57298 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Notices 

Data Confidentiality Provisions 

The data will be collected by an 

independent consulting firm under 

terms of its contract. The identifiable 

information about institutions will be 

kept confidential in accordance with 42 

U.S.C. 299c–3(c). AHRQ and HRSA will 

revieve only state-level summary data, 

and not individual hospital responses. 

Method of Collection 

The 2004 preparedness questionnaire 

will be administered electronically to 

each hospital via electronic mail. The 

estimated annual burden is as follows:

ESTIMATED ANNUAL RESPONDENT

BURDEN

Number of

questionnaire

recipients 

Estimated

burden/

respondent

(minutes) 

Total hours

of burden 

6000 .................. 60 6000 

The estimate burden is based on the 

completion of a paper version of the 

questionnaire by a pilot hospital. The 

more efficient data collection effort 

enabled by the electronic format has 

been taken into account in this estimate. 

The annualized cost to all potential 

respondents is estimated at $209,040 

Total ($34.84/hr [average staff time] × 1 

hr. 6000 respondents). Percentage of 

capital costs, operating costs or 

maintenance costs are negligible. We 

propose a census information collection 

approach as appropriate data on which 

to develop a stratified, purposive 

sample is unavailable. Future studies 

will utilize statistical methods based on 

our baseline data to develop a sampling 

scheme. 

Request for Comments 

In accordance with the above cited 

Paperwork Reduction Act legislation, 

comments on the AHRQ’s and HRSA’s 

information collection are requested 

with regard to any of the following: (a) 

Whether the proposed collection of 

information is necessary for the proper 

performance of functions of AHRQ and 

HRSA, including whether the 

information will have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden (including hours and 

costs) of the proposed collection of 

information (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will summarized and 

included in the request for OMB 

approval of the proposed information 

collection. All comments will become a 

matter of public record.

Dated: September 17, 2004. 

Carolyn M. Clancy, 

Director.

[FR Doc. 04–21469 Filed 9–23–04; 8:45 am] 

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Emerging Infections Programs 

Announcement Type: Competing 

Continuation. 

Funding Opportunity Number: CI05–

026. 

Catalog of Federal Domestic 

Assistance Number: 93.283. 

Key Dates:

Letter of Intent Deadline: October 11, 

2004. 

Application Deadline: November 1, 

2004. 

Executive Summary: The purpose of 

this program announcement is to 

provide continued support to existing 

Emerging Infections Programs (EIPs), or 

to develop new EIPs, as part of the 

national network. EIPs are populationbased centers which assess the public 

health impact of and respond to 

emerging infections. Activities of the 

EIPs fall into these general categories: 

(1) Active surveillance; (2) applied 

public health epidemiologic and 

laboratory activities; and (3) 

implementation and evaluation of pilot 

prevention/intervention projects. The 

EIPs function as a collaborative network 

of public and private organizations that 

have an interest in addressing infectious 

diseases health issues; EIPs maintain 

sufficient flexibility to address 

infectious disease health issues as they 

emerge. EIPs are strategically located to 

serve a variety of geographical areas and 

diverse groups of people. 

The following guiding principles 

motivate the work of the EIPs: (1) EIPs 

aim to be a national resource for 

surveillance, prevention, and control of 

emerging infectious diseases—EIP 

functions go beyond the routine 

functions of health departments in ways 

that allow important public health 

questions to be answered; (2) EIP 

activities address important issues in 

infectious diseases, selected with regard 

to what is appropriate for this 

population-based infrastructure; (3) EIPs 

maintain sufficient flexibility for 

emergency response and to address new 

problems as they arise; (4) training is a 

key function of the EIPs; (5) EIPs 

develop and evaluate public health 

practices and transfer what is learned to 

the public health community; and (6) 

EIPs give high priority to activities that 

lead directly to prevention of disease. 

I. Funding Opportunity Description

Authority: This program is authorized 

under the Public Health Service Act Sections 

301(a)[42 U.S.C. 241(a)], 317(k)(1)[42 U.S.C. 

247b(k)(1)], and 317(k)(2)[42 U.S.C. 

247b(k)(2)], as amended.

Purpose: The purpose of the program 

is to assist in local, state, and national 

efforts to conduct surveillance and 

public health epidemiologic and 

laboratory activities in emerging 

infectious diseases, and to pilot and 

evaluate methods for the prevention and 

control of emerging infectious diseases. 

This program addresses the ‘‘Healthy 

People 2010’’ focus area(s) of 

Immunization and Infectious Diseases. 

Measurable outcomes of the program 

will be in alignment with the following 

performance goal for the National 

Center for Infectious Diseases (NCID): 

Protect Americans from infectious 

diseases. 

Research Objectives: The overall 

objective of the EIP cooperative 

agreement is to assess the public health 

impact of and respond to emerging 

infections. Activities of the EIPs fall into 

these general categories: (1) Active 

surveillance; (2) applied public health 

epidemiologic and laboratory activities; 

and (3) implementation and evaluation 

of pilot prevention/intervention 

projects. Specific objectives for research 

and other activities supported by this 

cooperative agreement are outlined in 

the individual Activities, below.

Activities: Awardee activities for this 

program are as follows: 

(a) Functions and structure for EIP—

Establish and operate an EIP to further 

local, State, and national efforts to 

address emerging infectious diseases. 

(1) Establish each EIP activity in a 

defined population, which could 

include either an entire State or a 

geographically defined area (or areas) 

within a State. The population base may 

vary for various activities. For certain 

activities, the population base may be 

defined by a healthcare delivery system 

such as a health maintenance 

organization (HMO). To accomplish the 

objectives of certain EIP activities, a 

minimum population base of 

approximately 1,500,000 may be 

necessary. 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Notices 57299

(2) Provide effective scientific 

leadership, coordination, and execution 

of EIP activities. 

(3) Provide effective management to 

support operation of the EIP. 

(4) Organize the EIP so that it 

maintains the flexibility to respond to 

new health problems as they emerge. 

(5) Operate the EIP so that it can 

function effectively as part of a national 

network of EIPs. Collaborate with CDC 

and other EIPs, through the EIP steering 

group and other EIP working groups, to 

establish priorities, to coordinate and 

monitor projects, and to assure that 

important emerging infections issues are 

appropriately addressed. 

(6) Ensure that site representatives 

attend and participate in EIP Steering 

Group Meetings and other required EIP 

meetings. 

(7) As a part of certain EIP projects, 

provide specimens such as diseasecausing isolates or serum specimens to 

appropriate organizations (which may 

include, but is not limited to CDC) for 

laboratory evaluation (e.g., molecular 

epidemiologic studies, evaluation of 

diagnostic tools). 

(8) Manage, analyze, and interpret 

data from EIP projects; publish and 

disseminate important public health 

information stemming from EIP projects 

in collaboration with CDC and other EIP 

sites. 

(9) Monitor and evaluate scientific 

and operational accomplishments and 

progress in achieving the purpose of this 

program. 

(10) If a proposed project involves 

research on human participants, ensure 

appropriate IRB review. 

(11) Information systems used or 

developed through this cooperative 

agreement should conform to the Public 

Health Information Network (PHIN) 

standards, the goal of which is the 

creation of standards-based, 

interoperable public health information 

systems. For more information on PHIN, 

the PHIN architecture, PHIN messaging, 

and PHIN standards, functions, and 

specifications, see the CDC Web site: 

http://www.cdc.gov/phin. CDC will 

work with EIP sites to evolve EIP 

information systems to conform to PHIN 

standards. 

(b) Partnerships—Develop the EIP as 

a partnership between the health 

department and other public and private 

organizations that have an interest in 

addressing public health issues relating 

to emerging infectious diseases, e.g., 

local public health agencies, academic 

institutions, health care providers, 

infection control professionals, clinical 

laboratories, other Federal and state 

government agencies, and research 

organizations. Build and draw upon 

these relationships for the conduct of 

specific EIP activities.

(c) Tools and Capacities—Develop 

and utilize a set of tools or capacities to 

conduct EIP activities, e.g., active 

laboratory-based surveillance; medical 

records review for surveillance or 

studies; case-control studies; selected 

laboratory testing of isolates or 

specimens; surveys (e.g., of laboratories, 

providers, public); collection of isolates 

of disease-causing agents in the context 

of surveillance; network of infection 

control professionals; and analyses of 

hospital admission or discharge data. 

(d) General EIP Activities—Activities 

of the EIPs generally fall into three 

categories: 

(1) Active population-based 

surveillance projects. These may 

include collection and submission of 

disease-causing infectious agents to 

state, CDC, or other laboratories. For 

example, the surveillance case 

definition for the condition might 

involve detection of a positive culture or 

a drug resistant isolate in a microbiology 

laboratory, a serologic test result, a 

histopathologic finding, or a clinical 

syndrome, depending upon the disease 

or condition under surveillance. The 

specific approach to surveillance could 

also vary depending on the disease or 

condition under surveillance. 

Surveillance should be comprehensive 

(e.g., may include audits to assure 

complete reporting) with active casefinding. 

(2) Applied epidemiologic and 

applied laboratory projects. Examples of 

potential projects include: Evaluation of 

illnesses often not specifically 

diagnosed for which information about 

trends and etiology are important (e.g., 

pneumonia); evaluation of clinical 

outcomes or risk factors for drug 

resistant infections; evaluation of the 

role of human genomics in disease 

causation and individual susceptibility; 

and evaluation of the efficacy of 

pneumococcal and meningococcal 

conjugate vaccines. 

(3) Implementation and evaluation of 

pilot prevention/intervention projects 

for emerging infectious diseases. 

Examples might include, e.g., evaluation 

of the impact of Group B Streptococcus 

prevention guidelines, or evaluation of 

the role of human genomics in public 

health investigations. 

(e) Specific EIP activities—All 

applicants should propose activities #1–

5; additional activities may be proposed 

(#6–12) at the discretion of the 

applicant. Each application will be 

evaluated as a whole (see Criteria for 

evaluation in Section V.1 below). 

Therefore, any additional activity 

proposals should be commensurate with 

the applicant’s capacity and should be 

designed to enhance the applications as 

whole. Applicants are invited to consult 

with CDC programs in planning their 

proposed activities. [For details about 

these activities, see Appendices posted 

on the CDC Web site: http://

www.cdc.gov/od/pgo/funding/

grantmain.htm.] 

(1) Active Bacterial Core surveillance 

(ABCs) and related activities—ALL 

applicants should propose this activity. 

CDC expects to provide support for 

ABCs activities in all EIPs, although 

some ABCs activities are expected to be 

conducted only in certain sites. For 

more details, see Appendix 1 posted on 

the CDC Web site: http://www.cdc.gov/

od/pgo/funding/grantmain.htm.

(2) Active population-based 

laboratory surveillance for food-borne 

diseases (FoodNet) and related 

activities—ALL applicants should 

propose this activity. CDC expects to 

provide support for FoodNet activities 

in all EIPs, although some FoodNet 

activities are expected to be conducted 

only in certain sites. For more details, 

see Appendix 2 posted on the CDC Web 

site: http://www.cdc.gov/od/pgo/

funding/grantmain.htm.

(3) Surveillance for respiratory 

diseases and syndromes—ALL 

applicants should propose this activity. 

CDC expects to provide support for five 

to nine EIPs for one or more aspects of 

this activity. For more detailed 

guidance, see Appendix 3 posted on the 

CDC Web site: http://www.cdc.gov/od/

pgo/funding/grantmain.htm.

(4) Flexible Response to Emerging 

Problems—ALL applicants should 

propose this activity. Each EIP will be 

expected to participate in a workgroup 

to review newly emerging infectious 

disease issues on short notice and 

contribute to rapid study design, 

initiation, and completion. For more 

details, see Appendix 4 posted on the 

CDC Web site: http://www.cdc.gov/od/

pgo/funding/grantmain.htm.

(5) EIP rapid population-based survey 

capacity—ALL applicants should 

propose this activity. CDC expects to 

provide support for population-based 

survey capacity in all EIP sites. For 

detailed guidance on applying for this 

activity, see Appendix 5 posted on the 

CDC Web site: http://www.cdc.gov/od/

pgo/funding/grantmain.htm.

(6) Integrated hepatitis surveillance—

Applicants may choose to propose some 

or all components of this activity, and 

CDC may provide some support for each 

of the components. For detailed 

guidance and specific eligibility criteria 

for this activity, see Appendix 6 posted 

on the CDC Web site: http://

57300 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Notices 

www.cdc.gov/od/pgo/funding/

grantmain.htm.

(7) Surveillance for encephalitis 

syndrome—Applicants may choose to 

propose this activity. CDC expects to 

provide support for up to three EIPs for 

this activity. For more details, see 

Appendix 7 posted on the CDC Web 

site: http://www.cdc.gov/od/pgo/

funding/grantmain.htm.

(8) Surveillance for Unexplained 

Deaths (UNEX)—EIPs that are currently 

conducting UNEX may choose to 

propose to continue this activity. Any 

proposal for syndrome surveillance, e.g., 

respiratory syndromes, should be 

proposed and managed as part of the 

corresponding EIP syndrome activity, 

not separately as part of this activity. 

For more details, see Appendix 7 posted 

on the CDC Web site: http://

www.cdc.gov/od/pgo/funding/

grantmain.htm.

(9) Border Infectious Disease 

Surveillance (BIDS)—Applicants along 

the U.S./Mexico Border may propose 

this activity. For more details, see 

Appendix 7 posted on the CDC Web 

site: http://www.cdc.gov/od/pgo/

funding/grantmain.htm.

(10) Incorporate a training activity 

into the operation of the EIP—Any 

applicant may propose this activity. See 

Appendix 7 for details. 

(11) Prepare for and engage in 

activities to assess human genomics risk 

factors into acute public health 

investigations—Any applicant may 

propose this activity. CDC may provide 

support for one to three sites for this 

activity. For more details, see Appendix 

7 posted on the CDC Web site: http://

www.cdc.gov/od/pgo/funding/

grantmain.htm.

(12) Site-specific EIP activity—

Applicants may propose other activities 

of local interest or concern that are 

consistent with EIP objectives and 

guiding principles.

In a cooperative agreement, CDC staff 

is substantially involved in the program 

activities, above and beyond routine 

grant monitoring. 

CDC Activities for this program are as 

follows: 

(a) Provide general coordination for 

the EIPs as a network. 

(b) Assist in developing collaborative 

relationships and facilitate multi-site 

collaboration as needed to support the 

successful completion of the project. 

(c) Provide consultation, scientific 

and technical assistance in the 

operation of the EIP and in designing 

and conducting individual EIP projects. 

(Examples include, participating in 

protocol development, helping with 

study design, assisting in the 

development of information systems, 

data analysis and dissemination of 

results, coordinating and facilitating 

communications among EIPs). 

(d) Participate in analysis and 

interpretation of data from EIP projects. 

Participate in the dissemination of 

findings and information stemming 

from EIP projects. 

(e) Assist in monitoring and 

evaluating scientific and operational 

accomplishments of the EIP and 

progress in achieving the purpose and 

overall goals of this program. 

(f) If needed, perform laboratory 

evaluation of specimens or isolates (e.g., 

molecular epidemiologic studies, 

evaluation of diagnostic tools) obtained 

in EIP projects and integrate results with 

other data from EIP projects. 

(g) If a proposed project involves 

research with human subjects and CDC 

scientists will be co-investigators in that 

research, assist in the development of a 

research protocol for IRB review by all 

institutions participating in the research 

project. The CDC IRB will review and 

approve the project initially and on, at 

least, an annual basis until the research 

project is completed. 

(h) Consult with sites to assist 

evolution of EIP-related information 

systems to conform to Public Health 

Information Network (PHIN) standards. 

II. Award Information 

Type of Award: Cooperative 

Agreement. CDC involvement in this 

program is listed in the Activities 

Section above. 

Mechanism of Support: U01. 

Fiscal Year Funds: 2005. 

Approximate Total Funding:

$19,600,000.

Approximate Number of Awards: 9. 

Approximate Average Award:

$2,400,000. (This amount is for the first 

12-month budget period, and includes 

both direct and indirect costs.) 

Floor of Award Range: $1,400,000. 

Ceiling of Award Range: $3,500,000. 

Anticipated Award Date: December 

29, 2004. 

Budget Period Length: 12 months. 

Project Period Length: 5 years. 

Throughout the project period, CDC’s 

commitment to continuation of awards 

will be conditioned on the availability 

of funds, evidence of satisfactory 

progress by the recipient (as 

documented in required reports), and 

the determination that continued 

funding is in the best interest of the 

Federal Government. 

III. Eligibility Information 

III.1. Eligible Applicants 

Applications may be submitted by 

state governments or their Bona Fide 

Agents (this includes the District of 

Columbia, the Commonwealth of Puerto 

Rico, the Virgin Islands, the 

Commonwealth of the Northern Mariana 

Islands, American Samoa, Guam, the 

Federated States of Micronesia, the 

Republic of the Marshall Islands, and 

the Republic of Palau). 

A Bona Fide Agent is an agency/

organization identified by the state as 

eligible to submit an application under 

the state eligibility in lieu of a state 

application. If you are applying as a 

bona fide agent of a state or local 

government, you must provide a letter 

from the state or local government as 

documentation of your status. Place this 

documentation behind the first page of 

your application form. 

III.2. Cost Sharing or Matching 

Matching funds are not required for 

this program. 

III.3. Other 

CDC will accept and review 

applications with budgets greater than 

the ceiling of the award range. 

Special Requirements 

If your application is incomplete or 

non-responsive to the requirements 

listed in this section, it will not be 

entered into the review process. You 

will be notified that your application 

did not meet submission requirements.

• Late applications will be considered 

non-responsive. See ‘‘Section IV.3. 

Submission Dates and Times’’ for more 

information on deadlines. 

• Note: Title 2 of the United States 

Code section 1611 states that an 

organization described in section 

501(c)(4) of the Internal Revenue Code 

that engages in lobbying activities is not 

eligible to receive Federal funds 

constituting an award, grant, or loan. 

Individuals Eligible To Become 

Principal Investigators or Co-Principal 

Investigators 

Any individual with the skills, 

knowledge, and resources necessary to 

carry out the proposed EIP activities is 

invited to work with their institution to 

develop an application for support. 

Individuals from underrepresented 

racial and ethnic groups as well as 

individuals with disabilities are always 

encouraged to apply for CDC programs. 

IV. Application and Submission 

Information 

IV.1. Address To Request Application 

Package 

To apply for this funding opportunity 

use application form PHS 398 (OMB 

number 0925–0001 rev. 5/2001). Forms 

and instructions are available in an 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Notices 57301

interactive format on the CDC Web site, 

at the following Internet address: http:/

/www.cdc.gov/od/pgo/forminfo.htm.

Forms and instructions are also 

available in an interactive format on the 

National Institutes of Health (NIH) Web 

site, at the following Internet address: 

http://grants.nih.gov/grants/funding/

phs398/phs398.html.

If you do not have access to the 

Internet, or if you have difficulty 

accessing the forms on-line, you may 

contact the CDC Procurement and 

Grants Office Technical Information 

Management Section (PGO–TIM) staff 

at: (770) 488–2700. Application forms 

can be mailed to you. 

IV.2. Content and Form of Submission 

Letter of Intent (LOI) 

A letter of intent is requested to help 

plan the application review, but it is not 

mandatory. Your LOI must be written in 

the following format: 

• Maximum number of pages: 2. 

• Font size: 12-point unreduced. 

• Single spaced. 

• Paper size: 8.5 by 11 inches. 

• Page margin size: One inch. 

• Printed only on one side of page.

• Written in plain language, avoid 

jargon. 

Your LOI must include the following 

information: 

• Number and title of this Program 

Announcement (PA). 

• Name of Applicant (i.e. State Health 

Department or bona fide agent). 

If you are applying as a bona fide

agent of a state or local government, you 

must provide a letter from the state as 

documentation of your status at the time 

of application. 

• Name, address, e-mail address, and 

telephone number of the Principal 

Investigator and Co-Investigator. 

• Brief description of your eligibility 

and intent to apply. 

Application 

Follow the PHS 398 application 

instructions for content and formatting 

of your application. If the instructions 

in this announcement differ in any way 

from the PHS 398 instructions, follow 

the instructions in this announcement. 

For further assistance with the PHS 398 

application form, contact PGO–TIM staff 

at (770) 488–2700, or contact GrantsInfo, 

Telephone (301) 435–0714, e-mail: 

GrantsInfo@nih.gov.

Your research plan should address 

activities to be conducted over the 

entire project period, focusing in detail 

on the first year and summarizing plans 

for subsequent years. 

You are required to have a Dun and 

Bradstreet Data Universal Numbering 

System (DUNS) number to apply for a 

grant or cooperative agreement from the 

Federal government. Your DUNS 

number must be entered on line 11 of 

the face page of the PHS 398 application 

form. The DUNS number is a nine-digit 

identification number, which uniquely 

identifies business entities. Obtaining a 

DUNS number is easy and there is no 

charge. To obtain a DUNS number, 

access http://

www.dunandbradstreet.com or call 1–

866–705–5711. 

For more information, see the CDC 

Web site at: http://www.cdc.gov/od/pgo/

funding/pubcommt.htm.

This announcement uses just-in-time 

concepts. 

This announcement uses the nonmodular budgeting format.

In place of the format specified for the 

Research Plan in PHS Form 398, use the 

following format: 

• Maximum number of pages: 35 

single-spaced (excluding budget, budget 

narrative, appendices, and required 

forms). 

If your narrative exceeds the page 

limit, only the first pages which are 

within the page limit will be reviewed. 

Materials or information that should be 

included in the narrative will not be 

reviewed if placed in the appendices. 

• Font size: 12 point unreduced. 

• 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. 

Your narrative should address 

activities to be conducted over the 

entire project period, and must include 

the following items in the order listed: 

(1) Capacity to carry out the functions 

and responsibilities of an EIP. 

(2) Operational plan for the EIP in 

general and for specific EIP activities. 

(Include descriptions of populations for 

each proposed activity.) 

(3) Measures of Effectiveness (Include 

Measures for each of the specific EIP 

activities proposed.) 

(4) Human Subjects. 

Additional information may be 

included in the application appendices. 

The appendices will not be counted 

toward the narrative page limit. This 

additional information includes: 

• Documentation of bona fide agent 

status. 

• Letters of support (Do not solicit or 

include letters of support from CDC 

personnel.) 

• Curricula vitas. 

• Detailed budget justification (i.e., 

supporting budget information outlined 

in ‘‘Budget and Budget Narrative’’

below.) 

• Documentation of relevant 

accomplishments, such as abstracts, 

manuscripts, or bibliographies, may be 

included in appendices. 

Budget and Budget Narrative 

This part of the application does not 

count toward the narrative page limit. 

For each line-item (as identified on the 

PHS Form 398, Page 4), show both 

Federal and non-Federal (e.g., State 

funding) shares of total cost for the EIP. 

For each staff member listed under the 

Personnel line item, indicate their 

specific responsibilities relative to each 

of the proposed projects. All other lineitems should also be clearly justified. In 

addition to the budget justification, 

provide an estimate of the budget for 

each separate activity or project (e.g., 

FoodNet, ABCs, etc. as outlined above 

in Section I, Activities, section (e)). If 

requesting funds for any contracts, 

provide the following information for 

each proposed contract: (1) Name of 

proposed contractor; (2) breakdown and 

justification for estimated costs; (3) 

description and scope of activities to be 

performed by contractor; (4) period of 

performance; and (5) method of 

contractor selection (e.g. sole-source or 

competitive solicitation). 

Additional requirements that may 

require you to submit additional 

documentation with your application 

are listed in section ‘‘VI.2. 

Administrative and National Policy 

Requirements.’’

IV.3. Submission Dates and Times 

LOI Deadline Date 

October 11, 2004.

CDC requests that you send a LOI if 

you intend to apply for this program. 

Although the LOI is not required, not 

binding, and does not enter into the 

review of your subsequent application, 

the LOI will be used to gauge the level 

of interest in this program, and to allow 

CDC to plan the application review. 

Application Deadline Date 

November 1, 2004. 

Explanation of Deadlines 

Applications must be received in the 

CDC Procurement and Grants Office by 

4 p.m. eastern standard time on the 

deadline date. If you send your 

application by the United States Postal 

Service or commercial delivery service, 

you must ensure that the carrier will be 

able to guarantee delivery of the 

application by the closing date and 

time. If CDC receives your application 

after closing due to: (1) Carrier error, 

when the carrier accepted the package 

with a guarantee for delivery by the 

closing date and time, or (2) significant 

57302 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Notices 

weather delays or natural disasters, you 

will be given the opportunity to submit 

documentation of the carrier’s 

guarantee. If the documentation verifies 

a carrier problem, CDC will consider the 

application as having been received by 

the deadline. 

This announcement is the definitive 

guide on application submission 

address and deadline. It supersedes 

information provided in the application 

instructions. If your application does 

not meet the deadline above, it will not 

be eligible for review, and will be 

discarded. You will be notified that 

your application did not meet the 

submission requirements. 

CDC will not notify you upon receipt 

of your application. If you have a 

question about the receipt of your 

application, first contact your courier. If 

you still have a question, contact the 

PGO–TIM staff at: (770) 488–2700. 

Before calling, please wait two to three 

days after the application deadline. This 

will allow time for applications to be 

processed and logged. 

IV.4. Intergovernmental Review of 

Applications 

Your application is subject to 

Intergovernmental Review of Federal 

Programs, as governed by Executive 

Order (EO) 12372. This order sets up a 

system for state and local governmental 

review of proposed federal assistance 

applications. You should contact your 

state single point of contact (SPOC) as 

early as possible to alert the SPOC to 

prospective applications, and to receive 

instructions on your state’s process. 

Click on the following link to get the 

current SPOC list: http://

www.whitehouse.gov/omb/grants/

spoc.html.

IV.5. Funding Restrictions 

Restrictions, which must be taken into 

account while writing your budget, are 

as follows: 

• Funds relating to the conduct of 

research will not be released until the 

appropriate assurances and Institutional 

Review Board approvals are in place. 

• Continuation awards within an 

approved project period will be made 

on the basis of satisfactory progress as 

evidenced by required reports and the 

availability of funds. 

If you are requesting indirect costs in 

your budget, you must include a copy 

of your indirect cost rate agreement. If 

your indirect cost rate is a provisional 

rate, the agreement should be less than 

12 months of age. 

IV.6. Other Submission Requirements 

LOI Submission Address 

Submit your LOI by express mail, 

delivery service, fax, or e-mail to: 

Angela Slaughter, National Center for 

Infectious Diseases (NCID), Centers for 

Disease Control and Prevention (CDC), 

1600 Clifton Rd, NE., Mailstop D–59, 

Atlanta, GA 30333, Telephone: (404) 

371–5357, e-mail address: 

aslaughter@cdc.gov.

Application Submission Address 

Submit the original and four hard 

copies of your application by mail or 

express delivery service to: Technical 

Information Management—CI05–026, 

CDC Procurement and Grants Office, 

2920 Brandywine Road, Atlanta, GA 

30341. 

Applications may not be submitted 

electronically at this time. 

V. Application Review Information 

V.1. Criteria

Applicants are required to provide 

measures of effectiveness that will 

demonstrate the accomplishment of the 

various identified objectives of the 

cooperative agreement. Measures of 

effectiveness must relate to the 

performance goals stated in the 

‘‘Purpose’’ section of this 

announcement. Measures must be 

objective and quantitative, and must 

measure the intended outcome. These 

measures of effectiveness must be 

submitted with the application and will 

be an element of evaluation. 

The goals of CDC-supported research 

are to advance the understanding of 

biological systems, improve the control 

and prevention of disease and injury, 

and enhance health. In the written 

comments, reviewers will be asked to 

evaluate the application in order to 

judge the likelihood that the proposed 

research will have a substantial impact 

on the pursuit of these goals. 

Your application will be evaluated 

against the following criteria: 

(1) Capacity to carry out the functions 

and responsibilities of an EIP. (50 

points) 

(a) Does the applicant demonstrate a 

clear understanding of the objectives of 

the EIP in the following aspects? 

(i) Background and objectives of this 

cooperative agreement program. 

(ii) The roles and responsibilities of 

participation in the EIP network. 

(iii) The requirements, 

responsibilities, problems, constraints, 

and complexities that may be 

encountered in establishing and 

operating the EIP. 

(b) EIP functions and structure. 

(i) To what extent does the applicant’s 

plan for establishing and operating the 

EIP clearly describe the proposed 

organizational and operating structure/

procedures; and clearly identify the 

roles and responsibilities of all 

participating agencies, organizations, 

institutions, and individuals? 

(ii) To what extent does the applicant 

describe how the EIP as a whole will be 

established in a defined population with 

a minimum population base of 

approximately 1,500,000 persons? 

(iii) To what extent does the applicant 

clearly describe how the EIP, or its 

design for the EIP, is flexible and able 

to swiftly address new public health 

challenges in infectious diseases?

(iv) Does the applicant plan to 

provide effective scientific leadership 

and coordination, and adequate 

administrative infrastructure, to manage 

an EIP? 

(v) Does the applicant demonstrate 

ability to operate the EIP so it can 

function effectively as part of a national 

network of EIPs? 

(vi) To what extent does the applicant 

describe plans for collaboration with 

CDC and other EIP sites in the 

establishment and operation of the EIP 

and individual EIP projects, including 

project design/development (e.g., 

protocols), management and analysis of 

data, and synthesis and dissemination 

of findings? 

(c) Partnerships. 

(i) To what extent does the applicant 

demonstrate ability to develop and 

maintain strong cooperative 

relationships with public and private, 

local and regional, medical, public 

health, laboratory, academic, and 

community organizations? Does the 

applicant provide sufficient evidence of 

its ability to solicit and secure 

programmatic collaboration and support 

from such organizations? 

(ii) Are the applicant’s partnerships 

with necessary and appropriate 

organizations adequate for establishing 

and operating the proposed EIP and for 

conducting individual EIP projects? 

(d) EIP tools and capacities. 

To what extent does the applicant 

demonstrate past experience and 

documentation of accomplishments in 

conducting active surveillance, applied 

epidemiologic research, applied 

laboratory research, and prevention 

research, in general, and on emerging 

infectious diseases, including 

antimicrobial resistant, food-borne and 

waterborne, and currently or potentially 

vaccine preventable diseases? Is a list of 

relevant papers and abstracts included 

in an appendix? 

Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Notices 57303

(2) Operational Plan for the EIP in 

general and for specific EIP activities. 

(40 points) 

(a) General EIP Activities: 

(i) To what extent is the quality of the 

proposed projects (as requested in the 

Application Content section above), 

taken as a whole, consistent with EIP 

guiding principles, public health needs, 

intent of this program, feasibility, 

methodology/approach, and 

collaboration/participation of partner 

organizations? Does the proposal 

include clear descriptions of the 

population bases for each project, and 

include descriptions of race and ethnic 

distributions and descriptions of various 

special populations as they relate to the 

proposed activities, such as the rural or 

inner-city poor, under-served women 

and children, the homeless, immigrants 

and refugees, and persons infected with 

HIV? 

(ii) Does the applicant demonstrate 

support from non-applicant 

participating agencies, institutions, 

organizations, laboratories, individuals, 

and consultants included in the 

operational plan? Does the applicant 

provide (in an appendix) letters of 

support which clearly indicate 

collaborators’ commitment to 

participate in the EIP and define their 

roles? 

(iii) Does the applicant clearly 

identify key professional personnel to 

be assigned to the EIP and EIP projects 

as well as key professional personnel 

from other participating or collaborating 

institutions, agencies, and organizations 

outside of the applicant’s agency that 

will be assigned to EIP activities? (Is 

curriculum vitae for each person 

included in an appendix?) Is there a 

clear identification of participants’

respective roles in the management and 

operation of the EIP? Do participants 

have adequate experience in conducting 

work comparable to that described in 

this announcement? 

(iv) For projects involving human 

subjects research, does the application 

adequately address the CDC Policy 

requirements regarding the inclusion of 

women, ethnic, and racial groups in the 

proposed research? This includes: (1) 

The proposed plan for the inclusion of 

both sexes and racial and ethnic 

minority populations for appropriate 

representation; (2) The proposed 

justification when representation is 

limited or absent; (3) A statement as to 

whether the design of the study is 

adequate to measure differences when 

warranted; and (4) A statement as to 

whether the plans for recruitment and 

outreach for study participants include 

the process of establishing partnerships 

with community(ies) and recognition of 

mutual benefits.

(b) Specific EIP Activities: 

(i) What is the quality of each 

proposed project with respect to 

planned approach and methodology, as 

well as consistency with EIP guiding 

principles, public health needs, intent 

of this program, and collaborations? 

(ii) For each proposed activity, is 

there a clear definition of the geographic 

area and population base in which the 

activity will operate (different activities 

may use different populations)? 

(iii) For each proposed activity, is 

there evidence of support from nonapplicant participating agencies, 

institutions, organizations, laboratories, 

individuals, consultants, etc., included 

in the operational plan? Does the 

applicant provide (in an appendix) 

letters of support which clearly indicate 

collaborators’ commitment to 

participate in the EIP and define their 

roles? 

(iv) For each proposed activity, does 

the applicant clearly identify key 

professional personnel to be assigned to 

the EIP and EIP projects as well as key 

professional personnel from other 

participating or collaborating 

institutions, agencies, and organizations 

outside of the applicant’s agency that 

will be assigned to EIP activities 

(provide a curriculum vitae for each in 

an appendix). Clear identification of 

participants’ respective roles in the 

management and operation of the EIP? 

Do participants have adequate 

experience in conducting work 

comparable to that proposed in this 

announcement? 

(3) Measures of Effectiveness (10 

points) 

(a) Does the applicant provide 

measures of effectiveness for each 

proposed activity that will demonstrate 

the accomplishment of the cooperative 

agreement objectives identified in 

Section B ‘‘Purpose’’ of this program 

announcement? 

(b) Are the measures objective and 

quantitative, and do they adequately 

measure the intended outcome of each 

activity? 

(4) Budget (not scored) 

Is the line-item budget detail broken 

out for each activity (or project) and 

contract, clearly justified, and consistent 

with the purpose and objectives of this 

program? Does the applicant show both 

Federal and non-Federal (e.g., State 

funding) shares of total cost for the EIP? 

(5) Human Subjects (not scored) 

Does the application adequately 

address the requirements of Title 45 

CFR Part 46 for the protection of human 

subjects? (Not scored; however, an 

application can be disapproved if the 

research risks are sufficiently serious 

and protection against risks is so 

inadequate as to make the entire 

application unacceptable.) 

V.2. Review and Selection Process 

Applications will be reviewed for 

completeness by the Procurement and 

Grants Office (PGO) staff, and for 

responsiveness by National Centers for 

Infectious Diseases (NCID) Office of 

Surveillance. Incomplete applications 

and applications that are nonresponsive to the eligibility criteria will 

not advance through the review process.

Applicants will be notified that their 

application did not meet submission 

requirements. 

An objective review panel will 

evaluate complete and responsive 

applications against the evaluation 

criteria. In addition, the following 

factors may affect the funding decision: 

• Funding preference may be given to 

approved applications that would 

enhance the geographic diversity of the 

network to achieve appropriate 

geographic representation in the EIPs. 

• Funding preference may also be 

given to competing continuation 

applications over applications for 

programs not already receiving support 

under this cooperative agreement. 

VI. Award Administration Information 

VI.1. Award Notices 

Successful applicants will receive a 

Notice of Grant Award (NGA) from the 

CDC Procurement and Grants Office. 

The NGA shall be the only binding, 

authorizing document between the 

recipient and CDC. The NGA will be 

signed by an authorized Grants 

Management Officer, and mailed to the 

recipient fiscal officer identified in the 

application. 

Unsuccessful applicants will receive 

notification of the results of the 

application review by mail. 

VI.2. Administrative and National 

Policy Requirements 

45 CFR Part 74 and Part 92 

For more information on the Code of 

Federal Regulations, see the National 

Archives and Records Administration at 

the following Internet address: http://

www.access.gpo.gov/nara/cfr/cfr-tablesearch.html.

The following additional 

requirements apply to this project:

• AR–1 Human Subjects 

Requirements 

• AR–2 Requirements for Inclusion 

of Women and Racial and Ethnic 

Minorities in Research 

• AR–7 Executive Order 12372 

57304 Federal Register / Vol. 69, No. 185 / Friday, September 24, 2004 / Notices 

• AR–9 Paperwork Reduction Act 

Requirements 

• AR–10 Smoke-Free Workplace 

Requirements 

• AR–11 Healthy People 2010 

• AR–12 Lobbying Restrictions 

• AR–22 Research Integrity

Additional information on these 

requirements can be found on the CDC 

Web site at the following Internet 

address: http://www.cdc.gov/od/pgo/

funding/ARs.htm.

VI.3. Reporting Requirements 

You must provide CDC with an 

original, plus two hard copies of the 

following reports: 

(1) Interim progress report, (use form 

PHS 2590, OMB Number 0925–0001, 

rev. 5/2001 as posted on the CDC Web 

site) no less than 90 days before the end 

of the 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 including report specifically 

on progress towards stated Measures of 

Effectiveness from the current budget 

period (i.e., previous application). 

(b) Current Budget Period Financial 

Progress. 

(c) New Budget Period Program 

Proposed Activity and Objectives. 

(d) Budget. 

(e) Measures of Effectiveness. 

(f) Additional Requested Information 

(2) Financial status report and annual 

progress report, no more than 90 days 

after the end of the budget period. 

(3) Final financial and performance 

reports, no more than 90 days after the 

end of the project period. 

These reports must be mailed to the 

Grants Management or Contract 

Specialist listed in the ‘‘Agency 

Contacts’’ section of this announcement. 

VII. Agency Contacts 

For general questions about this 

announcement, contact: Technical 

Information Management Section, CDC 

Procurement and Grants Office, 2920 

Brandywine Road, Atlanta, GA 30341, 

Telephone: (770) 488–2700. 

For program technical assistance, 

contact: Catherine Rebmann, National 

Center for Infectious Diseases (NCID), 

Centers for Disease Control and 

Prevention (CDC), 1600 Clifton Rd, NE., 

Mailstop D–59, Atlanta, GA 30333, 

Telephone (404) 371–5363, e-mail 

address: csr9@cdc.gov.

For financial, grants management, or 

budget assistance, contact: Lynn 

Walling, Grants Management Specialist, 

CDC Procurement and Grants Office, 

2920 Brandywine Road, Atlanta, GA 

30341, Telephone: (770) 488–2612, email: lqw5@cdc.gov.

VIII. Other Information 

This and other CDC funding 

opportunity announcement can be 

found on the CDC Web site, Internet 

address: http://www.cdc.gov. Click on 

‘‘Funding’’ then ‘‘Grants and 

Cooperative Agreements.’’

Visit these websites for additional 

information about the EIPs:

http://www.cdc.gov/ncidod/EID/

vol9no7/03-0083.htm,

http://www.cdc.gov/ncidod/osr/site/

eip/index.htm,

http://www.cdc.gov/ncidod/osr/site/

eip/publications.htm.

Dated: September 20, 2004. 

William P. Nichols, 

Acting Director, Procurement and Grants 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–21474 Filed 9–23–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3154–N] 

Medicare Program; Request for 

Nominations for Members for the 

Medicare Coverage Advisory 

Committee

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Notice.

SUMMARY: This notice requests 

nominations for consideration for 

membership on the Medicare Coverage 

Advisory Committee (MCAC).

DATES: Nominations will be considered 

if received at the designated address, as 

provided below, no later than 5 p.m. on 

September 30, 2004.

ADDRESSES: You may mail nominations 

for membership to the following 

address: Centers for Medicare & 

Medicaid Services, Office of Clinical 

Standards and Quality, Attention: 

Michelle Atkinson, 7500 Security Blvd., 

Mail Stop: Central Building 1–09–06, 

Baltimore, MD 21244. 

A copy of the Secretary’s Charter for 

the Medicare Coverage Advisory 

Committee can be obtained from Maria 

Ellis, Office of Clinical Standards and 

Quality, Centers for Medicare & 

Medicaid Services, 7500 Security Blvd., 

Mail Stop: Central Building 1–09–06, 

Baltimore, MD 21244, or by e-mail to 

mellis@cms.hhs.gov. The charter is also 

posted on the web at http://

www.cms.hhs.gov/mcac/8b1–1.asp.

FOR FURTHER INFORMATION CONTACT:

Michelle Atkinson, 410–786–2881.

SUPPLEMENTARY INFORMATION: 

Background 

On December 14, 1998, we published 

a notice in the Federal Register (63 FR 

68780) announcing establishment of the 

Medicare Coverage Advisory Committee 

(MCAC). The Secretary signed the initial 

charter for the Medicare Coverage 

Advisory Committee on November 24, 

1998. The charter was renewed by the 

Secretary and will terminate on 

November 24, 2004, unless renewed 

again by the Secretary. 

The Medicare Coverage Advisory 

Committee is governed by provisions of 

the Federal Advisory Committee Act, 

Pub. L. 92–463, as amended (5 U.S.C. 

App. 2), which sets forth standards for 

the formulation and use of advisory 

committees, and is authorized by 

section 222 of the Public Health Service 

Act as amended (42 U.S.C. 217A). 

The MCAC consists of a pool of 100 

appointed members. Members are 

selected from among authorities in 

clinical medicine of all specialties, 

administrative medicine, public health, 

epidemiology and biostatistics, 

methodology of trial design, biologic 

and physical sciences, health care data 

and information management and 

analysis, the economics of health care, 

medical ethics, and other related 

professions. A maximum of 88 members 

are standard voting members, 12 are 

nonvoting members, 6 of whom are 

representatives of consumer interests, 

and 6 of whom are representatives of 

industry interests. 

The MCAC functions on a committee 

basis. The committee reviews and 

evaluates medical literature, reviews 

technology assessments, and examines 

data and information on the 

effectiveness and appropriateness of 

medical items and services that are 

covered or eligible for coverage under 

Medicare. The Committee works from 

an agenda provided by the Designated 

Federal Official that lists specific issues, 

and develops technical advice to assist 

us in determining reasonable and 

necessary applications of medical 

services and technology when we make 

national coverage decisions for 

Medicare. 

A few vacancies exist on the current 

MCAC roster, and terms for some 

members currently serving will expire 

in 2004. Accordingly, we are requesting 

nominations for both voting and 

nonvoting members to serve on the 

MCAC. Nominees are selected based 

upon their individual qualifications and 

not as representatives of professional 

associations or societies. We have a