26218 Federal Register / Vol. 65, No. 88 / Friday, May 5, 2000 / Notices

pediatric exclusivity as required by the

Federal Food, Drug, and Cosmetic Act

(the act). FDA is seeking public input on

the pediatric exclusivity program.

DATES: Submit written comments on the

pediatric exclusivity program by June 5,

2000.

ADDRESSES: Submit written comments

on the pediatric exclusivity program to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Copies of this notice are

available on the Internet at http://

www.fda.gov/cder/pediatrics.

FOR FURTHER INFORMATION CONTACT:

Terrie L. Crescenzi, Center for Drug

Evaluation and Research (HFD–

104), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–

7337, FAX 301–827–2520, e-mail:

crescenzit@cder.fda.gov, or

Elaine C. Esber, Center for Biologics

Evaluation and Research (HFM–30),

Food and Drug Administration,

1401 Rockville Pike, Rockville, MD

20852, 301–827–0641, FAX 301–

827–0644, e-mail:

esber@cber.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is seeking public comment on

the pediatric exclusivity program.

Section 111 of the Modernization Act

(Public Law 105–115), signed into law

by President Clinton on November 21,

1997, created section 505A of the act (21

U.S.C. 355a). Section 505A of the act

permits certain new drug applications to

obtain an additional 6 months of

marketing exclusivity if, in accordance

with the requirements of the statute, the

sponsor submits information relating to

the use of the drug in the pediatric

population.

Under section 505A(k) of the act, FDA

must submit a report to Congress on the

pediatric exclusivity program.

II. Description of the Report

Under section 505A(k) of the act, FDA

must conduct a study and report to

Congress not later than January 1, 2001,

on the experience under the pediatric

exclusivity provisions of the act. The

study and report must examine all

relevant issues, including:

1. The effectiveness of the program in

improving information about important

pediatric uses for approved drugs;

2. The adequacy of the pediatric

exclusivity incentive;

3. The economic impact of the

pediatric exclusivity program on

taxpayers and consumers and the

impact of the lack of lower cost generic

drugs on patients, including on lower

income patients; and

4. Any suggestions for modification.

III. Request for Comments

FDA invites all interested parties to

address the specific topics that will be

included in the report or any other

general issue appropriate for this report

relevant to the pediatric exclusivity

provision of the act. Interested persons

may submit to the Dockets Management

Branch (address above) written

comments on the pediatric exclusivity

program by June 5, 2000. Two copies of

any comments 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. Received comments may be

seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

Dated: April 28, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–11328 Filed 5–4–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–462A/B]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

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.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Clinical

Laboratory Improvement Amendments

(CLIA) Adverse Action Extract and

Supporting Regulations at 42 CFR

483.1840; Form No.: HCFA–462A/B

(OMB 0938–0655; Use: The CLIA

Adverse Action Extract will be used by

HCFA surveyors (State health

department, and other HCFA agents) to

report to regional staff and record the

adverse actions imposed against a

laboratory. The form will also serve to

track dates of the imposition of adverse

actions, date on which a laboratory

corrects deficiencies, and all appeals

activity; Frequency: On occasion,

Biennially; Affected Public: State, local,

or tribal government; Number of

Respondents: 52; Total Annual

Responses: 1573; Total Annual Hours:

786.

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

number, OMB number, and HCFA

document identifier, 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 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Julie Brown, Room N2–14–

26, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: April 26, 2000.

John P. Burke III,

Reports Clearance Officer, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 00–11215 Filed 5–4–00; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–1957]

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