Department of Health and Human Services July 30, 2021 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-16326
Type: Notice
Date: 2021-07-30
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.'' This proposed information collection was previously published in the Federal Register on May 12, 2021 and allowed 60 days for public comment. AHRQ did not receive substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Medicare Program; Virtual Meeting of the Medicare Evidence Development and Coverage Advisory Committee-September 22, 2021
Document Number: 2021-16314
Type: Notice
Date: 2021-07-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, September 22, 2021. The MEDCAC panel will examine relevant health outcomes in studies for cerebrovascular disease treatment with a particular focus on new technologies of interest to CMS. Given the increased emphasis on new and innovative medical products for treating diseases that have few proven therapies, studies on certain medical technologies have focused on intermediate and surrogate outcomes rather than longer-term data. As a result, there are more frequent evidence gaps with respect to the clinically meaningful health outcomes for CMS beneficiaries, and these gaps impact our assessments of medical technologies. The MEDCAC panel will examine the growing challenges associated with the decreased level of evidence of certain new and innovative technologies. By voting on specific questions, and by their discussions, MEDCAC panel members will advise CMS about the ideal health outcomes in research studies of cerebrovascular disease treatment technologies, appropriate measurement instruments and follow-up durations to help to provide clarity and transparency of National Coverage Analyses (NCAs). This meeting is open to the public in accordance with the Federal Advisory Committee Act.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-16307
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2021-16306
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2021-16305
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, National Institutes of Health
Community Health Aide Program: Tribal Planning & Implementation
Document Number: 2021-16283
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, Indian Health Service
Epidemiology Program for American Indian/Alaska Native Tribes and Urban Indian Communities
Document Number: 2021-16281
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, Indian Health Service
Community Health Aide Program: Tribal Assessment & Planning
Document Number: 2021-16280
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, Indian Health Service
National Institue of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2021-16262
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2021-16261
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, National Institutes of Health
Notice of a Supplemental Award to the University of Arkansas System Telehealth Focused Rural Health Research Center
Document Number: 2021-16255
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA announces a supplemental award in the amount of $100,000 annually through fiscal year 2024. This funding will support the University of Arkansas Telehealth Focused Rural Health Research Center (TF RHRC), a current HRSA-funded cooperative agreement. The supplemental request is for the remaining period of performance of the current cooperative agreement, subject to the availability of funds and successful performance of the activities in a given budget year.
Proposed Information Collection Activity; Intergovernmental Reference Guide (IRG) (OMB No.: 0970-0209)
Document Number: 2021-16244
Type: Notice
Date: 2021-07-30
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), is requesting the Office of Management and Budget (OMB) to approve the Intergovernmental Reference Guide (IRG), with content revisions, for an additional three years. The IRG contains state and tribal child support information that assists child support enforcement (CSE) agencies in the administration of their respective programs. The current OMB approval expires on January 31, 2022.
Matthew Hebert: Final Debarment Order
Document Number: 2021-16211
Type: Notice
Date: 2021-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Matthew Hebert for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Hebert was convicted of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Hebert was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of May 5, 2021 (30 days after receipt of the notice), Mr. Hebert has not responded. Mr. Hebert's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Medicaid and Children's Health Insurance Program (CHIP) Generic Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-16208
Type: Notice
Date: 2021-07-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance \1\ related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' 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 would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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.
Regulatory Agenda
Document Number: 2021-14870
Type: Proposed Rule
Date: 2021-07-30
Agency: Department of Health and Human Services, Office of the Secretary
The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.