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

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Yogurt Products Deviating From Standard of Identity; Temporary Permit for Market Testing
Document Number: 2023-06390
Type: Notice
Date: 2023-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have issued a temporary permit to Chobani, LLC (the applicant) to market test lower fat yogurt products deviating from the general definition and standard of identity for yogurt with modified milkfat and fat-containing flavoring ingredients, and yogurt deviating from the yogurt standard of identity by using ultrafiltered nonfat milk as a basic dairy ingredient. The temporary permit will allow the applicant to evaluate commercial viability of the products and to collect data on consumer acceptance of the products.
Soft (Hydrophilic) Daily Wear Contact Lenses-Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2023-06374
Type: Notice
Date: 2023-03-28
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 ``Soft (Hydrophilic) Daily Wear Contact LensesPerformance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidance identified in this notice was developed in accordance with the final guidance entitled ``Safety and Performance Based Pathway.''
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2023-06406
Type: Notice
Date: 2023-03-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2023-06405
Type: Notice
Date: 2023-03-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2023-06404
Type: Notice
Date: 2023-03-28
Agency: Department of Health and Human Services, National Institutes of Health
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2023-06396
Type: Notice
Date: 2023-03-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare and Medicaid Services, Center for Medicare, Office of Minority Health has modified its organizational structure.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
Document Number: 2023-06358
Type: Notice
Date: 2023-03-28
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on April 24, 2023. The topic for this meeting will be ``Type 1 Diabetes (T1D): Evolving Concepts in the Pathophysiology, Screening and Prevention''. The meeting is open to the public.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Members
Document Number: 2023-06332
Type: Notice
Date: 2023-03-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The National Advisory Council for Healthcare Research and Quality (the Council) advises the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) with respect to activities proposed or undertaken to carry out AHRQ's statutory mission. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and works within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven new members will be appointed to replace seven current members whose terms will expire in November 2023.
OWH Observance Champions; Correction
Document Number: 2023-06319
Type: Notice
Date: 2023-03-28
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health published a document in the Federal Register of September 14, 2022, inviting public and private sector organizations to apply to become a Women's Health Champion. The document includes contact information for a staff member who is no longer working in the Office on Women's Health.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Metarrestin and Its Analogs for the Treatment of Metastatic Cancers
Document Number: 2023-06318
Type: Notice
Date: 2023-03-28
Agency: Department of Health and Human Services, National Institutes of Health
The National Center for Advancing Translational Sciences, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Oncala Bio Inc. (``Oncala Bio''), headquartered in Bend, OR.
Advisory Committee on Breast Cancer in Young Women; Meeting
Document Number: 2023-06316
Type: Notice
Date: 2023-03-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Advisory Committee on Breast Cancer in Young Women (ACBCYW). This meeting is open to the public, limited only by audio and web conference lines (150 web conference participant spaces available). Online registration is required.
General Considerations for Animal Studies Intended To Evaluate Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2023-06254
Type: Notice
Date: 2023-03-28
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 ``General Considerations for Animal Studies Intended to Evaluate Medical Devices.'' FDA developed this guidance document to assist medical device sponsors, testing facilities, and other persons involved in designing, conducting, and reporting the results of animal studies intended to assess the safety of medical devices to support premarket submissions. These animal studies typically provide initial evidence of device safety, which may include device performance and handling, and the biological effects when used in a living system.
Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2023-06304
Type: Notice
Date: 2023-03-27
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 draft guidance for industry entitled ``Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry.'' The draft guidance, when finalized, will provide FDA's current thinking on the use of Dietary Guidance Statements on packaged food labels and more broadly in the labeling of foods, including any written, printed, or graphic material accompanying a food, such as labeling on websites. This draft guidance is not final nor is it in effect at this time.
Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2023
Document Number: 2023-06299
Type: Notice
Date: 2023-03-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the fee rates under the over-the-counter (OTC) monograph drug user fee program (OMUFA) for fiscal year (FY) 2023. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests. This notice publishes the OMUFA fee rates for FY 2023.
Transition Plan for Medical Devices Issued Emergency Use Authorizations Related to Coronavirus Disease 2019 (COVID-19); Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff; Availability
Document Number: 2023-06292
Type: Notice
Date: 2023-03-27
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 ``Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19).'' FDA recognizes that it will take time for device manufacturers, device distributors, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the COVID-19 pandemic to ``normal operations.'' To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA's general recommendations for this transition process with respect to devices issued EUAs related to COVID-19, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices.
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency; Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff; Availability
Document Number: 2023-06291
Type: Notice
Date: 2023-03-27
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 ``Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.'' FDA recognizes that it will take time for device manufacturers, device distributors, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the COVID-19 public health emergency (PHE) to ``normal operations.'' To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA's general recommendations for a phased transition process with respect to devices that fall within certain enforcement policies issued during the COVID-19 PHE declared by the Secretary of Health and Human Services (the Secretary) under the Public Health Service Act (PHS Act), including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices. This guidance applies to devices that fall within enforcement policies in guidances included in List 1 of this guidance. The phased transition process outlined in this guidance will begin on the ``implementation date.'' The implementation date is the day the PHE expires or 45 days after the finalization of this guidance, whichever comes later. Because the COVID-19 section 319 PHE declaration is anticipated to expire at least 45 days after the finalization of this guidance, or May 11, 2023, the implementation date is that date. The guidances in List 1 of this guidance will no longer be in effect after the 180-day transition period ends.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Requirements
Document Number: 2023-06249
Type: Notice
Date: 2023-03-27
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).
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2023-06238
Type: Notice
Date: 2023-03-27
Agency: Department of Health and Human Services, National Institutes of Health
Announcement of the Approval of the Accreditation Commission for Health Care (ACHC) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988
Document Number: 2023-06280
Type: Notice
Date: 2023-03-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the approval of the application of the Accreditation Commission for Health Care (ACHC) as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialty and subspecialty areas under CLIA. We have determined that the ACHC meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant the ACHC deeming authority for a period of 6 years.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2023-06232
Type: Notice
Date: 2023-03-27
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2023-06226
Type: Notice
Date: 2023-03-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Change of Address; Technical Amendment
Document Number: 2023-06260
Type: Rule
Date: 2023-03-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is amending its regulations to update the address, email address, and office name for the Office of Policy, Legislation, and International Affairs, Office of Global Policy and Strategy. This technical amendment is to ensure accuracy and clarity in the Agency's regulations and is nonsubstantive.
Advisory Committee to the Director, Centers for Disease Control and Prevention
Document Number: 2023-06258
Type: Notice
Date: 2023-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC). This is a hybrid meeting, accessible both in person and virtually (webcast live via the World Wide Web). It is open to the public and limited only by the space available. Time will be available for public comment.
Notice of Closed Meeting
Document Number: 2023-06256
Type: Notice
Date: 2023-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2023-06255
Type: Notice
Date: 2023-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Clinical Trial Considerations To Support Accelerated Approval of Oncology Therapeutics; Draft Guidance for Industry; Availability
Document Number: 2023-05910
Type: Notice
Date: 2023-03-27
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 Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.'' The purpose of this guidance is to provide recommendations to sponsors of anti-cancer drugs or biological products on considerations for designing trials intended to support accelerated approval. The accelerated approval pathway is commonly used for approval of oncology drugs due to the serious and life-threatening nature of cancer. Although single-arm trials have been commonly used to support accelerated approval, a randomized controlled trial is the preferred approach as it provides a more robust efficacy and safety assessment and allows for direct comparisons to an available therapy. This guidance describes considerations for designing, conducting, and analyzing data for trials intended to support accelerated approvals of oncology therapeutics.
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2023-06085
Type: Notice
Date: 2023-03-27
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; National Human Trafficking Training and Technical Assistance Center (NHTTAC) Evaluation Package (OMB #0970-0519)
Document Number: 2023-06097
Type: Notice
Date: 2023-03-24
Agency: Department of Health and Human Services, Administration for Children and Families
The Office on Trafficking of Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting renewal with revisions to the instruments previously approved for the National Human Trafficking Training and Technical Assistance Center (NHTTAC) Evaluation Package (Office of Management and Budget (OMB) #0970-0519, expiration 03/31/2023). Items were expanded to include measures related to specific skills, competencies, and knowledge and outcomes at the organizational and community levels, and the annual burden has increased for several forms.
Privacy Act of 1974; System of Records
Document Number: 2023-06096
Type: Notice
Date: 2023-03-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the requirements of the Privacy Act of 1974, as amended, HHS is modifying a system of records maintained by HRSA's Bureau of Health Workforce, System Number 09-15-0054, National Practitioner Data Bank (NPDB).
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2023-06086
Type: Notice
Date: 2023-03-24
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2023-06165
Type: Notice
Date: 2023-03-24
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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled, Advancing Violence Epidemiology in Real-Time (AVERT). This data collection will help improve state and local jurisdictions' ability to identify, respond to, and prevent violence.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2023-06162
Type: Notice
Date: 2023-03-24
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 information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Public Health Law Fellowship Program Information Collection. The goal of this information collection request (ICR) is to obtain a new ICR using nine data collection instruments including two applications, five surveys, one interview guide, and one focus group guide assessing the quality and value of the Public Health Law Program Fellowship (PHL Fellowship).
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2023-06161
Type: Notice
Date: 2023-03-24
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Countermeasures Injury Compensation Program-OMB No. 0915-0334-Extension
Document Number: 2023-06134
Type: Notice
Date: 2023-03-24
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.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2023-06155
Type: Notice
Date: 2023-03-24
Agency: Department of Health and Human Services, National Institutes of Health
Joint Meeting of the National Advisory Councils
Document Number: 2023-06154
Type: Notice
Date: 2023-03-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given of the combined (joint) meeting on April 26, 2023, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) four National Advisory Councils: the SAMHSA National Advisory Council (NAC), the Center for Mental Health Services NAC, the Center for Substance Abuse Prevention NAC, the Center for Substance Abuse Treatment NAC; and the two SAMHSA Advisory Committees: Advisory Committee for Women's Services (ACWS) and the Tribal Technical Advisory Committee (TTAC).
Meeting of the Substance Abuse and Mental Health Services Administration National Advisory Council
Document Number: 2023-06153
Type: Notice
Date: 2023-03-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given for the meeting on April 27, 2023, of the Substance Abuse and Mental Health Services Administration National Advisory Council (SAMHSA NAC). The meeting is open to the public and can also be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https:// www.samhsa.gov/about-us/advisory-councils/meetings. The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; approval of the meeting minutes of August 10, 2022; updates and recap of the joint meetings of the councils (JNAC) and Lessons Learned; presentations on initiatives by the National Mental Health and Policy Laboratory; update on the Strategic Plan and Public Comment Response; and Overview of the Evidence-Based Practices Resource Center with group discussion; a presentation and discussion regarding the integration of equity; updates on the Interagency Task Force on Trauma Informed Care; updates on the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC); updates on the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC); Council discussion and public comments.
Administrative Simplification: Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard; Extension of Comment Period
Document Number: 2023-06034
Type: Proposed Rule
Date: 2023-03-24
Agency: Department of Health and Human Services, Office of the Secretary
This document extends the comment period for the proposed rule that appeared in the Federal Register on December 21, 2022, titled ``Administrative Simplification: Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard. The comment period for the proposed rule, which would end on March 21, 2023, is extended until April 21, 2023.
Framework for the Use of Digital Health Technologies in Drug and Biological Product Development; Availability
Document Number: 2023-06066
Type: Notice
Date: 2023-03-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the publication of a digital health technology (DHT) framework by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. This framework is entitled ``Framework for the Use of Digital Health Technologies in Drug and Biological Product Development.'' This fulfills an FDA commitment under the seventh iteration of the Prescription Drug User Fee Act (PDUFA VII) reauthorization, incorporated as part of the FDA User Fee Reauthorization Act of 2022.
Food Labeling, Infant Formula Requirements, Food Additives and Generally Recognized as Safe Substances, New Dietary Ingredient Notification; Technical Amendments
Document Number: 2023-05418
Type: Rule
Date: 2023-03-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending its regulations that pertain to food labeling, infant formula requirements, food additives, direct food substances affirmed as generally recognized as safe (GRAS), and new dietary ingredient (NDI) notifications. These amendments correct typographical errors, correct errors in sample labels, restore inadvertent omissions, and update office and organization names, addresses, and other references. This action is ministerial or editorial in nature.
Proposed Information Collection Activity; Personal Responsibility Education Program (PREP)-Extension
Document Number: 2023-05992
Type: Notice
Date: 2023-03-23
Agency: Department of Health and Human Services, Administration for Children and Families
OPRE and the Family and Youth Services Bureau (FYSB) in ACF request an extension to a currently approved information collection of performance measures data for the PREP Program (OMB No. 0970-0497; expiration date: 06/30/2023). The purpose of the request is to (1) continue the ongoing data collection and submission of the performance measures by PREP grantees and (2) eliminate the requirement for grantees to aggregate participant survey data to the program level for submission.
Potential Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Survey on Prenatal and Childbirth Care Experiences in Ambulatory and Inpatient Settings: Request for Information
Document Number: 2023-05988
Type: Notice
Date: 2023-03-23
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) invites public comment in response to this Request for Information (RFI) about a potential Consumer Assessment of Healthcare Providers and Systems (CAHPS[supreg]) survey to assess patients' prenatal care and childbirth care experiences in ambulatory and inpatient care settings. Currently, no CAHPS instrument is available that is specifically designed to measure prenatal and childbirth care from the patient's perspective in these settings. Accordingly, this RFI seeks comments regarding methodologically sound approaches to assessing prenatal and childbirth care experiences in healthcare settings about topics such as communication with providers, respect, access to services, and patients' perceptions of bias in receiving care. This RFI also seeks comments about any (1) existing patient experience surveys or survey items that might be incorporated into public domain CAHPS ambulatory and inpatient prenatal and childbirth experience surveys; and, (2) special considerations or concerns associated with the collection of such information. This RFI will help inform the development of scientifically sound surveys to potentially measure the experience of patients receiving prenatal and childbirth care.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Shortage Designation Management System (SDMS)
Document Number: 2023-05986
Type: Notice
Date: 2023-03-23
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; CINTEC PLUS CYTOLOGY
Document Number: 2023-05908
Type: Notice
Date: 2023-03-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CINTEC PLUS CYTOLOGY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; TEGSEDI
Document Number: 2023-05906
Type: Notice
Date: 2023-03-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TEGSEDI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Menopause and Optimizing Midlife Health of Women
Document Number: 2023-05984
Type: Notice
Date: 2023-03-23
Agency: Department of Health and Human Services, National Institutes of Health
This symposium is sponsored by the NIH Office of Research on Women's Health (ORWH), the title of this year's symposium is ``Menopause and Optimizing Midlife Health of Women.'' The symposium will discuss menopausal transition, accumulation of morbidity after menopause, menopause in special populations, social determinants of health, menopausal hormonal therapy, and interventions to promote healthy aging.
Proposed Information Collection Activity; Operation Allies Welcome Afghan Supplement Survey (New Collection)
Document Number: 2023-05980
Type: Notice
Date: 2023-03-23
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services is proposing to collect data for a new Operation Allies Welcome (OAW) Afghan Supplement Survey.
National Advisory Committee on Individuals With Disabilities and Disasters
Document Number: 2023-05976
Type: Notice
Date: 2023-03-23
Agency: Department of Health and Human Services
The National Advisory Committee on Individuals with Disabilities and Disasters (NACIDD or the Committee) is required by the PHS Act as amended by the Pandemic and All Hazards Preparedness and Advancing Innovation Act (PAHPAIA) and governed by the provisions of the Federal Advisory Committee Act (FACA). The NACIDD shall evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS and ASPR to support and enhance all-hazards public health and medical preparedness, response, and recovery aimed at meeting the needs of people with disabilities. The Secretary of HHS has delegated authority to operate the NACIDD to ASPR.
Determination of Regulatory Review Period for Purposes of Patent Extension; RECELL AUTOLOGOUS CELL HARVESTING DEVICE
Document Number: 2023-05948
Type: Notice
Date: 2023-03-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RECELL AUTOLOGOUS CELL HARVESTING DEVICE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological device.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2023-05975
Type: Notice
Date: 2023-03-23
Agency: Department of Health and Human Services, National Institutes of Health
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