Federal Register / Vol. 63, No. 134 /Tuesday, July 14, 1998 / Notices 37889

component of IHS will be involved or

will support the research. If the Native

American community is involved, its

tribal government must also approve

that portion of the project applicable to

it.

Women, Racial and Ethnic Minorities

It is the policy of the Centers for

Disease Control and Prevention

(CDC)and the Agency for Toxic

Substances and Disease Registry

(ATSDR) to ensure that individuals of

both sexes and the various racial and

ethnic groups will be included in CDC/

ATSDR-supported research projects

involving human subjects, whenever

feasible and appropriate. Racial and

ethnic groups are those defined in OMB

Directive No. 15 and include American

Indian or Alaska Native, Asian, Black or

African American, Hispanic or Latino,

Native Hawaiian or Other Pacific

Islander. Applicants shall ensure that

women, racial and ethnic minority

populations are appropriately

represented in applications for research

involving human subjects. Where clear

and compelling rationale exist that

inclusion is inappropriate or not

feasible, this situation must be

explained as part of the application.

This policy does not apply to research

studies when the investigator cannot

control the race, ethnicity, and/or sex of

subjects. Further guidance to this policy

is contained in the Federal Register,

Vol. 60, No. 179, pages 47947–47951,

and dated Friday, September 15, 1995.

Animal Subjects

If the proposed project involves

research on animal subjects, the

applicant must comply with the ‘‘PHS

Policy on Humane Care and Use of

Laboratory Animals by Awardee

Institutions.’’ An applicant organization

proposing to use vertebrate animals in

PHS-supported activities must file an

Animal Welfare Assurance with the

Office for Protection from Research

Risks at the National Institutes of

Health.

Application Submission and Deadline

The original and five copies of each

application PHS Form 398 must be

submitted to Sharron Orum, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, N.E., Room 300,

Mailstop E–18, Atlanta, GA 30305, on or

before October 1, 1998.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

a. Received on or before the deadline

date; or

b. Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be acceptable as

proof of timely mailing.)

2. Late Applications: Applications

which do not meet the criteria in 1. a.

or 1. b. above are considered late

applications. Late applications will not

be considered and will be returned to

the applicant.

Where to Obtain Additional Information

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.

(Please refer to Announcement Number

99012.) You will receive a complete

program description, information on

application procedures and application

forms. If you have questions after

reviewing the contents of all the

documents, business management

technical assistance may be obtained

from Oppie M. Byrd, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, N.E., Room 314,

Mailstop E–18, Atlanta, GA 30305,

telephone (404) 842–6546, Facsimile

(404) 842–6513, Internet oxb3@cdc.gov.

Programmatic technical assistance

may be obtained from Bala

Swaminathan, Ph.D., National Center

for Infectious Diseases, Division of

Bacterial and Mycotic Diseases, Centers

for Disease Control and Prevention

(CDC), 1600 Clifton Road, N.E., Mailstop

C–07, Atlanta, GA 30333, Telephone

(404) 639–3669, Facsimile (404) 639–

3333, Internet bas5@cdc.gov.

Please refer to Announcement

Number 99012 when requesting

information regarding this program.

You may obtain this announcement

from one of two Internet sites on the

actual publication date: CDC’s

homepage at http://www.cdc.gov or at

the Government Printing Office

homepage (including free on-line access

to the Federal Register at http://

www.access.gpo.gov).

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) referenced

in the INTRODUCTION through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone:

(202) 512–1800.

Dated: July 8, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–18667 Filed 7–13–98; 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: Annual Statistical Report on

Children in Foster Homes and Children

in Families Receiving Payments in

Excess of the Poverty Income Level from

a State Program Funded under Part A of

Title IV of the Social Security Act.

OMB No.: 0970–0040.

Description: This information is

collected to meet the statutory

requirements of section 1124 of Title I

of the Elementary and Secondary

Education Act (as amended by PL 103–

382). It is collected by DHHS from State

public welfare agencies and turned over

to the Department of Education which

uses it to arrive at the formula for

allocating Title I grant funds to State

and Local elementary and secondary

schools for the purpose of providing

educational assistance to disadvantaged

children.

Respondents: State, Local or Tribal

Govt.

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

ACF–4125 ......................................................................................................... 52 1 264 13,746
37890 Federal Register / Vol. 63, No. 134 /Tuesday, July 14, 1998 / Notices

ANNUAL BURDEN ESTIMATES—Continued

Instrument Number of respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

Estimated Total Annual Burden Hours: 13,746

In compliance with the requirements

of Section 3506(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,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade, S.W., Washington, D.C.

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 clarify 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: July 8, 1998.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 98–18658 Filed 7–13–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Relocation of the Dockets Management

Branch; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appeared in the Federal

Register of June 16, 1998 (63 FR 32888).

The document announced the relocation

and partial closing of the Dockets

Management Branch (DMB). The

document published with an incorrect

zip code. This document corrects that

error.

FOR FURTHER INFORMATION CONTACT:

Jennie C. Butler, Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane,

Rockville, MD 20852, 301–827–6860.

In FR Doc. 98–15878, appearing on

page 32888, in the Federal Register of

Tuesday, June 16, 1998, the following

corrections are made:

1. On page 32888, in the second

column, under ‘‘SUPPLEMENTARY

INFORMATION,’’ in line six, the zip

code is corrected to read ‘‘20852,’’ and

in the second paragraph, in line eleven,

the zip code is corrected to read

‘‘20852.’’

Dated: July 7, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18691 Filed 7–13–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0481]

Guidance for Industry on 180–Day

Generic Drug Exclusivity Under the

Hatch-Waxman Amendments to the

Federal Food, Drug, and Cosmetic Act;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘180–Day Generic Drug

Exclusivity Under the Hatch-Waxman

Amendments to the Federal Food, Drug,

and Cosmetic Act.’’ The purpose of the

guidance is to inform the public of

FDA’s application of the 180-day

generic drug exclusivity provisions of

the Federal Food, Drug, and Cosmetic

Act (the act) in light of recent court

decisions on the issue.

DATES: Written comments may be

submitted on the guidance document by

October 13, 1998. General comments on

the agency guidances are welcome at

any time.

ADDRESSES: Copies of the guidance are

available on the Internet at ‘‘http://

www.fda.gov/cder/guidance/

index.htm.’’ Submit written requests for

single copies to the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your request.

Submit written comments on the

guidance to the Dockets Management

Branch, (HFD–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jerry

Phillips, Center for Drug Evaluation and

Research (HFD–610), 7500 Standish Pl.,

Rockville, MD 20855, 301–827–5846.

SUPPLEMENTARY INFORMATION: A

requirement of FDA’s regulations

implementing the 180-day generic drug

exclusivity provisions of the act has

recently been successfully challenged in

court. Section 314.107(c)(1) (21 CFR

314.107(c)(1)) applies and interprets

section 505(j)(5)(B)(iv) of the act (21

U.S.C. 355(j)(5)(B)(iv)). Section

314.107(c)(1) contains the ‘‘successful

defense’’ provision, which requires an

abbreviated new drug application

(ANDA) applicant to be sued for patent

infringement and to prevail in the

litigation in order to receive the 180-day

period of marketing exclusivity. Two

recent circuit court decisions, Mova

Pharmaceutical Corp. v. Shalala, No.

97–5082, 1998 U.S. App. Lexis 7391

(D.C. Cir. Apr. 14, 1998) and Granutec,

Inc. v. Shalala, No. 97–1873 and No.

97–1874, 1998 U.S. App. LEXIS 6685,

(4th Cir. Apr. 3, 1998), held that the

‘‘successful defense’’ requirement was

not supported by the act. The effect of

these decisions, together with a June 1,

1998, order of the district court in Mova,

is that FDA will not enforce the

‘‘successful defense’’ provisions of

§ 314.107(c)(1).

FDA intends to formally remove the

‘‘successful defense’’ provisions from

§ 314.107(c)(1), but that process is not

complete. Following withdrawal of the

regulatory provision, FDA expects to

begin a rulemaking to issue new