Federal Register / Vol. 65, No. 94 / Monday, May 15, 2000 / Notices 31011

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,761 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before July 14, 2000, submit to the

Dockets Management Branch (address

above) written comments and ask for a

redetermination. Furthermore, any

interested person may petition FDA, on

or before November 13, 2000, for a

determination on whether the applicant

for extension acted with due diligence

during the regulatory review period. To

meet its burden, the petition must

contain sufficient facts to merit an FDA

investigation. (See H. Rept. 857, part 1,

98th Cong., 2d sess., pp. 41–42, 1984.)

Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch. Three copies of any information

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: May 6, 2000.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug

Evaluation and Research.

[FR Doc. 00–12117 Filed 5–12–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301) 443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: Children’s Hospital

Graduate Medical Education

Program—New

Public Law Number 106–129

amended the Public Health Service Act

to establish a new program to support

graduate medical education (GME) in

children’s hospitals. The provision

authorizes payments in FY 2000 and FY

2001 for direct and indirect expenses

associated with operating approved

GME programs. Section 340E(c)(1) states

that the amount determined under this

subsection for payments for direct

medical expenses for a fiscal year is

equal to the product of (A) the updated

per resident amount as determined, and

(B) the average number of FTE residents

in the hospital’s approved graduate

medical residency training programs as

determined under section 1886(h)(4) of

the Social Security Act during the fiscal

year. The statute directs the Secretary to

take into account factors identified in

section 340E(b)(1)(B) and 340E(d)(2) ‘‘

case mix, number of FTE residents,

treatment of more severely ill patients

and the additional costs related to

teaching residents.

Administration of the Children’s

Hospital Graduate Medical Education

Program relies on the reporting of the

number of full-time equivalent residents

in applicant children’s hospital training

programs to determine the amount of

direct and indirect expense payments to

participating children’s hospitals.

Indirect expense payments will also be

derived from a formula that requires the

reporting of case mix index information

from participating children’s hospitals.

Hospitals will be requested to submit

such information in an annual

application. The statute also requires

reconciliation of the estimated numbers

of residents with the actual number

determined after the close of the fiscal

year. Participating children’s hospitals

would be required to complete an

adjusted report to correct such

information on an annual basis.

ESTIMATES OF ANNUALIZED HOUR BURDEN

Form name Number of

respondents

Responses

per

respondent

Total

responses

Hrs. per

response

Total

hour

burden

Form E (Short) ..................................................................... 42 1 42 *99.9 4,194

Form E (Long) ...................................................................... 12 1 12 *46.7 560

Form F (Short) ..................................................................... 42 1 42 8 336

Form F (Long) ...................................................................... 12 1 12 8 96

IME Data * ............................................................................ 54 1 54 14 756

Required GPRA Tables ....................................................... 54 1 54 28 1,512

Total .............................................................................. 54 7,454

*The hours per response are paradoxically greater for the short form because of the relatively large number of hospitals which have been reporting residency counts to Medicare but expect considerable work in translating resident counts based on hospital cost-reporting years to

counts, in part prospective, based on Federal fiscal years, including obtaining interim counts from other hospitals of incoming rotations.

HRSA is requesting from OMB an

emergency review and approval of this

data collection within 40 days from the

date of publication of this notice, with

a 180-day approval period. During this

180-day approval period, we will

publish a separate Federal Register

notice announcing the initiation of an

extensive 60-day review and public

comment period on the data collection

activity.

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

John Morrall, Human Resources and

Housing Branch, Office of Management

and Budget, 725 17th St., NM, New

Executive Office Building, Room 10235,

Washington, DC 20503.

Dated: May 8, 2000.

Claude Earl Fox,

Administrator.

[FR Doc. 00–11893 Filed 5–12–00; 8:45 am]

BILLING CODE 4160–15–P