[Federal Register Volume 59, Number 227 (Monday, November 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29116]


[Federal Register: November 28, 1994]


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Part II





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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International Harmonization; Draft Policy on Standards; Availability; 
Notice
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94D-0300]


International Harmonization; Draft Policy on Standards; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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