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

Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2016-18002
Type: Notice
Date: 2016-07-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute Of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2016-18001
Type: Notice
Date: 2016-07-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2016-18000
Type: Notice
Date: 2016-07-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2016-17999
Type: Notice
Date: 2016-07-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-17998
Type: Notice
Date: 2016-07-29
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-17997
Type: Notice
Date: 2016-07-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-17988
Type: Notice
Date: 2016-07-29
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-17987
Type: Notice
Date: 2016-07-29
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.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2016-17946
Type: Notice
Date: 2016-07-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
The 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 Health and Human Services 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.
Medical Device User Fee Rates for Fiscal Year 2017
Document Number: 2016-17903
Type: Notice
Date: 2016-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2017, which apply from October 1, 2016, through September 30, 2017. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2017, you should not submit a FY 2017 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2017 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
General Wellness: Policy for Low Risk Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-17902
Type: Notice
Date: 2016-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``General Wellness: Policy for Low Risk Devices.'' The guidance is intended to provide clarity to industry and FDA staff on Center for Devices and Radiological Health's (CDRH) compliance policy for low-risk products that promote a healthy lifestyle (general wellness products). By clarifying the policy on general wellness products, we hope to improve the predictability, consistency, and transparency on CDRH's regulation of these products. For purposes of the guidance, CDRH defines ``general wellness products'' as products which meet the following factors: They are intended for only general wellness use as defined in the guidance and present a low risk to the safety of users and other persons.
Change of Address for the Food and Drug Administration Center for Food Safety and Applied Nutrition
Document Number: 2016-17659
Type: Notice
Date: 2016-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is providing notice that the street address for the Center for Food Safety and Applied Nutrition's (CFSAN's) Harvey W. Wiley Federal Building in College Park, MD has changed. The new street address is 5001 Campus Drive.
Change of Address; Technical Amendment
Document Number: 2016-17658
Type: Rule
Date: 2016-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending our regulations to reflect a change in the address for the Center for Food Safety and Applied Nutrition (CFSAN). This action is editorial in nature and is intended to improve the accuracy of our regulations.
Medicare Program; 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: 2016-17928
Type: Notice
Date: 2016-07-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Social Security Act prohibits a physician-owned hospital from expanding its facility capacity, unless the Secretary of the Department of Health and Human Services (the Secretary) grants the hospital's request for an exception to that prohibition after considering input on the hospital's request from individuals and entities in the community where the hospital is located. The Centers for Medicare & Medicaid Services (CMS) has received a request from a physician-owned hospital for an exception to the prohibition against expansion of facility capacity. This notice solicits comments on the request from individuals and entities in the community in which the physician-owned hospital is located. Community input may inform our determination regarding whether the requesting hospital qualifies for an exception to the prohibition against expansion of facility capacity.
Notice of Opportunity for Hearing on Compliance of Arkansas State Plan Provisions Concerning Provision of Benefits During a Reasonable Opportunity Period With Titles XI and XIX (Medicaid) of the Social Security Act
Document Number: 2016-17923
Type: Notice
Date: 2016-07-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Department of Health and Human Services (hhs)
Prescription Drug User Fee Rates for Fiscal Year 2017
Document Number: 2016-17870
Type: Notice
Date: 2016-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for the review of human drug and biological products, on establishments where the products are made, and on such products. This notice establishes the fee rates for FY 2017.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-17867
Type: Notice
Date: 2016-07-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: 2016-17865
Type: Notice
Date: 2016-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting
Document Number: 2016-17864
Type: Notice
Date: 2016-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2017
Document Number: 2016-17848
Type: Notice
Date: 2016-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2017 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Drug User Fee Amendments of 2013 (ADUFA III), authorizes FDA to collect user fees for certain animal drug applications and supplements, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2017.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review; Cancelation
Document Number: 2016-17827
Type: Notice
Date: 2016-07-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This meeting was announced in the Federal Register on July 14, 2016, 81 FR 45506. This meeting is canceled in its entirety.
Board of Scientific Counselors, Office of Public Health Preparedness and Response; Meetings
Document Number: 2016-17826
Type: Notice
Date: 2016-07-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2017
Document Number: 2016-17811
Type: Notice
Date: 2016-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2017 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2017.
National Cancer Institute Notice of Closed Meetings
Document Number: 2016-17810
Type: Notice
Date: 2016-07-28
Agency: Department of Health and Human Services, National Institutes of Health
Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Establishment of a Public Docket; Request for Comments
Document Number: 2016-17804
Type: Notice
Date: 2016-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is establishing a public docket for comment on the Agency's blood donor deferral recommendations for reducing the risk of human immunodeficiency virus (HIV) transmission as described in the document entitled ``Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry'' dated December 2015. Interested persons are invited to submit comments, supported by scientific evidence such as data from research, regarding potential blood donor deferral policy options to reduce the risk of HIV transmission, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments. Additionally, comments are invited regarding the design of potential studies to evaluate the feasibility and effectiveness of such alternative deferral options. FDA will take the comments received into account as it continues to reevaluate and update blood donor deferral policies as new scientific information becomes available.
Agency Information Collection Activities; Proposed Collection; Comment Request; Pre-Submission Program for Medical Devices
Document Number: 2016-17802
Type: Notice
Date: 2016-07-28
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 requests for feedback submitted under the Pre-Submission program for medical devices.
Biosimilar User Fee Rates for Fiscal Year 2017
Document Number: 2016-17800
Type: Notice
Date: 2016-07-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain applications and supplements for approval of biosimilar biological products, establishments where approved biosimilar biological products are made, and a biosimilar biological product fee for each biosimilar biological product approved in a biosimilar biological product application. BsUFA directs FDA to establish, before the beginning of each fiscal year, the initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees. These fees are effective on October 1, 2016, and will remain in effect through September 30, 2017.
National Center for Chronic Disease Prevention and Health Promotion, Interagency Committee on Smoking and Health (ICSH)
Document Number: 2016-17799
Type: Notice
Date: 2016-07-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)-Advisory Council for the Elimination of Tuberculosis (ACET)
Document Number: 2016-17795
Type: Notice
Date: 2016-07-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Nominations of Candidates To Serve on the Advisory Committee to the Director, Centers for Disease Control and Prevention (ACD, CDC)
Document Number: 2016-17794
Type: Notice
Date: 2016-07-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2017
Document Number: 2016-17801
Type: Notice
Date: 2016-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on applications in the backlog as of October 1, 2012 (only applicable to FY 2013), on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference. This document establishes the fee rates for FY 2017.
Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-17750
Type: Notice
Date: 2016-07-27
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 ``Use of Real-World Evidence to Support Regulatory Decisionmaking for Medical Devices.'' FDA is issuing this draft guidance to clarify how we evaluate real- world data (RWD) to determine whether it may be sufficiently relevant and reliable to generate the types of real-world evidence that can be used in regulatory decisionmaking for medical devices. This guidance also clarifies when an investigational device exemption (IDE) may be needed to prospectively collect and use RWD for purposes of determining the safety and effectiveness of a device. This draft guidance is not final nor is it in effect at this time.
Statement of Organization, Functions, and Delegations of Authority: Office of the Deputy Assistant Secretary for Administration; Office of the Assistant Secretary
Document Number: 2016-17737
Type: Notice
Date: 2016-07-27
Agency: Department of Health and Human Services, Administration for Children and Families
Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Office of the Deputy Assistant Secretary for Administration (ODASA). This reorganization moves the Office of Information Services from ODASA and establishes it as the new Office of the Chief Information Officer, which reports directly to the Assistant Secretary for Children and Families.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Document Number: 2016-17729
Type: Notice
Date: 2016-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public to attend in person at the FDA White Oak campus in Silver Spring, MD. Members will participate via teleconference.
Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
Document Number: 2016-17724
Type: Notice
Date: 2016-07-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-17720
Type: Notice
Date: 2016-07-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-17716
Type: Notice
Date: 2016-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-17656
Type: Notice
Date: 2016-07-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2016-17655
Type: Notice
Date: 2016-07-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2016-17654
Type: Notice
Date: 2016-07-27
Agency: Department of Health and Human Services, National Institutes of Health
Adaptive Designs for Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-17651
Type: Notice
Date: 2016-07-27
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 ``Adaptive Designs for Medical Device Clinical Studies.'' This guidance provides sponsors and FDA staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. An adaptive design for a medical device clinical study is defined as a clinical trial design that allows for prospectively planned modifications based on accumulating study data without undermining the trial's integrity and validity. Adaptive designs, when properly implemented, can reduce resource requirements and/or increase the chance of study success.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-17643
Type: Notice
Date: 2016-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-17642
Type: Notice
Date: 2016-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
Document Number: 2016-17620
Type: Notice
Date: 2016-07-26
Agency: Department of Health and Human Services
The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twenty-sixth meeting on August 31, 2016. At this meeting, the Commission will reflect on the past, present, and future impact of national bioethics advisory bodies. Topics will include the history of national bioethics advisory bodies and their contributions to health policy, perspectives about similar bodies elsewhere, and discussion about what the future holds for groups like the Commission.
Submission for OMB Review; Comment Request
Document Number: 2016-17618
Type: Notice
Date: 2016-07-26
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-17611
Type: Notice
Date: 2016-07-26
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 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 the National Health Interview Survey (NHIS). The annual National Health Interview Survey is a major source of general statistics on the health of the U.S. population.
Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes
Document Number: 2016-17609
Type: Rule
Date: 2016-07-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-17604
Type: Notice
Date: 2016-07-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-17603
Type: Notice
Date: 2016-07-26
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 ``National Network of Sexually Transmitted Diseases Clinical Prevention Training Centers (NNPTC): Evaluation''. The purpose of this study is to improve sexually transmitted disease care in the United States.