Department of Health and Human Services October 26, 2016 – Federal Register Recent Federal Regulation Documents

Short-Term Alternative Animal Models or In Vitro Tests Used To Identify Substances With the Potential To Cause Excessive Inflammation or Exaggerated Immune Responses; Request for Information
Document Number: 2016-25924
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences (NIEHS) requests available data and information on approaches and/or technologies currently used to identify substances with the potential to cause excessive inflammation or exaggerated immune responses leading to tissue injury when swallowed, inhaled, or absorbed through the skin. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods that could be used to evaluate the potential of chemicals to induce inflammation and immune-related conditions.
Office of the Director, Office of Science Policy, Office of Biotechnology Activities; Amended Notice of Meeting
Document Number: 2016-25921
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2016-25920
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2016-25919
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Renewal of Charters for Certain Federal Advisory Committees
Document Number: 2016-25916
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. App), the U.S. Department of Health and Human Services is hereby announcing that the charters have been renewed for the following federal advisory committees for which Office of the Assistant Secretary for Health provides management support: Chronic Fatigue Syndrome Advisory Committee (CFSAC); President's Council on Fitness, Sports, and Nutrition (PCFSN; the Council); Secretary's Advisory Committee on Human Research Protections (SACHRP); and Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). Functioning as federal advisory committees, these committees are governed by the provisions of the Federal Advisory Committee Act (FACA). Under FACA, it is stipulated that the charter for a federal advisory committee must be renewed every two years in order for the committee to continue to operate.
Advisory Commission on Childhood Vaccines
Document Number: 2016-25875
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Public Law 92-463), notice is hereby given that a meeting is scheduled for the Advisory Commission on Childhood Vaccines (ACCV). This meeting will be open to the public. Information about the ACCV and the agenda for this meeting can be obtained by accessing the following Web site: http://www.hrsa.gov/advisorycommittees/ childhoodvaccines/index.html.
Renewal of Charter for the Advisory Commission on Childhood Vaccines
Document Number: 2016-25857
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Department of Health and Human Services is hereby giving notice that the Advisory Commission on Childhood Vaccines (ACCV) has been rechartered. The effective date of the renewed charter is July 21, 2016.
Advisory Committee on Organ Transplantation
Document Number: 2016-25855
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Advisory Committee on Organ Transplantation (ACOT). The meeting will be open to the public.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling
Document Number: 2016-25854
Type: Notice
Date: 2016-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA 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 (the PRA).
The Sentinel Post-Licensure Rapid Immunization Safety Monitoring Program; Public Workshop; Correction
Document Number: 2016-25853
Type: Notice
Date: 2016-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Thursday, September 1, 2016 (81 FR 60357). The document announced a public workshop entitled ``The Sentinel Post-Licensure Rapid Immunization Safety Monitoring (PRISM) Program.'' The document was published with a Web site that changed after the publication of the notice of the workshop. This document corrects that error.
Use of Ozone-Depleting Substances
Document Number: 2016-25852
Type: Proposed Rule
Date: 2016-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as ``essential uses'' under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. This action, if finalized, will remove the essential-use exemption for anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for application. FDA is proposing this action because these products are no longer being marketed in approved versions that contain ODSs and because alternative products that do not use ODSs are now available.
Use of Ozone-Depleting Substances
Document Number: 2016-25851
Type: Rule
Date: 2016-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as ``essential uses'' under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. The products that will no longer constitute an essential use are: Sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. FDA is taking this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in versions that contain ODSs.
Use of Ozone-Depleting Substances
Document Number: 2016-25850
Type: Proposed Rule
Date: 2016-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as ``essential uses'' under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. This action, if finalized, will remove the essential-use exemptions for sterile aerosol talc administered intrapleurally by thoracoscopy for human use and for metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. FDA is proposing this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in versions that contain ODSs.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2016-25823
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Amended Notice of Meeting
Document Number: 2016-25822
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2016-25821
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2016-25820
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2016-25819
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2016-25818
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25817
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25816
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-25815
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Medicaid Program; Final FY 2014 and Preliminary FY 2016 Disproportionate Share Hospital Allotments, and Final FY 2014 and Preliminary FY 2016 Institutions for Mental Diseases Disproportionate Share Hospital Limits
Document Number: 2016-25813
Type: Notice
Date: 2016-10-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2014 and the preliminary federal share DSH allotments for FY 2016, and corresponding limitations on aggregate state DSH payments to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states' FY DSH allotments.
Medicare Program; Listening Session Regarding the Implementation of Certain Medicare Part D Provisions in the Comprehensive Addiction and Recovery Act of 2016 (CARA)
Document Number: 2016-25806
Type: Proposed Rule
Date: 2016-10-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces a listening session to solicit input from stakeholders regarding our implementation of section 704 of the Comprehensive Addiction and Recovery Act of 2016 (CARA), which includes provisions to permit Part D sponsors to establish drug management programs for at-risk beneficiaries under which Part D sponsors may limit such beneficiaries' access to frequently abused drugs to certain prescribers and pharmacies. Medicare beneficiaries with Part A or Part B, advocacy groups representing Medicare beneficiaries, physicians, pharmacists, and other clinicians (particularly other lawful prescribers of controlled substances), retail pharmacies, plan sponsors, entities delegated by plan sponsors (such as pharmacy benefit managers), biopharmaceutical manufacturers, and other interested parties are invited to participate. The Listening Session will be held via teleconference and is open to the public.
Guidelines Stating Principles for Working With Federally Recognized Indian Tribes
Document Number: 2016-25794
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, Administration for Children and Families
The Department of Health and Human Services (HHS), Administration for Children and Families (ACF), is issuing guidelines stating principles for working with federally recognized Indian tribes.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
Document Number: 2016-25793
Type: Notice
Date: 2016-10-26
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.
Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2016-25788
Type: Notice
Date: 2016-10-26
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 ``Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in developing drugs for the treatment of low sexual interest, desire, and/ or arousal in women. Specifically, this guidance addresses FDA's current thinking regarding the overall clinical development program, with a focus on phase 3 trial designs, to support an indication for the treatment of these conditions.
Submission for OMB Review; Comment Request
Document Number: 2016-25787
Type: Notice
Date: 2016-10-26
Agency: Department of Health and Human Services, Administration for Children and Families