Department of Health and Human Services July 26, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Request for Information: Ensuring Patient Access and Effective Drug Enforcement
This Request for Information (RFI) seeks comment on ensuring legitimate access to controlled substances, including opioids, while also preventing diversion and abuse, as well as how federal, state, local, and tribal entities can collaborate to address these issues.
Agency Information Collection Activities: Proposed Collection; Comment Request
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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims (the Court) is charged by statute with responsibility for considering and acting upon the petitions.
Submission for OMB Review; Native Employment Works (NEW) Program Plan Guidance and Report Requirements, (OMB No.: 970-0174)
The Administration for Children and Families (ACF) is requesting a three-year extension of the form OFA-0086, NEW Plan Guidance and NEW Program Report (OMB #0970-0174, expiration 7/31/2019). There are changes requested to these forms.
Generic Drug User Fee Rates for Fiscal Year 2020
The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2020 rates for GDUFA II fees.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Health Resources and Service Administration Uniform Data System, OMB No. 0915-0193-Revision
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.
National Advisory Council on Nurse Education and Practice; Meeting Cancellation
This is to notify the public that the previously scheduled September 24, 2019, meeting of the National Advisory Council on Nurse Education and Practice (NACNEP) is cancelled. This meeting was announced in the Federal Register, Vol. 84, No. 45 on Thursday, March 7, 2019 (FR Doc. 2019-04074 Filed 3-6-19). Future meetings will occur in calendar year 2020 and be announced through the Federal Register at a later date.
Metal Expandable Biliary Stents-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Metal Expandable Biliary StentsPremarket Notification (510(k)) Submissions.'' This guidance provides recommendations for information and testing that should be included in 510(k) submissions for metal expandable biliary stents and their associated delivery systems intended to provide luminal patency of malignant strictures in the biliary tree.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Communities Opioid Response Program Performance Measures, OMB No. 0906-xxxx, New.
In compliance with of the Paperwork Reduction Act of 1995, 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.
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