HHS Technology Transfer Policies

HHS Technology Transfer Policies and Procedures Manual

**NOTE: GENERAL PROCEDURE CHAPTERS ARE FOR INTERNAL USE ONLY** 

The Public Health Service (PHS) Technology Transfer Policy Manual sets forth technology transfer policies for the National Institutes of Health, the Food & Drug Administration and the Centers for Disease Control and Prevention, agencies within PHS.  The Manual also includes certain policies related to interactions between PHS agencies and their grantees and contractors.   

Table of Contents

100 General
101
Policy for PHS Agencies to Coordinate Technology Transfer Activities

Revised
06/18/2009

  
103
Procedures for Revision of PHS Technology Transfer Policy and Procedure Manuals

Revised
12/08/2010

  
 
200 Inventions and Patents
200
Policy/ Procedures on the Filing of Patent Applications for PHS Inventions

Revised
06/17/2010

 
201
PHS Policy/ Procedures for Reporting Employee Inventions

Revised
06/20/2013

 
202
PHS Policy/ Procedures for Leaving Title to Inventor(s) for Intramural Inventions

Revised
12/08/2021

 
 
203
NIH Procedures Related to Disposition of Rights in Inventions by Non-Employees Working at NIH, Receiving NIH Intramural Training Support or Working On-Site under Research Collaborations

Revised
09/23/2013

  
205
Procedures for Coordination of Communications Between NIH OTT and Technology Development Coordinators During Patent Prosecution

Revised
12/08/2010

  
206
PHS Policy/ Procedures Regarding Infringement of Government-Owned Inventions

Revised
12/08/2010

 
 
300 Licenses and Royalties
300
PHS Licensing Policy/ Procedures
Revised
1/11/2024
                      Policy 
302
PHS Policy for Preparing and Submitting Notices Regarding Licensing of PHS Inventions to the Federal Register for Publication
Revised
12/08/2010
 
 
304
PHS Policy for Making Determinations Regarding the Grant of Nonexclusive Licenses
Revised
12/08/2010
 
 
305
PHS Policy for Making Determinations Regarding the Grant of Exclusive or Partially Exclusive Commercialization
Revised
06/20/2013
 
 
306
PHS Policy for the Licensing of Inventions Made Under Cooperative Research and Development Agreements 
Revised
11/17/2022
 
 
307
NIH Procedures for Handling Requests for Reconsideration and Appeals of Licensing Decisions
Revised
12/08/2021
 
 
309
PHS Policy for Handling Requests Related to the U.S. Manufacturing Requirement for PHS Inventions
Revised
2/08/2022
 
 
313
NIH Office of Technology Transfer Procedures for Communication with PHS Technology Development Coordinators about Licensing of PHS Inventions
Revised
12/08/2010
 
 
 
400 Cooperative Research and Development Agreements (CRADAs)
400
PHS Cooperative Research and Development Agreement Policy/ Procedures
Revised
03/08/2021
 
 
500 Material Transfers
500
Policy For The Transfer Of Materials From NIH Intramural Laboratories
Revised
06/15/2023
Policy 
501
Model Material Transfer Agreements
Revised
03/08/2012
  
502
PHS Uniform Biological Material Transfer Agreement
Revised
03/08/2012
  
503
NIH Simple Letter Agreement (SLA)
Revised
03/08/2012
  
504
NIH Model Material Transfer Agreement For The Transfer Of Organisms (MTA-TO) To Academic/Not-For-Profit Organizations
Revised
03/08/2012
  
505
NIH Model Material Transfer Agreement For The Transfer Of Human Materials For Non-Profit Research Purposes
Revised
03/08/2012
  
 

600 Extramural Technology Transfer

602
PHS Policy Regarding Waiver of PHS's Rights to Obtain Title to Subject Inventions
Revised
09/20/2012
 
603
PHS Policy/ Procedures Regarding Inventor Requests to Acquire Title in Extramural Inventions
Revised
09/23/2013
604
PHS Policy/ Procedures Regarding Waivers of the U.S. Manufacturing Requirement in Exclusive Licenses for Contractors’ Subject Inventions
Revised
09/20/2012
605
PHS Policy/ Procedures Regarding Requests for Permission to Assign Title to Extramural Subject Inventions Developed by PHS Nonprofit Contractors to Third Parties
Revised
09/20/2012
606
PHS Policy/ Procedures for Handling Appeals of Certain Extramural Waiver
Revised
06/20/2013
607
PHS Policy/ Procedures on Determinations of Exceptional Circumstances Under PHS Funding Agreements
Revised
03/14/2013
 
 

700 Administration and Distribution of Royalties

700
PHS Policy/ Procedures for the Administration and Distribution of Royalties

Revised
02/14/2022

701
PHS Policy/ Procedures for Technology Transfer Awards
Revised
03/08/2012
 

 

NOTES:

  • The procedures listed above are for NIH Technology Transfer staff use only.
  • For each series, the first chapter provides a broad policy overview, while any successive chapters address specific topics. 
  • Please also note that, within a given series, the numbering may not be sequential due to recent updates.
  • General changes in Procedures as a result of the reorganization of NIH technology transfer functions can be found here. (NIH Access Only)

For additional information about the PHS Technology Transfer Policy Manual, please contact
the NIH Office of Technology Transfer at nihott@mail.nih.gov