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 

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-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: http://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 http://www.cdc.gov/od/pgo/funding/

PHS5161-1-Certificates.pdf. Once you 

have filled out the form, attach it to the 

Grants.gov submission as Other 

Attachments Form. 

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 

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.’’

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: http://

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 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 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 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.

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: http://

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 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 

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. 

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 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

http://www.grants.gov. 

Application forms and instructions 

are available on the HHS/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 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 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, 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 

number, access http://

www.dunandbradstreet.com or call

1–866–705–5711. 

For more information, see the HHS/

CDC Web site at: http://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 http://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 

http://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 

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).

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: http://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: http://

www.grants.gov. You will be able to 

download a copy of the application 

package from http://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 

Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 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 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 

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: http://

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: http://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 http://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 

49654 Federal Register / Vol. 70, No. 163 / Wednesday, August 24, 2005 / Notices 

announcements on the HHS/CDC Web 

site, Internet address: http://

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: http://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 No. of Respondents Annual Frequency per 

Response 

Total Annual Responses Hours per Response Total Hours 

Recall Strategy 2,375 1 2,375 15 35,625

Firm Initiated Recall & Public Warnings Recall Communications 2,375 1 2,375 20 47,500

Recall Status Reports & 

Followup 2,375 4 9,500 10 95,000

Termination of a Recall 2,375 1 2,375 10 23,750

Total 201,875

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The annual reporting burdens are 

explained as follows:

Recall Strategy

Requests firms to develop a recall 

strategy including provision for public 

warnings and effectiveness checks. 

Under this portion of the collection of 

information, the agency estimates it will 

receive 2,375 responses annually.

Firm Initiated Recall and Recall 

Communications

Requests firms that voluntarily 

remove or correct foods and drugs 

(human or animal), cosmetics, medical 

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