Department of Health and Human Services August 12, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 10 of 10
Proposed Information Collection Activity; ACF Performance Progress Report, ACF-OGM-SF-PPR-B
The Office of Grants Management (OGM), in the Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF-OGM-SF-PPR-B (OMB #0970-0406, expiration 9/30/2019). There are no changes requested to the form.
Determination That LEVITRA (Vardenafil Hydrochloride) Tablets, 2.5 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that LEVITRA (vardenafil hydrochloride) tablets, 2.5 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is holding a public meeting on November 7, 2019 entitled ``Promoting Effective Drug Development Programs: Opportunities and Priorities for FDA's Office of New Drugs.'' The purpose of the public meeting is to solicit specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Center for Drug Evaluation and Research's (CDER's) Office of New Drugs to promote effective drug development programs without compromising our regulatory standards for the assessment of safety and effectiveness.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; State Plan for Independent Living Instrument and Instructions OMB Control Number 0985-0044
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 Proposed Revision of a Currently Approved Collection (ICR Rev) solicits comments on the information collection requirements related to the State Plan for Independent Living.
Proposed Information Collection Activity; Comment Request Tribal Child Support Enforcement Annual Data Report (OMB #0970-0320)
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a three-year extension of the form OCSE- 75Tribal Child Support Enforcement Annual Data Report (OMB # 0970- 0320, expiration 03/31/2020). There are no changes requested to the form.
Submission for OMB Review; Procedures for Requests From Tribal Lead Agencies To Use Child Care and Development Fund (CCDF) Funds for Construction or Major Renovation of Child Care Facilities (OMB #0970-0160)
The Administration for Children and Families (ACF) is requesting proposed revisions with a three-year extension to an approved information collection: Procedures for Requests from Tribal Lead Agencies to use Child Care and Development Fund (CCDF) Funds for Construction or Major Renovation of Child Care Facilities (OMB #: 0970- 0160, expiration date: 9/30/2019). There are minor changes requested to the form.
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.
Kellogg Company; Filing of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Kellogg Company, proposing that the food additive regulations be amended to provide for the safe use of vitamin D3 as a nutrient supplement in breakfast cereals and in grain-based nutrition bars (e.g., granola bars).
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