Department of Health and Human Services May 2023 – Federal Register Recent Federal Regulation Documents
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Determination of Regulatory Review Period for Purposes of Patent Extension; ENSPRYNG; Correction
The Food and Drug Administration (FDA or the Agency) is correcting a notice that appeared in the Federal Register of July 13, 2022. The document determined the regulatory review period for ENSPRYNG. After review of a timely request for reconsideration by the applicant of the calculation of the applicable regulatory review period of the biologic product ENSPRYNG in that notice, FDA has determined that a revision of the supplementary information section is warranted. This notice corrects the applicable regulatory review period language.
Food Labeling, Infant Formula Requirements, Food Additives and Generally Recognized as Safe Substances, New Dietary Ingredient Notification; Technical Amendments; Correction
The Food and Drug Administration is correcting a final rule entitled ``Food Labeling, Infant Formula Requirements, Food Additives and Generally Recognized as Safe Substances, New Dietary Ingredient Notification; Technical Amendments'' that appeared in the Federal Register of March 24, 2023. The final rule corrected typographical errors, corrected errors in sample labels, restored inadvertent omissions, and updated office and organization names, addresses, and other references. The document was published with an incorrect abbreviation to ``Potassium'' in the codified language. This document corrects that error.
Health Information Technology Advisory Committee 2023 Schedule of Meetings
The Health Information Technology Advisory Committee (HITAC) was established in accordance with the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2023. See list of public meetings below.
Agency 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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Nurse Faculty Loan Program-Program Specific Data Form, Annual Performance Report Financial Data Form and NFLP Due Diligence Form; OMB No. 0915-0314-Revision
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Abbott Laboratories Pharmaceutical Products Division; Withdrawal of Approval of New Drug Applications for CYLERT (Pemoline) Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams, and CYLERT (Pemoline) Chewable Tablets, 37.5 Milligrams
The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) 016832 for CYCLERT (pemoline) tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, as well as NDA 017703 for CYCLERT (pemoline) chewable tablets, 37.5 mg, held by Abbott Laboratories Pharmaceutical Products Division, c/o G&L Scientific, 25 Independence Blvd., 4th Floor, Warren, NJ 07059 (Abbott). Abbott requested that approval of these applications be withdrawn and has waived its opportunity for a hearing.
Request for Information on the Prioritization of Drug, Vaccine, and Dietary Supplement Research Needs for Pregnant, Postpartum, and Lactating Persons
The National Institute of Child Health and Human Development (NICHD) seeks nominations for drug, vaccine, and dietary supplement research needs to be considered in the development of a Priority List of Drug, Vaccine, and Dietary Supplement Research Needs for Pregnant, Postpartum, and Lactating Persons. The NICHD is gathering nominations for drugs prescribed for conditions specific to or that co-occur during pregnancy and the postpartum period, including for lactation; dietary supplements that may be used in preparation for, during, or after pregnancy; and vaccines used by pregnant or lactating persons to prevent or treat disease. Additionally, the NICHD is seeking information on factors and processes it could consider in prioritizing these nominations. Nominations are requested from public and private stakeholders such as, but not limited to, researchers, academia, small- and large-scale industries, non-profit organizations, patients, providers, advocacy groups, payors, and federal agencies.
Privacy Act of 1974; System of Records
In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying a system of records maintained by the Indian Health Service (IHS), System No. 09-17-0003, Indian Health Service Medical Staff Credentials and Privileges Records. The system of records covers records about individuals who request credentialing and privileging to serve as IHS medical or health care professionals.
Agency Information Collection Activities: Proposed Collection; Comment Request
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited clearance process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low- burden, and uncontroversial,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that may be submitted under that umbrella. This notice is intended to advise the public of our intent to extend OMB's approval of our MACPro (Medicaid and CHIP Program) umbrella and all of the individual generic collection of information requests that fall under that umbrella. This notice also provides the public with general instructions for obtaining documents that are associated with such collections and for submitting comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's third-party disclosure and recordkeeping requirements for reportable food.
Proposed Information Collection Activity; Case Plan Requirement, Title IV-E of the Social Security Act
The Administration for Children and Families (ACF) is requesting a three-year extension of the information collection Case Plan Requirement, Title IV-E of the Social Security Act, (Office of Management and Budget (OMB)) #0970-0428, expiration September 9, 2023). There are no changes to the requirements, but burden estimates have been updated to reflect current numbers of children in foster care.
Medicare and Medicaid Programs; Application by the Center for Improvement in Healthcare Quality (CIHQ) for Initial CMS Approval of Its Psychiatric Hospital Accreditation Program
This notice acknowledges the receipt of an application from the Center for Improvement in Healthcare Quality (CIHQ) for initial recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs: Application From the Center for Improvement in Healthcare Quality for Initial CMS-Approval of Its Critical Access Hospital Accreditation Program
This notice announces our decision to approve the Center for Improvement in Healthcare Quality for initial recognition as a national accrediting organization for critical access hospitals that wish to participate in the Medicare or Medicaid programs.
Office of the Deputy Assistant Secretary for Early Childhood Development, Office of Head Start, Office of Child Care; Statement of Organization, Functions, and Delegations of Authority
The Administration for Children and Families (ACF) has reorganized the Office of Early Childhood Development (ECD), the Office of Head Start (OHS), and the Office of Child Care (OCC).
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Proposed Information Collection Activity; Objective Work Plan/On-Going Progress Report (Office of Management and Budget #0970-0452)
The Administration for Children and Families' (ACF) Administration for Native Americans (ANA) is requesting a three-year extension to the Ongoing Progress Report (OPR) and the Objective Work Plan (OWP) (Office of Management and Budget (OMB) #0970-0452, expiration September 930, 2023). There are no changes requested to the forms.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Substance Use Disorder Treatment and Recovery Loan Repayment Program and the Pediatric Specialty Loan Repayment Program
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Proposed Information Collection Activity; Federal Case Registry (Office of Management and Budget #0970-0421)
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), is requesting from the Office of Management and Budget to extend approval of the Federal Case Registry (FCR) for an additional three years. The current approval expires November 30, 2023. OCSE is proposing minor changes to punctuation, formatting, grammar, clarity, and spacing to enable easier completion of the form.
Proposed Information Collection Activity: Center for States Evaluation Ancillary Data Collection (Office of Management and Budget #0970-0501)
The Administration on Children, Youth and Families, Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is requesting approval for a revision of a currently approved information collection, the Center for States Evaluation Ancillary Data Collection.
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