24384 Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices

NE, M/S D–66, Atlanta, Georgia 30333,

telephone 404/687–6672.

The Director, Management Analysis

and Services Office, has been delegated

the authority to sign Federal Register

Notices pertaining to announcements of

meetings and other committee

management activities, for both the

Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: May 8, 2001.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 01–12003 Filed 5–11–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcement No. ACYF–CCB–

2201–04]

Child Care Policy Research

Discretionary Grants

AGENCY: Administration on Children,

Youth, and Families (ACYF), ACF,

DHHS.

ACTION: Announcement of the

availability of funds and request for

applications for Field Initiated Child

Care Research Projects, Child Care

Research Scholars, and State Child Care

Data and Research Capacity Projects.

SUMMARY: The purpose of this program

announcement is to announce the

availability of $3.7 million in fiscal year

2001 funds for child care research,

demonstration, and evaluation

activities. Grants will be funded in the

following three priority areas: (1) Field

Initiated Child Care Research Projects;

(2) Child Care Research Scholars; and

(3) State Child Care Data and Research

Capacity Projects. Universities and

colleges, public agencies, non-profit

organizations, and for-profit

organizations agreeing to waive their

fees are invited to submit applications

for Field Initiated Child Care Research

Projects. Accredited universities and

colleges may submit a Child Care

Research Scholar application on behalf

of a doctoral student conducting

dissertation research on a child care

policy topic. Child Care and

Development Fund Lead Agencies

seeking to improve their capacity for

data analysis and policy-relevant

research are invited to submit

applications for the State Child Care

Data and Research Capacity Projects.

Projects funded under each of the

priority areas are expected to address

critical questions with implications for

children and families, especially lowincome working families and families

transitioning off welfare. In addition,

projects will contribute to a

comprehensive research agenda

designed to increase the capacity for

child care research at the national, State,

and local levels and promote better

linkages among research, policy,

practice, and outcomes for children and

families.

Statutory authority: The Child Care and

Development Block Grant Act of 1990 as

amended (CCDBG Act); section 418 of the

Social Security Act; Consolidated

Appropriations Act, 2001 (P.L. 106–554).

DATES: The closing date for submission

of applications is June 28, 2001. Mailed

applications postmarked after the

closing date will be classified as late.

Note: The full announcement, including all

the Standard Federal Forms can be

downloaded from the Internet at http://

www.acf.dhhs.gov/programs/ccb or by

contacting ACYF’s Operations Center at 1–

800–351–2293. For each priority area, the

required Standard Federal Forms are

identified under ‘‘Project Description and

Application Requirements.’’

Notice of Intent to Submit

Application: If you intend to submit an

application, please contact ACYF’s

Operations Center at 1–800–351–2293

with the number and title of this

announcement; your organization’s

name and address; and your contact

person’s name, phone number, fax

number, and Email address. The

information will be used to determine

the number of expert reviewers need to

evaluate applications and to update the

mailing list for program

announcements.

FOR FURTHER INFORMATION CONTACT: For

information about the application

process contact ACYF Operations

Center, 1815 North Fort Myer Drive,

Suite 300, Arlington, VA 22209, Phone:

800–351–2293. For program information

contact Dr. Ivelisse Martinez-Beck,

Policy Fellow, Administration for

Children and Families, Child Care

Bureau, Room 2046, Mary E. Switzer

Building, 330 C Street, SW.,

Washington, DC 20447, Phone: 202–

690–7885, Fax: 202–690–5600, Email:

imartinezbeck@acf.dhhs.gov. or Dr.

Patricia L. Divine, Program Specialist,

Administration for Children and

Families, Child Care Bureau, Room

2046, Mary E. Switzer Building, 330 C

Street, SW., Washington, DC 20447,

Phone: 202–690–6705, Fax: 202–690–

5600, Email: pdivine@acf.dhhs.gov.

SUPPLEMENTARY INFORMATION:

Priority Area 1: Field Initiated Child

Care Research Projects

A. Number of Awards

Approximately 7–10 grants will be

awarded during fiscal Year 2001, for an

initial budget period of twelve months,

subject to the availability of funds and

results of the evaluation process.

B. Project Duration, Funding Levels and

Budget Periods

This priority area is soliciting

applications for project periods up to

three years. Awards, on a competitive

basis, will be for a one-year budget

period, although project periods may be

for three years. Application for

continuation grants funded under these

awards beyond the one-year budget

period, but within the three year project

period, will be entertained in

subsequent years on a non-competitive

basis, subject to the availability of

funds, satisfactory progress of the

grantee, and a determination that

continued funding would be in the best

interest of the government. Significant

findings by the end of the first budget

period will be necessary to demonstrate

satisfactory progress on the part of the

grantee.

Funding for Field Initiated Child Care

Research Projects will range between

$150,000 and $250,000 for the first

budget period and up to $200,000 per

year (12 months) in subsequent periods.

C. Federal State

To maximize the Federal investment

in Field Initiated Child Care Research

Projects and in the interest of project

sustainability, a financial commitment

by the applicant organization (or other

participating entities) is required. The

Grantee must provide at least 20 percent

of the total approved cost of the project.

The total approved cost is the sum of

the Federal share and the non-Federal

share. Therefore, a project requesting

$250,000 for the first budget period

must include a match of at least

$62,500. A project receiving the

maximum total of $650,000 for the

three-year project period must include a

match of at least $162,500 for the threeyear project period. Applicants are

encouraged to meet their match

requirements through cash

contributions. However, the non-Federal

share may also be in-kind contributions

of staff time, employee benefits,

facilities, utilities, equipment, materials,

supplies or other forms of project

support. Grantees will be held

accountable for the commitment of nonFederal resources and failure to provide

the required amount will result in

Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices 24385

disallowance of unmatched Federal

funds.

D. Eligible Applicants

Eligible applicants include public

agencies, non-profit organizations, and

for-profit entities that agree to waive

their fees.

1. Public agencies include state or

local child care agencies; education

agencies, welfare or other human

services agencies, public schools,

colleges and universities; and other

public agencies with an interest in child

care.

2. Non-profit agencies include, but are

not limited to, community child care

and early childhood programs, child

care resource and referral programs,

professional organizations, schools,

colleges and universities, civic and

community groups, and foundations.

3. For-profit entities include, but are

not limited to, child care businesses,

private research corporations, and other

profit-making organizations. These

entities are only eligible to receive a

grant directly if they agree to waive their

fees. However, they may participate in

projects as subcontractors, sub-grantees,

or consultants without such a waiver.

Criterion 1: Objectives and Need for

Assistance (Maximum of 20 points)

In this section, applicants

demonstrate their understanding of the

relevant literature on critical issues and

existing knowledge, describe their

objectives, and demonstrate the

significant of their proposal.

Applicants are expected to show how

their proposal will address the Child

Care Bureau’s research agenda and

priorities, answer key questions, and

contribute to the child care research

infrastructure. Specifically, applicants

are expected to demonstrate a command

of the policy and research literature in

child care, as well as emerging issues.

The proposal is expected to demonstrate

understanding of current policies and

programs, to show how the proposed

research would further understanding,

and to suggest practical applications

which might be derived from the

findings.

Applications should clearly show

how the research would build on the

current knowledge base and contribute

to policy, practice, and future research.

Applicants are asked to consider the

significance, reliability, and validity of

existing data pertaining to key

questions. In addition, applicants

should identify important gaps in the

literature and areas in which findings

are contradictory or ambiguous. It will

also be important to consider what

demographic, economic, and social data

are available as a context for the

proposed child care research. A

bibliography of relevant literature must

be supplied.

Criterion 2: Approach (Research Design

and Methodology) (Maximum of 30

Points)

This section of the Project Narrative

Statement requires that the applicant

describe the technical approach for

addressing issues and achieving

objectives described in Criterion 1

above. In this section the applicant

should clearly demonstrate their ability

to produce significant and usable results

within the first 12-month budget period.

The methodological discussion must

include technical details of the

proposed research design, including (as

relevant): (1) Conceptual framework for

the research; (2) research questions,

hypotheses, and variables; (3) data

sources and sampling plan; (4) new data

on human subjects; (5) administrative

data; (6) secondary analysis of existing

data sets; (7) linkages with other

research; (8) data collection; (9) data

processing and statistical analysis; and,

(10) product development and

information dissemination. Qualitative

studies with well-defined methodology

are invited as well as those that use

quantitative methodology. As part of the

design section, applicants should

discuss the strengths and limitations of

all proposed approaches and

techniques. Applicants are also asked to

provide a flow chart or table showing

interrelationships among the proposed

research issues, questions, variables,

and data elements.

Criterion 3: Approach (Management

Plan) (Maximum of 10 Points)

The Management Plan is expected to

describe a sound and workable plan of

action for how the proposed project will

be carried out. This section should

detail how the project will be structured

and managed.

Applicants should provide a diagram

showing the organizational structure of

the project and the functional

relationships among components. If the

project is a collaborative, describe how

the project will be managed by the lead

organization to ensure that members of

the collaborative operate as a cohesive

research team and that cross-cutting

goals of the project are carried out

efficiently and cost-effectively. Describe

the make-up and role of any steering or

management committees, technical

work groups, advisory panels, and other

coordinating bodies.

Produce a project management chart

that lays out sequence and timing of the

major tasks and subtasks, including

startup activities such as staffing and

procurement of services, responsibilities

and time commitments to staff,

important milestones, reports, and

completion dates. Explain how

timeliness of activities will be ensured,

how quality control will be maintained,

and how costs will be controlled.

Applicants should discuss their

management of the project as a whole,

and the management and coordinating

roles of any collaborating entities.

Discuss potential problems or

difficulties with the proposed

management approach, including

factors which may affect the quality of

the research or its outcomes, may

undermine the ability of different

entities to collaborate effectively, and

may hinder the early spring, review and

dissemination of information.

Criterion 4: Staff and Position Data

(Maximum of 20 Points)

In this section, applicants must

provide evidence that project staff have

the experience, expertise and

commitment of sufficient time to carry

out the proposed project on time, within

budget, and with a high degree of

quality.

Identify all key staff positions for this

project, the professional requirements

for each, the proportion of time staff

holding these positions will be

committed to the project, the period of

time they will be employed, and

whether continued employment will be

dependent solely on the funds to be

awarded under this announcement.

Include a position description for

each key position, outlining the

qualifications necessary to carry out the

duties and responsibilities of each.

Include letters of commitment from any

key individuals who have been selected

but not yet hired. Describe the makeup

of the data collection team, what

expertise will be represented, and how

individuals will be selected. Identify all

proposed consultants or advisors,

document their expertise, and describe

how their services will be utilized.

Include letters of commitment or intent

if possible. And, identify the authors of

the proposal and describe their

continuing role in the project, if funded.

Criterion 5: Organizational Profiles

(Maximum of 10 Points)

In this section, the applicant must

demonstrate that the official grantee has

the organizational capacity and fiscal

resources to successfully carry-out the

project on time and to a high standard

of quality, including the capacity to

resolve a wide variety of technical and

management problems that may occur.

24386 Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices

Provide evidence of sufficient

organizational resources to ensure

successful project management,

compliance with terms and conditions

of the grant, and oversight of the proper

use of Federal funds.

If the project is a collaborative,

provide evidence that all collaborators

have the ability, willingness and

flexibility to collaborate effectively with

one another in carrying out the

proposed project. Include examples of

past or current collaborations that

demonstrate the ability to carry out

collaborative research. Describe how

each entity was included in the

planning of the project. Include letters

of specific commitment or support from

each entity. Describe all cooperative

agreements, subcontracts and other

formal relationships within the

collaborative. Entities who will provide

access to data or records must provide

a letter stipulating the terms of their

agreement with the researchers.

Describe the future commitment each

entity will make to ensure success of the

collaboration as it evolves. Include a

separate two-page organizational

capability statement for each

participating entity that documents the

entity’s ability to carry out its assigned

roles and functions.

Describe the relationship between this

project and other relevant work

planned, anticipated or underway by

the applicant or its collaborators.

Include funding sources for work in

progress. Provide a list of research and

financial partners including the name

and address of each organization, the

names of its director and primary

contact for this proposal, and the

telephone, fax and internet numbers of

each.

Criterion 6: Budget and Budget

Justification (maximum of 10 points)

Describe the nature and extent of

financial participation from all sources

during the proposed project period.

Present a detailed budget for each 12-

month interval of the proposed project

period, i.e., the 12 month budget period

to be funded under this announcement

and subsequent budget period that may

be funded under a non-competing

continuation process. Include a detailed

budget narrative that describes and

justifies line time expenses within the

object class categories listed on the

Standard Form 424A. (Line item

allocations and justification are required

for both Federal and non-Federal funds.)

If project funds will be subcontracted, a

detailed budget for the use of those

funds must be also included. In

estimating costs, applicant should

consider down time due to staff

vacancies, administrative processes, etc.

The budget should include funds to

allow key representatives from Field

Initiate Child Care Research Projects to

participate in the Child Care Bureau

Annual Policy Research Meeting in

Washington, DC.

Describe the extent to which funds,

staff time, in-kind services, and other

resources have been committed to the

research effort during the planning

period. Describe what other resources

are expected to help support the

proposed research, including existing

commitments and negotiations in

progress. Describe anticipated efforts to

obtain other funding partners

throughout the project.

Priority Area 2: Child Care Research

Scholars

A. Number of Awards

Up to 5 scholarships will be awarded.

No individual educational institution

will be funded for more than one

candidate unless applications from

different universities or colleges do not

qualify for support.

B. Project Period

The project period will be for a period

of up to 24 months (9/30/01–9/29/03).

For 24 month projects, the first 12

months will be funded through this

competition. The subsequent year

awards (12 months) will be considered

on a non-competitive basis subject to

the availability of funds from future

appropriations, satisfactory progress of

the grantee, and a determination that

continued funding is in the best interest

of the government. Significant findings

by the end of the first budget period will

be necessary to demonstrate satisfactory

progress on the part of the grantee. A

subsequent year award will not be

approved if the student has graduated

by the end of the first year.

C. Funding Levels

Up to $30,000 will be awarded to each

successful applicant for a 12-month

budget period. If the applicant expects

to receive a doctorate by the end of the

first one-year budget period, the

application should request funding for a

single grant period.

D. Matching Requirements and NonFederal Share

There are no matching requirements.

E. Maximum Federal Share

The maximum federal share is

$30,000 for the first 12-month budget

period and $20,000 for one subsequent

12-month period.

All monies must be used for the

dissertation research including required

personnel costs, travel, and other

expenses directly related to the

research.

F. Eligible Applicants

Eligible applicants include

universities or colleges on behalf of

doctoral candidates conducting

dissertation research on a child care

topic consistent with the research goals

described in Part II of the full

announcement, and who anticipate

completing the child care-related

dissertation within the two-year

scholarship period.

To be eligible to administer the grant

on behalf of the student, the institution

must be fully accredited by one of the

regional accrediting commissions

recognized by the Department of

Education. Although the faculty advisor

will be listed as the Principal

Investigator, this grant is intended for

dissertation work being conducted by a

doctoral candidate. Information about

both the graduate student and the

student’s faculty advisor is required as

part of this application. Any resultant

grant award is not transferable to

another student.

Criterion 1: Objectives and Need for

Assistance (Maximum of 20 Points)

The extent to which the application

reflects a solid understanding of critical

issues, information needs, and research

goals.

• The extent to which the conceptual

model, research issues, objectives and

hypotheses are significant, well

formulated and appropriately linked,

reflect the Child Care Bureau’s research

agenda and priorities, and will

contribute new knowledge and

understanding.

• The extent to which the proposed

project framework is appropriate,

feasible, and would significantly

contribute to the importance,

comprehensiveness, and quality of the

proposed research.

• The effectiveness with which the

proposal articulates the current state of

knowledge relative to issues being

addressed, including: critical child care

issues and the complex

interrelationships among major

variables; the significance of these

issues and variables for child care

policies and programs; how current

knowledge would be brought to bear on

the proposed research; and how the

research would benefit various

audiences.

• The importance of research

priorities identified for the first budget

period, the degree to which early

findings would be useful for policy and

practice, and the significance of these

Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices 24387

data for the ongoing research goals if the

project is continued beyond the first 17-

month period.

Criterion 2: Approach (Research Design

and Methodology) (Maximum of 40

Points)

The extent to which the applicant’s

proposed research design:

• Appropriately links critical research

issues, questions, variables, data

sources, samples, and analyses;

• Employs technically sound and

appropriate approaches, design

elements and procedures;

• Reflects sensitivity to technical,

logistical, cultural and ethical issues

that may arise;

• Includes realistic strategies for the

resolution of difficulties;

• Adequately protects human

subjects, confidentiality of data, and

consent procedures, as appropriate;

• Includes an effective plan for the

dissemination and utilization of

information by researchers, policymakers, and practitioners in the field;

and,

• Effectively utilizes collaborative

strategies, as appropriate to the project

goals and design.

Criterion 3: Approach (Management

Plan) (Maximum of 20 Points)

The extent to which the project

summary provides a management plan

that:

• Presents a sound, workable and

cohesive plan of action demonstrating

how the work would be carried out on

time, within budget and with a high

degree of quality;

• Includes a reasonable schedule of

target dates and accomplishments;

• Presents a sound administrative

framework for maintaining quality

control over the implementation and

ongoing operations of the study; and,

• Demonstrate the ability to gain

access to necessary organizations,

subjects, and data.

Criterion 4: Organizational Profile

(Applicant Qualifications and

Commitment) (maximum of 10 points).

The extent to which the applicant:

• Demonstrates competence in areas

addressed by the proposed research,

including relevant background,

experience, training and work on related

research or similar projects; and

• Demonstrates necessary expertise in

research design, sampling, field work,

data processing, statistical analysis,

reporting, and information

dissemination.

Criterion 5: Budget and Budget

Justification (maximum of 10 points).

The extent to which proposed project

costs are reasonable, the funds are

appropriately allocated across

component areas, and the budget is

sufficient to accomplish the objectives.

The budget should include funds to

allow the research scholar to participate

in the Child Care Bureau’s Annual

Policy Research Meeting in Washington,

DC.

Priority Area 3: State Child Care Data

and Research Capacity Projects

A. Eligible Applicants

State and Territorial Lead Agencies

administering child care programs

under the Child Care and Development

Block Grant (CCDBG) of 1990 as

amended.

B. Number of Awards

Five to six State Child Care Data and

Research Capacity Grants will be funded

in Fiscal Year 2001, subject to

availability of funds and results of the

evaluation process.

C. Project Duration, Funding Levels and

Budget periods

State Child Care Data and Research

Capacity Grants will be awarded for

project periods of up to three years. The

Child Care Bureau expects to invest up

to $250,000 during the initial 12-month

funding period for each project. Noncompetitive applications for

continuation of State Child Care Data

and Research Capacity Projects will be

considered in fiscal years 2002 and 2003

with up to $250,000 per project being

available for a 12-month period.

Applications for continuation grants

funded beyond the 12-month budget

period, but within the 36-month project

period, will be entertained in the

subsequent year on a noncompetitive

basis, subject to the availability of funds

from future appropriations, satisfactory

progress of the grantee, and a

determination that continued funding is

the best interest of the government.

D. Federal Share

To maximum the Federal investment

in the State Child Care Data and

Research Capacity Projects and in the

interest of project sustainability, a

financial commitment by the applicant

organization (or other participating

entity) is required. The grantee must

provide at least 20 percent of the total

approved cost of the project. The total

approved cost is the sum of the Federal

share and the non-Federal share.

Therefore, a project requesting $250,000

per budget period must include a match

of at least $62,500. A project receiving

the maximum $750,000 during the

three-year project period must include a

match of at least $187,500 for the threeyear project period. Applicants are

encouraged to meet their match

requirements through cash

contributions. However, the non-Federal

share may be in-kind contributions.

Grantees will be held accountable for

the commitment of non-Federal

resources and failure to provide the

required amount will result in a

disallowance of unmatched Federal

funds.

Criterion 1: Objectives and Need for

Assistance (35 Points)

In this section, applicants are

expected to provide a clear and

comprehensive description of their

agency’s current capacity to collect,

analyze and report child care

administrative data. This description

should include data collection, analysis

and reporting required by the State and

Federal governments, as well as reports

designed for the legislature and other

constituencies. Applicants are

encouraged to provide a description of

the internal and external information

needs of the agency, constituencies for

information, and the types of data

required or requested by these agencies,

organizations or groups.

Applicants are expected to describe

the current structure, management, and

process for collecting, analyzing and

reporting data. This description should

include a consideration of the strengths

and weaknesses of the current operating

system and analytic components. The

need for assistance should be clearly

stated.

In addition, applicants should

describe the research and evaluation

that would be conducted by the

proposed analysis unit. Applicants are

encouraged to identify specific research

questions to be addressed by the unit

and explain how the agency’s data

systems would be used to answer these

questions.

Criterion 2: Approach (30 points)

In this section, applicants are

expected to describe in detail how they

will implement the proposed analysis

unit, improve the State’s capacity for

collection, analysis, interpretation, and

reporting of data, and conduct child

care policy-relevant research.

Applicants are advised to present their

assessment of the advantages and

disadvantages of an in-house analysis

unit versus a contractual partner.

Applicants should describe in detail

why they have selected one approach

over the other. The justification should

include a description of how the chosen

24388 Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices

approach will mesh with current

information demands, operations and

procedures, management structure,

staffing and other resources.

Regardless of the approach selected

(in-house or contractual), the applicant

is expected to present an

implementation plan and describe in

detail how the unit will be established,

managed, operated and evaluated. This

section should also include a plan for

sustaining the unit after Federal funding

has ceased.

This section of the Project Narrative

Statement also requires that the

applicant describe the technical

approach for addressing issues and

achieving the objectives described in

Criterion above. This should include a

detailed plan that identifies goals and

objectives, relates those goals and

objectives to the strengths and weakness

identified regarding the State’s current

methods and systems used to collect

and compile administrative data, and

provides a work plan identifying

specific activities necessary to

accomplish the stated goals and

objectives. The plan must demonstrate

that each of the project objectives and

activities support the needs identified

and can be accomplished with the

available or expected resources during

the proposed project period.

For any research that is proposed

within the project period, a

methodological discussion must be

provided that includes technical details

of the proposed research design,

including: (1) conceptual framework for

the research; (2) research questions,

hypotheses and variables; (3) data

sources; (4) linkages with other

research; (5) data processing and

statistical analysis; and (6) product

development and information

dissemination. (For more details on the

information required in this section, see

Criterion 2, Research Design and

Methodology, in Evaluation Criteria for

Field Initiated Child Care Research

Projects.)

Criterion 3: Organization Profiles (25

Points)

Applicants need to demonstrate that

they have the capacity to implement the

proposed project. This criterion consist

of the three broad topics: (1)

Management plan, (2) staff

qualifications and commitment, and (3)

organizational capacity and resources.

Management Plan

Overview

Applicants are expected to present a

sound and feasible management plan for

implementing the analysis unit. This

section should detail how the unit will

be structured and managed, how the

timeliness of activities will be ensured,

how quality control will be maintained,

and how costs will be controlled. The

role and responsibilities of the lead

agency should be clearly defined and, if

appropriate, applicants should discuss

the management and coordination of

activities carried out by any partners,

subcontractors and consultants.

Applicants are required to provide a

plan that describes the role,

responsibilities and time commitments

of each proposed staff position,

including consultants, subcontractors

and/or partners. The plan should

include a list of organizations and

consultants who will work with the

program along with a short description

of the nature of their effort or

contribution.

Applicants are expected to have the

project fully staffed and ready for

implementation as quickly as possible

after notification of the grant award.

Therefore, strategies for ensuring timely

staffing and implementation should be

clearly and succinctly presented in the

management plan. The narrative should

include a description of the timeline for

hiring and procurement in the State,

and methods that the applicant will use

to expedite the process.

Applicants are also expected to

produce a timeline that presents a

reasonable schedule of target dates,

accomplishments and deliverables by

quarter. The timeline should include the

sequence and timing of the major tasks

and subtasks, important milestones,

reports, and completion dates. The

proposal should also discuss factors that

may affect project implementation or

the outcomes and present realistic

strategies for the resolution of these

difficulties. For instance, downtime due

to staff vacancies at start should be

reflected. Additional, if appropriate,

applicants should present a plan for

training project staff, as well as stuff of

cooperating organizations.

Staff Qualifications and Commitment

(10 Points)

Overview

In this section, applicants should

describe the qualifications of the project

manager and key staff, including

analysts who will staff the analysis unit

and the positions they will fill.

Applicants are also expected to describe

the educational background and

professional experience of other

professionals who will form the

interdisciplinary analysis unit or

organization. (Brief resumes should be

provided.) The proposed staff should

include persons with educational

backgrounds and professional

experiences in early childhood services,

child development, social work, public

policy, economics and other social

science disciplines such that the

analysis unit or organization will be

able to conduct research on a broad

range of child care issues and

approaches.

Organizational Capacity and Resources

(5 Points)

Overview

Applicants must show that they have

the organizational capacity and

resources to form, manage, operate,

evaluate and sustain an analysis unit,

including the capacity to resolve a wide

variety of technical and management

problems that may occur. If the proposal

involves partnering and/or

subcontracting with other agencies/

organizations, then the proposal should

include an organizational capability

statement for each participating

organization documenting the ability of

the partners/and or subcontractors to

carry out their assigned roles and

functions.

Criterion 4: Budget and Budget

Justification (10 Points)

Applicants are expected to present a

budget with reasonable project costs,

appropriately allocated across

component areas, and sufficient to

accomplish the objectives. They should

demonstrate that costs for the proposed

project are reasonable and justified in

terms of the proposed tasks and the

anticipated results and benefits.

Applicants should refer to the budget

information as presented on Standard

Forms 424 and 424A and the budget

justification.

The proposed budget should include

sufficient funding to cover travel

expenses for a key person from the

project and the evaluator to attend two

two-day meetings of grantees in the

Washington DC area hosted by the Child

Care Bureau. Attendance at these

meetings is a grant requirement.

Required Notification of the State

Single Point of Contact

This program is covered under

Executive Order 12372,

Intergovernmental Review of Federal

Programs, and 45 CFR part 100,

Intergovernmental Review of

Department of Health and Human

Services Program and Activities. Under

there Order, States may design their

own process for reviewing and

commenting on proposed Federal

assistance under covered programs.

Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices 24389

* All States and Territories except

Alabama, Alaska, Colorado,

Connecticut, Hawaii, Idaho, Kansas,

Louisiana, Massachusetts, Minnesota,

Montana, Nebraska, New Jersey, Ohio,

Oklahoma, Oregon, Pennsylvania, South

Dakota, Tennessee, Vermont, Virginia,

Washington, American Samoa and

Palau have elected to participate in the

Executive Order process and have

established Single Points of Contact

(SPOCs). Applicants from these twentyfour jurisdictions need take no action

regarding E.O. 12372. Applicants for

projects to be administered by

Federally-recognized Indian Tribes are

also exempt from the requirements of

E.O. 12372. Otherwise, applicants

should contact their SPOCs as soon as

possible to alert them of the prospective

applications and receive any necessary

instructions. Applicants must submit

any required material to the SPOCs as

soon as possible so that the program

office can obtain and review SPOC

comments as part of the award process.

It is imperative that the applicant

submit all required materials, if any, to

the SPOC and indicate the date of this

submittal (or the date of contact if no

submittal is required) on the Standard

Form 424, item 16a.

Under 45 CFR 100.8(a)(2), a SPOC has

60 days from the application deadline to

comment on proposed new or

competing continuation awards.

SPOCs are encouraged to eliminate

the submission of routine endorsements

as official recommendations.

Additionally, SPOCs are requested to

clearly differentiate between mere

advisory comments and those official

State process recommendations which

may trigger the accommodation or

explain rule.

When comments are submitted

directly to ACF, they should be

addressed to: Marguerite Pridgen, Office

of Grants Management, 330 C Street,

SW., Washington, DC 20447, Attn: Child

Care Policy Research Discretionary

Grants. A list of the Single Points of

Contact (SPOCs) for each State and

Territory can be found on the following

web site: http://www.whitehouse.gov/

omb/grants/spoc.html.

The Catalog of Federal Domestic

Assistance number for all priority areas is

93.647.

Dated: May 8, 2001.

James A. Harrell,

Acting Commissioner, Administration on

Children, Youth and Families.

[FR Doc. 01–12010 Filed 5–11–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E–0476]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Infergen

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for Infergen

and is publishing this notice of that

determination as required by law. FDA

has made the determination because of

the submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that human biological product.

ADDRESSES: Submit written comments

and petitions to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Claudia Grillo, Regulatory Policy Staff

(HFD–007),Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–5645.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and

Patent Term Restoration Act (Public

Law 100–670) generally provide that a

patent may be extended for a period of

up to 5 years so long as the patented

item (human drug product, animal drug

product, medical device, food additive,

or color additive) was subject to

regulatory review by FDA before the

item was marketed. Under these acts, a

product’s regulatory review period

forms the basis for determining the

amount of extension an applicant may

receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human

biological products, the testing phase

begins when the exemption to permit

the clinical investigations of the

biological becomes effective and runs

until the approval phase begins. The

approval phase starts with the initial

submission of an application to market

the human biological product and

continues until FDA grants permission

to market the biological product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a human biological product will include

all of the testing phase and approval

phase as specified in 35 U.S.C.

156(g)(1)(B).

FDA recently approved for marketing

the human biological product Infergen

(interferon alfacon–1 or consensus

interferon). Infergen is indicated for the

treatment of chronic hepatitis C virus

(HCV) infection in patients 18 years of

age or older with compensated liver

disease who have anti-HCV serum antibodies and/or presence of HCV RNA

(ribonucleic acid). Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for Infergen (U.S. Patent No.

4,695,623) from Amgen, Inc., and the

Patent and Trademark Office requested

FDA’s assistance in determining this

patent’s eligibility for patent term

restoration. In a letter dated September

9, 1998, FDA advised the Patent and

Trademark Office that this human

biological product had undergone a

regulatory review period and that the

approval of Infergen represented the

first permitted commercial marketing or

use of the product. Later, the Patent and

Trademark Office requested that FDA

determine the product’s regulatory

review period.

FDA has determined that the

applicable regulatory review period for

Infergen is 4,394 days. Of this time,

3,849 days occurred during the testing

phase of the regulatory review period,

while 545 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(i))

became effective: September 27, 1985.

FDA has verified the applicant’s claim

that the date the investigational new

drug application became effective was

on September 27, 1985.

2. The date the application was

initially submitted with respect to the

human biological product under section

351 of the Public Health Service Act (42

U.S.C. 262): April 10, 1996. FDA has

verified the applicant’s claim that the

product license application (PLA) for

Infergen (PLA 96–0486) was initially

submitted on April 10, 1996.

3. The date the application was

approved: October 6, 1997. FDA has

verified the applicant’s claim that PLA

96–0486 was approved on October 6,

1997.