Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Notices 23715

Equipment

Description: ‘‘Equipment’’ means an article

of nonexpendable, tangible personal property

having a useful life of more than one year

and an acquisition cost which equals or

exceeds the lesser of (a) the capitalization

level established by the organization for the

financial statement purposes, or (b) $5,000.

(Note: Acquisition cost means the net invoice

unit price of an item of equipment, including

the cost of any modifications, attachments,

accessories, or auxiliary apparatus necessary

to make it usable for the purpose for which

it is acquired. Ancillary charges, such as

taxes, duty, protective in-transit insurance,

freight, and installation shall be included in

or excluded from acquisition cost in

accordance with the organization’s regular

written accounting practices.)

Justification: For each type of equipment

requested, provide a description of the

equipment, the cost per unit, the number of

units, the total cost, and a plan for use on the

project, as well as use or disposal of the

equipment after the project ends. An

applicant organization that uses its own

definition for equipment should provide a

copy of its policy or section of its policy

which includes the equipment definition.

Supplies

Description: Costs of all tangible personal

property other than that included under the

Equipment category.

Justification: Specify general categories of

supplies and their costs. Show computations

and provide other information which

supports the amount requested.

Contractual

Description: Costs of all contracts for

services and goods except for those which

belong under other categories such as

equipment, supplies, construction, etc.

Third-party evaluation contracts (if

applicable) and contracts with secondary

recipient organizations, including delegate

agencies and specific project(s) or businesses

to be financed by the applicant, should be

included under this category.

Justification: All procurement transactions

shall be conducted in a manner to provide,

to the maximum extent practical, open and

free competition. Recipients and

subrecipients, other than States that are

required to use Part 92 procedures, must

justify any anticipated procurement action

that is expected to be awarded without

competition and exceed the simplified

acquisition threshold fixed at 41 USC 403(11)

currently set at $100,000. Recipients might be

required to make available to ACF pre-award

review and procurement documents, such as

request for proposals or invitations for bids,

independent cost estimates, etc.

Note: Whenever the applicant intends to

delegate part of the project to another agency,

the applicant must provide a detailed budget

and budget narrative for each delegate

agency, by agency title, along with the

required supporting information referred to

in these instructions.

Other

Enter the total of all other costs. Such

costs, where applicable and appropriate, may

include but are not limited to insurance,

food, medical and dental costs

(noncontractual), professional services costs,

space and equipment rentals, printing and

publication, computer use, training costs,

such as tuition and stipends, staff

development costs, and administrative costs.

Justification: Provide computations, a

narrative description and a justification for

each cost under this category.

Indirect Charges

Description: Total amount of indirect costs.

This category should be used only when the

applicant currently has an indirect cost rate

approved by the Department of Health and

Human Services (HHS) or another cognizant

Federal agency.

Justification: An applicant that will charge

indirect costs to the grant must enclose a

copy of the current rate agreement. If the

applicant organization is in the process of

initially developing or renegotiating a rate, it

should immediately upon notification that an

award will be made, develop a tentative

indirect cost rate proposal based on its most

recently completed fiscal year in accordance

with the principles set forth in the cognizant

agency’s guidelines for establishing indirect

cost rates, and submit it to the cognizant

agency. Applicants awaiting approval of their

indirect cost proposals may also request

indirect costs. It should be noted that when

an indirect cost rate is requested, those costs

included in the indirect cost pool should not

also be charged as direct costs to the grant.

Also, if the applicant is requesting a rate

which is less than what is allowed under the

program, the authorized representative of the

applicant organization must submit a signed

acknowledgment that the applicant is

accepting a lower rate than allowed.

Program Income

Description: The estimated amount of

income, if any, expected to be generated from

this project.

Justification: Describe the nature, source

and anticipated use of program income in the

budget or refer to the pages in the application

which contain this information.

Nonfederal Resources

Description: Amounts of non-Federal

resources that will be used to support the

project as identified in Block 15 of the SF–

424.

Justification: The firm commitment of

these resources must be documented and

submitted with the application in order to be

given credit in the review process. A detailed

budget must be prepared for each funding

source.

Total Direct Charges, Total Indirect Charges,

Total Project Costs.

[Self-explanatory]

[FR Doc. 01–11680 Filed 5–8–01; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0208]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Voluntary National

Retail Food Regulatory Program

Standards

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, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

FDA’s collection of information from

local, State, and tribal agencies

concerning their use of or planned use

of all or part of the Voluntary National

Retail Food Regulatory Program

Standards.

DATES: Submit written or electronic

comments on the collection of

information by July 9, 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:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane, rm.

16B–26, 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

23716 Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Notices

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

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.

Voluntary National Retail Food

Regulatory Program Standards

FDA has developed the Voluntary

National Retail Food Regulatory

Program Standards (the National

Standards) to assist and promote the

uniform application of provisions of the

model FDA Food Code by several

thousand local, State, and tribal

jurisdictions that have primary

responsibility for the regulation or

oversight of retail level food operations.

The National Standards are intended to

serve as a guide to regulatory retail food

program managers in the design and

management of a retail food program

that is focused on the reduction of risk

factors know to cause foodborne illness.

The National Standards also promote

active management control by industry

of all risk factors that may cause

foodborne illness. Authority for

providing such assistance is derived

from section 311 of the Public Health

Service Act (42 U.S.C. 243), and

delegation of authority from the Public

Health Service to the Commissioner of

Food and Drugs related to food

protection is contained in 21 CFR

5.10(a)(2) and (a)(4). Under 31 U.S.C.

1535, FDA provides financial assistance

to other Federal agencies such as the

Indian Health Service. FDA has

established a section on the Internet at

http://vm.cfsan.fda.gov/dms/rettoc.html under ‘‘Federal/State Food

Programs—Retail Food Safety

References’’ to list jurisdictions that

have voluntarily elected to use the

National Standards.

Utilization of the National Standards

by local, State, and tribal regulatory

agencies is an important step to further

the goals of the President’s Council on

Food Safety and FDA program goals. All

regulatory agencies are encouraged to

voluntarily utilize the National

Standards as a guide for the design and

management of a retail food safety

program. There is no reporting or

recordkeeping requirement for those

jurisdictions that wish to utilize part or

all of the National Standards to enhance

or measure program performance.

Reporting is only a requirement for

those jurisdictions that request to be

listed in the FDA National Registry.

Jurisdictions that request listing in the

FDA National Registry of participating

regulatory agencies will be expected to

perform certain management tasks and

periodically report the results to FDA.

Voluntary listing in the FDA National

Registry requires that the following

tasks be performed by State, local, and

tribal program managers: (1) Conduct a

program self assessment, (2) conduct a

baseline survey of the regulated

industry, and (3) obtain an independent

outside audit. All three tasks must be

completed within a 3-year time span.

The tasks must be performed in

accordance with the guidance provided

in the National Standards and the

results reported to FDA.

FDA based its estimate on the number

of State agencies (100) involved in Food

Code related regulatory programs, 300

local agencies with local ordinance

authority that may consider Food Code

adoption in any one year and 100 tribal

agencies. The presumption being that

those agencies most likely to utilize the

National Standards are also those

agencies with authority to adopt and

enforce the model FDA Food Code.

There is only one required report, the

FDA National Registry Report

(Appendix I), which is used to report

program self assessment, baseline

surveys of industry, and outside audits.

The time required to complete the

actual reporting document is minimal,

however, additional time is required to

analyze and review existing records,

conduct baseline inspections, and

secure an outside audit. The hour

burden estimate includes the time

required to review the instructions in

the National Standards, search existing

data sources, gather and maintain the

data needed, complete worksheets, and

review the collected information. The

estimate of 92 hours to complete a

program self assessment is based on the

average time reported by the four State

and three local jurisdictions that

participated in the National Standards

Pilot. The amount of time expended by

individual jurisdictions ranged from 40

to 215 hours. This range is reflective of

the difference in size between

jurisdictions. The baseline survey of

industry and the outside audit are

expected to require a similar amount of

time to complete. Because only one of

the three tasks is required per year, the

average annual reporting burden is

estimated to be 92 hours per year for

each participating jurisdiction.

Because the records of establishment

inspections, investigations, and

enforcement activities are routinely

maintained and accepted management

practices already necessitate the

collection of some required information

and maintenance of records, the

recordkeeping burden is minimal.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Standard No. No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses

Hours per

Response Total Hours

92 ............................................................ 500 1 500 92 46,000

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

2Includes the use of Forms FDA 3519 and 3520.

Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Notices 23717

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Standard No. No. of Recordkeepers

Annual Frequency

per Recordkeeping

Total Annual

Records

Hours per Recordkeeper Total Hours

3, 4, and 62 ............................................ 500 1 500 5 2,500

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

2The standards incorporate the best program management practices currently in use in the regulatory community. The recommended policies,

procedures, and standard operating procedures contained in the various national standards are considered usual and customary management

practices for State, local, and tribal agencies that regulate the retail segment of the food industry.

Dated: May 4, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–11618 Filed 5–8–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–0239]

Agency Information Collection

Activities; Announcement of OMB

Approval; Request for Resolution of

Scientific Disputes Concerning the

Regulation of Medical Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Request for Resolution of Scientific

Disputes Concerning the Regulation of

Medical Devices’’ has been approved by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995.

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: In the

Federal Register of February 8, 2001 (66

FR 9585), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. 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. OMB has now approved the

information collection and has assigned

OMB control number 0910–0467. The

approval expires on April 30, 2004. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: May 3, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–11583 Filed 5–8–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0179]

Purina Mills, Inc., et al.; Withdrawal of

Approval of New Animal Drug

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 11 new animal drug

applications (NADAs) listed below. In a

final rule published elsewhere in this

issue of the Federal Register, FDA is

amending the animal drug regulations to

remove the portions reflecting approval

of the NADAs because the products are

no longer manufactured or marketed.

DATES: Withdrawal of approval is

effective May 21, 2001.

FOR FURTHER INFORMATION CONTACT:

Pamela K. Esposito, Center for

Veterinary Medicine (HFV–210), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

5593.

SUPPLEMENTARY INFORMATION: The

following sponsors have requested that

FDA withdraw approval of the NADAs

listed below because the products are no

longer manufactured or marketed:

Sponsor NADA No. Product

(Drug)

21 CFR Cite Affected

(Sponsor Drug Labeler Code)

Purina Mills, Inc., P.O. Box 66812, St.

Louis, MO 63166–6812.

NADA 48–915 Purina Bot Control (trichlorfon) 520.2520a (017800)

Golden Sun Feeds, Inc., 111 South Fifth

St., Estherville, IA 51334.

NADA 97–567 Tylan 10 Premix (tylosin phosphate).558.625(b)(17) (021780)

.................................................................... NADA 97–615 Swine Med-A-Mix TS 8000 Pre

mix, Tylan 5, 10, 20, 40 Sulfa-G (tylosin

phosphate and sulfamethazine).

558.630(b)(4) and (b)(10) (021780)

Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, MN 55318–1093.NADA 110–440 Hygromix Hygrowormer

Hyanthelmix (hygromycin B).

558.274(a)(2), (a)(3), (a)(4), (c)(1)(i), and

(c)(1)(ii) (016968)

Steris Laboratories, Inc., 620 North 51st

Ave., Phoenix, AZ 85043–4705.

NADA 44–585 Oxytocin Injection ........................ 522.1680 (000402)

.................................................................... NADA 45–578 Lidocaine Hydrochloride with

Epi-nephrine Injection 2%.

522.1258 (000402)

.................................................................... NADA 45–737 Sodium Pentobarbital Injection ... 522.1704(b) (000402)

.................................................................... NADA 45–848 Phenylbutazone Injection ............ 522.1720 (000402)

.................................................................... NADA 110–349 Dexamethasone Injection ......... 522.540(c)(2) (000402)