Department of Health and Human Services August 27, 2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products.

The Office of Rural Health Policy (ORHP) will award program expansion supplemental awards to the current Small Health Care Provider Quality Improvement (Quality) program grantees. The program expansion supplemental funds will allow current Quality program grantees: To provide education to those new to health care coverage about health care benefits to which they have access; to raise awareness about the importance of receiving routine primary care and regular preventive services; and to expand outreach and enrollment activities for the next Affordable Care Act's (ACA) Health Insurance Marketplace open enrollment period (November 15, 2014-February 15, 2015). The goals of this supplemental funding are to (1) increase the number of newly insured individuals educated about the benefits and primary care and preventive services to which they now have access, (2) increase the number of uninsured individuals educated about their coverage options, and (3) increase the number of uninsured individuals enrolled into the Health Insurance Marketplaces or other available sources of insurance, such as Medicaid and the Children's Health Insurance Program.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a tropical disease priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each FY based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the tropical disease priority review fee rate for FY 2015.

The Food and Drug Administration is correcting a notice entitled ``Biosimilar User Fee Rates for Fiscal Year 2015'' that appeared in the Federal Register of August 1, 2014 (79 FR 44795). The document announced the rates for biosimilar user fees for fiscal year 2015. The document was published with the incorrect docket number. This document corrects that error.

The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of a single-source program expansion supplement grant to U.S. Committee for Refugees and Immigrants in Arlington, Virginia for a total of $361,286. The supplemental funding will ensure sufficient that clients' essential needs, such as housing, transportation, communication, food, and medical care will be met.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.'' This guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostic devices (HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture.

This document proposes a change to the definition of an eligible organization that can avail itself of an accommodation with respect to coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. Among these services are women's preventive health services, as specified in guidelines supported by the Health Resources and Services Administration (HRSA). As authorized by the current regulations, and consistent with the HRSA Guidelines, group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) are exempt from the otherwise applicable requirement to cover certain contraceptive services. Additionally, under current regulations, accommodations are available with respect to the contraceptive coverage requirement for group health plans established or maintained by eligible organizations (and group health insurance coverage provided in connection with such plans), and student health insurance coverage arranged by eligible organizations that are institutions of higher education, that effectively exempt them from this requirement. The regulations establish a mechanism for separately furnishing payments for contraceptive services on behalf of participants and beneficiaries of the group health plans of eligible organizations that avail themselves of an accommodation, and enrollees and dependents of student health insurance coverage arranged by eligible organizations that are institutions of higher education that avail themselves of an accommodation. These rules propose and seek comments on potential changes to the definition of ``eligible organization'' in the Departments' regulations in light of the Supreme Court's decision in Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751 (2014), to ensure that participants and beneficiaries in group health plans (and enrollees and dependents in student health insurance coverage arranged by institutions of higher education) obtain, without additional cost, coverage of the full range of Food and Drug Administration (FDA) approved contraceptive services, as prescribed by a health care provider, while respecting certain closely held for-profit entities' religion-based objections to contraceptive coverage. These proposed rules also seek comments on any additional steps the government should take to help ensure coverage of the full range of FDA-approved contraceptives, as prescribed by a health care provider, without cost sharing, for participants and beneficiaries in group health plans of such entities (and enrollees and dependents in student health insurance coverage arranged by such entities that are institutions of higher education).