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

This notice announces our decision to renew the Medicare Advantage ``deeming authority'' of the Utilization Review Accreditation Commission (URAC) for health maintenance organizations and preferred provider organizations for a term of 6 years.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The United States has a long history of providing protections in health care for individuals and entities on the basis of religious beliefs or moral convictions. Congress has passed many such laws applicable to the Department of Health and Human Services (``HHS'' or the ``Department'') and the programs or activities it funds or administers, some of which are the subject of existing HHS regulations. This final rule revises existing regulations to ensure vigorous enforcement of Federal conscience and anti-discrimination laws applicable to the Department, its programs, and recipients of HHS funds, and to delegate overall enforcement and compliance responsibility to the Department's Office for Civil Rights (``OCR''). In addition, this final rule clarifies OCR's authority to initiate compliance reviews, conduct investigations, supervise and coordinate compliance by the Department and its components, and use enforcement tools otherwise available in existing regulations 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, this final rule requires certain recipients to maintain records; cooperate with OCR's investigations, reviews, or other proceedings; and submit written assurances and certifications of compliance to the Department. The final rule also encourages the recipients of HHS funds to provide notice to individuals and entities about their right to be free from coercion or discrimination on account of religious beliefs or moral convictions.

The Agency for Healthcare Research and Quality (AHRQ) requests public comments about the impact and use of Evidence-based Practice Center (EPC) Program evidence reviews. Members of the public include health care delivery organizations, guideline developers, payers, quality measure developers, research funders, and other organizations, including patient organizations, that have used AHRQ EPC evidence reviews.

The Food and Drug Administration (FDA), Office of the Commissioner, Headquarters organizations, and Centers have modified their structures.

The Office of Child Care (OCC), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new Onsite Monitoring System to evaluate grantee compliance with (1) The Child Care and Development Block Grant (CCDBG) Act; (2) CCDF Regulations; and (3) The State/ Territory CCDF approved Plan.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``The Use of an Alternate Name for Potassium Chloride in Food Labeling.'' The draft guidance, when finalized, will explain our intent to exercise enforcement discretion for the declaration of the name ``potassium chloride salt,'' as an alternative to ``potassium chloride,'' in the ingredient statement on the labels of foods that contain potassium chloride as an ingredient.

The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of April 12, 2019. That document was published with the instruction to add a section to the incorrect subpart. This correction is being made to improve the accuracy of the final classification action.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or Agency) 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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the evaluation of FDA's General Market Youth Tobacco Prevention Campaigns.

The Food and Drug Administration (FDA or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.