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