Thursday, June 22, 2023

Recent Requests for Information

national institute of biomedical imaging and bioengineering - listserv


Recent Requests for Information (RFIs) & Requests for Public Comment

 


Recommendations for Improving NRSA Fellowship Review

NIH is recommending changes to the peer review of Ruth L. Kirschstein National Research Service Award (NRSA) fellowship applications by restructuring the review criteria and modifying some sections of the PHS Fellowship Supplemental Form that are specific to NRSAs. The goal of this effort is to facilitate the mission of NRSA fellowship peer review – to identify the most promising trainees and the excellent, individualized training programs that will help them become the outstanding scientists of the next generation. The proposed changes will 1) allow peer reviewers to better evaluate the applicant's potential and the quality of the scientific training plan without undue influence of the sponsor's or institution's reputation; and 2) ensure that the information provided in the application is aligned with the restructured criteria and targeted to the fellowship candidate's specific training needs.

The goal of the change is to improve the chances that the most promising applicants, no matter who they are or where they are based, will be consistently identified by peer review. The proposed changes are intended to:

- Better focus reviewer attention on three key assessments: potential of the applicant, strength of the science, and quality of the training plan.

- Define criteria to give less advantaged applicants a better chance, without disadvantaging others. The fellowship application instructions will be modified to align with the 3 core criteria and emphasize substantive statements pertinent to the individual student. Reviewers will evaluate accomplishments and trajectory in the context of their opportunities, and personal characteristics that contribute to success.

- Reduce bias in review by reducing inappropriate consideration of sponsor and institutional reputation. Reviewers will evaluate sponsor and institution with respect to the quality of the science and quality of the training plan.

Through the RFI, NIH continues to seek public comment on the proposed changes. The RFI will be open through June 23, 2023. Questions may be directed to: nrsareview@mail.nih.gov.


NIH Seeks Input on Challenges and Opportunities for the Further Development and Use of Novel Alternative Methods  

NIH is seeking public input on challenges and opportunities for the further development and use of novel alternative methods (NAMs) in biomedical research. Input received from this request will inform the NIH and the development of the Advisory Committee to the NIH Director (ACD)'s recommendations on high-priority areas for future investment in NAMs. 

Comments on the RFI must be submitted by August 16, 2023 through the online comment portal found here. The ACD Working Group on Novel Alternative Methods will also be hosting an expert workshop on August 21, 2023. The agenda for this meeting along with videocast information will be posted to the OSP website later this summer. 

For additional context on the NAMs issue, please see the latest Under the Poliscope blog here

Questions may be sent to SciencePolicy@od.nih.gov.


CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies

The U.S. Food and Drug Administration's (FDA's) Center for Devices and Radiological Health (CDRH) seeks input from the public, particularly patients, patient advocacy organizations, health care providers, consumers, the medical device industry, clinical researchers, and others on advancing health equity and facilitating access to medical devices designed to be safe and effective when used outside of traditional clinical settings, for example, medical devices intended for use in the home.

Advancing health equity will ensure all patients, regardless of race, sexual orientation, gender identity, age, physical abilities, geographic location, educational background, and economic status will have access to safe, effective, and high-quality medical technologies, including at-home use devices, which may provide significant improvements in healthcare, quality of life, and wellness.

Read more here. Please submit all public comments to the docket (FDA-2023-N-1956), available at Regulations.gov. Comments will be accepted through August 30, 2023. If you have questions, contact cdrhhealthequity@fda.hhs.gov.


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