On October 1, the first day of fiscal year (FY) 2021, President Donald Trump signed into law a continuing resolution (CR) that funds most federal agencies and programs at last year’s levels through December 11, 2020. The CR, which was approved by the House (359-57) and the Senate (84-10) in late September, was necessary to avert a government shutdown, because none of the twelve annual appropriations bills for FY 2021 had been completed.

Under the CR, NIH begins FY 2021 with a flat budget of ~$41.7 billion. AAI has recommended, and will continue to advocate for, an increase of at least $3 billion for NIH. Though NIH did not receive increased funding in the CR, the new law does contain an important provision that permits NIH to provide no-cost extensions to multi-year grants that were set to expire at the end of FY 2020.

The appropriations bill which funds NIH was approved by the House Labor, Health and Human Services, Education, and Related Agencies (Labor-HHS) Appropriations Subcommittee in July. That measure contains a $5.5 billion funding increase for NIH, including $5 billion in emergency spending. Due in part to their opposition to including emergency spending on a regular appropriations bill, all subcommittee Republicans voted against the measure. A slightly modified version of the subcommittee bill was subsequently approved by the House Appropriations Committee and the full House. The Senate, meanwhile, has not yet completed any of its appropriations bills for FY 2021, even at the subcommittee and committee levels. However, on November 10, the Senate Appropriations Committee released all 12 of its annual appropriations bills, including the Labor-HHS bill. That measure includes a $2 billion increase for NIH that, if enacted, would bring the total NIH budget to $43.7 billion.

AAi is hopeful that Congress and the White House will make significant progress on appropriations during the lame duck session of Congress (the period after the November elections and before the next Congress is sworn in on January 3, 2021), especially on the Labor-HHS bill. Because a CR may not include the final budget amount, operating under a CR is difficult for NIH and NIH grantees. As a result, many NIH Institutes and Centers set conservative paylines. In a Notice issued on October 21, NIH announced that it will continue the practice of funding non-competing research grant awards at up to 90% of the previously committed level until a final appropriations agreement is reached.

AAI cosponsored and participated in the 8th annual Rally for Medical Research Capitol Hill Day (Rally Hill Day), which took place in mid-September. The event, which was held virtually for the first time, brings together a large coalition of individuals, including scientists, physicians, and patients, to advocate for the shared goal of increasing funding for NIH. This year more than 500 individuals from over 350 organizations participated, and meetings were held with congressional offices from all 50 states.

In addition to providing financial support, AAI supported the Rally through the formal participation of CPA Chair Ross Kedl, Ph.D., CPA member Tullia Bruno, Ph.D., AAI Director of Public Policy and Government Affairs Lauren Gross, J.D., and AAI Manager of Science Policy and Legislative Affairs Jake Schumacher. Kedl visited the Colorado delegation, Bruno and Gross participated in meetings with members of the House and Senate from Pennsylvania, and Schumacher led meetings of a group from Kentucky. Many other immunologists represented the community as well, including FASEB President and former CPA member Louis Justement, Ph.D., who visited the congressional delegation from Alabama.

Rally Hill Day participants urged Members of Congress to support an NIH funding increase of at least $3 billion for FY 2021, consistent with the AAI funding request. In addition, they talked about how they, and their colleagues, have been impacted by the COVID-19 pandemic, and stressed the importance of providing NIH with at least $15.5 billion in supplemental funding in the next COVID-19 relief bill, a request that is strongly supported by AAI.

The final NIH Policy for Data Management and Sharing (DMS Policy), together with a statement by NIH Director Francis Collins, M.D., Ph.D., was released in late October. The DMS Policy requires all NIH-funded researchers to submit a plan, at the time of application, for how the data they generate will be managed and shared. It will replace the 2003 NIH Data Sharing Policy once it goes into effect on January 25, 2023.

In November 2019, NIH released a draft DMS Policy and sought public comments. AAI submitted comments to NIH agreeing with the principle of and need for data sharing, preservation, and management, but offering numerous suggestions and raising important questions for NIH to consider before moving forward with a final policy. The AAI comments stressed the importance of providing clear definitions of “scientific data,” “preliminary analyses,” “negative data,” and “unpublished data.” Other issues raised by AAI include the need to ensure that the policy is not a new unfunded mandate, to establish how it will be monitored and enforced, and to determine what metrics will be used to evaluate its efficacy.

The final policy does define some key terms, including “scientific data,” which importantly also describes what the term does not include. The definition reads as follows: “[t]he recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens.”

The DMS Policy also includes a section that describes the ways in which compliance will be monitored and enforced during and after the funding period. NIH Institutes, Centers, and Offices (ICOs) will be given the discretion to monitor plans as they see fit, including potentially at the time that progress reports are submitted. After the funding period is over, “non-compliance with the NIH ICO-approved Plan may be taken into account by NIH for future funding decisions for the recipient institution.”

On the issue of cost, NIH does include some clarifications, including that personnel costs for activities related to complying with the policy will be allowable in budget requests, as will costs for long-term data preservation and sharing. Meanwhile, metrics to measure the success of this new requirement are not included in the DMS Policy.

Dr. Collins’ statement notes that NIH will continue to seek input from the biomedical research community as the policy moves toward implementation. AAI looks forward to continuing to work with NIH on this important effort.

AAI recently submitted comments to the Department of Homeland Security (DHS) opposing a proposed rule that would make significant changes to the F (academic student) and J (exchange visitor) visa categories utilized by many international students and postdoctoral scholars across the country. The comments were formally submitted by AAI President Jenny Ting, Ph.D., and CPA Chair Ross Kedl, Ph.D.

Currently, international students and trainees are granted visas for “duration of status,” allowing them to remain in the United States until the completion of their studies/training. The proposed DHS rule would dramatically alter this process by eliminating “duration of status” for the F and J visa categories, and instead would award visas for a fixed period of time, no longer than four years. While the proposed policy would allow individuals to apply for extensions of stay, such extensions are not automatically granted. AAI is concerned that this additional burden and the uncertainty of receiving an extension is likely to be a huge deterrent to prospective international students and trainees considering enrolling in programs that are expected to last longer than four years.

Another provision of the proposed rule would place a lifetime cap of three on the number of programs in which an international student (F-1 status) can participate at the same, or a lower, educational level. In its proposed rule, DHS alleges that some students are pursuing additional courses of study “as a de facto way to permanently stay in the United States.” The AAI comments express the association’s concern that this cap “could impede the careers of young scientists who are increasingly pursuing trans-disciplinary programs, or who choose to enroll in multiple advanced degree programs.”

More than 32,000 comments on the proposed rule were submitted. It is not known when the Trump Administration will have time to issue a final rule and implement the policy before the President leaves office on January 20, 2021.

AAI President Jenny Ting, Ph.D., and CPA Chair Ross Kedl, Ph.D., wrote to NIH in October to express support for an effort by 47 scientists, including many AAI members and leaders, to “elevate to scorable status the Recruitment and Retention Plan to Enhance Diversity for all new and renewal institutional training grant applications (T32, T35, among others)” and to “extend the Recruitment and Retention Plan to Enhance Diversity to include diversity among training grant program faculty trainers (mentors) as a review criterion” across all NIH Institutes and Centers.

Though developing a Recruitment and Retention Plan to Enhance Diversity is already a requirement for institutional training grants, AAI agrees that elevating it to scorable status is an appropriate and efficient way to ensure that these plans are thoughtfully developed and considered. AAI urges NIH “to adopt the policy as a first step, and in so doing, to provide clear guidance regarding the new scorable category.”

The Trump Administration recently announced two executive actions that will result in the suspension, and possible elimination, of many federal diversity and inclusion training programs. The first action, a “Memorandum for the Heads of Executive Departments and Agencies,” was issued by the White House Office of Management and Budget (OMB) on September 4 and was followed about three weeks later by an Executive Order (EO) entitled, “Combating Race and Sex Stereotyping.” The Administration is taking these actions because it alleges that “some Federal worker ‘training’ sessions are being held – at taxpayer expense – that demonstrably undermine this core American principle [fair and equal treatment of all individuals] by stereotyping and scapegoating certain groups of people.”

Under these new directives, Federal agencies are being asked to identify all training programs that relate to diversity and inclusion, determine the spending allocated to these programs, and identify those training sessions that teach “divisive concepts.” Some of the keywords and phrases that agencies are advised to look for include “critical race theory,” “white privilege,” “intersectionality,” “systemic racism,” “positionality,” “racial humility,” and “unconscious bias.” Those training programs deemed to be divisive by the Office of Personnel Management will be eliminated.

AAI was one of 50 organizations to co-sign a letter led by the American Institute of Physics urging OMB “to rescind its elimination of federal employee training programs related to diversity, equity, and inclusion.” AAI will closely monitor how these Executive actions are implemented, particularly at the National Institutes of Health.

AAI co-signed a September letter to Representative Eddie Bernice Johnson (D-TX, 30th), Chair of the House Committee on Science Space and Technology, supporting her call for a National Academies of Science, Engineering, and Medicine (NASEM) study on systemic racism in academia. The letter, which was initiated by the American Physiological Society, a fellow FASEB member, was co-signed by 80 organizations.

NASEM has yet to receive any federal funding for the project. Although Rep. Johnson successfully amended an appropriations bill, subsequently passed by the House, to provide NASEM with $1.5 million for the study, the bill’s fate in the Senate is uncertain.