Department of Health and Human Services August 1, 2016 – Federal Register Recent Federal Regulation Documents
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Opportunity to Co-sponsor an Office on Women's Health Awards Ceremony and Event for its 25th Anniversary
Pursuant to 42 U.S.C. 300u, 42 U.S.C. 300u-2, and 42 U.S.C. 237a (3509 of the Patient Protection and Affordable Care Act), notice is given that the Office on Women's Health (OWH) is soliciting proposals from non-federal public and private sector entities to co- sponsor the OWH Anniversary Celebration event in the Washington, DC area in late September, 2016.
Proposed Information Collection Activity; Comment Request; State Developmental Disabilities Council 5-Year State Plan
The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL) is announcing an opportunity to comment on the proposed collection of 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 30 days for public comment in response to the notice. This notice collects comments on the information collection requirements relating to an existing collection: State Developmental Disabilities Council 5-Year State Plan, 0985-0029.
Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Extension of Compliance Date
The Food and Drug Administration (FDA or we) is extending the compliance date for certain requirements in the final rule requiring disclosure of calorie declarations for food sold from certain vending machines. The final rule appeared in the Federal Register of December 1, 2014. We are taking this action in response to requests for an extension and for reconsideration of the rule's requirements pertaining to the size of calorie disclosures on front-of-package labeling.
Outsourcing Facility Fee Rates for Fiscal Year 2017
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2017 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility. This document establishes the FY 2017 rates for the small business establishment fee ($5,279), the non-small business establishment fee ($16,852), and the re-inspection fee ($15,837) for outsourcing facilities; provides information on how the fees for FY 2017 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2016, and will remain in effect through September 30, 2017.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Tobacco Retailers on Tobacco Retailer Training Programs
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.
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2017
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2017 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2016, and will remain in effect through September 30, 2017.
Request for Nominations on the Tobacco Products Scientific Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting member to represent the interests of tobacco growers to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products (CTP), notify FDA in writing. FDA is also requesting nominations for a nonvoting member to represent the interests of tobacco growers to serve on the Tobacco Products Scientific Advisory Committee, and an alternate to this representative. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Electronic Drug Product Reporting of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
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.
Medicare Program; FY 2017 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update
This notice updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs) (which include freestanding IPFs and psychiatric units of an acute care hospital or critical access hospital). These changes are applicable to IPF discharges occurring during the fiscal year (FY) beginning October 1, 2016 through September 30, 2017 (FY 2017).
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