21396 Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Notices

other relevant considerations. The

Commissioner may also elect not to

fund any applicants having known

management, fiscal, reporting, program,

or other problems which make it

unlikely that they would be able to

provide effective services.

Successful applicants will be notified

through the issuance of a Financial

Assistance Award that sets forth the

amount of funds granted, the terms and

conditions of the grant award, the

effective date of the award, and the

budget period for which support is

given, and the total project period for

which support is provided.

Organizations whose applications will

not be funded will be notified in writing

by the Commissioner, ACF. Every effort

will be made to notify all unsuccessful

applicants as soon as possible after final

decisions are made.

Part VII. Application Content and

Submission Instructions

A. Application Content

Each application must contain the

following items in the order listed:

1. A signed cover letter. The

application must include a cover letter

that includes the announcement

number, contact information for the

applicant, and information about the

entity that has designated the Local

Council (local government, Indian

Tribe, Regional Corporation, or Native

Hawaiian entity). The letter must be

signed by an individual authorized to

act for the applicant agency and to

assume responsibility for the obligations

imposed by terms and conditions of the

grant award.

2. Application for Federal Assistance

(Standard Form 424, REV 4–92). Follow

the instructions in the Application Kit.

In Item 8 of Form 424, check ‘‘New.’’ In

Item 10 of the 424, clearly identify the

Catalog of Federal Domestic Assistance

(CFDA) program title and number: Early

Learning Opportunities Act, 93.577.

3. Budget and Budget Justification

(Standard Form 424A, REV 4–92).

Follow the instructions in the

Application Kit. The budget justification

should be typed on standard size plain

white paper, provide breakdowns for

major budget categories and justify

significant costs. List amounts and

sources of all funds, both Federal and

non-Federal, to be used for this project.

4. Standard Form 424B, ‘‘Assurances:

Non-Construction Programs.’’ A duly

authorized representative of the

applicant organization must certify that

the applicant is in compliance with

these assurances and certifications.

5. Assurances/Certifications. The

applicant must certify its compliance

with: (1) Drug-Free Workplace

Requirements; (2) Debarment and Other

Responsibilities; (3) Pro-Children Act of

1994 (Certification Regarding

Environmental Tobacco Smoke). A

signature on the SF 424 indicates

compliance with the Drug Free

Workplace Requirements, Debarment

and Other Responsibilities and

Environmental Tobacco Smoke

Certifications. A signature on the

application constitutes an assurance

that the applicant will comply with the

pertinent Departmental regulations

contained in 45 CFR Part 74. In

addition, applicants must provide a

certification concerning Lobbying. Prior

to receiving an award in excess of

$100,000, applicants shall furnish an

executed copy of the lobbying

certification. Applicants must sign and

return the certification with their

applications.

6. Table of Contents.

7. Project Summary/Abstract (one

page maximum). Clearly mark this page

with the applicant name as shown on

item 5 of the SF 424, identify the title

of the proposed project as shown in

item 11 and the service area as shown

in item 12 of the SF 424. The summary

description should not exceed 300

words. Care should be taken to produce

a summary that accurately and

concisely reflects the proposed project.

It should describe the objectives of the

project, the approach to be used and the

results and benefits expected.

8. The Project Description. The

applicant is strongly encouraged to use

the evaluation criteria in Part V to

organize its response to Part IV, the

Uniform Project Description. Specific

information should be provided that

addresses all components of each

criterion. It is in the applicant’s best

interest to ensure that the project

description is easy to read, logically

developed in accordance with the

evaluation criteria, and adheres to page

limitations. In addition, the applicant

should be mindful of the importance of

preparing and submitting applications

using language, terms, concepts, and

descriptions that are generally known to

the field of early learning as defined

under this announcement.

9. The pages of the project description

must be numbered and are limited to 40

typed pages, double spaced, printed on

only one side, with at least 1/2 inch

margins. Pages over the limit will be

removed from the application and will

not be reviewed. In addition, please

note that previous attempts by

applicants to circumvent space

limitations or to exceed page limits by

using small print have resulted in

negative responses from reviewers

because of the difficulty in reviewing

the application.

10. Documents of Support. The

maximum number of pages for

supporting documentation is 30 pages,

double-spaced, exclusive of letters of

support or agreement. These documents

must be numbered and might include

excerpts from the needs and resources

assessment, resumes, photocopies of

news clippings, evidence of the

program’s efforts to coordinate child

care services at the local level, etc.

Documentation over the 30-page limit

will not be reviewed. The applicant

may, however, include as many letters

of support or agreement as are

appropriate.

B. Application Submission

To be considered for funding, the

applicant must submit one signed

original and two additional copies of the

application, including all attachments,

to the application receipt point

specified above. The original copy of the

application must have original

signatures, signed in black ink. Each

copy must be stapled (back and front) in

the upper left corner. All copies of an

application must be submitted in a

single package.

Because each application will be

duplicated, do not use or include

separate covers, binders, clips, tabs,

plastic inserts, maps, brochures or any

other items that cannot be processed

easily on a photocopy machine with an

automatic feed. Do not bind, clip, staple,

or fasten in any way separate

subsections of the application,

including supporting documentation.

Applicants are advised that the copies

of the application submitted, not the

original, will be reproduced by the

Federal government for review.

Dated: April 24, 2001.

Gail E. Collins,

Acting Deputy Commissioner, Administration

on Children, Youth and Families.

[FR Doc. 01–10640 Filed 4–27–01; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0176]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Good Laboratory

Practices (GLP) Regulations for

Nonclinical Laboratory Studies

AGENCY: Food and Drug Administration,

HHS.

Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Notices 21397

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

the GLP for Nonclinical Laboratory

Studies regulations.

DATES: Submit written or electronic

comments on the collection of

information by June 29, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information via the Internet at http://

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

dockets/comments/commentdocket.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.

Good Laboratory Practices (GLP)

Regulations for Nonclinical Laboratory

Studies—(21 CFR Part 58)—(OMB

Control Number 0910–0119)—Extension

Sections 409, 505, 512, and 515 of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 348, 355, 360b, and 360e) and

related statutes require manufacturers of

food additives, human drugs and

biological products, animal drugs, and

medical devices to demonstrate the

safety and utility of their product by

submitting applications to FDA for

research or marketing permits. Such

applications contain, among other

important items, full reports of all

studies done to demonstrate product

safety in man and/or other animals. In

order to ensure adequate quality control

for these studies and to provide an

adequate degree of consumer protection,

the agency issued the GLP regulations.

The regulations specify minimum

standards for the proper conduct of

safety testing and contain sections on

facilities, personnel, equipment,

standard operating procedures (SOPs),

test and control articles, quality

assurance, protocol and conduct of a

safety study, records and reports, and

laboratory disqualification.

The GLP regulations contain

requirements for the reporting of the

results of quality assurance unit

inspections, test and control article

characterization, testing of mixtures of

test and control articles with carriers,

and an overall interpretation of

nonclinical laboratory studies. The GLP

regulations also contain recordkeeping

requirements relating to the conduct of

safety studies. Such records include: (1)

Personnel job descriptions and

summaries of training and experience;

(2) master schedules, protocols and

amendments thereto, inspection reports,

and SOPs; (3) equipment inspection,

maintenance, calibration, and testing

records; (4) documentation of feed and

water analyses and animal treatments;

(5) test article accountability records;

and (6) study documentation and raw

data.

The information collected under GLP

regulations is generally gathered by

testing facilities routinely engaged in

conducting toxicological studies and is

used as part of an application for a

research or marketing permit that is

voluntarily submitted to FDA by

persons desiring to market new

products. The facilities that collect this

information are typically operated by

large entities, e.g., contract laboratories,

sponsors of FDA-regulated products,

universities, or government agencies.

Failure to include the information in a

filing to FDA would mean that agency

scientific experts could not make a valid

determination of product safety. FDA

receives, reviews and approves

hundreds of new product applications

each year based on information

received. The recordkeeping

requirements are necessary to document

the proper conduct of a safety study, to

assure the quality and integrity of the

resulting final report, and to provide

adequate proof of the safety of regulated

products. FDA conducts onsite audits of

records and reports, during its

inspections of testing laboratories, to

verify reliability of results submitted in

applications.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency per

Response

Total Annual

Responses Hours per Response Total Hours

58.35(b)(7) 300 60.25 18,075 1 18,075

58.185 300 60.25 18,075 27.65 499,774

Total 517,849

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

21398 Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Notices

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual Frequency per

Recordkeeping Total Annual Records Hours per Recordkeeper Total Hours

58.29(b) 300 20 6,000 .21 1,260

58.35(b)(1) through

(b)(6) and (c) 300 270.56 81,228 3.36 279,926

58.63(b) and (c) 300 60 18,000 .09 1,620

58.81(a) through (c) 300 301.8 90,540 .14 12,676

58.90(c) and (g) 300 62.7 18,810 .13 2,445

58.105(a) and (b) 300 5 1,500 11.8 17,700

58.107(d) 300 1 300 4.25 1,275

58.113(a) 300 15.33 4,599 6.8 31,273

58.120 300 15.38 4,614 32.7 150,878

58.195 300 251.5 75,450 3.9 294,255

Total 793,308

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

Dated: April 24, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–10623 Filed 4–27–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0178]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Premarket

Notification 510(k) Submissions

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

information collection requirements for

premarket notification 510(k)

submissions.

DATES: Submit written or electronic

comments on the collection of

information by June 29, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to 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:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

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.

Premarket Notification 510(k)

Submissions (21 CFR Part 807) (OMB

Control No. 0910–0120)—Extension

Section 510(k) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360(k)) requires a person who

intends to market a medical device to

submit a premarket notification

submission to FDA at least 90 days

before proposing to begin the

introduction, or delivery for

introduction into interstate commerce,

for commercial distribution of a device

intended for human use. The definition

of ‘‘person’’ has been expanded to

include hospitals who reuse or

remanufacture single-use medical

devices. The estimated submissions

below include those submitted by

hospitals remanufacturing single-use

medical devices.

Section 510(k) of the act allows for

exemptions to the 510(k) submissions

(i.e., a premarket notification

submission would not be required if

FDA determines that premarket

notification is not necessary for the

protection of the public health, and they

are specifically exempted through the

regulatory process). Under 21 CFR

807.85, ‘‘Exemption from premarket

notification,’’ a device is exempt from

premarket notification if the device

intended for introduction into

commercial distribution is not generally

available in finished form for purchase

and is not offered through labeling and

advertising by the manufacturer,

importer, or distributor for commercial

distribution. In addition, the device

must meet one of the following