[Federal Register Volume 60, Number 115 (Thursday, June 15, 1995)]
[Notices]
[Pages 31485-31487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-14587]
[[Page 31485]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94D-0123]
International Memoranda of Understanding; New Compliance Policy
Guide; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a new
Compliance Policy Guide (CPG) 7150.19 entitled ``International
Memoranda of Understanding.'' The text of the CPG is published in this
document. The guide sets forth policy for initiating, developing, and
monitoring agreements such as memoranda of understanding (MOU's)
between FDA and foreign governments.
ADDRESSES: CPG 7150.19 is available for public examination in the
Dockets Management Branch (HFA-305), Food and Drug Administration, rm.
1-23, 12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4
p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Richard M. Garwood, Office of
Regulatory Affairs (HFC-10), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-443-2175.
SUPPLEMENTARY INFORMATION: The FDA International Harmonization Task
Force recommended in December 1992 that guidance be developed that
describes the agency's objectives, and promotes uniformity, in
developing MOU's with foreign government agencies or with international
organizations. MOU's enhance FDA's ability to carry out its mission and
promote harmonization of laws and regulations, compliance activities,
and enforcement actions. Harmonization facilitates the efficient and
effective execution of FDA's programs and promotes international trade.
It is the policy of FDA to pursue the development of MOU's that
will further the agency's domestic public health mission. MOU's between
FDA and an agency of a foreign government or an international
organization should be designed to:
(1) Enhance FDA's ability to ensure that regulated products are
safe, effective, of good quality, and properly labeled;
(2) Allow FDA to utilize its resources more effectively or
efficiently, without compromising its ability to carry out its
responsibilities; and
(3) Improve communications between FDA and foreign officials
concerning FDA-regulated products.
This policy is detailed in the new CPG 7150.19, entitled
``International Memoranda of Understanding,'' the text of which is
provided below. FDA MOU's are negotiated in accordance with the
Department of State's Circular 175 procedures.
In order to facilitate future reorganization of the CPG manual
system, the entire contents of CPG 7150.19 will be duplicated, assigned
a second number, 7156.00, and carried in a second location in the CPG
manual system. This fact will be cross-referenced and notated in the
CPG manual system.
The text of CPG 7150.19 entitled ``International Memoranda of
Understanding'' follows:
Compliance Policy Guide, Food and Drug Administration, International
Memoranda of Understanding
SUBJECT:
This guide sets forth policy for initiating, developing, and
monitoring agreements such as memoranda of understanding (MOU's)
between the Food and Drug Administration (FDA) and foreign
governments. The general principles herein may also be applicable to
MOU's with international organizations.
BACKGROUND:
The FDA International Harmonization Task Force recommended in
December 1992 that guidance be developed that describes the agency's
objectives and promotes uniformity in developing MOU's with foreign
government agencies. MOU's promote harmonization of laws,
regulations, and enforcement activities. Further, MOU's, if
negotiated and implemented properly, enhance FDA's ability to carry
out its mission. Attachment A to this Compliance Policy Guide (CPG)
sets forth the agency's criteria for setting priorities for
international MOU's.
The three categories of MOU's described in the following
paragraphs are merely examples. These categories are not mutually
exclusive, and the concepts may be altered or combined as necessary.
Because officials of sovereign nations have different approaches to
regulation, FDA needs to maintain flexibility in its discussions
with these officials.
Reciprocal Agreements with Countries Having the Same or Similar
Systems
MOU's may provide for the mutual assessment of the comparability
of specific FDA programs or activities with those of a foreign
regulatory authority. These MOU's are similar to mutual recognition
agreements (MRA's), referred to in recent trade agreements, and
include equivalence agreements. FDA MOU's that provide for the
mutual assessment of the comparability of a foreign regulatory
system or measure are suitable when it can be determined that FDA's
controls and the foreign regulatory authority's controls are
comparable and are designed to provide the same level of protection.
Under one form of such agreements, mutual acceptance of data and
information, such as analytical findings and inspection results, may
ordinarily be considered adequate for regulatory decisions. The
MOU's now in place for the exchange of results of good manufacturing
practices and good laboratory practices inspections are examples.
Under another form of such agreements, FDA and another country may
agree that their regulatory systems governing certain products are
the same or similar and are designed to provide the needed level of
protection, enabling each country to consider reducing the rate of
inspection or sampling of imports from the other country that would
otherwise be necessary.
Certification of Import/Exports
MOU's may establish certification criteria for products
regulated by FDA. Historically, these MOU's have concerned products
exported to the United States with inherent or consistent quality or
safety problems. However, they may also involve products with a good
compliance history (see Attachment A of this CPG). They may identify
controls to be employed by the exporting country to assure the
validity and reliability of certification. Such agreements should be
designed with the intent of reducing the FDA rate of inspection or
sampling that would otherwise be necessary and with the intent of
providing a basis for assurance that the consumer protection
objectives of FDA are being met. Certification may be shown by marks
on the product, container, or entry documents or by other paper or
electronic communication. An MOU based on the controls to be
employed and maintained by the exporting country to ensure that
articles exported comply with FDA laws and regulations may render
such certifying marks, documents, or other communication
unnecessary.
Communications
Formalizing communication links facilitates the exchange of
technical, scientific, and regulatory information. Technical
cooperation leads to better understanding of safety and quality
standards for products traded between the United States and other
countries and promotes harmonization. Improved communications with
foreign officials may improve FDA decisionmaking and reduce resource
expenditures for monitoring foreign made products.
POLICY:
It is the policy of FDA to pursue the development of MOU's that
will further the agency's public health mission. FDA intends to
enter into an MOU only with an agency of a foreign government or an
international organization. The MOU should be designed to meet the
following goals:
(1) To enhance FDA's ability to ensure that regulated products
are safe, effective, of good quality, and properly labeled;
(2) To allow FDA to utilize its resources more effectively or
efficiently, without compromising its ability to carry out its
responsibilities; and
(3) To improve communications between FDA and foreign officials
concerning FDA regulated products. [[Page 31486]]
Further, before accepting the procedures and activities,
including enforcement methods, of foreign governments as equivalent
to its own, FDA will seek assurance that such activities provide the
same level of product quality, safety and efficacy that is provided
under the Federal Food, Drug, and Cosmetic Act (the act); the Fair
Packaging and Labeling Act; the Public Health Service Act; and any
other relevant law of the United States. FDA may find it necessary
to confirm by on-site review or other appropriate means that the
foreign government agency has the necessary authorities, product
standards, capabilities, and infrastructure to successfully achieve
the proposed terms of the MOU, and, therefore, that a determination
of equivalence can be made. Where appropriate, FDA will publish a
proposed equivalence determination for comment.
FDA's criteria for deciding when to initiate consideration of
developing MOU's are set forth in Attachment A of this CPG. FDA
intends to review and update these criteria periodically.
Affected agency units will review the proposal for a new or
revised MOU for consistency with the agency's international policy
objectives and priorities before an FDA component begins substantive
discussions with foreign officials about the MOU.
FDA auditing may be necessary to assure that the circumstances
supporting the basis for an agreement continue to exist, whether or
not the foreign government intends to conduct audits. The liaison
office identified in the MOU is responsible for preparing a written
evaluation. Participating FDA components will be queried by the
responsible liaison office as to the overall effectiveness of the
agreement, whether provisions should be added or deleted, and
whether the MOU should be terminated.
Countersigned agreements are commonly referred to by FDA as
``Memoranda of Understanding.'' However, some foreign governments
have requested that such documents be titled as ``Notes Verbale,''
``Arrangements,'' or ``Mutual Recognition Agreements.'' Regardless
of title, such agreements will be filed in chapter 56 of the
Compliance Policy Guides Manual, and a notice of availability will
be published in the Federal Register.
An ``exchange of letters'' should be used in lieu of a formal
agreement when the actions contemplated require only a limited
resource expenditure and do not rise to the significance of a formal
agreement. For example, an exchange of letters could formalize an
understanding that each agency will provide the other with documents
that are available upon request to any member of the public. Each
letter should set out only the actions to be carried out by the
agency signing the letter and not mutual considerations. Clearance
of exchange of letters will be by the same process as used for MOU's
except that, after clearance, the FDA letter may be signed by the
appropriate Center or Office Director. Copies of the letters
exchanged should be placed in the cooperative agreements portion of
the Compliance Policy Guide Manual.
FDA's practice is to enter into MOU's for a period of 5 years.
Each existing MOU should be evaluated at least once during the 5
year period of the agreement to determine whether the MOU should be
modified, continued, or canceled. As part of the evaluation of an
MOU, the agency may conduct independent or joint inspections or
analyze imported products to evaluate the effectiveness of the MOU.
DEVELOPMENT GUIDANCE:
Developing an MOU with a foreign government requires
coordination between the sponsoring center or office, the Office of
Regulatory Affairs (ORA), the International Affairs Staff/Office of
Health Affairs (IAS/OHA), and the Office of Policy (OP). Generally,
there are three phases in the process as described below:
Stage I--Exploring Feasibility
a. The sponsoring Center or Office makes a preliminary
assessment whether the proposed MOU is in line with FDA policy
goals. If the sponsoring Center or Office believes that the MOU
should be pursued, the Center or Office informs ORA (HFC-10) in
writing and explain why it believes that the MOU should be pursued.
b. The initiating agency component provides a general
description of the agreement it wishes to develop, e.g., mutual
recognition of a quality assurance program, product certification,
information exchange, etc.
c. The parties exchange information on laws, standards, and
other requirements for subject products, inspection and sampling
abilities, and analytical methodology, as appropriate.
d. On-site review of facilities, operations, and controls may be
arranged.
e. If the foreign government appears not to be, and in FDA's
opinion is not, capable of developing an adequate infrastructure to
carry out the intended program, the sponsoring agency component will
explain FDA's position in writing and suspend further action until
FDA's concerns are adequately addressed. The letter addressing this
issue should be reviewed by OP and IAS/OHA.
Stage II--Determining Effectiveness
a. If discussions are to continue, IAS/OHA should be notified so
that appropriate notification to the Department of State (DOS) can
be made.
b. The parties may consider an informal trial to gain confidence
in the planned agreement. A draft MOU may be prepared along with a
protocol that may provide a basis for the trial. Together these
documents may include:
(1) A complete description of the trial program.
(2) Information regarding roles and capabilities of involved
government and private organizations.
(3) Certificate issuance and use procedure, if any.
(4) Audit frequency and measures to be applied.
(5) Description of training or information needs.
c. Whether or not there is a trial, FDA may conduct as
appropriate independent or joint inspections with the foreign
government, or analyze imported products to evaluate the
effectiveness of the program.
Stage III--Finalizing an MOU
a. The MOU should be prepared for clearance after the substance
of the MOU has been finalized, including after rulemaking, where
appropriate.
b. If appropriate, instructions for auditing the agreement
should be issued to field offices by the sponsoring center or
office, through ORA.
Attachment A
Food and Drug Administration Criteria for Memoranda of Understanding
In deciding whether to begin discussions that could lead to the
development of an MOU, an agency component should consider the
factors that are listed below.
Health Benefits (Including Risk Reduction) Associated With Products
or Programs
FDA should consider the benefits to public health (particularly
for the United States population) when it sets priorities for its
international activities.
Products Imported into the United States
FDA should place a higher priority on international activities
that are directed toward improving the quality, safety, or efficacy
of products offered to consumers in the United States. For example,
FDA should give a low priority to investing resources in developing
a memorandum of understanding with a foreign country that covers a
product where there is little likelihood of significant exports to
the United States or significant risk to the public.
History of Compliance Problems
FDA should place a higher priority on international activities
directed toward remedying product defects that have been
demonstrated to be previous compliance problems or where there is a
demonstrated scientific basis for increased surveillance.
Comparative Costs of Alternative Programs
FDA should pursue international programs and activities that
provide the greatest benefit in relation to the resources required
to administer them. For example, the costs of developing,
implementing, and monitoring an agreement should be weighed against
the costs of higher sampling levels to obtain the same degree of
confidence in rates of compliance in the absence of an agreement.
Regulatory Burden on Industry
FDA should consider the regulatory burden on industry that could
be diminished by harmonization efforts. However, these activities
need to be compatible with FDA's primary public health mission, the
act, and other laws and regulations that FDA enforces.
U.S. Foreign Policy Objectives and Priorities of Other U.S.
Government Agencies
FDA should be knowledgeable of U.S. foreign policy objectives
and international programs and policies of other U.S. Government
agencies and appropriately [[Page 31487]] balance these interests
with those of FDA's primary mission.
The statements made herein are not intended to bind the courts,
the public, or FDA, or to create or confer any rights, privileges,
immunities, or benefits on or for any private person, but are
intended merely for internal FDA guidance.
Dated: June 7, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-14587 Filed 6-14-95; 8:45 am]
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