38836 Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Notices

receiving, reviewing, evaluating, and

taking appropriate action on a variety of

submissions concerning various

regulated products, including: (1)

Investigational new drug applications

(IND’s) and investigational device

exemption applications (IDE’s) for

certain products for which CBER has

been assigned responsibility; (2) BLA’s,

PLA’s, and ELA’s submitted for

biological products; and (3) new drug

applications (NDA’s), premarket

approval applications (PMA’s), and

premarket notifications (510k’s) for

which CBER has been assigned

responsibility.

In an effort to upgrade CBER’s data

base and tracking system for license

applications, CBER is converting to a

new data base system starting in June

2000. Because of this conversion, CBER

will be unable to start work or continue

work on certain pending submissions

and reports until conversion to the new

system is ready; therefore, FDA plans to

temporarily defer action on certain

submissions subject to CBER review and

approval, including BLA’s, PLA’s,

ELA’s, and related correspondence.

Other submissions subject to CBER

review and approval, including IND’s,

NDA’s, 510k’s, PMA’s, or IDE’s will not

be affected by the conversion and

temporary deferment. FDA is requesting

that applicants voluntarily refrain from

filing the affected submissions during

the conversion period, which will begin

on June 26, 2000, and is expected to

continue until July 20, 2000. CBER will

try to complete the conversion and

begin processing submissions sooner

than the specified timeframe.

Confirmation of the resumption of

normal review procedures and any

change in this timeframe will be

announced on the Internet on CBER’s

home page at http://www.fda.gov/cber/

genadmin.htm.

FDA anticipates that this period will

be about 1 month or less. Although FDA

will continue to accept mail during this

period, affected submissions and related

correspondence will neither be officially

logged in nor will review of affected

submissions or related correspondence

begin. Any review period will not begin

until the conversion is completed and

CBER review functions resume. CBER

will attempt to keep the mail in the

order of the day received. When work

resumes, the mail will be handled in the

order in which it was received. Also, the

review periods on pending submissions

will be suspended during the

conversion period. The action due date

for all pending submissions will be

extended by the length of the actual

deferment. CBER will attempt to

minimize the period during which

regular procedures are suspended.

Persons who may be affected by this

temporary deferment should call the

contact person listed above or CBER’s

Office of Communication, Training, and

Manufacturer’s Assistance at 301–827–

2000 with any questions regarding the

conversion.

Dated: June 14, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–15554 Filed 6–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10008]

Emergency Clearance: Public

Information Collection Requirements

Submitted to the Office of Management

and Budget (OMB)

AGENCY: Health Care Financing

Administration.

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, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this 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.

We are, however, requesting an

emergency review of the Information

collections referenced below. In

compliance with the requirement of

section 3506(c)(2)(A) of the Paperwork

Reduction Act of 1995, we have

submitted to the Office of Management

and Budget (OMB) the following

requirements for emergency review. We

are requesting an emergency review

because the collection of this

information is needed prior to the

expiration of the normal time limits

under OMB’s regulations at 5 CFR part

1320. This collection of information will

be used to determine items eligible for

payment as new technology within the

ambulatory payment classification

(APC) system as well as items eligible

for the transitional pass-through

payment provision as required by

section 201 of the BBRA. Without this

information, HCFA would be unable to

determine eligible items for transitional

pass-through or new technology

payments; therefore being unable to

make additional payments to hospitals

for a period of 2 to 3 years as required

by the BBRA of 1999. The Agency

cannot reasonably comply with the

normal clearance procedures because of

a statutory deadline imposed by the

Balanced Budget Refinement Act of

1999 (Section 201(b)). Without this

information, HCFA would not be able to

properly implement the requirements

set forth in the statute.

HCFA is requesting OMB review and

approval of this collection by July 6,

2000, with a 180-day approval period.

Written comments and

recommendations will be accepted from

the public if received by the individuals

designated below by July 3, 2000.

During this 180-day period, we will

publish a separate Federal Register

notice announcing the initiation of an

extensive 60-day agency review and

public comment period on these

requirements. We will submit the

requirements for OMB review and an

extension of this emergency approval.

Type of Information Collection

Request: New Collection;

Title of Information Collection:

Recognition of New Technology/PassThrough Items Under the Prospective

Payment System for Hospital Outpatient

Services;

Form No.: HCFA–10008 (OMB# 0938–

NEW);

Use: This information is necessary to

determine items eligible for payment as

new technology within the ambulatory

payment classification (APC) system as

well as items eligible for the transitional

pass-through payment provision as

required by section 201 of the BBRA.

This collection will enable HCFA to

implement those special payment

provisions.;

Frequency: On Occasion;

Affected Public: Business or other forprofit;

Number of Respondents: 500;

Total Annual Responses: 500;

Total Annual Hours: 1,500.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Notices 38837

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326.

Interested persons are invited to send

comments regarding the burden or any

other aspect of these collections of

Information requirements. However, as

noted above, comments on these

Information collection and

recordkeeping requirements must be

mailed and/or faxed to the designees

referenced below, by July 3, 2000:

Health Care Financing Administration,

Office of Information Services,

Security and Standards Group,

Division of HCFA Enterprise

Standards, Attention: Dawn

Willinghan (HCFA–10008), Room N2–

14–26, 7500 Security Boulevard,

Baltimore, Maryland 21244–1850

and

Office of Information and Regulatory

Affairs, Office of Management and

Budget, Room 10235, New Executive

Office Building, Washington, DC

20503, Fax Number: (202) 395–6974

or (202) 395–5167, Attn: Allison

Herron Eydt, HCFA Desk Officer.

Dated: June 15, 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. 00–15800 Filed 6–21–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10006]

Notice; Correction

SUMMARY: In the Federal Register issue

of Tuesday, June 6, 2000, make the

following correction:

Correction

In the Federal Register issue of

Tuesday, June 6, 2000, Volume 65: FR

Doc. 00–14263, on page 35947, the

fourth sentence of the first paragraph in

column 1 (beginning ‘‘Prior to that

time’’) should be deleted and replaced

with the following sentence: ‘‘Prior to

that time, we must send a State

Medicaid Directors letter soliciting

applications and have sufficient time to

review all applications adequately.’’

Dated: June 8, 2000.

Victoria Quigley,

Acting Manager, HCFA Office of Information

Services, Security and Standards Group,

Division of HCFA Enterprise Standards.

[FR Doc. 00–15799 Filed 6–21–00; 8:45 am]

BILLING CODE 4120–03–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Center for Research

Resources; Notice of Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Center for

Research Resources Special Emphasis Panel,

Comparative Medicine.

Date: July 25, 2000.

Time: 8:30 AM to 12:00 PM.

Agenda: To review and evaluate grant

applications.

Place: Gaithersburg Marriott,

Washingtonian Center, 9751 Washingtonina

Blvd., Gaithersburg, MD 20878.

Contact Person: John D. Harding, PhD,

Scientific Review Administrator, Office of

Review, National Center for Research

Resources, 6705 Rockledge Drive, MSC 7965,

Room 6018, Bethesda, MD 20892–7965, (301)

435–0810.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.306, Comparative Medicine,

93.306; 93.333, Clinical Research, 93.333;

93.371, Biomedical Technology; 93.389,

Research Infrastructure, National Institutes of

Health, HHS)

Dated: June 15, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–15756 Filed 6–21–00; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute, Notice of Closed Meetings

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings.

The meetings will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Heart, Lung,

and Blood Institute, Special Emphasis Panel,

Clinical Research Curriculum Awards (K30s)

Date: July 11–12, 2000.

Time: 7:00 PM to 5:00 PM.

Agenda: To review and evaluate grant

applications.

Place: Chevy Chase Holiday Inn, 5520

Wisconsin Ave., Chevy Chase, MD 20815.

Contact Person: Diane M. Reid, MD,

Scientific Review Administrator, NIH,

NHLBI, DEA, Two Rockledge Center, 6701

Rockledge Drive, Room 7182, Bethesda, MD

20892–7924 (301) 435–0277.

Name of Committee: National Heart, Lung,

and Blood Institute, Special Emphasis Panel,

In Vitro Inactivation of Viruses in Blood

Components.

Date: July 20, 2000.

Time: 8:00 AM to 4:00 PM.

Agenda: To review and evaluate grant

applications.

Place: Holiday Inn-Bethesda, 8120

Wisconsin Avenue, Bethesda, MD 20814.

Contact Person: Eric H. Brown, PhD

Scientific Review Administrator, NIH/NHLB/

DEA Review Branch, Rockledge Building II,

Suite 7204, 6701 Rockledge Drive, Bethesda,

MD 20892–7924, 301/435–0299,

browne@gwgate.nhlbi.nih.gov.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.233, National Center for

Sleep Disorders Research; 93.837, Heart and

Vascular Diseases Research; 93.838, Lung

Diseases Research; 93.839, Blood Diseases

and Resources Research, National Institutes

of Health, HHS)

Dated: June 15, 2000.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 00–15757 Filed 6–21–00; 8:45 am]

BILLING CODE 4140–01–M