Genetics/Genomics

FDA Comment Deadline: Definition of the Term “Biological Product”

The Food and Drug Administration (FDA or the Agency) is seeking comments on a proposed rule to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009, and to provide its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.” Under that interpretation, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. A chemically synthesized polypeptide would mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. This proposed rule is intended to clarify the statutory framework under which such products are regulated.

Comments on this proposal may be submitted electronically at Regulations.gov or by mail. More information on the proposal and the comment submission process can be found at this Federal Register notice

NASEM Workshop: Developing and Sustaining an Effective and Resilient Oncology Careforce

The National Academies of Sciences, Engineering, and Medicine (NASEM), National Cancer Policy Forum, will hold a workshop titled "Developing and Sustaining an Effective and Resilient Oncology Careforce."

Rapid advances in cancer research, new technological innovations, the expanding clinical evidence base, and changing demographics are all transforming the landscape of cancer care. As the US population ages, more people are being diagnosed with cancer, but the mortality rate is declining and thus the population of long-term cancer survivors is growing. Advances in cancer diagnosis and treatment, including the growth in precision oncology therapies, have improved outcomes for patients with cancer, but have also increased the complexity of cancer care. Reflecting this complexity, the delivery of high-quality care is dependent on effective teamwork, transparency, and collaboration among health care professionals, patients, and their families.

Given these trends, there is a need to ensure the availability of an effective and well-coordinated oncology careforce that can provide high-quality care to people diagnosed with cancer. The oncology careforce includes the spectrum of health care professionals taking care of patients with cancer (e.g., physicians, nurses, and other clinicians), as well as home care workers, volunteers, and family caregivers. 

This National Cancer Policy Forum workshop will provide a venue for the cancer community to examine the impact of evolving trends in cancer incidence and care on the oncology careforce. A primary goal of the workshop is to consider opportunities to enhance the delivery of high-quality patient care by improving the development and support of the oncology careforce. The workshop will feature invited presentations and panel discussions on topics that may include:

  • Factors in the oncology care setting that contribute to inefficiencies, clinician burnout, and reduced quality of care, as well as potential systems interventions to address these issues.
  • Approaches to stratify and optimize care across the cancer care continuum.
  • The impact of new payment models. 
  • Strategies to improve the recruitment, training, mentorship, and retention of oncology care professionals.
  • Approaches to enhance cancer care competencies across the spectrum of non-oncology care providers, from physicians and advanced practice nurses to family caregivers.
  • Opportunities for collaboration and information-sharing among health care providers and across clinical specialties to identify best practices for careforce coordination and utilization.

Members of the public may attend in person. More information regarding the workshop, including location and attendance, can be found at this NASEM website.

FDA Meeting: Tobacco Products Scientific Advisory Committee

The Food and Drug Administration (FDA) is announcing a forthcoming meeting of the Tobacco Products Scientific Advisory Committee. The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The Committee will convene for two sessions. 

The first session will convene on February 6, 2019, during which the Committee will discuss an amendment to the modified risk tobacco product applications (MRTPAs), submitted by Swedish Match North America for the following snus smokeless tobacco products:

  • MR0000020: General Loose;
  • MR0000021: General Dry Mint Portion Original Mini;
  • MR0000022: General Portion Original Large;
  • MR0000024: General Classic Blend Portion White Large-12ct;
  • MR0000025: General Mint Portion White Large;
  • MR0000027: General Nordic Mint Portion White Large-12ct;
  • MR0000028: General Portion White Large; and
  • MR0000029: General Wintergreen Portion White Large.

The second session will convene, after the first session has concluded, on February 6, 2019, and continue on February 7, 2019. During the second session the Committee will discuss the MRTPA, submitted by Altria Client Services LLC on behalf of U.S. Smokeless Tobacco Company LLC for the following smokeless tobacco product:

  • MR0000108: Copenhagen Snuff Fine Cut.

This meeting will be open to the public to attend in person. Persons interested in attending the meeting can find more information regarding location and the committee itself at this Federal Register notice.

FDA Comment Deadline: Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products

The Food and Drug Administration (FDA) is announcing the availability of and seeking public comments on a draft guidance for industry entitled “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products.” This draft guidance describes considerations for the development and labeling of companion diagnostics to support the indicated uses of multiple therapeutic oncology products, when appropriate. This draft guidance expands on existing policy, surrounding broader labeling, which notes that in some cases, if evidence is sufficient to conclude that the companion diagnostic is appropriate for use with a specific group or class of therapeutic products (as discussed in the draft guidance), the companion diagnostic's intended use/indications for use should name the specific group or class of therapeutic products, rather than specific products. To describe FDA's thinking on the topic, the draft guidance discusses a specific example of companion diagnostics for a specific biomarker, disease, and specimen type (specific epidermal growth factor receptor mutations in tumors of patients with nonsmall cell lung cancer in tissue specimens).

Trials designed to support approval of a specific therapeutic product and a specific companion diagnostic have led to companion diagnostic labels that reference only a specific therapeutic product(s). Such specificity in labeling can limit a potentially broader use of a companion diagnostic that may be scientifically appropriate. In clinical practice, an oncologist generally considers the mutation profile of the tumor along with other factors when determining the treatment for a patient, such as the toxicity profile of the therapeutic product, the patient's preference, and formulary options. When a companion diagnostic is labeled for use with a specific therapeutic product, the clinician may need to order a different companion diagnostic (i.e., one that includes other therapeutic products in the labeling), obtain an additional biopsy(ies) from a patient, or both, to have additional therapy treatment options.

The draft guidance describes considerations for when broader labeling may be scientifically appropriate and when it may not. FDA recommends developers of therapeutic oncology products and associated companion diagnostics collaboratively consider development programs that may result in broader labeling of companion diagnostics that are most clinically useful. Developers are encouraged to discuss development programs that could result in broader labeling with the CBER, Center for Devices and Radiological Health (CDRH), or Center for Drug Evaluation and Research, in coordination with the Oncology Center of Excellence, as appropriate, early to determine if the approach described in this guidance is appropriate for consideration. Developers whose approved companion diagnostics may be appropriate for broader labeling are encouraged to contact CDRH or CBER, as appropriate, to discuss.

In addition to providing stakeholders an opportunity to comment on the draft guidance, the Agency is interested in responses from stakeholders to the following:

  1. Please describe any specific challenges with developing the evidence needed to identify in labeling a companion diagnostic for use with a specific group or class of oncology therapeutic products, rather than a specific therapeutic product. For example, please describe any challenges resulting from industry or business practices, including business agreements. What actions can FDA take to address the challenge(s)?
  2. Please describe any specific challenges with submitting a premarket approval (PMA) supplement to FDA to expand the labeling for an approved companion diagnostic for use with a specific group or class of oncology therapeutic products. What actions can FDA take to address the challenge(s)?
  3. Please describe any additional actions FDA can take to facilitate or encourage broader, evidence-based labeling that supports the use of a specific group or class of oncology therapeutic products with a companion diagnostic.
  4. The guidance notes that variations in defined cut-points established for specific biomarkers for companion diagnostics can lead to challenges in implementing broader labeling for a specific group or class of oncology therapeutic products. Are there actions that FDA, or the broader scientific community, can take to facilitate standardization in this area?

Comments may be submitted by members of the general public by mail or at Regulations.gov. More information regarding this draft guidance and public comment regarding it can be found at this Federal Register notice

NIH Comment Deadline: Laboratory Animal Welfare – Draft Report on Recommendations To Reduce Administrative Burden on Researchers

The National Institutes of Health (NIH) is seeking input on the draft report by the 21st Century Cures Act Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research. The draft report is a coordinated effort of the Director of the National Institutes of Health, in collaboration with the Department of Agriculture and the Food and Drug Administration. It describes the proposed actions that the working group has identified to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals.

This request for information is a coordinated effort of the Director of the National Institutes of Health, in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs, to seek input on the draft report by the 21st Century Cures Act, Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research.

Input is sought on the draft report of the Working Group and others within the federal government and the proposed recommendations to reduce the administrative burden associated with research activities with laboratory animals while maintaining appropriate protections and scientific integrity.

Comments must be submitted electronically to this portal. More information on the submission of comments and the draft report itself can be found at this Federal Register notice

HHS Meeting: Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

The Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The public meeting will be dedicated to hosting stakeholders to explore priority areas that have emerged since the original National Action Plan on Combating Antibiotic Resistant Bacteria was launched in 2015.

The Advisory Council will provide advice, information, and recommendations to the Secretary of HHS regarding programs and policies intended to support and evaluate the implementation of Executive Order 13676, including the National Strategy for Combating Antibiotic-Resistant Bacteria and the National Action Plan for Combating Antibiotic-Resistant Bacteria. The Advisory Council shall function solely for advisory purposes.

In carrying out its mission, the Advisory Council will provide advice, information, and recommendations to the Secretary regarding programs and policies intended to preserve the effectiveness of antibiotics by optimizing their use; advance research to develop improved methods for combating antibiotic resistance and conducting antibiotic stewardship; strengthen surveillance of antibiotic-resistant bacterial infections; prevent the transmission of antibiotic-resistant bacterial infections; advance the development of rapid point-of-care and agricultural diagnostics; further research on new treatments for bacterial infections; develop alternatives to antibiotics for agricultural purposes; maximize the dissemination of up-to-date information on the appropriate and proper use of antibiotics to the general public and human and animal healthcare providers; and improve international coordination of efforts to combat antibiotic resistance.

This meeting will be open to members of the general public. Persons may register to attend the meeting in person, or view the meeting through a live webcast. Comments may also be sent in prior to the meeting. For more information on the meeting, attendance and comments, please see this Federal Register notice.

DHS Comment Deadline: Extension of a Currently Approved Collection – AABB Accredited Laboratory Testing

The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information titled "Extension, Without Change, of a Currently Approved Collection: AABB Accredited Laboratory Testing; Rapid DNA Prototype Accelerated Nuclear DNA Equipment (ANDE) by NetBio; Rapid DNA Prototype RapidHIT200 by IntegenX." In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments. 

This proposed extension is open to comments from members of the general public. Comments may be submitted online at Regulations.gov. For more information regarding the information collection and the comment submission process, please see this notice.