Department of Health and Human Services June 21, 2019 – Federal Register Recent Federal Regulation Documents
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Privacy Act of 1974; Matching Program
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), is providing notice of a re-established matching program between HHS/ACF/OCSE and state agencies administering the Supplemental Nutrition Assistance Program (SNAP). The matching program compares state SNAP agency records with new hire, quarterly wage, and unemployment insurance information maintained in the National Directory of New Hires (NDNH). The outcomes of the comparisons help state agencies with establishing or verifying eligibility for applicants and recipients of SNAP benefits; reducing SNAP benefit errors; and, maintaining program integrity.
Determining the Number of Employees for Purposes of the “Small Business” Definition (Current Good Manufacturing Practices and Preventive Controls Regulations for Human and Animal Food): Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry describing the Agency's current thinking on how to determine the number of employees for purposes of the ``small business'' definition in the current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls for human and animal food rules. The guidance will help industry subject to these rules determine the number of employees for purposes of the ``small business'' definition.
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework.'' The purpose of this guidance is to describe the benefit- risk framework the Agency uses in evaluating applications for opioid analgesic drugs. This guidance summarizes the information that should be included in a new drug application (NDA) for an opioid analgesic drug to facilitate the Agency's benefit-risk assessment.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure
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.
Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing
The Food and Drug Administration (FDA, Agency, we) is holding a public hearing on September 17, 2019, entitled ``Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.'' The Agency today is issuing a draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs. This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Organ Transplantation
HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Organ Transplantation (ACOT). ACOT shall: (1) Advise the Secretary, acting through the HRSA Administrator, on all aspects of organ donation, procurement, allocation, and transplantation, and on such other matters that the Secretary determines; (2) advise the Secretary on federal efforts to maximize the number of deceased donor organs made available for transplantation and to support the safety of living organ donation; (3) at the request of the Secretary, review significant proposed Organ Procurement and Transplantation Network (OPTN) policies submitted for the Secretary's approval to recommend whether they should be made enforceable; and (4) provide expert input to the Secretary on the latest advances in the science of transplantation, the OPTN's system of collecting, disseminating, and ensuring the validity, accuracy, timeliness, and usefulness of data, and additional medical, public health, patient safety, ethical, legal, financial coverage, social science, and socioeconomic issues that are relevant to transplantation. Authority: As provided by 42 CFR 121.12, the Secretary established ACOT. ACOT is governed by the Federal Advisory Committee Act (FACA; 5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Small Rural Hospital Transition Project (SRHT), OMB No. 0906-0026-Extension
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. This meeting was announced in the Federal Register of May 6, 2019. The amendment is being made to reflect a change in the DATES, Agenda, and Procedure portions of the document. There are no other changes.
Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Oncology Indications in Direct-to-Consumer Television Advertising
The Food and Drug Administration (FDA) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on research entitled ``Study of Oncology Indications in Direct-to-Consumer Television Advertising.'' This research consists of two studies examining the presentation of oncology indications in direct-to-consumer (DTC) television ads.
Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
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 requests for data needed to evaluate requests for threshold of regulation exemptions for substances used in food-contact articles.
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