Genetics/Genomics

HHS Comment Deadline: Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

The Department of Health and Human Services (HHS) maintains a Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria due to the evolution of antibiotic resistance and the long-term nature of the problem. The HHS tasked the Advisory Council with identifying significant areas of the craze that have emerged since the release of National Action Plan for Combating Antibiotic-Resistant Bacteria. 

To aid in the process of developing its response to the HHS task, the Advisory Council has posted this Request for Information (RFI) to hear from a wide range of stakeholders and sectors relevant to the overall effort. The Advisory Council requests information from the general public and stakeholders related to efforts and strategies to combat antibiotic resistance.

Members of the public may submit responses to the RFI by filling out an online form or by sending an email. Email submissions should include "RFI Response" along with the corresponding goal number(s) in the subject line. More information is available at this Federal Register notice or at the Advisory Council's website

BIS Comment Deadline: Review of Controls for Certain Emerging Technologies

The Department of Commerce's Bureau of Industry and Security (BIS) controls the export of dual-use and less sensitive military items, including the Commerce Control List (CCL). Certain emerging technologies may not yet be listed on the CCL and thus have not been evaluated for their national security impacts. This advance of notice proposed of rulemaking (ANPRM) seeks public comment on criteria for identifying emerging technologies that are essential to U.S. national security. 

The representative general categories of technology for which Commerce currently seeks to determine whether there are specific emerging technologies that are essential to the national security of the United States include:

  1. Biotechnology, such as: 
    1. Nanobiology;
    2. Synthetic biology;
    3. Genomic and genetic engineering; or
    4. Neurotech.
  2. Artificial intelligence (AI) and machine learning technology, such as:
    1. Neural networks and deep learning (e.g., brain modelling, time series prediction, classification);
    2. Evolution and genetic computation (e.g., genetic algorithms, genetic programming);
    3. Reinforcement learning;
    4. Computer vision (e.g., object recognition, image understanding);
    5. Expert systems (e.g., decision support systems, teaching systems);
    6. Speech and audio processing (e.g., speech recognition and production);
    7. Natural language processing (e.g., machine translation);
    8. Planning (e.g., scheduling, game playing);
    9. Audio and video manipulation technologies (e.g., voice cloning, deepfakes);
    10. AI cloud technologies; or
    11. AI chipsets.
  3. Position, Navigation, and Timing (PNT) technology.
  4. Microprocessor technology, such as:
    1. Systems-on-Chip (SoC); or
    2. Stacked Memory on Chip.
  5. Advanced computing technology, such as:
    1. Memory-centric logic. 
  6. Data analytics technology, such as:
    1. Visualization;
    2. Automated analysis algorithms; or
    3. Context-aware computing.
  7. Quantum information and sensing technology, such as
    1. Quantum computing;
    2. Quantum encryption; or
    3. Quantum sensing.
  8. Logistics technology, such as
    1. Mobile electric power;
    2. Modeling and simulation;
    3. Total asset visibility; or
    4. Distribution-based Logistics Systems (DBLS).
  9. Additive manufacturing (e.g., 3D printing);
  10. Robotics such as:
    1. Micro-drone and micro-robotic systems;
    2. Swarming technology;
    3. Self-assembling robots;
    4. Molecular robotics;
    5. Robot compliers; or
    6. Smart Dust.
  11. Brain-computer interfaces, such as
    1. Neural-controlled interfaces;
    2. Mind-machine interfaces;
    3. Direct neural interfaces; or
    4. Brain-machine interfaces.
  12. Hypersonics, such as:
    1. Flight control algorithms;
    2. Propulsion technologies;
    3. Thermal protection systems; or
    4. Specialized materials (for structures, sensors, etc.).
  13. Advanced Materials, such as:
    1. Adaptive camouflage; 
    2. Functional textiles (e.g., advanced fiber and fabric technology); or
    3. Biomaterials.
  14. Advanced surveillance technologies, such as:​
    1. Faceprint and voiceprint technologies.

BIS welcomes comments on: (1) How to define emerging technology to assist identification of such technology in the future; (2) criteria to apply to determine whether there are specific technologies within these general categories that are important to U.S. national security; (3) sources to identify such technologies; (4) other general technology categories that warrant review to identify emerging technology that are important to U.S. national security; (5) the status of development of these technologies in the United States and other countries; (6) the impact specific emerging technology controls would have on U.S. technological leadership; (7) any other approaches to the issue of identifying emerging technologies important to U.S. national security, including the stage of development or maturity level of an emerging technology that would warrant consideration for export control.

Members of the public may submit comments by mail or at Regulations.gov. More information is available at this Federal Register notice. 

FDA Nomination Deadline: Various Advisory Committees

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. 

FDA is seeking nominations for the following advisory committees and panels:

  • Antimicrobial Advisory Committee
  • Bone Reproductive and Urological Drugs Advisory Committee
  • Cardiovascular and Renal Drugs Advisory Committee
  • Medical Imaging Advisory Committee
  • Pharmacy Compounding Advisory Committe
  • Clinical Chemistry and Clinical Toxicology Devices Panel
  • Gastroenterology and Urology Devices Panel
  • Ear, Nose and Throat Devices Panel
  • Medical Devices Dispute Resolution Panel
  • Microbiology Devices Panel, Radiology Devices Panel
  • Orthopaedic and Rehabilitation Devices Panel

Members of the public may submit nominations by email or by mail. More information is available at this Federal Register notice.

FDA Comment Deadline: Rare Diseases – Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings.” The purpose of this draft guidance is to assist sponsors of drug and biological products for the treatment of rare diseases in planning and conducting more efficient and productive pre-investigational new drug application (pre-IND) meetings.

Drug development for rare diseases has many challenges related to the nature of these diseases. This draft guidance is intended to advance and facilitate the development of drugs and biological products for the treatment of rare diseases.

Members of the public may submit comments by mail or at Regulations.gov. More information is available at the Federal Register notice.

NIH Meeting: Cures Acceleration Network (CAN) Review Board

The Cures Acceleration Network (CAN) Review Board of the National Center for Advancing Translational Sciences (NCATS) within the NIH will meet to advise and provide recommendations for identifying significant barriers to successful translation of basic science into clinical application.

Authorized to reduce significant barriers to successful translation and accelerate the development of high-need cures, the Cures Acceleration Network (CAN) provides NCATS with flexibility in how it funds projects. Implementation of this authority is guided by the CAN Review Board, which advises and provides recommendations to the NCATS director on the policies, programs and procedures for carrying out the duties of the Office of the Director and on identifying significant barriers to successful translation of basic science into clinical application. The CAN Review Board also discusses concept clearances for potential NCATS initiatives.

This meeting of the NCATS Cures Acceleration Network Review Board will feature presentations by NCATS leadership and invited guests. NCATS staff will present proposed initiative concepts for CAN Review Board consideration.

The meeting is open to the public and will be webcast. Further information can be found on the meeting agenda and Federal Register Notice, both linked from the meeting website.

CDC Meeting: Advisory Council for the Elimination of Tuberculosis Meeting

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Council for the Elimination of Tuberculosis Meeting (ACET).

This Council advises and makes recommendations to the Secretary of Health and Human Services, the Assistant Secretary for Health, and the Director, CDC, regarding the elimination of tuberculosis. Specifically, the Council makes recommendations regarding policies, strategies, objectives, and priorities; addresses the development and application of new technologies; and reviews the extent to which progress has been made toward eliminating tuberculosis.

The agenda will include discussions on (1) Division of Tuberculosis Elimination (DTBE) funded Demonstration Project on Latent Tuberculosis Infection (LTBI) Testing and Treatment; (2) DTBE Communications Messaging and Campaigns; (3) Update on LTBI Treatment Guidelines; (4) Update on Drug Resistant Tuberculosis Guidelines; and (5) Update from ACET workgroups.

This meeting is open to the general public, and can be attended in person or by phone line. Members of the public may also submit written comments through email or make oral statements at the end of the meeting. More information regarding the meeting can be found at this Federal Register notice.