funds (program-specific
audit) by a U.S.-based audit firm with
international branches and current
licensure/authority in-country, and in
accordance with International
Accounting Standards or equivalent
standards(s) approved in writing by
HHS/CDC.
• A fiscal Recipient Capability
Assessment may be required, prior to or
post award, in order to review the
applicant’s business management and
fiscal capabilities regarding the
handling of U.S. Federal funds.
Prostitution and Related Activities
The U.S. Government is opposed to
prostitution and related activities,
which are inherently harmful and
dehumanizing, and contribute to the
phenomenon of trafficking in persons.
Any entity that receives, directly or
indirectly, U.S. Government funds in
connection with this document
(‘‘recipient’’) cannot use such U.S.
Government funds to promote or
advocate the legalization or practice of
prostitution or sex trafficking. Nothing
in the preceding sentence shall be
construed to preclude the provision to
individuals of palliative care, treatment,
or post-exposure pharmaceutical
prophylaxis, and necessary
pharmaceuticals and commodities,
including test kits, condoms, and, when
proven effective, microbicides.
A recipient that is otherwise eligible
to receive funds in connection with this
document to prevent, treat, or monitor
HIV/AIDS shall not be required to
endorse or utilize a multisectoral
approach to combating HIV/AIDS, or to
endorse, utilize, or participate in a
prevention method or treatment
program to which the recipient has a
religious or moral objection. Any
information provided by recipients
about the use of condoms as part of
projects or activities that are funded in
connection with this document shall be
medically accurate and shall include the
public health benefits and failure rates
of such use.
In addition, any recipient must have
a policy explicitly opposing prostitution
and sex trafficking. The preceding
sentence shall not apply to any ‘‘exempt
organizations’’ (defined as the Global
Fund to Fight AIDS, Tuberculosis and
Malaria, the World Health Organization
and its six Regional Offices, the
International AIDS Vaccine Initiative or
any United Nations agency).
VerDate jul<14>2003
15:23 Aug 23, 2005
Jkt 205001
The following definition applies for
purposes of this clause:
• Sex trafficking means the
recruitment, harboring, transportation,
provision, or obtaining of a person for
the purpose of a commercial sex act. 22
U.S.C. 7102(9).
All recipients must insert provisions
implementing the applicable parts of
this section, ‘‘Prostitution and Related
Activities,’’ in all subagreements under
this award. These provisions must be
express terms and conditions of the
subagreement, must acknowledge that
compliance with this section,
‘‘Prostitution and Related Activities,’’ is
a prerequisite to receipt and
expenditure of U.S. government funds
in connection with this document, and
must acknowledge that any violation of
the provisions shall be grounds for
unilateral termination of the agreement
prior to the end of its term. Recipients
must agree that HHS may, at any
reasonable time, inspect the documents
and materials maintained or prepared
by the recipient in the usual course of
its operations that relate to the
organization’s compliance with this
section, ‘‘Prostitution and Related
Activities.’’
All prime recipients that receive U.S.
Government funds (‘‘prime recipients’’)
in connection with this document must
certify compliance prior to actual
receipt of such funds in a written
statement that makes reference to this
document (e.g., ‘‘[Prime recipient’s
name] certifies compliance with the
section, ‘Prostitution and Related
Activities.’ ’’) addressed to the agency’s
grants officer. Such certifications by
prime recipients are prerequisites to the
payment of any U.S. Government funds
in connection with this document.
Recipients’ compliance with this
section, ‘‘Prostitution and Related
Activities,’’ is an express term and
condition of receiving U.S. Government
funds in connection with this
document, and any violation of it shall
be grounds for unilateral termination by
HHS of the agreement with HHS in
connection with this document prior to
the end of its term. The recipient shall
refund to HHS the entire amount
furnished in connection with this
document in the event HHS determines
the recipient has not complied with this
section, ‘‘Prostitution and Related
Activities.’’
You may find guidance for
completing your budget on the HHS/
CDC Web site, at the following Internet
address: https://www.cdc.gov/od/pgo/
funding/budgetguide.htm.
PO 00000
Frm 00099
Fmt 4703
Sfmt 4703
IV.6. Other Submission Requirements
Application Submission Address:
HHS/CDC strongly encourages you to
submit electronically at: https://
www.grants.gov. You will be able to
download a copy of the application
package from https://www.grants.gov,
complete it offline, and then upload and
submit the application via the
Grants.gov site. We will not accept email submissions. If you are having
technical difficulties in Grants.gov, you
may reach them by e-mail at
support@grants.gov, or by phone at 1–
800–518–4726 (1–800–518–GRANTS).
The Customer Support Center is open
from 7 a.m. to 9 p.m. eastern time,
Monday through Friday.
HHS/CDC recommends that you
submit your application to Grants.gov
early enough to resolve any
unanticipated difficulties prior to the
deadline. You may also submit a backup paper submission of your
application. We must receive any such
paper submission in accordance with
the requirements for timely submission
detailed in Section IV.3. of the grant
announcement.
You must clearly mark the paper
submission: ‘‘BACK-UP FOR
ELECTRONIC SUBMISSION.’’
The paper submission must conform
to all requirements for non-electronic
submissions. If we receive both
electronic and back-up paper
submissions by the deadline, we will
consider the electronic version the
official submission.
We strongly recommended that you
submit your grant application by using
Microsoft Office products (e.g.,
Microsoft Word, Microsoft Excel, etc.). If
you do not have access to Microsoft
Office products, you may submit a PDF
file. You may find directions for
creating PDF files on the Grants.gov
Web site. Use of files other than
Microsoft Office or PDF could make
your file unreadable for our staff.
or
Submit the original and two hard
copies of your application by mail or
express delivery service to the following
address:
Technical Information Management—
AA172, CDC Procurement and Grants
Office, U.S. Department of Health and
Human Services, 2920 Brandywine
Road, Atlanta, GA 30341.
V. Application Review Information
V.1. Criteria
Applicants must provide measures of
effectiveness that will demonstrate the
accomplishment of the various
identified objectives of the cooperative
agreement. Measures of effectiveness
E:\FR\FM\24AUN1.SGM
24AUN1
Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices
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.
Applicants must submit these measures
of effectiveness with the application and
will be an element of evaluation.
Your application will be evaluated
against the following criteria:
1. Plan (30 Points). Does the applicant
demonstrate an understanding of the
national cultural and political context
and the technical and programmatic
areas covered by the project? Does the
applicant display knowledge of the fiveyear strategy and goals of the President’s
Emergency Plan, such that it can build
on these to develop a comprehensive,
collaborative project to reach
underserved populations in Zambia and
meet the goals of the Emergency Plan?
Is the plan adequate to carry out the
proposed objectives? How complete and
comprehensive is the plan for the entire
project period? Does the plan include a
quantitative process to measure
outcomes?
2. Personnel (20 Points). Do the staff
members have appropriate experience?
Are the staff roles clearly defined? As
described, will the staff be sufficient to
meet the goals of the Emergency Plan?
3. Need (20 Points). To what extent
does the applicant justify the need for
this program within the target
community?
4. Methods (15 Points). Does the
application include an overall design
strategy, including measurable time
lines, clear monitoring and evaluation
procedures, and specific activities for
meeting the proposed objectives? Does
the applicant describe a plan to build
progressively the capacity of local
organizations and of target beneficiaries
and communities to respond to the
epidemic?
5. Ability to carry out the project (15
Points). Does the applicant provide a
clear plan for the administration and
management of the proposed activities,
to manage the resources of the program,
prepare reports, monitor and evaluate
activities and audit expenditures?
6. Budget and Justification (Reviewed,
but not scored).
V.2. Review and Selection Process
The HHS/CDC Procurement and
Grants Office (PGO) staff will review
applications for completeness, and HHS
Global AIDS program will review them
for responsiveness. Incomplete
applications and applications that are
non-responsive to the eligibility criteria
will not advance through the review
process. Applicants will receive
VerDate jul<14>2003
15:23 Aug 23, 2005
Jkt 205001
notification 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. All persons who serve on the
panel will be external to the U.S.
Government Country Program Office.
The panel may include both Federal and
non-Federal participants.
In addition, the following factors
could affect the funding decision:
Applications will be funded in order
by score and rank determined by the
review panel. HHS/CDC will provide
justification for any decision to fund out
of rank order.
49653
VI.3. Reporting Requirements
VI.2. Administrative and National
Policy Requirements
You must provide CDC with an
original, plus two hard copies of the
following reports:
1. Interim progress report, due 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. Measures of Effectiveness,
including progress against the
numerical goals of the President’s
Emergency Plan for AIDS Relief for
Zambia.
f. Additional Requested Information.
2. Financial status report no more
than 90 days after the end of the budget
period.
3. Final financial and performance
reports, due no later than 90 days after
the end of the project period.
4. Annual progress report, due no
later than 90 days after the end of the
budget period. Reports should include
progress against the numerical goals of
the President’s Emergency Plan for
AIDS Relief for Zambia.
Recipients must mail these reports to
the Grants Management or Contract
Specialist listed in the ‘‘Agency
Contacts’’ section of this announcement.
45 CFR Part 74 and Part 92
VII. Agency Contacts
For more information on the Code of
Federal Regulations, see the National
Archives and Records Administration at
the following Internet address: https://
www.access.gpo.gov/nara/cfr/cfr-tablesearch.html.
The following additional
requirements apply to this project:
• AR–4 HIV/AIDS Confidentiality
Provisions
• AR–6 Patient Care
• AR–10 Smoke-Free Workplace
Requirements
Applicants can find additional
information on these requirements on
the HHS/CDC Web site at the following
Internet address: https://www.cdc.gov/
od/pgo/funding/ARs.htm.
An additional Certifications form
from the PHS5161–1 application needs
to be included in the Grants.gov
electronic submission only. Please refer
to https://www.cdc.gov/od/pgo/funding/
PHS5161-1-Certificates.pdf. Once you
have filled out the form, please attach it
to the Grants.gov submission as Other
Attachments Form.
We encourage inquiries concerning
this announcement. For general
questions, contact:
Technical Information Management
Section, CDC Procurement and Grants
Office, U.S. Department of Health and
Human Services, 2920 Brandywine
Road, Atlanta, GA 30341, Telephone:
770–488–2700.
For program technical assistance,
contact:
Marc Bulterys, Project Officer, 1600
Clifton Road MS E–04, Atlanta, GA
30333, Telephone: 011 260 1 250 955
ext 246, E-mail: bulterysm@cdczm.org.
For financial, grants management, or
budget assistance, contact:
Shirley Wynn, Grants Management
Specialist, CDC Procurement and Grants
Office, U.S. Department of Health and
Human Services, 2920 Brandywine
Road, Atlanta, GA 30341, Telephone:
770/488–1515, E-mail: zbx6@cdc.gov.
V.3. Anticipated Announcement and
Award Dates
September 23, 2005.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a
Notice of Award (NoA) from the HHS/
CDC Procurement and Grants Office.
The NoA shall be the only binding,
authorizing document between the
recipient and HHS/CDC. An authorized
Grants Management Officer will sign the
NoA, and mail it to the recipient fiscal
officer identified in the application.
Unsuccessful applicants will receive
notification of the results of the
application review by mail.
PO 00000
Frm 00100
Fmt 4703
Sfmt 4703
VIII. Other Information
Applicants can find this and other
HHS funding opportunity
E:\FR\FM\24AUN1.SGM
24AUN1
49654
Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices
announcements on the HHS/CDC Web
site, Internet address: https://
www.cdc.gov (Click on ‘‘Funding’’ then
‘‘Grants and Cooperative Agreements’’),
and on the Web site of the HHS Office
of Global Health Affairs, Internet
address: https://www.globalhealth.gov.
Dated: August 17, 2005.
William P. Nichols,
Director, Procurement and Grants Office,
Centers for Disease Control and Prevention,
U.S. Department of Health and Human
Services.
[FR Doc. 05–16838 Filed 8–23–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N–0442]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration Recall Regulations
(Guidelines)
AGENCY: Food and Drug Administration,
HHS.
ACTION: Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
23, 2005.
ADDRESSES: The Office of Management
and Budget (OMB) is still experiencing
significant delays in the regular mail,
including first class and express mail,
and messenger deliveries are not being
accepted. To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: Fumie Yokota, Desk Officer
for FDA, FAX: 202–395–6974.
FOR FURTHER INFORMATION CONTACT:
Karen Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Food and Drug Administration Recall
Regulations (Guidelines)—(OMB
Control Number 0910–0249)—Extension
Section 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 371) and
part 7 (21 CFR part 7), subpart C sets
forth the recall regulations (guidelines)
and provides guidance to manufacturers
on recall responsibilities. The
guidelines apply to all FDA-regulated
products (i.e., food, including animal
feed; drugs, including animal drugs;
medical devices, including in vitro
diagnostic products; cosmetics; and
biological products intended for human
use). These responsibilities include
development of a recall strategy that
requires time by the firm to determine
the actions or procedures required to
manage the recall; providing FDA with
complete details of the recall including
reason(s) for the removal or correction,
risk evaluation, quantity produced,
distribution information, firm’s recall
strategy, a copy of any recall
communication(s), and a contact
official; notifying direct accounts of the
recall, providing guidance regarding
further distribution, giving instructions
as to what to do with the product,
providing recipients with a ready means
of reporting to the recalling firm;
submitting periodic status reports so
that FDA may assess the progress of the
recall. Status report information may be
determined by, among other things
evaluation return reply cards,
effectiveness checks and product
returns; and providing the opportunity
for a firm to request in writing that FDA
terminate the recall.
A search of the FDA database was
performed to determine the number of
recalls that took place during fiscal year
2003. The resulting number of recalls
from this database search (2,375) is used
in estimating the current annual
reporting burden for this report. FDA
estimates the total annual industry
burden to collect and provide the above
information to 201,875 burden hours.
The following is a summary of the
estimated annual burden hours for
recalling firms (manufacturers,
processors, and distributors) to comply
with the voluntary reporting
requirements of FDA’s recall
regulations.
Recognizing that there may be a vast
difference in the information collection
and reporting time involved in different
recalls of FDA’s regulated products,
FDA estimates on average the burden of
collection for recall information to be as
follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
Recall Strategy
Firm Initiated Recall & Public Warnings Recall Communications
Recall Status Reports &
Followup
Termination of a Recall
Total
1There
Annual Frequency per
Response
No. of Respondents
Total Annual Responses
Hours per Response
Total Hours
2,375
1
2,375
15
35,625
2,375
1
2,375
20
47,500
2,375
2,375
4
1
9,500
2,375
10
10
95,000
23,750
201,875
are no capital costs or operating and maintenance costs associated with this collection of information.
The annual reporting burdens are
explained as follows:
information, the agency estimates it will
receive 2,375 responses annually.
Recall Strategy
Firm Initiated Recall and Recall
Communications
Requests firms to develop a recall
strategy including provision for public
warnings and effectiveness checks.
Under this portion of the collection of
VerDate jul<14>2003
15:23 Aug 23, 2005
Jkt 205001
Requests firms that voluntarily
remove or correct foods and drugs
(human or animal), cosmetics, medical
PO 00000
Frm 00101
Fmt 4703
Sfmt 4703
devices, and biologicals to immediately
notify the appropriate FDA district
office of such actions. The firm is to
provide complete details of the recall
reason, risk, evaluation, quantity
produced, distribution information,
firm’s recall strategy, and a contact
official as well as requires firms to
E:\FR\FM\24AUN1.SGM
24AUN1
Agencies
[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Notices]
[Pages 49648-49654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16838]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Implementation of Multi-Disciplinary HIV Care for Sexually Abused
Children in Zambia, as Part of the President's Emergency Plan for AIDS
Relief
Announcement Type: New.
Funding Opportunity Number: CDC-RFA-AA172.
Catalog of Federal Domestic Assistance Number: 93.067.
Key Dates: Application Deadline: September 19, 2005.
I. Funding Opportunity Description
Authority: This program is authorized under Sections 301(a) and 307
of the Public Health Service Act [42 U.S.C. 241 and 242l], as amended,
and under Public Law 108-25 (United States Leadership Against HIV/AIDS,
Tuberculosis and Malaria Act of 2003) [U.S.C. 7601].
Background: President Bush's Emergency Plan for AIDS Relief has
called for immediate, comprehensive and evidence-based action to turn
the tide of global HIV/AIDS. The initiative aims to treat more than two
million HIV-infected people with effective combination anti-retroviral
therapy by 2008; care for ten million HIV-infected and affected
persons, including those orphaned by HIV/AIDS, by 2008; and prevent
seven million infections by 2010, with focus on 15 priority countries,
including 12 in sub-Saharan Africa. The five-year strategy for the
Emergency Plan is available at the following Internet address: https://
www.state.gov/s/gac/rl/or/c11652.htm.
Over the same time period, as part of a collective national
response, the Emergency Plan goals specific to Zambia are to treat at
least 120,000 HIV-infected individuals and care for 600,000 HIV-
affected individuals, including orphans.
Under the leadership of the U.S. Global AIDS Coordinator, as part
of the President's Emergency Plan, the U.S. Department of Health and
Human Services (HHS) works with host countries and other key partners
to assess the needs of each country and design a customized program of
[[Page 49649]]
assistance that fits within the host nation's strategic plan.
HHS focuses on two or three major program areas in each country.
Goals and priorities include the following:
Achieving primary prevention of HIV infection through
activities such as expanding confidential counseling and testing
programs, building programs to reduce mother-to-child transmission, and
strengthening programs to reduce transmission via blood transfusion and
medical injections.
Improving the care and treatment of HIV/AIDS, sexually
transmitted diseases (STDs) and related opportunistic infections by
improving STD management; enhancing care and treatment of opportunistic
infections, including tuberculosis (TB); and initiating programs to
provide anti-retroviral therapy (ART).
Strengthening the capacity of countries to collect and use
surveillance data and manage national HIV/AIDS programs by expanding
HIV/STD/TB surveillance programs and strengthening laboratory support
for surveillance, diagnosis, treatment, disease-monitoring and HIV
screening for blood safety.
To carry out its activities in these countries, HHS works in a
collaborative manner with national governments and other agencies to
develop programs of assistance to address the HIV/AIDS epidemic. In
particular, HHS' mission in Zambia is to work with the Ministry of
Health, and its partners, to develop and apply effective interventions
to prevent and treat HIV infection and associated illness and death
from AIDS.
Purpose: The Demographic and Health Survey (2001-2002) from Zambia
indicates that in the age group 15 to 19 the HIV prevalence among women
is 6.6 percent, compared to a prevalence of 1.9 percent in men of the
same age. Reports from South Africa indicate that death rates among
girls between 15 to 19 years have increased by over 50 percent in the
last ten years. In the last few years, there has been a disturbing rise
in the number of cases of child rape and sexual abuse reported in the
media. In some sub-Saharan African countries, including Zambia, there
are myths surrounding HIV, such as that sex with a virgin can cure a
man of HIV. In addition, older men seek sex with very young partners in
the belief the young are free from HIV. These practices expose young
children to HIV infection, and have consequences on the child's
physical, psychological and social development. The actual extent of
this problem is often unclear, because the perpetrators are sometimes
close family members.
The University Teaching Hospital (UTH) is the main referral
hospital for pediatric care in Zambia. Cases of sexual abuse reported
to the hospital are seen first at the Police Post based there. In 2003,
a total of 659 cases of child sexual abuse were reported at the Police
Post. Currently, 15 to 20 sexually abused children are seen in the
clinic each week. However, many other cases might be missed because of
a lack of awareness of attending clinicians of evidence of sexual
abuse, or reluctance to discuss such issues with parents and guardians.
This leads to lost opportunities to provide post-exposure prophylaxis
and psychological support to the child, and increases the possibility
of HIV infection.
The Zambian UTH Department of Pediatrics, the National AIDS Council
Technical Group on Orphans and Vulnerable Children and the Zambian
Society for the Prevention of Child Abuse and Neglect (ZSPCAN), in
collaboration with international partners, has instituted various
activities on child sexual abuse, and the purpose of the program is to
strengthen the human capacity in Zambia to provide a child-friendly and
parent sensitive environment in which to provide counseling and
support; clinical care; and ongoing care including post-exposure
prophylaxis and anti-retroviral treatment (ART), as required, to
children who have suffered sexual abuse.
Measurable outcomes of the program will be in alignment with the
numerical goals of the President's Emergency Plan for AIDS Relief and
one (or more) of the following performance goal(s) for the National
Center for HIV, Sexually Transmitted Diseases and Tuberculosis
Prevention (NCHSTP) of the Centers for Disease Control and Prevention
(CDC) within HHS: Increase the proportion of HIV-infected people who
are linked to appropriate prevention, care and treatment services and
to strengthen the capacity nationwide to monitor the epidemic, develop
and implement effective HIV prevention interventions and evaluate
prevention programs.
This announcement is only for non-research activities supported by
HHS, including CDC. If research is proposed, the application will not
be reviewed. For the definition of ``research,'' please see the HHS/CDC
Web site at the following Internet address: https://www.cdc.gov/od/ads/
opspoll1.htm.
Activities: The recipient of these funds is responsible for
activities in multiple program areas designed to target underserved
populations in Zambia. Either the awardee will implement activities
directly or will implement them through its subgrantees and/or
subcontractors; the awardee will retain overall financial and
programmatic management under the oversight of HHS/CDC and the
strategic direction of the Office of the U.S. Global AIDS Coordinator.
The awardee must show a measurable, progressive reinforcement of the
capacity of indigenous organizations and local communities to respond
to the national HIV epidemic, as well as, progress towards the
sustainability of activities.
Applications should describe activities in detail as part of a
four-year action plan (U.S. Government Fiscal Years 2005-2008
inclusive) that reflects the policies and goals outlined in the five-
year strategy for the President's Emergency Plan.
The grantee will produce an annual operational plan in the context
of this four-year plan, which the U.S. Government Emergency Plan team
on the ground in Zambia will review as part of an annual Emergency Plan
for AIDS Relief Country Operational Plan review and approval process
managed by the Office of the U.S. Global AIDS Coordinator. The grantee
may work on some of the activities listed below in the first year and
in subsequent years, and then progressively add others from the list to
achieve all of the Emergency Plan performance goals, as cited in the
previous section. HHS/CDC, under the guidance of the U.S. Global AIDS
Coordinator, will approve funds for activities on an annual basis,
based on documented performance towards achieving Emergency Plan goals,
as part of the annual Emergency Plan for AIDS Relief Country
Operational Plan review and approval process.
Awardee activities for this program are as follows:
1. Train health workers in the Zambia UTH Departments of Pediatrics
and Obstetrics and Gynecology to recognize and care for child sexual
abuse.
2. Train health care workers to provide post-exposure prophylaxis
and ART, in general, for pediatric HIV care.
3. Provide culturally and age-appropriate psycho-social support in
local languages to sexually abused children and their families.
4. Develop a system to record accurately cases of child sexual
abuse, and to follow up such cases in the community.
5. Strengthen links with the Zambian Society for Child Abuse and
Neglect, and design activities to increase community awareness.
6. Develop a multi-disciplinary team to provide pediatric HIV care.
Administration: The winning applicant must comply with all HHS
[[Page 49650]]
management requirements for meeting participation and progress and
financial reporting for this cooperative agreement (See HHS Activities
and Reporting sections below for details), and comply with all policy
directives established by the Office of the U.S. Global AIDS
Coordinator.
In a cooperative agreement, HHS staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
HHS/CDC activities for this program are as follows:
1. Provide scientific and technical assistance in developing the
awardee's operational plan.
2. Provide ongoing technical assistance in program implementation.
3. Assist the awardee in assessments of the program's operations to
determine the overall effectiveness of the program, including
developing a monitoring and evaluation tool for the activities in the
program.
4. Design the program activities in conjunction with the UTH
Department of Pediatrics and other partners.
5. Participate in training of health staff.
6. Provide technical assistance from HHS-headquarters and the in-
country HHS office in Zambia to assure other related U.S. Government
activities are well-coordinated with the national program.
7. Organize an orientation meeting with the grantee to brief it on
applicable U.S. Government, HHS, and Emergency Plan expectations,
regulations and key management requirements, as well as report formats
and contents. The orientation could include meetings with staff from
HHS agencies and the Office of the U.S. Global AIDS Coordinator.
8. Review and approve the process used by the grantee to select key
personnel and/or post-award subcontractors and/or subgrantees to be
involved in the activities performed under this agreement, as part of
the Emergency Plan for AIDS Relief Country Operational Plan review and
approval process, managed by the Office of the U.S. Global AIDS
Coordinator.
9. Review and approve grantee's annual work plan and detailed
budget, as part of the Emergency Plan for AIDS Relief Country
Operational Plan review and approval process, managed by the Office of
the U.S. Global AIDS Coordinator.
10. Review and approve grantee's monitoring and evaluation plan,
including for compliance with the strategic information guidance
established by the Office of the U.S. Global AIDS Coordinator.
11. Meet on a monthly basis with grantee to assess monthly
expenditures in relation to approved work plan and modify plans as
necessary.
12. Meet on a quarterly basis with grantee to assess quarterly
technical and financial progress reports and modify plans as necessary.
13. Meet on an annual basis with grantee to review annual progress
report for each U.S. Government Fiscal Year, and to review annual work
plans and budgets for subsequent year, as part of the Emergency Plan
for AIDS Relief review and approval process for Country Operational
Plans, managed by the Office of the U.S. Global AIDS Coordinator.
14. Provide technical assistance, as mutually agreed upon, and
revise annually during validation of the first and subsequent annual
work plans. This could include expert technical assistance and targeted
training activities in specialized areas, such as strategic
information, project management, confidential counseling and testing,
palliative care, treatment literacy, and adult learning techniques.
15. Provide in-country administrative support to help grantee meet
U.S. Government financial and reporting requirements.
II. Award Information
Type of Award: Cooperative Agreement.
HHS involvement in this program is listed in the Activities Section
above.
Fiscal Year Funds: 2005.
Approximate Total Funding: $225,000. (This amount is an estimate,
and is subject to availability of funds.)
Approximate Number of Awards: One.
Approximate Average Award: $75,000. (This amount is for the first
12-month budget period, and includes direct costs.)
Floor of Award Range: None.
Ceiling of Award Range: $95,000. (This ceiling is for the first 12-
month budget period.)
Anticipated Award Date: September 23, 2005.
Budget Period Length: 12 months.
Project Period Length: Three years.
Throughout the project period, HHS' 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, through the annual Country
Operational Plan review and approval process, managed by the Office of
the U.S. Global AIDS Coordinator.
III. Eligibility Information
III.1. Eligible Applicants
We will provide assistance only to university teaching hospitals
that are referral hospitals and provide a full range of care, including
pediatric care, and have a mandate and specialty in caring for sexually
abused children. Eligible applicants must already have established
activities to monitor cases of child sexual abuse by working with the
local police post, to which all such cases, are initially referred.
III.2. Cost-Sharing or Matching Funds
Matching funds are not required for this program. Although matching
funds are not required, preference will go to organizations that can
leverage additional funds to contribute to program goals.
III.3. Other
If you request a funding amount greater than the ceiling of the
award range, we will consider your application non-responsive, and it
will not enter into the review process. We will notify you that your
application did not meet the submission requirements.
Special Requirements: If your application is incomplete or non-
responsive to the special requirements listed in this section, it will
not enter into the review process. We will notify you that your
application did not meet the submission requirements.
HHS/CDC will consider late applications 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 organization described in Section 501(c)(4) of the
Internal Revenue Code that engages in lobbying activities is not
eligible to receive Federal funds constituting an award, grant, or
loan.
IV. Application and Submission Information
IV.1. Address to Request Application Package
To apply for this funding opportunity use application form PHS
5161-1.
HHS strongly encourages you to submit your application
electronically by using the forms and instructions posted for this
announcement on https://www.grants.gov.
Application forms and instructions are available on the HHS/CDC Web
site, at the following Internet address: https://www.cdc.gov/od/pgo/
forminfo.htm.
If you do not have access to the Internet, or if you have
difficulty
[[Page 49651]]
accessing the forms on-line, you may contact the HHS/CDC Procurement
and Grants Office Technical Information Management Section (PGO-TIM)
staff at 770-488-2700. We can mail application forms to you.
IV.2. Content and Form of Submission
Application: You must submit a project narrative with your
application forms. You must submit the narrative in the following
format:
Maximum number of pages: 25. If your narrative exceeds the
page limit, we will only review the first pages within the page limit.
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.
Held together only by rubber bands or metal clips; not
bound in any other way.
Application must be written in English.
Your narrative should address activities to be conducted over the
entire project period, and must include the following items in the
order listed:
Justification for program.
Eligibility and organizational capacity.
Proposed program plan, including goals, objectives and
plan of operation.
Program Management, staffing, collaborations, and
infrastructure.
Evaluation plan.
Budget and 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. This additional information includes:
Curriculum Vitae.
Organizational Charts.
Letters of support.
Applicants must document eligibility by submitting
verification of their Zambian registration status.
Job descriptions of proposed key positions to be created
for the activity.
Quality-Assurance, Monitoring-and-Evaluation, and
Strategic-Information Forms.
Applicant's Corporate Capability Statement.
Evidence of Legal Organizational Structure.
You must 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
https://www.dunandbradstreet.com or call 1-866-705-5711.
For more information, see the HHS/CDC Web site at: https://
www.cdc.gov/od/pgo/funding/grantmain.htm. If your application form does
not have a DUNS number field, please write your DUNS number at the top
of the first page of your application, and/or include your DUNS number
in your application cover letter.
Additional requirements that could 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: September 19, 2005.
Explanation of Deadlines: Applications must be received in the HHS/
CDC Procurement and Grants Office by 4 p.m. eastern time on the
deadline date.
You may submit your application electronically at https://
www.grants.gov. We consider applications completed on-line through
Grants.gov as formally submitted when the applicant organization's
Authorizing Official electronically submits the application to https://
www.grants.gov. We will consider electronic applications as having met
the deadline if the applicant organization's Authorizing Official has
submitted the application electronically to Grants.gov on or before the
deadline date and time.
If you submit your application electronically through Grants.gov,
your application will be electronically time/date stamped, which will
serve as receipt of submission. You will receive an e-mail notice of
receipt when HHS/CDC receives the application.
If you submit your application by the United States Postal Service
or commercial delivery service, you must ensure the carrier will be
able to guarantee delivery by the closing date and time. If HHS/CDC
receives your submission after the closing date because: (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 have the opportunity to submit
documentation of the carrier's guarantee. If the documentation verifies
a carrier problem, HHS/CDC will consider the submission as received by
the deadline.
If you submit a hard copy application, HHS/CDC will not notify you
upon receipt of your submission. If you have a question about the
receipt of your application, first contact your carrier. 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 submission deadline.
This will allow time for us to process and log submissions.
This announcement is the definitive guide on application content,
submission address, and deadline. It supersedes information provided in
the application instructions. If your submission does not meet the
deadline above, it will not be eligible for review, and we will discard
it. We will notify you that you did not meet the submission
requirements.
IV.4. Intergovernmental Review of Applications
Executive Order 12372 does not apply to this program.
IV.5. Funding Restrictions
Restrictions, which you must take into account while writing your
budget, are as follows:
Funds may not be used for research.
Reimbursement of pre-award costs is not allowed.
Needle Exchange--No funds appropriated under this Act
shall be used to carry out any program of distributing sterile needles
or syringes for the hypodermic injection of any illegal drug.
Funds may be spent for reasonable program purposes,
including personnel, travel, supplies, and services. Equipment may be
purchased if deemed necessary to accomplish program objectives;
however, prior approval by HHS/CDC officials must be requested in
writing.
All requests for funds contained in the budget shall be
stated in U.S. dollars. Once an award is made, HHS/CDC will not
compensate foreign grantees for currency exchange fluctuations through
the issuance of supplemental awards.
The costs that are generally allowable in grants to
domestic organizations are allowable to foreign institutions and
international organizations, with the following exception: With the
exception of the American University, Beirut, and the World Health
Organization, Indirect Costs will not be paid (either directly or
through sub-award) to organizations located outside the territorial
limits of the U.S. or to international organizations, regardless of
their location.
The applicant may contract with other organizations under
this program; however the applicant must perform a
[[Page 49652]]
substantial portion of the activities (including program management and
operations, and delivery of prevention services for which funds are
required).
You must obtain an annual audit of these HHS/CDC funds
(program-specific audit) by a U.S.-based audit firm with international
branches and current licensure/authority in-country, and in accordance
with International Accounting Standards or equivalent standards(s)
approved in writing by HHS/CDC.
A fiscal Recipient Capability Assessment may be required,
prior to or post award, in order to review the applicant's business
management and fiscal capabilities regarding the handling of U.S.
Federal funds.
Prostitution and Related Activities
The U.S. Government is opposed to prostitution and related
activities, which are inherently harmful and dehumanizing, and
contribute to the phenomenon of trafficking in persons.
Any entity that receives, directly or indirectly, U.S. Government
funds in connection with this document (``recipient'') cannot use such
U.S. Government funds to promote or advocate the legalization or
practice of prostitution or sex trafficking. Nothing in the preceding
sentence shall be construed to preclude the provision to individuals of
palliative care, treatment, or post-exposure pharmaceutical
prophylaxis, and necessary pharmaceuticals and commodities, including
test kits, condoms, and, when proven effective, microbicides.
A recipient that is otherwise eligible to receive funds in
connection with this document to prevent, treat, or monitor HIV/AIDS
shall not be required to endorse or utilize a multisectoral approach to
combating HIV/AIDS, or to endorse, utilize, or participate in a
prevention method or treatment program to which the recipient has a
religious or moral objection. Any information provided by recipients
about the use of condoms as part of projects or activities that are
funded in connection with this document shall be medically accurate and
shall include the public health benefits and failure rates of such use.
In addition, any recipient must have a policy explicitly opposing
prostitution and sex trafficking. The preceding sentence shall not
apply to any ``exempt organizations'' (defined as the Global Fund to
Fight AIDS, Tuberculosis and Malaria, the World Health Organization and
its six Regional Offices, the International AIDS Vaccine Initiative or
any United Nations agency).
The following definition applies for purposes of this clause:
Sex trafficking means the recruitment, harboring,
transportation, provision, or obtaining of a person for the purpose of
a commercial sex act. 22 U.S.C. 7102(9).
All recipients must insert provisions implementing the applicable
parts of this section, ``Prostitution and Related Activities,'' in all
subagreements under this award. These provisions must be express terms
and conditions of the subagreement, must acknowledge that compliance
with this section, ``Prostitution and Related Activities,'' is a
prerequisite to receipt and expenditure of U.S. government funds in
connection with this document, and must acknowledge that any violation
of the provisions shall be grounds for unilateral termination of the
agreement prior to the end of its term. Recipients must agree that HHS
may, at any reasonable time, inspect the documents and materials
maintained or prepared by the recipient in the usual course of its
operations that relate to the organization's compliance with this
section, ``Prostitution and Related Activities.''
All prime recipients that receive U.S. Government funds (``prime
recipients'') in connection with this document must certify compliance
prior to actual receipt of such funds in a written statement that makes
reference to this document (e.g., ``[Prime recipient's name] certifies
compliance with the section, `Prostitution and Related Activities.' '')
addressed to the agency's grants officer. Such certifications by prime
recipients are prerequisites to the payment of any U.S. Government
funds in connection with this document.
Recipients' compliance with this section, ``Prostitution and
Related Activities,'' is an express term and condition of receiving
U.S. Government funds in connection with this document, and any
violation of it shall be grounds for unilateral termination by HHS of
the agreement with HHS in connection with this document prior to the
end of its term. The recipient shall refund to HHS the entire amount
furnished in connection with this document in the event HHS determines
the recipient has not complied with this section, ``Prostitution and
Related Activities.''
You may find guidance for completing your budget on the HHS/CDC Web
site, at the following Internet address: https://www.cdc.gov/od/pgo/
funding/budgetguide.htm.
IV.6. Other Submission Requirements
Application Submission Address: HHS/CDC strongly encourages you to
submit electronically at: https://www.grants.gov. You will be able to
download a copy of the application package from https://www.grants.gov,
complete it offline, and then upload and submit the application via the
Grants.gov site. We will not accept e-mail submissions. If you are
having technical difficulties in Grants.gov, you may reach them by e-
mail at support@grants.gov, or by phone at 1-800-518-4726 (1-800-518-
GRANTS). The Customer Support Center is open from 7 a.m. to 9 p.m.
eastern time, Monday through Friday.
HHS/CDC recommends that you submit your application to Grants.gov
early enough to resolve any unanticipated difficulties prior to the
deadline. You may also submit a back-up paper submission of your
application. We must receive any such paper submission in accordance
with the requirements for timely submission detailed in Section IV.3.
of the grant announcement.
You must clearly mark the paper submission: ``BACK-UP FOR
ELECTRONIC SUBMISSION.''
The paper submission must conform to all requirements for non-
electronic submissions. If we receive both electronic and back-up paper
submissions by the deadline, we will consider the electronic version
the official submission.
We strongly recommended that you submit your grant application by
using Microsoft Office products (e.g., Microsoft Word, Microsoft Excel,
etc.). If you do not have access to Microsoft Office products, you may
submit a PDF file. You may find directions for creating PDF files on
the Grants.gov Web site. Use of files other than Microsoft Office or
PDF could make your file unreadable for our staff.
or
Submit the original and two hard copies of your application by mail
or express delivery service to the following address:
Technical Information Management--AA172, CDC Procurement and Grants
Office, U.S. Department of Health and Human Services, 2920 Brandywine
Road, Atlanta, GA 30341.
V. Application Review Information
V.1. Criteria
Applicants must provide measures of effectiveness that will
demonstrate the accomplishment of the various identified objectives of
the cooperative agreement. Measures of effectiveness
[[Page 49653]]
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. Applicants must submit these
measures of effectiveness with the application and will be an element
of evaluation.
Your application will be evaluated against the following criteria:
1. Plan (30 Points). Does the applicant demonstrate an
understanding of the national cultural and political context and the
technical and programmatic areas covered by the project? Does the
applicant display knowledge of the five-year strategy and goals of the
President's Emergency Plan, such that it can build on these to develop
a comprehensive, collaborative project to reach underserved populations
in Zambia and meet the goals of the Emergency Plan? Is the plan
adequate to carry out the proposed objectives? How complete and
comprehensive is the plan for the entire project period? Does the plan
include a quantitative process to measure outcomes?
2. Personnel (20 Points). Do the staff members have appropriate
experience? Are the staff roles clearly defined? As described, will the
staff be sufficient to meet the goals of the Emergency Plan?
3. Need (20 Points). To what extent does the applicant justify the
need for this program within the target community?
4. Methods (15 Points). Does the application include an overall
design strategy, including measurable time lines, clear monitoring and
evaluation procedures, and specific activities for meeting the proposed
objectives? Does the applicant describe a plan to build progressively
the capacity of local organizations and of target beneficiaries and
communities to respond to the epidemic?
5. Ability to carry out the project (15 Points). Does the applicant
provide a clear plan for the administration and management of the
proposed activities, to manage the resources of the program, prepare
reports, monitor and evaluate activities and audit expenditures?
6. Budget and Justification (Reviewed, but not scored).
V.2. Review and Selection Process
The HHS/CDC Procurement and Grants Office (PGO) staff will review
applications for completeness, and HHS Global AIDS program will review
them for responsiveness. Incomplete applications and applications that
are non-responsive to the eligibility criteria will not advance through
the review process. Applicants will receive notification 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. All persons who serve on the panel will be external to
the U.S. Government Country Program Office. The panel may include both
Federal and non-Federal participants.
In addition, the following factors could affect the funding
decision:
Applications will be funded in order by score and rank determined
by the review panel. HHS/CDC will provide justification for any
decision to fund out of rank order.
V.3. Anticipated Announcement and Award Dates
September 23, 2005.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Award (NoA) from the
HHS/CDC Procurement and Grants Office. The NoA shall be the only
binding, authorizing document between the recipient and HHS/CDC. An
authorized Grants Management Officer will sign the NoA, and mail it 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: https://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
The following additional requirements apply to this project:
AR-4 HIV/AIDS Confidentiality Provisions
AR-6 Patient Care
AR-10 Smoke-Free Workplace Requirements
Applicants can find additional information on these requirements on
the HHS/CDC Web site at the following Internet address: https://
www.cdc.gov/od/pgo/funding/ARs.htm.
An additional Certifications form from the PHS5161-1 application
needs to be included in the Grants.gov electronic submission only.
Please refer to https://www.cdc.gov/od/pgo/funding/PHS5161-1-
Certificates.pdf. Once you have filled out the form, please attach it
to the Grants.gov submission as Other Attachments Form.
VI.3. Reporting Requirements
You must provide CDC with an original, plus two hard copies of the
following reports:
1. Interim progress report, due 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. Measures of Effectiveness, including progress against the
numerical goals of the President's Emergency Plan for AIDS Relief for
Zambia.
f. Additional Requested Information.
2. Financial status report no more than 90 days after the end of
the budget period.
3. Final financial and performance reports, due no later than 90
days after the end of the project period.
4. Annual progress report, due no later than 90 days after the end
of the budget period. Reports should include progress against the
numerical goals of the President's Emergency Plan for AIDS Relief for
Zambia.
Recipients must mail these reports to the Grants Management or
Contract 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, U.S. Department of Health and Human Services, 2920
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
For program technical assistance, contact:
Marc Bulterys, Project Officer, 1600 Clifton Road MS E-04, Atlanta,
GA 30333, Telephone: 011 260 1 250 955 ext 246, E-mail:
bulterysm@cdczm.org.
For financial, grants management, or budget assistance, contact:
Shirley Wynn, Grants Management Specialist, CDC Procurement and
Grants Office, U.S. Department of Health and Human Services, 2920
Brandywine Road, Atlanta, GA 30341, Telephone: 770/488-1515, E-mail:
zbx6@cdc.gov.
VIII. Other Information
Applicants can find this and other HHS funding opportunity
[[Page 49654]]
announcements on the HHS/CDC Web site, Internet address: https://
www.cdc.gov (Click on ``Funding'' then ``Grants and Cooperative
Agreements''), and on the Web site of the HHS Office of Global Health
Affairs, Internet address: https://www.globalhealth.gov.
Dated: August 17, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention, U.S. Department of Health and Human Services.
[FR Doc. 05-16838 Filed 8-23-05; 8:45 am]
BILLING CODE 4163-18-P