45 CFR Chapter XXV - CORPORATION FOR NATIONAL AND COMMUNITY SERVICE

On November 18, 2015, the Departments of Labor, Health and Human Services, and the Treasury (the Departments) published a final rule in the Federal Register titled “Final Rules for Grandfathered Plans, Preexisting Condition Exclusions, Lifetime and Annual Limits, Rescissions, Dependent Coverage, Appeals, and Patient Protections Under the Affordable Care Act” (the November 2015 final rule), regarding, in part, the coverage of emergency services by non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage, including the requirement that non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage limit cost-sharing for out-of-network emergency services and, as part of that rule, pay at least a minimum amount for out-of-network emergency services. The American College of Emergency Physicians (ACEP) filed a complaint in the United States District Court for the District of Columbia, which on August 31, 2017 granted in part and denied in part without prejudice ACEP's motion for summary judgment and remanded the case to the Departments to respond to the public comments from ACEP and others. In response, the Departments are issuing this notice of clarification to provide a more thorough explanation of the Departments' decision not to adopt recommendations made by ACEP and certain other commenters in the November 2015 final rule.

This document corrects the Regulatory Identification Number (RIN) that appeared in the heading of a Notice of Proposed Rulemaking published in the Federal Register of March 15, 2018. Through that document, the Children's Bureau proposed to delay the compliance and effective dates in the Adoption and Foster Care Analysis and Reporting System (AFCARS) 2016 final rule for title IV-E agencies to comply with agency rules for an additional two fiscal years.

In a final rule published on January 19, 2017, federal departments and agencies made revisions to the Federal Policy for the Protection of Human Subjects (hereafter the “2018 Requirements”). The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The 2018 Requirements were scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). The departments and agencies listed in this document have also published an interim final rule delaying the effective date and general compliance date for the 2018 Requirements for six months, to cover the time period of January 19, 2018 until July 19, 2018. As per the interim final rule, the effective date of the 2018 Requirements is now July 19, 2018. The departments and agencies listed in this document propose delaying the general compliance date for the 2018 Requirements for an additional six months, for the time period of July 19, 2018 until January 21, 2019. This proposed rule is intended to provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements. This proposed rule, if finalized, would require regulated entities to continue to comply with the requirements of the current Federal Policy for the Protection of Human Subjects (hereafter the “pre-2018 Requirements”) until January 21, 2019. This proposal also takes comment on whether to permit institutions to implement, for certain research studies, the following provisions in the 2018 Requirements during the period from July 19, 2018, until January 21, 2019, that the general compliance date is delayed. Those three provisions, intended to reduce burdens on regulated entities, are the 2018 Requirements' definition of “research,” which deems certain activities not to be research, the allowance for no annual continuing review of certain categories of research, and the elimination of the requirement that institutional review boards (IRBs) review grant applications related to the research. The way that this option is proposed, regulated entities would be required to comply with all pre-2018 Requirements during the period that the general compliance date is delayed, except for provisions substituted by the three burden-reducing provisions of the 2018 Requirements. As described in section III, below, this flexibility is proposed only for studies for which an institution makes a choice to transition to comply with the 2018 Requirements, beginning on July 19, 2018. In order to clearly describe this proposed flexibility, including how it would impact institutions choosing to transition research to comply with the 2018 Requirements, this document proposes a redrafted transition provision.

This final rule governs subpoenas and requests for LSC documents and testimony by non-federal litigants in cases in which LSC is not a party. This rule provides the public with guidance on where to send requests and establishes procedures by which those requests will be processed.

The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), is issuing this final rule to make effective the exemptions that HHS/NIH proposed for a subset of records covered in a new Privacy Act system of records, System No. 09-25-0225, NIH Electronic Research Administration (eRA) Records (NIH eRA Records). The new system covers records used in managing NIH research and development applications and awards throughout the award lifecycle. The listed exemptions are necessary to maintain the integrity of the NIH extramural peer review and award processes, and will enable the agency to prevent, when appropriate, individual record subjects from having access to, and other rights under the Privacy Act with respect to, confidential source-identifying material in the records.

This rule contains proposals amending the definition of short-term, limited-duration insurance for purposes of its exclusion from the definition of individual health insurance coverage. This action is being taken to lengthen the maximum period of short-term, limited-duration insurance, which will provide more affordable consumer choice for health coverage.

In the regulation of health care, the United States has a long history of providing conscience-based protections for individuals and entities with objections to certain activities based on religious belief and moral convictions. Multiple such statutory protections apply to the Department of Health and Human Services (HHS, or the Department) and the programs or activities it funds or administers. The Department proposes to revise regulations previously promulgated to ensure that persons or entities are not subjected to certain practices or policies that violate conscience, coerce, or discriminate, in violation of such Federal laws. Through this rulemaking, the Department proposes to grant overall responsibility to its Office for Civil Rights (OCR) for ensuring that the Department, its components, HHS programs and activities, and those who participate in HHS programs or activities comply with Federal laws protecting the rights of conscience and prohibiting associated discriminatory policies and practices in such programs and activities. In addition to conducting outreach and providing technical assistance, OCR will have the authority to initiate compliance reviews, conduct investigations, supervise and coordinate compliance by the Department and its components, and use enforcement tools otherwise available in civil rights law to address violations and resolve complaints. In order to ensure that recipients of Federal financial assistance and other Department funds comply with their legal obligations, the Department will require certain recipients to maintain records; cooperate with OCR's investigations, reviews, or other enforcement actions; submit written assurances and certifications of compliance to the Department; and provide notice to individuals and entities about their conscience and associated anti-discrimination rights, as applicable.

The Legal Services Corporation (LSC) is required by law to establish maximum income levels for individuals eligible for legal assistance. This document updates the specified income levels to reflect the annual amendments to the Federal Poverty Guidelines issued by the U.S. Department of Health and Human Services (HHS).

In a final rule published on January 19, 2017, federal departments and agencies listed in this document made revisions to the Federal Policy for the Protection of Human Subjects. The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The revised policy, reflected in both final rules, is described here as the “2018 Requirements.” The 2018 Requirements are scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). This interim final rule delays the effective date and general compliance date of the 2018 Requirements to July 19, 2018. The federal departments and agencies listed in this document are in the process of developing a proposed rule to further delay implementation of the 2018 Requirements. The limited implementation delay accomplished by this interim final rule both provides additional time to regulated entities for the preparations necessary to implement the 2018 Requirements, and additional time for the departments and agencies listed in this document to seek input from interested stakeholders through a notice and comment rulemaking process that allows for public engagement on the proposal for a further implementation delay.

With this document, the Secretary exercises his authority to waive the August 1, 2019 Head Start center-based service duration requirements, effectively lowering this requirement from 50 percent to 0 percent. However, the requirement that Early Head Start programs provide 1,380 annual hours of planned class operations for all center-based enrollment by August 1, 2018 remains in effect.

The National Endowment for the Arts (NEA) is adjusting the maximum civil monetary penalties that may be imposed for violations of the Program Fraud Civil Remedies Act (PFCRA) and the NEA's Restrictions on Lobbying to reflect the requirements of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act). The 2015 Act further amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act) to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. This final rule finalizes the catch-up inflation adjustment interim final rule required by the Inflation Adjustment Act.

OHS invites public comment on several specific changes being considered for the CLASS condition of the Designation Renewal System (DRS) as outlined in the Head Start Program Performance Standards. We are considering changes to the CLASS condition with a goal of improving implementation and transparency of the DRS. Changes being considered include removal of the “lowest 10 percent” provision of the CLASS condition, an increase of the minimum thresholds for the Emotional Support and Classroom Organization domains to a score of 5, removal of the minimum threshold for the Instructional Support domain, and establishment of authority for the Secretary to set an absolute minimum threshold for the Instructional Support domain prior to the start of each fiscal year to be applied for DRS CLASS reviews in the same fiscal year. OHS requests feedback on these possible changes as well as alternative changes to the CLASS condition, particularly ways the Instructional Support threshold could be set and/or adjusted that would incentivize program improvement while acknowledging the current state of the field. OHS also invites feedback on other conditions of the DRS.

The Legal Services Corporation (LSC) is correcting a final rule that appeared in the Federal Register on August 10, 2017. LSC's Property Acquisition and Management Manual (PAMM) and its cost standards rule required grantees to seek approval prior to making any real estate purchase with LSC funds, regardless of the purchase price. The final rule's language describing this longstanding policy was incorrect. This document corrects the language to remain consistent with LSC's current policy. The document also contained an incorrect cross-reference to another section. This document corrects the final rule by revising that cross-reference.