Department of Health and Human Services November 8, 2017 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Review Staff on Target Product Profile-A Strategic Development Process Tool
Document Number: 2017-24335
Type: Notice
Date: 2017-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-24318
Type: Notice
Date: 2017-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 ``Healthy Homes and Lead Poisoning Surveillance System (HHLPSS)''. The overarching goal of the Healthy Homes and Lead Poisoning Surveillance System (HHLPSS) is to support healthy homes surveillance activities at the state and national levels.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-24317
Type: Notice
Date: 2017-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 generic information collection project titled ``Assessments to Inform Program Refinement for HIV, other STD, and Pregnancy Prevention among Middle and High-School Aged Youth.'' CDC seeks to collect qualitative and quantitative data from adolescents (ages 11-19) and their parents/ caregivers to assess program needs and services.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-24316
Type: Notice
Date: 2017-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 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 assessment of cancer prevention services at selected community mental health centers. CDC seeks to request an Office of Management and Budget (OMB) clearance for a three-year data collection project.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-24315
Type: Notice
Date: 2017-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-24314
Type: Notice
Date: 2017-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-24313
Type: Notice
Date: 2017-11-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; Guidance for Industry; Availability
Document Number: 2017-24308
Type: Notice
Date: 2017-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention.'' The purpose of this guidance is to assist sponsors in all phases of development of treatments for recurrent herpes labialis (RHL). The guidance also addresses prevention of RHL. The guidance outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of antiviral drug products for the treatment or prevention of RHL. This guidance finalizes the draft guidance of the same name issued on July 1, 2016.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-24305
Type: Notice
Date: 2017-11-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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; Proposed Collection; Comment Request; Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics
Document Number: 2017-24296
Type: Notice
Date: 2017-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
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 revision 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 in the guidance for industry ``Expedited Programs for Serious ConditionsDrugs and Biologics.''
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-24267
Type: Notice
Date: 2017-11-08
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute: Notice of Closed Meeting
Document Number: 2017-24266
Type: Notice
Date: 2017-11-08
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2017-24265
Type: Notice
Date: 2017-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review: Amended Notice of Meeting
Document Number: 2017-24264
Type: Notice
Date: 2017-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-24263
Type: Notice
Date: 2017-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review: Notice of Closed Meetings
Document Number: 2017-24262
Type: Notice
Date: 2017-11-08
Agency: Department of Health and Human Services, National Institutes of Health
Intent To Review an Analysis Data Reviewer's Guide; Notice of Availability, Request for Comments
Document Number: 2017-24237
Type: Notice
Date: 2017-11-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is establishing a public docket to collect comments related to a proposed Analysis Data Reviewer's Guide (ADRG) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE ADRG template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE ADRG template for regulatory submissions.