Federal Register / Vol. 65, No. 121 / Thursday, June 22, 2000 / Notices 38835

Obtain Additional Information’’ section

of this announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application kit.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 301(a) and 317(k)(2) of the

Public Health Service Act, [42 U.S.C.

sections 241(a) and 247b(k)(2)], as

amended. The Catalog of Federal

Domestic Assistance number is 93.283.

J. Where To Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address—http://www.cdc.gov.

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements.’’ To receive

additional written information and to

request an application kit, call 1–888–

GRANTS (1–888–472–6874). You will

be asked to leave your name and

address and will be instructed to

identify the announcement number of

interest.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from: Gladys

Gissentanna, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

Room 3000, 2920 Brandywine Road,

Atlanta, GA 30341–4146. Telephone

Number: 770–488–2753; Email Address:

gcg4@cdc.gov.

For program technical assistance,

contact: Rana A. Hajjeh, M.D., National

Center for Infectious Diseases, Centers

for Disease Control and Prevention,

1600 Clifton Road, NE., Atlanta, GA

30333, Telephone Number: 404–639–

4753; E-mail Address: rfh5@cdc.gov.

Dated: June 16, 2000.

Henry S. Cassell, III,

Acting Director, Procurement and Grants

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–15769 Filed 6–21–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title: State Human Services System.

OMB No.: New Collection.

Description: Collect Data from States

to Provide Updated Information on what

systems software each State has created

in the area of State Systems which effect

TANF, CW, OCSE and Child Care

Projects.

Respondents: 54 States and

Territories.

Annual Burden Estimates:

Instrument Number of respondents

Number of responses per respondentAverage burden

hours per response

Total burden

hours

Survey ...................................................................................................... 54 4 1 216

Estimated Total Annual Burden

Hours: 216.

In compliance with the requirements

of Section 350(c)(2)(A) of the Paperwork

Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

370 L’Enfant Promenade, SW.,

Washington, DC 20447, Attn: ACF

Reports Clearance Officer. All requests

should be identified by the title of the

information collection.

The Department specifically requests

comments on: (a) Whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

the quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: June, 15, 2000.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 00–15844 Filed 6–21–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Temporary Deferment of Activities

Relating to Certain Biologics

Submissions

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the Center for Biologics Evaluation

and Research (CBER) will be converting

its current biologics license application

(BLA) data base system into a new data

base system. During the period required

for this conversion, the agency will

temporarily defer certain submissions

subject to CBER review and approval,

and the review period, if any, on

pending submissions will be suspended.

FDA plans to temporarily defer action

on submissions related to BLA’s,

product license applications (PLA’s),

establishment license applications

(ELA’s), and any related

correspondence. FDA is also requesting

that sponsors voluntarily refrain from

filing the affected submissions during

this period. FDA estimates that the

deferment period will be about 1 month.

FOR FURTHER INFORMATION CONTACT:

Robert A. Yetter, Center for Biologics

Evaluation and Research (HFM–10),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–2000.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 201 et seq.) and section 351

of the Public Health Service Act (42

U.S.C. 262), CBER is responsible for

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