Department of Health and Human Services November 2018 – Federal Register Recent Federal Regulation Documents

This notice replaces all language in Part Q (Office of the Secretary) of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS or the Department), Office of Inspector General (OIG) (81 FR 13807, as published March 15, 2016). The Statement of Organization, Functions, and Delegations of Authority conforms to and carries out the statutory requirements for operating OIG. The organizational changes reflected in this notice are primarily to realign the functions within OIG to better reflect the current work environment and priorities and to more clearly delineate responsibilities for the various activities within OIG's offices. OIG was established by law as an independent and objective oversight unit of the Department to carry out the mission of preventing fraud and abuse and promoting economy, efficiency, and effectiveness of HHS programs and operations. In furtherance of this mission, the organization: Conducts and supervises audits, investigations, evaluations, and inspections relating to HHS programs and operations; identifies systemic weaknesses giving rise to opportunities for fraud and abuse in HHS programs and operations and makes recommendations to prevent their recurrence; leads and coordinates activities to prevent and detect fraud and abuse in HHS programs and operations; detects wrongdoers and abusers of HHS programs and beneficiaries so appropriate remedies may be brought to bear, including imposing administrative sanctions against providers of health care under Medicare and Medicaid who commit certain prohibited acts; and keeps the Secretary of Health and Human Services and Congress fully and currently informed about problems and deficiencies in the administration of HHS programs and operations and about the need for and progress of corrective action. In addition, OIG works with the Department of Justice (DOJ), on behalf of the Secretary, to operate the Health Care Fraud and Abuse Control Program. In accordance with authority enacted in its annual appropriations, OIG also provides protection services to the Secretary and conducts criminal investigations of violations of Federal child support provisions. In support of its mission, OIG carries out and maintains an internal quality assurance system and a peer-review system with other Offices of Inspector General, including periodic quality assessment studies and quality control reviews, to provide reasonable assurance that applicable laws, regulations, policies, procedures, standards, and other requirements are followed, are effective, and are functioning as intended in OIG operations. Section Q, Office of Inspector GeneralOrganization

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health Office of Intramural Training & Education (OITE) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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 Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Guidance for Industry.'' This guidance is intended for conventional food and dietary supplement manufacturers. The guidance finalizes the draft guidance we issued in January 2017, which provides questions and answers (Q&A) on topics related to compliance with the Nutrition Facts and Supplement Facts label and Serving Size final rules, the labeling of added sugars, declaration of quantitative amounts of vitamins and minerals, and format issues on the Nutrition Facts and Supplement Facts labels.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 New Data Collection (ICR New) solicits comments on the information collection requirements relating to the Aging and Disability Resource Center/No Wrong Door System (ADRC/NWD). The statutory authority for ADRC/NWD is contained in Title IV of the Older Americans Act (OAA), as amended by the Older Americans Act Amendments of 2006, Public Law 109-365.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This meeting is open to the public limited only by the space and ports available. The meeting room accommodates 70 participants and there will be 75 ports available. Due to the limited availability of phone line ports, we are encouraging the pubic to please register using the link provided: Register Here. There will be a public comment period at the end of the day from 03:30 p.m.04:00 p.m.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Council for the Elimination of Tuberculosis Meeting (ACET). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 80 people and has 100 ports for audio phone lines. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt is Monday, December 10, 2018. Persons who desire to make an oral statement, may request it at the time of the public comment period on December 12, 2018 at 11:40 a.m., EST.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Product Development in Hemophilia.'' The purpose of the public workshop is to discuss issues related to development and regulation of novel hemophilia products.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2018, relating to the Medicare and Medicaid programs and other programs administered by CMS.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Bonamar Corp., proposing that we amend our food additive regulations to provide for the safe use of sources of ionizing radiation to control food-borne pathogens in finfish and flatfish.

The Food and Drug Administration (FDA or we) is classifying the insulin therapy adjustment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the insulin therapy adjustment device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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 bar code label requirements for human drug and biological products.

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of synthetic iron oxides as color additives to include use in dietary supplement tablets and capsules. This action is in response to a color additive petition (CAP) filed by Colorcon, Inc.

This proposed rule would revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Bipartisan Budget Act of 2018; improve quality and accessibility; clarify certain program integrity policies; reduce burden on providers, MA plans, and Part D sponsors through providing additional policy clarification; and implement other technical changes regarding quality improvement. This proposed rule would also revise the appeals and grievances requirements for Medicaid managed care and MA special needs plans for dually eligible individuals to implement certain provisions of the Bipartisan Budget Act of 2018.