Department of Health and Human Services 2015 – Federal Register Recent Federal Regulation Documents

The U.S. Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), announces the publication of Final Safeguards and Research Criteria for transplantation of HIV-positive donor organs in HIV-positive recipients. All such transplants must occur under an institutional review board (IRB)-approved research protocol that is compliant with federal regulations governing human subjects' research. The goal of this research is to increase knowledge about the safety, efficacy, and effectiveness of solid organ transplantation (SOT) utilizing HIV- positive donors in HIV-positive recipients. A summary of public comments on the previously published Draft Safeguards and Research Criteria and HHS' responses follow, as well as the Final Safeguards and Research Criteria.

The Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for Fiscal Year 2017 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2016 through September 30, 2017. This notice announces the calculated FMAP rates, in accordance with sections 1101(a)(8) and 1905(b) of the Act, that the U.S. Department of Health and Human Services (HHS) will use in determining the amount of federal matching for state medical assistance (Medicaid), Temporary Assistance for Needy Families (TANF) Contingency Funds, Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Foster Care Title IV-E Maintenance payments, and Adoption Assistance payments, and the eFMAP rates for the Children's Health Insurance Program (CHIP) expenditures. Table 1 gives figures for each of the 50 states, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. This notice reminds states of available disaster-recovery FMAP adjustments for qualifying states, and adjustments available for states meeting requirements for negative growth in total state personal income. At this time, no states qualify for such adjustments. This notice also contains the increased eFMAPs for CHIP as authorized under the Patient Protection and Affordable Care Act (Affordable Care Act) for fiscal years 2016 through 2019 (October 1, 2015 through September 30, 2019). Programs under title XIX of the Act exist in each jurisdiction. Programs under titles I, X, and XIV operate only in Guam and the Virgin Islands. The percentages in this notice apply to state expenditures for most medical assistance and child health assistance, and assistance payments for certain social services. The Act provides separately for federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Social Security Act (the Act) require the Secretary of HHS to publish the FMAP rates each year. The Secretary calculates the percentages, using formulas in sections 1905(b) and 1101(a)(8), and calculations by the Department of Commerce of average income per person in each state and for the Nation as a whole. The percentages must fall within the upper and lower limits specified in section 1905(b) of the Act. The percentages for the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 states.

The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Psoriasis. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of psoriasis, including on daily life and patient views on treatment approaches. FDA is interested in patients' perspectives for the types of psoriasis with primarily skin symptoms (such plaque psoriasis, nail psoriasis, guttate psoriasis, etc.), patient views on treatment approaches, and decision factors taken into account when selecting a treatment.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (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 or we) is announcing the availability of a draft guidance for industry entitled ``Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon: Guidance for Industry.'' We developed the draft guidance to assist food manufacturers that wish to voluntarily label their food product or ingredients (for humans or animals) derived from Atlantic salmon as either containing or not containing products from genetically engineered (GE) Atlantic salmon.

The Food and Drug Administration (FDA, the Agency) is amending the animal drug regulations to reflect the approval of a new animal drug application (NADA) filed by AquaBounty Technologies, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) gene construct in a lineage of genetically engineered Atlantic salmon.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed revision of the information collection entitled Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for MetricsCollege of American Pathologists, which will allow for a fuller exploration of the factors that underlie the reasons why laboratorians adhere to the College of American Pathologists' laboratory practice guideline for immunohistochemistry test validation.

The Food and Drug Administration (FDA) is announcing that BASF Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of sodium formate as a feed acidifier in poultry feed.

This notice amends Federal Register notice 80 FR 61831, published October 14, 2015, announcing the National Toxicology Program (NTP) Board of Scientific Counselors (BSC) meeting and requesting comments. The deadline for written public comment submission has been changed to January 8, 2016. Persons submitting comments for the BSC meeting are encouraged to send them by November 30, 2015, to facilitate review by the BSC and NTP staff prior to the meeting. NTP is extending the written public comment period beyond the BSC meeting to provide additional opportunity for the public to comment on two draft concepts, Mountaintop Removal Mining: Impacts on Health in the Surrounding Community and Systematic Review on Fluoride and Developmental Toxicity. All other information in the original notice has not changed. Information about the meeting and registration is available at https:// ntp.niehs.nih.gov/go/165.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Nonprescription Sunscreen Drug ProductsContent and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act''. This draft guidance addresses FDA's current thinking on how we will determine whether a sponsor's submission of safety and efficacy data is sufficiently complete to support a substantive review and determination under the Sunscreen Innovation Act (SIA) that an active ingredient is or is not generally recognized as safe and effective (GRASE) for use in nonprescription sunscreen products. This guidance is being issued in accordance with the SIA.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.'' This draft guidance explains the process by which FDA intends to carry out the section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Sunscreen Innovation Act (SIA), which governs the convening of advisory committees and the number of requests to be considered per meeting. The recommendations in this draft guidance apply to 586A requests submitted under the FD&C Act and to pending requests as defined by the SIA that seek a determination from FDA on whether a nonprescription sunscreen active ingredient, or a combination of nonprescription sunscreen active ingredients, is generally recognized as safe and effective for use under specified conditions and should be included in the over-the-counter (OTC) sunscreen drug monograph. The SIA describes specific circumstances under which FDA is ``not'' required to convene or submit requests to the Nonprescription Drugs Advisory Committee (NDAC). We are issuing this draft guidance pursuant to the SIA, which directs FDA to issue four guidances on various topics, including this draft guidance.

The Food and Drug Administration (FDA) is classifying the prostate lesion documentation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the prostate lesion documentation system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.