Federal Register / Vol. 66, No. 91 / Thursday, May 10, 2001 / Notices 23943

Debarment and Other Responsibilities

certifications, and need not be mailed

back with the application.

In addition, applicants are required

under section 162(c)(3) of the Act to

provide assurances that the human

rights of all individuals with

developmental disabilities (especially

those individuals without familial

protection) who will receive services

under projects assisted under Part E will

be protected consistent with section 110

(relating to the rights of individuals

with developmental disabilities). Each

application must include a statement

providing this assurance.

For research projects in which human

subjects may be at risk, a Protection of

Human Subjects Assurance may be

required. If there is a question regarding

the applicability of this assurance,

contact the Office for Research Risks of

the National Institutes of Health at (301)

496–7041.

E. Checklist for a Complete Application

The checklist below is for your use to

ensure that your application package

has been properly prepared.

—One original, signed and dated

application, plus two copies.

Applications for different Area of

Emphasis are packaged separately;

—Application is from an organization

which is eligible under the eligibility

requirements defined in the Priority

Area description (screening

requirement);

—Application length does not exceed 60

pages, unless otherwise specified in

the Priority Area description.

A complete application consists of the

following items in this order:

—Application for Federal Assistance

(SF 424, REV 4–88);

—A completed SPOC certification with

the date of SPOC contact entered in

line 16, page 1 of the SF 424 if

applicable.

—Budget Information—NonConstruction Programs (SF 424A, REV

4–88);

—Budget justification for Section B—

Budget Categories;

—Table of Contents;

—Letter from the Internal Revenue

Service, etc. to prove non-profit

status, if necessary;

—Copy of the applicant’s approved

indirect cost rate agreement, if

appropriate;

—Project Description (See Part III,

Section C);

—Any appendices/attachments;

—Assurances—Non-Construction

Programs (Standard Form 424B, REV

4–88);

—Certification Regarding Lobbying; and

—Certification of Protection of Human

Subjects, if necessary.

—Certification of the Pro-Children Act

of 1994; signature on the application

represents certification.

F. The Application Package

Each application package must

include an original and two copies of

the complete application. Each copy

should be stapled securely (front and

back if necessary) in the upper left-hand

corner. All pages of the narrative

(including charts, tables, maps, exhibits,

etc.) must be sequentially numbered,

beginning with page one. In order to

facilitate handling, please do not use

covers, binders or tabs. Do not include

extraneous materials as attachments,

such as agency promotion brochures,

slides, tapes, film clips, minutes of

meetings, survey instruments or articles

of incorporation.

G. Paper Reduction Act of 1995 (Pub. L.

104–13)

The Uniform Project Description

information collection within this

announcement is approved under the

Uniform Project Description (0970–

0139), Expiration Date 12/31/2003.

Public reporting burden for this

collection of information is estimated to

average 10 hours per response,

including the time for reviewing

instructions, gathering and maintaining

the data needed, and reviewing the

collection of information.

An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless it displays a currently valid OMB

control number.

(Federal Catalog of Domestic Assistance

Number 93.631 Developmental Disabilities—

Projects of National Significance)

Dated: May 4, 2001.

Sue Swenson,

Commissioner, Administration on

Developmental Disabilities.

[FR Doc. 01–11762 Filed 5–9–01; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99F–5522]

Food Irradiation Coalition c/o National

Food Processors Association; Filing of

Food Additive Petition; Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

filing notice for a food additive petition

filed by the National Food Processors

Association (NFPA) on behalf of The

Food Irradiation Coalition, to provide

for the safe use of ionizing radiation for

control of food-borne pathogens, and

extension of shelf-life, in a variety of

human foods up to a maximum

irradiation dosage of 4.5 kilograys (kGy)

for non-frozen and non-dry

FOR FURTHER INFORMATION CONTACT:

Lane A. Highbarger, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3032.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

January 5, 2000 (65 FR 493), FDA

announced that a food additive petition

(FAP 9M4697) had been filed by the

NFPA on behalf of The Food Irradiation

Coalition, 1350 I St. NW., suite 300,

Washington, DC 20005, proposing that

the food additive regulations in part 179

Irradiation in the Production, Processing

and Handling of Food (21 CFR part 179)

be amended to provide for the safe use

of ionizing radiation for control of foodborne pathogens, and extension of shelflife, in a variety of human foods up to

a maximum irradiation dosage of 4.5

kGy for non-frozen and non-dry

products, and 10.0 kGy for frozen or dry

products, including: (1) Pre-processed

meat and poultry; (2) both raw and preprocessed vegetables, fruits, and other

agricultural products of plant origin; (3)

certain multi-ingredient food products.

The notice stated that the petition does

not cover products composed in whole

or in part of raw meat, poultry, or fish

nor does it cover ‘‘ready-to-eat’’ fish

products or ingredients made from fish.

Subsequent to the publication of the

filing notice, FDA learned from

discussions with NFPA that the

petitioner intended to include in the

scope of the petition certain multiingredient products that contain

uncooked meat or poultry. In particular,

the petitioner noted a clarifying letter,

dated October 18, 1999, that it had

submitted prior to FDA’s filing the

petition, that mentioned certain foods,

such as country hams and dry and semidry sausages, as examples of foods

intended to be within the scope of the

petition. In preparing the filing notice,

FDA did not recognize that these

products are uncooked and, thus,

mistakenly excluded such products by

virtue of the exclusion for food

containing raw meat or poultry. The

petitioner recently informed FDA that

the January, 2000, filing notice would

23944 Federal Register / Vol. 66, No. 91 / Thursday, May 10, 2001 / Notices

appear to restrict the scope of the

petition and that it was (and is) the

petitioner’s intent that multi-ingredient

meat products (whether containing

cooked or uncooked meat or poultry) be

included in the scope of the pending

petition.

Therefore, FDA is amending the filing

notice of January 5, 2000, to indicate

that the petitioner has requested that the

food additive regulations be amended to

permit the irradiation of multiingredient foods containing uncooked

meat or poultry.

The agency has determined under 21

CFR 25.32(i) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: April 20, 2001.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 01–11733 Filed 5–9–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–379]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Extension of a currently

approved collection;

Title of Information Collection: The

Financial Statement of Debtor and

Supporting Regulations in 42 CFR,

Section 405.376;

Form No.: HCFA–379 (OMB# 0938–

0270);

Use: This form is used to collect

financial information which is needed

to evaluate requests from physicians/

suppliers to pay indebtedness under an

extended repayment schedule, or to

compromise a debt less than the full

amount.;

Frequency: Other: As needed;

Affected Public: Business or other forprofit, and Individuals or Households;

Number of Respondents: 500;

Total Annual Responses: 500;

Total Annual Hours: 1,000.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Dawn Willinghan, HCFA–

379, Room N2–14–26, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

Dated: May 2, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–11735 Filed 5–9–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–142]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Information

Collection Requirements Contained in

BPD–393, Examination and Treatment

for Emergency Medical Conditions and

Women in Labor and HCFA–1005–IFC,

PPS for Hospital Outpatient Services

and Supporting Regulations Contained

in 42 CFR 488.18, 489.20 and 489.24;

Document No.: HCFA–R–142 (OMB#

0938–0667); Use: The Information

Collection Requirements contained in

BPD–393, Examination and Treatment

for Emergency Medical Conditions and

Women in Labor and HCFA–1005–IFC,

contains requirements for hospitals to

prevent them from inappropriately

transferring individuals with emergency

medical conditions, as mandated by

Congress. HCFA will use this

information to help assure compliance

with this mandate and protect the

public. This information is not

contained elsewhere in regulations.

Frequency: On occasion; Affected

Public: Individuals or Households, Notfor-profit institutions, Federal

Government, and State, Local or Tribal

Government; Number of Respondents:

5,600; Total Annual Responses: 5,600;

Total Annual Hours Requested: 1.

It should be noted, that based on

industry input and HCFA analysis, the

applicability and burden associated

with the information collection

requirements (ICR) captured in this

submission have been adjusted to

properly reflect the degree of burden

associated with this collection. In

particular, the ICRs captured in this

submission have been determined to be

either exempt or the burden has been

deemed usual and customary in

accordance with the 1995 PRA. In order

to comply and properly reflect the Act,

HCFA assigned a token one-hour of

burden for this submission.