International Harmonization; Draft Policy on Standards; Availability

SUMMARY: The Food and Drug Administration (FDA) is publishing a draft

policy on its development and use of standards with respect to

international harmonization of regulatory requirements and guidelines.

Specifically, the draft policy is intended to address the conditions

under which FDA participates with standards bodies outside of FDA,

domestic or international, in the development of standards applicable

to products regulated by FDA. The policy also covers the conditions

under which FDA uses the resultant standards, or other available

domestic or international standards, in fulfilling its statutory

mandates for safeguarding the public health.

DATES: Written comments by February 13, 1995.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Linda R. Horton, Director,

International Policy Staff (HF-23), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-443-2831.

SUPPLEMENTARY INFORMATION:

The text of the draft policy follows:

International Harmonization of Regulatory Requirements and

Guidelines

I. Background

The purpose of this document is to articulate FDA's policy on

development and use of standards with respect to international

harmonization of regulatory requirements and guidelines. As used

throughout this document, the term ``standards'' includes what are

commonly referred to as ``consensus standards,'' ``voluntary

standards,'' and ``industry standards.'' Also, FDA sometimes adopts

standards, making them mandatory regulatory requirements. Although

the draft policy focuses on international harmonization and

international standards, its principles are applicable as well to

domestic standards activities in which FDA participates.

A. Statutory Mandates for FDA-Regulated Products

FDA is the principal regulatory agency within the Public Health

Service (PHS). The agency protects the public health by, among other

things, implementing statutory provisions designed to ensure that

food is safe and otherwise not adulterated or misbranded; that human

and veterinary drugs, human biological products, and medical devices

are safe and effective; that cosmetics are safe; and that electronic

product radiation is properly controlled. FDA-regulated products

must be truthfully and accurately labeled and in compliance with all

applicable laws and regulations. The statutory mandates for

safeguarding the public health in these product sectors are

prescribed in several statutes, notably in the Federal Food, Drug,

and Cosmetic Act; the Public Health Service Act; and the Fair

Packaging and Labeling Act.

B. International Harmonization of Regulatory Requirements

In recent decades, great changes in the world economy, together

with expanded working relationships of regulatory agencies around

the globe, have resulted in increased interest in international

harmonization of regulatory requirements. Increased international

commerce, opportunities to enhance public health through cooperative

endeavors, and scarcity of government resources for regulation have

resulted in efforts by the regulatory agencies of different nations

to work together on standards and harmonize their regulatory

requirements. Such harmonization enhances public health protection

and improves government efficiencies by reducing both unwarranted

contradictory regulatory requirements and redundant applications of

similar requirements by multiple regulatory bodies. Harmonization

facilitates cooperation in regulatory activities.

In 1991, the FDA Task Force on International Harmonization was

formed to provide a broad assessment of the goals, scope, and

direction of FDA's international harmonization activities. These

activities were found to comprise a wide variety of efforts by FDA

to retain and strengthen its public health safeguards, while trying

to reach common ground with its foreign government counterparts on

product standards, criteria for the assessment of test data, and

enforcement procedures. Based on these findings, the task force, in

its report of December 1992, formulated a number of recommendations

for the agency, including an overall policy with goals and general

principles. As reflected in that report, the FDA policy on

international harmonization is: ``* * * to encourage the initiation

and support of efforts, consistent with the goals and principles

below, that will further the international harmonization of

standards and policies for the regulation of products for which FDA

has authority.''

1. Goals

FDA's goals in participating in international harmonization

activities are:

To safeguard U.S. public health,

To assure that consumer protection standards and

requirements are met,

To facilitate the availability of safe and effective

products,

To develop and utilize product standards and other

requirements more effectively, and

To minimize or eliminate inconsistent standards

internationally.

2. General Principles

FDA participation in international harmonization should be

guided by the following general principles:

The harmonization activity should be consistent with

U.S. Government policies and procedures and should promote U.S.

interests with foreign countries.

The harmonization activity should further FDA's mission

to protect the public health by, among other things, ensuring that

food is safe and otherwise not adulterated or misbranded; that human

and veterinary drugs, human biological products, and medical devices

are safe and effective as required by law; that cosmetics are safe;

and that electronic product radiation is properly controlled; and

that these products are labeled truthfully and informatively.

FDA's input into international standard setting

activities should be open to public scrutiny and provide the

opportunity for the consideration of views of all parties concerned.

FDA should accept, where legally permissible, the

equivalent standards, compliance activities, and enforcement

programs of other countries, provided that FDA is satisfied such

standards, activities, and programs meet FDA's goals.

Scientific and regulatory information and knowledge

should be exchanged with foreign government officials, to the extent

possible within legal constraints, to expedite the approval of

products and protect public health.

Thus, the agency's primary goal in all of its international

harmonization activities is to preserve and enhance its ability to

accomplish its public health mission. Global harmonization is also

approached with the aim of enhancing regulatory effectiveness, by

providing more consumer protection with scarce government resources,

and increasing worldwide consumer access to safe, effective, and

high quality products.

C. Other Obligations and Policies

1. International Agreements

The U.S. Government is a party to international trade

agreements. In the United States, such trade agreements become

effective only after implementing legislation is signed into law.

FDA has participated in recent international trade negotiations to

ensure that FDA's requirements are preserved and the regulatory

practices can remain focused on fulfilling the agency's mission to

protect the public health while being supportive of emerging,

broader U.S. Government obligations and policies.

The principal international trade agreement is the General

Agreement on Tariffs and Trade (GATT), which entered into force on

January 1, 1948. GATT has since been amended several times following

negotiation sessions known as rounds.

The GATT Agreement on Technical Barriers to Trade (TBT),

popularly known as the Standards Code, was negotiated during the

Tokyo Round of the GATT in the 1970's and entered into force on

January 1, 1980. As part of a general effort to reduce unnecessary

nontariff barriers to trade, the TBT agreement was intended to

promote use by countries of standards, technical regulations, and

conformity assessment procedures that have been developed by

international standard bodies. To assure that such harmonization

would not result in lowering safety or quality standards for U.S.

consumers, the implementing legislation for the TBT agreement,

provided in the Trade Agreements Act of 1979 (Pub. L. 96-39; 19

U.S.C 2531-2582), provides additional authority for FDA's

international standards activity and contains the safeguard that:

``* * * No standard-related activity of any private person,

Federal agency, or State agency shall be deemed to constitute an

unnecessary obstacle to the foreign commerce of the United States if

the demonstrable purpose of the standards-related activity is to

achieve a legitimate domestic objective including, but not limited

to, the protection of legitimate health or safety, essential

security, environmental, or consumer interests and if such activity

does not operate to exclude imported products which fully meet the

objective of such activity.''

The most recent GATT round, the Uruguay Round, was concluded on

December 15, 1993, and was formally signed at the Marrakech

Ministerial Meeting on April 15, 1994. Congressional consideration

of the legislation to implement the Uruguay Round is now occurring.

One of the agreements of the Uruguay Round, the new GATT

agreement on TBT, is similar in many respects to the 1980 TBT

agreement. As with the 1980 TBT agreement, the purpose of the new

TBT agreement is to ensure that product standards, technical

regulations, and related procedures do not create unnecessary

obstacles to trade. The new World Trade Organization (WTO) will

administer the new TBT agreement, and every country that is a member

of the WTO will be required to adhere to it.

The new TBT agreement ensures, and clearly states, that each

country has the right to establish and maintain technical

regulations for the protection of human, animal, and plant life, and

health of the environment and for prevention against deceptive

practices. The new TBT agreement provides that each country may

determine its appropriate level of protection and ensures that the

encouragement to use international standards as the bases for

technical regulations will not result in ``downward harmonization.''

In the new TBT agreement, the term ``standard'' is defined as:

``[A] document approved by a recognized body, that provides, for

common and repeated use, rules, guidelines or characteristics for

products or related processes and production methods, with which

compliance is not mandatory (emphasis added). It may also include or

deal exclusively with terminology, symbols, packaging, marking or

labelling requirements as they apply to a product, process or

production method.''

Also, ``technical regulation'' is defined as:

``[A] document which lays down product characteristics or their

related processes and production methods, including applicable

administrative provisions, with which compliance is mandatory

(emphasis added). It may also include or deal exclusively with

terminology, symbols, packaging, marking, or labelling requirements

as they apply to a product, process or production method.''

Thus, in the language of the new TBT agreement, when a

government acts to adopt a voluntary standard to make it mandatory,

the resulting document is a technical regulation. A measure used to

ascertain compliance with a standard or technical regulation is a

conformity assessment procedure.

The new TBT agreement continues and strengthens the reference to

international standards found in the 1980 TBT agreement.

Specifically, the agreement states that, where technical regulations

are required and relevant international standards exist or their

completion is imminent, WTO-member countries shall use them, or the

relevant parts of them, as a basis for their technical regulations,

except when such international standards or relevant parts would be

an ineffective or inappropriate means for the fulfillment of the

legitimate objectives pursued. Further, the agreement states that

with a view towards harmonizing technical regulations on as wide a

basis as possible, WTO-member countries shall play a full part

within the limits of their resources in the preparation by

appropriate international standards bodies of international

standards for products for which they either have adopted or expect

to adopt technical regulations.

Another agreement of the Uruguay Round is the Agreement on the

Application of Sanitary and Phytosanitary Measures (SPS). SPS

pertains to those measures intended: (1) To protect animal or plant

life or health within a territory from risks arising from the entry,

establishment, or spread of pests, diseases, disease carrying

organisms, or disease causing organisms; (2) to protect human or

animal life or health within a territory from risks arising from

additives, contaminants, toxins, or disease-causing organisms in

foods, beverages, or feedstuffs; (3) to protect human life or health

within a territory from risks arising from diseases carried by

animals, plants, or products thereof, or from entry, establishment,

or spread of pests; or (4) to prevent or limit other damage within a

territory from the entry, establishment, or spread of pests. The SPS

agreement like the new TBT agreement encourages use of international

standards. The SPS agreement refers specifically to standards

established by the Codex Alimentarius Commission, as discussed

below.

The North American Free Trade Agreement (NAFTA) also contains

TBT and SPS agreements similar to those in the new GATT agreements

to be administered by WTO.

2. Internal U.S. Government

The United States Office of Management and Budget (OMB), in its

revision to OMB Circular No. A-119 (58 FR 57643, October 26, 1993),

provides policy on Federal use of standards and agency participation

in voluntary standards bodies and standards-developing groups:

``It is the policy of the Federal Government in its procurement

and regulatory activities to:

a. Rely on voluntary standards, both domestic and international,

whenever feasible and consistent with the law and regulation

pursuant to law;

b. Participate in voluntary standards bodies when such

participation is in the public interest and is compatible with

agencies' missions, authorities, priorities, and budget resources;

and

c. Coordinate agency participation in voluntary standards bodies

so that: (1) The most effective use is made of agency resources and

representatives; and (2) the views expressed by such representatives

are in the public interest and, as a minimum, do not conflict with

the interests and established views of the agencies.''

OMB Circular No. A-119 also establishes additional policy

guidance and responsibilities for U.S. Government agencies. It is

applicable to all executive agency participation in voluntary

standards activities, domestic and international, but not to

activities carried out pursuant to treaties and international

standardization agreements.

The term ``standard,'' as defined in OMB Circular No. A-119,

means:

``* * * a prescribed set of rules, conditions, or requirements

concerned with the definition of terms; classification of

components; delineation of procedures; specification of dimensions,

materials, performance, design, or operations; measurement of

quality and quantity in describing materials, products, systems,

services, or practices; or descriptions of fit and measurement of

size.''

The circular defines ``voluntary standards'' as:

``* * * established generally by private sector bodies, both

domestic and international, and are available for use by any person

or organization, private or governmental. The term voluntary

standard includes what are commonly referred to as ``industry

standards'' as well as ``consensus standards,'' but does not include

professional standards of personal conduct, institutional codes of

ethics, private standards of individual firms, or standards mandated

by law, such as those contained in the United States Pharmacopeia

and the National Formulary, as referenced in 21 U.S.C. 351.''

These definitions in OMB Circular No. A-119 conform to common

usage and are consistent with the usage of these terms throughout

this policy document. It should be noted that under the TBT,

``standards'' are considered to be nonmandatory (i.e., voluntary)

unless promulgated into mandatory technical regulations.

II. Standards Programs and Practices Within FDA

A. Purpose of FDA Involvement in Standards

The central purpose of FDA involvement in the development and

use of standards is to assist the agency in fulfilling its public

health, regulatory missions. The agency intends to participate in

the development of standards, domestic or international, and adopt

or use standards when such action will enhance its ability to

protect consumers and the effectiveness or efficiency of its

regulatory efforts. In doing so, FDA recognizes that standards often

serve as useful adjuncts to agency regulatory controls and that

economies of time and human resources are often realized in solving

problems when consensus-building activities are undertaken and

conducted in open, public arenas. The working together of FDA staff

with other professionals outside the agency in standards bodies

effectively multiplies the technical resources available to FDA.

Further, standards bodies generally have in place procedures for

periodically reviewing and updating completed standards, thus

extending the resource-multiplier effect, as well as keeping the

solutions current with the state of knowledge. The economy of effort

translates into monetary savings to the agency, regulated

industries, and ultimately consumers. Further, using standards,

especially international ones, is a means to facilitate the

harmonization of FDA regulatory requirements with those of foreign

governments, to better serve domestic and global public health.

Another benefit of participating in the development of standards

at both domestic and international levels is that in sharing

technical information with technical groups and professionals

outside FDA, staff members have opportunities to learn of other

viewpoints on an issue, to establish scientific leadership, and to

remain informed of state-of-the-art science and technology.

B. Past and Present Activities

FDA has been involved in standards activities for many years,

and in June 1977 the agency promulgated a final regulation at 21 CFR

10.95 (Sec. 10.95) covering the participation by FDA employees in

standards-setting activities outside the agency. This regulation

encourages FDA participation in standards setting activities that

are in the public interest and specifies the respective

circumstances under which FDA employees can participate in various

types of standards bodies.

Standards activities of multilateral organizations such as the

World Health Organization (WHO) and the Organization for Economic

Cooperation and Development (OECD) are often important to FDA and

frequently involve multiple product types. For example, OECD is

developing Genetic Toxicology Test Guidelines that are of interest

to all FDA Centers. Similarly, guidelines developed under the

International Programme on Chemical Safety of the WHO relate to

chemicals that may be in a wide variety of FDA-regulated products,

such as food additives, pesticides, drugs, animal drugs, biologics,

and devices.

1. Foods and Veterinary Medicine

FDA's Center for Food Safety and Applied Nutrition (CFSAN) and

Center for Veterinary Medicine (CVM) actively participate in the

development of international standards by the Codex Alimentarius

Commission (Codex). Codex is an international organization formed in

1962 to facilitate world trade in foods and to promote consumer

protection. It is a subsidiary of two United Nations groups, the

Food and Agriculture Organization (FAO) and the World Health

Organization (WHO). Codex standards cover products such as food

commodities, food additives, food contaminants, and residues of

veterinary drugs in food. FDA officials chair two Codex committees,

the Food Hygiene Committee and the Residues of Veterinary Drugs in

Foods Committee, and participate in many others. Through its

involvement, FDA has been influential in the establishment of a

number of Codex standards. FDA's procedures for reviewing Codex

standards for purposes of regulation are codified in 21 CFR 130.6.

In 1988, the governments of the United States and Canada entered

into the U.S.-Canada Free Trade Agreement (now largely superseded by

NAFTA). Since then, officials from CFSAN and CVM have participated

in technical working groups responsible for implementation of the

chapter of the agreement that deals with agriculture, food,

beverage, and related goods (the CUSFTA Groups).

Officials from CFSAN and CVM also participate in the development

of standards by such domestic and international groups as the Food

Chemicals Codex (FCC), the Association of Official Analytical

Chemists International (AOAC), expert committees of the WHO, the

International Organization for Standardization (ISO), and other

international consensus standards bodies. Standards developed by

these organizations are used by industry, both in the United States

and abroad. These standards provide industry with guidance for food

grade materials and processes, and thus help elevate the quality of

food and food chemicals in domestic and international trade.

CFSAN has adopted many FCC and ASTM standards and AOAC methods,

incorporating them into regulations for both food additives and

generally recognized as safe food ingredients. CFSAN also refers

industry to relevant FCC, Codex, or ASTM standards when discussing

particular issues related to good manufacturing practices. CFSAN

accepts many AOAC and equivalent methods for use by laboratories in

assaying food and in testing for contaminants in food.

CVM accepts many AOAC and equivalent methods for use by

laboratories in testing for drug residues in animal tissues. CVM

also is working towards harmonizing its approach to the development

of standards for drug residues in animal tissues with those of

Codex.

2. Biologics and Drugs

There has been active international standard setting for

biological products for more than 50 years. Officials from FDA's

Center for Biologic Evaluation and Research (CBER) serve as experts

or members of a variety of international committees which perform

standard-setting functions. Activities have encompassed

collaborative studies to establish international units of measure

and to develop internationally accepted standards and requirements

for control of biologics, including WHO requirements. Efforts have

been directed to many kinds of biological products, including

vaccines, human blood and plasma products, blood testing reagents,

and allergenic extracts, and have extended to biotechnology-derived

growth factors, cytokines, and monoclonal antibody products.

FDA's Center for Drug Evaluation and Research (CDER), CBER, and

the National Center for Toxicological Research (NCTR) actively

participate in the International Conference on Harmonisation of

Technical Requirements for Registration of Pharmaceuticals for Human

Use (ICH). This ongoing project begun in 1989 has been undertaken by

governmental agencies responsible for regulation of drugs and by

industry trade organizations from the European Union (EU), Japan,

and the United States. Specifically, ICH is sponsored jointly by the

Commission of the European Communities (CEC), the Japanese Ministry

of Health and Welfare (MHW), FDA, the European Federation of

Pharmaceutical Industries' Associations (EFPIA), the Japan

Pharmaceutical Manufacturers Association (JPMA), and the

Pharmaceutical Research and Manufacturers Association (PhMA) of the

United States. In addition, the International Federation of

Pharmaceutical Manufacturers Associations (IFPMA) participates as an

umbrella organization for the pharmaceutical industry and provides

the secretariat function for ICH, which operates under the direction

of the ICH Steering Committee. The Steering Committee is comprised

of representatives of these organizations. Official observer status

has been given to WHO, the European Free Trade Area (EFTA), and the

Health Protection Branch of Canada.

The purposes of ICH are to: (1) Provide a forum for a dialogue

between regulatory agencies and the pharmaceutical industry on

differences in the technical requirements for product registration

(i.e., requirements for product marketing) in the EU, Japan, and the

United States; (2) identify areas where modifications in technical

requirements or greater mutual acceptance of research and

development procedures could lead to more efficient use of human,

animal, and material resources without compromising safety, quality,

and efficacy; and (3) make recommendations of practical ways to

achieve greater harmonization in the interpretation and application

of technical guidelines and requirements for registration. The work

products of ICH, created in working groups of experts from the

regulatory agencies and industry, consist of a series of consensus

guidance documents. These guidance documents, after successive ICH

steps of review and acceptance, including an opportunity for public

review and comment in the respective jurisdictions, are forwarded to

the regulatory agencies with the expectation that they will be

formally adopted by the agencies.

Officials from both CBER and CDER also participate in a

consensus standard setting activity sponsored by the Council for

International Organizations of Medical Sciences (CIOMS) that is

aimed at standardizing the safety-related terminology used in

adverse experience reporting.

3. Medical Devices

FDA's Center for Devices and Radiological Health (CDRH) has had

extensive involvement with standards in its regulation of medical

devices and electronic products that emit radiation. The development

of standards to solve problems related to medical devices involves

many groups outside FDA. The interaction between CDRH and the

manufacturing and health care communities that frequently occurs

during the standards development process provides knowledge and

insight into the use of products, problems, and the effectiveness of

solutions. Frequently, the public discussion of the problem that

occurs in the consensus-building process results in the

manufacturers and the users of the subject medical device

implementing the solution before a standard is formally completed.

Thus, CDRH has encouraged participation in the development of

standards as a useful adjunct to regulatory controls. CDRH's general

policy on use and participation in the development of consensus

standards was set forth in an open letter dated June 29, 1993, to

all interested parties from the Director of CDRH. (This policy did

not apply to mandatory performance standards (i.e., technical

regulations) for class II medical devices as specified under the

Medical Device Amendments of 1976 (Pub. L. 94-295). The Safe Medical

Device Act of 1990, SMDA (Pub. L. 101-629), puts the promulgation of

mandatory standards at the discretion of the agency.)

Over 100 completed consensus standards and selected sections of

additional draft standards that are not yet complete have been

incorporated into guidance documents for applications for conducting

clinical trials with investigational devices and applications for

permitting devices to be marketed. Such guidance documents are

widely disseminated by CDRH to all interested parties. Other

standards used by CDRH, or which CDRH has helped to develop, concern

measurement or test methods, or support good manufacturing practices

and quality assurance.

CDRH recently proposed to revise the good manufacturing practice

regulations for medical devices, in part to ensure that they are

compatible with specifications for quality systems contained in an

international quality standard developed by ISO, namely ISO 9001

``Quality Systems Part 1. Specification for Design/Development,

Production, Installation, and Servicing'' (58 FR 61952, November 23,

1993). This standard (ISO 9001) is becoming widely recognized by

medical device regulatory authorities worldwide and is finding

application in many other industry sectors as well. CDRH officials,

working with counterpart foreign government officials, are pursuing

in step-wise fashion the harmonization of quality system inspection

procedures and enforcement. The process of harmonizing regulatory

requirements is facilitated by using an international standard as a

basis. Such harmonization is not only recognized public policy, but

for medical devices, it is explicitly encouraged by provisions of

SMDA (Pub. L. 101-629), which states, in part, that ``* * * the

Secretary may enter into agreements with foreign countries to

facilitate commerce in devices between the United States and such

countries consistent with the requirements of the Act.''

In a recent November 1993 program review, CDRH reported that it

reviews and comments on more than 300 standards documents each year,

participating in 388 standards efforts with 36 standards bodies; of

these, 94 standards efforts with nine bodies are international. The

experience CDRH has acquired over the years has provided the

foundation for the standards policy it announced for its own use on

June 29, 1993. The essential features of that policy are reflected

in the draft FDA policy presented below.

III. FDA Policy on Standards

It is the intent of this policy to enable FDA to: (1) Continue

to participate in international standards activities that assist it

in implementing statutory provisions for safeguarding the public

health, (2) increase its efforts to harmonize its regulatory

requirements with those of foreign governments, including setting

new standards that better serve public health, and (3) respond to

laws and policies such as the Trade Agreements Act of 1979 (19

U.S.C. 2531) and OMB Circular No. A-119 that encourage agencies to

use international standards that provide the desired degree of

protection. Accordingly, it is the policy of FDA, concerning the

development and use of standards that:

A. FDA participation in standards development will be based on

the extent to which the development activity and expected standard

conform to certain factors, with consideration also being given to

the resources available in FDA to devote to the effort and expected

efficiencies to be gained as a result of the effort; the factors are

as follows:

1. The standard contributes to safer, more effective, and higher

quality products;

2. The standard is based on sound scientific and technical

information and permits revision on the basis of new information;

3. The development process for the standard is transparent

(i.e., open to public scrutiny), consistent with legal or procedural

requirements, and commensurate with the codes of ethics that must be

followed by FDA employees;

4. The development of an international standard that achieves

the agency's public health objectives is generally, but not always,

given a higher priority than the development of a domestic standard;

5. The development of a horizontal standard which applies to

multiple types of products is generally, but not always, given

higher priority than the development of a vertical standard which

applies to a limited range of types of products;

6. Wherever appropriate for the product, the standard stresses

product performance rather than product design, but where necessary,

covers all factors required to ensure safety, effectiveness, and

quality; and

7. The development process for the standard complies with

applicable statutes, regulations, and policies, specifically

including Sec. 10.95 and OMB Circular A-119.

B. FDA is not bound to use standards developed with FDA

participation. For example, the agency will not use a standard when,

in the judgment of FDA, doing so will compromise the public health.

C. The uses of final (and selected draft or proposed) standards,

or selected relevant parts, will include, where appropriate: (1)

Incorporating such standards into guidance documents for nonclinical

testing, applications for conducting clinical trials with

investigational products, and applications for permitting products

to be marketed; (2) conducting reviews of such applications; (3)

incorporating such standards into compliance policy guides; (4)

conducting reviews of test protocols used by firms as part of good

manufacturing practices; (5) conducting reviews of study protocols

submitted by firms as required for postmarket surveillance studies

or programs; (6) serving as the basis for mandatory standards or

other regulations promulgated by FDA; and (7) serving as the basis

for reference (e.g., evaluation criteria) in a memorandum of

understanding with other government agencies.

D. The use of a standard in the regulatory programs of FDA is

dependent upon the following factors:

1. The standard, if adhered to, would help ensure the safety,

effectiveness, or quality of products;

2. The standard is based on sound science and is current;

3. The development process for the standard was transparent

(i.e., open to public scrutiny), consistent with legal or procedural

requirements, and commensurate with the codes of ethics that must be

followed by FDA employees;

4. Where a relevant international standard exists or completion

is imminent, it will generally be used in preference over a domestic

standard, except when such international standard would be, in FDA's

judgment, insufficiently protective, ineffective or otherwise

inappropriate;

5. Where a relevant horizontal standard which applies to

multiple types of products exists or completion is imminent, it will

generally be used in preference over a vertical standard, which

applies to a limited range of types of products, except when such

horizontal standard would be ineffective or otherwise inappropriate;

6. Wherever appropriate for the product, the standard stresses

product performance rather than product design, but where necessary,

covers all factors required to ensure safety, effectiveness, or

quality; and

7. The standard is not in conflict with any statute, regulation,

or policy under which FDA operates.

E. FDA has a senior official who will serve as the Standards

Executive, as specified in OMB Circular No. A-119, to serve on an

Interagency Committee on Standards Policy (ICSP). At present, the

Standards Executive is the Director, International Policy Staff.

F. FDA employees will comply with agency regulations

(Sec. 10.95) covering participation in standard setting activities

outside the agency.

Invitation to Comment

Interested persons may, on or before February 13, 1995, submit to

the Dockets Management Branch (address above) written comments

regarding this draft policy. 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. Received comments may be seen in the office above

between 9 a.m. to 4 p.m., Monday through Friday.

Dated: November 18, 1994.

William K. Hubbard,

Interim Deputy Commissioner for Policy.

[FR Doc. 94-29116 Filed 11-25-94; 8:45 am]

BILLING CODE 4160-01-F