Department of Health and Human Services December 27, 2016 – Federal Register Recent Federal Regulation Documents
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Protecting Our Infants Act Report to Congress
Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment, in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain public comment on a report to Congress in response to the Projecting Our Infants Act of 2015 (POIA) (Pub. L. 114-91). The POIA mandated HHS to: Conduct a review of planning and coordination activities related to prenatal opioid exposure and neonatal abstinence syndrome; develop recommendations for the identification, prevention, and treatment of prenatal opioid exposure and neonatal abstinence syndrome; and develop a strategy to address gaps, overlap, and duplication among Federal programs and Federal coordination efforts to address neonatal abstinence syndrome.
Questions and Answers Regarding Food Facility Registration (Seventh Edition); Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a revised draft guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.'' The revised draft guidance supersedes the version of the food facility registration draft guidance that we announced on November 8, 2016. When finalized, this guidance is intended to provide updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Announcement of Updated Requirements and Registration for “The Simple Extensible Sampling Tool Challenge”
On September 29, 2016, OIG announced ``The Simple Extensible Sampling Tool Challenge''. This notice serves as an update to the original notice which stated that upon receipt of an updated submission the previous submission would be excluded in its entirety from the competition. This updated notice removes this restriction for entries from teams that have been previously identified as finalists. Any finalist may update their entry without losing their finalist designation. Updates from the finalists will be accepted until 5:00 p.m. EST on the fourteenth day after the fifth finalist has been identified or May 15, 2017, 5:00 p.m. EST, whichever comes first. The newest entry from each team will be used for all judging purposes unless otherwise requested by the team. Other than the above change, all rules and requirements outlined in the September 29, 2016, Federal Register notice remain in effect.
Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.'' This guidance is intended to provide clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. Although product availability and other medical device compliance and enforcement decisions are generally fact-specific, FDA believes that explaining how we consider the factors listed in the guidance will improve the consistency and transparency of these kinds of decisions. A common understanding of how FDA considers benefit and risk may better align industry's and FDA's focus on actions that maximize benefit to patients, improve medical device quality, and reduce risk to patients. This guidance is in effect at this time.
Psychopharmacologic Drugs Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic 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.
Coordinated Registry Network for Devices Used for Acute Ischemic Stroke Intervention; Public Workshop; Request for Comments
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Coordinated Registry Network (CRN) for Devices Used for Acute Ischemic Stroke Intervention (DAISI).'' The purpose of the public workshop is to obtain stakeholders' input on the coordination of registries for DAISI.
Updating the HRSA-Supported Women's Preventive Services Guidelines
Effective December 20, 2016, the Health Resources and Services Administration (HRSA) updated the HRSA-supported Women's Preventive Services Guidelines for purposes of health insurance coverage for preventive services that address health needs specific to women based on clinical recommendations from the Women's Preventive Services Initiative. This notice serves as an announcement of the decision to update the guidelines as listed below. Please see https://www.hrsa.gov/ womensguidelines2016 for additional information.
Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 43 supplemental new animal drug applications (NADAs) and 52 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) to prescription (Rx) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated drinking water. These applications were submitted in voluntary compliance with the goals of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative.
New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and ANADAs that were affected by this initiative. The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.
New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 11 new animal drug applications (NADAs) and 4 abbreviated new animal drug applications (ANADAs). These withdrawals of approval of NADAs and ANADAs for antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed are being made because the products are no longer being manufactured or marketed. These actions are consistent with the FDA Center for Veterinary Medicine's initiative for the Judicious Use of Antimicrobials.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Forms for Use With Applications to the Maternal and Child Health Bureau and Bureau of Health Workforce Research and Training Grants
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate
The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete poultry feeds. This action is in response to a food additive petition filed by BASF Corp.
Announcing the Intent To Award a Single-Source Program Expansion Supplements to Cooperative Agreements Within the Office of Refugee Resettlement's Unaccompanied Children's (UC) Program
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), announces its intent to award a cooperative agreement of up to $3,311,087 as a single-source expansion supplements to the Post Release Services Programs within the Unaccompanied Children's (UC) Program. The expansion supplement grants will support the immediate need for additional post-release services to accommodate the increasing number of UCs being referred by DHS, and as a result, the increase of UCs referred for post-release services. The increase in the UC population necessitates the need for expansion of services to expedite the release of UC. The Flores v. Reno settlement agreement requires that requires the timely release of children and youth to qualified parents, guardians, relatives or other adults, referred to as ``sponsors.''
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