Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Notices 20825

albendazole solution for treatment of

adult liver flukes (Fasciola hepatica) in

nonlactating goats. These data are

contained in PMF 5582.

Under 21 CFR 25.15(d) and

25.33(d)(4), sponsors of NADA’s and

supplemental NADA’s for drugs in

minor species, including wildlife and

endangered species, are categorically

excluded from the requirement to

prepare an environmental assessment or

an environmental impact statement

when the drug has been approved for

use in another or the same species

where similar animal management

practices are used. The categorical

exclusion applies unless, as defined in

§ 25.21 (21 CFR 25.21), extraordinary

circumstances exist which indicate that

the proposed action may significantly

affect the quality of the human

environment. Therefore, based upon

information available, FDA agrees that

when the application is submitted, the

applicant may claim a categorical

exclusion under § 25.33(d)(4) provided

that the applicant can state that to the

best of the applicant’s knowledge, as in

§ 25.21, no extraordinary circumstances

exist. It is assumed that the applicant

has made a reasonable effort to

determine that no extraordinary

circumstances exist.

Sponsors of NADA’s or supplemental

NADA’s may, without further

authorization, reference the PMF 5582

to support approval of an application

filed under § 514.1(d). An NADA or

supplemental NADA must include, in

addition to reference to the PMF, animal

drug labeling and other information

needed for approval, such as: Data

supporting extrapolation from a major

species in which the drug is currently

approved or authorized reference to

such data; data concerning

manufacturing methods, facilities, and

controls; and information addressing

potential environmental impacts of the

manufacturing process. Persons desiring

more information concerning the PMF

or requirements for approval of an

NADA or supplement may contact

Gillian A. Comyn (address above).

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, from 9 a.m.

to 4 p.m., Monday through Friday.

Dated: March 20, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–9571 Filed 4–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0497]

Request for Proposed Standards for

Unrelated Allogeneic Peripheral and

Placental/Umbilical Cord Blood

Hematopoietic Stem/Progenitor Cell

Products; Reopening of Comment

Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; reopening of comment

period.

SUMMARY: The Food and Drug

Administration (FDA) is reopening for

90 days the comment period for the

notice requesting the submission of

proposed product standards for

unrelated allogeneic peripheral and

placental/umbilical cord blood

hematopoietic stem/progenitor cells.

The notice was published in the Federal

Register of January 20, 1998 (63 FR

2985). FDA is taking this action in

response to a request for an extension

and to allow interested parties

additional time for review and to submit

comments on proposed product

standards.

DATES: Submit written comments by

July 17, 2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Valerie A. Butler, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 20, 1998 (63

FR 2985), FDA published a notice

requesting proposed product standards

intended to ensure the safety and

effectiveness of minimally manipulated

hematopoietic stem/progenitor cells

derived from peripheral and cord blood

for unrelated allogeneic use. Interested

persons were given until January 20,

2000, to submit written comments. On

January 18, 2000, a comment requesting

that the agency extend the comment

period was submitted to the docket. The

comment noted that comprehensive

standards that cover all aspects of cord

blood banking have been drafted.

However, additional editing and final

review is required before submission to

the docket. FDA finds it appropriate to

reopen the comment period to permit

interested persons additional time to

submit proposed product standards

intended to ensure the safety and

effectiveness of minimally manipulated

hematopoietic stem/progenitor cells

derived from peripheral and cord blood

for unrelated allogeneic use. Therefore

the agency is reopening the comment

period for an additional 90 days, until

July 17, 2000, to allow the public more

time to submit proposed product

standards.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on proposing

product standards intended to ensure

the safety and effectiveness of

minimally manipulated hematopoietic

stem/progenitor cells derived from

peripheral and cord blood for unrelated

allogeneic use by July 17, 2000. Two

copies of any comments are to be

submitted, except individuals may

submit one copy. Comments are to be

identified with the docket number

found in the brackets in the heading of

this document. A copy of the document

and received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: April 10, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–9582 Filed 4–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 79N–0113; DESI 2847]

Pediatric Parenteral Multivitamin

Products; Drug Efficacy Study

Implementation; Announcement of

Marketing Conditions; 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 January 26, 2000 (65 FR

4253). The document announced the

conditions for marketing pediatric

parenteral multivitamin drug products

for the indications for which they are

20826 Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Notices

now regarded as effective. The

document was published with an

inadvertent error. This document

corrects that error.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In FR Doc.

00–1787 appearing on page 4253 in the

Federal Register of Wednesday, January

26, 2000, the following correction is

made:

On page 4255, in the first column, in

paragraph B.2.(a), beginning in the

second line, the sentence ‘‘Caution:

Federal law prohibits dispensing

without prescription’’ is corrected to

read ‘‘Rx only.’’

This change is made in accordance

with section 126(a) of the Food and

Drug Modernization Act of 1997.

Section 126(a) modified section

503(b)(4) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 353(b)(4)).

Dated: April 7, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–9580 Filed 4–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of May 2000.

Name: HRSA AIDS Advisory Committee

(HAAC).

Date and Time: May 17, 2000; 8:30 a.m.–

5 p.m.; May 18, 2000; 8:30 a.m.–5 p.m.

Place: Doubletree Park Terrace, 1515

Rhode Island Avenue, NW, Washington, DC

20005, Telephone: (202) 232–7000.

The meeting is open to the public.

Agenda: Agenda items for the meeting

include reauthorization issues of the Ryan

White CARE Act, program updates, policy

paper presentations, and health services

research/evaluation meeting update and

discussion.

Anyone requiring further information

should contact Joan Holloway, HIV/AIDS

Bureau, Parklawn Building, Room 7–13, 5600

Fishers Lane, Rockville, Maryland 20857,

telephone (301) 443–5761.

Dated: April 12, 2000.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–9584 Filed 4–17–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of May 2000.

Name: National Advisory Council on

Migrant Health.

Date and Time: May 4, 2000; 9 a.m.–5

p.m.; May 5, 2000; 9 a.m.–5 p.m.

Place: Portland Marriott Downtown, 1401

SW Naito Parkway, Portland, Oregon 97201,

Phone: (503) 226–7600; Fax: (503) 221–1789.

The meeting is open to the public.

Agenda: This will be a meeting of the

Council. The agenda includes an overview of

general Council business activities and

priorities. Topics of discussion will include

the Year 2000 recommendations, Migrant

issues in the Upper Northwest, and updates

on research related to the Migrant Health

Program. The Council meeting is being held

in conjunction with the National Association

of Community Health Centers, annual

National Farmworker Health Conference,

May 5–7, 2000.

Anyone requiring information regarding

the subject Council should contact Judy

Rodgers, Migrant Health Program, staff

support to the National Advisory Council on

Migrant Health, Bureau of Primary Health

Care, Health Resources and Services

Administration, 4350 East-West Highway,

Bethesda, Maryland 20814, Telephone (301)

594–4304.

Agenda items are subject to change as

priorities indicate.

Dated: April 12, 2000.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–9583 Filed 4–17–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families; Office of Refugee

Resettlement

Modification to the Standing

Announcement Published in the

Federal Register on December 9, 1997

(62 FR 64856)

AGENCY: Office of Refugee Resettlement

(ORR) Administration for Children and

Families, DHHS.

ACTION: Notice of cancellation.

SUMMARY: The Office of Refugee

Resettlement Standing Announcement

(62 FR 64856) issued December 9, 1997

is hereby modified to reflect the

cancellation of three program areas:

Category 3, Community Orientation,

Category 4, Technical Assistance to

Orientation Grantees, and Category 5,

Mental Health.

Closing dates for Category 1, Preferred

Communities, Category 2, Unanticipated

Arrivals, and Category 6, Ethnic

Community Organizations will remain

unchanged, i.e. January 31 and June 30

every year.

These changes are effective with the

date of this publication.

For further information, please

contact Marta Brenden, Office of

Refugee Resettlement, telephone 202–

205–3589.

Dated: April 13, 2000.

Carmel Clay-Thompson,

Acting Director, Office of Refugee

Resettlement.

[FR Doc. 00–9634 Filed 4–17–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4561–N–28]

Notice of Submission of Proposed

Information Collection to OMB;

Cooperative Membership

AGENCY: Office of the Chief Information

Officer, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments Due Date: May 18,

2000.