Department of Health and Human Services December 2, 2014 – Federal Register Recent Federal Regulation Documents
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Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2015 Through September 30, 2016
The Federal Medical Assistance Percentages (FMAP), Enhanced Federal Medical Assistance Percentages (eFMAP), and disaster-recovery FMAP adjustments for Fiscal Year 2016 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2015 through September 30, 2016. This notice announces the calculated FMAP rates 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. 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, while a program under title XVI (Aid to the Aged, Blind, or Disabled) operates only in Puerto Rico. 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.
Medicare and Medicaid Programs; CY 2015 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Survey and Enforcement Requirements for Home Health Agencies; Correction
This document corrects a technical error in the final rule that appeared in the Federal Register on November 6, 2014, entitled ``Medicare and Medicaid Programs; CY 2015 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Survey and Enforcement Requirements for Home Health Agencies.''
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Meeting of the National Advisory Committee on Children and Disasters
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will be holding a meeting via teleconference. The meeting is open to the public.
Infusion Pumps Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff; Availability
Food and Drug Administration (FDA) is announcing the availability of the final guidance entitled, ``Infusion Pumps Total Product Life Cycle; Guidance for Industry and FDA Staff.'' The recommendations in this guidance are intended to improve the safety and effectiveness of these devices. This guidance also describes considerations in preparing premarket submissions for infusion pumps and identifies device features that manufacturers should address throughout the total product life cycle.
Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Recommendations for Labeling Medical Products to Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Guidance for Industry and Food and Drug Administration Staff.'' The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product, product container, and/or packaging. FDA is concerned that statements submitted for inclusion in medical product labeling, such as ``latex-free,'' ``does not contain natural rubber latex,'' or ``does not contain latex'' are not accurate because it is not possible to reliably assure that there is a complete absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product.
Establishment of a Public Docket; Electronic Cigarettes and the Public Health Workshop
The Food and Drug Administration (FDA), Center for Tobacco Products, is establishing a public docket in conjunction with the first public workshop to gather scientific information about electronic cigarettes (e-cigarettes) as announced in Docket No. FDA-2014-N-0001- 0079. Regardless of attendance at the public workshop, interested parties are invited to submit comments, supported by research and data, regarding electronic cigarettes and the public health.
Guidance for Industry on Scale-Up Post-Approval Changes: Manufacturing Equipment Addendum; Availability
The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) guidance for industry entitled ``SUPAC: Manufacturing Equipment Addendum.'' This replaces the draft guidance of the same name that combined and superseded ``SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum,'' published on January 1, 1999; and ``SUPAC-SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,'' published as a draft on December 1, 1998. FDA revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced.
Recommendations for Providers Counseling Male Patients and Parents Regarding Male Circumcision and the Prevention of HIV Infection, STIs, and Other Health Outcomes
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is seeking public comment on draft recommendations for health care providers who deliver information and counseling about elective male circumcision and the prevention of HIV and other adverse health outcomes to male patients and parents in the United States. The draft recommendations include information about the health benefits and risks of elective male circumcision performed by health care providers.
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