Department of Health and Human Services May 2019 – Federal Register Recent Federal Regulation Documents
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Submission for OMB Review; 30-Day Comment Request; Proposed Collection; Generic Clearance for Conferences, Meetings, Workshops, Poster Sessions and Registration (OD)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements
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.
Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations; Public Workshop
The Food and Drug Administration (FDA, we) is announcing the following pubic workshop entitled ``Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations.'' This public workshop is convened by Duke University's Robert J. Margolis, MD, Center for Health Policy and supported by a cooperative agreement with FDA. The purpose of the public workshop is to capture stakeholder experiences with risk-based approaches to monitoring of clinical investigations and gather stakeholder input on opportunities to further the implementation of risk-based approaches to monitoring.
Agency Information Collection Activities: Submission for OMB Review; 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Proposed Information Collection Activity; American Indian and Alaska Native (AIAN) Facility Survey (New Collection)
The Office Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data on the condition and ownership of American Indian and Alaska Native (AIAN) facilities to meet congressional reporting requirements under the Head Start Act.
Proposed Information Collection Activity; Head Start Program Performance Standards (OMB #0970-0148)
The Office Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a three-year extension of the Head Start Program Performance Standards (HSPPS) information collection (OMB #0970-0148, expiration 1/ 31/2020). There are no changes requested to these record keeping requirements.
Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that certain solid, oral dosage forms of immediate-release (IR) opioid analgesics commonly prescribed for treatment of acute pain be made available in fixed- quantity unit-of-use blister packaging for outpatient dispensing. This could reduce the amount of unused opioid analgesics, thereby reducing opportunities for misuse, abuse, inappropriate access, and overdose, and possibly reducing the development of new opioid addiction.
Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability; Correction
The Food and Drug Administration is correcting a notice entitled ``Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability'' that appeared in the Federal Register of May 10, 2019. The document announced the availability of a guidance for industry. The document was published with the incorrect docket number. This document corrects that error.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
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: Proposed Collection; Comment Request; Correction
The Agency for Healthcare Research and Quality published a document in the Federal Register of May 20, 2019 concerning the impact and use of Evidence-based Practice Center (ECP) Program evidence reviews. This document contained an incorrect deadline date.
Notice of Subcommittee Meetings for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
The Secretary of Health and Human Services (Secretary) announces subcommittee meetings of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meetings are open to the public and can be accessed via telephone only. Agenda with call-in information will be posted on the SAMHSA website prior to the meetings at: https://www.samhsa.gov/about- us/advisory-councils/meetings The meetings will include information on the following focus areas: Data, Access, Treatment and Recovery, Justice, and Finance. Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee (subcommittee meetings) Date/Time/Type: June 20, 2019/1:00 p.m.-2:30 p.m. (EDT)/OPEN/Focus Area 1: Data, June 26, 2019/9:00 a.m.-10:30 a.m. (EDT)/OPEN/Focus Area 2: Access, June 26, 2019/9:00 a.m.-10:30 a.m. (EDT)/OPEN/Focus Area 3: Treatment and Recovery, June 26, 2019/10:45 a.m.-12:15 p.m. (EDT)/OPEN/ Focus Area 4: Justice, June 26, 2019/10:45 a.m.-12:15 p.m. (EDT)/OPEN/ Focus Area 5: Finance.
Determination That LUPRON (Leuprolide Acetate) Injection, 1 Milligram/0.2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that LUPRON (leuprolide acetate) injection, 1 milligram (mg)/0.2 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Notice of Meeting
The Agency for Healthcare Research and Quality (AHRQ) is announcing a Special Emphasis Panel (SEP) meeting on AHRQ-HS-19-002, ``Using Data Analytics to Support Primary Care and Community Interventions to Improve Chronic Disease Prevention and Management and Population Health (R18).''
Notice of Meeting
The Agency for Healthcare Research and Quality (AHRQ) is announcing a Special Emphasis Panel (SEP) meeting on AHRQ-HS-19-003, ``AHRQ Health Services Research Project: Partners Enabling Diagnostic Excellence (R01).''
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products
The Food and Drug Administration (FDA or Agency) 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 (PRA).
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled WISEWOMAN National Program Evaluation. The goal of the study is to assess the implementation of the WISEWOMAN program under the current cooperative agreement and measure the effect of the program on individual-, organizational-, and community-level outcomes.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Program of Cancer Registries Cancer Surveillance System (NPCR CSS). The NPCR CSS provides useful data on cancer incidence and trends.
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 a proposed information collection entitled ``State Unintentional Drug Overdose Reporting System (SUDORS).'' CDC will use the information collected to perform fatal unintentional drug overdose surveillance in a quick and comprehensive way.
Medicare Program; Inpatient Rehabilitation Facility (IRF) Prospective Payment System for Federal Fiscal Year 2020 and Updates to the IRF Quality Reporting Program; Correction
This document corrects technical errors in the proposed rule that appeared in the April 24, 2019 Federal Register entitled, ``Medicare Program; Inpatient Rehabilitation Facility (IRF) Prospective Payment System for Federal Fiscal Year 2020 and Updates to the IRF Quality Reporting Program.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Adverse Event Reports; Electronic Submissions
The Food and Drug Administration (FDA, Agency, 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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Medicare Rural Hospital Flexibility Program Performance, OMB No. 0915-0363-Extension
In compliance with 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.
Review and Update of Device Establishment Inspection Processes and Standards; Extension of Comment Period
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register on March 29, 2019. FDA requested comments on the draft guidance for industry entitled ``Review and Update of Device Establishment Inspection Processes and Standards.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
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