Department of Health and Human Services October 23, 2017 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Revision of a Currently Approved Information Collection (ICR-Rev) (OMB Approval Number 0985-0004); Maintenance of Effort for Title III and Extension of, and Minor Revisions Due to Statutory Language Changes to the Certification of Long-Term Care Ombudsman Program Expenditures
Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995 (the PRA). This 30-Day notice requests comments on the information collection requirements related to the proposed revision of an existing data collection regarding the information collection requirements in the Maintenance of Effort collection form for all ACL/AoA Title III Grantees.
Determination of Regulatory Review Period for Purposes of Patent Extension; OBIZUR
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OBIZUR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; Inspire Upper Airway Stimulation System
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Inspire Upper Airway Stimulation System (Inspire UAS System) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; MITRACLIP CDS
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MITRACLIP CDS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.
Agency Forms Undergoing Paperwork Reduction Act Review-Evaluation of the National Tobacco Prevention and Control Public Education Campaign; Correction
The Centers for Disease Control and Prevention (CDC) published a document in the Federal Register on October 13, 2017, concerning request for comments on Agency Forms Undergoing Paperwork Reduction Act ReviewAnnual Progress Report (APR) for Injury Control Research Centers (ICRC). The document provided the incorrect proposed project title, number of annual reporting responses for each respondent and average burden per response estimate.
Determination That ELAVIL (Amitriptyline Hydrochloride) Oral Tablets, 10, 25, 50, 75, 100, and 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that ELAVIL (amitriptyline hydrochloride) oral tablets, 10 milligrams (mg), 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for amitriptyline hydrochloride oral tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, if all other legal and regulatory requirements are met.
Product-Specific Guidance for Methylphenidate Hydrochloride; New Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a new draft guidance for industry on generic methylphenidate hydrochloride oral extended-release tablets entitled ``Draft Guidance on Methylphenidate Hydrochloride.'' The new draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride oral extended-release tablets.
Division of Behavioral Health; Youth Regional Treatment Center Aftercare Pilot Project; Correction of Due Dates
The Indian Health Service published a notice in the Federal Register (FR) on October 11, 2017, for the Fiscal Year 2018 Youth Regional Treatment Center Aftercare Pilot Project, Funding Announcement Number: HHS-2018-IHS-YRTC-0001. Several Key Dates have been modified. The Application Due Date is November 12, 2017 and the Earliest Anticipated Start Date is December 1, 2017.
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