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

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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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion
Document Number: 2017-08306
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 (the PRA).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Blood Establishment Registration and Product Listing
Document Number: 2017-08305
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 that two collections of information: ``Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution'' and ``Blood Establishment Registration and Product Listing'' 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; Good Laboratory Practice Regulations for Nonclinical Studies
Document Number: 2017-08304
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 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 provisions of FDA's good laboratory practice (GLP) regulations for nonclinical laboratory studies.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Certification of Identity for Freedom of Information Act and Privacy Act Requests
Document Number: 2017-08303
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 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.
Sentinel Training at the Food and Drug Administration; Public Workshop
Document Number: 2017-08302
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) is announcing the following public workshop entitled ``Sentinel Training at FDA.'' The purpose of the public workshop is to provide training to understand the kinds of questions that can be asked using health care claims data generally and within the FDA Sentinel System specifically, allowing an understanding of the capabilities of the Sentinel System.
Pediatric Studies of Ampicillin Conducted in Accordance With the Public Health Service Act
Document Number: 2017-08301
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 making available to the public a report, submitted by Duke Clinical Research Institute on December 15, 2015, of the pediatric studies of ampicillin that were conducted in accordance with the Public Health Service Act (PHS Act) and submitted to the Director of the National Institutes of Health (NIH) and the Commissioner of Food and Drugs. This notice is to announce the 30-day open public comment period on the report.
Agency Information Collection Activities; Proposed Collection; Comment Request; Radioactive Drug Research Committees
Document Number: 2017-08300
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 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 contained in regulations governing the use of radioactive drugs for basic informational research.
Joint Meeting of the Pediatric Advisory Committee and the Pediatric Ethics Subcommittee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2017-08299
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) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) and the Pediatric Ethics Subcommittee (PES). The general function of the committees is to provide advice and make recommendations to the Agency on pediatric ethical issues. The meeting will be open to the public. FDA is establishing a docket for public comments on this document.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The National Health Service Corps and NURSE Corps Interest Capture Form, OMB No. 0915-0337-Extension
Document Number: 2017-08298
Type: Notice
Date: 2017-04-25
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Nurse Faculty Loan Program, Annual Performance Report Financial Data Form; Revision
Document Number: 2017-08297
Type: Notice
Date: 2017-04-25
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Questionnaire and Data Collection Testing, Evaluation, and Research for the Health Resources and Services Administration; Extension
Document Number: 2017-08296
Type: Notice
Date: 2017-04-25
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Title: Nurse Faculty Loan Program (NFLP)-Program Specific Data Form; Revision
Document Number: 2017-08295
Type: Notice
Date: 2017-04-25
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.
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 2017-08294
Type: Notice
Date: 2017-04-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-08293
Type: Notice
Date: 2017-04-25
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2017-08220
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, notice is hereby given of the following meeting for the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC). The meeting will be open to the public but advance registration is required. The online registration deadline is Thursday, May 4, 2017, 5:00 p.m. Eastern Time. Please check the Web site for additional guidance and registration information. The registration link is http://www.achdncmeetings.org/. Information about the agenda for this meeting can be obtained by accessing the following Web site: http://www.hrsa.gov/ advisorycommittees/mchbadvisory/heritabledisorders.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2017-08200
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of 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 revision of the approved information collection assigned OMB control number 0990-0452, scheduled to expire on January 31, 2020. 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.
Product-Specific Guidance for Naloxone Hydrochloride; New Draft Guidance for Industry; Availability
Document Number: 2017-08199
Type: Notice
Date: 2017-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic naloxone hydrochloride nasal spray entitled ``Draft Guidance on Naloxone Hydrochloride.'' The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for naloxone hydrochloride nasal spray.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: AIDS Drug Assistance Program Data Report, OMB No. 0915-0345-Extension
Document Number: 2017-08197
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2017-08189
Type: Notice
Date: 2017-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices 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.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2017-08188
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3507(a)(1)(D) of 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 a new collection. 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: Proposed Collection: Public Comment Request; Information Collection Request Title: Delta States Rural Development Network Grant Program, OMB No. 0915-0386-Revision
Document Number: 2017-08187
Type: Notice
Date: 2017-04-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Training Program for Regulatory Project Managers; Information Available to Industry
Document Number: 2017-08183
Type: Notice
Date: 2017-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.