Department of Health and Human Services May 2017 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 277
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with 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 0955-0009, scheduled to expire on May 31, 2017. 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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Protecting Our Infants Act Report to Congress: Summary of Public Comment and Final Strategy
The Substance Abuse and Mental Health Services Administration (SAMHSA) in the Department of Health and Human Services (HHS) announces the release of the ``Protecting Our Infants Act: Final Strategy'' in response to sections 3(a)(2) and 3(b) of the Protecting Our Infants Act of 2015 (POIA). The POIA mandated HHS to: conduct a review of planning and coordination activities related to prenatal opioid exposure and neonatal abstinence syndrome; develop recommendations for the identification, prevention, and treatment of prenatal opioid exposure and neonatal abstinence syndrome; and develop a strategy to address gaps, overlap, and duplication among Federal programs and Federal coordination efforts to address neonatal abstinence syndrome. The Protecting Our Infants Act: Report to Congress which satisfied these requirement was made available January 17, 2017, through February 21, 2017, for public comment in the following docket SAMHSA-2016-0004-0001. As a result of the public comments, summarized below, several recommendations were added to the original strategy and others expanded. The Final Strategy can be read and downloaded at https:// www.samhsa.gov/specific-populations/age-gender-based#poia.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
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/reinstatement 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 information collection provisions of FDA's guidance for industry entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.''
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments; Amended Notice
This notice amends Federal Register notice 82 FR 20484, published May 2, 2017, announcing the National Toxicology Program (NTP) Board of Scientific Counselors (BSC) meeting and requesting comments. The deadline for registration has been changed to June 29, 2017. The BSC will provide input to the NTP on programmatic activities and issues. The preliminary agenda has been updated and topics include reports from the NIEHS/NTP Director and NTP Associate Director, and presentations on programmatic activities including NTP efforts and challenges toward studying real world exposures and a state of the science evaluation of transgenerational inheritance of health effects. This meeting will also provide opportunity for input on an effort being coordinated by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) to explore new approaches for evaluating the safety of chemicals and medical products in the United States. All other information in the original notice has not changed. Interested individuals should visit the meeting Web page to stay abreast of agenda topics and other arrangements for the meeting. Information about the meeting and registration is available at https:// ntp.niehs.nih.gov/go/165.
Medicare Program: Announcement of the Advisory Panel on Hospital Outpatient Payment (the Panel) Meeting on August 21-22, 2017
This notice announces the annual meeting of the Advisory Panel on Hospital Outpatient Payment for 2017. The purpose of the Panel is to advise the Secretary of Department of Health and Human Services and the Administrator of Centers for Medicare & Medicaid Services concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues. The advice provided by the Panel will be considered as we prepare the annual updates for the hospital outpatient prospective payment system.
Agency Information Collection Activities: Submission for OMB Review; Comment Request; Revised Annual and Final Reports for Performance Reporting Data From NIDILRR Grantees
In compliance with the Paperwork Reduction Act of 1995 (PRA), the National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR), Administration for Community Living (ACL), is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance.
Call for Nominations for the Non-Federal Members of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
The Secretary of Health and Human Services, in accordance with the 21st Century Cures Act, is seeking nominations for the non-federal members of the ISMICC.
Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format
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, 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 collection of information associated with the Guidance ``Providing Post-market Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report).''
Agency Information Collection Activities; Proposed Collection; Comment Request; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
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 information collection requirements related to the exceptions or alternatives to labeling requirements for products held by the Strategic National Stockpile (SNS).
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry-User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
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 recommendations to applicants considering whether to request a waiver or reduction in user fees.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Advertisements
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 reporting requirements, including third party disclosure, contained in FDA's current regulations on prescription drug advertisements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Cosmetic Labeling Regulations
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection provisions in FDA's cosmetic labeling regulations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advisory Committee Nomination Applications
The Food and Drug Administration (FDA or we) 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 PRA).
Request for Public Comment 30 Day Proposed Information Collection: Mashpee Wampanoag Indian Health Service Unit Community Health Assessment
In compliance the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the new information collection Office of Management and Budget (OMB) Control Number 0917-XXXX, titled, ``Mashpee Wampanoag Community Health Assessment.'' This proposed information collection project was recently published in the Federal Register (82 FR 11361) on February 22, 2017, and allowed 60 days for public comment, as required by law. The IHS received no comments regarding this collection. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001-0293).
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
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