Genetics/Genomics

NOAA Comment Deadline: Draft Strategy Document for 'Omics

The National Oceanic and Atmospheric Administration (NOAA) seeks public comments on a draft strategy documents for 'Omics. This strategy is intended to dramatically expand NOAA's application of this emerging science and technology focus areas by improving the efficiency, effectiveness, and coordination of its development and usage across the agency.

In recent years, individual NOAA programs and its multisector partners have worked to advance successful `omics solutions that improve the delivery of its respective missions.

The draft strategy NOAA developed for this science and technology focus areas directly follows guidance from the Administration and Congress, including the Office of Science and Technology Policy FY21 Research and Development Priorities letter, the National Science and Technology Council report “Science and Technology for America's Oceans: a Decadal Vision”, the Executive Order on Maintaining American Leadership in Artificial Intelligence, the Weather Research and Forecasting Innovation Act, and the Commercial Engagement Through Ocean Technology (CENOTE) Act.

The draft strategy will ensure robust agency-wide coordination and strong institutional support from NOAA senior leadership for this emerging science and technology focus area to guide transformational advances in the quality and efficiency of NOAA's science, products, and services.

In recognition of the opportunities and challenges presented by the advent of `omics tools (a suite of advanced methods used to analyze material such as DNA, RNA, or proteins), the NOAA `Omics Strategy provides a framework to advance the application of `omics to address mission priorities. The strategy leverages NOAA's current organizational structure to more effectively implement `omics through improvements in computational and analytical capacities, targeted research, technology transition, workforce proficiency, and partnerships across NOAA's lines, federal agencies, and extramural research and commercial communities.

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

FDA Workshop: Medication Adherence: Landscape, Strategies, and Evaluation Methods

The Food and Drug Administration, in collaboration with the Robert J. Margolis, MD, Center for Health Policy at Duke University, will hold a workshop titled "Medication Adherence: Landscape, Strategies, and Evaluation Methods." This public meeting will explore the state of the science of clinical research evaluating medication adherence involving FDA-regulated products.

Medication adherence—the extent to which patients take medications as prescribed in agreement with their health care provider—is an ongoing public health priority. Although the prevalence of medication non-adherence varies by disease and condition, increased adherence can improve health and reduce economic burden. Numerous strategies, including innovative tools and technologies, are used to assess and enhance medication, with variable success. 

Specific topics include:

  • Current landscape of interventions intended to (a) track (monitor) medication adherence, (b) improve medication adherence, and (c) improve clinical outcome(s) due to increased medication adherence;
  • Measurements of medication adherence; and
  • Study designs to evaluate the effectiveness of FDA-regulated products intended to track and/or improve medication adherence, with or without an association to clinical outcomes.

Members of the public may attend in person with advance registration, or via webcast. More information is available at this FDA website.

FDA Workshop: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making

The Food and Drug Administration (FDA) will hold a workshop titled "Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making." The FDA intends the workshop to gather input from the wider community of patients, patient advocates, academic researchers, expert practitioners, drug developers, and other stakeholders. The workshop will address a range of issues and considerations related to the collection and analysis of clinical outcome assessment (COA) data for drug development and regulatory decision making.

The purpose of this public workshop is to obtain feedback from stakeholders on considerations for:

  1. Endpoint development
  2. Estimands and analysis models
  3. Addressing heterogeneity in disease symptoms and functional status between patients and within the same patient over time
  4. Data collection, storage, transmission, and analysis

This public workshop is intended to support FDA implementation of requirements for guidance development under section 3002 of the 21st Century Cures Act (Pub. L. 114-255) and to meet a performance goal included in the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). Section 3002 of Title III Subtitle A of the 21st Century Cures Act directs FDA to develop patient-focused drug development guidance to address several areas including methodologies, standards, and technologies to collect and analyze COA data for purposes of regulatory decision making.

In addition, FDA is committed to meet certain performance goals under PDUFA VI. As part of the FDA Reauthorization Act of 2017 signed by the President on August 18, 2017, PDUFA VI includes a number of performance goals and procedures that are documented in the PDUFA VI Commitment Letter.

Members of the public may attend in person with advance registration, or via webcast. More information is available at this FDA website.

APHIS Meeting: Biotechnology Regulatory Services Stakeholders

The Animal and Plant Health Inspection Service (APHIS), part of the Department of Agriculture (USDA), will hold its annual Biotechnology Regulatory Services Stakeholder Meeting. Opening remarks will be delivered by USDA Under Secretary, Greg Ibach. Bernadette Juarez, the new APHIS Deputy Administrator for BRS will review FY 2019 and take a look ahead to FY2020 priorities; Dr. Fan-Li Chou with USDA’s Office of the Chief Economist will review biotechnology education and outreach efforts; and various oversight activities will be discussed.

In order to protect plant health, Biotechnology Regulatory Services (BRS) implements APHIS regulations for certain genetically engineered (GE) organisms that may pose a risk to plant health. APHIS coordinates these responsibilities along with the other designated federal agencies as part of the Federal Coordinated Framework for the Regulation of Biotechnology.

Members of the public may attend with advance registration, or via webcast. More information is available at this APHIS website.

NIH Meeting: Novel and Exceptional Technology and Research Advisory Committee

The National Institutes of Health (NIH), Office of Science Policy, will hold a meeting of the Novel and Exceptional Technology and Research Advisory Committee. The Committee will discuss (1) pathways for responsible innovation in emerging biotechnologies; (2) characteristics of emerging biotechnologies, including presentations on horizon scanning, gene editing in the clinic, gene drives, neurotechnology, artificial intelligence, and synthetic biology; and (3) proactively addressing scientific and societal implications of emerging biotechnologies.

The Novel and Exceptional Technology and Research Advisory Committee is a federal advisory committee that provides recommendations to the NIH Director and a public forum for the discussion of the scientific, safety, and ethical issues associated with emerging biotechnologies.

Members of the public may attend in person or via webcast. More information is available at this Federal Register notice.

NASEM Workshop: Exploring the Frontiers of Innovation to Tackle Microbial Threats

The National Academies of Sciences, Engineering, and Medicine (NASEM), Board on Global Health, will hold a workshop titled "Exploring the Frontiers of Innovation to Tackle Microbial Threats." The workshop will examine the major advancements in scientific, technological, and social innovations that have been taking place to tackle microbial threats, including diagnostics, vaccine development and production, new antimicrobials as well as non-pharmaceutical interventions and surveillance. Particular considerations will be given to innovations that occur at the human-animal-plant-environment interface and those that are practical and can be implemented in different resource-level settings.

Members of the public may attend in person or via webcast with advance registration. More information is available at this NASEM website.

NIH Meeting: Muscular Dystrophy Coordinating Committee

The National Institutes of Health (NIH) will hold a meeting of its Muscular Dystrophy Coordinating Committee. The purpose of this meeting is to bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and improvements in patients' and their families' lives.

The Coordinating Committee is a Federal Advisory Committee that coordinates the activities across the National Institutes and with other Federal health programs and activities relating to the various forms of muscular dystrophy.

Members of the public may attend in person with advance email registration, or via webinar. More information is available at this Federal Register notice.

APHIS Comment Deadline: Determination of Nonregulated Status of Cotton Genetically Engineered for Insect Resistance

The Animal and Plant Health Inspection Service (APHIS) is seeking public comments on a petition they received from Monsanto Company seeking a determination of nonregulated status for cotton designated as MON 88702, which has been genetically engineered for resistance to certain insects, primarily Lygus spp. The petition has been submitted in accordance with APHIS's regulations concerning the introduction of certain genetically engineered organisms and products. APHIS is making the Monsanto petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in their evaluation of the petition.

Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), the regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered “regulated articles.”

The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the submission procedures, format, and the information that must be included in the petition.

APHIS has received a petition (APHIS Petition Number 19-091-01p) from Monsanto Company (Monsanto) seeking a determination of nonregulated status for cotton designated as MON 88702, which has been genetically engineered for resistance to certain insects. The Monsanto petition states that this cotton is unlikely to pose a plant pest risk and, therefore, should not be a regulated article under APHIS's regulations in 7 CFR part 340.

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