Department of Health and Human Services August 18, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Determination That BORTEZOMIB (Bortezomib) Solution, 2.5 Milligrams/Milliliter and 3.5 Milligrams/1.4 Milliliter (2.5 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that BORTEZOMIB (bortezomib) solution, 2.5 milligrams (mg)/ milliliter (mL) and 3.5 mg/1.4 mL (2.5 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for BORTEZOMIB (bortezomib) solution, 2.5 mg/mL and 3.5 mg/1.4 mL (2.5 mg/ mL), if all other legal and regulatory requirements are met.
Medicare and Medicaid Programs: Application From the Joint Commission for Continued CMS Approval of Its Critical Access Hospital Accreditation Program
This notice announces our decision to approve the Joint Commission for continued recognition as a national accrediting organization for critical access hospitals that wish to participate in the Medicare or Medicaid programs.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Evidence Based Telehealth Network Program Measures, OMB No. 0906-0043-Revision
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.
David Winne; Denial of Hearing; Final Debarment Order
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by David Roy Winne (Winne) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Winne from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Winne was convicted of multiple felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Winne was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Winne submitted a request for hearing but failed to file with the Agency information and analysis sufficient to create a basis for a hearing.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Agency Information Collection Activities; Proposed Collection; Comment Request; Assessing ACL's American Indian, Alaskan Natives and Native Hawaiian Programs (OMB Control Number 0985-0059)
The Administration for Community Living (ACL) is providing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 a proposed extension without change information collection and solicits comments on the information collection requirements related to the project titled Assessing ACL's American Indian, Alaskan Natives and Native Hawaiian Programs (OMB Control Number 0985-0059).
World Trade Center Health Program; Youth Research Cohort; Request for Information
CDC's National Institute for Occupational Safety and Health (NIOSH) is extending the public comment period for a request for information (RFI) that published April 26, 2023, regarding a World Trade Center (WTC) Health Program research cohort for future studies on health, social, and educational impacts among persons exposed to the September 11, 2001, terrorist attacks who were aged 21 years or younger at the time of their exposures. An organization interested in responding to the RFI asked CDC to extend the comment period to allow more time to submit comments. With this notice, the comment period is extended an additional 60 days, to allow interested parties additional time to respond.
Supplements to Sickle Cell Disease Newborn Screening Follow-up Program Recipients (HRSA-21-036)
HRSA will provide supplemental award funds to all 25 Sickle Cell Disease (SCD) Newborn Screening (NBS) Follow-up Program (FP) grantees for $56,000 each for fiscal year 2023. The funds will support in-scope grant activities related to health care services, increasing access to medical and social support services, and conducting outreach to help connect individuals living with SCD to follow-up care.
Notice of Supplemental Award; Women's Preventive Services Initiative
HRSA is providing supplemental funds not to exceed $449,000 to the Women's Preventive Services Initiative (WPSI) in fiscal year 2023.
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