Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Notices 34713

Applications should demonstrate

sufficient personnel resources and staff

competence to assure that project

activities can be successfully carried out

and list each consultant, or key

individuals who will work on the

project.

Applicants must refer to the specific

evaluation criteria for each competitive

area contained in the full Program

Announcement in order to adequately

prepare their applications.

Criterion 5: Organization Profile (10

Points Plus 5 Possible Bonus Points)

Applicants are expected to provide

information on the applicant

organization(s) and cooperating

partners, including information such as

organization charts, along with a brief

description of the nature of their

contribution and knowledge of and

experience with youth development,

youth issues and youth and family

services.

Applicants must refer to the specific

evaluation criteria for each competitive

area contained in the full Program

Announcement in order to adequately

prepare their applications.

Criterion 6: Budget and Budget

Justification (10 Points)

Applicants are expected to provide a

detailed line item budget and a narrative

budget justification that described how

the categorical costs are derived;

discusses the necessity, reasonableness,

and allocability of the proposed costs;

and discusses and justifies the costs of

the proposed project in terms of types

and quantities of activities to be

implemented and the anticipated results

and benefits.

Applicants are expected to describe

the fiscal control and accounting

procedures that will be used to ensure

the prudent use, proper disbursement

and accurate accounting of funds

received under this program

announcement.

Applicants must refer to the specific

evaluation criteria for each competitive

area contained in the full Program

Announcement in order to adequately

prepare their applications.

Part 2. Required Notification of the

Single Point of Contact

Most portions of this program are

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 Territories except Alabama,

Alaska, Colorado, Connecticut, Hawaii,

Idaho, Kansas, Louisiana,

Massachusetts, Minnesota, Montana,

Nebraska, New Jersey, New York, Ohio,

Oklahoma, Oregon, Palau,

Pennsylvania, South Dakota, Tennessee,

Vermont, Virginia, Washington, and

American Samoa have elected to

participate in the Executive Order

process and have established Single

Points of Contact (SPOCs). Applicants

from these twenty-three 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,

applicant 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

Application for Federal Assistance,

Standard Form 424, item 16.

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. A list

of the Single Points of Contact for each

State and Territory can be found on the

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

omb/grants/spoc.html. or by calling the

ACYF Operations Center at 1–800–351–

2293.

Dated: May 12, 2000.

James A. Harrell,

Deputy Commissioner, Administration on

Children, Youth, and Families.

[FR Doc. 00–12376 Filed 5–16–00; 8:45 am]

BILLING CODE 4184–01–M

Editorial Note: FR-Doc.00-12376 was

originally published at 65 FR 31338-31343,

Wednesday, May 17, 2000. Due to printing

errors it is being republished in its entirety.

[FR Doc. R0–12376 Filed 5–30–00; 8:45 am]

BILLING CODE 1505–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 99D–4575 and 99D–4576]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; FoodContact Substance Notification System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written comments on the

collection of information by June 30,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Wendy

Taylor, Desk Officer for FDA.

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

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Title: Food-Contact Substances

Notification System

Description: Section 409(h) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 348(h)) establishes a

premarket notification (PMN) process

for food-contact substances (FCS’s).

Section 409(h)(6) of the act defines a

‘‘food contact substance’’ as ‘‘any

substance intended for use as a

component of materials used in

manufacturing, packing, packaging,

transporting, or holding food if such use

is not intended to have any technical

effect in such food.’’ Section 409(h)(3) of

the act requires that the notification

process be utilized for authorizing the

marketing of FCS’s, except where FDA

determines that the submission and

premarket review of a food additive

petition (FAP) under section 409(b) of

the act is necessary to provide adequate

assurance of safety. Section 409(h)(1) of

34714 Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Notices

the act requires that a notification

include information on the identity and

the intended use of the FCS and the

basis for the notifier’s determination

that the FCS is safe under the intended

conditions of use. Because section

409(h)(1) of the act references the

general safety standard for food

additives, the data in a PMN should be

comparable to the data in an FAP.

In the Federal Register of November

12, 1999 (64 FR 61648), FDA announced

the availability for comment of two draft

guidance documents that are part of the

agency’s implementation of the PMN

program, which will largely replace the

FAP process for those food additives

that are FCS’s. The information to be

collected is information on the

manufacture and intended use of the

FCS, studies relating to the safety of the

FCS, and other information necessary to

demonstrate that the FCS is safe under

the intended conditions of use. FDA

also made available for comment FDA

Form No. 3480, entitled ‘‘Notification

for New Use of a Food Contact

Substance,’’ which is to be used for a

notification for a new use of a FCS. FDA

believes that this form will facilitate

both preparation and review of

notifications because the form will serve

to organize information necessary to

support the safety of the use of the FCS.

The burden of filling out the appropriate

form has been included in the burden

estimate for the notification. The agency

requested comments on the proposed

collections of information.

One comment was received on FDA’s

paperwork reduction analysis for the

notification program for FCS’s. Portions

of this comment concern the content of

the guidance documents announced in

the November 12, 1999, notice. FDA

will consider these portions of the

comment in preparing the final version

of the guidance documents.

Portions of the comment addressed

the format, content, and utility of the

proposed FDA Form 3480. The

comment stated that FDA Form 3480

would be more useful if it were made

available in a common word processor

format such as WordPerfect or Word.

FDA has made the form available in a

portable document format that is

compatible with and can be read by

most current versions of word

processing software packages.

Therefore, FDA disagrees that it is

necessary for the form to be available in

a word processor format in order for it

to be useful. However, FDA does expect

to make the form available in

WordPerfect and Word formats once

the form has been approved by OMB.

The comment further stated that the

form should be pilot tested to insure its

compatibility throughout the industry.

FDA has designed Form 3480 to

function as summary form for many

types of notifications. FDA expects to

modify the form to suit the needs of the

agency and the various types of

notifications and notifiers. FDA expects

to make it possible for notifiers to fill

out the form through the agency’s

Internet site, and to ultimately use the

form to facilitate electronic submissions.

FDA believes that the most efficient way

to evaluate this form is to begin using

it and examine the problems and any

suggestions for improvement on a

continuing basis. FDA expects to

accomplish this through the periodic

reauthorization of the form required by

OMB.

The comment correctly states that, in

many cases, only summary information

may be included in the form and that

more detailed information will need to

be referenced and attached. Moreover,

the comment states that this caused the

form to be a many-segmented document

forcing the reader to jump back and

forth within the document. The

comment also states that a summary

form with all supporting information

attached in a specified format would be

more useful to FDA and the regulated

industry. The comment further states

that all notifications should contain the

same information in the same place

within the submission.

As explained above, FDA believes

that FDA Form 3480 is the summary

form that the comment suggests is

needed. FDA has not mandated, and

does not expect to mandate, a particular

format for notifications in regulations.

Therefore, notifiers are free to present

and organize the supporting information

exactly as the notifier wishes. FDA

recognizes that all sections of FDA Form

3480 will not be applicable to all

notifications nor to all notifiers.

However, FDA believes that most if not

all notifiers will find the form useful in

organizing their submissions. In

addition, FDA disagrees with the

notifier that the form will not assist FDA

in processing notifications because it

will be a many-segmented document.

FDA’s review of notifications is

generally segmented into chemical,

toxicological, and environmental

disciplines. FDA Form 3480 was

designed with this review process in

mind. The proposed Form 3480 will

assist FDA reviewers in locating the

pertinent portions of the data and

information that relate specifically to

their discipline and their specific

review responsibilities.

Description of Respondents:

Manufacturers of food-contact

substances.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Form No. of Respondents

Annual Frequency per Response

Total Annual

Responses

Hours per Response Total Hours

FDA 3480 2 200 1 200 25 5,000

FDA 3480 3 55 2 110 120 13,200

FDA 3480 4 45 2 90 150 13,500

FDA 3480 5 16 1 16 150 2,400

Total 34,100 6

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

2 Duplicate notifications for uses of FCS’s.

3 Notifications for uses that would currently be the subject of exemptions under 21 CFR 170.39 or very simple FAP’s.

4 Notifications for uses that would currently be the subject of moderately complex FAP’s.

5 Notifications for uses that would currently be the subject of more complex FAP’s.

6 Due to a clerical error, the reporting burden hours for FDA 3480 3 that appeared in the FEDERAL REGISTER of November 12, 1999 (64 FR

61648), were incorrect. Table 1 of this document contains the correct estimates.

The above estimate is based on the

types of submissions that FDA currently

receives for FCS’s in the threshold of

regulation (TOR) and the FAP processes

and the following assumptions and

information:

Federal Register / Vol. 65, No. 105 / Wednesday, May 31, 2000 / Notices 34715

1. FDA estimates that the likely

increase in PMN’s over the number of

FAP’s and TOR requests will be

approximately four times the highest

recent influx of these submissions (50

and 54, respectively). This factor is

based on an analysis of the number of

companies producing various types of

FCS’s and the types of FCS’s for which

FAP’s and TOR’s are most commonly

submitted to FDA.

2. FDA also has included 200

expected duplicate submissions in the

second lowest tier. FDA expects that the

burden for preparing these notifications

will primarily consist of the notifier

filling out FDA Form No. 3480,

verifying that a previous notification is

effective, and preparing necessary

documentation.

3. Based on the amount of data

typically submitted in FAP’s and TOR

requests, FDA identified three other

tiers of PMN’s that represent escalating

levels of burden required to collect

information.

4. FDA estimated the median number

of hours necessary for collecting

information for each type of notification

within each of the three tiers, and the

cost of developing necessary data based

on input from industry sources.

Dated: May 23, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–13585 Filed 5–30–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–205/

Supplement]

Agency Information Collection

Activities: Submission For OMB

Review; Comment Request

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, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the 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: New Collection.

Title of Information Collection:

Individual Market-Guarantee Issue

Election Packet, and Supporting

Regulations in 45 CFR 148, and Forms/

Instructions.

Form No.: HCFA-R–205/Supplement

(OMB# 0938-NEW).

Use: This collection is a Supplement

of the existing collection for

‘‘Information Collection Requirements

Referenced in HIPAA for the Individual

Market, Supporting Regulations in 45

CFR 148, and forms/instructions (OMB

0938–0703). This supplement is

intended to simplify the filing

obligations of issuers who participate in

the individual market of more than one

direct enforcement state. A direct

enforcement state is a state in which

HCFA has the responsibility to enforce

the requirements of HIPAA. This

supplement allows the issuer to submit

the requested information for multiple

states at one time, rather than having to

complete a separate transmittal form for

each state.

Frequency: On occasion.

Affected Public: Business or other forprofit, Individuals or Households, Notfor-profit institutions, Federal

Government, and State, Local or Tribal

Government.

Number of Respondents: 15.

Total Annual Responses: 150.

Total Annual Hours: 566.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s Web Site Address at http://

www.hcfa.gov/regs/prdact95.htm, or Email your request, including your

address and phone number, 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 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, DC 20503.

Dated: May 8, 2000.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–13544 Filed 5–30–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–2076–N]

RIN 0938–AK16

Medicaid Infrastructure Grant Program

To Support the Competitive

Employment of People With

Disabilities

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

availability of HCFA funding, through

grants, for eligible States under the

Ticket to Work and Work Incentives

Improvement Act of 1999 (TWWIIA).

The grant program is designed to assist

States in developing infrastructures to

support the competitive employment of

people with disabilities by facilitating

targeted improvement to States’

Medicaid programs. This notice

contains information about the grants,

application requirements, review

procedures, and other relevant

information.

DATES: States should submit a Notice of

Intent to Apply for a grant by June 12,

2000. Grant applications must be

submitted July 31, 2000, in order to be

considered for funding beginning in

October 2000. For an explanation of a

timely submission, see Section V of this

notice entitled ‘‘Applying for a Grant.’’

Application Requests: To receive an

application package contact Marilyn

Lewis-Taylor, (410) 786–5701,

mlewistaylor@hcfa.gov.

ADDRESSES: Mail applications to the

following: Health Care Financing

Administration, Room C2–21–15, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850, Attn: Marilyn

Lewis-Taylor, OICS, AGG, Grants

Management Staff.

Please Note: While State agencies are only

required to submit an original and two

copies, submission of an original and seven

copies will greatly expedite the application

process.

Web Site Address for Additional

Information: We have a website that

provides additional details and