Memorandum of Understanding
The Customs and Border Protection
The Food and Drug Administration
1. Parties. The parties to this Memorandum of Understanding (MOU) are Customs and Border Protection (CBP), Department of Homeland Security, and the Food and Drug Administration (FDA), Department of Health and Human Services.
2. Authority. The authorities for entering into this MOU are the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 372 and 381(m), 19 C.F.R § 12.1, 19 C.F.R. § 147.23, and 44 U.S.C. § 3510.
3. Purpose. The purpose of this MOU is to allow FDA to commission CBP officers. These commissioned officers will assist FDA with examinations and investigations pursuant to, or based on information obtained under, the prior notice requirements found in 21 U.S.C. § 381(m) and its implementing regulations, at ports and other facilities and locations subject to CBP jurisdiction.
A. The Food and Drug Administration agrees:
1. To commission all CBP officers deemed necessary by the Commissioners of CBP and FDA to conduct examinations and investigations in accordance with the prior notice requirements in 21 U.S.C. § 381(m) and its implementing regulations.
2. To provide appropriate training for the commissioned officers and employees that would allow them to conduct FDA examinations and investigations subject to this MOU.
3. To provide 24 hour operational and technical assistance to CBP for the stated purpose of this MOU.
4. To reimburse CBP for costs for training and costs incurred while performing FDA functions for which the CBP officers have been commissioned. Such reimbursement shall be pursuant to the terms of an interagency agreement to be negotiated between FDA and CBP.
5. To not disclose information received from CBP unless CBP approves, in advance, its disclosure in writing, including information contained in CBP databases.
6. To share information with CBP to fulfill the stated purpose of this MOU, such as information relating to bioterrorism threats, except as restricted by law.
7. To jointly develop and implement additional agreements and plans to help fulfill the stated purpose of this MOU.
B. Customs and Border Protection agrees:
1. To assist FDA in the execution of the prior notice requirements in 21 U.S.C. § 381 (m) and its implementing regulations.
2. To collect samples upon FDA's request, and to forward those samples to FDA for analysis.
3. To collect and analyze samples upon FDA's request and to forward the results of the CBP analyses to FDA.
4. To share information with FDA to fulfill the stated purpose of this MOU.
5. To not disclose information received from FDA unless FDA approves, in advance, its disclosure in writing, including information contained in FDA databases.
6. To jointly develop and implement additional agreements and plans to help fulfill the stated purpose of this MOU.
5. Date Effective. The terms of this MOU will become effective upon signature of the parties. They will remain in effect until either modified or terminated as described in this MOU.
6. Modification. This MOU may be modified upon the mutual written consent of the Commissioner of Customs and Border Protection and the Commissioner of the Food and Drug Administration.
7. Confidentiality. CBP and FDA agree that any sharing of non-public information pursuant to this agreement will occur according to all applicable laws and regulations. Each agency understands that disclosure by the recipient of nonpublic information could be a violation of federal law.
8. Termination. Either party may revoke this MOU upon 30 days written notice.
9. Severability Clause. Nothing in this MOU is intended to conflict with the current laws, regulations, or directives of CBP or FDA. If a term of this MOU is inconsistent with such authority, then that term shall be invalid, but the remaining terms and conditions of this MOU shall remain in full force and effect.
10. Emergency Situations. In the event that a national or regional disaster disrupts communications between FDA and CBP, an emergency contingency plan shall become operational. The procedures of that system are to be agreed upon an annex to this MOU.
11. No Private Right of Action Created. This intra-governmental MOU is not intended to create or confer any rights, privileges, or benefits for any private person or party.
12. Relationship to Other Authorities. Nothing in this MOU is intended to restrict CBP or FDA from taking any action that the agencies would be otherwise authorized to take under law.
13. Contact Information for Liaison Offices. The following offices will act as liaisons between FDA and CBP for the purpose of coordinating the implementation of this MOU:
A. Contact for FDA:
Director, Office of Regional Operations
Office of Regulatory Affairs
Food and Drug Administration
Rockville, MD 20857
B. Contact for CBP:
Director, Special Enforcement
Office of Field Operations
Trade Compliance and Administration
Customs and Border Protection
Department of Homeland Security
The undersigned approve the terms and conditions of this MOU and represent that they have the requisite authority to enter into it.
Approved and Accepted
Signed by: Douglas M. Browning
Date: December 3, 2003
Approved and Accepted
Signed by: Mark B. McClellan, M.D., Ph.D.
Date: December 3, 2003