Department of Health and Human Services June 2019 – Federal Register Recent Federal Regulation Documents

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is updating its Strategic Plan for Fiscal Years (FY) 2020-2024 to help guide the research it supports over the next five years. The Institute issued a previous Request for Information (RFI) (NOT-AR-19-009) to solicit initial comments on how the previous plan for Fiscal Years 2015-2019 should be modified to reflect progress over the past five years. The Institute also gathered additional input through listening sessions with the community. Based on this feedback, along with input from the NIAMS Advisory Council and its Working Group for the Strategic Plan, the Institute has drafted the NIAMS Strategic Plan for FY 2020-2024. We are now seeking input on this draft. Through this RFI, NIAMS invites feedback from researchers in academia and industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, Federal agencies, and other interested members of the public on the draft NIAMS Strategic Plan for FY 2020-2024. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership as a whole. The final draft of the Strategic Plan will be presented at the September 2019 meeting of the NIAMS Advisory Council and the final plan will be posted on the NIAMS website once it is approved.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ZOLGENSMA (onasemnogene abeparvovec-xioi), manufactured by AveXis, Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Allergenic Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Providing Regulatory Submissions in Electronic and Non-Electronic Format Promotional Labeling and Advertising Materials for Human Prescription Drugs.'' This guidance outlines the requirements and recommendations for various types of submissions of promotional materials for prescription drugs and biological products, including the specific formats needed for use in the electronic common technical document (eCTD) as well as non-eCTD and non-electronic formats. This guidance finalizes the draft guidance issued in April 2015.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), is providing notice of a re-established matching program between HHS/ACF/OCSE and state agencies administering the Supplemental Nutrition Assistance Program (SNAP). The matching program compares state SNAP agency records with new hire, quarterly wage, and unemployment insurance information maintained in the National Directory of New Hires (NDNH). The outcomes of the comparisons help state agencies with establishing or verifying eligibility for applicants and recipients of SNAP benefits; reducing SNAP benefit errors; and, maintaining program integrity.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.'' The purpose of this guidance is to describe the benefit- risk framework the Agency uses in evaluating applications for opioid analgesic drugs. This guidance summarizes the information that should be included in a new drug application (NDA) for an opioid analgesic drug to facilitate the Agency's benefit-risk assessment.

The Food and Drug Administration (FDA, Agency, we) is holding a public hearing on September 17, 2019, entitled ``Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.'' The Agency today is issuing a draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs. This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Study of Oncology Indications in Direct-to-Consumer Television Advertising.'' This research consists of two studies examining the presentation of oncology indications in direct-to-consumer (DTC) television ads.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register of April 3, 2019. The notice announced a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. In addition, it notified the public that FDA was establishing a docket for public comment on this hearing and that the docket would close on July 2, 2019. We are extending the comment period to give interested parties more time to comment.

In accordance with the requirements of the Privacy Act of 1974, as amended, the HHS is modifying a system of records maintained by HRSA, Healthcare Systems Bureau (HRSA/HSB), System No. 09-15-0056, ``National Vaccine Injury Compensation Program'' (VICP), and renaming it ``Injury Compensation Programs, HHS/HRSA/HSB.'' The primary purpose of the modification is to include records covered by a related system of records also maintained by HRSA/HSB, System No. 09-15-0071, ``Countermeasures Injury Compensation Program, HHS/HRSA/HSB'' (CICP), in order to consolidate the two systems of records and rescind System No. 09-15-0071.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``The Declaration of Added Sugars on Honey, Maple Syrup, Other Single- Ingredient Sugars and Syrups, and Certain Cranberry Products.'' This guidance provides clarification on the labeling requirements for single-ingredient packages and/or containers of pure honey, pure maple syrup, and other pure sugars and syrups, which are not required to bear the words ``Includes Xg Added Sugars,'' but must still include the percent Daily Value for added sugars on their labels. This guidance is also intended to advise food manufacturers of our intent to exercise enforcement discretion related to the use of a ``[dagger]'' symbol immediately following the percent Daily Value for added sugars on single-ingredient packages and/or containers of pure honey, pure maple syrup, and other pure sugars and syrups; the ``[dagger]'' symbol would lead the consumer to a statement that is truthful and not misleading in a footnote at the bottom of the Nutrition Facts label. The guidance also advises food manufacturers of our intent to exercise enforcement discretion with respect to the use of a ``[dagger]'' symbol immediately after the added sugars percent Daily Value information that leads the consumer to a statement that is truthful and not misleading outside of the Nutrition Facts label on certain dried cranberry and cranberry beverage products that are made up of cranberry juice sweetened with added sugars and that contain total sugars at levels no greater than comparable products with endogenous (inherent) sugars, but no added sugars. Further, this guidance advises of our intent to exercise enforcement discretion regarding compliance with Nutrition Facts label final rule and Serving Size final rule requirements until July 1, 2021, for the single-ingredient sugars and syrups as well as the cranberry products discussed in the guidance document.

This document sets forth final rules to expand opportunities for working men and women and their families to access affordable, quality healthcare through changes to rules under various provisions of the Public Health Service Act (PHS Act), the Employee Retirement Income Security Act (ERISA), and the Internal Revenue Code (Code) regarding health reimbursement arrangements (HRAs) and other account-based group health plans. Specifically, the final rules allow integrating HRAs and other account-based group health plans with individual health insurance coverage or Medicare, if certain conditions are satisfied (an individual coverage HRA). The final rules also set forth conditions under which certain HRAs and other account-based group health plans will be recognized as limited excepted benefits. Also, the Department of the Treasury (Treasury Department) and the Internal Revenue Service (IRS) are finalizing rules regarding premium tax credit (PTC) eligibility for individuals offered an individual coverage HRA. In addition, the Department of Labor (DOL) is finalizing a clarification to provide assurance that the individual health insurance coverage for which premiums are reimbursed by an individual coverage HRA or a qualified small employer health reimbursement arrangement (QSEHRA) does not become part of an ERISA plan, provided certain safe harbor conditions are satisfied. Finally, the Department of Health and Human Services (HHS) is finalizing provisions to provide a special enrollment period (SEP) in the individual market for individuals who newly gain access to an individual coverage HRA or who are newly provided a QSEHRA. The goal of the final rules is to expand the flexibility and use of HRAs and other account-based group health plans to provide more Americans with additional options to obtain quality, affordable healthcare. The final rules affect employees and their family members; employers, employee organizations, and other plan sponsors; group health plans; health insurance issuers; and purchasers of individual health insurance coverage.