NPRM To Harmonize FDA Rules with Revised Common Rule Pushed to September
The FDA has pushed back its plan to issue a notice of proposed rulemaking (NPRM) to harmonize its regulations with the revised Common Rule to September, according to the 2019 Spring Unified Agenda of Regulatory and Deregulatory Actions.
According to the Fall Unified Agenda, the NPRM was expected to be released in June.
“This proposed rule would harmonize, to the extent practicable and consistent with other statutory provisions, several sections certain provisions of FDA’s regulations on human subject protection and institutional review boards with the recently revised Common Rule (45 C.F.R. 46, subpart A)),” the notice said.
The rule also will propose minor amendments to related regulatory provisions.
The NPRM pertains to 21 C.F.R. 50 (protection of human subjects), 21 C.F.R. 56 (institutional review boards), and 21 C.F.R. 812 (investigational device exemptions).
The agency has a statutory deadline of Dec. 13, 2019, to make the changes under the 21st Century Cures Act.
In addition, the Department of Health and Human Services expects to issue an NPRM to amend subpart E of 45 C.F.R. Part 46, which deals with institutional review board (IRB) registration. The NPRM, which was listed in the spring agenda as being released in May, will align subpart E with the revised Common Rule to eliminate unnecessary administrative burden on IRBs and institutions.
The spring agenda lists 80 FDA planned regulatory actions.
The FDA also plans to release an NPRM in February 2020 that creates a regulatory framework and procedures for imposing a clinical hold on any investigation involving human subjects, whenever the test article is a medical device. The proposed rule would implement section 606 of the Food and Drug Administration Safety and Innovation Act authorizing clinical holds for device investigations subject to the Federal Food, Drug, and Cosmetic Act.
The FDA also plans to issue a final rule next April that would permit an IRB to waive or alter the informed consent requirements under certain conditions for minimal risk clinical investigations.
“This would facilitate certain minimal risk clinical investigations to support the development of new products to diagnose or treat disease and would harmonize with the HHS Common Rule waiver provision that has been adopted and successfully employed by other agencies,” the Unified Agenda said. “This proposed regulation is intended to aid patient access to new products by facilitating investigators’ ability to conduct studies that may contribute substantially to the development of products to diagnose or treat diseases or conditions or address unmet medical needs.”
The NPRM for this proposed rule was issued in November 2018.
The FDA also pushed back its plans to update its investigational new drug application (IND) regulations to define and clarify the roles and responsibilities of the various persons engaged in the initiation, conduct and oversight of clinical investigations subject to IND requirements.
The NPRM had been expected this July but is now slated to be released in April 2020.
“The proposed changes should better protect the rights, safety, and welfare of subjects participating in clinical investigations and help ensure the integrity of clinical trial data,” the agency said. The proposed rule is expected to “help reduce study misconduct, enhance protection of subjects and ensure the reliability and integrity of clinical trial data (benefits) while requiring additional documenting and reporting for clinical investigators (cost),” the Unified Agenda said.
The FDA also will delay the release of an NPRM that would replace the current FDA requirements for cooperative research and require that any institution located in the United States participating in multisite cooperative research rely on approval by a single IRB for the portion of the research that is conducted in the U.S., with some exceptions. The proposed rule also would establish an IRB recordkeeping requirement for research that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution.
The NPRM had been expected last April and is now slated to be released in August. The agency has a statutory deadline of Dec. 13, 2019, under the 21st Century Cures Act.
The FDA also still plans to issue an NPRM in June proposing to amend its medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs). Under the proposed rule, the FDA would discontinue publishing a quarterly list of PMA and HDE approvals in the Federal Register. The agency would continue to make copies of the current PMA and HDE approval and denial documents, copies of summaries of safety and effectiveness for PMAs, and copies of summaries of safety probable benefit for HDEs available through the Division of Dockets Management.
In addition, the agency would continue to post this information on FDA’s web page on the Internet. “The FDA is taking this action to improve the efficiency of announcing approvals and denials of PMAs and HDEs and to eliminate duplication in the current process of announcing the information,” the agency said.