Comments

HHS Comment Deadline: Draft Report on Pain Management Best Practices – Updates, Gaps, Inconsistencies, and Recommendations

The Department of Health and Human Services (HHS) is seeking public comments on the draft report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations, which proposes updates to best practices and recommendations for pain management, including chronic and acute pain.

The Task Force is required to propose updates on best practices and recommendations to address gaps or inconsistencies for pain management, including chronic and acute pain, and submit such updates and recommendations to relevant Federal agencies and the general public. The duties of the Task Force are to:

  • Identify, review, determine, and propose updates to gaps or inconsistencies between best practices for pain management, taking into consideration:
    • Existing pain management research and other relevant research;
    • Recommendations from relevant conferences and existing evidence-based guidelines;
    • Ongoing efforts at the state and local level and by medical professional organizations to develop improved pain management strategies;
    • The management of high-risk populations who receive opioids in the course of medical care, other than for pain management;
    • The 2016 Guideline for Prescribing Opioids for Chronic Pain issued by the CDC; and
    • Private sector, State, and local government efforts related to pain management and prescribing pain medication.
  • Provide the public with at least ninety (90) days to submit comments on any proposed updates and recommendations.
  • Develop a strategy for dissemination of information on best practices for pain management to stakeholders, if appropriate.

The Draft Report highlights the progress made towards identifying, reviewing, and determining whether there are gaps in or inconsistencies between best practices for pain management (including chronic and acute pain) developed or adopted by Federal agencies. It includes the Task Force's proposed updates to best practices and recommendations on addressing gaps or inconsistencies. On September 26, 2018, the Task Force voted on the proposed updates and recommendations that would be provided to the public for comment. The proposed updates and recommendations are included in the Draft Report. Once the ninety (90) day comment period concludes, the Task Force will consider comments received and compile a Final Recommendations Report with its proposed updates and recommendations.

The goal of this Request for Comment is to solicit feedback on the Draft Report, which includes the Task Force's proposed updates and recommendations. The Task Force invites comment on the full range of issues that may be relevant to the proposed updates and recommendations.

Comments may be submitted electronically, either by email or at Regulations.gov, or in written form. More information regarding the task force and the comment submission process can be found at this Federal Register notice.

 

HHS Comment Deadline: Assays and Approaches for Evaluating Chemical Effects on Cancer Pathways

The National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences within the Department of Health and Human Services (HHS) is seeking input on assays and approaches for evaluating chemical effects on cancer pathways, specifically pathways that map to the hallmarks of cancer and key characteristics of carcinogens.

Cancer is a leading cause of mortality worldwide. While the defining feature of cancer is uncontrolled division of abnormal cells, it is a complex disease with varied presentations (i.e., different etiologies and target tissues) that involves dysregulation of multiple interconnected signaling pathways. Diverse environmental factors have been associated with the development and progression of various cancer types. A critical question in the field of environmental health is how to harness what is known about cancer biology and associated environmental exposures to improve public health outcomes. This Request for Information is in support of the Converging on Cancer Workshop, which is aimed at providing a clear path forward for evaluating the interactions between environmental exposures and cancer biology using the latest tools in toxicology and identifying knowledge gaps that require research attention. Potential applications of this understanding include building a framework for incorporating mechanistic data into cancer risk assessment, developing efficient and reliable screening tools to detect the carcinogenic potential of environmental chemicals (including mixtures), engineering safer products, and designing more effective multi-target therapeutics.  

The hallmarks of cancer (1) and key characteristics of carcinogens (2) offer two paradigms for organizing information to better understand the interactions between environmental exposures and biological systems that lead to cancer. The hallmarks of cancer represent the biological traits of tumors that allow for the unchecked growth of cancer, while the key characteristics framework begins with known human carcinogens and identifies their defining properties. It is clear from biomonitoring studies that we are constantly exposed to numerous structurally-diverse chemicals. A recent nomination to NTP was for development of a testing strategy to better understand how environmental chemicals might interact with multiple cancer-relevant biological pathways to elicit mixture effects that would not be expected based on single chemical considerations. This request for information (RFI) is intended to generate input that will facilitate new testing approaches designed to evaluate these hypotheses in a cancer context. Responses to the RFI should provide information on technologies targeting cancer-specific pathways and mechanisms, including organotypic and/or mechanistically insightful tools, preferred animal models, and in silico/computational approaches to link relevant pathways, as well as cancer types for use in evaluating hypotheses regarding the joint action of chemicals that target cancer pathways.

The NTP requests information regarding assays and approaches to measure the key biological mechanisms/pathways associated with chemical carcinogenesis. Responses to any or all of the questions below are invited from interested individuals/groups, including, but not limited to, the environmental health research community, health professionals, educators, policy makers, industry, and the public.

  • Systematic review approaches to transparently identify and evaluate mechanistic information on the carcinogenic properties of chemicals and chemical mixtures.
  • Assays associated with the biological mechanisms/pathways described by the hallmarks of cancer and the key characteristics of carcinogens.
  • Assays that integrate across multiple cancer-related pathways (e.g., organotypic microphysiological systems, mechanistic animal models).
  • Modeling approaches to assess the joint effects of multiple chemicals on carcinogenic potential.
  • Feedback on critical pathways and mechanisms to target when developing novel carcinogenicity testing strategies.
  • Feedback on cancer types conducive to exploring chemical interaction hypotheses.
  • Environmental chemicals known to affect key biological mechanisms/pathways leading to cancer and which key biological mechanisms/pathways are affected by these chemicals.
  • Types of scientific data (e.g., mechanistic, epidemiological) needed to address underlying knowledge gaps of chemical exposures leading to carcinogenesis.
  • New technologies and innovative research approaches that could be leveraged to address these underlying knowledge gaps.

Responses to this request are open to members of the public. Responses should be submitted via email to Cynthia V. Rider Ph.D. More information regarding the submission process and other additional information can be found at this notice.

EPA Comment Deadline: Mercury and Air Toxics Standards for Coal- and Oil-Fired Electric Utility Steam Generating Units

The Environmental Protection Agency (EPA) is seeking public comment on its proposal to delist coal- and oil-fired electric utility steam generating units (EGUs) from the Clean Air Act (CAA) section 112(c) and rescind (or to rescind without delisting) the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Coal- and Oil-Fired EGUs, commonly known as the Mercury and Air Toxics Standards (MATS).

After considering the cost of compliance relative to the HAP benefits of regulation, the EPA proposes to find that it is not “appropriate and necessary” to regulate hazardous air pollution (HAP) emissions from coal- and oil-fired EGUs, thereby reversing the EPA's prior conclusion under CAA section 112(n)(1)(A) and correcting flaws in the EPA's prior response to Michigan v. EPAThe EPA further proposes that finalizing this new response to Michigan v. EPA will not remove the Coal- and Oil-Fired EGU source category from the CAA section 112(c) list of sources that must be regulated under CAA section 112(d) and will not affect the existing CAA section 112(d) emissions standards that regulate HAP emissions from coal- and oil-fired EGUs. 

The EPA is also proposing the results of the residual risk and technology review (RTR) of the NESHAP that the EPA is required to conduct in accordance with CAA section 112. The results of the residual risk analysis indicate that residual risks due to emissions of air toxics from this source category are acceptable and that the current standards provide an ample margin of safety to protect public health. No new developments in HAP emission controls to achieve further cost-effective emissions reductions were identified under the technology review. Therefore, based on the results of these analyses and reviews, the EPA is proposing that no revisions to MATS are warranted. Finally, the EPA is also taking comment on establishing a subcategory for emissions of acid gas HAP from existing EGUs firing eastern bituminous coal refuse.

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

EPA Comment Deadline: New Source Performance Standards for Greenhouse Gas Emissions from New, Modified, and Reconstructed Electric Generating Units

The US Environmental Protection Agency (EPA) is welcoming public comment on a proposal to revise the New Source Performance Standards (NSPS) for greenhouse gas emissions from new, modified, and reconstructed fossil fuel-fired power plants. 

In December 2018, after analysis and review, the EPA proposed to determine that the best system of emission reduction (BSER) for newly constructed coal-fired units, is the most efficient demonstrated steam cycle in combination with the best operating practices. As a result the EPA proposed to revise the New Source Performance Standards (NSPS) for greenhouse gas emissions from new, modified, and reconstructed fossil fuel-fired power plants. 

Members of the public may submit comments by mail, fax or at Regulations.gov. More information is available at the EPA's website

NRC Comment Deadline: Ground Water Protection at Uranium In Situ Recovery Facilities

The US Nuclear Regulatory Commission (NRC) is requesting views from interested stakeholders on whether the NRC should resume rulemaking to amend its regulations governing the domestic licensing of source material by codifying general requirements to address ground water protection at uranium in situ recovery (ISR) facilities. The NRC currently regulates ISR operations through application of regulations that primarily focus on conventional uranium mills and site-specific license conditions.

The NRC initiated rulemaking in 2006 to develop requirements to provide regulatory consistency and improve the efficiency of the ISR licensing process but placed this rulemaking on hold in 2010. Information provided to the NRC during the public comment period will be factored into the decision as to whether the NRC will continue this rulemaking.

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

DOL Comment Deadline: National Health Emergency Demonstration Grants to Address the Opioid Crisis

The Department of Labor (DOL) is providing the general public with the opportunity to comment on proposed data collection instruments that will be used in the implementation evaluation of the National Health Emergency Demonstration Grants to Address the Opioid Crisis. 

This notice provides the opportunity to comment on proposed data collection instruments that will be used in the implementation evaluation: Key informant interview protocols, survey of key informants (state- and local-level administrators) and a program participant interview guide.

1. Key informant interview protocol. The protocol will be used during site visits to the grantees to collect information from administrators and staff at the state- and local-level, and with partner organizations and employers at either the state or local level. Issues to be covered include the state and local community context, strategies and approaches to service delivery, target populations and recruiting, the role of various partners in grant and subgrant activities, successes and challenges, preliminary outcomes, promising practices, and other topics.

2. Survey of key informants. This short questionnaire for key informants (administrators and staff at the state- and local-level) includes basic background information, such as their highest education level and experience, and brief questions about their perspectives on the opioid crisis and the state's partnerships to address the crisis.

3. Program participant interview guide. The guide will be used for individual or group discussions with approximately 10 program participants in each state. Topics will include participant background, service receipt, participants' views on the quality and effectiveness of the workforce services received, and their current or anticipated labor market experiences as a result of the services.

 Desired Focus of Comments: Currently, the Department of Labor is soliciting comments concerning the above data collection for the Implementation Evaluation of the National Health Emergency (NHE) Demonstration Grants to Address the Opioid Crisis. DOL is particularly interested in comments that do the following:

  • Evaluate whether the proposed collection of information is necessary for the proper performance functions of the agency, including whether the information will have practical utility;
  • Evaluate the accuracy of the agency's burden estimate of the proposed information collection, including the validity of the methodology and assumptions;
  • Enhance the quality, utility, and clarity of the information to be collected; and
  • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology—for example, permitting electronic submissions of responses.

Comments may be submitted electronically or in written form. For more information regarding the information collection and the comment submission process, please see this Federal Register notice

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