Department of Health and Human Services August 25, 2014 – Federal Register Recent Federal Regulation Documents

Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics
Document Number: 2014-20156
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) hereby announces the Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics for 2014. The BPCA, reauthorized in 2012 as part of the Food and Drug Safety and Innovation Act, seeks to improve the level of information on the safe and effective use of pharmaceuticals used to treat children. The BPCA requires that the NIH identify the drugs of highest priority for study in pediatric populations and publish a list of drugs/needs in pediatric therapeutics. This notice fulfills the requirement to publish that list.
Office of Direct Service and Contracting Tribes; National Indian Health Outreach and Education
Document Number: 2014-20113
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services, Indian Health Service
Office of Direct Service and Contracting Tribes; National Indian Health Outreach and Education Funding Opportunity
Document Number: 2014-20109
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services, Indian Health Service
Office of Direct Service and Contracting Tribes; National Indian Health Outreach and Education II Program; Correction
Document Number: 2014-20108
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service published a document in the Federal Register on August 6, 2014 for the FY 2014 National Indian Health Outreach and Education IIMethamphetamine Suicide Prevention Intervention/Domestic Violence Prevention Initiative Program Announcement and Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome. The notice contained incorrect dates.
Medical Devices; Technical Amendment
Document Number: 2014-20107
Type: Rule
Date: 2014-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of Federal Regulations (CFR). This action is editorial in nature and is intended to correct outdated Web site addresses.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-20103
Type: Notice
Date: 2014-08-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-20101
Type: Notice
Date: 2014-08-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-20100
Type: Notice
Date: 2014-08-25
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2014-20099
Type: Notice
Date: 2014-08-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
ICD-10 Coordination and Maintenance (C&M) Committee
Document Number: 2014-20067
Type: Notice
Date: 2014-08-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2014-20065
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2014-20058
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases Cancellation of Meeting
Document Number: 2014-20057
Type: Notice
Date: 2014-08-25
Agency: Department of Health and Human Services, National Institutes of Health
Determination That SULAR (Nisoldipine) Extended-Release Tablets, 10 Milligrams, 20 Milligrams, 25.5 Milligrams, 30 Milligrams, and 40 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2014-20043
Type: Notice
Date: 2014-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that SULAR (nisoldipine) extended-release tablets, 10 milligrams (mg), 20 mg, 25.5 mg, 30 mg, and 40 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 these drug products, and it will allow FDA to approve ANDAs for nisoldipine extended-release tablets, 10 mg, 20 mg, 25.5 mg, 30 mg, and 40 mg, if all other legal and regulatory requirements are met.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-20041
Type: Notice
Date: 2014-08-25
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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Hemoglobin A1c Test System
Document Number: 2014-20022
Type: Rule
Date: 2014-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying hemoglobin A1c test system into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the hemoglobin A1c test system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
Document Number: 2014-20021
Type: Notice
Date: 2014-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Advisory Committee Renewals
Document Number: 2014-20017
Type: Notice
Date: 2014-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of certain FDA advisory committees by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the charters of the committees listed in the following table for an additional 2 years beyond charter expiration date. The new charters will be in effect until the dates of expiration listed in the following table.
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
Document Number: 2014-20016
Type: Notice
Date: 2014-08-25
Agency: Food and Drug Administration, Department of Health and Human Services