Department of Health and Human Services July 11, 2024 – Federal Register Recent Federal Regulation Documents
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Proposed Information Collection Activity; Intergovernmental Reference Guide (IRG) (Office of Management and Budget No.: 0970-0209)
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
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
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
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
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
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.
Emergency Reinstatement: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)
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.
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