Department of Health and Human Services February 10, 2022 – Federal Register Recent Federal Regulation Documents
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Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Development of Non-Opioid Analgesics for Acute Pain.'' In connection with the SUPPORT for Patients and Communities Act (SUPPORT Act), the purpose of this guidance is to spur the development of alternatives to opioids for the management of acute pain by providing information about product development-related issues, ``opioid-sparing'' claims, and expedited programs as they pertain to this purpose.
Proposed Collection; 60-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery National Institute of Allergy and Infectious Diseases (NIAID)
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 Institute of Allergy and Infectious Diseases (NIAID) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements; Corrections
In the November 19, 2021 issue of the Federal Register, we published a final rule entitled ``Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment and Post-Payment Medical Review Requirements'' (referred to hereafter as the ``CY 2022 PFS final rule''). The effective date was January 1, 2022. This document corrects a limited number of technical and typographical errors identified in the November 19, 2021 final rule.
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 HHS with notice and copy of such complaint. FDA is required to publish notice of the complaint in the Federal Register.
Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the proposed clinical practice guideline, CDC Clinical Practice Guideline for Prescribing OpioidsUnited States, 2022 (the clinical practice guideline). The clinical practice guideline updates and expands the CDC Guideline for Prescribing Opioids for Chronic PainUnited States, 2016, and provides evidence-based recommendations for clinicians who provide pain care, including those prescribing opioids, for outpatients age 18 years and older with acute pain (duration less than 1 month), subacute pain (duration of 1-3 months), or chronic pain (duration of 3 months or more), not including sickle cell disease-related pain management, cancer pain treatment, palliative care, and end-of-life care. The clinical practice guideline includes recommendations for primary care clinicians (including physicians, nurse practitioners, and physician assistants) as well as for outpatient clinicians in other specialties (including those managing dental and postsurgical pain in outpatient settings and emergency clinicians providing pain management for patients being discharged from emergency departments). This voluntary clinical practice guideline provides recommendations and does not require mandatory compliance; and the clinical practice guideline is intended to be flexible so as to support, not supplant, clinical judgment and individualized, patient-centered decision-making.
Brenda K. Marmas: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Brenda K. Marmas for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Ms. Marmas engaged in a pattern of importing or offering for import misbranded drugs (i.e., in an amount, frequency, or dosage that is inconsistent with her personal or household use) that are not designated in an authorized electronic data interchange system as products regulated by FDA. Ms. Marmas was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of December 12, 2021 (30 days after receipt of the notice), Ms. Marmas had not responded. Ms. Marmas' failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.
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