[Federal Register Volume 85, Number 95 (Friday, May 15, 2020)]
[Proposed Rules]
[Pages 29366-29368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09469]


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EXECUTIVE OFFICE OF THE PRESIDENT

Office of National Drug Control Policy

21 CFR Part 1401

RIN 3201-AA02


Criteria for Designation of Emerging Drug Threats in the United 
States

AGENCY: Office of National Drug Control Policy.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Office of National Drug Control Policy is announcing this 
Advance Notice of Proposed Rulemaking (ANPRM) and requests information 
relevant to criteria for designating and terminating the designation of 
emerging drug threats in the United States pursuant to the Substance 
Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for 
Patients and Communities Act (SUPPORT Act). This ANPRM briefly 
summarizes the White House Office of National Drug Control Policy's 
(ONDCP) ongoing work in this area and describes the criteria that ONDCP 
is considering to monitor and identify emerging drug threats. The ANPRM 
invites interested parties to submit comments, data, and other 
pertinent information concerning ONDCP's development of proposed 
criteria for designating emerging drug threats and terminating such 
designations.

DATES: Send comments on or before June 30, 2020.

ADDRESSES: You may send comments, identified by RIN number 3201-AA02 
and/or docket number ONDCP-2020-0001, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. See SUPPLEMENTARY 
INFORMATION for file formats and other information about electronic 
filing.
     Email: [email protected], Include docket number ONDCP-
2020-0001 and/or RIN number 3201-AA02 in the subject line of the 
message.
     Mail: Executive Office of the President, Office of 
National Drug Control Policy, 1800 G Street NW, 9th Floor, Washington, 
DC 20006, Attn: Office of General Counsel.
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
rulemaking. All comments received will be posted without change to 
http://www.regulations.gov including any personal information provided. 
For detailed instructions on sending comments and additional 
information on the rulemaking process, see the ``Public Participation'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Questions concerning this ANPRM should 
be directed to Michael J. Passante, Acting General Counsel, Office of 
General Counsel, Office of National Drug Control Policy, Executive 
Office of the President, at [email protected] (email) or (202) 395-6622 
(voice).

SUPPLEMENTARY INFORMATION: 

I. Public Participation

    ONDCP strongly recommends using electronic means for submitting 
comments. Due to COVID-19, comments submitted through conventional mail 
delivery services may not be received in a timely manner. To ensure 
proper handling, please reference RIN 3201-AA02 on your correspondence. 
The mailing address may be used for paper, disk, or CD-ROM submissions.
    Interested persons are invited to submit written data, views, or 
arguments on all aspects of this ANPRM. All comments must be submitted 
in English, or accompanied by an English translation. Please note that 
all comments received are considered part of the public record and made 
available for public inspection at www.regulations.gov. Such 
information includes personally identifiable information (such as a 
person's name, address, or any other data that might personally 
identify that individual) that the commenter voluntarily submits.
    If you want to submit personally identifiable information as part 
of your comment, but do not want it to be posted online, you must 
include the phrase ``PERSONALLY IDENTIFIABLE INFORMATION'' in the first 
paragraph of your comment and precisely and prominently identify the 
information for which you seek redaction.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online, you must include 
the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the first paragraph 
of your comment and precisely and prominently identify the confidential 
business information for which you seek redaction. If a comment has so 
much confidential business information that it cannot be effectively 
redacted, all or part of that comment may not be posted on 
www.regulations.gov. Personally identifiable information and 
confidential business information provided as set forth above will be 
placed in the agency's public docket file, but not posted online. To 
inspect the agency's public docket file in person, you must make an 
appointment with agency counsel. Please see the FOR FURTHER INFORMATION 
CONTACT paragraph above for the agency counsel's contact information 
specific to this rulemaking.

II. Introduction

    Through enacting Section 8218 of the SUPPORT Act, 21 U.S.C. 1708, 
Congress codified its intention for the Federal government to closely 
monitor emerging drug threats and to take action at the outset of a 
trend to prevent such threats from reaching levels seen during the 
opioid crisis. The SUPPORT Act requires ONDCP to promulgate standards 
for designating an emerging drug threat and terminating such a 
designation. 21 U.S.C. 1708(c). The SUPPORT Act created the Emerging 
Threats Committee consisting of representatives from National Drug 
Control Program Agencies and other agencies, representatives from 
State, local and Tribal governments, and representatives from other 
entities designated by the ONDCP Director. 21 U.S.C. 1708(b). The 
Emerging Threats Committee is responsible for, among other matters, 
monitoring evolving and emerging drug threats in the United States. One 
of the Committee's principal responsibilities is to develop and 
recommend criteria that ONDCP may use to designate and terminate the 
designation of emerging drug threats. 21 U.S.C. 1708(b)(6).
    How best to monitor and identify emerging drug threats in the 
United States is a question with broad public health implications. 
Before proceeding, ONDCP intends to benefit from a full airing of the 
issues through the public comment process. ONDCP's objective is to 
develop criteria that will enable the United States to be proactive in 
identifying emerging drug threats and taking action to prevent such 
drug threats from becoming public health emergencies.

[[Page 29367]]

III. ONDCP's Emerging Threats Activities

    On May 21, 2019, ONDCP Director James W. Carroll announced the 
formation of the Emerging Threats Committee to identify and respond to 
emerging drug threats in the United States. The Committee consists of 
13 representatives from Federal, state, local, and Tribal governments 
and members of non-governmental entities.
    The Emerging Threats Committee first met on May 22, 2019, and had 
several subsequent in-person and telephonic meetings. One of the 
Committee's responsibilities was to develop standards/criteria that 
ONDCP may use to identify and designate emerging drug threats and to 
terminate the designation of such drug threats. In developing proposed 
standards, the Committee considered various data sources, health 
statistics, and other indicators that may signal emerging drug threats.
    After careful deliberations and discussions, the Committee 
developed a set of 11 proposed criteria for designating emerging drug 
threats. The 11 criteria consist of:
    (1) The identification of a new drug, class of drugs, or other 
substance that creates the potential to substantially harm or adversely 
affect the public.
    (2) An increase in morbidity or mortality due to drug overdose.
    (3) A new regional or national outbreak of overdoses or other 
significant health harms associated with a drug, class of drugs, or 
other substance.
    (4) Increased emergency department visits, hospitalizations, or 
treatment admissions related to the use of a new or evolving drug, 
class of drugs, or other substance.
    (5) An increase in polysubstance use and substance use disorders 
involving multiple substances.
    (6) Increased reporting by health care providers of new or novel 
clinical illnesses by patients with suspected or known exposure to a 
drug, class of drugs, or other substance.
    (7) An increase in individuals or cohorts (e.g., a particular 
population or age group) diagnosed with substance use disorder.
    (8) An increase in timely surveillance of drug use measures, either 
regionally or nationwide, that indicates a new or evolving outbreak of 
illicit drug use or an increase in substance use disorders.
    (9) Increased discussion through online drug user sites regarding a 
new or evolving drug, class of drugs, or other substances.
    (10) State, local, tribal, or Federal reports of seizures involving 
a new or evolving drug, class of drugs, or other substances.
    (11) An increase in reports by law enforcement and fire department 
agencies using tools such as the Overdose Detection Mapping Application 
Program or other near real-time suspected overdose surveillance data 
systems.
    The Emerging Threats Committee selected these 11 proposed criteria 
because the Committee believes that these criteria reflect the best 
available standards for detecting emerging drug threats. The Committee 
focused on establishing standards that were fairly broad, but with the 
understanding that a sliding scale would be necessary to determine 
whether a new drug threat needed to be designated or if an ongoing 
designated drug threat could be safely terminated such that it no 
longer requires intensive efforts to prevent it from growing into a 
public health crisis. The notion of a sliding scale was considered to 
be applicable for the individual criteria as well as for all 11 
evaluated holistically. As the Committee formulated the criteria, they 
looked at the environment from which an emerging threat would most 
likely be identified at the earliest possible point given the negative 
public health and law enforcement impacts of the drug. For example, 
there is evidence that increases in morbidity and mortality due to drug 
overdoses and increased emergency department visits, hospitalizations, 
or treatment admissions related to the use of a new drug or substance 
are good indicators of emerging drug trends.

IV. Request for Comments

    ONDCP requests public comments to assist us in determining the best 
criteria for designating emerging drug threats and removing such 
designations. ONDCP also requests that interested parties submit any 
pertinent public health data not discussed in this ANPRM. We request 
comments on the following issues relating to the public health impact, 
the economic impact, and provisions that should be considered for 
inclusion in emerging drug threats criteria. Specifically, expert 
analysis and opinion as well as medical, scientific, economic, and 
technical data are sought on the following issues:
    1. Proposed Criteria: ONDCP requests comments on whether the 11 
proposed criteria listed in Section III of this ANPRM are useful 
criteria for identifying emerging threats. Should any of the 11 
proposed criteria be modified or eliminated? Should other criteria be 
considered by ONDCP in designating emerging drug threats? In both 
cases, if so, please explain your rationale for making the 
recommendation. ONDCP is particularly interested in comments on the 
issue of how individual criteria should be evaluated to identify 
emerging drug threats. Should some criteria be given more weight than 
others? Should a combination of some, but not all, proposed criteria be 
sufficient to designate an emerging drug threat? ONDCP is also 
interested in whether the criteria that reference increased occurrences 
of specific conditions should be held to certain numerical or 
statistical thresholds. What metrics, if any, should be used for the 
criteria to evaluate whether an emerging drug threat exists?
    2. Significance of Threat: How significant should the drug threat 
be before ONDCP initiates the process of designating an emerging 
threat? How should significance be determined with respect to assessing 
whether a drug trend rises to a level that warrants an emerging drug 
threat classification? Are there any data, such as medical records or 
clinical research that should be included in ONDCP's decision-making 
process? How should the danger of the drug threat be determined?
    3. Termination of Emerging Threat Designation: The SUPPORT Act 
requires ONDCP to terminate an emerging drug threat designation after 
the circumstances that gave rise to the designation have been abated. 
ONDCP is interested in comments that address the point at which an 
emerging drug threat designation should be terminated. Should 
termination of the designation be linked to decreases in numerical or 
statistical benchmarks associated with use of the drug? What criteria 
should be used to evaluate whether the threat posed by a designated 
drug has declined to the point that it is no longer considered an 
emerging drug threat?
    4. Economic impact: Issuing an emerging drug threat designation 
under the SUPPORT Act triggers a series of actions that ONDCP and other 
National Drug Control Program Agencies must take to mitigate the impact 
of the designated threat. The ONDCP Director is required to publish an 
Emerging Threat Response Plan within 90 days of the designation and 
must update the plan each year until the emerging drug threat 
designation is terminated. That plan is required to include a 
comprehensive assessment of the drug threat, goals to address the 
threat, and performance measures related to the plan's goals, among 
other requirements. 21 U.S.C. 1708(d). The ONDCP Emerging Threats 
Coordinator is required to facilitate information

[[Page 29368]]

sharing and coordination with relevant agencies and entities concerning 
the implementation or status of emerging threats, monitor 
implementation of Emerging Threat Response Plans, and coordinate the 
development and implementation of reporting systems to support 
performance measurement and adherence to the plan. Agencies identified 
in an Emerging Threat Response Plan are required to submit a report to 
the Coordinator on implementation of the plan within 180 days of 
designation. Upon making an emerging threats designation, the ONDCP 
Director is required to evaluate whether a media campaign to address 
the threat is appropriate. If the Director determines that a media 
campaign is warranted and enough appropriations are available for that 
purpose, the Director will conduct a national anti-drug media campaign 
in accordance with the requirements of 21 U.S.C. 1708(f). The Director 
must ensure that the media campaign is evidence-based and accurate, 
meets accepted standards for public awareness campaigns, and uses 
effective strategies.
    ONDCP seeks comments about the relative costs and benefits of 
designating emerging drug threats and implementing response plans to 
address such threats. What activities would federal agencies, state, 
local and tribal governments, health care providers and other entities 
be required to incur as a result of an emerging drug threat 
designation, and what would those activities cost? What activities 
would federal agencies, state, local and tribal governments, health 
care providers and other entities take voluntarily as result of an 
emerging drug threat designation, and what would those activities cost? 
What benefits, such as lives saved and improved public health outcomes, 
would result from an emerging drug threat designation? Information 
submitted should include any negative or positive economic effects that 
could result from promulgation.
    5. Effectiveness of Alternative Approaches: How can ONDCP best 
accomplish its goal of monitoring and identifying emerging drug threats 
in the United States? What other approaches to designating emerging 
drug threats should ONDCP consider in carrying out its responsibilities 
under the SUPPORT Act?
    Interested parties are invited to submit comments on any or all of 
these and other pertinent issues related to the development of criteria 
for designating or terminating the designation of emerging drug 
threats. ONDCP appreciates any and all comments, but those most useful 
and likely to influence decisions on the proposed criteria will be 
those that are either informed by medical, public health, or law 
enforcement research on evidence-based methods for monitoring or 
identifying drug trends or involve personal experience with drug misuse 
and addiction.

V. Statutory and Executive Order Review

    This ANPRM has been drafted and reviewed in accordance with 
Executive Order 12866, ``Regulatory Planning and Review,'' section 
1(b), The Principles of Regulation; Executive Order 13563, ``Improving 
Regulation and Regulatory Review,'' section 1(b), General Principles of 
Regulation; and Executive Order 13771, ``Reducing Regulation and 
Controlling Regulatory Costs.'' The Office of Management and Budget 
(OMB) has determined that this ANPRM is a significant regulatory action 
under Executive Order 12866, section 3(f), and accordingly this ANPRM 
has been reviewed by OMB.
    Pursuant to guidance issued by OMB, the requirements of E.O. 13771 
do not apply to this ANPRM. This action does not propose or impose any 
requirements. ONDCP is merely collecting information and data on the 
possible economic impact that may occur as a direct or indirect result 
of promulgation of emerging drug threats criteria.
    The requirements of the Regulatory Flexibility Act (RFA) do not 
apply to this action because, at this stage, it is an ANPRM and not 
``rule'' as defined in 5 U.S.C. 601. Following review of the comments 
received in response to this ANPRM, when ONDCP decides to proceed with 
a notice of proposed rulemaking regarding this matter, ONDCP will 
conduct all relevant analyses as required by statute or Executive 
Order.
    This ANPRM was prepared under the direction of James W. Carroll, 
Jr., Director, Office of National Drug Control Policy, 1800 G Street 
NW, 9th Floor, Washington, DC 20006. It is issued pursuant to section 
8218(c) of the SUPPORT for Patients and Communities Act, 21 U.S.C. 
1708(c).

Michael J. Passante,
Acting General Counsel.
[FR Doc. 2020-09469 Filed 5-14-20; 8:45 am]
 BILLING CODE 3280-F5-P