The Feds Want (to hear from) YOU!

Uncle Sam pointingWhen we think of practicing citizenship, we often think about exercising the right to vote and calling our representatives. But did you know the federal government regularly seeks public comments about specific topics and rules that are under consideration?

 

Both NIH and FDA currently are currently seeking comments on topics of interest to the human subjects research community. Share your thoughts on informed consent language that fosters participant data and specimen sharing, leveraging existing data to advance pediatric drug development, and more.

In this article:


How does the public comment process work?

Most invitations for public comment are published through Regulations.gov, the U.S. government’s portal through which members of the public can participate in the federal rulemaking process. Individual federal agencies (such as the NIH or FDA) may seek comment on new or proposed changes to regulations (laws), policies (interpretation of the law), or guidance documents. Sometimes comments are requested well before a rule is finalized; other times, the public can comment on a rule or policy that has already taken effect.

Anyone can respond to requests for public comment. Feedback from individuals or organizations with relevant expertise or stakeholders likely to be impacted by the revisions can be especially helpful. The public comment period is usually 60 days, and the agency seeking comment will respond to feedback, typically in summary form.

Introduction to Regulations.gov, including how to search for and respond to requests for public comment

A great example of the rulemaking process is the Revised Common Rule (also known as the “2018 Requirements”), which went into effect in January 2019: the initial request for comments was published in 2011! Because changes were proposed to the law itself (Title 45 of the Code of Federal Regulations, Part 46), the rulemaking process was especially lengthy and included several periods of public comment. Comment processes on agency policies or guidance documents are usually much shorter.

Check out the entire Revised Common Rule timeline, including each request for comments, supporting documents, public comments received, and agency responses here.


What can I comment on right now?

Below are four opportunities that may be of interest to Ohio State’s research community. You can find others by searching Regulations.gov.

FDA Crowdsourcing challenge

Pediatric Drug Development

Did you know the FDA doesn’t just evaluate clinical trials but also conducts its own research? Scientific staff from the Division of Pediatrics and Maternal Health (a division of the Center for Drug Evaluation and Research) are seeking ideas for research questions that could help accelerate or inform pediatric drug development using pooled data from over 1,600 clinical trials submitted to FDA as part of marketing applications.

In a nutshell

  • Agency: Food & Drug Administration
  • Submit comments by: August 20, 2021

FDA is interested in:

  • What research question(s) should FDA staff investigate using pooled analyses of pediatric clinical trial data to advance pediatric drug development?
  • Why is/are these question(s) important and how will it/they advance pediatric drug development?
  • What types of data would be most valuable in answering your question?

Note: As this initiative is unrelated to new or existing regulations, FDA is soliciting questions via a stand-alone crowdsourcing platform rather than Regulations.gov.

Related: FDA is also collaborating with the University of Maryland to host a public workshop on innovative clinical trial design for advancing the development of pediatric therapeutics. The workshop will be streamed live on September 1, 2021. Learn more here.


Developing Consent Language for Future Use of Data and Biospecimens

As many awardees of NIH funds know, the agency is committed to broad sharing of participant data and biospecimens from studies it supports to enable additional research projects. But how can researchers best communicate the implications of broad sharing to research participants? NIH has developed a new resource with sample consent language and wants to know what you think!

In a nutshell

  • Agency: National Institutes of Health
  • Submit comments by: September 29, 2021

NIH is interested in input on:

  • The sample consent language
  • Hurdles or barriers to the voluntary use of sample language and “points to consider” by the community
  • Any gaps or additional components that should be included in the new resource

Input is welcome from research investigators, institutional review board members, study participants, professional organizations, associations with a focus on research oversight, and other interested members of the public.


Request for Information

Use of AI/ML to develop, validate, and interpret data from Next Generation Sequencing and Radiological Tools

The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are requesting comment on a pair of topics related to the use of artificial intelligence (AI) and machine learning (ML) to support development of genetic testing and radiological tools.

The first seeks information from stakeholders on what critical resource gaps exist to support Next Generation Sequencing (NGS) test validation and development (e.g., highly characterized reference materials, infrastructure) and tool development and data interpretation (e.g., AI/ML technologies).

In a nutshell

  • Agencies: National Institutes
    of Health; Food & Drug Administration
  • Submit comments by: November 1, 2021

The second requests information on what critical resource gaps exist for validation and use of AI/ML to support radiological tool development and clinical data interpretation. Since the algorithmic needs for the development and validation of AI/ML algorithms may go beyond the “training” aspect of AI/ML, NIH and FDA would be interested in information related to both training and real-world use of unlocked AI/ML algorithms.

The agencies welcome input from research investigators, study participants, professional organizations, and other interested members of the public.


Request for Comment

Drug Products Approved Under Abbreviated New Drug Applications Before the Enactment of the Hatch-Waxman Amendments (1984)

FDA is soliciting comments on several issues related to the post-approval regulation of certain drug products approved in abbreviated applications prior to the establishment of the current abbreviated new drug application (ANDA) process.

In a nutshell

  • Agency: Food & Drug Administration
  • Submit comments by: December 11, 2021

While the scope of the announcement is quite broad, the agency is primarily considering whether generic drugs approved under abbreviated pathways prior to the Drug Price Competition and Patent Term Restoration Act of 1984 (a.k.a., the Hatch-Watchman Amendments) should be regulated differently than those approved afterward.

Reader beware: This notice is especially heavy on regulatory language!


Where can I learn more about how to submit my comments?

Below are some resources to help you develop an effective public comment. Of course, you’ll want to follow the specific instructions in each of the notices/requests above.

If you decide to submit comments, please do so as an individual rather than on behalf of the university.

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