Department of Health and Human Services June 2021 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 259
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-11881
Type: Notice
Date: 2021-06-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-11880
Type: Notice
Date: 2021-06-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2021-11879
Type: Notice
Date: 2021-06-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2021-11872
Type: Notice
Date: 2021-06-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Cancer Institute; Notice of Closed Meetings
Document Number: 2021-11843
Type: Notice
Date: 2021-06-07
Agency: Department of Health and Human Services, National Institutes of Health
Determination That QUELICIN PRESERVATIVE FREE (Succinylcholine Chloride) Injection, 20 Milligrams/Milliliter, 50 Milligrams/Milliliter, and 100 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-11802
Type: Notice
Date: 2021-06-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 milligrams (mg)/milliliter (mL), 50 mg/mL, and 100 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness.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 QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, if all other legal and regulatory requirements are met.
Determination That ATROVENT (Ipratropium Bromide) Metered Spray, 0.021 Micrograms/Spray and 0.042 Micrograms/Spray, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-11800
Type: Notice
Date: 2021-06-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that ATROVENT (ipratropium bromide) metered spray, 0.021 micrograms (mcg)/spray and 0.042 mcg/spray, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2021-11785
Type: Notice
Date: 2021-06-04
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2021-11784
Type: Notice
Date: 2021-06-04
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2021-11783
Type: Notice
Date: 2021-06-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-11782
Type: Notice
Date: 2021-06-04
Agency: Department of Health and Human Services, National Institutes of Health
Intent To Award 54 Single-Source Supplements for Current Senior Medicare Patrol (SMP) State Grantee
Document Number: 2021-11779
Type: Notice
Date: 2021-06-04
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award 54 administrative supplements in the form of cooperative agreements to existing SMP project grantees to further support SMP activities in each state, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands. The purpose of existing grantees' work is to empower and assist Medicare beneficiaries, their families, and caregivers to prevent, detect, and report health care fraud, errors, and abuse through outreach, counseling, and education with an emphasis on reaching Medicare beneficiaries with limited income and those residing in rural areas. The administrative supplements for FY 2021 will be distributed via formula to the existing 54 SMP state grantees, bringing the total for the supplement awards to $2,002,468. These current SMP grantees will use this funding to further enhance or expand existing and prior established plans to empower and assist Medicare beneficiaries, their families, and caregivers to prevent, detect, and report health care fraud, errors, and abuse through outreach, counseling, and education. This additional funding will be targeted to reach Medicare beneficiaries with limited income, and/or those residing in rural areas.
Proposed Information Collection Activity; Head Start REACH: Strengthening Outreach, Recruitment, and Engagement Approaches With Families (New Collection)
Document Number: 2021-11777
Type: Notice
Date: 2021-06-04
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect data on different approaches that Head Start programs use for the recruitment, selection, enrollment, and retention (RSER) of families facing adversities and the community organizations with which it partners to support these activities. This study aims to present an internally valid description of RSER approaches used by six purposively selected programs, not to promote statistical generalization to different sites or service populations.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-11774
Type: Notice
Date: 2021-06-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH), National Firefighter Registry Subcommittee
Document Number: 2021-11772
Type: Notice
Date: 2021-06-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Board of Scientific Counselors (BSC), National Institute for Occupational Safety and Health (NIOSH), National Firefighter Registry Subcommittee. This is a virtual meeting. It is open to the public, limited only by web conference seats (500 web conference seats are available). If you wish to attend, please register at the NIOSH website https://www.cdc.gov/niosh/bsc/nfrs/ registration.html or call (404-498-2581) no later than August 6, 2021. Time will be available for public comment.
Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC)
Document Number: 2021-11771
Type: Notice
Date: 2021-06-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This is a virtual meeting open to the public, limited by the capacity of the conference webinar which is 2,000 participants. Pre-registration is required by accessing the link at: https://dceproductions.zoom.us/ webinar/register/WN_vCTciAdyQIeDK5g3NfFPow. There will be a public comment period from 2:15 p.m. to 4:15 p.m., EDT. The public is encouraged to register to provide public comment using the registration form available at the link provided in the meeting information section below.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-11738
Type: Notice
Date: 2021-06-04
Agency: Department of Health and Human Services, National Institutes of Health
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability
Document Number: 2021-11735
Type: Notice
Date: 2021-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.'' The draft guidance is intended to help industry better understand the definitions of ``suspect'' and ``illegitimate'' product as defined in the Drug Supply Chain Security Act (DSCSA). The draft guidance lays out FDA's current understanding of the following key terms used to define ``suspect'' and ``illegitimate'' product: ``Counterfeit,'' ``diverted,'' ``stolen,'' ``fraudulent transaction,'' and ``unfit for distribution.'' This revised draft guidance clarifies certain points of the draft guidance for industry ``Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act'' issued in March 2018 (March 2018 draft guidance), including FDA's current understanding of the term ``stolen.''
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Draft Guidance for Industry; Availability
Document Number: 2021-11734
Type: Notice
Date: 2021-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act.'' The Drug Supply Chain Security Act (DSCSA) outlines critical enhanced drug distribution security requirements for building an electronic, interoperable system by November 27, 2023, that will identify and trace certain prescription drugs at the package level as they are distributed within the United States. This draft guidance clarifies these requirements and provides recommendations on the system attributes necessary to enable the secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation, as necessary.
Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry; Availability
Document Number: 2021-11733
Type: Notice
Date: 2021-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers.'' The guidance is intended to address questions regarding product identifiers that, under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Drug Supply Chain Security Act (DSCSA), are required to be affixed to, or imprinted on, packages and homogenous cases of certain drug products intended to be introduced in a transaction into commerce. This guidance is intended to clarify FDA's interpretation of these requirements, including as they relate to the linear barcode requirements under the Code of Federal Regulations. This guidance finalizes the draft guidance issued on September 20, 2018.
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability
Document Number: 2021-11732
Type: Notice
Date: 2021-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.'' The guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with FDA. In addition, this guidance describes when manufacturers should notify FDA of a high risk that a product is illegitimate. This guidance responds to comments from stakeholders in order to clarify certain points and finalizes the remaining draft portion of the final guidance for industry entitled ``Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification,'' issued in December 2016.
Notice of Diabetes Mellitus Interagency Coordinating Committee Meeting
Document Number: 2021-11728
Type: Notice
Date: 2021-06-04
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a joint meeting with the National Institutes of Arthritis and Musculoskeletal and Skin Diseases on June 4, 2021. The topic for this meeting will be ``Diabetes and Bone.'' The meeting is open to the public.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2021-11723
Type: Notice
Date: 2021-06-04
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.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-11711
Type: Notice
Date: 2021-06-04
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Refugee Support Services (RSS) and RSS Set Aside Sub-Agency List (0970-0556)
Document Number: 2021-11653
Type: Notice
Date: 2021-06-03
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) Office of Refugee Resettlement (ORR) seeks approval for a revision to an existing information collection, requesting Refugee Support Services (RSS) grantees and RSS Set Aside grantees to provide the agency name, city, state, website, and funding amount for each contracted sub-grantee. Additionally, ORR seeks approval to have the option to make this information public. This would enhance the accessibility of refugee service provider information to eligible clients in support of the service referral responsibilities of the State Refugee Coordinators. Similar information for ORR's discretionary grants is currently made public.
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2021-11644
Type: Notice
Date: 2021-06-03
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2021-11643
Type: Notice
Date: 2021-06-03
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Secretary; Notice of Meeting
Document Number: 2021-11641
Type: Notice
Date: 2021-06-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2021-11640
Type: Notice
Date: 2021-06-03
Agency: Department of Health and Human Services, National Institutes of Health
Final Current Intelligence Bulletin 70: Health Effects of Occupational Exposure to Silver Nanomaterials
Document Number: 2021-11626
Type: Notice
Date: 2021-06-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH announces the availability of the final Current Intelligence Bulletin (CIB) 70: Health Effects of Occupational Exposure to Silver Nanomaterials.
Oral Drug Products Administered via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations; Draft Guidance for Industry; Availability
Document Number: 2021-11622
Type: Notice
Date: 2021-06-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations.'' This draft guidance provides recommendations for consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral tube. In addition, it supports the development of clear product-specific enteral tube administration instructions in labeling for administration to patients unable to ingest oral drug products.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-11591
Type: Notice
Date: 2021-06-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Determination That SANDOSTATIN (Octreotide Acetate) Injection, Equal to 0.2 Milligrams Base/Milliliter and Equal to 1 Milligrams Base/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2021-11575
Type: Notice
Date: 2021-06-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) has determined that SANDOSTATIN (octreotide acetate) injection, equal to (EQ) 0.2 milligrams (mg) base/milliliter (mL) and 1 mg base/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2021-11569
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-11546
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-11545
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2021-11544
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-11543
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Care Coordination Program Performance Improvement and Measurement System Database, OMB No. 0906-0024-Reinstate With Changes
Document Number: 2021-11542
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with 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.
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2021-11522
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-11521
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2021-11520
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-11519
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-11518
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting
Document Number: 2021-11516
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-11515
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2021-11514
Type: Notice
Date: 2021-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Advisory Committee on Infant Mortality
Document Number: 2021-11504
Type: Notice
Date: 2021-06-02
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 Advisory Committee on Infant Mortality (ACIM) has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https:// www.hrsa.gov/advisory-committees/infant-mortality/index.html.
Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All Inclusive Care for the Elderly; Corrections
Document Number: 2021-11446
Type: Rule
Date: 2021-06-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the final rule that appeared in the January 19, 2021 Federal Register titled ``Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All Inclusive Care for the Elderly.'' The effective date of the final rule was March 22, 2021.
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2021-11495
Type: Notice
Date: 2021-06-01
Agency: Department of Health and Human Services, National Institutes of Health