Department of Health and Human Services April 2017 – Federal Register Recent Federal Regulation Documents

Announcement of Requirements and Registration for Healthy Behavior Challenge
Document Number: 2017-08778
Type: Notice
Date: 2017-04-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Healthy Behavior Data Challenge. The Healthy Behavior Data Challenge responds to the call for new ways to address the challenges and limitations of self-reported health surveillance information and tap into the potential of innovative data sources and alternative methodologies for public health surveillance. Challenge participants will propose data sources and approaches for aggregating data from wearable devices, mobile applications and/or social media in the areas of nutrition, physical activity, sedentary behaviors, and/or sleep. Conducted in two phases, Phase I (Prototype Development) entails Challenge participants developing a concept proposal for obtaining data collected from wearable devices, mobile applications and/or social media for public health surveillance purposes. In Phase II (Prototype Implementation), a subset of submissions (up to 3) with promising concepts will be invited to test their proposed approaches for ongoing public health surveillance.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-08738
Type: Notice
Date: 2017-04-28
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 (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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-08663
Type: Notice
Date: 2017-04-28
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 (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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-08652
Type: Notice
Date: 2017-04-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Generic Clearance for Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-08650
Type: Notice
Date: 2017-04-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed changes to the currently approved information collection project: ``Developing a Registry of Registries.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-08649
Type: Notice
Date: 2017-04-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) reapprove the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component.''
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2017-08631
Type: Notice
Date: 2017-04-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2017-08630
Type: Notice
Date: 2017-04-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2017-08629
Type: Notice
Date: 2017-04-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2017-08628
Type: Notice
Date: 2017-04-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2017-08627
Type: Notice
Date: 2017-04-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2017-08626
Type: Notice
Date: 2017-04-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2017-08625
Type: Notice
Date: 2017-04-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2017-08624
Type: Notice
Date: 2017-04-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2017-08599
Type: Notice
Date: 2017-04-28
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0421, which expires on July 31, 2017. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-08596
Type: Notice
Date: 2017-04-28
Agency: Food and Drug Administration, Department of Health and Human Services
The invention listed in this document is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-08588
Type: Notice
Date: 2017-04-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Health Workforce Connector, OMB No. 0906-xxxx-NEW
Document Number: 2017-08584
Type: Notice
Date: 2017-04-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information
Document Number: 2017-08583
Type: Notice
Date: 2017-04-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the Request for Information that appeared in the Federal Register of April 15, 2016. In the Request for Information, FDA requested comments regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from additional public comments will further inform the design and development of the pilot project(s) that FDA establishes under the DSCSA. FDA is reopening the comment period to receive updated comments and any new information.
Determination That DEMEROL (Meperidine Hydrochloride) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-08582
Type: Notice
Date: 2017-04-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were 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 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. Through this notice, FDA is hoping to stimulate the economy and increase the regulatory certainty with respect to generic versions of these drug products by confirming that generic versions of the subject drug products may continue to be marketed.
Solicitation of Nominations for Three Organizations To Serve as Non-Voting Liaison Representatives to the Chronic Fatigue Syndrome Advisory Committee
Document Number: 2017-08383
Type: Notice
Date: 2017-04-28
Agency: Department of Health and Human Services
The Chronic Fatigue Syndrome Advisory Committee (CFSAC) is one of the federal advisory committees for which the Department of Health and Human Services (HHS) provides management support. The Office of the Assistant Secretary for Health (OASH), a staff division in the Office of the Secretary, HHS, is assigned responsibility to provide management support for CFSAC activities. The CFSAC is authorized to have three non-voting liaison representative positions. The organizations designated to fill these positions will be selected from those concerned with myalgic encephalomyelitis/chronic fatigue syndrome (ME/ CFS). The Designated Federal Officer (DFO) for CFSAC will select the organizations from which the representative will be selected to fill these vacant positions. The representatives selected to fill these positions will serve a two-year term as a non-voting liaison representative. Details of nomination requirements are provided below.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices
Document Number: 2017-07800
Type: Proposed Rule
Date: 2017-04-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of these proposed changes would implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation. We also are making proposals relating to the provider-based status of Indian Health Service (IHS) and Tribal facilities and organizations and to the low-volume hospital payment adjustment for hospitals operated by the IHS or a Tribe. In addition, we are providing the proposed estimated market basket update that would apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2018. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2018. In addition, we are proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities). We also are proposing to establish new requirements or revise existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. We are proposing to update policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are proposing changes relating to transparency of accrediting organization survey reports and plans of correction of providers and suppliers; electronic signature and electronic submission of the Certification and Settlement Summary page of the Medicare cost reports; and clarification of provider disposal of assets.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-08540
Type: Notice
Date: 2017-04-27
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 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 new information collection project titled ``A Novel Framework for Structuring Industry- Tuned Public-Private Partnerships and Economic Incentives for U.S. Health Emergency Preparedness and Response''. This data collection will conduct interviews with industry leaders and survey private sector organization managers to systematically evaluate and explore the partnership preferences of private sector organizations, specifically when they are interacting or considering an interaction with government agencies.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-08539
Type: Notice
Date: 2017-04-27
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 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 the proposed information collection project titled ``Awardee Lead Profile Assessment (ALPA).'' The information collection project includes a questionnaire to collect information to identify jurisdictional legal frameworks governing funded childhood lead poisoning prevention programs in the United States, and strategies for implementing childhood lead poisoning prevention activities in the United States.
Submission for OMB Review; Comment Request
Document Number: 2017-08510
Type: Notice
Date: 2017-04-27
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2017-08506
Type: Notice
Date: 2017-04-27
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-08493
Type: Notice
Date: 2017-04-27
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 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 data collection project titled ``Emergency Zika Package: Zika Reproductive Health Call-Back Survey ZRHCS), 2017.''
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-08492
Type: Notice
Date: 2017-04-27
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 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 revision to the information collection project titled ``Information Collection on Cause-Specific Absenteeism in Schools.'' Changes include a revised title. The proposed title is ``Information Collection on Cause-Specific Absenteeism in Schools and Evaluation of Influenza Transmission within Student Households.'' The project will continue to address the original aim of improving our understanding of the role of influenza-like illness (ILI)specific absenteeism in schools in predicting community-wide influenza transmission.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-08491
Type: Notice
Date: 2017-04-27
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 the information collection project titled ``Information Collections to Advance State, Tribal, Local and Territorial (STLT) Governmental Agency and System Performance, Capacity, and Program Delivery.'' Information, collected across a range of public health topics using standard modes of administration (e.g., web, in- person, phone), will be used to assess situational awareness of current public health emergencies; make decisions that affect planning, response and recovery activities of subsequent emergencies; fill CDC gaps in knowledge of programs and/or STLT governments that will strengthen surveillance, epidemiology, and laboratory science; improve CDC's support and technical assistance to states and communities.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-08490
Type: Notice
Date: 2017-04-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meetings
Document Number: 2017-08458
Type: Notice
Date: 2017-04-27
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2017-08457
Type: Notice
Date: 2017-04-27
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-08456
Type: Notice
Date: 2017-04-27
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Funding Opportunity Announcement and Grant Application Template for ACL Discretionary Grant Programs
Document Number: 2017-08436
Type: Notice
Date: 2017-04-26
Agency: Department of Health and Human Services
The Administration for Community Living 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 as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to a Revision of a Currently Approved Collection (ICR Rev).
Administration for Community Living; Agency Information Collection Activities: Proposed Collection; Public Comment Request; Protection and Advocacy for Traumatic Brain Injury (PATBI) Program Performance Report
Document Number: 2017-08435
Type: Notice
Date: 2017-04-26
Agency: Department of Health and Human Services
The Administration on Disability 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 as required under section 506 (c)(2)(A) of the Paperwork Reduction Act of 1995. This notice collects comments on the information collection requirements related to a new data collection (ICR New).
Submission for OMB Review; Comment Request
Document Number: 2017-08401
Type: Notice
Date: 2017-04-26
Agency: Department of Health and Human Services, Administration for Children and Families
Request for Comment on the NSDUH Redesign
Document Number: 2017-08400
Type: Notice
Date: 2017-04-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This document is a request for comment on National Survey on Drug Use and Health (NSDUH) redesign. The Department of Health and Human Services, as part of its continuing effort to produce current data, as well as reduce paperwork and respondent burden, 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-08399
Type: Notice
Date: 2017-04-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Interagency Coordinating Committee on the Validation of Alternative Methods; Notice of Public Meeting; Request for Public Input
Document Number: 2017-08354
Type: Notice
Date: 2017-04-25
Agency: Department of Health and Human Services, National Institutes of Health
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or view the meeting remotely by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is requested for both public attendance and oral statements, and required for remote access. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/iccvamforum- 2017.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-08351
Type: Notice
Date: 2017-04-25
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-08350
Type: Notice
Date: 2017-04-25
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-08349
Type: Notice
Date: 2017-04-25
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Cancellation of Meeting
Document Number: 2017-08348
Type: Notice
Date: 2017-04-25
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Institutional Review Boards
Document Number: 2017-08327
Type: Notice
Date: 2017-04-25
Agency: Food and Drug Administration, Department of Health and Human Services
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 (PRA).
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles; Draft Guidance for Government Public Health and Emergency Response Stakeholders; Availability
Document Number: 2017-08326
Type: Notice
Date: 2017-04-25
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 draft guidance for government public health and emergency response stakeholders entitled ``Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.'' This document, once finalized, will provide guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This draft guidance has been prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturer's labeled expiration date so the replacement of stockpiled product could be deferred. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other non- emergency purpose.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions
Document Number: 2017-08325
Type: Notice
Date: 2017-04-25
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis; Public Workshop; Request for Comments
Document Number: 2017-08314
Type: Notice
Date: 2017-04-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we), in association with National Science Foundation (NSF) and Department of Homeland Security, Science and Technology (DHS S&T) is announcing the following public workshop entitled ``Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis.'' The objective of the workshop is to facilitate a discussion on the current state of regulatory science in the field of cybersecurity of medical devices, with a focus on patient safety. The purpose of this public workshop is to catalyze collaboration among Health Care and Public Health (HPH) stakeholders to identify regulatory science challenges, discuss innovative strategies to address those challenges, and encourage proactive development of analytical tools, processes, and best practices by the stakeholder community to strengthen medical device cybersecurity.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2017-08309
Type: Notice
Date: 2017-04-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that EMFLAZA (deflazacort) oral tablets, and oral suspension manufactured by Marathon Pharmaceuticals, LLC, meets the criteria for a priority review voucher.
Food and Drug Administration Small Business and Industry Assistance Regulatory Education for Industry Spring Conference; Public Conference
Document Number: 2017-08308
Type: Notice
Date: 2017-04-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), together with the Center for Devices and Radiological Health (CDRH), is sponsoring a 2-day public conference entitled ``FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Spring Conference.'' The goal of this public conference is to provide direct, relevant, and helpful information on the key aspects of drug and medical device regulations in order to increase regulatory certainty and predictability for pharmaceutical and/or medical device industry. Our primary audience is that of small manufacturers of drug and/or medical devices who want to learn about how FDA approaches the regulation of drugs and medical devices and for whom increased certainty and predictability will help to decrease the regulatory burdens that can be associated with a lack of understanding of, or familiarity with, FDA's drug and medical device regulations. However, anyone involved in the pharmaceutical and/or medical device industry may attend.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act
Document Number: 2017-08307
Type: Notice
Date: 2017-04-25
Agency: Food and Drug Administration, Department of Health and Human Services
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.