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

Results 301 - 350 of 29,744
Notice of Closed Meeting
Document Number: 2019-08000
Type: Notice
Date: 2019-04-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-07998
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2019-07969
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Amended Notice of Meeting
Document Number: 2019-07968
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-07967
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 2019-07966
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meetings
Document Number: 2019-07965
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-07964
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2019-07963
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-07962
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2019-07961
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2019-07960
Type: Notice
Date: 2019-04-22
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.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2019-07959
Type: Notice
Date: 2019-04-22
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.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2019-07958
Type: Notice
Date: 2019-04-22
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.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2019-07957
Type: Notice
Date: 2019-04-22
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 Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2019-07956
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meetings
Document Number: 2019-07955
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-07954
Type: Notice
Date: 2019-04-22
Agency: Department of Health and Human Services, National Institutes of Health
Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-07936
Type: Notice
Date: 2019-04-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.'' This draft guidance document provides recommendations on the information that should be included in premarket submissions for devices that include quantitative imaging functions. This draft guidance is not final nor is it in effect at this time.
Removal of Compliance Deadline for Closed-Circuit Escape Respirators and Clarification of Post-Approval Testing Standards for Closed-Circuit Escape Respirators
Document Number: 2019-07935
Type: Rule
Date: 2019-04-19
Agency: Department of Health and Human Services
With this deregulatory action, the Department of Health and Human Services (HHS) revises regulatory language to remove a deadline by which respirator manufacturers must discontinue the manufacturing, labeling, and sale of certain self-contained self-rescuer models. The National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention, HHS, has determined that discontinuing the manufacturing, labeling, and sale of certain self-contained self-rescuer models is likely to result in a shortage of person-wearable large capacity escape respirators for underground coal miners who rely on these devices. In addition to removing the compliance deadline, HHS is also modifying regulatory language to clarify that post-approval testing of closed-circuit escape respirators may exclude human subject testing and environmental conditioning, at the discretion of NIOSH.
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-07931
Type: Notice
Date: 2019-04-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol.'' Due to the unique properties of nitinol, the Agency has developed this draft guidance to provide FDA's current thinking on technical considerations specific to devices using nitinol. This draft guidance document is intended to provide clarity and consistency in recommended non-clinical assessments across a variety of medical devices that contain nitinol. This draft guidance is not final nor is it in effect at this time.
Bispecific Antibody Development Programs; Draft Guidance for Industry; Availability
Document Number: 2019-07930
Type: Notice
Date: 2019-04-19
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 ``Bispecific Antibody Development Programs.'' This draft guidance provides recommendations to assist industry and other parties involved in the bispecific antibody drug development process. The draft guidance focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. Industry and other stakeholders are encouraged to engage FDA to discuss their individual bispecific antibody under development.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling: Nutrition Facts Label and Supplement Facts Label
Document Number: 2019-07929
Type: Notice
Date: 2019-04-19
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 the collection of information for the nutrition facts label and supplement facts label, which the Agency believes will serve to promote and protect public health.
Proposed Substances To Be Evaluated for Toxicological Profile Development
Document Number: 2019-07916
Type: Notice
Date: 2019-04-19
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services is initiating the development of another set of Toxicological Profiles. This notice solicits public nominations of substances for ATSDR to evaluate for Toxicological Profile development. ATSDR will consider nominations from the Substance Priority List (available at https://www.atsdr.cdc.gov/ SPL/). ATSDR also accepts nominations for non-Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERLA) substances that may have public health implications, on the basis of ATSDR's authority to prepare Toxicological Profiles for substances not found at sites on the CERCLA National Priorities List. For more information on the CERCLA National Priorities List, visit https:// www.epa.gov/superfund/superfund-national-priorities-list-npl. The agency will do so in order to establish and maintain an inventory of literature, research, and studies on the health effects of toxic substances, to respond to requests for consultation, and to support the site-specific response actions conducted by ATSDR, as otherwise necessary.
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities
Document Number: 2019-07839
Type: Notice
Date: 2019-04-19
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 the information collection provisions of the Agency's regulations that require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.
Adoption and Foster Care Analysis and Reporting System
Document Number: 2019-07827
Type: Proposed Rule
Date: 2019-04-19
Agency: Department of Health and Human Services, Administration for Children and Families
ACF proposes to amend the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations. This notice of proposed rulemaking (NPRM) amends the AFCARS regulations that require title IV-E agencies to collect and report data to ACF on children in out-of-home care, who exit out-of-home care to adoption or legal guardianship, and children who are covered by a title IV-E adoption or guardianship assistance agreement.
Aurolife Pharma, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
Document Number: 2019-07833
Type: Notice
Date: 2019-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 31 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide; Confirmation of Effective Date
Document Number: 2019-07829
Type: Rule
Date: 2019-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is confirming the effective date of December 4, 2018, for the final rule that appeared in the Federal Register of November 1, 2018, and that amended the color additive regulations to provide for the expanded safe use of synthetic iron oxides as color additives to include use in dietary supplement tablets and capsules.
Determination That TRISENOX (Arsenic Trioxide) Injection, 1 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-07828
Type: Notice
Date: 2019-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that TRISENOX (arsenic trioxide) injection, 1 milligram (mg)/milliliter (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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications
Document Number: 2019-07764
Type: Notice
Date: 2019-04-18
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 the information collection provisions of abbreviated new animal drug applications.
The Declaration of Allulose and Calories From Allulose on Nutrition and Supplement Facts Labels: Draft Guidance for Industry; Availability
Document Number: 2019-07763
Type: Notice
Date: 2019-04-18
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 draft guidance for industry entitled ``The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels.'' The draft guidance, when finalized, will provide guidance on the declaration of allulose on Nutrition Facts and Supplement Facts labels as well as on the caloric content of allulose. The draft guidance, when finalized, also would advise manufacturers of 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.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-07750
Type: Notice
Date: 2019-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-07748
Type: Notice
Date: 2019-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Sunscreen Drug Products for Over-the-Counter Human Use; Correction
Document Number: 2019-07712
Type: Proposed Rule
Date: 2019-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a proposed rule relating to the regulation of over-the-counter (OTC) sunscreen monograph products that appeared in the Federal Register of February 26, 2019. The document was published with formulas that were illegible. These corrections are being made to improve the accuracy of the proposed rule.
Sunscreen Drug Products for Over-the-Counter Human Use; Extension of Comment Period
Document Number: 2019-07710
Type: Proposed Rule
Date: 2019-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of February 26, 2019. In the proposed rule, FDA requested comments on its proposals relating to the regulation of over- the-counter (OTC) sunscreen monograph products. These proposals described the conditions under which the Agency proposes that OTC sunscreen monograph products are generally recognized as safe and effective and not misbranded. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Individual Patient Expanded Access Applications
Document Number: 2019-07711
Type: Notice
Date: 2019-04-17
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 Committee on Vital and Health Statistics: Meeting
Document Number: 2019-07709
Type: Notice
Date: 2019-04-17
Agency: Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards
Document Number: 2019-07706
Type: Notice
Date: 2019-04-17
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 the manufactured food regulatory program standards.
Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities; Public Workshop
Document Number: 2019-07700
Type: Notice
Date: 2019-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities.'' Convened by the Duke-Robert J. Margolis Center for Health Policy at Duke University in partnership with the Critical Path Institute and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to discuss challenges and opportunities to advance the development and application of analysis data standards in drug development and regulatory review. This public workshop is being organized to fulfill FDA's commitment in section (I)(J)(5)(c) of the Prescription Drug User Fee Reauthorization Performance Goals and Procedures Fiscal Years 2018 through 2022 (PDUFA VI goals letter; available at https://www.fda.gov/downloads/forindustry/userfees/ prescriptiondruguserfee/ucm511438.pdf) to convene a public workshop to advance the development and application of analysis data standards. FDA will use the information from this public workshop to inform ongoing and future analysis data standards initiatives and strategic planning to improve the efficiency of regulatory review of electronic submissions.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-07644
Type: Notice
Date: 2019-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2019-07643
Type: Notice
Date: 2019-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-07581
Type: Notice
Date: 2019-04-16
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-07555
Type: Notice
Date: 2019-04-16
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; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
Document Number: 2019-07523
Type: Notice
Date: 2019-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-07500
Type: Notice
Date: 2019-04-16
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-07493
Type: Notice
Date: 2019-04-16
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-07491
Type: Notice
Date: 2019-04-16
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.
Agency Information Collection Activities: Proposed Collection; Extension of Comment Period
Document Number: 2019-07474
Type: Notice
Date: 2019-04-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice extends the comment period for a 60-day notice request for proposed information collection request associated with the notice [Document Identifier: CMS-10630] entitled ``Programs of All- Inclusive Care for the Elderly (PACE) 2020 Audit Protocol'' that was published in the March 15, 2019 (84 FR 9526) Federal Register. The comment period for the information collection request, which would have ended on May 14, 2019, is extended to May 28, 2019.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Registering With the Center for Veterinary Medicine's Electronic Submission System
Document Number: 2019-07468
Type: Notice
Date: 2019-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
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 the Center for Veterinary Medicine (CVM) Guidance for Industry (GFI) #108 entitled ``Registering with CVM's Electronic Submission System.''
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2019-07467
Type: Notice
Date: 2019-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.