39912 Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1318]

Draft Guidance for Industry on Chronic

Cutaneous Ulcer and Burn Wounds—

Developing Products for Treatment;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Chronic Cutaneous

Ulcer and Burn Wounds—Developing

Products for Treatment.’’ This draft

document is intended to provide

guidance on the development of drug

and biological products intended to

treat venous stasis ulcers, diabetic foot

ulcers, pressure ulcers, and burn

wounds. The draft guidance contains

recommendations about labeling claims,

outcome measures, trial design, and

special considerations for preclinical

development.

DATES: Submit written comments on the

draft guidance by August 28, 2000.

General comments on agency guidance

documents are welcome at any time.

ADDRESSES: Submit written comments

on the draft guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

For information on how to obtain

copies, see the SUPPLEMENTARY

INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT:

Maryjane Walling, Center for Drug

Evaluation and Research (HFD–105),

Food and Drug Administration, 9201

Corporate Blvd., Rockville, MD 20850,

301–827–2268;

Bette A. Goldman, Center for Biologics

Evaluation and Research (HFM–500),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–5098; or

Charles N. Durfor, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–3090.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance for industry entitled

‘‘Chronic Cutaneous Ulcer and Burn

Wounds—Developing Products for

Treatment.’’ This draft document is

intended to provide guidance on the

development of drug and biological

products intended to treat venous stasis

ulcers, diabetic foot ulcers, pressure

ulcers, and burn wounds. The draft

guidance contains recommendations

about labeling claims, outcome

measures, trial design, and special

considerations for preclinical

development.

Extensive discussions were held

during two advisory committee

meetings in July and November 1997

about the treatment of ulcers and burns.

In response to requests from industry,

the agency has developed this draft

guidance. The comments received from

industry, professional societies, and

consumer groups represented at those

meetings have been taken into

consideration in drafting this guidance.

This draft guidance is being issued

consistent with FDA’s good guidance

practices (62 FR 8961, February 27,

1997). The draft guidance represents the

agency’s current thinking on clinical

development of products for the

treatment of chronic cutaneous ulcer

and burn wounds. 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 the applicable statutes,

regulations, or both.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. 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. The draft

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

III. How to Obtain Copies

You may submit written requests for

single copies of the draft guidance by

sending one self-addressed adhesive

label to assist the office in processing

your request to:

The Office of Training and

Communications,

Division of Communications

Management,

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research,

Food and Drug Administration,

5600 Fishers Lane,

Rockville, MD 20857;

Or

The Office of Communication, Training

and Manufacturers Assistance (HFM–

40),

Center for Biologics Evaluation and

Research,

Food and Drug Administration,

1401 Rockville Pike,

Rockville, MD 20852–1448,

CBER Voice Information System: 1–

800–835–4709 or 301–827–1800

Fax: 1–888–CBER–FAX or 301–827–

3844;

Or

The Division of Small Manufacturers

Assistance (HFZ–220),

Center for Devices and Radiological

Health,

Food and Drug Administration,

1350 Piccard Dr.,

Rockville, MD 20850,

Phone: 800–638–2041,

E-mail: DSMA@CDRH.FDA.GOV,

Fax: 1–301–443–8818,

Facts-On-Demand: 800–899–0381.

An electronic version of the draft

guidance also is available via the

Internet at CDER’s Internet site at http:/

/www.fda.gov/cder/guidance/index.htm

or at CBER’s Internet site at http://

www.fda.gov/cber/guidelines.htm.

Dated: June 16, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–16294 Filed 6–27–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1296]

Final Guidance: Importation of

Pasteurized Milk Ordinance (PMO)

Defined Dairy Products (M–I–00–4);

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a final guidance

document entitled ‘‘Importation of PMO

Defined Dairy Products (M–I–00–4)’’.

This guidance provides information that

States can use to respond to inquiries

regarding the importation of ‘‘Grade A’’

dairy products from other countries.

DATES: Submit written or electronic

comments at any time.

ADDRESSES: 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.

Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Notices 39913

Persons who wish to submit electronic

comments should go to FDA’s home

page at www.fda.gov, select ‘‘Dockets,’’

and follow the instructions. Submit

written requests for single copies of the

guidance entitled ‘‘Importation of PMO

Defined Dairy Products (M–I–00–4)’’ to

Charlotte Epps, Milk Safety Branch

(HFS–625), Center for Food Safety and

Applied Nutrition, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204. Send one selfaddressed adhesive label to assist that

office in processing your requests. See

section III of this document for

electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:

Joseph M. Smucker, Center for Food

Safety and Applied Nutrition, Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–8178,

e-mail: jsmucker@bangate.fda.gov.

SUPPLEMENTARY INFORMATION: FDA is the

Federal agency with responsibility

under the Federal Food, Drug, and

Cosmetic Act for the safety of the United

States’ dairy products. In the case of

those dairy products regulated by the

States under the Grade ‘‘A’’ milk safety

program, one way FDA has chosen to

fulfill this charge is by providing

technical assistance to State regulators

under the authority of various sections

of the U.S. Public Health Service Act.

The National Conference on Interstate

Milk Shipments (NCIMS) is a voluntary

coalition of regulators from U.S. States

and one U.S. commonwealth. These

regulators have banded together in this

organization to ensure the safety of

Grade ‘‘A’’ milk and milk products

shipped in interstate commerce and to

minimize duplicate regulatory

restrictions on these products if they are

produced according to this group’s

stringent public health standards.

As the need arises, FDA provides

information to the States in the NCIMS

and others interested in production and

processing of Grade ‘‘A’’ milk and milk

products.

Under the procedures of the NCIMS,

administrative and other miscellaneous

information is transmitted to FDA

regional staff and through them to State

agencies in the form of a memorandum

of information (M–I). Several M–I’s are

issued each year; M–I–00–4 is this type

of memorandum. It is being provided to

transmit an FDA opinion. This opinion

clarifies that the food protective

measures provided under the NCIMS

system are an important part of the

U.S.’s appropriate level of protection for

Grade ‘‘A’’ dairy products. This

guidance also describes three options

that both FDA and the NCIMS have

accepted to ensure that the public

health effect of these food protective

measures is not circumvented when

these dairy products are imported.

This level 2 guidance is being issued

consistent with FDA’s good guidance

practices (62 FR 8961, February 27,

1997). This guidance document

represents the agency’s current thinking

on the subject and 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 the applicable statute,

regulation or both.

What follows is a verbatim copy of

this memorandum.

‘‘M–I–00–4’’

April 11, 2000

To: All Regional Food and Drug Directors

Attn: Regional Milk Specialists

From: Milk Safety Branch (HFS–626)

Subject: Importation of PMO Defined Dairy

Products

This memorandum provides guidance that

States can use to respond to inquiries

regarding the importation of ‘‘Grade A’’ dairy

products from other countries. This guidance

document represents the agency’s current

thinking on this subject and 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 the

applicable statute, regulation or both.

I. Background Information

International trade agreements to which

the United States is signatory allow countries

to establish measures to ensure safety of food

within their countries. The measures,

however, must be applied in a manner so that

they do not arbitrarily discriminate between

products from different countries or treat

domestic products more favorably than

imported products without justification.

The World Trade Organization’s (WTO)

Agreement on the Application of Sanitary

and Phytosanitary Measures (SPS Agreement)

also obligates the over 160 member countries

to consider the ‘‘equivalence’’ of another

country’s food protection measures if an

exporting country requests such

consideration. The determination of

equivalence is made by the importing

country based on whether the exporting

country’s measures meet the level of

protection deemed appropriate by the

importing country, as provided by its own

measures. Because the WTO agreements only

went into effect in 1995, the concept of

equivalence is only now beginning to be

utilized in international trade. Nevertheless,

Article 4. Equivalence of the SPS Agreement

exists as an obligation for all WTO Member

governments.

The system of controls used to provide the

U.S.’s appropriate level of protection for

‘‘Grade A’’ dairy products is described in the

current edition of the ‘‘Grade A Pasteurized

Milk Ordinance’’ (PMO) and related

documents. Since the early 1950’s, States and

FDA using a system of ratings and check

ratings have verified the level of protection

provided by the PMO in domestic (interstate)

commerce. The requirements for these ratings

and check ratings are specified in the current

edition of the ‘‘Procedures Governing the

Cooperative State-Public Health Service/

Food and Drug Administration Program of

the National Conference on Interstate Milk

Shipments’’ (Procedures).

In a 1977 Memorandum of Understanding

(MOU) with the National Conference on

Interstate Milk Shipments (NCIMS), FDA

accepted the standards, requirements and

procedures of the NCIMS to manage the

public health risks associated with ‘‘Grade

A’’ milk and milk products. FDA considers

this NCIMS milk safety program to be

adequate for the protection of the health and

safety of the consumer.

Current Status

FDA and the NCIMS have identified and

mutually accepted three options which are

consistent with NCIMS ‘‘Procedures’’ and

which will allow States to receive PMO

defined ‘‘Grade A’’ products produced

outside of the United States.

These options are:

1. A dairy firm outside of the United States

could contract with any current NCIMS

member’s regulatory/rating agency to provide

the ’’Grade A’’ milk safety program in total.

This would include the regulatory licensing,

dairy farm and milk plant inspection and

sampling, pasteurization equipment testing,

laboratory certification and rating/NCIMS

listing certification. To use this option the

firm would be required to abide by all

applicable NCIMS regulatory and rating

requirements and the regulatory/rating

agency would have to agree to treat the firm

as if it were located within its jurisdiction for

all purposes, including inspection and

enforcement. Ratings of the firm would be

check-rated by FDA.

2. The importing country, or a political

subdivision thereof, may become a full

member of the NCIMS subject to all NCIMS

rules and enjoying all privileges of a U.S.

State. This would require, among other

things, that the milk regulatory agency(ies) of

the importing countries adopt and enforce

rules and regulations which are the same as

those required in the United States and abide

by all applicable NCIMS regulatory and

rating requirements. Their ratings would be

check-rated by FDA in the same way as State

ratings. FDA would certify their rating,

sampling surveillance and laboratory

evaluation officers.

3. FDA can evaluate the importing

country’s system of assuring the safety of

dairy products and compare the effect of that

system with the effect of the United States

system on the safety of dairy products

produced domestically. The NCIMS has

adopted a procedure to accept FDA findings

of equivalence and to allow NCIMS member

States to accept products produced within

the scope of such a finding.

Emerging International Issue

As trade barriers are removed and trade

between countries increases, there are more

frequent requests to allow the importation of

‘‘Grade A’’ defined products that originate in

39914 Federal Register / Vol. 65, No. 125 / Wednesday, June 28, 2000 / Notices

1Milk or cream may also need a permit under the

provisions of the Federal Import Milk Act.

other countries. The most common concern

is how an adequate level of safety can be

verified.

Under current Federal law and regulation,

FDA can only take action on imported food

products based on a violation of the Federal

Food, Drug, and Cosmetic Act (FFDCA).

Importation of milk products without

adhering to any of the three options

described above, is NOT, in and of itself, a

violation of the FFDCA.1

Based on the 1977 MOU, milk protection

measures in the United States have been set

by the combined efforts of FDA and the

States under the NCIMS milk safety program.

Under this program the States must adopt

as law and enforce the provisions of the PMO

as specified in the ‘‘Procedures’’. Their

collective actions are intended to insure that

milk marketed in the United States meets the

U.S. appropriate level of protection.

FDA works with the States to verify that

the U.S. level of protection is met under

authority of the Public Health Service Act (42

U.S.C.). Under this act FDA has a broad

mandate to assist States technically and to

evaluate their performance under the

‘‘Procedures’’. However, current regulations

promulgated under this act do not provide an

adequate base for direct FDA enforcement of

the PMO.

If the U.S. level of protection, as currently

met by consistent State enforcement of the

PMO, is to continue to be met, it must be

accomplished by States continuing to

collectively require this level of protection.

Under U.S. trade agreements products

imported from another country must be

treated by States and by FDA, no less

favorably than those products imported from

another State.

The three options in this memorandum can

be used by States to assure that the same

level of safety for ‘‘Grade A’’ defined

products is achieved for products produced

in other countries.

In order for the agency to function within

the provisions of the MOU and fulfill its food

safety responsibility, FDA will note, in State

program evaluations, if a State is not

requiring the NCIMS ‘‘Grade A’’ level of

protection in interstate or international

commerce.

If after a reasonable opportunity to correct

this situation, a State still does not provide

their citizens with this level of protection,

FDA may declare that the State is not in

substantial compliance under the

‘‘Procedures * * *’’

Copies of this memorandum are enclosed

for your distribution to District Milk

Specialists, State milk regulatory agencies,

State Laboratory Evaluation Officers and

State Milk Rating Officers in your region.

This memorandum is also available on the

FDA Prime Connection Computer bulletin

board system (Internet address: http://

www.cfsan.fda.gov), and should be widely

distributed to representatives of the dairy

industry and other interested parties. /S/’’

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written or electronic comments

on the guidance entitled ‘‘Importation of

PMO Defined Dairy Products (M–I–00–

4)’’ at any time. Two copies of written

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. A copy of the

guidance and written and electronic

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain copies of the guidance

entitled ‘‘Importation of PMO Defined

Dairy Products (M–I–00–4)’’ at http://

www.cfsan.fda.gov.

Dated: June 19, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–16292 Filed 6–28–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995, Pub.

L. 104–13), the Health Resources and

Services Administration (HRSA)

publishes periodic summaries of

proposed projects being developed for

submission to OMB under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited 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)

ways to enhance the quality, utility, and

clarity 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.

Proposed Project: AIDS Drug Assistance

Program (ADAP): ADAP Monthly Client

Utilization and Program Expenditures

Report (OMB No. 0915–0219)—Revision

State AIDS Drug Assistance Programs

(ADAPs), funded under Title II of the

Ryan White Comprehensive AIDS

Resources Emergency (CARE) Act

Amendments of 1996 [Pub. L. 104–146],

are designed to provide low income,

uninsured, and underinsured

individuals with access to HIV/AIDS

medications that prevent serious

deterioration of health arising from HIV

disease, including the prevention and

treatment of opportunistic infections.

During the last several years, there has

been an increasing need for

pharmaceuticals among uninsured and

underinsured low-income individuals

who are HIV positive or diagnosed with

AIDS. Due to the increasing demand,

the Division of Service Systems (DSS),

Health Resources and Services

Administration (HRSA) recognizes the

importance of program planning and

budget forecasting in order to maximize

resources, and proposes to revise the

current data collection form to better

collect relevant client utilization data

and program expenditure information

from State ADAPs. This data collection

effort is designed to allow DSS/HRSA

(the funding agency) to monitor

nationwide trends in program growth,

client utilization, expenditures and to

assess the capacity of State ADAPs to

maintain services for clients throughout

the fiscal year. The revised form will

improve DSS/HRSA’s ability to track the

prices of HIV/AIDS drugs in order to

ensure that State ADAPs are receiving

the best price possible, to identify

emerging issues and technical assistance

needs, and to share information among

State ADAPs. It will also assist Title II

grantees, State ADAPs, DSS/HRSA staff,

and policymakers at both the Federal

and State level to better understand the

level of client demand for medications

and the resources needed to meet those

needs.

The revised report will collect timespecific data for the number of enrolled

clients, the number of new clients, the

number of utilizing clients, the level of

funds expended, and the price of HIV/

AIDS drugs. A text box is provided to

allow State ADAPs to report significant

changes to their program, such as a

projected budget shortfall, program

restrictions, client waiting lists, a

change in eligibility criteria, or

formulary changes. On a quarterly basis,

State ADAPs will report the purchase

price paid on a select number of HIV