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

Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-26248
Type: Notice
Date: 2016-10-31
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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``Understanding the Needs, Challenges, Opportunities, Vision and Emerging Roles in Environmental Health (UNCOVER EH).'' The purpose of the data collection is to collect information from the health department environmental health (EH) workforce to determine demographics, education/training, experience, areas of practice, and current and future needs to address emerging environmental issues.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
Document Number: 2016-26247
Type: Notice
Date: 2016-10-31
Agency: Food and Drug Administration, Department of Health and Human Services
Under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), the Food and Drug Administration (FDA or Agency) is required to report annually in the Federal Register on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct. A supplemental report entitled ``Supplementary Report: Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements (PMRs) and Postmarketing Commitments (PMCs) (FY 2013 and FY 2014),'' containing additional information and analyses on the status of PMRs and PMCs as of September 30, 2013, and September 30, 2014, is available on FDA's Web site at http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Post- marketingPhaseIVCommitments/ucm064436.htm.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-26246
Type: Notice
Date: 2016-10-31
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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry; Availability
Document Number: 2016-26245
Type: Proposed Rule
Date: 2016-10-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry.'' This draft guidance explains our current thinking on disclosure statements made by an entity, in documents accompanying food, that certain hazards have not been controlled by that entity as required by certain provisions in four final rules. This document describes our current thinking on how to describe the hazard under each of the four rules and which documents we consider to be ``documents of the trade'' for the purpose of disclosure statements.
Good Laboratory Practice for Nonclinical Laboratory Studies; Extension of Comment Period
Document Number: 2016-26244
Type: Proposed Rule
Date: 2016-10-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of August 24, 2016. In the proposed rule, FDA requested comments on its proposal to amend the regulations for good laboratory practice for nonclinical studies. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Labeling for Permanent Hysteroscopically Placed Tubal Implants Intended for Sterilization; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-26243
Type: Notice
Date: 2016-10-31
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 guidance entitled ``Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.'' This guidance addresses the inclusion of a boxed warning and patient decision checklist in the product labeling for permanent hysteroscopically placed tubal implants intended for female sterilization, and the content and format of those materials. FDA believes that the labeling described in this guidance will help to ensure that a woman receives and understands information regarding the benefits and risks of this type of device prior to undergoing implantation. FDA considered comments received on the draft guidance and revised the guidance as appropriate. The guidance identifies the content and format of certain labeling components for permanent, hysteroscopically placed tubal implants that are intended for sterilization. The guidance applies to all devices of this type, regardless of the insert material composition, location of intended implantation, or exact method of delivery.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-26242
Type: Notice
Date: 2016-10-31
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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals; Correction
Document Number: 2016-26182
Type: Rule
Date: 2016-10-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects a typographical error in the final rule that appeared in the August 22, 2016 Federal Register as well as additional typographical errors in a related correction to that rule that appeared in the October 5, 2016 Federal Register. The final rule was titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals''.
Excepted Benefits; Lifetime and Annual Limits; and Short-Term, Limited-Duration Insurance
Document Number: 2016-26162
Type: Rule
Date: 2016-10-31
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains final regulations regarding the definition of short-term, limited-duration insurance for purposes of the exclusion from the definition of individual health insurance coverage, and standards for travel insurance and supplemental health insurance coverage to be considered excepted benefits. This document also amends a reference in the final regulations relating to the prohibition on lifetime and annual dollar limits.
Patient Safety Organizations: Voluntary Relinquishment From the Patient Safety Leadership Council PSO
Document Number: 2016-26144
Type: Notice
Date: 2016-10-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732-70814, establish a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient safety events. 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 longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the Patient Safety Leadership Council PSO of its status as a PSO, and has delisted the PSO accordingly. The Patient Safety Leadership Council PSO submitted this request for voluntary relinquishment after receiving a Notice of Preliminary Finding of Deficiency.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-26143
Type: Notice
Date: 2016-10-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Agency for Healthcare Research and Quality's (AHRQ) Guide to Improving Patient Safety in Primary Care Settings by Engaging Patients and FamiliesEvaluation.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 11th, 2016 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
National Cancer Institute; Notice of Meeting
Document Number: 2016-26130
Type: Notice
Date: 2016-10-31
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2016-26129
Type: Notice
Date: 2016-10-31
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-26128
Type: Notice
Date: 2016-10-31
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-26122
Type: Notice
Date: 2016-10-31
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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Medicare Program; Approval of Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition for Rockwall Regional Hospital, Limited Liability Company Doing Business as (d/b/a) Texas Health Presbyterian Hospital Rockwall
Document Number: 2016-26119
Type: Notice
Date: 2016-10-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the request of Rockwall Regional Hospital, Limited Liability Company (LLC) doing business as (d/b/a) Texas Health Presbyterian Hospital Rockwall (Texas Health Rockwall) for an exception to the prohibition on expansion of facility capacity.
Medicare Program; Approval of Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition
Document Number: 2016-26117
Type: Notice
Date: 2016-10-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the request of Deaconess Women's Hospital of Southern Indiana doing business as (d/b/a) The Women's Hospital (The Women's Hospital) for an exception to the prohibition on expansion of facility capacity.
Privacy Act of 1974; System of Records Notice
Document Number: 2016-26116
Type: Notice
Date: 2016-10-28
Agency: Department of Health and Human Services, Office of the Secretary
The Office of the Assistant Secretary for Administration (ASA) within the Department of Health and Human Services (HHS) is deleting eighteen (18) systems of records established pursuant to the Privacy Act of 1974, as amended (5 U.S.C. 552a), because HHS has determined that they duplicate other systems of records or are obsolete.
National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy
Document Number: 2016-26098
Type: Notice
Date: 2016-10-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Zika Virus; Availability
Document Number: 2016-26066
Type: Notice
Date: 2016-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of four Emergency Use Authorizations (EUAs) (the Authorizations) for four in vitro diagnostic devices for detection and/ or diagnosis of Zika virus in response to the Zika virus outbreak in the Americas. FDA issued these Authorizations under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Siemens Healthcare Diagnostics, Inc., Luminex Corporation, InBios International, Inc., and Roche Molecular Systems, Inc. The Authorizations contain, among other things, conditions on the emergency use of the authorized in vitro diagnostic devices. The Authorizations follow the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.
Listing of Ingredients in Tobacco Products; Revised Draft Guidance for Industry; Availability
Document Number: 2016-26065
Type: Notice
Date: 2016-10-28
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 revised draft guidance for industry entitled ``Listing of Ingredients in Tobacco Products.'' The revised draft guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Postmarketing Studies Status Reports
Document Number: 2016-26064
Type: Notice
Date: 2016-10-28
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.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-26058
Type: Notice
Date: 2016-10-28
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Institute of General Medical Sciences; Amended Notice of Meeting
Document Number: 2016-26050
Type: Notice
Date: 2016-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-26049
Type: Notice
Date: 2016-10-28
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products
Document Number: 2016-26044
Type: Notice
Date: 2016-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on communication studies involving medical devices and radiation-emitting products regulated by FDA. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the Agency's mission to protect the public health.
New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
Document Number: 2016-26043
Type: Proposed Rule
Date: 2016-10-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is proposing to amend our 2012 document entitled ``New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.'' The document proposed to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. We also proposed to add definitions for key terms. We are taking this action to more clearly explain our current thinking about certain provisions of the 2012 document based on comments from stakeholders, and to more accurately reflect the rationale FDA relied on in the past to approve certain new animal drugs without a tolerance. We are reopening the comment period only with respect to the specific issues identified in this supplemental proposed rule.
Freedom of Information Regulations
Document Number: 2016-25684
Type: Rule
Date: 2016-10-28
Agency: Department of Health and Human Services, Office of the Secretary
This rule amends the Department of Health and Human Services (HHS's) Freedom of Information Act (FOIA) regulations. The regulations have been revised in order to incorporate changes made to the FOIA by the Electronic FOIA Act of 1996 (E-FOIA Act), the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act), and the FOIA Improvement Act of 2016 (FOIA Improvement Act). Additionally, the regulations have been updated to reflect changes to the organization, to make the FOIA process easier for the public to navigate, to update HHS's fee schedule, and to make provisions clearer.
Performance Review Board Members
Document Number: 2016-26023
Type: Notice
Date: 2016-10-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2016.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-26019
Type: Notice
Date: 2016-10-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2016-26012
Type: Notice
Date: 2016-10-27
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 Section 2112(b)(2) of 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-25956
Type: Notice
Date: 2016-10-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Independent Living Services and Centers for Independent Living
Document Number: 2016-25918
Type: Rule
Date: 2016-10-27
Agency: Department of Health and Human Services
This rule implements the Rehabilitation Act as amended by the Workforce Innovation and Opportunity Act, which established an Independent Living Administration within the Administration for Community Living (ACL) of the Department of Health and Human Services (HHS). The rule helps implement changes to the administration of Independent Living Services and the Centers for Independent Living made under the current law in alignment with ACL and HHS policies and practices.
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