{"description":"Documents matching '\"diversity action plans\"'","count":4,"total_pages":1,"results":[{"title":"Agency Information Collection Activities; Proposed Collection; Comment Request; Diversity Action Plans for Clinical Studies","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collections of information related to Diversity Action Plans for Clinical Studies.","document_number":"2024-15988","html_url":"https://www.federalregister.gov/documents/2024/07/22/2024-15988/agency-information-collection-activities-proposed-collection-comment-request-diversity-action-plans","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-07-22/pdf/2024-15988.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-15988.pdf?1721393115","publication_date":"2024-07-22","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"and other forms of information technology.\n \n <span class=\"match\">Diversity Action Plans</span> (DAPs) for Clinical Studies \n OMB Control No. 0910-NEW \n \n This information collection supports the implementation of sections 3601 and 3602 of the Food and Drug Omnibus Reform Act of 2022 (FDORA) included as part of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328). In the \n Federal Register \n of June 28, 2024 (89 FR 54010), FDA announced the availability of a draft guidance for industry entitled “<span class=\"match\">Diversity Action Plans</span> To Improve Enrollment of Participants from Underrepresented"},{"title":"Diversity Action Plans To Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies; Draft Guidance for Industry; Availability","type":"Notice","abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled \"Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.\" FDA is issuing this draft guidance as mandated under the Food and Drug Omnibus Reform Act of 2022 (FDORA) which requires that FDA update or issue guidance relating to the format and content of Diversity Action Plans required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by FDORA. This guidance describes the format and content of Diversity Action Plans, including the timing and process for submitting such plans by application or notification type. In addition, this draft guidance describes the criteria and process by which FDA will evaluate sponsors' requests for waivers from the FD&C Act. Because FDA is required by statute to specify the form and manner for the submission of Diversity Action Plans in guidance, insofar as this draft guidance specifies the form and manner for submission of Diversity Action Plans, when this guidance is finalized, it will have binding effect.","document_number":"2024-14284","html_url":"https://www.federalregister.gov/documents/2024/06/28/2024-14284/diversity-action-plans-to-improve-enrollment-of-participants-from-underrepresented-populations-in","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-28/pdf/2024-14284.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-14284.pdf?1719492337","publication_date":"2024-06-28","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"guidance for industry entitled “<span class=\"match\">Diversity Action Plans</span> to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” FDA is issuing this draft guidance as mandated under the Food and Drug Omnibus Reform Act of 2022 (FDORA) which requires that FDA update or issue guidance relating to the format and content of <span class=\"match\">Diversity Action Plans</span> required by the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act), as amended by FDORA. This guidance describes the format and content of <span class=\"match\">Diversity Action Plans</span>, including the timing and process"},{"title":"Medical Devices; Laboratory Developed Tests","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, FDA is proposing a policy under which FDA intends to phase out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. FDA is proposing this phaseout to better protect the public health by helping to assure the safety and effectiveness of LDTs. If finalized, this phaseout may also foster the manufacturing of innovative IVDs for which FDA has determined there is a reasonable assurance of safety and effectiveness.","document_number":"2023-21662","html_url":"https://www.federalregister.gov/documents/2023/10/03/2023-21662/medical-devices-laboratory-developed-tests","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-10-03/pdf/2023-21662.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-21662.pdf?1695991649","publication_date":"2023-10-03","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"addition, when FDA conducts premarket review of a device, FDA may ask that sponsors provide data for different intended patient populations, and with new authorities under the Food and Drug Omnibus Reform Act of 2022 (FDORA), sponsors generally are required to submit <span class=\"match\">diversity action plans</span> to FDA, including the sponsor's goals for enrollment in device clinical studies. In contrast, with limited oversight over these tests, FDA does not know whether diverse patient populations are being included in validation studies for these IVDs. FDA has made a preliminary"},{"title":"Medical Devices; Laboratory Developed Tests","type":"Rule","abstract":"The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the Food and Drug Administration is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs. This phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.","document_number":"2024-08935","html_url":"https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08935.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-08935.pdf?1714398256","publication_date":"2024-05-06","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"demographic characteristics if performance differs within the target population, and population-specific limitations, if applicable. In addition, during FDA premarket review, FDA may ask that sponsors provide data for different intended use populations as well as <span class=\"match\">diversity action plans</span> to improve the generation of evidence regarding device performance in diverse populations. As such, in general, there is greater confidence in the accuracy and reliability of FDA authorized genetic tests, and FDA oversight of IVDs offered as LDTs may help to advance"}]}