Who do I contact if I have questions?
Contact Ellen Ciesielski, PRS Administrator, at 860-679-6004 or email@example.com.
Is more information available?
For more information about the NIH policy requirement, see: https://directorsblog.nih.gov/2016/09/16/clinical-trials-sharing-of-data-and-living-up-to-our-end-of-the-bargain/
For more information about the ICMJE registration requirement, see: http://www.icmje.org/news-and-editorials/
For more information about Final Rule issued by the U.S. Department of Health and Human Services, see: https://www.nih.gov/news-events/news-releases/hhs-takes-steps-provide-more-information-about-clinical-trials-public
To receive notification of future draft FDAAA 801 documents, join the NIH FDAAA Update LISTSERV at: https://list.nih.gov/cgi-bin/wa.exe?SUBED1=fdaaa-update-l&A=1