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Document Number:

MAN-000050

Revision #: 04

Revised:

27 Jul 2022

Title: 

ORA Lab Manual Vol. III Section 6 - ORS Method Development and Validation 

Program (III-06)

Page 1 of 24

For the most current and official copy, check QMiS.

Sections in This Document

Introduction...............................................................................................................................2

Purpose ....................................................................................................................................3

Program Overview....................................................................................................................3

3.1. Program Goals...............................................................................................................3

3.2. ORS Method Development and Validation Program......................................................4

3.2.1. ORS Planned Method Development and Validation Studies ...........................4

3.2.2. Compliance Program Directed Method Development and Validation..............4

3.2.3. Other Programs Available to ORS for Method Development and Validation...4

3.2.4. Directed Method Development and Validation.................................................5

3.2.5. ORS Research Center Method Development and Validation ..........................5

3.2.6. Science Advisor Program ................................................................................5

3.2.7. Cooperative Research and Development Agreement .....................................6

4. Roles and Responsibilities........................................................................................................7

4.1. Associate Commissioner for Regulatory Affairs (ACRA) and Director of Office of 

Regulatory Science (ORS).............................................................................................7

4.2. Foods Program Regulatory Science Steering Committee .............................................7

4.3. Medical Product Centers................................................................................................8

4.4. Office of Research Coordination Evaluation and Training (ORCET) .............................8

4.5. ORS Laboratory Management .......................................................................................8

4.6. Quality Managers...........................................................................................................9

4.7. ORS Analysts.................................................................................................................9

4.8. Science Advisors..........................................................................................................10

4.9. FDA Center Scientists..................................................................................................12

5. ORS Method Development and Validation Process ...............................................................12

5.1. Laboratory Method Development and Validation Program (MDVP) Overview ............12

5.1.1. Method Development.....................................................................................12

5.1.2. Method Validation ..........................................................................................12

5.1.3. Method Modification, Enhancement, and Extension......................................12

5.1.4. Technology Exploration .................................................................................12

5.1.5. Applied Studies ..............................................................................................13

5.2. Method Development and Validation Program (MDVP) Procedures ...........................13
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Document Number:

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Revision #: 04

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Title: 

ORA Lab Manual Vol. III Section 6 - ORS Method Development and Validation 

Program (III-06)

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5.2.1. ORCET Management of New Research........................................................13

5.2.2. Proposal Preparation and Submission...........................................................14

5.2.3. Proposal Review and Project Assignment .....................................................15

5.2.4. MDVP Proposal Approval Process: ...............................................................15

5.2.5. Project Execution and Reporting of Accomplishment Hours .........................15

5.2.6. Presentation, Assessment, and Implementation............................................16

5.2.7. Patent Application & Licensing ......................................................................18

5.2.8. Assessment and Implementation...................................................................18

6. Scientific Conduct When Performing Research......................................................................18

6.1. Data Management........................................................................................................18

6.2. Review and Clearance Policy ......................................................................................19

6.3. Authorship....................................................................................................................20

7. References .............................................................................................................................20

Document History ...................................................................................................................22

Change History.......................................................................................................................23

Attachments............................................................................................................................24

Introduction

As the regulatory agency designated to maintain the safety of the nation's foods, 

drugs, biologics, medical devices, tobacco and radiological health products, FDA 

has broad responsibilities to protect the public health. It is the vision of the Office of 

Regulatory Science (ORS) to provide a defensible and prevailing scientific, research 

and analytical base for regulatory decisions that protect and promote public health.

Vital to carrying out this mission is the continual development, validation and 

improvement of methods that support our regulatory responsibilities. 

The ORS Method Development and Validation Program (MDVP) is designed to 

satisfy the need for regulatory analytical methods meeting current and anticipated 

public health program needs and agency priorities through collaboration across the 

FDA Centers and ORS Laboratories. Furthermore, ORS Laboratories must continue 

to maintain good laboratory practices through necessary quality assurance and 

regulatory requirements. The exploration of new technologies and methods for rapid 

analyses, as well as modernization of existing methods to achieve higher efficiency 

or broader scope, are also important components of this science program. 
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Title: 

ORA Lab Manual Vol. III Section 6 - ORS Method Development and Validation 

Program (III-06)

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Purpose

The goal is to satisfy the need for regulatory analytical methods meeting current and 

anticipated public health program needs and agency priorities. This ORA Laboratory 

Manual section provides the procedures for the identification, development, 

submission, review and publication of method protocols, validation studies, method 

extensions or other research studies. 

The procedures assure projects meet regulatory needs, accomplish their intended 

purpose, include validation for Agency-wide distribution (where appropriate and/or 

in conjunction with the appropriate Centers), and become meaningful analytical 

tools. Additionally, it provides scientific guidelines for the program and encourages 

and enhances the creative skills of talented scientists in ORS Laboratories. 

Program Overview

ORA’s program alignment that took effect in 2017 led to the creation of ORA’s first 

office dedicated to leadership and management of research: Office of Research 

Coordination, Evaluation and Training (ORCET) within ORA’s Office of Regulatory 

Science (ORS). Method development and validation efforts comprise most of the 

research activities within ORS and are managed by ORCET. 

3.1. Program Goals

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

A. Provide opportunities for ORS 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. 

B. Support FDA Center research through method validation and 

collaboration with FDA Center scientists. 

C. Revise existing methods to use improved instrumentation or technology 

and validate methods to “Standard/Official” method status for FDA use. 

D. Incorporate the developed methods into routine regulatory operations; 

and to transfer the technology, where appropriate, to our stakeholders 

and customers. 

E. Develop the knowledge, investigative skills, and abilities of ORS staff 

analysts
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3.2. ORS Method Development and Validation Program 

3.2.1. ORS Planned Method Development and Validation Studies

Planned development of methods and studies are designed to address

regulatory program analytical testing problems. Designated full time employee 

(FTE) resources are allocated in the annual ORA work plan for these method 

development and validation activities. The method or analytical need can be 

conceived by ORS headquarters in communication with Centers, ORS analysts, 

Food Emergency Response Network (FERN), and Science Advisors. ORS Lab 

Directors will be responsible for resource management (personnel, funds, 

equipment) to perform planned method development and validation activities. 

The outcome of method development and validation work may directly affect 

Center regulatory program development and implementation.

3.2.2. Compliance Program Directed Method Development and Validation

Method development and validation operations mandated in compliance 

programs are planned in the Centers, conducted by ORS labs, and monitored 

by ORCET. The ORS analyst(s) assigned to the project have latitude to plan 

activities to explore and solve the problem and can ask for input from ORCET; 

ORCET will define the parameters for the scope of the study and provide final 

approval on the study. 

Laboratory Management coordinates local method development/validation 

activities with ORCET. ORCET communicates with appropriate Center 

regarding criteria for validation.

Foods Program multi-laboratory method validation activities are coordinated 

through the Research Coordinating Groups under the Foods Program 

Regulatory Science Steering Committee (RSSC). ORS members are 

represented on these Research Coordinating Groups and provide their review 

and feedback as part of the RSSC process.

3.2.3. Other Programs Available to ORS for Method Development and 

Validation 

Some methods are developed and validated in real time in response to an 

emergency or a product related adverse event or based on a consumer 

complaint. Method development and validation ideas and priorities can also be 

derived from various joint ORA and Center Scientific Steering Committees 

(ORA-CDER Strategic and Scientific and Compliance Steering Committee, 

Center for Tobacco Products, agency-wide initiatives identified by FDA Office of 

the Chief Scientist, intramural grant opportunities, and through the 

Nanotechnology Program).
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Program (III-06)

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3.2.4. Directed Method Development and Validation

In each ORS 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 not covered by other 

programs. 

New method development work will be identified and specified by ORCET. The 

ORA 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 operationally controlled by local 

management, approved, coordinated, and evaluated by ORCET. Utilization of 

all specified number of hours assigned to research activities within the ORS 

laboratories is ultimately the responsibility of ORCET to promote missionrelevant research within the ORS laboratory network. 

3.2.5. ORS Research Center Method Development and Validation

In the early 1980s, ORS research centers were established in several ORS 

laboratories to focus research efforts in support of a variety of program areas.

Three ORS research centers remain: The Applied Technology Center (Bothell, 

WA), Animal Drugs Research Center (Denver, CO), and Total Diet and Pesticide 

Research Center (Lenexa, KS). ORS Laboratory Network also includes two 

specialty Labs and two specialty groups: Winchester Engineering and Analytical 

Center (Winchester, MA), Forensic Chemistry Center (Cincinnati, OH); 

Southeast Tobacco Products Lab (Atlanta, GA), and the ORA-NCTR Nano Core 

Facility (Jefferson, AR). The ORS research centers provide complex analytical 

support to ORS 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 ORS Research Center will develop a research plan in consultation with 

ORCET that aligns with Center and Agency priorities. Projects are defined 

through planning meetings with the research centers and ORCET. Projects are 

selected to support existing regulatory needs and are tracked for progress and 

impact via the Component Automated Research Tracking System (CARTS). 

3.2.6. Science Advisor Program 

The Science Advisor is a special government employee (SGE) and serves as a 

consultant to the specific FDA/ORA/ORS Laboratory. Due to their status as 

SGEs, Science Advisors’ time reporting is governed by special rules. ORS 

Headquarter Science Advisors report to ORCET. ORS Laboratory Science 
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Advisors report to local lab management; however, ORCET will coordinate their 

selection and evaluation for continued service to ensure their expertise remains 

impactful and aligned to Center and Agency scientific initiatives. 

The Science Advisor reports directly to the Lab Director and advises 

management (local and headquarters) on scientific issues as they relate to the 

regulatory operations of the unit. Up to one Science Advisor FTE may be 

assigned to each ORS Laboratory. ORCET will leverage science advisors as an 

enterprise-wide resource and oversee renewals to ensure maximum utilization 

of their expertise.

Science Advisors provide scientific expertise in many areas including 

methodology, training, new technology, instrumentation, research, literature 

searches, publications, etc. Science Advisors work formally and informally with 

analysts, researchers, Supervisors, Branch Directors, Laboratory Directors, 

ORCET, and the Science Advisor Working Group to assist in formulating 

research objectives and goals.

3.2.7. Cooperative Research and Development Agreement

The Federal Technology Transfer Act of 1986, (FTTA), authorizes government 

agencies to enter 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 at the Science First Homepage under FDA 

Scientific Resources FDA Technology Transfer Overview
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All ORS Laboratory CRADA activities will be overseen by ORCET. Labs are 

required to develop a new CRADA in consultation with ORCET as well as 

engage with ORCET on renewal of existing CRADAs.

4. Roles and Responsibilities

4.1. Associate Commissioner for Regulatory Affairs (ACRA) and Director of 

Office of Regulatory Science (ORS)

The Associate Commissioner for Regulatory Affairs and the Director of Office of 

Regulatory Science share responsibility for promoting and supporting a strong 

ORS method development and validation program as part of ORS research as 

well as determining ORS scientific goals.

4.2. Foods Program Regulatory Science Steering Committee 

FDA Foods Program Regulatory Science Steering Committee (RSSC) operates 

under the sponsorship of FDA Foods Program Governance Board and is 

composed of members from the Office of Regulatory Affairs (ORA), Center for 

Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary 

Medicine (CVM) which are the agency components that perform regulatory and 

scientific work in the foods area. Chairmanship of RSSC rotates between ORA, 

CFSAN, and CVM annually.

The primary function of the RSSC is to coordinate scientific research and 

method development activities among CFSAN, CVM, and ORA to ensure 

research projects are not duplicated; appropriate collaborations on scientific 

projects are facilitated; and standardized scientific processes, where feasible, 

are established. Key components of the mission include: 

a. Promoting individual Center and ORA strategic science plans and 

coordinating Center and ORA cross-cutting research portfolios, so that 

projects are complimentary, not redundant nor conflicting; proposed 

scientific work builds upon previous explorations, findings, 

recommendations and is supported by current FDA policy; collaborations 

are leveraged when appropriate; and individual foods program unit and 

agency scientific mission priorities are upheld

b. Developing and implementing a risk-based approach to identifying and 

coordinating new research areas of common scientific interest

c. Maintaining a unified analytical methods development, validation and 

implementation program that is mission-aligned
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d. Identifying new technologies that can be leveraged in analytical work, 

advocating investigation of such new technologies via research, and 

facilitating integration of newly developed methods into foods program

scientific work

e. Generating a candid forum where effective horizon scanning can be 

performed to identify pro-active steps that can be taken by the foods 

program scientific community to attain analytical readiness for future 

consumer safety threats in the foods program regulated areas Medical 

Product Centers

4.3. Medical Product Centers

FDA Centers including the Center for Drug Evaluation and Research (CDER), 

the Center for Biologics Evaluation and Research (CBER), the Center for 

Devices and Radiological Health (CDRH), the Center for Tobacco Products, and

CVM are responsible for providing strategic input regarding direction and priority 

of method development and validation respective of each Center’s program 

area. Center procedures for carrying out such work should be incorporated into 

ORS MDVP.

4.4. Office of Research Coordination Evaluation and Training (ORCET) 

ORCET is responsible for the scientific management of ORS laboratories. As 

such, ORCET sets direction for the ORS method development and validation 

program and provides scientific support. ORCET issues the call for proposals, 

assigns reviewers, and approves proposals, and maintains the approved and 

completed project list. Additionally, ORCET is responsible for tracking research 

progress, achievement of deliverables and evaluation of impact.

ORCET works with the Laboratory Directors, the Centers, and ORS analysts to 

guide and assist with the method development and validation process. The 

Director of ORCET or designee is the recommending and approving official for 

ORS laboratory method development and validation programs documented in 

CARTS. ORCET is responsible for directing, monitoring, and coordinating ORS 

research, inclusive of all method development and validation and 

implementation activities across the entire ORS Laboratory Network. 

4.5. ORS Laboratory Management 

Laboratory management is responsible for developing and executing their 

laboratory’s approved method development and validation program. Laboratory 

Management includes supervisory personnel with titles that may include 

Laboratory Director, Branch Managers, and Supervisors. Operational 

management of the ORS method development and validation resources reside 
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at the local laboratory management level. The Laboratory Director is responsible 

for providing resources and ensuring implementation of procedures. Other 

management personnel are responsible for implementing the procedures. This 

includes assuring that relevant expertise and proficiency exists at the lab to 

support a proposed project, necessary equipment is available, all facility needs 

are properly evaluated and addressed, and FTE resources are available to 

conduct the project without impacting the lab’s programmatic testing obligations.

Timely planning, direction, and accomplishment of these projects are crucial. 

Laboratory Directors rely on supervisors, quality managers, senior laboratory 

staff, and Science Advisors and can consult with ORCET regarding any 

challenges and issues.

Laboratory management must establish an environment where there is vigorous 

growth, development, and accomplishment of projects within the laboratories.

Recognition that is commensurate with the level of contribution to the regulatory 

mission of ORS and FDA by scientists who successfully complete method 

development and validation projects is an important aspect of a successful 

program. 

Laboratory Management (namely, Supervisor, Branch Director and Lab 

Director) are assigned the first three levels of approval in CARTS and are 

responsible for thoroughly reviewing any submitted MDVP projects for missionrelevance, technical merit, feasibility, and resource utilization before providing 

concurrence. Last two levels of approval in CARTS belong to the in-depth 

technical/program reviewer and ORCET Director/Deputy Director.

4.6. Quality Managers

The ORS Headquarters and ORS Laboratory Quality Managers are responsible 

for ensuring the ORA Laboratory Manual, ORS-level directives, and local 

laboratory procedures are implemented to ensure traceability and defensibility 

of data provided for method development and method validation in accordance 

with maintaining accreditation. ORS Quality Managers also serve as resources 

to provide input on questions related to formal validation/verification protocols, 

document practices, statistical analyses of data, or study design. ORS Quality 

Managers can consult with other experts to provide thorough responses on such 

questions that may arise at the laboratory.

4.7. ORS Analysts

ORS analysts are responsible for:

A. Following the ORA Laboratory Manual procedures, ORS-level directives, 

local laboratory procedures, and any other procedures and/or guidance 

documents appropriate for the specific project.
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B. Submitting method development and validation needs through local 

management in response to ORCET initiatives and/or programmatic 

needs.

C. Developing and submitting proposals in accordance with the approved 

procedures.

D. Timely accomplishment of approved projects.

E. Adhering to the highest standards of intellectual honesty and ethical 

standards in formulating, conducting, and presenting method 

development and validation work.

F. Following Agency level and ORCET research and publication 

requirements and guidelines.

G. Submitting new proposals into CARTS and tracking timelines and 

milestones in CARTS.

4.8. Science Advisors

Science Advisors aid laboratory management and analysts by providing 

technical analytical guidance and method development and validation process 

guidance at the local level. More specifically, the advisors provide direction 

towards the development of concept and method development and validation 

project papers, and assist in the conduct, evaluation, and presentation of 

method development and validation end-products. They promote interaction and 

collaborations with their respective universities and other science advisors 

where appropriate, including outside partnerships.

The Science Advisor is responsible for understanding and keeping abreast in 

the major areas concerning regulatory responsibilities and policies of the 

Agency as they relate to the unit he or she serves. To accomplish this, Science 

Advisors must acquire and maintain knowledge of the major thrusts of the 

agency/district/region and areas of scientific expertise to appropriately provide 

overall guidance on field research efforts. The Science Advisor assists in 

keeping the local research program on track, i.e., providing technical 

guidance/troubleshooting advice to researchers, working with ORCET to ensure 

research aligns with current agency needs, ensuring the technical accuracy of 

CARTS proposals, abstracts, presentations, and research publications, 

identifying needs for major instruments and equipment. The Science Advisor 

also will occasionally review CARTS proposals, abstract, presentations, and 

research publications from other ORA/ORS laboratories when they fall within 

the Advisor’s area of expertise.
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The major area of involvement of Science Advisors in ORA/ORS laboratories is 

Coordination of Research Activities by:

a. Providing input to ORCET on ORA/ORS field research needs.

b. Guiding analysts in developing high quality CARTS proposals and grant 

proposals.

c. Assisting in literature searches on the research topics.

d. Reviewing CARTS proposals and recommends changes as necessary.

e. Assisting in critical thinking and troubleshooting during the actual 

research period as necessary.

f. Assisting researchers in analysis of data and interpretation of results.

g. Ensuring researchers developing new methods conduct validations that 

meet relevant guidelines.

h. Assisting researchers in the preparation of CARTS progress and final 

reports.

i. Advising researchers and management and facilitates preparation and 

submission of abstracts, presentations, and manuscripts.

j. Co-authoring papers and presentations, where appropriate, when 

contributions meet relevant authorship guidelines.

k. Monitoring schedules for the research progress timelines, ensures final 

approval of CARTS proposals prior to initiating research, assists in timely 

submission of CARTS progress reports and final reports, assists in timely 

abstract submission to facilitate clearance prior to deadlines, etc. and is 

a conduit for keeping the research program on track.

Additionally, the science advisors recommend improvements towards the 

method development and validation program, provide periodic follow-up reports 

regarding method development and validation’s regulatory impact including 

associated publications, presentations, collaborative studies, adoption as official 

methods by additional field laboratories and headquarters, and inclusion in 

compliance programs.
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4.9. FDA Center Scientists

FDA Center scientists contribute to ORCET’s planning and prioritization for 

method development and method validation projects for ORS laboratories.

Center scientists will work through their appropriate ORA-Center steering 

committees to provide this input and will contribute technical guidance, scientific 

consultation/review, method documents, and validation protocols as requested 

by ORCET for projects included in the method development and validation 

program. 

5. ORS Method Development and Validation Process

5.1. Laboratory Method Development and Validation Program (MDVP) Overview

The MDVP program supports five project categories:

5.1.1. Method Development 

A. Projects are designed to develop, validate, and implement new methods.

B. Expected Outcome: A new method is implemented within a single 

laboratory or method validation proposal for field wide implementation.

5.1.2. Method Validation 

A. Projects are designed to evaluate innovator validated methods via peer 

reviewed assessment and inter-laboratory collaborations.

B. Expected Outcome: Validated regulatory method for ORS lab wide 

implementation. 

5.1.3. Method Modification, Enhancement, and Extension 

A. Projects are designed to extend an existing method to one or more 

additional matrices, analytes, or instrumentation; projects designed to 

improve an existing method.

B. Expected Outcome: Modified method implemented within the laboratory 

or method validation proposal for enterprise-wide implementation.

5.1.4. Technology Exploration 

A. Projects are designed to investigate and evaluate the usefulness and 

applicability of new technologies and increase the analyst’s base 

expertise in these new technologies.
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B. Expected Outcome: New technology accepted by one or more 

publications summarizing experiments performed, data collected, and 

recommendations.

5.1.5. Applied Studies

A. Projects are designed to test hypotheses related to FDA mission such as 

food safety, quality mechanisms, contaminants, analyte/matrix 

interactions, metabolism studies, degradation/depletion studies, process 

effects, stability studies. Although method development may be a 

component of these projects, it is not the primary focus.

B. Expected Outcome: Study, results, and impact for FDA described in one 

or more publications.

5.2. Method Development and Validation Program (MDVP) Procedures

The MDVP process is designed to increase flexibility and timely planning of 

quality projects that benefit the agency. Each ORS laboratory is required to have 

an ongoing MVDP plan commensurate with their method development and 

validation time allotment. A good program is mission related and does not 

duplicate research work being done elsewhere. 

5.2.1. ORCET Management of New Research

ORCET utilizes different mechanisms to identify research proposals that support 

core agency mission, in collaboration with Laboratory management, quality 

managers, analysts, and Science Advisors have an important role in managing 

the program. Throughout the year, method development and validation progress 

and accomplishments are monitored, and adjustments made to react to 

emerging analytical needs as they arise. Laboratories are expected to fully plan 

and accomplish their assigned method development and validation time. 

A. ORCET Priorities for Proposals:

ORCET, via its annual research summit, performs horizon scanning with ORS 

Laboratories and identifies regulatory gaps. ORCET also collects input from 

Centers and generates a list of the highest priority method development and 

validation projects that target validation, development, and enhancement of 

regulatory methods, capability building and technology expansion and shares 

with ORS laboratories as part of the ORCET research forum. Additionally, at 

that time, laboratories may also submit proposals for projects in areas not listed 
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in the ORCET priorities based on what they perceive to be emerging needs. 

ORCET will evaluate all these submissions for mission-relevance, feasibility,

and projected impact. 

B. Lab-Directed Method Validation Proposal 

ORCET can choose a laboratory to develop a method based on Center priorities 

and programmatic needs. The ORS lab scientist will work with ORCET and the 

relevant programmatic office (ORS/OFFLO or ORS/OMPSLO) to develop a 

method through the different topic areas as specified in section 5.1

C. Agency Level Call for Proposals:

As part of FDA’s efforts to strengthen the science through innovation and to 

support regulatory decision-making, the Office of the Chief Scientist (OCS) puts 

out a yearly “Call for Proposals” to the intramural grant cycle program with the 

following five programs:

1. Chief Scientist Challenge Grants

2. Collaborative Nanotechnology (CORES) Grants

3. Medical Countermeasures Initiative (MCMi) Challenge Grants

4. Office of Minority Health Intramural Research Program

5. Office of Women’s Health Intramural Scientific Research Funding 

Program

ORS Labs can collaborate with Center scientists or enter independently to 

develop a full proposal based on these program areas. The proposals are 

reviewed by ORCET prior to submission to OCS for the agency program review 

and awardee selection process based on scientific merit.

5.2.2. Proposal Preparation and Submission

Method development and validation for product commodities that fall under 

other Centers will follow the guidance in this document or appropriate Center 

SOPs. All proposals for projects to be considered must be initiated through 

CARTS. Project types may include:

A. Method development 

B. Single laboratory method validation 

C. Multi laboratory validation 

D. Tech modernization projects requiring new equipment 

E. Method development and validation program funding for reagents
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Refer to ORA-LAB.014 Component Automated Research Tracking System 

(CARTS) for detailed guidance.

ORCET will solicit specific proposals as needed and will manage laboratory 

research portfolio to support Agency needs. 

All research proposals initiated in ORS Laboratories need to be submitted and 

tracked electronically in CARTS. 

5.2.3. Proposal Review and Project Assignment 

All proposals must be submitted through CARTS. After clearing local 

management review, ORCET performs the headquarters review. Reviewers can 

come from ORCET, an ORS laboratory, or be a Center technology expert. Indepth review consists of input from a technical reviewer and input from a 

programmatic reviewer. ORCET will complete the CARTS review within 30 days 

of submission. 

Proposal review considers, but is not limited to, scientific merit (e.g., objectives 

are realistic and scientifically sound), relevance to ORA and FDA mission, FDA 

impact, literature background, technical and equipment capability of the 

proposing lab, budget, timeframe, improvements over existing methodology, 

accuracy and completeness of the submission, and likelihood of success. 

5.2.4. MDVP Proposal Approval Process:

After proposals are received, ORCET will coordinate technical and 

programmatic review of each project. As part of its review, ORCET will seek 

input from the relevant Center as a stakeholder. Once the review is concluded,

ORCET will either recommend the proposal for development, validation, or the 

proposal will be returned with comments to the investigators. In cases where 

ORCET finds the proposed project not feasible, ORCET will suggest alternate 

avenues of research to the investigators.

5.2.5. Project Execution and Reporting of Accomplishment Hours 

Projects are managed and executed at the laboratory. Project records shall be 

maintained in accordance with the local laboratory validation procedure, the 

ORA Laboratory Manual, and the approved research proposal.

Reporting of MDVP accomplishment hours by ORS Labs per instructions below 

is mandatory (refer to SOP-000401 ORS Reporting Accomplishment Hours for 

additional information)

The recommended timeline and schedule for project completion is: 

≤ 500 hours = 6 months
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> 500 hours = 12 months

Upon project completion, a final project report shall be submitted through 

CARTS and other reporting mechanisms summarizing results and conclusions. 

Please see ORA-LAB.014 Component Automated Research Tracking System

(CARTS) for guidance related to method verifications, project management 

timelines, milestone reporting, publications and research impacts. 

ORCET will survey the investigators on completed projects to collect information 

on impact of the project. This survey will be performed at the one-year point after 

completion of the project to allow time for impact to develop. Research impacts 

include: 

A. Peer-review publications. 

B. Use the of newly developed/validated methods in regulatory testing. 

C. Incorporation of the newly developed/validated methods in compliance 

programs. 

D. Use of the newly developed/validated methods in response to an adverse 

event or public emergency. 

5.2.6. Presentation, Assessment, and Implementation

The basic product of scientific research is information. Dissemination of 

information ensures others interested in the problem can use the data. To 

accomplish this, ORS encourages and supports several types of research 

products. All such research products as defined in the section below must be 

submitted to ORS/ORCET for scientific evaluation and approved by ORCET for 

dissemination. All publications submitted for clearance must have supporting 

material (data package) readily available for review by manuscript reviewers 

upon request. 

Authors are expected to produce manuscripts that are coherent, scientifically 

sound, and likely to be accepted for publication. Publications may include, but 

not limited to the following:

A. Scientific Articles

The FDA encourages various publication avenues such as peer-reviewed 

journals, book chapters, compliance programs, compendiums, etc. Manuscripts 

for these types of publications must be reviewed and approved for technical 

correctness; and adhere to Agency policy for review and clearance (Section 

6.2). Local management is responsible for funding any page charges and 

ordering reprints.
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Authors are responsible for selecting the most appropriate mechanism for 

dissemination of their scientific work. ORCET encourages authors consider the 

Impact Factor (IF) when selecting a journal. While many factors must be

considered in selecting a journal, IF can provide a valuable indicator on quality 

and reach of the journal’s publications. 

For U.S. Government Employees, work within the scope of their employment 

duties is public domain, not subject to copyright protection and no copyright 

transfer is necessary. It is the responsibility of the author to be knowledgeable 

in this respect. 

Plagiarism of any kind will not be tolerated. In general terms, plagiarism is the 

act of representing someone else’s words or ideas as one’s own without 

crediting the true source or origin.

The ORCET Manuscript Submission and Clearance Portal should be used for 

all ORS publication clearance.

B. Laboratory Information Bulletins (LIB)

LIBs are internal FDA publications, currently used to disseminate work at 

various stages of development, therefore, it is important to specify the level of 

completeness the work represents, such as: 

• Preliminary, original work to claim first ownership

• Single laboratory validation

• Multi laboratory validation. 

Methods described in LIBs may be used for regulatory work if they have been 

fully validated following appropriate requirements and have been verified by 

each laboratory. If a laboratory participated in the multi lab validation and its data 

was accepted for inclusion in the publication, that data can count towards initial 

implementation. Methods included in assignments or compliance programs are 

considered “official FDA methods” and only need to be verified in those specific 

instances.

If the LIB represents un-validated work, the LIB shall include a disclaimer that 

the user must validate the method properly before use. This disclaimer is 

addition to the generic LIB disclaimer that all LIBs should bear.

Draft LIB manuscripts must be reviewed and approved by the Science Advisor 

(if applicable), Laboratory Director, Laboratory Management, and Quality 

Manager, before submission to ORCET for review and publication as specified 

in ORS.005 Laboratory Information Bulletins. 
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C. Presentations and Posters

Results may be presented at scientific meetings as oral presentations or posters 

Following review and clearance in accordance with Agency and ORS policy.

Currently, all ORA presentations are submitted and cleared through the 

Appearance Request Tracking System (ARTS) system except for those 

presentations that will be delivered at an ORA-only forum.

5.2.7. Patent Application & Licensing

If the intellectual property produced by authors has potential for patent 

application or licensing, the Laboratory Director and the Principal Investigator 

should contact ORCET for information on their willingness to license the 

discovery to partners interested in commercializing the technologies.

FDA Technology Transfer - Licensing of Inventions 

5.2.8. Assessment and Implementation

ORCET, in conjunction with the appropriate Center, established ORA/Center 

steering committee or headquarter offices, and with ORS laboratory 

management input, can determine how methods are to be implemented, 

including proficiency testing schedules, and the required validation level for 

each. Methods can be implemented through compliance programs, FERN 

exercises, and Center assignments. New or improved methods, validated 

methods, adoption of new technology or rapid methods can be implemented 

field wide.

6. Scientific Conduct When Performing Research

ORS analysts are responsible for adhering to the highest standards of 

intellectual honesty and ethical standards when formulating, conducting, or 

presenting method development/validation, studies or research. ORS scientists 

are expected to follow the guidelines below. Violation of these guidelines can 

undermine trust and confidence in the author’s work which in turn can undermine 

the public’s trust in the Agency. Please consult Agency Staff Manual Guide 

(SMG) 9003.1 Policy for Responding to Allegations of Research Misconduct” 

and SMG 9010.1 Scientific Dispute Resolution at FDA for additional information. 

6.1. Data Management

Data from analysis, studies, instrument data, and statistical data is recorded with 

integrity and is inseparable from the acquisition. 

All data generated is recorded directly, promptly, and legibly. 
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Data is retained by the laboratory to allow analysis and repetition by others. The 

schedule for retention is included in the ORA Laboratory Manual, Volume II,

MAN-000032 ORA Lab Manual Vol. II - Record and Data Management (ORALAB.4.13) and local laboratory’s procedures. 

Per agency requirements, all new projects require a data management plan

(DMP) that details how data generated as part of a project is going to be 

organized, managed, and stored. Implementation of DMP was necessitated by 

the exponential increase in volume of data generated from new scientific 

instruments such as whole genome sequencing. 

6.1.1. Ensuring public access to Agency funded work:

On February 22, 2013, the White House Office of Science and Technology 

Policy (OSTP) issued a memorandum entitled “Increasing Access to the Results 

of Federally Funded Scientific Research” (OSTP Memo or Public Access Memo) 

directing federal agencies to maximize public access to digital data resulting 

from funded work. The FDA has developed guidance documents in accordance 

with the OSTP Memo and other executive and Office of Management and 

Budget (OMB) memos. This FDA guidance can be found in Staff Manual Guide 

(SMG) 2126.4 Access to Results of FDA-Funded Scientific Research, Plan to 

Increase Access to Results of FDA-Funded Scientific Research and User Guide 

for Public Access to FDA-Funded Research. It is the responsibility of the author 

to ensure all publications are publicly accessible following the procedures 

outlined in the preceding guidance documents. 

See Section 5.2.6. A “Scientific Articles” for publication practice guidance. 

6.2. Review and Clearance Policy

ORS laboratory management, quality managers, and analysts shall follow 

current FDA and local policy and procedures for review and clearance of 

scientific articles. ORS Labs must follow Agency wide publication clearance 

practices outlined in Staff Manual Guide (SMG) 2126.3 Review of FDA-Related

Articles and Speeches. See (SOP-000522) ORCET: Scientific Review and 

Clearance for ORS-specific clearance procedures. 

Scientific articles are reviewed for the following: scientific and technical 

accuracy; agreement with current Agency policy or future regulatory programs; 

and not adversely affecting the requirements of policies on other FDA centers 

or offices.
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It is the responsibility of the author to make revisions and corrections deemed 

necessary by their supervisors, quality manager, laboratory director and ORS 

reviewer during the clearance process. 

A disclaimer should be added to the scientific article. Generic disclaimers can 

be obtained from ORCET. 

See Section 5.2.6 C “Presentations and Posters” for presentation clearance 

processes.

Clearance for oral presentations are to be submitted, reviewed, and cleared 

using ARTS. The link to ARTS is found on the ORCET Scientific Review and 

Clearance intranet page.

6.3. Authorship

Authorship refers to the listing of participating scientists’ names in all 

communications, oral and written, experimental results and their interpretation 

to scientific colleagues.

Authorship is based on significant contributions to the conceptualization, design, 

execution or interpretation of a research study.

For those individuals who have limited contributions to a study, e.g., providing 

certain advice, reagents, analyses and support, these individuals may more 

appropriately be acknowledged but not listed as co-authors. See HHS Office of 

Research Integrity Author Guidance for more information.

Any authorship disputes need to follow the established agency guidelines and 

referred to the appropriate agency level committees for resolution.

7. References

A. FDA Office of Foods and Veterinary Medicine, Guidelines for the 

Validation of Chemical Methods for the FDA FVM Program, 3rd Edition, 

October 2019. (Available on FDA.GOV at Foods Program Methods 

Validation Processes and Guidelines) 

B. FDA Office of Foods and Veterinary Medicine, Guidelines for the 

Validation and Analytical Methods for the Detection of Microbial 

Pathogens in Foods and Feeds, 3rd Edition, October 2019. (available 

on FDA.GOV at Foods Program Methods Validation Processes and 

Guidelines) 
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C. Guidelines for the Validation of Analytical Methods for Nucleic Acid 

Sequence-Based Analysis of Food, Feed, Cosmetics and Veterinary 

Products, 1ST Edition, September, 2019 (available on FDA.GOV at 

Foods Program Methods Validation Processes and Guidelines) 

D. FDA Office of Foods and Veterinary Medicine, Acceptance Criteria for 

Confirmation of Identity of Chemical Residues using Exact Mass Data 

for the FDA Foods and Veterinary Medicine Program, 1st Edition, 

September 2015. (available on FDA.GOV at Foods Program Methods 

Validation Processes and Guidelines) 

E. FDA Staff Manual Guide Vol III 2126.3 Review of FDA-Related Articles 

and Speeches, certified as Current: 5/19/2021

F. FDA Staff Manual Guide Volume III, 2126.4 Access to Results of FDAFunded Scientific Research Effective Date: July 12, 2017; Changed 

October 15, 2019

G. FDA Staff Manual Guide Volume IV, 9003.1 Policy for Responding to 

Allegations of Research Misconduct Effective 04/09/2012

H. FDA Staff Manual Guide Volume IV, 9010.1 Scientific Dispute 

Resolution at FDA; Effective Date: 01/13/2009; Changed 5/21/2021

I. MAN-000032 ORA Laboratory Manual, Volume II, ORA-LAB.4.13, 

Records and Data Management

J. MAN-000037 ORA Lab Manual Vol. II - Methods, Method Verification 

and Validation (ORA-LAB.5.4.5)

K. ORA-LAB.014 Component Automated Research Tracking System 

(CARTS)

L. ORS.005, Laboratory Information Bulletin

M. Plan to Increase Access to Results of FDA-Funded Scientific Research

N. (SOP-000522) ORCET: Scientific Review and Clearance

O. User Guide for Public Access to FDA-Funded Research
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Document History

Revision

#

Status*

(D, I, R) Date Author Name and Title Approving Official Name and Title

1.2 R 06/23/05 LMEB LMEB

2.0 R 12/06/06 LMEB LMEB

2.1 R 06/06/08 LMEB LMEB

2.2 R 08/15/08 LMEB LMEB

2.3 R 12/03/08 LMEB LMEB

2.4 R 07/13/11 LMEB LMEB

2.5 R 02/06/12 LMEB LMEB

2.6 R 01/31/13 LMEB LMEB

03 R 05/05/2020 LMEB LMEB

04 R REFER TO 

QMIS LMEB LMEB

* - D: Draft, I: Initial, R: Revision
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Change History

Revision 

# Change

2.0 Chapter underwent major revision to reflect the current Method Development and 

Validation Program.

2.1 6.5.2.2 and 6.5.2.3 – Calls for Proposals changed from quarterly to semiannually.

Reference 2. changed to the accessible policy on publication.

2.2

Table of Contents – 6.5.2.1-6.5.2.7 revised

Appendix III – added

– added “the Centers” to second paragraph

6.5.2.1- 6.5.2.7 - revised

6.5.2.6 – revised sixth paragraph

2.3

6.3.2 – inserted “in” after described

6.5.1. Technology Exploration – changed implemented to accepted

6.5.2.3 – added (Appendix III) at end of first paragraph

6.5.2.4 – updated SOP information in fourth paragraph

6.5.2.5 Scientific Articles – added last paragraph

2.4

6.5.2.2 1. a., third bullet – changed “or” to “and”

Appendix I – replaced

Appendix III – replaced

2.5

6.1 – added FDA Office of Foods Guidelines for Validation in Food to fourth sentence

6.2 – deleted “of this program”; added and/or in conjunction with the Office of Foods 

to third sentence

6.3 – deleted first sentence

6.3.2 – deleted “Sources” from the title and deleted sentence

6.4 – changed Associate Commissioner for Regulatory Affairs to Office of Regulatory 

Affairs Associate Commissioner

6.5.2 – added NOTE: and revised section for CARTS implementation

6.5.2.1 – changed “semiannually” to “at least annually” in second paragraph

6.52.4 – added last two sentence to first paragraph

2.6

Header - Division of Field Science and DFS changed to Office of Regulatory Science 

and ORS throughout the document 

6.5.2.6 – RPN Project ####### changed to CARTS Project #######

03

Updated procedure to include ORCET.

Removed Appendices I (Method Development and Validation Project Record) and III 

(MDVP Flowchart). Removed Attachment for LIB format

The document was reformatted and as a result, section and bullet numbering 

changed. Removed instructions for CARTS submissions

Removed instructions for FACTS reporting of hours

Updated the References to include additional entries from the Staff Manual Guide

Removed footnotes for References Updated links for the ARTS homepage 

Added link for the HHS Authorship Guide

04 Added, updated, and verified links. Re-formatted. Content revisions are highlighted within 

document. 
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