20824 Federal Register / Vol. 65, No. 75 / Tuesday, April 18, 2000 / Notices

Locust Street, St. Louis, Missouri

63166–2034:

1. National Commerce

Bancorporation, Memphis, Tennessee;

through its existing wholly owned

nonbank subsidiary, TransPlatinum

Service Corp., Nashville, Tennessee, to

acquire Prime Financial Services, Inc.,

Dresden, Tennessee, and thereby engage

in factoring activities, pursuant to

§ 225.28(b)(1) of Regulation Y.

Board of Governors of the Federal Reserve

System, April 12, 2000.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 00–9601 Filed 4–17–00; 8:45 am]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration on Aging

[Program Announcement No. AoA–00–3]

Fiscal Year 2000 Program

Announcement; Availability of Funds

and Notice Regarding Applications

AGENCY: Administration on Aging, HHS.

ACTION: Announcement of availability of

funds and request for applications to

establish, or expand and improve,

Statewide Senior Legal Hotlines whose

purpose is to advance the quality and

accessibility of the legal assistance

provided to older people.

SUMMARY: The Administration on Aging

announces that under this program

announcement it will hold a

competition for grant awards for four (4)

to five (5) projects that establish, or

expand and improve, Statewide Senior

Legal Hotlines aimed at advancing the

quality and accessibility of the legal

assistance provided to older people.

The deadline date for the submission

of applications is June 16, 2000.

Eligibility for grant awards is limited to

public and/or nonprofit agencies,

organizations, and institutions

experienced in providing legal

assistance to older persons.

Application kits are available by

writing to the Department of Health and

Human Services, Administration on

Aging, Office of Program Development,

330 Independence Avenue, SW, Room

4264, Washington, DC 20201, or by

calling 202/619–2987.

Dated: April 12, 2000.

Jeanette C. Takamura,

Assistant Secretary for Aging.

[FR Doc. 00–9643 Filed 4–17–00; 8:45 am]

BILLING CODE 4154–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Disease, Disability and Injury

Prevention and Control Special

Emphasis Panel: Human

Immunodeficiency Virus Prevention

Projects for Community-Based

Organizations, Program

Announcement #00023

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

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following meeting.

Name: Disease, Disability and Injury

Prevention and Control Special Emphasis

Panel: Human Immunodeficiency Virus

Prevention Projects for Community-Based

Organizations, Program Announcement

#00023.

Times and Dates: 9 a.m.–9:15 a.m., April

14, 2000 (Open); 9:15 a.m.–12 p.m., April 14,

2000 (Closed).

Place: This meeting will be conducted in

two separate, simultaneous conference call

sessions. To participate, please dial 1–800–

713–1971 and when prompted, enter

participant code #848941, and 1–800–713–

1971 and when prompted, enter participant

code #868508. The call will only be open to

the public for the first fifteen minutes, after

which the review process will begin.

Status: Portions of the meeting will be

closed to the public in accordance with

provisions set forth in section 552b(c)(4) and

(6), Title 5 U.S.C., and the Determination of

the Associate Director for Management and

Operations, CDC, pursuant to Public Law 92–

463.

Matters To Be Discussed: The meeting will

include the review, discussion, and

evaluation of five applications received in

response to Program Announcement #00023.

These five applications were originally

deemed ineligible, however, after careful

reconsideration, it was determined that they

should be given the same consideration as

applications reviewed during the original

SEP meeting that took place March 20–24,

2000.

Contact Person for More Information:

Megan Foley or Beth Wolfe, Prevention

Support Office, National Center for HIV,

STD, and TB Prevention, CDC, Corporate

Square Office Park, 11 Corporate Square

Boulevard, M/S E07, Atlanta, Georgia 30329,

telephone 404/639–8025, e-mail

MZF3@cdc.gov or EOW1@cdc.gov.

This notice is being published less than 15

days in advance of the meeting due to

administrative oversight and program delays.

The Director, Management Analysis and

Services Office, has been delegated the

authority to sign Federal Register Notices

pertaining to announcements of meetings and

other committee management activities, for

both the Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: April 12, 2000.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 00–9608 Filed 4–13–00; 11:52 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Albendazole Suspension for Goats;

Availability of Data

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of effectiveness, target

animal safety, and human food safety,

and environmental data that may be

used in support of a new animal drug

application (NADA) or supplemental

NADA for oral use of albendazole

suspension for treatment of adult liver

flukes in nonlactating goats. The data,

contained in Public Master File (PMF)

5582, were compiled under National

Research Support Project–7 (NRSP–7), a

national agricultural research program

for obtaining clearances for use of new

drugs in minor animal species and for

special uses.

ADDRESSES: Submit NADA’s or

supplemental NADA’s to the Document

Control Unit (HFV–199), Center for

Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:

Gillian A. Comyn, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–7568.

SUPPLEMENTARY INFORMATION:

Albendazole suspension, used for the

treatment of adult liver flukes (Fasciola

hepatica) in nonlactating goats, is a new

animal drug under section 201(v) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 321(v)). As a new

animal drug, albendazole is subject to

section 512 of the act (21 U.S.C. 360b),

requiring that its uses in goats be the

subject of an approved NADA or

supplemental NADA. Goats are a minor

species under § 514.1(d)(1)(ii) (21 CFR

514.1(d)(1)(ii)).

The NRSP–7 Project, Western Region,

College of Veterinary Medicine,

University of California, Davis, CA

95616, has provided target animal

safety, effectiveness, human food safety,

and environmental data for oral use of

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