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Friday's Health & Human Services Policy Alerts

Federal Register - Articles

Older articles are available in the Policy Alerts Archive.

Health and Human Services Department
Notice February 23, 2018 Document# 2018-03768
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the...
Health and Human Services Department
Agency for Healthcare Research and Quality
Notice February 23, 2018 Document# 2018-03744
Patient Safety Organizations: Expired Listing for Quality Solutions
The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no...
Health and Human Services Department
Community Living Administration, Aging Administration
Notice February 23, 2018 Document# 2018-03767
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Annual Long-Term Care Ombudsman Report Known as the National Ombudsman Reporting System (NORS) and Instructions (OMB No: 0985-0005)
The Administration for Community Living/Administration on Aging (ACL/AoA) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under...
Health and Human Services Department
Food and Drug Administration
Notice February 23, 2018 Document# 2018-03701
Determination of Regulatory Review Period for Purposes of Patent Extension; ZYDELIG-New Drug Application 206545
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZYDELIG based on new drug application (NDA) 206545 and is publishing this notice of that determination as required by law. FDA has made the...
Health and Human Services Department
Food and Drug Administration
Notice February 23, 2018 Document# 2018-03700
Sebela Ireland, Ltd. et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 24 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer...
Health and Human Services Department
National Institutes of Health
Notice February 23, 2018 Document# 2018-03704
National Human Genome Research Institute; Notice of Closed Meetings
Health and Human Services Department
National Institutes of Health
Notice February 23, 2018 Document# 2018-03703
Center for Scientific Review; Notice of Meeting
Health and Human Services Department
National Institutes of Health
Notice February 23, 2018 Document# 2018-03702
Center for Scientific Review; Notice of Closed Meetings

Articles from Yesterday

Older articles are available in the Policy Alerts Archive.

Health and Human Services Department
Children and Families Administration
Notice February 22, 2018 Document# 2018-03583
Announcement of Intent To Issue One OPDIV-Initiated Supplement to BCFS Health and Human Services Under the Standing Announcement for Residential (Shelter) Services for Unaccompanied Children, HHS-2017-ACF-ORR-ZU-1132
ACF, ORR, announces the issuance of one OPDIV-Initiated Supplement to BCFS Health and Human Services, San Antonio, TX in the amount of $15,000,000. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions...
Health and Human Services Department
Food and Drug Administration
Notice February 22, 2018 Document# 2018-03614
Joint Meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming joint public advisory committee meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee. The Committee will function as...
Health and Human Services Department
Food and Drug Administration
Notice February 22, 2018 Document# 2018-03613
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle
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...
Health and Human Services Department
Food and Drug Administration
Notice February 22, 2018 Document# 2018-03612
Determination of Regulatory Review Period for Purposes of Patent Extension; ESBRIET
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ESBRIET and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of...
Health and Human Services Department
Food and Drug Administration
Notice February 22, 2018 Document# 2018-03610
Determination of Regulatory Review Period for Purposes of Patent Extension; LYMPHOSEEK
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LYMPHOSEEK and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an...
Health and Human Services Department
Food and Drug Administration
Notice February 22, 2018 Document# 2018-03609
Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drugs for Investigational Use
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...
Health and Human Services Department
Food and Drug Administration
Notice February 22, 2018 Document# 2018-03608
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
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...
Health and Human Services Department
Food and Drug Administration
Notice February 22, 2018 Document# 2018-03607
Parke-Davis, Subsidiary of Pfizer, Inc. et al.; Withdraw of Approval of 38 New Drug Applications and 43 Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 38 new drug applications (NDAs) and 43 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that...
Health and Human Services Department
Food and Drug Administration
Notice February 22, 2018 Document# 2018-03606
Determination of Regulatory Review Period for Purposes of Patent Extension; OFEV
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OFEV and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application...
Health and Human Services Department
Food and Drug Administration
Notice February 22, 2018 Document# 2018-03605
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority
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...
Health and Human Services Department
Food and Drug Administration
Notice February 22, 2018 Document# 2018-03604
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing
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...
Health and Human Services Department
Food and Drug Administration
Notice February 22, 2018 Document# 2018-03603
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to...
Health and Human Services Department
National Institutes of Health
Notice February 22, 2018 Document# 2018-03669
National Institute of Mental Health; Notice of Closed Meetings
Health and Human Services Department
National Institutes of Health
Notice February 22, 2018 Document# 2018-03668
National Institute of Mental Health; Notice of Closed Meetings
Health and Human Services Department
National Institutes of Health
Notice February 22, 2018 Document# 2018-03667
National Institute of General Medical Sciences; Notice of Closed Meeting
Health and Human Services Department
National Institutes of Health
Notice February 22, 2018 Document# 2018-03666
Center for Scientific Review; Notice of Closed Meeting
Health and Human Services Department
National Institutes of Health
Notice February 22, 2018 Document# 2018-03559
Predictive Models for Acute Oral Systemic Toxicity; Notice of Meeting; Registration Information
The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announces the workshop ``Predictive Models for Acute Oral System Toxicity.'' Workshop attendees will discuss development of in silico models for acute oral system...
Health and Human Services Department
National Institutes of Health
Notice February 22, 2018 Document# 2018-03558
National Institute on Aging; Notice of Meeting

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