Department of Health and Human Services August 30, 2017 – Federal Register Recent Federal Regulation Documents

CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment
Document Number: 2017-18426
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. This meeting will be open to the public. Information about the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment and the agenda for this meeting can be obtained by contacting CDR Holly Berilla at (301) 443-9965 or hberilla@hrsa.gov.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-18410
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-18407
Type: Notice
Date: 2017-08-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-18405
Type: Notice
Date: 2017-08-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed project titled ``ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia.''
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-18404
Type: Notice
Date: 2017-08-30
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed request to extend the information collect project titled ``Assessment of Chemical Exposures (ACE) Investigations.'' The purpose of ACE Investigations is to focus on performing rapid epidemiological assessments to assist state, regional, local, or tribal health departments (the requesting agencies) to respond to or prepare for acute chemical releases.
Product-Specific Guidance for Digoxin; Draft Revised Guidance for Industry; Availability
Document Number: 2017-18386
Type: Notice
Date: 2017-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft revised guidance for industry on generic digoxin tablets entitled ``Draft Guidance on Digoxin.'' The guidance, once finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for digoxin tablets.
Determination of Regulatory Review Period for Purposes of Patent Extension; KENGREAL
Document Number: 2017-18380
Type: Notice
Date: 2017-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KENGREAL 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 drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; XTORO
Document Number: 2017-18379
Type: Notice
Date: 2017-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XTORO 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 human drug product.
Determination That CENESTIN (Estrogens, Conjugated Synthetic A) Tablets, 0.3 Milligrams, 0.45 Milligrams, 0.625 Milligrams, 0.9 Milligrams, and 1.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-18376
Type: Notice
Date: 2017-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that CENESTIN (estrogens, conjugated synthetic A) Tablets, 0.3 milligrams (mg), 0.45 mg, 0.625 mg, 0.9 mg, and 1.25 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 these products, if all other legal and regulatory requirements are met.
Upsher-Smith Laboratories, Inc.; Withdrawal of Approval of an Abbreviated New Drug Application for PROPRANOLOL HYDROCHLORIDE
Document Number: 2017-18375
Type: Notice
Date: 2017-08-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of an abbreviated new drug application (ANDA) for PROPRANOLOL HYDROCHLORIDE Extended-Release Capsules, held by Upsher- Smith Laboratories, Inc. (Upsher-Smith), 6701 Evenstad Dr., Maple Grove, MN 55369. Upsher-Smith has voluntarily requested that approval of this application be withdrawn and has waived its opportunity for a hearing.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-18344
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-18342
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-18341
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institutes of Health
Document Number: 2017-18340
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Amended Notice of Meeting
Document Number: 2017-18338
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy And Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-18337
Type: Notice
Date: 2017-08-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-18275
Type: Notice
Date: 2017-08-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
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