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Federal Agency Public Access Compliance

A Research Guide summarizing the Federal public access policies resulting from the US Office of Science and Technology Policy memorandum of February 2013.

Implementation Timeline: FDA

Publications Implementation: October 2015

Data Implementation: January 2016

Reference(s):

Compliance Monitoring: FDA

Extramural research:

  • FDA will ensure grantee and contractor compliance with planned publication access and data management requirements by requiring, as a term and condition of the grant or contract award, periodic reporting to contracting officer representatives and program officers as a part of regular grants and contract management.
  • Failure to comply with the publication access and data management requirements—including the periodic reporting requirements―may serve as grounds to terminate the contract or cancel the grant. This decision rests with the contracting or grants management officer and will be made only after a careful review of all relevant facts and circumstances, and with appropriate consultation with the program office administering the grant or contract. 
  • Prior to funding new grant and contract awards or continuing non-competing continuation awards, FDA will confirm awardees are in compliance with the FDA Public Access Policy. FDA will not award a grant or contract until an awardee has come into compliance with the policy.

Intramural research:

  • FDA will develop policies and mechanisms to require the reporting of the final publication citation and the unique identifier assigned by PMC, the FDA-designated scientific article repository, for employee authored articles.
  • Agency policies will further require researchers to periodically report to supervisors the status of data collection, preservation, and access pursuant to approved data management plans, as well as compliance with applicable open data requirements developed by the agency and Department.
  • Center management will consider compliance with public access requirements in evaluating an employee’s subsequent research proposals.

Additional compliance monitoring:

  • FDA will report public access compliance rates on its website annually starting at the conclusion of FY 2016.

Reference(s):

Publication and Data Repositories: FDA

Publication Repository: PubMed Central

  • FDA will use PubMed Central (PMC)—the NIH digital archive of biomedical and life sciences journal literature, developed and operated by the National Library of Medicine—as its designated scientific article repository.

Data Repository: Discipline specific data repositories.

  • In general, FDA will not house publicly accessible agency research datasets that would be made publicly available pursuant to agency public access policies. Rather, FDA expects that, in accordance with their data management plans, researchers would make datasets publicly accessible in discipline specific data repositories, wherever available. 

Reference(s):

FAQ: FDA

What is the embargo period for publications and datasets?

Peer-reviewed articles must be made available to the public in a centralized article repository no later than 12 months after publication. 

Where can I find the full Public Access Policy?

Does this agency require a data management plan (DMP)?

Yes. FDA will create or modify agency policies to require that data management plans be developed and followed by both intramural and extramural researchers. 

How do I comply with the public access policy and submit a publication?

Submit publications using the NIH Manuscript Submission System (NIHMS). FDA will use the NIHMS as a mechanism for allowing researchers to submit the final, peer-reviewed version of their articles for inclusion in PMC