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

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National Institute of Allergy and Infectious Diseases; Notice of Meetings
Document Number: 2024-15711
Type: Notice
Date: 2024-07-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Meeting
Document Number: 2024-15710
Type: Notice
Date: 2024-07-17
Agency: Department of Health and Human Services, National Institutes of Health
Platform Technology Designation Program; Draft Guidance for Industry; Extension of Comment Period
Document Number: 2024-15696
Type: Notice
Date: 2024-07-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance for industry "Platform Technology Designation Program for Drug Development" that appeared in the Federal Register of May 29, 2024. In the notice of availability for the draft guidance, FDA requested comments on the proposed collection of information. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)
Document Number: 2024-15695
Type: Notice
Date: 2024-07-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) 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 issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application (Supplement-5) for VYVGART HYTRULO (efgartigimod alfa and hyaluronidase-qvfc), approved June 21, 2024, meets the criteria for redeeming a priority review voucher.
Proposed Information Collection Activity; Child Support Portal Registration (Office of Management and Budget #: 0970-0370)
Document Number: 2024-15692
Type: Notice
Date: 2024-07-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Services (OCSS), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) approve the "Child Support Portal Registration," with minor revisions, for an additional three years. The OCSS Child Support Portal ("Portal") contains applications to help state child support agencies administer their programs. Authorized Portal users must register with OCSS to access Portal applications and provide OCSS with certain Portal application preferences. The current OMB approval expires on February 28, 2025.
Agency Information Collection Revision 30-Day Public Comment Request
Document Number: 2024-15655
Type: Notice
Date: 2024-07-17
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 reinstatement for public comment.
Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants
Document Number: 2024-15644
Type: Rule
Date: 2024-07-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and have earned an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current information needed to disburse the payment. This advisory provides information to QPs on how to update their Medicare billing information so that CMS can disburse APM Incentive Payments.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2024-15566
Type: Notice
Date: 2024-07-16
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public via webcast. The committee will discuss and vote on recommendations related to tissue biovigilance. The committee will also hear presentations and updates on recent committee work related to blood and organ safety.
National Institute on Minority Health and Health Disparities; Notice of Partially Closed Meeting
Document Number: 2024-15582
Type: Notice
Date: 2024-07-16
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2024-15581
Type: Notice
Date: 2024-07-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
National Cancer Institute; Notice of Closed Meeting
Document Number: 2024-15579
Type: Notice
Date: 2024-07-16
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2024-15578
Type: Notice
Date: 2024-07-16
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2024-15577
Type: Notice
Date: 2024-07-16
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Requirements
Document Number: 2024-15570
Type: Notice
Date: 2024-07-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 premarket tobacco product applications and recordkeeping requirements.
Agency Information Collection Activities; Proposed Collection; Comment Request; Substantial Equivalence Reports for Tobacco Products
Document Number: 2024-15569
Type: Notice
Date: 2024-07-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 substantial equivalence reports for tobacco products.
Announcing the Intent To Award a Single-Source Supplement for the National Paralysis Resource Center (PRC)
Document Number: 2024-15611
Type: Notice
Date: 2024-07-16
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award a single-source supplement to the current cooperative agreement held by the Christopher and Dana Reeve Foundation. The National Paralysis Resource Center (NPRC) is operated by the Christopher and Dana Reeve Foundation and offers important programmatic opportunities for persons with disabilities and older adults. The NPRC provides comprehensive information for people living with spinal cord injury, paralysis, and mobility-related disabilities and their families. Resources include information and referral by phone and email in multiple languages; a peer and family support mentoring program; a military and veterans' program; multicultural outreach services; multiple quality of life grants; and a national website. The administrative supplement for FY 2024 will be in the amount of $1,300,000, bringing the total award for FY 2024 to $10,000,000.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program Client-Level Data Reporting System
Document Number: 2024-15616
Type: Notice
Date: 2024-07-16
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA 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. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Proposed Collection; 60-Day Comment Request; NIH NeuroBioBank Tissue Access Request Form, National Institutes of Health
Document Number: 2024-15588
Type: Notice
Date: 2024-07-16
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 (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2024-15583
Type: Notice
Date: 2024-07-16
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2024-15536
Type: Notice
Date: 2024-07-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2024-15535
Type: Notice
Date: 2024-07-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Increase Flexibility for Tribes in Child Care and Development Fund (CCDF) Eligibility
Document Number: 2024-15244
Type: Proposed Rule
Date: 2024-07-16
Agency: Department of Health and Human Services
The Department of Health and Human Services, Administration for Children and Families proposes to amend the Child Care and Development Fund (CCDF) regulations through this notice of proposed rulemaking (NPRM) to allow all Indian Tribes and Tribal Organizations operating CCDF programs, at their discretion, to establish and use eligibility criteria regardless of family income.
Meeting of the Substance Abuse and Mental Health Services Administration, Center for Mental Health Services National Advisory Council
Document Number: 2024-15493
Type: Notice
Date: 2024-07-16
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given of the meeting on August 27, 2024, of the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services National Advisory Council (CMHS NAC). The meeting is open to the public and can also be accessed virtually (best option as space is restricted). 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, consideration of the meeting minutes from the February 27, 2024, SAMHSA, CMHS NAC meeting; updates from the CMHS Director; remarks from SAMHSA's Assistant Secretary; updates on Disasters; and updates on Subcommittee Tasks.
Medicare and Medicaid Programs: Application by DNV Healthcare USA Inc. for Continued CMS Approval of Its Psychiatric Hospital Accreditation Program
Document Number: 2024-15519
Type: Notice
Date: 2024-07-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice acknowledges the approval of an application from DNV Healthcare USA Inc. for continued CMS approval as a national accrediting organization for its psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2024-15473
Type: Notice
Date: 2024-07-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2024-15460
Type: Notice
Date: 2024-07-15
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.
Medicare Program; Announcement of the Advisory Panel on Hospital Outpatient Payment Meeting-August 26-27, 2024
Document Number: 2024-15393
Type: Notice
Date: 2024-07-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This meeting notice announces the virtual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) on Monday, August 26, 2024 and Tuesday, August 27, 2024. The purpose of the Panel is to advise the Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, which are major elements of the Medicare Hospital Outpatient Prospective Payment System and the Ambulatory Surgical Center payment system, and supervision of hospital outpatient therapeutic services.
Advisory Council on Blood Stem Cell Transplantation
Document Number: 2024-15391
Type: Notice
Date: 2024-07-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Council on Blood Stem Cell Transplantation (ACBSCT or Advisory Council) has scheduled public meetings. Information about the Advisory Council and the agenda for these meetings can be found on the ACBSCT website at https:// bloodstemcell.hrsa.gov/about/advisory-council.
Takeda Pharmaceuticals U.S.A., Inc.; Withdrawal of Approval of New Drug Application for EXKIVITY (Mobocertinib Succinate) Capsule, Equivalent to 40 Milligrams Base
Document Number: 2024-15371
Type: Notice
Date: 2024-07-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for EXKIVITY (mobocertinib succinate) capsule, equivalent to (EQ) 40 milligrams (mg) base, held by Takeda Pharmaceuticals U.S.A., Inc., 95 Hayden Ave., Lexington, MA 02421 (Takeda). Takeda has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
Cellular and Gene Therapies Interactive Site Tours Program for Regulatory Project Managers and Reviewers; Information Available to Industry
Document Number: 2024-15351
Type: Notice
Date: 2024-07-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or the Agency) Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) is announcing the Cellular and Gene Therapies Interactive Site Tours Program (the Interactive Site Tours Program). This program is intended to give CBER regulatory project managers and/or reviewers an opportunity to tour biotechnology manufacturing facilities developing cellular and gene therapy products, and to exchange regulatory experiences with their industry counterparts. With this program, CBER intends to enhance review efficiency and quality by providing CBER staff with a better understanding of the biotechnology manufacturing industry and its operations. The purpose of this notice is to invite companies developing cellular and gene therapy products interested in participating in this program to contact OTP for more information.
National Library of Medicine; Notice of Meetings
Document Number: 2024-15388
Type: Notice
Date: 2024-07-15
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meetings
Document Number: 2024-15384
Type: Notice
Date: 2024-07-15
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Communities Opioid Response Program Performance Measures, OMB No 0906-0044, Revision
Document Number: 2024-15441
Type: Notice
Date: 2024-07-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA 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. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Meeting of the Substance Abuse and Mental Health Services Administration's Tribal Technical Advisory Committee (TTAC)
Document Number: 2024-15344
Type: Notice
Date: 2024-07-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given for the meeting on August 27, 2024, of the Substance Abuse and Mental Health Services Administration's Tribal Technical Advisory Committee (TTAC). The meeting is open to the public and will be held 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; updates on SAMHSA priorities; follow up on topics related to the previous TTAC meetings; planning for the in-person September 2024 meeting; and council discussions.
Dental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability
Document Number: 2024-15337
Type: Notice
Date: 2024-07-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of two draft guidances entitled "Dental Composite Resin DevicesPremarket Notification (510(k)) Submissions" and "Dental Curing LightsPremarket Notification (510(k)) Submissions." These draft guidance documents provide recommendations for device description, performance testing, and labeling to include in 510(k) submissions for dental composite resin devices and dental curing lights. When final, these guidances will supersede the guidances "Dental Composite Resin DevicesPremarket Notification [510(k)] Submissions" dated October 26, 2005 and "Dental Curing Lights Premarket Notification [510(k)] Submissions" dated March 27, 2006. The recommendations in these draft guidances are intended to promote consistency and facilitate efficient review of these submissions. These draft guidances are not final nor are they for implementation at this time.
Submission for Office of Management and Budget (OMB) Review; Community Services Block Grant (CSBG) Model State Plan Applications (OMB No. 0970-0382)
Document Number: 2024-15368
Type: Notice
Date: 2024-07-12
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Community Services (OCS), Administration for Children and Families (ACF) requests a 3-year extension of the Community Services Block Grant (CSBG) State Plan, CSBG Eligible Entity Master List, and the American Customer Survey Index (ACSI) forms (OMB #0970-0382, expiration 8/31/2024). There are no changes requested to these information collections.
Proposed Collection; 60-Day Comment Request; Investigational Agent Accountability Record Forms and International Investigator Statement in the Conduct of Investigational Trials for the Treatment of Cancer National Cancer Institute (NCI)
Document Number: 2024-15352
Type: Notice
Date: 2024-07-12
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 an opportunity for public comment on proposed data collection projects, the 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.
Meeting of the Substance Abuse and Mental Health Services Administration National Advisory Council
Document Number: 2024-15312
Type: Notice
Date: 2024-07-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given for the meeting on August 29, 2024, 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; consideration and approval of the meeting minutes of February 29, 2024; a recap of the Joint meetings of the councils (JNAC) of August 28, 2024, and Lessons Learned. There will be presentations with council discussions on the following topics: Older Adults, Workforce, Legislative updates, OMTO, Budget, and Credentialing Work.
Joint Meeting of the National Advisory Councils
Document Number: 2024-15311
Type: Notice
Date: 2024-07-12
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given of the combined (joint) meeting on August 28, 2024, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) 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).
Proposed Information Collection Activity; Intergovernmental Reference Guide (IRG) (Office of Management and Budget No.: 0970-0209)
Document Number: 2024-15277
Type: Notice
Date: 2024-07-11
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Child Support Services (OCSS), is requesting the Office of Management and Budget (OMB) to approve the Intergovernmental Reference Guide (IRG), for an additional three years. The IRG contains State and Tribal child support information that helps child support agencies (CSAs) administer their respective programs. Minor updates are proposed, as described below. The current OMB approval (OMB #: 0970-0209) expires on February 28, 2025.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2024-15250
Type: Notice
Date: 2024-07-11
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve a revision of the currently approved information collection project: "The AHRQ Safety Program for Telemedicine: Improving the Diagnostic Process and Improving Antibiotic Use." This proposed information collection was previously published in the Federal Register on April 29th, 2024 and allowed 60 days for public comment. AHRQ received no substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Meeting of the Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Prevention National Advisory Council
Document Number: 2024-15245
Type: Notice
Date: 2024-07-11
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given for the meeting on August 27, 2024, of the Center for Substance Abuse Prevention National Advisory Council (CSAP 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 February 27, 2024; an update from the CSAP NAC Substance Use Prevention Workforce Subcommittee; overview and discussion on CSAP's primary prevention portfolio; Council discussion and public comments.
Determination of Regulatory Review Period for Purposes of Patent Extension; SPEVIGO
Document Number: 2024-15239
Type: Notice
Date: 2024-07-11
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 SPEVIGO 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 product.
Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar or Interchangeable Biosimilar Applicant
Document Number: 2024-15237
Type: Notice
Date: 2024-07-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing notice that an applicant for a biologics license application (BLA) for a biosimilar or interchangeable biosimilar product submitted under the Public Health Service Act (PHS Act) (a "subsection (k) applicant") notified FDA that an action for patent infringement was filed in connection with the applicant's BLA. Under the PHS Act, within 30 days after the subsection (k) applicant is served with a complaint in an action for patent infringement described under the PHS Act, the subsection (k) applicant shall provide the Secretary of Health and Human Services (HHS) with notice and copy of such complaint. FDA is required to publish notice of the complaint in the Federal Register.
Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2024-15130
Type: Notice
Date: 2024-07-11
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 "Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder." Design of clinical studies for devices intended to treat opioid use disorder (OUD) is challenging. To help spur innovative options to combat the opioid overdose crisis and treat OUD, this guidance provides recommendations on the design of pivotal clinical studies for devices intended to treat OUD (OUD device studies). Through these recommendations, FDA intends to aid sponsors in developing OUD device studies that provide scientific evidence used to determine whether there is a reasonable assurance of safety and effectiveness for treating OUD.
National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting
Document Number: 2024-15188
Type: Notice
Date: 2024-07-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting
Document Number: 2024-15187
Type: Notice
Date: 2024-07-11
Agency: Department of Health and Human Services, National Institutes of Health
Emergency Reinstatement: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
Document Number: 2024-15185
Type: Notice
Date: 2024-07-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is requesting that this information collection request (ICR), for the reinstatement of certain generic information collection requests (GenICs) be processed under the emergency Paperwork Reduction Act of 1995 (PRA) clearance process. Such GenICs are without change. We seek emergency reinstatement since we believe that public harm is reasonably likely to ensue if the normal, non-emergency clearance procedures are followed.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2024-15220
Type: Notice
Date: 2024-07-11
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2024-15137
Type: Notice
Date: 2024-07-10
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
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