[Federal Register Volume 61, Number 245 (Thursday, December 19, 1996)]
[Notices]
[Pages 67034-67035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32274]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[FDA-225-96-4000]


Memorandum of Understanding Between the Food and Drug 
Administration and the United States Customs Service

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) between the FDA and the United 
States Customs Service. The purpose of this MOU is to establish a 
partnership between both agencies to participate in an international 
trade Compliance Measurement (CM) Program.

DATES: The agreement became effective October 23, 1995.

FOR FURTHER INFORMATION CONTACT: Thomas D. Gardine, Division of Import 
Operations and Policy, Office of Regulatory Affairs (HFC-170), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
6553.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOU's between FDA and other 
shall be published in the Federal Register, the agency is publishing 
notice of an MOU.


[[Page 67035]]


    Dated: December 11, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.

Memorandum of Understanding Between the United States Customs Service 
and the United States Food and Drug Administration

    The parties of this Memorandum of Understanding (MOU) are the 
United States Food and Drug Administration, hereinafter called 
Customs.
    The purpose of this MOU is to establish a partnership between 
both agencies to participate in an international trade Compliance 
Measurement (CM) Program.
    The Customs CM Program assesses the potential risk that 
importations do not comply with the law based on a statistically 
valid random methodology. Customs has the authority to examine and 
detain all imported merchandise for the purpose of ensuring that 
such merchandise complies with all U.S. laws governing 
admissibility; or, Customs may conditionally release the merchandise 
under bond pending a final admissibility determination. This 
authority applies to merchandise for which a particular 
determination relating to admissibility is vested in other 
government agencies. To streamline initiatives in the area of public 
health and safety, Customs intends to work more closely with other 
Government agencies regarding commodities which pose a risk to the 
United States from a public health and safety standpoint. By working 
jointly with FDA to determine the compliance rates of specific 
commodities entering the United States, each agency intends to gain 
a better understanding of the public health and safety threat these 
commodities pose to the public. Coordinating activities as part of 
the CM Program is intended to enhance each agency's overall mission 
performance.
    Specifically, this MOU provides the framework for the 
cooperative efforts of Customs and FDA under the Compliance 
Measurement Program to ensure maximum compliance with the laws 
enforced by both agencies and the regulations promulgated 
thereunder, and that appropriate procedures pertaining to 
importation are followed. This MOU is intended to establish improved 
communications between the signatories. Further, the goals of the 
MOU include increasing efficiency, reducing individual agency costs 
through the pooling of resources, and expediting clearance of 
compliant imported products into the United States. Having both 
agencies working together on the Customs CM Program assists in the 
implementation of the aforementioned goals.
    This MOU serves to solidify our positions regarding cooperation 
among government agencies as described in Vice President Al Gore's 
Reports of the National Performance Review, From Red Tape to 
Results: Creating a Government That Works Better & Costs Less (1993) 
and the Government Performance and Results Act of 1993, 103 Pub. L. 
No. 62, 107 Stat. 285.
    Both Customs and the FDA recognize that this MOU in no way 
compromises the efforts of both agencies in protecting the public 
health and safety of the United States from merchandise that falls 
outside the parameters of the Customs CM Program.

I. Customs Agrees To:

    1. Incorporate into Customs FY 96 CM Program for the second 
quarter of the fiscal year (FY), the Harmonized Tariff Schedule 
(HTS) numbers FDA and Customs jointly agree to include in the 
program. These HTS numbers may be modified in the second quarter of 
FY 96 and beyond.
    2. Notify FDA of all compliance measurement examination results 
of these selected products.
    3. In accordance with FDA's written instructions, examine the 
products FDA and Customs jointly agree to be included in the CM 
Program.
    4. Assign a representative to facilitate communication and 
interaction between Customs and FDA.

II. FDA Agrees To:

    1. Provide Customs with written instructions to use to examine 
the products FDA and Customs jointly agree to be included in the CM 
Program.
    2. Provide Customs with a list of HTS numbers and advise Customs 
of any changes to the list.
    3. Provide training and/or material necessary to accomplish 
examination procedures, e.g., equipment, tools, forms, etc., as 
outlined in the examination instructions written by FDA.
    4. Assign a representative to facilitate communication and 
interaction between Customs and FDA.

III. It is Mutually Understood And Agreed That:

    1. This MOU is to develop a partnership between the two agencies 
with respect to Customs CM Program solely. This MOU does not 
supersede, or relate in any way, to any other MOU's signed by the 
two agencies. This MOU is to define in general terms the basis on 
which the parties concerned will cooperate and, as such, does not 
constitute a financial obligation to serve as a basis for 
expenditures. No transfer of Federal funds will be involved under 
this MOU.
    2. This MOU is a FY 96-97 planning document. Implementation of 
the CM Program initiatives commence October 1, 1995.
    3. The above provisions will be exercised to the extent 
authorized by law, Customs and FDA directives, statutes, and 
regulations, and will be consistent with the respective agency's 
missions. To that extent, it is understood that a Customs compliance 
measurement determines only whether there is reason to believe 
merchandise is noncompliant. Furthermore, Customs release of 
merchandise following a compliance measurement examination does not 
constitute a determination by Customs that the merchandise does or 
does not comply with FDA law. Any final determination of 
admissibility under FDA law remains vested in the FDA.
    4. If, for any reason, the HTS numbers, examination 
instructions, or necessary training/materials, are not acceptable to 
either Customs or FDA, modifications will be made to ensure mutual 
agreement by both agencies.
    5. This MOU is an internal Government agreement and is not 
intended to confer any right or benefit on any private person or 
party.
    6. Information gathered as a result of the CM Program may be 
highly sensitive, proprietary information. Any information obtained 
by one agency from the other will be used only for the purpose of 
enforcing applicable laws and regulations; the information will not 
be released to third parties except as provided by statute or 
regulation. In accordance with 44 U.S.C. 3510, any information 
obtained by one agency from the other will continue to be subject to 
all the provisions of law of the originating agency.
    7. Access to the information described in this MOU is based on 
the compliance of both FDA and Customs with the Privacy Act of 1974 
(5 U.S.C. 552a).
    8. This MOU shall become effective upon the date of final 
signature by both agencies and remain in effect for 5 years or until 
cancelled by either party upon a 30-day notice in writing.
    This MOU may be amended or continued by mutual consent of the 
parties hereto in writing.

By: George J. Weise.

Title: Commissioner, United States Customs Service.

Date: October 23, 1995.

By: Mary K. Pendergast,

Title: Deputy Commissioner/Senior Advisor to the Commissioner, United 
States Food and Drug Administration, for the Commissioner of Food and 
Drugs.

[FR Doc. 96-32274 Filed 12-18-96; 8:45 am]
BILLING CODE 4160-01-F