Department of Health and Human Services August 25, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Statement of Organization, Functions, and Delegations of Authority
Statement of Organization, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has realigned the Office of Community Services (OCS). This notice announces the realignment of OCS functions to rename the Division of State Assistance to the Division of Community Assistance and establishes the Division of Social Services. It also consolidates the Division of Community Discretionary Programs and the Division of Community Demonstration Programs to establish the Division of Community Discretionary and Demonstration Programs.
Abbreviated New Drug Application Submissions-Refuse To Receive for Lack of Justification of Impurity Limits; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Abbreviated New Drug Application SubmissionsRefuse to Receive for Lack of Justification of Impurity Limits.'' This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and prior approval supplements for which the applicant is seeking approval of a new strength of the drug product. The guidance highlights deficiencies about impurity information that may cause FDA to refuse to receive (RTR) an ANDA.
Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
The Food and Drug Administration (FDA or we) 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 the information collection provisions of our guidance document entitled ``Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.''
Submission for OMB Review; 30-Day Comment Request Health Information National Trends Survey V (HINTS V) (National Cancer Institute)
In compliance with the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 6, 2016, page 36316 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Submission for OMB Review; 30-Day Comment Request Study To Estimate Radiation Doses and Cancer Risks From Radioactive Fallout From the Trinity Nuclear Test-National Cancer Institute (NCI)
In compliance with the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 13, 2016, p 29875 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Human Food By-Products for Use as Animal Food; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GIF) #239 entitled ``Human Food By-Products For Use As Animal Food.'' This draft guidance helps domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), because they manufacture, process, pack, or hold human food for consumption in the United States, determine what requirements to follow for their human food by-products for use as animal food and provides examples and recommendations for how to meet those requirements.
Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/ Processing for Farms and Facilities; Draft Guidance for Industry.'' The draft guidance, when finalized, will help food establishments determine whether the activities that they perform are within the ``farm'' definition established in our regulation for Registration of Food Facilities. Determining whether the activities a food establishment performs are within the ``farm'' definition plays a key role in determining whether its business is exempt from our regulations for Registration of Food Facilities, and from certain requirements in our regulations for ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' and ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.''
Current Good Manufacturing Practice Requirements for Food for Animals; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry #235 entitled ``Current Good Manufacturing Practice Requirements for Food for Animals.'' This draft guidance helps domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) determine whether and how they need to comply with the current good manufacturing practice requirements of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule.
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