Department of Health and Human Services July 3, 2017 – Federal Register Recent Federal Regulation Documents
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Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Product Identifier Requirements Under the Drug Supply Chain Security Act Compliance Policy.'' This draft guidance describes FDA's intention with regard to enforcement of requirements related to product identifiers under the Drug Supply Chain Security Act (DSCSA). Specifically, this guidance addresses manufacturers' product identifier and verification requirements, which begin November 27, 2017. This guidance also addresses certain requirements for repackagers, wholesale distributors, and dispensers to only engage in transactions involving products with product identifiers and to verify the product identifier when investigating suspect product, in addition to repackager and wholesale distributor requirements related to saleable returned products.
Agency Information Collection Activities: Proposed Collection; Comment Request
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Public Stakeholder Listening Session on Strategies for Improving Parity for Mental Health and Substance Use Disorder Coverage
This notice announces a public stakeholder listening session on Strategies for Improving Parity for Mental Health and Substance Use Disorder Coverage. The public meeting, mandated in the 21st Century Cures Act, seeks public comment on improved Federal and State coordination related to section 2726 of the Public Health Service Act, section 712 of the Employee Retirement Income Security Act of 1974, section 9812 of the Internal Revenue Code of 1986, and any comparable provisions of State law. The public meeting will seek participation from the required stakeholders in statute, State health commissioners, State agencies, State attorneys general, the National Association of Insurance Commissioners, health insurance issuers, providers of mental health and substance use disorder treatment, employers, and patients or their advocates. Written comments may be submitted to parity@hhs.gov for two weeks prior to the meeting through August 10, 2017.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ ohrp/sachrp-committee/meetings/.
Disease, Disability, and Injury Prevention and Control Special
This meeting was announced in the Federal Register on June 12, 2017, Volume 82, Number 111, pages 26933 and 26934. This meeting is canceled in its entirety.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.samhsa.gov/workplace.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the interim final rule that appeared in the Federal Register of May 4, 2017. In the interim final rule, FDA requested comments on the extension of the compliance date for our final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The interim final rule extended the compliance date from May 5, 2017, to May 7, 2018, and invited comment on several specific questions on how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives to provide consumers with nutrition information so that they can make informed choices for themselves and their families. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Waivers From Requirements of the Sanitary Transportation of Human and Animal Food Rule; Correction
The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of Thursday, April 6, 2017 (82 FR 16733). That notification published three waivers from the Requirements of 21 CFR part 1, subpart OSanitary Transportation of Human and Animal Food (the Sanitary Transportation rule). That document was published with an error in the Background section. This correction is being made to improve the accuracy of the notification.
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products 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. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document.
Advisory Committees; Filing of Closed Meeting Reports
The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2016.
Advisory Committee; Medical Imaging Drugs Advisory Committee, Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Medical Imaging Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 18, 2019.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Safety Communication Readership Survey
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Safety Survey
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a voluntary consumer survey entitled ``Food Safety Survey.''
Listing of Color Additives Exempt From Certification; Spirulina Extract
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) filed by McCormick & Company, Inc. (McCormick).
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