[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.
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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]
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