28182 Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Notices

and Drug Administration, 5630 Fishers

Lane, rm. 1060, Rockville, MD 20852.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Received comments

may be reviewed at the FDA Dockets

Management Branch (address above)

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

through Friday.

Submit one original and two copies of

written comments to FSIS Docket Clerk,

Docket No. 00–048N, U.S. Department

of Agriculture, Food Safety and

Inspection Service, rm. 102, Cotton

Annex, 300 12th St, SW., Washington,

DC 20250–3700. All comments

submitted in response to this notice will

be available for public inspection in the

Docket Clerk’s office between 8:30 a.m.

and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

For information concerning the draft

risk assessment document: Sherri B.

Dennis, Risk Assessment

Coordinator, Center for Food Safety

and Applied Nutrition (HFS–032),

Food and Drug Administration, 200

C St. SW., Washington, DC 20204,

202–260–3984, FAX 202–260–9653,

e-mail: sdennis@cfsan.fda.gov.

For information concerning the risk

management action plan: Kathy

Gombas, Center for Food Safety and

Applied Nutrition (HFS–615), Food

and Drug Administration, 200 C St.

SW., Washington, DC 20204, 202–

205–4231, FAX 202–260–0136, email: kgombas@cfsan.fda.gov or

Charles Edwards, Food Safety and

Inspection Service, U.S. Department

of Agriculture, rm. 405, Cotton

Annex, 300 12th St. SW.,

Washington, DC 20250–3700, 202–

205–0675, FAX 202–205–0080.

SUPPLEMENTARY INFORMATION: In the

Federal Register of January 19, 2001 (66

FR 5515), the Department of Health and

Human Services and USDA announced

the availability of two documents: A

draft risk assessment on the relationship

between foodborne L. monocytogenes

and human health and a draft risk

management action plan. Comments

were sought on the technical aspects of

the draft risk assessment in the

following areas: (1) The assumptions

made, (2) the modeling technique, (3)

the data used, and (4) the transparency

of the draft risk assessment document.

The agencies also invited comments on

the risk management strategies as

presented in the draft action plan.

Interested persons were given until

March 20, 2001, to comment on the

draft risk assessment and draft action

plan. FDA and USDA/FSIS extended the

comment period to May 21, 2001 (66 FR

13545, March 6, 2001), in response to

the requests of the National Food

Processors Association and the LM

Working Group and because a public

meeting to receive comments on these

documents was scheduled on March 19,

2001, only 1 day before the close of the

comment period. The LM Working

Group has requested a second extension

of the comment period in part to allow

time to: (1) Collect and review new data,

and (2) evaluate the model and the

appropriateness of the new data to

improve the assessment. In response,

FDA and USDA/FSIS are extending the

comment period to July 18, 2001;

however, the agencies do not anticipate

further extensions of the comment

period for these draft documents.

To be considered, submit written

comments to FDA Dockets Management

Branch or the FSIS Dockets Clerk

(addresses above) by July 18, 2001.

Printed copies of the draft risk

assessment and the risk management

action plan and/or a CD–ROM of the

risk assessment model may be requested

by faxing your name and mailing

address with the names of the

documents you are requesting to the

CFSAN Outreach and Information

Center at 1–877–366–3322. The

documents may be reviewed at the FDA

Dockets Management Branch or the

FSIS Docket Clerk’s Office at the

addresses and hours noted above. The

draft risk assessment and action plan

documents are also available

electronically as follows:

www.cfsan.fda.gov, www.fsis.usda.gov,

www.foodsafety.gov.

Dated: May 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13055 Filed 5–18–01; 2:59 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–4071]

International Cooperation on

Harmonisation of Technical

Requirements for Registration of

Veterinary Medicinal Products (VICH);

Final Guidance for Industry on

‘‘Impurities: Residual Solvents in New

Veterinary Medicinal Products, Active

Substances and Excipients’’ (VICH

GL18); Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a final guidance for

industry (#100) entitled ‘‘Impurities:

Residual Solvents in New Veterinary

Medicinal Products, Active Substances

and Excipients’’ (VICH GL18). This

guidance has been adapted for

veterinary use by the International

Cooperation on Harmonisation of

Technical Requirements for Registration

of Veterinary Medicinal Products

(VICH) from a similarly titled guidance

regarding pharmaceuticals for human

use, which was adopted by the

International Conference on

Harmonisation of Technical

Requirements for Registration of

Pharmaceuticals for Human Use (ICH).

The guidance is intended to recommend

acceptable amounts of residual solvents

in new animal drugs (referred to as

pharmaceuticals or veterinary medicinal

products in the final guidance) for the

safety of the target animal as well as for

the safety of human consumers of

products derived from treated food

producing animals. It is intended to

assist in developing new animal drug

applications (referred to as marketing

applications in the final guidance)

submitted to the European Union,

Japan, and the United States.

DATES: You may submit written

comments at any time.

ADDRESSES: You may submit written

requests for a single copy of the final

guidance entitled ‘‘Impurities: Residual

Solvents in New Veterinary Medicinal

Products, Active Substances and

Excipients’’ (VICH GL18) to the

Communications Staff (HFV–12), Center

for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that

office in processing your requests. See

the SUPPLEMENTARY INFORMATION section

for electronic access to the guidance

document.

You may submit written comments on

the guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Kevin J. Greenlees (HFV–150), Center

for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–6977, email, kgreenle@cvm.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important

initiatives have been undertaken by

regulatory authorities and industry

associations to promote the

international harmonization of

regulatory requirements. FDA has

Federal Register / Vol. 66, No. 99 / Tuesday, May 22, 2001 / Notices 28183

participated in efforts to enhance

harmonization and has expressed its

commitment to seek scientifically based

harmonized technical requirements for

the development of pharmaceutical

products. One of the goals of

harmonization is to identify and then

reduce the differences in technical

requirements for drug development

among regulatory agencies in different

countries.

FDA has actively participated in the

ICH for several years to develop

harmonized technical requirements for

the approval of human pharmaceutical

and biological products among the

European Union, Japan, and the United

States. The VICH is a parallel initiative

for veterinary medicinal products. The

VICH is concerned with developing

harmonized technical requirements for

the approval of veterinary medicinal

products in the European Union, Japan,

and the United States, and includes

input from both regulatory and industry

representatives.

The VICH Steering Committee is

composed of member representatives

from the: European Commission;

European Medicines Evaluation Agency;

European Federation of Animal Health;

the U.S. FDA; the U.S. Department of

Agriculture; the Animal Health

Institute; the Japanese Veterinary

Pharmaceutical Association; the

Japanese Association of Veterinary

Biologics; and the Japanese Ministry of

Agriculture, Forestry and Fisheries.

Two observers are eligible to

participate in the VICH Steering

Committee: One representative from the

Government of Australia/New Zealand,

and one representative from the

industry in Australia/New Zealand. The

VICH Secretariat, which coordinates the

preparation of documentation, is

provided by the Confe ́de ́ration

Mondiale de L’Industrie de la Sante ́

Animale (COMISA). A COMISA

representative also participates in the

VICH Steering Committee meetings.

II. Guidance on Impurities: Residual

Solvents

In the Federal Register of October 12,

1999 (64 FR 55296), FDA published the

notice of availability of the draft

guidance entitled ‘‘Impurities: Residual

Solvents’’ (VICH GL18) giving interested

persons until November 12, 1999, to

submit comments. FDA received no

comments. The final guidance was

submitted to the VICH Steering

Committee. At a meeting held on June

14 through 16, 2000, the VICH Steering

Committee endorsed the final guidance

for industry, VICH GL18.

This guidance is intended to

recommend acceptable amounts of

residual solvents in new animal drugs

(referred to as pharmaceuticals or

veterinary medicinal products in the

final guidance) for the safety of the

target animal as well as for the safety of

human consumers of products derived

from treated food-producing animals.

The guidance is intended to assist in

developing new animal drug

applications (referred to as marketing

applications in the final guidance)

submitted to the European Union,

Japan, and the United States.

This final level 1 guidance is being

issued consistent with FDA’s good

guidance practices regulation (65 FR

56468, September 19, 2000). It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of applicable

statutes and regulations. Information

collected is covered under OMB control

number 0910–0032.

III. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/cvm.

IV. Comments

As with all of FDA’s guidances, the

public is encouraged to submit written

comments with new data or other new

information pertinent to this guidance.

FDA will periodically review the

comments in the docket and, where

appropriate, will amend the guidance.

The agency will notify the public of any

such amendments through a notice in

the Federal Register.

Interested persons may, at any time,

submit written or electronic comments

regarding this guidance. Written

comments should be submitted to the

Dockets Management Branch (address

above). Two copies of any comments are

to be submitted, except individuals may

submit one copy. Comments should 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.

Comments may also be submitted

electronically on the Internet at http://

www.fda.gov/dockets/ecomments. Once

on this Internet site, select ‘‘99D–4071

Impurities: Residual Solvents in New

Veterinary Medicinal Products’’ and

follow the directions.

Dated: May 11, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–12770 Filed 5–21–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–2125–N]

Medicaid Program; Infrastructure

Grant Program To Support the Design

and Delivery of Long Term Services

and Supports That Permit People of

Any Age Who Have a Disability or

Long-Term Illness To Live in the

Community

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of funding availability.

SUMMARY: This notice announces the

availability of approximately $70

million in grant funding through

‘‘Systems Change Grants for Community

Living’’. The ‘‘Systems Change’’ grants

include four distinct competitive grant

opportunities: (1) ‘‘Nursing Facility

Transitions’’; (2) ‘‘CommunityIntegrated Personal Assistance Services

and Supports’’; (3) ‘‘Real Choice

Systems Change’’; and (4) ‘‘National

Technical Assistance Exchange for

Community Living’’. The four grants are

designed to assist States to develop

enduring infrastructures that support

people of any age who have a disability

or long-term illness to live and

participate in their communities.

Applicants include States, State

instrumentalities, and other eligible

entities as further described in the

notice. This notice also contains

information about the application

process.

DATES: Deadline for Letter of Intent To

Apply: Applicants should submit a

letter of intent to apply for a grant no

later than June 8, 2001. Although it is

not mandatory for an applicant to

submit a letter of intent, we would

appreciate receiving a letter of intent

from each applicant because it will help

us to plan our review panels.

Deadlines for Submission of Grant

Applications: To be considered under

the Fiscal Year 2001 funding cycle,

grant applications must be submitted by

the deadlines listed below: