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

Results 101 - 150 of 29,744
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2019-09735
Type: Notice
Date: 2019-05-13
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Amended Notice of Meeting
Document Number: 2019-09734
Type: Notice
Date: 2019-05-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2019-09733
Type: Notice
Date: 2019-05-13
Agency: Department of Health and Human Services, National Institutes of Health
Testing Services and Scores for Foreign Health Care Workers To Demonstrate English Language Proficiency
Document Number: 2019-09730
Type: Notice
Date: 2019-05-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA announces a request for comments and notice of a public meeting to receive feedback on proposed updates to the list of testing services and scores for foreign health care workers to demonstrate English language proficiency pursuant to section 343 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA).
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
Document Number: 2019-09692
Type: Notice
Date: 2019-05-10
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 final guidance for industry entitled ``Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.'' This guidance represents FDA's current thinking on the conduct of in vivo absorption trials for topically applied active ingredients that are under consideration for inclusion in an over-the- counter (OTC) monograph.
Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations; Guidance for Industry; Availability
Document Number: 2019-09691
Type: Notice
Date: 2019-05-10
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 final guidance for industry entitled ``Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.'' The purpose of this guidance is to assist sponsors in evaluating reproductive toxicity (mainly related to embryo-fetal development (EFD)) for anticancer pharmaceuticals and to provide recommendations to applicants for pharmaceutical labeling on duration of contraception following cessation of therapy to minimize potential risk to a developing embryo or fetus. The guidance also clarifies FDA's current thinking on when nonclinical studies for reproductive toxicology assessment may not be needed (e.g., for pharmaceuticals intended for use in postmenopausal women only). The intended outcome of this guidance is to facilitate the development of oncology pharmaceuticals while avoiding unnecessary use of animals, in accordance with the 3R (reduce, refine, replace) principles, and to provide a consistent approach to labeling recommendations for the duration of contraception after completion of therapy. This guidance finalizes the guidance of the same name issued September 29, 2017.
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Guidance for Industry; Availability
Document Number: 2019-09676
Type: Notice
Date: 2019-05-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is announcing the availability of a final guidance entitled ``Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis.'' The final guidance document notifies blood establishments that collect blood and blood components that we have determined babesiosis to be a relevant transfusion-transmitted infection (RTTI) and provides recommendations for donor screening, donation testing, donor deferral, and product management to reduce the risk of transfusion-transmitted babesiosis (TTB). The recommendations contained in the guidance apply to the collection of blood and blood components, except Source Plasma. The guidance announced in this notice finalizes the draft guidance of the same title dated July 2018.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Chart Abstraction of Ryan White HIV/AIDS Program Recipient Data, OMB No. 0906-xxxx-New
Document Number: 2019-09666
Type: Notice
Date: 2019-05-10
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, 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.
Determining Whether To Submit an Abbreviated New Drug Application or a 505(b)(2) Application; Guidance for Industry; Availability
Document Number: 2019-09662
Type: Notice
Date: 2019-05-10
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 final guidance entitled ``Determining Whether to Submit an ANDA or a 505(b)(2) Application.'' This guidance is intended to serve as a foundational guidance to assist applicants in determining which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FD&C Act) is appropriate for the submission of a marketing application to FDA. The guidance announced in this notice finalizes the draft guidance with the same name dated October 2017.
Proposed Information Collection Activity; State Temporary Assistance for Needy Families Case Studies (New Collection)
Document Number: 2019-09658
Type: Notice
Date: 2019-05-10
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE) is proposing a data collection activity as part of the State Temporary Assistance for Needy Families (TANF) Case Studies project. This study seeks to document innovative employment and training programs for low- income individuals including TANF recipients and examine the ways the programs provide or link families to wraparound services. Over a three- year period, the study will conduct up to 12 comprehensive qualitative case studies and up to 20 profiles of innovative programs to showcase promising approaches.
Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency
Document Number: 2019-09655
Type: Rule
Date: 2019-05-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule revises the Federal Health Insurance Programs for the Aged and Disabled by amending regulations for the Medicare Parts A, B, C and D programs, as well as the Medicaid program, to require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC or list price) of that drug or biological product. This rule is intended to improve the efficient administration of the Medicare and Medicaid programs by ensuring that beneficiaries are provided with relevant information about the costs of prescription drugs and biological products so they can make informed decisions that minimize their out-of-pocket (OOP) costs and expenditures borne by Medicare and Medicaid, both of which are significant problems.
Notice of Temporary Suspension of Dogs Entering the United States From Egypt
Document Number: 2019-09654
Type: Notice
Date: 2019-05-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces that, effective immediately, it is temporarily suspending the importation of dogs from Egypt. This includes dogs originating in Egypt that are imported from third-party countries if the dogs have been present in those countries for less than six months. CDC is taking this action in response to an increase of imported cases of rabies in dogs from Egypt. This action is needed to prevent the reintroduction of canine rabies virus variant (CRVV), which has been eliminated from the United States. This suspension will remain in place until appropriate veterinary controls have been established in Egypt to prevent the export of rabid dogs. CDC will coordinate with other federal agencies and entities as necessary to implement this action.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-09621
Type: Notice
Date: 2019-05-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-09619
Type: Notice
Date: 2019-05-10
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2019-09618
Type: Notice
Date: 2019-05-10
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 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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-09617
Type: Notice
Date: 2019-05-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2019-09616
Type: Notice
Date: 2019-05-10
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-Day Comment Request; Introduction to Cancer Research Careers (ICRC) Application (NCI)
Document Number: 2019-09615
Type: Notice
Date: 2019-05-10
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Health Information Technology Advisory Committee 2019 Schedule
Document Number: 2019-09612
Type: Notice
Date: 2019-05-10
Agency: Department of Health and Human Services
The Health Information Technology Advisory Committee (HITAC) was established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2019. See list of public meetings below.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program, OMB Number 0915-0327-Revision
Document Number: 2019-09601
Type: Notice
Date: 2019-05-09
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). Before submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Meeting of the Tick-Borne Disease Working Group
Document Number: 2019-09545
Type: Notice
Date: 2019-05-09
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (Working Group) will hold a meeting. The meeting will be open to the public. For this meeting, Working Group members will focus on plans to develop the next report to the HHS Secretary and Congress on federal tick-borne activities and research, taking into consideration the 2018 report. The 2020 report will also address a wide range of federal activities and research related to tick-borne diseases, such as, surveillance, prevention, diagnosis, diagnostics, and treatment; identify gaps in tick-borne disease research; and provide recommendations to the HHS Secretary regarding changes or improvements to such activities and research. In developing the report, the Working Group will solicit stakeholder input.
Availability of Draft Toxicological Profiles
Document Number: 2019-09538
Type: Notice
Date: 2019-05-09
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on Draft Toxicological Profiles for Dinitrophenols, 2-Butanone, Mirex and Chlordecone, 1,2- Diphenylhydrazine, 1,2,3-Trichloropropane, Lead, and Endrin. ATSDR has updated these profiles based on availability of new health effects information since their initial release. On March 21, 2016 ATSDR announced that it was preparing to develop Draft Toxicological Profiles for public comment release (81 FR 15110), which include those profiles mentioned above. All toxicological profiles issued as ``Drafts for Public Comment'' represent the result of ATSDR's evidence-based evaluations to provide important toxicological information on priority hazardous substances. ATSDR is seeking public comments and additional information or reports on studies about the health effects of dinitrophenols, 2-butanone, mirex and chlordecone, 1,2- diphenylhydrazine, 1,2,3-trichloropropane, lead, and endrin for review and potential inclusion in the profiles. ATSDR considers key studies for these substances during the profile development process. This document solicits any relevant, additional studies. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile.
Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Guidance for Industry; Availability
Document Number: 2019-09530
Type: Notice
Date: 2019-05-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk.'' This guidance is intended to provide industry with our current thinking on how to prepare a food contact notification (FCN) submission for our review and evaluation of the safety of food contact substances (FCSs) used in contact with infant formula and/or human milk.
Submitting Documents Using Real-World Data and Real-World Evidence to the Food and Drug Administration for Drugs and Biologics; Draft Guidance for Industry; Availability
Document Number: 2019-09529
Type: Notice
Date: 2019-05-09
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 industry entitled ``Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics.'' This draft guidance is intended to encourage sponsors and applicants who are using real-world data (RWD) to generate real-world evidence (RWE) as part of their regulatory submissions to provide certain information to FDA so that FDA can internally track the submissions. The purpose of this guidance is to provide instructions on how to document that a submission includes RWE.
Clinical Lactation Studies: Considerations for Study Design; Draft Guidance for Industry; Availability
Document Number: 2019-09528
Type: Notice
Date: 2019-05-09
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 industry entitled ``Clinical Lactation Studies: Considerations for Study Design.'' This guidance reflects FDA's current recommendations to sponsors regarding lactation studies during drug development. This guidance provides recommendations to facilitate the conduct of lactation studies. Such studies can inform breastfeeding with drug use recommendations included in the Lactation subsection of labeling. The recommendations in this guidance also reflect discussions from the 2007 Pediatric Advisory Committee meeting and the 2016 Lactation Workshop, which considered how data from clinical lactation studies can inform the safety of a drug when used during lactation. This guidance replaces the draft guidance for industry entitled ``Clinical Lactation StudiesStudy Design, Data Analysis, and Recommendations for Labeling'' issued February 2005.
Postapproval Pregnancy Safety Studies; Draft Guidance for Industry; Availability
Document Number: 2019-09527
Type: Notice
Date: 2019-05-09
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 industry entitled ``Postapproval Pregnancy Safety Studies.'' When finalized, the purpose of this guidance will be to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes of pregnancies in women exposed to drugs and biological products regulated by FDA (i.e., pregnancy safety studies). This draft guidance, when finalized, will represent the current thinking of FDA on postapproval pregnancy safety studies. This draft guidance is intended to help industry develop more comprehensive and scientifically sound studies to assess the safety of drug and biological products during pregnancy in the postmarketing setting. The previous guidance for industry entitled ``Establishing Pregnancy Exposure Registries,'' issued on August 23, 2002, has been withdrawn.
Submission for OMB Review; 30-Day Comment Request; NIH Office of Intramural Training & Education-Application, Registration, and Alumni Systems (Office of the Director)
Document Number: 2019-09517
Type: Notice
Date: 2019-05-09
Agency: Department of Health and Human Services, National Institutes of Health
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.
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2019-09504
Type: Notice
Date: 2019-05-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-09503
Type: Notice
Date: 2019-05-09
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2019-09502
Type: Notice
Date: 2019-05-09
Agency: Department of Health and Human Services, National Institutes of Health
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2019-09444
Type: Notice
Date: 2019-05-09
Agency: Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-09463
Type: Notice
Date: 2019-05-08
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 Performance Progress and Monitoring Report (PPMR). This collection of information assists CDC in being responsible for the stewardship of funds provided via contracts, grants, and cooperative agreements, from CDC to partners throughout the world, while providing excellent, professional services to our partners and stakeholders.
National Committee on Vital and Health Statistics: Visioning Session
Document Number: 2019-09460
Type: Notice
Date: 2019-05-08
Agency: Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority: Office of the Assistant Secretary for Financial Resources
Document Number: 2019-09459
Type: Notice
Date: 2019-05-08
Agency: Department of Health and Human Services, Office of the Secretary
The Department of Health and Human Services (HHS) is updating a portion of one office, the Office of the Assistant Secretary for Financial Resources (ASFR), which is located within the Office of the Secretary (OS). ASFR is modifying its structure to streamline and improve operational functionality by replacing the Office of Grants and Acquisition Policy and Accountability (AMT) and establishing in its place the Office of Acquisitions (AMV), and the Office of Grants (AMU).
Notice of Interest Rate on Overdue Debts
Document Number: 2019-09445
Type: Notice
Date: 2019-05-08
Agency: Department of Health and Human Services, Office of the Secretary
Meeting of the Advisory Council on Blood Stem Cell Transplantation
Document Number: 2019-09434
Type: Notice
Date: 2019-05-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Advisory Council on Blood Stem Cell Transplantation (ACBSCT) meeting has been rescheduled due to unforeseen circumstances and will now be held on Tuesday, July 2, 2019, from 10:00 a.m.-4:00 p.m. Eastern Time. The meeting will be held by webinar and conference call. The webinar link, conference call-in number, agenda, and instructions for registration will be posted 15 business days before the meeting on the ACBSCT website at https:// bloodcell.transplant.hrsa.gov/about/advisory_council/meetings / index.html.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping
Document Number: 2019-09425
Type: Notice
Date: 2019-05-08
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of an Accelerated Approval Disclosure
Document Number: 2019-09418
Type: Notice
Date: 2019-05-08
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 (PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2019-09414
Type: Notice
Date: 2019-05-08
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.
Submission for OMB Review; Comment Request
Document Number: 2019-09413
Type: Notice
Date: 2019-05-08
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission of Medical Device Registration and Listing
Document Number: 2019-09412
Type: Notice
Date: 2019-05-08
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.
CooperVision, Inc.; Filing of Color Additive Petition
Document Number: 2019-09411
Type: Proposed Rule
Date: 2019-05-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by CooperVision, Inc., proposing that the color additive regulations be amended to provide for the safe use of disperse orange 3 methacrylamide to color contact lenses. The color additive is intended to be copolymerized with various monomers to produce colored contact lens materials.
Policy Clarification for Certain Fluoroscopic Equipment Requirements; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-09406
Type: Notice
Date: 2019-05-08
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 final guidance entitled ``Policy Clarification for Certain Fluoroscopic Equipment Requirements.'' This guidance document intends to clarify FDA's interpretation of certain aspects of the performance standard requirements in FDA's regulations for fluoroscopic equipment.
Medical X-Ray Imaging Devices Conformance With International Electrotechnical Commission Standards; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-09405
Type: Notice
Date: 2019-05-08
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 final guidance for industry entitled ``Medical X- Ray Imaging Devices Conformance with IEC Standards.'' This guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that is subject to the Federal Food, Drug and Cosmetic Act (FD&C Act) and FDA's regulations that apply to medical devices and electronic products.
Utilizing Animal Studies To Evaluate Organ Preservation Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-09402
Type: Notice
Date: 2019-05-08
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 final guidance entitled ``Utilizing Animal Studies to Evaluate Organ Preservation Devices.'' The intent of this guidance is to provide recommendations regarding best practices for utilizing animal studies for the evaluation of organ preservation devices.
Vessel Sanitation Program: Annual Program Status Meeting; Request for Comment
Document Number: 2019-09393
Type: Notice
Date: 2019-05-08
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 2019 annual Vessel Sanitation Program (VSP) public meeting. The annual meeting serves as a forum for HHS/CDC to update cruise industry representatives and other interested persons on work completed in 2018 and plans for future activities. HHS/CDC is also opening a public docket so that written comments and materials regarding VSP's 2018 and future work may be submitted. The official record of this meeting will remain open through July 26, 2019, so that comments related to the topics discussed at the meeting may be submitted and made part of the record.
Laser Products-Conformance With IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56); Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-09381
Type: Notice
Date: 2019-05-08
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 final guidance for industry entitled ``Laser ProductsConformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).'' This guidance describes the Agency's approach regarding compliance with FDA's performance standards for laser products. FDA believes that under the circumstances described in this guidance, conformance with certain International Electrotechnical Commission (IEC) standards would provide adequate protection of the public health and safety for laser products similar to performance standards in FDA's regulations. Accordingly, for laser product manufacturers that comply with the comparable clauses in IEC standards specified in the guidance, FDA does not intend to enforce the specified laser performance standards in FDA's regulations.
Classification and Requirements for Laser Illuminated Projectors (Laser Notice No. 57); Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-09380
Type: Notice
Date: 2019-05-08
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 final guidance entitled ``Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57).'' This guidance describes FDA's policy with respect to certain LIPs that comply with International Electrotechnical Commission (IEC) standards during laser product classification under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to electronic products.
Office of the Secretary; Notice of Meeting
Document Number: 2019-09353
Type: Notice
Date: 2019-05-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting
Document Number: 2019-09352
Type: Notice
Date: 2019-05-07
Agency: Department of Health and Human Services, National Institutes of Health