Public Comment Opportunities
The Office of Minority Health (OMH) uses public dockets through the Federal Register to solicit information from all stakeholders on a number of specific issues.
NAME: Demographic Subgroup Data for FDA Approved Medical Products
ACTION: Notice; Establishment Of Docket; Request For Comments.
Docket No: FDA- 2012-N-0212
DATES: Submit either electronic or written comments by November 20, 2013.
SUMMARY: Report outlining clinical trial participation and safety and effectiveness data by demographic subgroups (sex, age, race, ethnicity) in medical product applications submitted to FDA. (FDASIA Section 907).
NAME: Communications Report with Special Attention to Underrepresented Subpopulations
ACTION: Establishment of Docket; Request for Comments
Docket No: FDA-2013-N-0757
DATES: Submit either electronic or written comments by September 09, 2013.
SUMMARY:Report outlining FDA actions to improve communications with underrepresented populations, including actions already underway. (FDASIA Section 1138)