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Public Access Policies: Other Federal Agencies

This guide provides basic information regarding the public access policies of U.S. federal agencies.

Plan for the FDA's Public Access Policy

The FDA's Staff Manual Guides 2126.4 (SMG 2126.4)- Access to Results of FDA-Funded Scientific Research provides details regarding the FDA's implementation of processes to ensure public access to scientific publications and digital data that arise form FDA funding.

  • The FDA requires funded authors to ensure that a final version of their peer-reviewed articles are deposited in PubMed Central.
  • The FDA requires applicants for FDA funding provide a data management plan for their digital data.  For additional details on data management plan components please see SMG 2126.4 as well as the Funding Opportunity Announcement (FOA) or similar instrument. 

Digital data is defined in the FDA guide "as the digitally recorded factual material that would be commonly accepted in the scientific community as necessary to validate published, peer-reviewed scientific articles."

Effective Date

Extramural FDA-funded researchers must comply with the policy related to peer-reviewed articles if the articles result from a grant, contract or assistance agreement related to scientific research that is initiated or renewed, on or after December 29, 2015.

 

Extramural FDA-funded researchers must comply with the policy related to data management if their contract, grant or assistance agreement related to scientific research is initiated or renewed, on or after October 1, 2016.

The data management policy does not apply to research that only acquires, collects or otherwise uses data excluded from the definition of digital data.

Submission Methods

The FDA uses the National Institutes of Health Manuscript Submission System (NIHMS) to allow researchers to submit the final, peer-reviewed version of their articles.  

For additional information on using NIHMS, please see the following:

Manuscript Version Required

Either the final published article or the final peer-reviewed manuscript is required to be deposited in PubMed Central.

The final peer-reviewed manuscript is the version of the article that has been accepted for publication and includes all changes made by the author during the peer-review process.   It does not include the publisher's formatting.

Embargo Period

The time before an article will be freely available to the public is typically called the embargo period.

For the FDA, the maximum allowed embargo period is 12 months from date of publication.

Repository

For peer-reviewed manuscripts, the FDA uses PubMed Central (PMC).

The FDA expects researchers to use discipline specific data repositories, wherever available.