Department of Health and Human Services July 29, 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.