31010 Federal Register / Vol. 65, No. 94 / Monday, May 15, 2000 / Notices

Committee, dated April 1984, and the

Panel on Review of Allergenic Extracts,

dated December 1983, that are the

subject of this proposed order. Copies of

these reports can be obtained from the

Office of Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. By sending

a self-addressed adhesive label, you will

assist that office in processing your

requests more quickly. The documents

may also be obtained by mail by calling

the CBER Voice Information System at

1–800–835–4709 or 301–827–1800, or

by fax by calling the FAX Information

System at 1–888–CBER–FAX or 301–

827–3844, or by mail by contacting

CBER electronically at

www.CBERlINFO@CBER.FDA.GOV.

Interested persons may, on or before

August 13, 2000 submit written

comments regarding this proposal to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Two copies of any comments

should be submitted, except that

individuals should submit one copy.

Comments may also be submitted

electronically at www.fda.gov/ohrms/

dockets. Comments should be identified

with the docket number found in

brackets in the heading of this

document. Data and information

submitted to FDA that fall within the

confidentiality provisions of 18 U.S.C.

1905, 5 U.S.C. 552(b), or 21 U.S.C. 331(j)

are not available for public disclosure.

Consistent with the provisions of

§ 601.25(b), when FDA publishes this

proposed order and the Reclassification

Committee’s reclassification findings,

data and information submitted to FDA

in connection with these reclassified

products will be made publicly

available after June 14, 2000, and may

be viewed at the Dockets Management

Branch (address above). Data and

information submitted and shown to fall

within the confidentiality provisions of

one or more of the above statutes will

not be disclosed. Comments concerning

confidentiality should be received by

FDA by June 14, 2000. Received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

After review of the public comments

received in response to this proposed

order and in consideration of the results

of hearings, if any, FDA intends to issue

in the Federal Register a final order

announcing its final conclusions and

revoking those licenses which are

placed in Category II by the final order.

Dated: May 3, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–12116 Filed 5–12–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E–0228]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Neuro Cybernetic

Prosthesis (NCP) System;

Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending a

previous determination regarding the

regulatory review period for the Neuro

Cybernetic Prosthesis (NCP) System

that appeared in the Federal Register of

November 10, 1998 (63 FR 63066). FDA

is amending the notice because the

agency agrees with the information

provided in a request from the applicant

for revision of the regulatory review

period (Request) (Docket No. 98E–022 8/

PRC 1, dated and received on January 8,

1999).

ADDRESSES: Submit written comments

and petitions to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Regulatory Policy

Staff (HFD–7), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–5645.

SUPPLEMENTARY INFORMATION: In its

original application for patent term

extension, the applicant claimed

December 16, 1991, as the date the

premarket approval application (PMA)

for the Neuro Cybernetic Prosthesis

(NCP) System (PMA 910070) was

initially submitted. FDA first

determined that the PMA was initially

submitted on January 27, 1997, because

FDA records indicated that the PMA

submitted on December 16, 1991, had

not been filed, but an amended PMA,

renumbered as PMA 970003, was the

PMA for the approved product.

The applicant later claimed in its

request that FDA’s determination of the

regulatory review period failed to take

into account an approved amendment to

the applicant’s originally submitted

PMA. Therefore, the applicant requested

that the agency correct the date the PMA

was initially submitted to June 1, 1993,

the date the approved amendment to the

PMA was received by FDA.

FDA reviewed its records and

confirmed that the amended PMA,

received on June 1, 1993, was filed by

the agency based on a threshold

determination that the amended PMA

was sufficiently complete to permit a

substantive review. FDA later

determined that additional studies were

required and issued a major deficiency

letter dated September 30, 1994,

requesting that additional clinical

studies be performed. The applicant

submitted a second amendment to the

PMA, which the agency received on

January 27, 1997. FDA reviewed the

amendment and determined that the

second amendment sufficiently

responded to the September 30, 1994,

deficiency letter, and filed the newly

amended PMA on the date of the receipt

of the completed PMA, January 27,

1997. For administrative reasons, the

second amendment to the PMA was

considered a resubmission of the PMA,

and it was assigned a new PMA number,

P970003, which is the PMA number of

the approved PMA for the product.

In the past, FDA has determined that

the start of the approval phase began

with the submission of the first filed

PMA for an approved product, even if

the original filed PMA was later

withdrawn and filed under a new

number. For this reason, FDA now

accepts the date of June 1, 1993,

submitted by the applicant in its

request, as the date the first PMA was

filed for the product and the date that

the PMA was initially submitted.

Therefore, the applicable regulatory

review period for the Neuro Cybernetic

Prosthesis (NCP) System is 3,237 days.

Of this time, 1,730 days occurred during

the testing phase of the regulatory

review period, while 1,507 days

occurred during the approval phase.

These periods of time were derived

from the following dates, summarized

from the November 10, 1998, notice and

modified by this technical amendment:

1. The date a clinical investigation

involving this device was begun:

September 6, 1988.

2.The date an application was

initially submitted with respect to the

device under section 515 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360e): June 1, 1993.

3. The date the application was

approved: July 16, 1997.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

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