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

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Document Number: 2016-10165
Type: Notice
Date: 2016-04-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the Institute for Medical Quality (IMQ) for recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs. An ASC that participates in Medicaid must also meet the Medicare conditions for coverage (CfCs) as required under our regulations.
Document Number: 2016-10164
Type: Notice
Date: 2016-04-29
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service published a document in the Federal Register on March 14, 2016, for the FY 2016 4-in-1 Grant Program. The notice contained incorrect page limits for one section of the project narrative and the overall project narrative.
Document Number: 2016-10144
Type: Notice
Date: 2016-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-10142
Type: Notice
Date: 2016-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-10132
Type: Notice
Date: 2016-04-29
Agency: Department of Health and Human Services
Document Number: 2016-10128
Type: Notice
Date: 2016-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-10126
Type: Notice
Date: 2016-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-10106
Type: Notice
Date: 2016-04-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the notice of a public workshop that appeared in the Federal Register of March 9, 2016. In the notice of the public workshop, FDA requested comments on the workshop topics concerning the use of liquid chromatography/mass-spectrometry (LC/MS)-based in vitro diagnostic devices (IVDs) in the clinical laboratory. The Agency is taking this action in response to requests to allow interested persons additional time to submit comments.
Document Number: 2016-10084
Type: Notice
Date: 2016-04-29
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.
Document Number: 2016-10083
Type: Notice
Date: 2016-04-29
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 require; 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.
Document Number: 2016-10066
Type: Notice
Date: 2016-04-29
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.
Document Number: 2016-10062
Type: Notice
Date: 2016-04-29
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.
Document Number: 2016-10048
Type: Notice
Date: 2016-04-29
Agency: Department of Health and Human Services, Health Resources and Services Administration
Document Number: 2016-10030
Type: Notice
Date: 2016-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-10029
Type: Notice
Date: 2016-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-10028
Type: Notice
Date: 2016-04-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is reopening the comment period and requesting public input on possible modifications to the current review processes for new animal drug applications (NADAs) for the use of multiple new animal drugs in combination drug medicated feeds. We are also announcing the availability of a Center for Veterinary Medicine (CVM) recommendations document for the animal drug user fee negotiating committee.
Document Number: 2016-10025
Type: Notice
Date: 2016-04-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency), Center for Biologics Evaluation and Research (CBER) is announcing the availability of a Vaccine Adverse Event Reporting System (VAERS) eSubmitter program for the electronic submission of postmarketing individual case safety reports (ICSRs) and ICSR attachments of adverse events for human vaccine products (VAERS eSubmitter program). The VAERS eSubmitter program is a free software program for voluntary use that is intended to help persons subject to mandatory postmarketing requirements for vaccines including applicants, manufacturers, packagers, and distributors to electronically submit ICSRs and ICSR attachments as required by the final rule titled ``Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements.'' The VAERS eSubmitter program creates a simple and efficient mechanism for the secure electronic submission of postmarketing ICSRs and ICSR attachments into the VAERS database without the need for an internal database that is compatible with the International Conference on Harmonisation (ICH)-based direct database to database submission system.
Document Number: 2016-09980
Type: Notice
Date: 2016-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-09979
Type: Notice
Date: 2016-04-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-09978
Type: Notice
Date: 2016-04-29
Agency: Department of Health and Human Services, National Institutes of Health
This is 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 license to MeiraGTx, having a principal place of business in New York, New York, U.S.A. to practice the inventions embodied in the following patent applications, entitled ``AAV-mediated aquaporin gene transfer to treat Sj[ouml]gren's syndrome'':
Document Number: 2016-09932
Type: Proposed Rule
Date: 2016-04-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Keller and Heckman LLP on behalf of 3M Corporation (Petitioner), requesting that we amend our food additive regulations to no longer provide for the use of two different perfluoroalkyl containing substances as water and oil repellents for paper and paperboard in contact with aqueous and fatty foods because these uses have been abandoned.
Document Number: 2016-09953
Type: Notice
Date: 2016-04-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Document Number: 2016-09951
Type: Notice
Date: 2016-04-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a Compliance Policy Guide (CPG) relating to fresh and frozen crabmeat adulteration with filth involving the presence of Escherichia coli (E. coli). The CPG updates the previously issued CPG on this topic. The CPG provides guidance for FDA staff on the level of E. coli in crabmeat at which we may consider the crabmeat to be adulterated with filth.
Document Number: 2016-09940
Type: Notice
Date: 2016-04-28
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 information collection requirements for postmarket surveillance of medical devices.
Document Number: 2016-09939
Type: Notice
Date: 2016-04-28
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service published a document in the Federal Register on March 28, 2016, for the FY 2016 American Indians into Nursing. The notice contained incorrect project period lengths.
Document Number: 2016-09925
Type: Notice
Date: 2016-04-28
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Family Violence and Prevention Services (DFVPS) announces its intent to award a cooperative agreement of up to $3,750,000 as a single-source expansion supplement to the National Domestic Violence Hotline (Hotline) in Austin, TX.
Document Number: 2016-09865
Type: Rule
Date: 2016-04-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) published a document in the Federal Register of April 18, 2016 (81 FR 22520), amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. That rule included two amendatory instructions that cited incorrect sections of 21 CFR part 524.
Document Number: 2016-09784
Type: Rule
Date: 2016-04-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending a final rule published in the Federal Register of November 27, 2015. That final rule established requirements for importers to verify that food they import into the United States is produced consistent with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. The final rule published with some editorial and inadvertent errors. This document corrects those errors.
Document Number: 2016-09631
Type: Proposed Rule
Date: 2016-04-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2017. In addition, this rule proposes changes to the hospice quality reporting program, including proposing new quality measures. The proposed rule also solicits feedback on an enhanced data collection instrument and describes plans to publicly display quality measures and other hospice data beginning in the middle of 2017. Finally, this proposed rule includes information regarding the Medicare Care Choices Model (MCCM).
Document Number: 2016-09842
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services
This document corrects an error in the request for information entitled ``Office of the National Coordinator for Health Information Technology; Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), Request for Information (RFI) Regarding Assessing Interoperability for MACRA.''
Document Number: 2016-09840
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (DHHS) is hereby giving notice that a meeting of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will take place via webinar and will be open to the public.
Document Number: 2016-09818
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.
Document Number: 2016-09812
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services, Indian Health Service
Document Number: 2016-09803
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2016-09786
Type: Notice
Date: 2016-04-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: National Occupational Research Agenda (NORA) National Total Worker Health[supreg] Agenda (2016-2026): A National Agenda to Advance Total Worker Health[supreg] Research, Practice, Policy, and Capacity [2016- 114].
Document Number: 2016-09785
Type: Notice
Date: 2016-04-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for patients who have received an organ transplant. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of receiving an organ transplant on daily life and patient views on treatment approaches; the input from this public meeting will help in developing topics for further discussion. FDA is also interested in discussing issues related to scientific challenges in developing drugs to manage organ transplantation. In the afternoon, FDA will hold a workshop and provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to manage organ transplantation.
Document Number: 2016-09772
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Document Number: 2016-09769
Type: Notice
Date: 2016-04-27
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 requests for Clinical Laboratory Improvement Amendments of 1998 (CLIA) categorization of in vitro diagnostic tests when a premarket review is not needed.
Document Number: 2016-09762
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services
This notice announces the meeting date for the Physician- Focused Payment Model Technical Advisory Committee (hereafter referred to as ``the Committee'') on Wednesday, May 4, 2016 in Washington, DC.
Document Number: 2016-09761
Type: Notice
Date: 2016-04-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Office of Medical Products and Tobacco, Center for Drug Evaluation and Research, Office of Medical Policy has modified its structure. This new organizational structure was approved by the Secretary of Health and Human Services on December 15, 2016, and effective on April 17, 2016.
Document Number: 2016-09758
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services, Office of the Secretary
Document Number: 2016-09741
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-09740
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-09739
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-09738
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-09737
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2016-09705
Type: Notice
Date: 2016-04-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (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.
Document Number: 2016-09120
Type: Proposed Rule
Date: 2016-04-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2017. Some of the proposed changes would implement certain statutory provisions contained in the Pathway for Sustainable Growth (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Notice of Observation Treatment and Implications for Care Eligibility Act of 2015, and other legislation. We also are providing the estimated market basket update to apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2017. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2017. In addition, we are proposing to make changes relating to direct graduate medical education (GME) and indirect medical education (IME) payments to hospitals with rural track training programs. We are proposing to establish new requirements or revise requirements for quality reporting by specific providers (acute care hospitals, PPS- exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities) that are participating in Medicare, including related provisions for eligible hospitals and critical care hospitals (CAHs) participating in the Electronic Health Record (EHR) Incentive Program. We are proposing to update policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are proposing to: Implement statutory provisions that require hospitals and CAHs to furnish notification to Medicare beneficiaries, including Medicare Advantage enrollees, when the beneficiaries receive outpatient observation services for more than 24 hours; announce the implementation of the Frontier Community Health Integration Project Demonstration; and make technical corrections and changes to regulations relating to costs to organizations and Medicare cost reports.
Document Number: 2016-09657
Type: Notice
Date: 2016-04-26
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 an extension request for the information collection entitled Application for Permit to Import Biological Agents and Vectors of Human Disease into the United States and Application for Permit to Import or Transport Live Bats (42 CFR 71.54).
Document Number: 2016-09638
Type: Notice
Date: 2016-04-26
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 Workplace Health In America, a nationally representative survey of employer-based workplace health programs to describe the current state of U.S. workplace health promotion and protection programs and practices in employers of all sizes, industries and regions.
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