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

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National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
Document Number: 2020-23444
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is by webcast only and is open to the public. Written comments will be accepted and registration is required to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.
21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comments
Document Number: 2020-23439
Type: Notice
Date: 2020-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and to the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2020-23397
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 69th full Council meeting utilizing virtual technology. PACHA members will be discussing HIV, the Ending the HIV Epidemic: A Plan for America (EHE) initiative, and the novel coronavirus (COVID- 19). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required to provide public comment. To pre-register to attend or to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business Friday November 20, 2020. If you decide you would like to provide public comment but do not pre- register, you may submit your written statement by emailing PACHA@hhs.gov by close of business Thursday, December 10, 2020. The meeting agenda will be posted on the PACHA page on HIV.gov at https:// www.hiv.gov/ federal-response/pacha/about-pacha prior to the meeting.
Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide Developmental and Reproductive Toxicology: Version 1.1
Document Number: 2020-23393
Type: Notice
Date: 2020-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing that it intends to conduct a Fit for Use (FFU) pilot program to test the processing and analysis of nonclinical study data provided electronically for the Clinical Data Interchange Standards Consortium (CDISC) for Standard for Exchange of Nonclinical Data (SEND) Implementation Guide (IG): Developmental and Reproductive Toxicology v1.1 (SEND-DART). The Agency's Center for Drug Evaluation and Research (CDER) will test the processing and analysis of nonclinical study data provided electronically in SEND-DART format. FDA is inviting individual firms that wish to participate in this pilot program to submit participation requests via email or in writing.
Prospective Grant of an Exclusive Patent License: Development of a Direct Ocular Administered Formulation of Metformin for Use in Therapeutic Treatment of Retinal Degenerative Diseases in Humans
Document Number: 2020-23386
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services, National Institutes of Health
The National Eye Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice certain of the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to Connectyx Technologies Holdings Group located in Boca Raton, Florida.
Prospective Grant of an Exclusive Patent License: Development of a Topical Ointment Containing Immunostimulatory CpG Oligodeoxynucleotides (ODN) for Dermatological Wound Healing
Document Number: 2020-23385
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services, National Institutes of Health
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 Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Six Therapeutics Technologies Holdings Group. (``Six Therapeutics'') located in New Jersey.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-23374
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-23373
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2020-23371
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2020-23370
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-23369
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-23368
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-23365
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Establishment of the Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2020-23363
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act (FACA) and section 1111 of the Public Health Service (PHS) Act, HHS announces the establishment of the ACHDNC as a discretionary advisory committee.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded-Time and Extent Applications for Nonprescription Drug Products
Document Number: 2020-23357
Type: Notice
Date: 2020-10-22
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.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2020-23356
Type: Notice
Date: 2020-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-23335
Type: Notice
Date: 2020-10-21
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 BUTISOL SODIUM (Butabarbital Sodium) Oral Tablets, 15 Milligrams, 50 Milligrams, and 100 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2020-23300
Type: Notice
Date: 2020-10-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document 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 if they meet relevant legal and regulatory requirements.
Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2020-23290
Type: Notice
Date: 2020-10-21
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 ``Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.'' Forms FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics, are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on postmarketing requirements (PMRs) and postmarketing commitments (PMCs) in a consistent format. Forms FDA 3988 and 3989 are published in draft form in Appendix A and B of the draft guidance for comment and are not intended to be used until the forms are finalized. The forms were developed, in part, in response to the recommendations from the Government Accountability Office (GAO) and the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) regarding the need for comparable information across annual status reports (ASRs) on PMRs and PMCs, to eliminate manual data entry, and to enhance FDA's ability to track PMRs and PMCs. These forms are expected to result in improved accuracy and timeliness of FDA's identification and review of those submissions containing information on PMRs and PMCs. This draft guidance covers the purpose of each form, when to use these forms, and how to submit these forms. The draft guidance also explains where applicants will be able to find the forms and instructions for their completion once the forms and instructions are finalized.
Agency Information Collection Activities; Proposed Collection; Comment Request; Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim
Document Number: 2020-23285
Type: Notice
Date: 2020-10-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, 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 record retention requirement of the soy protein/coronary heart disease health claim.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2020-23265
Type: Notice
Date: 2020-10-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-23248
Type: Notice
Date: 2020-10-21
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 Application for Permit to Import Biological Agents and Vectors of Human Disease into the United States, Application for Permit to Import or Transport Live Bats, and Application for Permit to Import Infectious Human Remains into the United States (OMB Control No. 0920-0199). The purpose of this data collection is to support Section 361 of the Public Health Service (PHS) Act and to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-23247
Type: Notice
Date: 2020-10-21
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 Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. This Generic Information Collection enables the CDC to garner customer and stakeholder feedback on service delivery through routine surveys, focus groups, usability testing, and customer comment cards.
Medicare and Medicaid Programs; Application From The Joint Commission for Continued Approval of Its Ambulatory Surgical Center (ASC) Accreditation Program
Document Number: 2020-23230
Type: Notice
Date: 2020-10-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve The Joint Commission for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-23221
Type: Notice
Date: 2020-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-23219
Type: Notice
Date: 2020-10-21
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 (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.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-23218
Type: Notice
Date: 2020-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2020-23217
Type: Notice
Date: 2020-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2020-23216
Type: Notice
Date: 2020-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-23213
Type: Notice
Date: 2020-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-23212
Type: Notice
Date: 2020-10-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2020-23211
Type: Notice
Date: 2020-10-21
Agency: Department of Health and Human Services, National Institutes of Health
Assisted Reproductive Technology (ART) Success Rates Reporting and Data Validation Procedures
Document Number: 2020-23188
Type: Notice
Date: 2020-10-20
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 opening of a public docket to obtain public comment on proposed changes in assisted reproductive technology (ART) data validation selection process; data validation approach; and data discrepancy reporting.
Submission for OMB Review; Identifying and Addressing Human Trafficking in Child Welfare Agencies (New Collection)
Document Number: 2020-23160
Type: Notice
Date: 2020-10-20
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 child welfare agencies' efforts to identify human trafficking and subsequent service delivery. The goal of the study is to better understand child welfare practice in screening for human trafficking, and the degree to which screening is related to subsequent referrals for, access to, and delivery of specialized services for children identified as trafficking victims or at high risk of trafficking.
Keith Komar: Final Debarment Order
Document Number: 2020-23135
Type: Notice
Date: 2020-10-20
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 Keith Komar for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Komar was convicted of one felony count under Federal law for mail fraud. The factual basis supporting Mr. Komar's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Komar was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of 30 days after receipt of the notice (July 22, 2020), Mr. Komar had not responded. Mr. Komar's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-23128
Type: Notice
Date: 2020-10-20
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: 2020-23124
Type: Notice
Date: 2020-10-20
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; Information Collection Request Title: Maternal Health Portfolio Evaluation Design, OMB No. 0906-xxxx-NEW
Document Number: 2020-23114
Type: Notice
Date: 2020-10-20
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.
Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2021 Proposed Guidance Development
Document Number: 2020-23104
Type: Notice
Date: 2020-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post two lists of guidance documents that the Center for Devices and Radiological Health (CDRH or the Center) intends to publish in fiscal year (FY) 2021. In addition, FDA has established a docket where interested persons may comment on the priority of topics for guidance, provide comments and/or propose draft language for those topics, suggest topics for new or different guidance documents, comment on the applicability of guidance documents that have issued previously, and provide any other comments that could benefit the CDRH guidance program and its engagement with stakeholders. This feedback is critical to the CDRH guidance program to ensure that we meet stakeholder needs.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2020-23076
Type: Notice
Date: 2020-10-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-23046
Type: Notice
Date: 2020-10-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-23045
Type: Notice
Date: 2020-10-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-23044
Type: Notice
Date: 2020-10-19
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: 2020-23043
Type: Notice
Date: 2020-10-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-23042
Type: Notice
Date: 2020-10-19
Agency: Department of Health and Human Services, National Institutes of Health
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2020-22998
Type: Notice
Date: 2020-10-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Request for Information and Comments on Fostering Research Integrity and the Responsible Conduct of Research
Document Number: 2020-22992
Type: Notice
Date: 2020-10-19
Agency: Department of Health and Human Services, Office of the Secretary
The Department of Health and Human Services (HHS), Office of Research Integrity (ORI) seeks information and comments from entities and individuals regarding activities that foster research integrity and promote the responsible conduct of research under 42 CFR part 93. In particular, ORI is interested in learning about best practices, challenges, and needs related to teaching the responsible conduct of research, promoting research integrity, and preventing research misconduct. ORI will use this information to support the goal of conducting outreach and developing educational resources that best support the Public Health Service (PHS) funded research community.
NCCIH Workshop 2020: Exploring the Mechanisms Underlying Analgesic Properties of Minor Cannabinoids and Terpenes
Document Number: 2020-22990
Type: Notice
Date: 2020-10-19
Agency: Department of Health and Human Services, National Institutes of Health
The National Center for Complementary and Integrative Health (NCCIH) will hold a workshop on October 23, 2020. The topic of this workshop will be ``Exploring the Mechanisms Underlying Analgesic Properties of Minor Cannabinoids and Terpenes''. The overall goals of this workshop are to convene principal investigators funded by NCCIH on the topic of the analgesic properties of minor cannabinoids and terpenes from natural products and the underlying mechanisms as well as to discuss current research barriers and opportunities on this topic.
The Declaration of Allulose and Calories From Allulose on Nutrition and Supplement Facts Labels; Availability
Document Number: 2020-22901
Type: Rule
Date: 2020-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.'' The guidance describes FDA's views on the declaration of allulose on Nutrition Facts and Supplement Facts labels and the caloric content of allulose. The guidance also announces our intent to exercise enforcement discretion for the exclusion of allulose from the amount of Total Sugars and Added Sugars declared on the Nutrition Facts and Supplement Facts label and use of a general factor of 0.4 calories per gram (kcal/g) for allulose when calculating declarations on Nutrition and Supplement Facts labels.
Sugars that Are Metabolized Differently Than Traditional Sugars
Document Number: 2020-22900
Type: Notice
Date: 2020-10-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is establishing a docket and invites information about and comments on the nutrition labeling of sugars that are metabolized differently than traditional sugars. We are taking this action to inform our regulatory approach to these distinctly metabolized sugars to promote the public health and help consumers make informed dietary decisions.