Department of Health and Human Services December 10, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organizations and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers
This notification is to inform the public that CMS is exercising its discretion in how it enforces the payer-to-payer data exchange provisions. As a matter of enforcement discretion, CMS does not expect to take action to enforce compliance with these specific provisions until we are able to address certain implementation challenges.
Medical Devices; General and Plastic Surgery Devices; Classification of the Negative Pressure Wound Therapy Device for Reduction of Wound Complications
The Food and Drug Administration (FDA, Agency, or we) is classifying the negative pressure wound therapy device for reduction of wound complications into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the negative pressure wound therapy device for reduction of wound complications' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for Attention Deficit Hyperactivity Disorder
The Food and Drug Administration (FDA, the Agency, or we) is classifying the transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder (ADHD) into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the transcutaneous electrical nerve stimulator for ADHD's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingested, Transient, Space Occupying Device for Weight Management and/or Weight Loss
The Food and Drug Administration (FDA or we) is classifying the ingested, transient, space occupying device for weight management and/or weight loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the ingested, transient, space occupying device for weight management and/or weight loss's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Development of Anti-Infective Drug Products for the Pediatric Population; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Development of Anti-Infective Drug Products for the Pediatric Population.'' The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for pediatric patients. The guidance addresses enrollment strategies, extrapolation of efficacy, safety database, and other considerations to help facilitate pediatric anti-infective drug product development. This guidance finalizes the draft guidance of the same title issued on June 30, 2020.
Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``CMC Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports.'' This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA generally considers to have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. Under FDA regulations, such minor changes in the product, production process, quality controls, equipment, facilities, or responsible personnel must be documented by applicants in an annual report. The guidance finalizes the draft guidance of the same title dated August 2017.
Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Specifically, this draft guidance addresses FDA's current recommendations regarding trial design, safety, and efficacy considerations for CRSwNP clinical trials.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Labeling Requirements for Prescription Drugs
The Food and Drug Administration (FDA, Agency, 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.
Additional Comment Period for Updated HRSA-Supported Women's Preventive Services Guidelines Statement on Breastfeeding Services and Supplies
On August 20, 2021, HRSA published a notice soliciting public comments regarding proposed updated draft recommendations to the HRSA- Supported Women's Preventive Services Guidelines (Guidelines) in the areas of Well-Women Preventive Visits, Counseling for Sexually Transmitted Infections, and Breastfeeding Services and Supplies, which, when accepted by HRSA, are required to be covered without cost-sharing by certain health insurance issuers under the Public Health Service Act. The updated draft recommendation statements were developed through a national cooperative agreement, the Women's Preventive Services Initiative (WPSI), by the American College of Obstetricians and Gynecologists (ACOG). Since the publication of that notice, WPSI has further updated its recommendation statement on Breastfeeding Services and Supplies. HRSA encourages members of the public to review this revised updated recommendation statement and provide comments for consideration.
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Reopening of the Comment Period
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the document entitled ``Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance of Industry,'' published in the Federal Register on September 30, 2021. The Agency is taking this action to allow interested persons additional time to submit comments.
Medicare and Medicaid Programs: Application From the Joint Commission for Continued Approval of Its Hospital Accreditation Program
This proposed notice acknowledges the receipt of an application from The Joint Commission for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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 Father Generic Information Collection Request. 30-Day Public Comment Request
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.
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