Department of Health and Human Services May 25, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Request for Information on Drinking Water Contaminants of Emerging Concern for the National Emerging Contaminant Research Initiative
The National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS), on behalf of the Office of Science and Technology Policy (OSTP), requests input from all interested parties on research needed to identify, analyze, monitor, and mitigate drinking water contaminants of emerging concern (DW CECs). Comments provided through this Request for Information (RFI) will inform the development of a National Emerging Contaminant Research Initiative (NECRI). The NECRI will be the precursor to Federal coordination of DW CEC research; and agencies will publish external grant solicitations that align with the goals of the NECRI.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Shortages Data Collections
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 (PRA).
Bispecific Antibody Development Programs; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Bispecific Antibody Development Programs.'' This guidance provides recommendations to assist industry and other parties involved in the development of bispecific antibodies. The guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. This guidance finalizes the draft guidance of the same title issued on April 19, 2019.
FDA Reauthorization Act Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs.'' This guidance addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original new drug applications (NDAs) and biologics license applications (BLAs) are expected to be submitted to FDA, in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the FDA Reauthorization Act of 2017 (FDARA). Early pediatric evaluation of certain molecularly targeted oncology drugs as required by the FD&C Act is expected to accelerate the creation of an informed pediatric development plan and ultimately the development of promising drugs for pediatric patients. This guidance finalizes the draft guidance entitled ``FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs'' issued on December 13, 2019, and finalizes certain material related to implementation of FDARA that was included in the draft guidance entitled ``Pediatric Study Plans for Oncology Drugs: Questions and Answers'' issued on January 16, 2020. Accordingly, FDA does not intend to finalize the draft guidance entitled ``Pediatric Study Plans for Oncology Drugs: Questions and Answers,'' which is now withdrawn.
Determination That MANGANESE SULFATE, Injectable, Equivalent 0.1 Milligram Manganese/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that MANGANESE SULFATE, injectable, equivalent (Eq) 0.1 milligram (mg) manganese/milliliter (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 MANGANESE SULFATE, injectable, Eq 0.1 mg manganese/mL, if all other legal and regulatory requirements are met.
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) reapprove the proposed information collection project ``Ambulatory Surgery Center Survey on Patient Safety Culture Database.''
Notification of Interpretation and Enforcement of Section 1557 of the Affordable Care Act and Title IX of the Education Amendments of 1972
This Notification is to inform the public that, consistent with the Supreme Court's decision in Bostock and Title IX, beginning May 10, 2021, the Department of Health and Human Services (HHS) will interpret and enforce section 1557 of the Affordable Care Act prohibition on discrimination on the basis of sex to include: Discrimination on the basis of sexual orientation; and discrimination on the basis of gender identity. This interpretation will guide the Office for Civil Rights (OCR) in processing complaints and conducting investigations, but does not itself determine the outcome in any particular case or set of facts.
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