Department of Health and Human Services December 7, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
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 Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for renewal of the approved information collection assigned OMB control number 0937-0191, scheduled to expire on December 31, 2016. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Meeting Announcement for the Technical Advisory Panel on Medicare Trustee Reports
This notice announces the meeting dates for the Technical Advisory Panel on Medicare Trustee Reports on Monday, December 19, 2016 and Tuesday, December 20, 2016 in Washington, DC.
Announcement of the Award of Five Single-Source Low-Cost Extension Supplement Grants Within the Office of Refugee Resettlement's Unaccompanied Children's Program
ACF, ORR, announces the award of five single-source low-cost extension supplement grants for a total of $19,604,765 under the UC Program.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 the proposed information collection project entitled ``Formative Assessment Regarding Contraception Use in the U.S. Virgin Islands (USVI) in the Context of Zika''.
Determination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL 9
The Food and Drug Administration (FDA) has determined the regulatory review period for GARDASIL 9 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry and FDA staff entitled ``Third- Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.'' The guidance contains FDA recommendations on third-party certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA program required by the FDA Food Safety Modernization Act (FSMA). The guidance is intended to describe the standards for accreditation of third-party certification bodies as required under the final rule entitled ``Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications.'' In addition, this guidance discusses specific clauses of ISO/IEC 17021: 2015 and industry practice that are currently being used by third-party certification bodies and that FDA recommends accreditation bodies consider as a model when making accreditation decisions.
Posting Adverse Event Report Data Associated With Conventional Foods, Dietary Supplements, and Cosmetics on the Internet; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of data extracted from adverse event reports from January 2004 to the present involving food (including food additives, color additives, and dietary supplements) and cosmetics regulated by our Center for Food Safety and Applied Nutrition (CFSAN). The data files are being made publicly available on FDA's Web site to improve transparency about adverse event reports involving CFSAN-regulated products and increase awareness about reporting these adverse events to FDA.
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements
In this final rule, OIG amends the safe harbors to the anti- kickback statute by adding new safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. The OIG also amends the civil monetary penalty (CMP) rules by codifying revisions to the definition of ``remuneration,'' added by the Balanced Budget Act (BBA) of 1997 and the Patient Protection and Affordable Care Act, Public Law 111-148, 124 Stat. 119 (2010), as amended by the Health Care and Education Reconciliation Act of 2010 (ACA). This rule updates the existing safe harbor regulations and enhances flexibility for providers and others to engage in health care business arrangements to improve efficiency and access to quality care while protecting programs and patients from fraud and abuse.
Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Civil Monetary Penalty Rules
This final rule amends the civil monetary penalty (CMP or penalty) rules of the Office of Inspector General to incorporate new CMP authorities, clarify existing authorities, and reorganize regulations on civil money penalties, assessments, and exclusions to improve readability and clarity.
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