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Volume III - 6.3 Background and Program Overview

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-06

VERSION NO.:2.7

Section 6 ORA Method Development and Validation Program

EFFECTIVE DATE:
04-02-04
REVISED: 01-09-14

The historical research process is described in Field Management Directive 143.

 6.3.1 Program Goals

The goals of the Method Development and Validation Program are the following:

  • provide opportunities for ORA scientists to develop analytical methodologies and expertise that support the regulatory and public health protection mission of FDA and solve continuing, new, or emerging regulatory problems;
  • support FDA Center research through method validation and collaboration with FDA Center scientists;
  • upgrade present methods to use improved instrumentation or technology and validate methods to “Standard” method status for FDA use;
  • incorporate the developed methods into daily operations; and to transfer the technology, where appropriate, to our stakeholders and customers; and
  • develop the knowledge, skills, and abilities of ORA staff analysts.

 6.3.2 ORA Method Development and Validation Program

6.3.2.1 ORA Planned Method Development and Validation Studies

Planned development of methods and studies are designed to handle regulatory program-oriented analytical testing problems. The method or analytical need can be conceived by the ORA analysts, headquarters units, Food Emergency Response Network (FERN), district offices, and Science Advisors. Laboratory Directors determine how their assigned Full Time Equivalents (FTEs) will be used. These resources are allocated in the annual ORA work plan. The outcome of this work may directly affect Center regulatory program development.

6.3.2.2 Compliance Program Directed Method Development and Validation

Method development and validation operations mandated in compliance programs are planned in the Centers and conducted by ORA. The ORA analyst assigned to the project has latitude to plan activities to explore and solve the problem, but the Center and ORA through ORS, define the parameters for the scope of the study.

Laboratory Directors coordinate collaborations and method development/validation by communicating with the appropriate Center and ORS regarding criteria for validation.

 6.3.3 Other Programs Available to ORA for Method Development and Validation

6.3.3.1 District Discretionary Method Development and Validation

In each ORA laboratory's annual work plan, a specified number of hours are assigned per operational scientist to plan and complete method development and validation needs that arise during the year and are not covered by other programs. The Laboratory Manual policies and procedures applicable to method development and validation are followed as well as applicable technology requirements and local procedures. This work is controlled by local management.

6.3.3.2 Field Research Center Method Development and Validation

In the early 1980s, field research centers were established in several ORA laboratories to focus research efforts in support of a variety of program areas. Three field research centers remain: Seafood Products Research Center (Seattle), Animal Drugs Research Center (Denver), and Total Diet and Pesticide Research Center (Kansas City). In addition, the Atlanta Center for Nutrient Analysis performs similar functions in part. The field research centers provide complex analytical support to field laboratories and the Centers, conducting research on current methodology, developing and refining new rapid chemical and biological methodology, conducting and participating in collaborative studies and validation trials of analytical methods, and providing expert technical scientific assistance and consultative services. Each Center’s method development programs are independent of the field laboratory process described in this chapter. Projects are defined through meetings with the associated Centers and ORS, or by a call for projects and needs to all field laboratories.

6.3.3.3 Science Advisor Research Associate Program

The Science Advisor Research Associate Program (SARAP) was initiated in 1973 in order to provide field professionals with an opportunity for uninterrupted training and research involvement. The program allows researchers to become or remain current in advancing scientific and technical skills.

The purpose of the SARAP program is the following:

  • permit and encourage scientifically competent field employees to develop themselves for research and specialty positions through a planned staff development program;
  • upgrade the quality and status of field scientific research development and investigations;
  • develop a cadre of well-trained field scientists and investigators capable of meeting the challenges posed by the demand for more complex method development and investigations; and
  • introduce new scientific techniques and capability into our field laboratories.

SARAP research can be conducted at a local college or university, FDA laboratory, or a combination of both under the direction of laboratory management, and Science Advisor or other academic professor.

Up to one full FTE of research time may be granted to the SARAP associate. The Associate Commissioner for Regulatory Affairs approves all the necessary funding for SARAP research. (Please refer to SARAP guidelines at ORS).

6.3.3.4 Cooperative Research and Development Agreement

The Federal Technology Transfer Act of 1986, (FTTA), authorizes government agencies to enter into collaborations with the private sector, academic institutions, and other organizations. The mechanism used is known as the Cooperative Research and Development Agreement (CRADA).

A CRADA is used to formalize a specific collaborative project which may involve research leading to new inventions or further development of existing government or non-government inventions in fulfillment of FDA missions. The primary purpose is to transfer the technology and intellectual property to the commercial marketplace. The terms of a CRADA, which are negotiated by FDA and the collaborator, may address patent rights and licensing matters as well as the collaborative research project.

A CRADA is not intended to be a general funding mechanism. CRADA-derived funds are to be used for costs associated with the project specified in the CRADA. Laboratories must be prepared to address the impact to ongoing research if a CRADA and related financial support is terminated unexpectedly. Time allotted to a CRADA project can be taken from a laboratory’s discretionary time, planned research allotment, or by agreement with a Center to use other compliance program planned time.

More information can be obtained from http://eric.fda.gov under Acquisition and Grants and under Technology Transfer.