SMG 9100.1 APPENDIX 1 – Development of “Standards” - Memorandum of Understanding between FDA's Office of International Programs (OIP) and Office of the Chief Scientist (OCS)

Whereas:

* As a public health agency charged with protecting and promoting the public health of the United States by assuring the safety, effectiveness, and quality of medical products and the safety and wholesomeness of food products, FDA develops, helps develop, adopts, and uses “standards” of many types at every level in the organization.  

* As the complexity of and overlap between products over which we have jurisdiction increases, the interactions between product centers that manage the products on a day-to-day basis and between the product centers and the Office of the Commissioner must increase.

* The ongoing attempts to lower international trade barriers increase the international flow of FDA-regulated products and increase the importance of effective collaboration between FDA and both foreign government regulators and international organizations seeking to harmonize regulatory policies and requirements as much as possible in bilateral and multilateral fora. As a world leader in regulatory science and policy, FDA must have a visible, effective, and coordinated presence in these fora.

* When initiatives involve the development of standards, it is imperative that there be a clear understanding of the responsibilities within FDA for coordinating FDA participation in standards development both domestically and internationally and for assuring the most appropriate scientists within FDA are engaged in these initiatives.  In addition to a strong and committed application of scientific expertise, FDA must contribute a visionary policy and cooperative strategy to standards development initiatives.  To accomplish this, FDA must have well-coordinated policy staffs to direct and maintain FDA’s standards development efforts.  

* We note that the National Technology Transfer and Advancement Act of 1995 guides U.S. Government participation in the development and use of standards. [P.L. 104-113, 110 Stat. 775, 783 (15 U.S.C. 272 note)].

Therefore, the Office of the Chief Scientist and the Office of International Programs within the Office of the Commissioner agree to the following.

* To establish needed visibility within the Office of the Commissioner and to improve coordination of efforts: (a) the Office of the Chief Scientist (OCS) will assume primary responsibility for coordinating domestic standards development and for assuring that appropriate scientific expertise from the Agency is engaged in both domestic and international standards development initiatives, and (b) the Office of International Programs (OIP) will assume primary responsibility for coordinating international standards development initiatives (including coordination with that the Office of the Chief Scientist to ensure that appropriate scientific expertise from the Agency is engaged in the initiative), and (c) the Office of International Programs will assume primary responsibility for coordinating international policy issues relating to standards with respect to trade, treaties, and mutual recognition agreements.

* The offices will use both formal and informal coordinating mechanisms in order to coordinate these efforts.

* The program centers will continue to provide the bulk of scientific expertise on standards committees and working groups within their areas of competence.

* OCS will carry out the functions of the Standards Executive for the Department of Health and Human Services pursuant to Office of Management and Budget (OMB) Circular A-119.  These duties include attendance at the Interagency Committee on Standards Policy (ICSP), which is responsible for implementing the NTTAA and preparation of the annual report to OMB on the use of standards.

* OCS will maintain a liaison with the FDA Data Council.  OCS will coordinate with OIP on FDA Data Council activities potentially affecting international standards.

* ANSI is the principal organization for coordination of national standards activities and representation of U.S. standards policies to the international standards development organizations.  FDA participates in ANSI deliberations through a large number of policy and standards development committees.  For those committees dealing with primarily scientific issues for which technical expertise is paramount, program center offices with the requisite expertise should provide support with the guidance and coordination of OCS and OIP.  OCS will participate in the several management councils and forums of ANSI, including the ANSI Government Member Forum, the ANSI Consumer Interest Forum, the ANSI National Policy Committee, and the ANSI Board of Directors (if appropriate).  OIP will research the need for membership on the ANSI Health Informatics Committee, International Policy Committee (and related Regional Standing Committees) and the International Conformity Assessment Committee.

* OIP will continue its oversight of the ISO Technical Committee (TC) 34 on Food Products and is exploring the possibility of the U.S. becoming a Participating Member on the ISO TC 217 on Cosmetics.  The remainder of FDA involvement on the ISO Technical Committees will continue to reside primarily within the FDA program centers, mainly within CDRH.

* OIP will continue its role in overseeing and coordinating bilateral and multilateral international standards development/regulatory harmonization programs, including ICH, VICH, GHTF, CHIC, Codex, OECD, WHO, FAO, OIE.

Future

The FDA must take a strong role in promoting the visibility and use of standards applicable to FDA’s public health mission.  This MOU represents the first step in achieving these goals.  We will work together to develop a long-term plan for implementing a greater focus on standards.  In their various roles, OIP and OCS will continue to serve as a mechanism for coordinating, integrating and reporting on our progress.  These offices should report regularly to their leadership and to the joint executive leadership of the Agency, including the program center directors, on the actions taken and the progress made in the realm of standards development.

_____________________
Jesse Goodman, M.D., M.P.H.
Chief Scientist
(for Office of the Chief Scientist)


______________________
Mary Lou Valdez, M.S.M.
Associate Commissioner
(for Office of International Programs)