Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices 21765

trigger the accommodate or explain rule.

A list of the Single Points of Contact for

each State and Territory can be found

on line at http://www.whitehouse.gov/

omb/grants/spoc.html.

Dated: April 25, 2001.

Gail E. Collins,

Acting Deputy Commissioner, Administration

on Children, Youth and Families.

[FR Doc. 01–10792 Filed 4–30–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcement No. ACYF/HS–

2001–10]

Fiscal Year 2001 Discretionary

Announcement for Head Start—Higher

Education Hispanic/Latino Service

Partnerships: Availability of Funds and

Request for Applications

AGENCY: Administration on Children,

Youth and Families (ACYF).

ACTION: Notice.

Statutory Authority: The Head Start Act, as

amended 42 U.S.C. 9801 et seq.

SUMMARY: The Administration for

Children and Families (ACF),

Administration on Children, Youth and

Families (ACYF) announces the

availability of approximately $500,000

annually for each of four (4) years to

support Head Start-Higher Education

Hispanic/Latino Service Partnerships

(HS–HEHLSPs). The goal of this HS–

HEHLSPs initiative is to improve the

quality and long term effectiveness of

Head Start and Early Head Start

programs by developing models of

academic training through partnerships

between institutions of higher education

and Head Start and Early Head Start

agencies. The priority for this funding

is: Partnerships to increase the number

of center-based teachers with AA, BA or

advanced degrees in early childhood

education or related fields earned by

Head Start teachers, in order to assist

Head Start grantees to meet the 2003

Congressional mandate and to provide

teachers with knowledge areas vital in

building quality Head Start programs.

DATES: The closing date and time for

receipt of application is 4:30 p.m.

(Eastern Time Zone), June 15, 2001.

Note: Applications should be submitted to:

ACYF Operations Center, 1815 North Fort

Myer Drive, Suite 300, Arlington, Virginia

22209.

However, prior to preparing and

submitting an application, in order to

satisfactorily compete under this

announcement, it will be necessary for

potential applicants to read the full

announcement which is available

through the addresses listed below.

ADDRESSES: Applications, including all

necessary forms can be downloaded

from the Head Start Web site at

www.acf.dhhs.gov/programs/hsb. The

Web site also contains a listing of all

Head Start and Early Head Start

programs. Hard copies of the

application may be obtained by writing

or calling the Operations Center or

sending an e-mail to hrs@lcgnet.com.

FOR FURTHER INFORMATION CONTACT:

ACYF Operations Center at: 1815 N.

Fort Myer Drive, Suite 300, Arlington,

Virginia 22209 or 1–800–351–2293.

SUPPLEMENTARY INFORMATION:

Eligible Applicants: Institutions of

higher education with experience and

capability in educating and preparing

professionals to work effectively with

Hispanic young children and families

are eligible to apply. Institutions that are

currently funded under the Head Start—

Higher Education Hispanic Service

partnerships are not eligible to apply

under this announcement.

Project Duration: The announcement

is soliciting applications for project

periods up to four years. Awards, on a

competitive basis, will be for a one-year

budget period, although projects may be

for four years. Applications for

continuation funds under these awards

beyond the first year budget period, but

within the established project period,

will be entertained in subsequent years

on a non-competitive basis, subject to

availability of funds, satisfactory

progress of the grantee, and a

determination that continued funding

would be in the best interest of the

Government.

Federal Share of Project Costs: The

maximum share is $150,000 for the first

year of the four-year period. The Federal

share is inclusive of indirect costs.

Matching Requirements: There are no

matching requirements.

Anticipated Number of Projects to be

Funded: It is anticipated that

approximately four projects will be

funded.

Anticipated Number of Projects to be

Funded: It is anticipated that

approximately four projects will be

funded.

Review Criteria

Criterion 1. Objectives and Need for

Assistance: (10 Points)

The extent to which the application

identifies relevant physical, economic,

social, financial, institutional or other

problems requiring a grant;

demonstrates the need for assistance;

and states the principal and subordinate

objectives of the project consistent with

the purposes of the program

announcement.

The Head Start Bureau is particularly

interested in the following aspects of the

applications:

1. State the specific training objectives

for the program. Indicate how these

objectives are based on an assessment of

staff training and program improvement

needs of participant Head Start and

Early Head Start agencies; how they

related to Head Start goals, outcomes

and policy priorities, and how they will

enhance the quality of Head Start

services to Hispanic/Latino children

and their families.

2. Describe the process used to assess

the needs for the proposed program

design. Specifically identify the

population to be served in terms of

numbers and types of staff to be trained

and the proposed areas of training,

course, and/or degrees to be awarded.

3. Describe the development of the

HS–HEHLSPs agreement and other

consultation related to the development

of the proposed initiative. Describe any

efforts to frame the proposed initiative

within broader state or community

efforts to enhance professional and

career development for staff in all forms

of early childhood and child care

programs.

Criterion 2. Results or Benefits

Expected: (20 points)

The extent to which the application

identifies the results and benefits to be

derived; describes the anticipated

contribution to policy, practice, theory

and/or research; specific benefits should

be described for both the HS–HEHLSPs

and Head Start/Migrant Head Start/

Early Head Start partners.

The Head Start Bureau is particularly

interested in the following aspects of the

applications:

1. Based on the stated program

objectives, identify the results and

benefits to be derived. Identify the

specific results or benefits that could be

expected for the Head Start grantee(s)

and the institution. Describe how the

trainees benefit from the project.

2. Identify both qualitative and

quantitative data the applicant will

collect to measure progress towards the

stated results or benefits. Identify how

the program will determine the extent to

which it has achieved its stated

objectives.

3. Provide a projection of the

estimated number of trainees, by

category, who will earn degrees over the

four year duration of the project based

on an analysis of the current levels of

21766 Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices

credits/courses earned by participants

and a proposed sequence of courses.

Criterion 3. Approach (40 points)

A. The extent to which the

application outlines a sound and

realistic plan of action pertaining to the

scope of the project which details how

the proposed work will be

accomplished, including a timeline;

lists of each organization, consultants,

including the evaluator, or other key

individuals who will work on the

project along with a short description of

the nature of their effort or contribution;

and assures the adequacy of time

devoted to the project by key staff;

B. The extent to which the project

approach, if successfully carried out, is

likely to achieve the proposed project

objectives; and

C. The applicant must fully describe

the approach and/or methodology and

delineate the relationship of each task to

the accomplishment of the proposed

objectives. There should be evidence

that the planned approach reflects

sufficient input from and partnership

with Head Start/Migrant Head Start/

Early Head Start and the HS–HEHLPs.

The Head Start Bureau is particularly

interested in the following aspects of the

applications:

1. Describe the planning the applicant

will conduct during the start-up period

to prepare for implementation of the

program. Provide assurance that no

more than six months will be devoted

to planning activities.

2. Indicate how Head Start staff will

be recruited and selected to participate

in the program, including staff from

other child care organizations that are

collaborating with Head Start grantees

and delegate agencies and meet Head

Start performance standards within a

given community.

3. Describe how the training and

coursework will be contextually and

culturally relevant to the Head Start,

Migrant Head Start and the Early Head

Start environment and how it will

contribute to enhancing the

effectiveness of teachers, staff, program

quality and outcomes for Head Start

children and families.

4. Describe efforts by the institution

and Head Start partners to make training

and coursework accessible to Head Start

participants and to support their

successful completion of courses,

training, and degrees. Include a

discussion of issues such as the timing,

scheduling, and location of classes or

training; support to enhance the literacy

and study skills of participants; and

approaches to integrate HS–HEHLSPs

training in the working environment of

the Head Start program.

5. Describe efforts to complement the

federal funds requested in this proposal

with other resources to maximize the

benefits to Head Start and HS–HEHLSPs

participants. Include any efforts or plans

to assist Head Start staff in accessing

sources of financial assistance or to

make use of other funding for training

and career development of early

childhood program staff. In addition,

describe any proposed contributions of

funds from local Head Start programs to

the partnership. Provide assurance that

trainees will not be required to bear any

costs of participating in training.

6. Describe how previous CDA

training and certification of Head Start

staff, as well as previous coursework,

credits or AA degrees from 2-year

institutions, will be linked to academic

credits and course sequences leading to

BA degrees.

7. Describe the organizational

structure that will support the project

objectives. Indicate how joint planning

and assessment with the Head Start,

Migrant Head Start and Early Head Start

grantees will be implemented with

timelines and clear lines of

responsibility. Indicate how staff

positions are assigned and describe their

major functions and responsibilities.

8. Describe the activities that will

continue after the completion of this

project that will ensure that the

institution will continue to participate

in providing educational opportunities

for Head Start, Migrant Head Start and

Early Head Start staff.

9. Include support letters that

document consultation and support

from the proposed grantee or delegate

agency partners, the Head Start

Collaboration Office, and any existing

state level early childhood career

development initiative.

Criterion 4. Staff and Position Data (20

points)

Key staff should be qualified and

knowledgeable of Head Start, Migrant

Head Start and Early Head Start. The

extent of the demonstrated capacity of

the applicant organization, key leaders,

managers and project personnel to:

1. provide high quality, relevant, and

responsive training to Head Start staff;

2. assure participating project staff are

competent to plan and deliver

appropriate course material to Head

Start trainees that is culturally relevant;

3. manage the implementation of the

training grant in an effective and timely

manner; and

4. manage successful partnership that

involve sharing resources, staffing, and

facilities.

Criterion 5. Budget and Budget

Justification: (10 points)

The extent to which the project’s costs

are reasonable and appropriate in view

of the activities to be carried out and the

anticipated outcomes. Provide a line

item detail for the costs of attendance of

project staff to attend ACF-sponsored

conferences in Washington, DC. It is the

expectation that applicants should limit

budget projections to those costs

necessary to build institutional capacity

for and execute training and career

development partnerships with

participating Head Start grantees.

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

the Order, States may design their own

processes for reviewing and

commenting on proposed Federal

assistance under covered programs.

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 Executive Order 12372.

Applicants for projects to be

administered by Federally-recognized

Indian Tribes are also exempt from the

requirements of Executive Order 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 6a.

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

Federal Register / Vol. 66, No. 84 / Tuesday, May 1, 2001 / Notices 21767

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: William Wilson, Head

Start Bureau, 330 C Street, SW.,

Washington, DC 20447, Attn: Head

Start-Higher Education Hispanic/Latino

Service Partnerships. 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.

Dated: April 25, 2001.

Gail E. Collins,

Acting Deputy Commissioner, Administration

on Children, Youth and Families.

[FR Doc. 01–10720 Filed 4–30–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0174]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Recall Regulations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

FDA’s recall regulations (guidelines)

and provides guidances to

manufacturers on recall responsibilities.

DATES: Submit written or electronic

comments on the collection of

information by July 2, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information via the Internet at http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

FDA Recall Regulations—Part 7

(Subpart C) (21 CFR Part 7 (Subpart

C))—(OMB Control Number 0910–

0249)—Extension

Section 701 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 371) and 21

CFR part 7, subpart C sets forth the

recall regulations (guidelines) and

provides guidance to manufacturers on

recall responsibilities. The guidelines

apply to all FDA regulated products

(i.e., food, including animal feed; drugs,

including animal drugs; medical

devices, including in vitro diagnostic

products; cosmetics; and biological

products intended for human use).

These responsibilities include

development of a recall strategy that

requires time by the firm to determine

the actions or procedures required to

manage the recall (§ 7.42); providing

FDA with complete details of the recall

including reason(s) for the removal or

correction, risk evaluation, quantity

produced, distribution information,

firm’s recall strategy, copy of any recall

communication(s), and a contact official

(§ 7.46); notifying direct accounts of the

recall, providing guidance regarding

further distribution, giving instructions

as to what to do with the product,

providing recipients with a ready means

of reporting to the recalling firm (§ 7.49);

submitting periodic status reports so

that FDA may assess the progress of the

recall. Status report information may be

determined by, among other things,

evaluating return reply cards,

effectiveness checks and product

returns (§ 7.53); and providing the

opportunity for a firm to request in

writing that FDA terminate the recall

(§ 7.55).

A search of the FDA database was

performed to determine the number of

recalls that took place during fiscal year

2000. The resulting number of recalls

from this database search (1,933) is used

in estimating the current annual

reporting burden for this report. FDA

estimates the total annual industry

burden to collect and provide the above

information to 84,665 burden hours.

The following is a summary of the

estimated annual burden hours for

manufacturers, processors, and

distributors to comply with the

voluntary reporting requirements of

FDA’s recall regulations.

Recognizing that there may be a vast

difference in the information collection

and reporting time involved in different

recalls of FDA’s regulated products,

FDA estimates on average the burden of

collection for recall information as

follows: