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###### Department of Commerce

###### Office of the Secretary 

          - 15 CFR Part 3
          - [Docket No. 241210-0320]
          - RIN 0605-AA64

# AGENCY:

Department of Commerce.

      ( print page 102702)    

# ACTION:

Final rule.

# SUMMARY:

This rule implements the HAVANA Act of 2021 (the Act) for the Department of Commerce (Department). The Act provides the authority for the Secretary of Commerce and other agency heads to provide payments to certain individuals who have incurred qualifying injuries to the brain. The rule covers current and former Department employees and dependents of current or former employees.

# DATES:

This final rule is effective December 18, 2024.

# ADDRESSES:

                        Public comments and materials associated with this final rule are available through the Federal eRulemaking Portal at                         *http://www.Regulations.gov,*                         Docket No. DOC-2023-0001.                    

# FOR FURTHER INFORMATION CONTACT:

                        Charles Cutshall, Chief Privacy Officer, at 202-482-5735 or                         *ccutshall@doc.gov*.                    

# SUPPLEMENTARY INFORMATION:

## Background

This rule implements the Helping American Victims Affected by Neurological Attacks (HAVANA) Act of 2021, Public Law 117-46, codified in 22 U.S.C. 2680b(i), which (among other things) required Department heads to prescribe regulations implementing the HAVANA Act for covered individuals. The Department published an interim final rule (IFR) on April 19, 2023 (88 FR 24110), which laid out the process for HAVANA Act claimants to submit claims for payment for a qualifying injury to the brain suffered by current and former employees of the Department, and dependents of current or former employees. Under the IFR, the criteria for a qualifying injury to the brain are based on current medical practices related to brain injuries. Further, the injury must have occurred in connection with certain hostile acts or other incidents designated by the Secretary of State or the Secretary of Commerce. Further background is contained in the preamble to the IFR. The IFR provided for 30 days of public comment, and the Department provides responses to those comments below.

## Responses to Comments

The Department received a total of eight public comment submissions in response to the IFR. Many comments provided input on multiple subjects. The Department received identical comment submissions from four commentors. All comments are addressed below.

Several commentors focused on the Department's definition of “qualifying injury to the brain.” First, numerous commentors urged the Department to adopt a broad definition of a “qualifying injury to the brain.” Under the IFR, individuals may be eligible for a HAVANA Act payment if they meet one of three criteria under the definition of “qualifying injury to the brain”: (1) An acute injury to the brain such as, but not limited to, a concussion, penetrating injury, or as the consequence of an event that leads to permanent alterations in brain function as demonstrated by confirming correlative findings on imaging studies (to include computed tomography scan (CT), or magnetic resonance imaging scan (MRI)), or electroencephalogram (EEG); or (2) A medical diagnosis of a traumatic brain injury (TBI) that required active medical treatment for 12 months or more; or (3) acute onset of new persistent, disabling neurologic symptoms as demonstrated by confirming correlative findings on imaging studies (to include CT or MRI), or EEG, or physical exam, or other appropriate testing, and that required active medical treatment for 12 months or more.

The Department believes that this definition is broad and flexible enough to cover a wide range of brain injuries. The Department also notes that this definition is consistent with regulations issued by the State Department (Jan. 25, 2023, at 88 FR 4722). Therefore, this final rule does not change the IFR definition of “qualifying injury to the brain.”

Multiple comments requested that the Department remove the requirement that an individual receive 12 months of active medical treatment before they are eligible for a HAVANA Act payment. Of the three criteria for a qualifying brain injury, as set forth above, only (2) and (3) require 12 months of treatment. Under (1), 12 months of treatment is not required if an individual demonstrates permanent alterations in brain function with confirming correlative findings on imaging studies. The Department believes that the requirement for 12 months of treatment, which is consistent with State Department regulations (Jan. 25, 2023, at 88 FR 4722), demonstrates that an individual suffers from a chronic condition even if that individual does not demonstrate a permanent condition. Further, even if a covered individual has not yet received 12-months or more of treatment as outlined in (2) or (3), the covered individual may nevertheless qualify at a later time if treatment lasts for twelve months or more.

A number of comments asked that the Department establish an eligibility threshold for benefits that does not rest in whole or in part on the contemporaneous diagnosis of a brain injury. Instead, the commentors urged the Department to allow claimants to establish eligibility based on the presence of one or more of the symptoms that have come to be associated with Anomalous Head Injuries. The Department does not believe that it is appropriate to grant claims without appropriate medical documentation of a qualifying injury to the brain. The Department also notes that the standard that it uses to determine payment eligibility is consistent with the standard used by the Department of State.

One comment asked that the Department recognize a “qualifying brain injury” even when an individual is receiving ongoing treatment; or the treatment was “split up” or the individual was diagnosed years later. Nothing in the IFR prevents the payment of compensation under such circumstances, provided that the definition of a “qualifying brain injury” is otherwise met.

One comment focused on the date of the injury, expressing a belief that the Department should compensate individuals who suffered qualifying injuries prior to January 1, 2016. The Department is unable to accept this suggestion. The HAVANA Act specifies that payments are for injuries occurring on or after January 1, 2016. The Department does not have the authority to provide payments for injuries occurring prior to that date without an amendment to the HAVANA Act or additional legislative action.

In addition to the comments discussed above concerning the Department's definition of a “qualifying brain injury,” multiple comments urged that the final rule incorporate some mechanism to facilitate changes to the Department's framework for determining eligibility for payment based on science or diagnostic breakthroughs. The Department declines to incorporate such a mechanism into this final rule but may conduct rulemaking in the future in accordance with existing laws and regulations, should circumstances so dictate.

                    One comment urged the Department to provide reasons for a denial of requests for benefits to a claimant and develop a meaningful appeals process that employees can use in the event of a denial of benefits. Under the IFR, the Department already provides claimants who have been denied a payment with the reason for the denial. Additionally, the Department believes that its current appeals process, which provides for                           ( print page 102703)                        higher-level review of any denial, offers adequate and meaningful review of denials.                

One comment, seeking to ensure greater transparency about the Department's decision-making process, raised concerns with the use of non-public information maintained by the State Department in the Department's consultation process with the State Department. Consultation with the State Department may assist the Department in determining, in part, a claimant's eligibility for benefits under the HAVANA Act. In particular, because a qualifying injury to the brain must have occurred in connection with war, insurgency, hostile act, terrorist activity, or other incidents designated by the Secretary of State or the Secretary of Commerce, consultation with the State Department may assist in determining whether an injury is connected to an incident designated by the Secretary of State. However, the State Department, not the Department of Commerce, determines whether such information is administratively controlled or made publicly available.

## Regulatory Analysis

### Administrative Procedure Act

                    Because this rule is a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts, it is exempt from the requirements of 5 U.S.C. 553.                     *See*5 U.S.C. 553(a)(2). Furthermore, because this final rule does not change the regulatory provisions previously implemented by the IFR, a delay in effective date is unnecessary and therefore the Department finds good cause for this rule to take effect immediately. Furthermore, because this final rule does not change the regulatory provisions previously implemented by the IFR, a delay in effective date is unnecessary and therefore the Department finds good cause for this rule to take effect immediately.                     *See*5 U.S.C. 553 (d)(3).                

### Regulatory Flexibility Act

                    The Chief Counsel for Regulations for the Department certified that this rulemaking does not have a significant impact on a substantial number of small entities. This rule applies only to certain individuals who are current and former Department employees and family members who are eligible for payments as a result of certain injuries. The rule provides for payments to certain individuals and is not expected to impact any small entities. As a result, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act (5 U.S.C. 601,                     *et seq.*), and none has been prepared.                

### Executive Order 12866 and Executive Order 13563

This rule has been determined to be a significant regulatory action under Executive Order 12866, as amended by Executive Order 14094.

The Department has reviewed the rule to ensure its consistency with the regulatory philosophy and principles set forth in Executive Order 12866 and finds that the benefits of the rule (in providing mechanisms for individuals to obtain compensation for certain injuries) outweigh any costs to the public. The Department has also considered this rulemaking in light of Executive Order 13563 and affirms that this proposed regulation is consistent with the guidance therein.

### Paperwork Reduction Act

                    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501,                     *et seq.*) (PRA), the information collection associated with this final rule was approved by the Office of Management and Budget (OMB) under OMB Control Number 0690-0037. Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.                

Accordingly, the Department of Commerce adopts the interim rule published April 19, 2023, at 88 FR 24110, as final without change.

Dated: December 13, 2024.

Jeremy Pelter,

Deputy Assistant Secretary for Administration, performing the non-exclusive functions and duties of the Chief Financial Officer and Assistant Secretary of Commerce for Administration, U.S. Department of Commerce.

[FR Doc. 2024-29993 Filed 12-17-24; 8:45 am]

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