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

Results 251 - 300 of 323
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.
Notice of Office of Urban Indian Health Programs Strategic Plan
Document Number: 2016-21485
Type: Notice
Date: 2016-09-07
Agency: Department of Health and Human Services, Indian Health Service
Indian Health Service (IHS) has entered into a contract with the National Academy of Public Administration (the Academy) to assist in the development of a five-year strategic plan. Funding for this project was provided by Congress in the 2016 Consolidated Appropriations Act, which directs IHS to develop the plan in consultation with urban Indians and the Academy. As part of this project, the Academy project team is in the process of conducting extensive outreach to IHS/Office of Urban Indian Health Programs (OUIHP) leadership and employees, as well as conferring with urban Indian organizations and other key external stakeholder groups. The final product will be a strategic plan to guide the work of the headquarters office of OUIHP, area urban coordinators, and urban Indian organizations participating in IHS programs. The strategic plan will be completed by the end of December 2016. IHS is requesting input on the strategic planning process, the strengths and weaknesses of OUIHP, and the opportunities and threats facing the program. Comments will be used to help develop the mission, goals, objectives, and strategies to be included in the strategic plan.
Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)
Document Number: 2016-21400
Type: Notice
Date: 2016-09-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
Document Number: 2016-21399
Type: Notice
Date: 2016-09-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-21395
Type: Notice
Date: 2016-09-07
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Prospective Grant of Exclusive Patent License: The Development of an Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancers
Document Number: 2016-21366
Type: Notice
Date: 2016-09-07
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following Patents and Patent Applications and all continuing U.S. and foreign patents/ patent applications to Sangamo BioSciences, Inc. located in Richmond, California, USA:
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-21365
Type: Notice
Date: 2016-09-07
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: 2016-21364
Type: Notice
Date: 2016-09-07
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: 2016-21363
Type: Notice
Date: 2016-09-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-21360
Type: Notice
Date: 2016-09-07
Agency: Department of Health and Human Services, Office of the Secretary
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 the ICR to OMB, OS seeks comments from the public regarding the burden estimate below or any other aspect of the ICR. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Compliance With Title X Requirements by Project Recipients in Selecting Subrecipients
Document Number: 2016-21359
Type: Proposed Rule
Date: 2016-09-07
Agency: Department of Health and Human Services
This document seeks comment on the proposed amendment of Title X regulations specifying the requirements Title X projects must meet to be eligible for awards. The amendment precludes project recipients from using criteria in their selection of subrecipients that are unrelated to the ability to deliver services to program beneficiaries in an effective manner.
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Zika Virus; Availability
Document Number: 2016-21353
Type: Notice
Date: 2016-09-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of the Zika virus in response to the Zika virus outbreak in the Americas. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as requested by Viracor-IBT Laboratories, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the February 26, 2016, determination by the Secretary of Health and Human Services (HHS) that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves Zika virus. On the basis of such determination, the Secretary of HHS declared on February 26, 2016, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization
Document Number: 2016-21352
Type: Notice
Date: 2016-09-07
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; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Eligibility Determination for Donors; and Current Good Tissue Practice
Document Number: 2016-21351
Type: Notice
Date: 2016-09-07
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 the information collection requirements for FDA regulations related to human cells, tissues, and cellular and tissue-based products (HCT/Ps) involving establishment registration and listing using Form FDA 3356; eligibility determination for donors; and current good tissue practice (CGTP).
Request for Comment on the Status of Vinpocetine
Document Number: 2016-21350
Type: Notice
Date: 2016-09-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is requesting comments related to the regulatory status of vinpocetine. Specifically, we request comments on our tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is being taken as part of an administrative proceeding to determine the regulatory status of vinpocetine. All comments submitted by the comment deadline (see DATES) will be accepted as part of the official record for this proceeding.
Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
Document Number: 2016-21337
Type: Rule
Date: 2016-09-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA.
Submission for OMB Review; 30-Day Comment Request; NIDDK Office of Minority Health Research Coordination (OMHRC) Research Training and Mentor Programs Applications (National Institute of Diabetes and Digestive and Kidney Diseases)
Document Number: 2016-21329
Type: Notice
Date: 2016-09-06
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 (Vol. 81, No. 93, page 29877) on May 13, 2016 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.
Request for Public Comment on Draft Health Center Program Compliance Manual
Document Number: 2016-21321
Type: Notice
Date: 2016-09-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is inviting public comment on the Draft Health Center Program Compliance Manual, hereafter referred to as the Compliance Manual. The purpose of the Compliance Manual is to provide a consolidated web-based resource to assist current and prospective health centers in understanding and demonstrating compliance with requirements of the Health Center Program, a HRSA-administered program authorized under 42 U.S.C. 254b. The Compliance Manual identifies requirements found in the Health Center Program's authorizing legislation and implementing regulations, as well as certain applicable grant regulations. The Compliance Manual also addresses HRSA's approach to determining eligibility for and oversight of the Health Center Program. In addition, the Compliance Manual includes the requirements for obtaining deemed Public Health Service (PHS) employee status under the Federally Supported Health Centers Assistance Acts of 1992 and 1995, for purposes of Federal Tort Claims Act (FTCA) liability protections for the performance of medical, surgical, dental, and related functions within the scope of deemed PHS employment.
Senior Executive Service Performance Review Board
Document Number: 2016-21320
Type: Notice
Date: 2016-09-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
In this notice, the Health Resources and Services Administration (HRSA) located within the Department of Health and Human Services (HHS) publishes a list of persons who may be named to serve on the Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members within HRSA.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-21296
Type: Notice
Date: 2016-09-06
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 National Violent Death Reporting System (NVDRS) to continue collecting state- based surveillance data on violent deaths that will provide more detailed and timely information.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-21273
Type: Notice
Date: 2016-09-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2016-21250
Type: Notice
Date: 2016-09-06
Agency: Department of Health and Human Services, Administration for Children and Families
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-21243
Type: Notice
Date: 2016-09-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2016-21235
Type: Notice
Date: 2016-09-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-21234
Type: Notice
Date: 2016-09-06
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute Notice of Closed Meetings
Document Number: 2016-21233
Type: Notice
Date: 2016-09-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-21232
Type: Notice
Date: 2016-09-06
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
Document Number: 2016-21229
Type: Notice
Date: 2016-09-06
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 the application for participation in the Medical Device Fellowship Program.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications
Document Number: 2016-21228
Type: Notice
Date: 2016-09-06
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.
Determination That AQUAMEPHYTON (Phytonadione) Injectable and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2016-21227
Type: Notice
Date: 2016-09-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document 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 continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2018
Document Number: 2016-20896
Type: Proposed Rule
Date: 2016-09-06
Agency: Department of Health and Human Services
This proposed rule sets forth payment parameters and provisions related to the risk adjustment program; cost-sharing parameters and cost-sharing reductions; and user fees for Federally- facilitated Exchanges and State-based Exchanges on the Federal platform. It also provides additional guidance relating to standardized options; qualified health plans; consumer assistance tools; network adequacy; the Small Business Health Options Program; stand-alone dental plans; fair health insurance premiums; guaranteed renewability; the medical loss ratio program; eligibility and enrollment; appeals; and other related topics.
Head Start Performance Standards
Document Number: 2016-19748
Type: Rule
Date: 2016-09-06
Agency: Department of Health and Human Services, Administration for Children and Families
This final rule modernizes the Head Start Program Performance Standards, last revised in 1998. In the Improving Head Start for School Readiness Act of 2007, Congress instructed the Office of Head Start to update its performance standards and to ensure any such revisions to the standards do not eliminate or reduce quality, scope, or types of health, educational, parental involvement, nutritional, social, or other services programs provide. This rule responds to public comment, incorporates extensive findings from research and from consultation with experts, reflects best practices, lessons from program input and innovation, integrates recommendations from the Secretary's Advisory Committee Final Report on Head Start Research and Evaluation, and reflects the Obama Administration's deep commitment to improve the school readiness of young children. These performance standards will improve program quality, reduce burden on programs, and improve regulatory clarity and transparency. They provide a clear road map for current and prospective grantees to support high-quality Head Start services and to strengthen the outcomes of the children and families Head Start serves.
Adjustment of Civil Monetary Penalties for Inflation
Document Number: 2016-18680
Type: Rule
Date: 2016-09-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary, Administration for Children and Families, Office of the Inspector General
The Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. In addition, this interim final rule includes updates to certain agency-specific regulations to identify their updated information, and note the location of HHS-wide regulations.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-21201
Type: Notice
Date: 2016-09-02
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: 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-21199
Type: Notice
Date: 2016-09-02
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Generic Drug User Fee Act Cover Sheet
Document Number: 2016-21177
Type: Notice
Date: 2016-09-02
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 the information collection requirements of the Animal Generic Drug User Fee Act (AGDUFA) cover sheet.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Countermeasures Injury Compensation Program
Document Number: 2016-21168
Type: Notice
Date: 2016-09-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Document Number: 2016-21157
Type: Notice
Date: 2016-09-02
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.