Department of Health and Human Services September 8, 2016 – Federal Register Recent Federal Regulation Documents

Substances Generally Recognized as Safe
Document Number: C1-2016-19164
Type: Rule
Date: 2016-09-08
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-21628
Type: Notice
Date: 2016-09-08
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 (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 any of the following subjects: 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.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2016-21619
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2016-21618
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2016-21617
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases Notice of Closed Meeting
Document Number: 2016-21616
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2016-21609
Type: Notice
Date: 2016-09-08
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 requires by the Paperwork Reduction Act of 1995. This notice invites comments on Early Hearing Detection and Intervention Pediatric Audiology Links to Services (EDHI- PALS)
National Advisory Council on the National Health Service Corps; Notice of Meeting
Document Number: 2016-21581
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, Health Resources and Services Administration
Final Revised Vaccine Information Materials for Polio Vaccine
Document Number: 2016-21575
Type: Notice
Date: 2016-09-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On March 15, 2016, CDC published a notice in the Federal Register (81 FR 13794) seeking public comments on proposed updated vaccine information materials for polio vaccine and varicella vaccine. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for polio vaccine. Copies of the final vaccine information materials for polio vaccine are available to download from http:// www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0029). CDC will publish the final vaccine information materials for varicella vaccine when they are completed.
Final Revised Vaccine Information Materials for Serogroup B Meningococcal Vaccine
Document Number: 2016-21574
Type: Notice
Date: 2016-09-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On October 14, 2015, CDC published a notice in the Federal Register (80 FR 61819) seeking public comments on proposed updated vaccine information materials for meningococcal ACWY and serogroup B meningococcal vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for serogroup B meningococcal vaccine. Copies of the final vaccine information materials for serogroup B meningococcal vaccine are available to download from http:/ /www.cdc.gov/vaccines/hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2015-0059). Final updated vaccine information materials for meningococcal ACWY were published in the Federal Register on April 20, 2016 (81 FR 23301).
Final Revised Vaccine Information Materials for Hepatitis A and Hepatitis B Vaccines
Document Number: 2016-21573
Type: Notice
Date: 2016-09-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On February 8, 2016, CDC published a notice in the Federal Register (81 FR 6520) seeking public comments on proposed updated vaccine information materials for hepatitis A and hepatitis B vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for hepatitis A and hepatitis B vaccines. Copies of the final vaccine information materials for hepatitis A and hepatitis B vaccines are available to download from http://www.cdc.gov/vaccines/ hcp/vis/index.html or http://www.regulations.gov (see Docket Number CDC-2016-0015).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance
Document Number: 2016-21554
Type: Notice
Date: 2016-09-08
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations
Document Number: 2016-21553
Type: Notice
Date: 2016-09-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on recordkeeping requirements related to the medical devices current good manufacturing practice (CGMP) quality system (QS) regulation (CGMP/QS regulation).
ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies-Questions and Answers; International Council for Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2016-21552
Type: Notice
Date: 2016-09-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity StudiesQuestions and Answers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This question and answer (Q&A) guidance provides additional information to facilitate interpretation of the ``S3A Guidance: The Assessment of Systemic Exposure in Toxicity Studies'' (S3A guidance), especially to address the benefit and use of microsampling techniques in main study animals. The Q&A guidance is intended to provide points to consider before incorporating the microsampling method in toxicokinetic studies, and acknowledges the benefits (and some limitations) of the use of microsampling.
Determination That PREVACID IV (Lansoprazole) Intravenous Injection, 30 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2016-21551
Type: Notice
Date: 2016-09-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that PREVACID IV (lansoprazole) intravenous injection, 30 milligrams (mg)/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for lansoprazole intravenous injection, 30 mg/vial, if all other legal and regulatory requirements are met.
Advisory Committee; Oncologic Drugs Advisory Committee, Renewal
Document Number: 2016-21550
Type: Notice
Date: 2016-09-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic 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 Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until September 1, 2018.
Submission for OMB Review; 30-Day Comment Request; Cancer Prevention Fellowship Program Fellowship Program and Summer Curriculum Applications
Document Number: 2016-21518
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on June 17, 2016 page 39679 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
National Institute on Aging Notice of Closed Meeting
Document Number: 2016-21516
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-21515
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2016-21514
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-21513
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Delegation of Authorities
Document Number: 2016-21504
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, Office of the Secretary
Announcement of Requirements and Registration for “Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test” Challenge
Document Number: 2016-21328
Type: Notice
Date: 2016-09-08
Agency: Department of Health and Human Services, National Institutes of Health
Through the ``Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test'' Challenge (the ``Challenge''), the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR) are searching for novel and innovative in vitro diagnostic tests that would rapidly inform clinical treatment decisions and be of potential significant clinical and public health utility to combat the development and spread of antibiotic resistant bacteria. Tests of interest will provide novel, innovative solutions for use in inpatient and/or outpatient settings. The goal of the challenge is to identify a diagnostic test that when utilized would lead to more rapid clinical decision making such that antibiotic use and/or outcomes of patients infected with resistant pathogens are fundamentally improved compared to current standard of care, and/or reduce transmission of resistant pathogens such that population infection rates significantly decrease. The Challenge competition seeks to incentivize a broad range of scientists, engineers, and innovators to develop diagnostic tests that would enable health care providers to make more informed decisions on appropriate antibiotic use and infection prevention. This Challenge, structured in three steps, will complement existing BARDA and NIH research portfolios by reaching out to a diverse population of innovators and solvers, including not only those from academic institutions, but also those from research and development communities in the private sector and others who are outside biomedical disciplines. The NIH and the BARDA believe this Challenge will stimulate investment from both public and private sectors in rapid, point-of-need in vitro diagnostic assay research and product development, which, in turn, could lead to the development of more sensitive, accurate, robust, and cost-effective assay approaches and devices for clinical diagnosis.