Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

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National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2020-09048
Type: Notice
Date: 2020-04-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-09047
Type: Notice
Date: 2020-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Modernizing the Food and Drug Administration's Data Strategy; Public Meeting; Extension of Comment Period
Document Number: 2020-09045
Type: Notice
Date: 2020-04-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing a new date, June 30, 2020, for the postponed public meeting entitled ``Modernizing FDA's Data Strategy'' and extending the comment period for docket number FDA-2019-N-5799 that appeared in the Federal Register on January 8, 2020. In the Federal Register notice, FDA requested comments on the purpose of the meeting, which is related to possible Agency level approaches to modernizing FDA's data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics. The Agency is taking this action in response to the associated postponed public meeting to allow interested persons additional time to submit comments.
Agency Emergency Information Collection Clearance Request for Public Comment
Document Number: 2020-09039
Type: Notice
Date: 2020-04-29
Agency: Department of Health and Human Services
Medicare Program; Application From National Association of Boards of Pharmacy for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program
Document Number: 2020-08990
Type: Notice
Date: 2020-04-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from National Association of Boards of Pharmacy for initial recognition as a national accrediting organization for suppliers of home infusion therapy services that wish to participate in the Medicare program. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publishes a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Pilot Program
Document Number: 2020-08989
Type: Notice
Date: 2020-04-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Network Development Planning Performance Improvement and Measurement System Database, OMB No. 0915-0384-Revision
Document Number: 2020-08967
Type: Notice
Date: 2020-04-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of the Paperwork Reduction Act of 1995, HRSA has 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.
CDC Recommendations for Hepatitis C Screening Among Adults-United States, 2020
Document Number: 2020-08960
Type: Notice
Date: 2020-04-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) announces the availability of the final CDC Recommendations for Hepatitis C Screening Among AdultsUnited States, 2020.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: The National Health Service Corps and Nurse Corps Interest Capture Form, OMB No. 0915-0337-Extension
Document Number: 2020-08950
Type: Notice
Date: 2020-04-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
National Institute of Dental & Craniofacial Research; Notice of Meeting
Document Number: 2020-08924
Type: Notice
Date: 2020-04-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-08923
Type: Notice
Date: 2020-04-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-08922
Type: Notice
Date: 2020-04-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-08921
Type: Notice
Date: 2020-04-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Recall Regulations
Document Number: 2020-08894
Type: Notice
Date: 2020-04-27
Agency: Food and Drug Administration, Department of Health and Human Services
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 information collection provisions in FDA's infant formula recall regulations.
Standardized Medicated Feed Assay Limits; Draft Guidance for Industry; Availability; Extension of Comment Period
Document Number: 2020-08890
Type: Notice
Date: 2020-04-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that published in the Federal Register on February 27, 2020. In that notice, FDA requested comments on the draft guidance for industry (GFI) #264 entitled ``Standardized Medicated Feed Assay Limits.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Advisory Commission on Childhood Vaccines
Document Number: 2020-08883
Type: Notice
Date: 2020-04-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Commission on Childhood Vaccines (ACCV) has scheduled a public meeting. Information about ACCV and the agenda for this meeting can be found on the ACCV website at https://www.hrsa.gov/advisory-committees/vaccines.
Prospective Grant of an Exclusive Patent License: Development, Production, and Commercialization of a Seasonal Influenza Vaccine
Document Number: 2020-08879
Type: Notice
Date: 2020-04-27
Agency: Food and Drug Administration, Department of Health and Human Services
The U.S. Food and Drug Administration (FDA) is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to Sciogen Inc. located in San Jose, California.
Office of Minority Health and Health Equity Strategic Priorities; Reopening of the Comment Period
Document Number: 2020-08878
Type: Notice
Date: 2020-04-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice, published in the Federal Register of January 3, 2020. In the notice, FDA opened a public docket to solicit input and comments from interested stakeholders, including racial and ethnic minority, underrepresented, and underserved populations on the Office of Minority Health and Health Equity Strategic Priorities (OMHHE). FDA is reopening the comment period to update comments and to receive any new information.
Notice of Closed Meeting
Document Number: 2020-08808
Type: Notice
Date: 2020-04-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Solicitation of Nominations for Appointment as Members of the Community Preventive Services Task Force (CPSTF)
Document Number: 2020-08804
Type: Notice
Date: 2020-04-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) is soliciting nominations for appointment of individuals qualified to serve as new members of the Community Preventive Services Task Force (CPSTF). New CPSTF members will serve a five-year term starting in 2021 or 2022. For efficiency and to reduce the burden on the public, the CPSTF nomination process seeks to fill vacancies anticipated for both calendar years 2021 and 2022.
Meeting of the Community Preventive Services Task Force (CPSTF)
Document Number: 2020-08801
Type: Notice
Date: 2020-04-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention within the Department of Health and Human Services announces the next meeting of the Community Preventive Services Task Force (CPSTF) on June 10- 11,2020.
Notice of Change in Reporting Requirements for The Federal Cigarette Labeling and Advertising Act (FCLAA) and Comprehensive Smokeless Tobacco Health Education Act (CSTHEA)
Document Number: 2020-08797
Type: Notice
Date: 2020-04-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces that it is extending the March 31, 2020 deadline for submissions required under the Federal Cigarette Labeling and Advertising Act (FCLAA) and the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) for cigarette and smokeless tobacco products, respectively. CDC also announces that it is extending the deadline for ingredient reports for new products that are due at the time of first importation. Previous notices announced that ingredient reports are due annually on March 31, and/or upon initial importation of cigarettes and/or smokeless tobacco products. Due to the current public health response to COVID-19, CDC is not able to accept any ingredient submissions and will not be issuing Certificates of Compliance at this time. CDC is communicating this information to state government entities and will re-evaluate this approach as necessary.
Medicare Program; Application From Community Health Accreditation Partner (CHAP) for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program
Document Number: 2020-08796
Type: Notice
Date: 2020-04-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from Community Health Accreditation Partner for initial recognition as a national accrediting organization for suppliers of home infusion therapy services that wish to participate in the Medicare program. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-08794
Type: Notice
Date: 2020-04-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Leptospirosis and melioidosis active hospital-based surveillance in Puerto Rico.'' The project aims to identify leptospirosis and melioidosis cases in Puerto Rico by establishing active surveillance for both diseases at four hospital sites for timelier disease identification and treatment and to improve understanding of leptospirosis and melioidosis epidemiology and ecology in Puerto Rico for public health control and prevention planning.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-08793
Type: Notice
Date: 2020-04-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-08788
Type: Notice
Date: 2020-04-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled The National Firefighter Registry (NFR). In accordance with the Firefighter Cancer Registry Act of 2018, the National Firefighter Registry (NFR) will develop and maintain a voluntary registry of firefighters to collect relevant health and occupational information of such firefighters for purposes of determining cancer incidence.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-08787
Type: Notice
Date: 2020-04-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Alcohol Abuse and Alcoholism; Amended Notice of Meeting
Document Number: 2020-08779
Type: Notice
Date: 2020-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Amended Notice of Meeting
Document Number: 2020-08778
Type: Notice
Date: 2020-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2020-08777
Type: Notice
Date: 2020-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Amended Notice of Meeting
Document Number: 2020-08776
Type: Notice
Date: 2020-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Drug Supply Chain Security Act Implementation
Document Number: 2020-08766
Type: Notice
Date: 2020-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Imports and Electronic Import Entries
Document Number: 2020-08763
Type: Notice
Date: 2020-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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).
Canned Pacific Salmon Deviating From Identity Standard; Amendment of Temporary Marketing Permit
Document Number: 2020-08762
Type: Notice
Date: 2020-04-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending Bumble Bee Seafoods Inc.'s temporary permit to market test canned skinless and boneless chunk salmon packed in water that contains sodium tripolyphosphate to inhibit protein curd formation during retorting. The temporary permit is amended to allow for the canned skinless and boneless chunk salmon packed in water with or without sodium tripolyphosphate and to update the manufacturing location. This amendment will allow the applicant to continue to test market the test product and collect data on consumer acceptance of the test product.
Agency Information Collection Activities: Proposed Collection; Request
Document Number: 2020-08727
Type: Notice
Date: 2020-04-24
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
For the ``Opioid Management in Older Adults'' project, AHRQ is seeking to identify innovative approaches to managing opioid medications for chronic pain that are particularly relevant for older adults. Use of long-term opioid therapy in older adults can be especially problematic because of increased risks such as delirium, falls, and dementia. Through this notice, the comment period has been extended to June 30, 2020. The subject matter content remains unchanged from the original notice which was previously published on March 18, 2020 (https://www.govinfo.gov/content/pkg/FR-2020-03-18/pdf/2020- 05612.pdf).
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2020
Document Number: 2020-08719
Type: Notice
Date: 2020-04-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2020, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Medicare Program; Approval of Application by the Accreditation Commission for Healthcare for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program
Document Number: 2020-08718
Type: Notice
Date: 2020-04-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the Accreditation Commission for Healthcare for initial recognition as a national accrediting organization for home infusion therapy suppliers that wish to participate in the Medicare program. A home infusion therapy supplier that participates must meet the Medicare conditions for coverage (CfCs).
Medicare Program: Comprehensive Care for Joint Replacement Model Three-Year Extension and Changes To Episode Definition and Pricing; Extension of Comment Period
Document Number: 2020-08717
Type: Proposed Rule
Date: 2020-04-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document extends the comment period for the proposed rule titled ``Medicare Program: Comprehensive Care for Joint Replacement Model Three-Year Extension and Changes to Episode Definition and Pricing'' that was published in the February 24, 2020 Federal Register. The comment period for the proposed rule, which would end on April 24, 2020, is extended until June 23, 2020.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2020-08702
Type: Notice
Date: 2020-04-24
Agency: Department of Health and Human Services
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.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
Document Number: 2020-08685
Type: Notice
Date: 2020-04-24
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on April 30, 2020. The topic for this meeting will be ``Improving Cardiovascular Outcomes in People with Type 1 Diabetes.'' The meeting is open to the public.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-08684
Type: Notice
Date: 2020-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting
Document Number: 2020-08683
Type: Notice
Date: 2020-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2020-08682
Type: Notice
Date: 2020-04-24
Agency: Department of Health and Human Services, National Institutes of Health
Grants, Contracts, and Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General's Civil Money Penalty Rules
Document Number: 2020-08451
Type: Proposed Rule
Date: 2020-04-24
Agency: Department of Health and Human Services, Office of Inspector General
This proposed rule would amend the civil money penalty (CMP or penalty) rules of the Department of Health and Human Services (HHS or Department) Office of Inspector General (OIG) to: Incorporate new authorities for CMPs, assessments, and exclusions related to HHS grants, contracts, other agreements; incorporate new CMP authorities for information blocking; and increase the maximum penalties for certain CMP violations.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-08651
Type: Notice
Date: 2020-04-23
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On Wednesday, April 15, 2020, the Centers for Medicare & Medicaid Services (CMS) published a notice entitled, ``Agency Information Collection Activities: Submission for OMB Review; Comment Request.'' That notice invited public comments on two separate information collection requests specific to document identifiers: CMS- 10716 and CMS-R-262. Through the publication of this document, we are withdrawing the portion of the notice requesting public comment on the information collection request titled ``CMS Plan Benefit Package (PBP) and Formulary CY 2021.'' Form number CMS-R-262 (OMB control number 0938-0673).
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry; Extension of Comment Period
Document Number: 2020-08609
Type: Notice
Date: 2020-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability entitled ``Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry'' that appeared in the Federal Register of January 30, 2020. The Agency is taking this action to allow interested persons additional time to submit comments.
Notice of Interest Rate on Overdue Debts
Document Number: 2020-08564
Type: Notice
Date: 2020-04-23
Agency: Department of Health and Human Services, Office of the Secretary
Government-Owned Inventions; Availability for Licensing
Document Number: 2020-08562
Type: Notice
Date: 2020-04-23
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2020-08561
Type: Notice
Date: 2020-04-23
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of an Exclusive Patent License: Thio Compounds and Thalidomide Analogues for the Treatment of Neurological Diseases
Document Number: 2020-08560
Type: Notice
Date: 2020-04-23
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute on Aging and the National Cancer Institute, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the U.S. and foreign Patents and Patent Applications listed in the Supplementary Information section of this notice to AevisBio, Inc. located in 814 W Diamond Ave., Suite 203, Gaithersburg, MD 20870.