Department of Health and Human Services November 2021 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 235
Adjustment of Civil Monetary Penalties for Inflation and the Annual Civil Monetary Penalties Inflation Adjustment for 2021
This final rule finalizes the provisions of the September 6, 2016 interim final rule that adjusts for inflation the maximum civil monetary penalty (CMP) amounts for all agencies within the Department of Health and Human Services (HHS) and updates certain agency-specific regulations. It also updates our required annual inflation-related increases to the CMP amounts in our regulations, under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015; adds references to new penalty authorities; and reflects technical changes to correct errors.
Announcement of the Intent To Award a Supplement to Upwardly Global in New York, NY
The ACF, ORR, Division of Refugee Services (DRS) announces the intent to award a supplement in the amount of up to $1,500,000 to Upwardly Global in New York, NY. The purpose of this award is to enable the recipient to provide program services to Afghan Special Immigrant Visa holders and humanitarian parolees currently housed on U.S. military installations awaiting resettlement. Upwardly Global will provide on-base services for four months, and then continue to provide remote support to eligible Afghan entrants at resettlement sites throughout the U.S.
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections
The Office for Human Research Protections (OHRP), a program office in the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS (Secretary), through the Assistant Secretary for Health, on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill three positions on the Committee membership that will be vacated during the 2022 calendar year.
Optional Exceptions to the Prohibition Against Treating Incarceration as Voluntary Unemployment Under Child Support Guidelines
OCSE is withdrawing a previously published notice of proposed rulemaking (NPRM) that solicited public comment on two optional exceptions to the prohibition against treating incarceration as voluntary unemployment in child support cases.
Proposed Information Collection Activity; State Self-Assessment Review and Report
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) requests a 3-year extension of the State Self-Assessment Review and Report with minor revisions. The information collected in the report assists state child support agencies and OCSE in determining whether the agencies meet federal child support performance requirements. The current Office of Management and Budget (OMB) approval expires on April 30, 2022.
Agency Information Collection Activities: Proposed Collection; 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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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 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.
Health Center Program
HRSA provided supplemental funding to the Association of Clinicians for the Underserved (ACU), a currently funded National Training and Technical Assistance Partner award recipient. ACU leverages data tools and learning collaboratives to enhance current national training and technical assistance activities delivered to health centers to improve their capacity to recruit, develop, and retain their workforce to address national health care workforce shortages.
Updated Evaluation Policy; Cooperative Research or Demonstration Projects
The Administration for Children and Families is announcing updates to its evaluation policy for research or demonstration projects.
Child Support Enforcement Program Quarterly Financial Report (OCSE-396) and Quarterly Collection Report (OCSE-34) (OMB #0970-0510)
The Administration for Children and Families (ACF) is requesting public comment on the following forms: OCSE-34 ``Child Support Enforcement Program Quarterly Collection Report'' and OCSE-396 ``Child Support Enforcement Program Quarterly Financial Report.'' These forms are currently approved under the ACF Generic Clearance for Financial Reports (OMB #0970-0510; expiration June 30, 2024). There are no changes requested to the forms, but the instructions have been updated to address comments received in response to a notice published in the Federal Register and update burden hours.
Prospective Grant of an Exclusive Patent License: Use of Tomentosenol in Treating or Preventing Skin Disorders
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to University of the Sunshine Coast (``USC''), a public university based on the Sunshine Coast, Queensland, Australia, in its rights to the inventions and patents listed in the SUPPLEMENTARY INFORMATION section of this notice.
Determination of Regulatory Review Period for Purposes of Patent Extension; DOJOLVI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DOJOLVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human drug product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping
The Food and Drug Administration (FDA, Agency, or we) 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 our reporting and recordkeeping requirements for antimicrobial animal drug sales and distribution.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program
The Food and Drug Administration (FDA, the 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.
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.
Agency Information Collection Activities: Proposed Collection; Comment Request; Correction
This document corrects the information provided for [Document Identifier: CMS-10790] titled ``Medicare-Funded GME Residency Positions in accordance with Section 126 of the Consolidated Appropriations Act, 2020.''
Supplemental Evidence and Data Request on Partial Breast Irradiation for Breast Cancer
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Partial Breast Irradiation for Breast Cancer, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
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