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

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Document Number: 2015-01818
Type: Notice
Date: 2015-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-01817
Type: Notice
Date: 2015-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-01790
Type: Notice
Date: 2015-01-30
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: (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: 2015-01777
Type: Notice
Date: 2015-01-30
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: 2015-01769
Type: Notice
Date: 2015-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-01768
Type: Notice
Date: 2015-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-01767
Type: Notice
Date: 2015-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-01766
Type: Notice
Date: 2015-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-01723
Type: Notice
Date: 2015-01-30
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-01720
Type: Notice
Date: 2015-01-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-01719
Type: Notice
Date: 2015-01-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-01718
Type: Notice
Date: 2015-01-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-01717
Type: Notice
Date: 2015-01-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-01716
Type: Notice
Date: 2015-01-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-01715
Type: Notice
Date: 2015-01-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-01714
Type: Notice
Date: 2015-01-30
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-01698
Type: Notice
Date: 2015-01-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: C1-2015-01046
Type: Rule
Date: 2015-01-29
Agency: Department of Health and Human Services
Document Number: 2015-01685
Type: Notice
Date: 2015-01-29
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of 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 November 21, 2014, volume #79, page 69500 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. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Document Number: 2015-01682
Type: Notice
Date: 2015-01-29
Agency: Department of Health and Human Services
The Office of Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). ACBTSA is a Federal advisory committee within the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBTSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to four-year terms.
Document Number: 2015-01680
Type: Notice
Date: 2015-01-29
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public.
Document Number: 2015-01670
Type: Notice
Date: 2015-01-29
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.
Document Number: 2015-01669
Type: Notice
Date: 2015-01-29
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.
Document Number: 2015-01668
Type: Notice
Date: 2015-01-29
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.
Document Number: 2015-01652
Type: Notice
Date: 2015-01-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2015-01643
Type: Notice
Date: 2015-01-29
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-01628
Type: Notice
Date: 2015-01-29
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2015-01626
Type: Notice
Date: 2015-01-29
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 collection of information concerning class II special controls for an automated blood cell separator device operating by centrifugal or filtration separation principle.
Document Number: 2015-01625
Type: Notice
Date: 2015-01-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, the North American Society for the Study of Celiac Disease, and the Pediatric Inflammatory Bowel Disease Foundation, is announcing a 2-day public workshop entitled ``Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT III).'' The purpose of this workshop is to provide a forum to consider issues related to selection of endpoints and clinical outcome measures appropriate for drug development in the following disease areas: Inflammatory bowel diseases and celiac disease.
Document Number: 2015-01619
Type: Rule
Date: 2015-01-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use).
Document Number: 2015-01612
Type: Notice
Date: 2015-01-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-01611
Type: Notice
Date: 2015-01-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-01610
Type: Notice
Date: 2015-01-29
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Document Number: 2015-01057
Type: Rule
Date: 2015-01-29
Agency: Department of Health and Human Services
In March 2012, the Department of Health and Human Services (HHS) published a final rule establishing new standards for the certification of closed-circuit escape respirators (CCERs) by the National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC). The new standards were designed to take effect over a 3-year transition period. HHS has determined that extending the concluding date for the transition is necessary to allow sufficient time for respirator manufacturers to meet the demands of the mining, maritime, railroad, and other industries. Pursuant to this interim final rule, NIOSH will extend the phase-in period until 6 months after the date that the first approval is granted to certain CCER models.
Document Number: 2015-01537
Type: Notice
Date: 2015-01-28
Agency: Department of Health and Human Services
Document Number: 2015-01536
Type: Notice
Date: 2015-01-28
Agency: Department of Health and Human Services
Document Number: 2015-01535
Type: Notice
Date: 2015-01-28
Agency: Department of Health and Human Services
This notice announces the availability of test tools and test procedures approved by the National Coordinator for Health Information Technology (the National Coordinator) for the testing of EHR technology to the 2014 Edition Release 2 EHR certification criteria under the ONC HIT Certification Program. The approved test tools and test procedures are identified on the ONC Web site at: http://healthit.gov/policy- researchers-implementers/testing-and-test-methods. The test tools and test procedures for the ``optionaltransitions of care'' certification criterion (Sec. 170.314(b)(8)) and the optional testing and certification for the ``view, download, and transmit to 3rd party'' certification criterion (Sec. 170.314(e)(1)) have not yet been approved.
Document Number: 2015-01486
Type: Notice
Date: 2015-01-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-01485
Type: Notice
Date: 2015-01-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-01484
Type: Notice
Date: 2015-01-28
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2015-01429
Type: Notice
Date: 2015-01-27
Agency: Department of Health and Human Services, Office of the Secretary
Document Number: 2015-01428
Type: Notice
Date: 2015-01-27
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting to discuss essential health benefits and provider networks, the integration of the Affordable Care Act (ACA) qualified health plan and the Ryan White Program; an update on the National HIV/AIDS Strategy; and a discussion on surveillance data. The meeting will be open to the public.
Document Number: 2015-01427
Type: Notice
Date: 2015-01-27
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Dong Xiao, Ph.D., University of Pittsburgh: Based on the report of an inquiry conducted by the University of Pittsburgh (UP), additional analysis conducted by ORI in its oversight review, and an admission by the Respondent that he had ``intentionally fabricated data contained in a paper entitled `Guggulsterone inhibits prostate cancer growth via inactivation of Akt regulated by ATP citrate signaling,' specifically Figure 6G,'' ORI found that Dr. Dong Xiao, former Research Assistant Professor, Department of Urology, UP, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA157477. ORI found that Respondent engaged in research misconduct by reporting falsified data in Figures 1, 4, 5, S2, and S3 in the following paper published online: Gao, Y., Zeng, Y., Tian, J., Kslam, M.S., Jiang, G., & Xiao, D., ``Gugglesterone inhibits prostate cancer growth via inactivation of Akt regulated by ATP citrate signaling.'' Oncotarget, June 26, 2014 [Epub ahead of print], PMID: 24980815; hereafter referred to as the ``Oncotarget paper.'' Specifically, in the Oncotarget paper, Respondent:
Document Number: 2015-01421
Type: Notice
Date: 2015-01-27
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Pothur Srinivas, Ph.D., Project Officer/ICD Contact, Two Rockledge Center, 6701 Rockledge Drive, Room 10188, MSC 10193, Bethesda, MD 20892, or call non-toll-free number (301) 435-0550, or Email your request to: srinivap@nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Evaluation of the NHLBI Proteomics Centers Program: Qualitative Interviews 0925-New, National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH). Need and Use of Information Collection: The Proteomics Centers Program was established in 2010 with the goal of applying proteomic approaches to gain a better mechanistic understanding of the physiologic pathways underlying defined clinical conditions related to heart, lung, and blood diseases. The primary goal of the program is to help facilitate a better understanding of the underlying mechanisms in heart, lung, and blood diseases which could contribute to more effective diagnoses, risk stratification, intervention, and prevention. Given the rapid developments in proteomic technologies and approaches in the last five years, it is important to determine the extent to which the efforts of the centers have matured, leading to discovery of new targets for intervention and clinically actionable tool sets. An eighteen-month outcome evaluation will coincide with the completion of funding for the program. This information collection request is being made for one component of this evaluation: Semi-structured interviews with key informants across four targeted groups, internal and external to the program. The results of the evaluation will help determine the extent to which these desired outcomes were achieved as well as to inform future of proteomics research funding and commitments by the NHLBI. The key informant interviews are necessary to understand the perspectives of internal and external program stakeholders as it relates to the success, limitations, and opportunities that can shape future research funding. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 48.
Document Number: 2015-01420
Type: Notice
Date: 2015-01-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 038'' (Recognition List Number: 038), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Document Number: 2015-01418
Type: Notice
Date: 2015-01-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.'' The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA and includes presentations from key FDA officials, global regulators, and industry experts. Each presentation challenges the status quo and conventional wisdom to create synergies focused on finding solutions which make a difference. The experience level of the audience has fostered engaged dialog that has led to innovative initiatives. Dates and Times: The public conference will be held on March 25, 2015, from 8:30 a.m. to 5 p.m.; March 26, 2015, from 8:30 a.m. to 5 p.m.; and March 27, 2015, from 8:30 a.m. to 12:45 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3020. Contact Persons: For information regarding this notice: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East 7th Street, Cincinnati, OH 45202, 513-246-4134, email: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207- 5471, 513-745-3073, email: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and dinners for the 2\1/2\ days of the conference. There will be onsite registration. The cost of registration is as follows:
Document Number: 2015-01410
Type: Notice
Date: 2015-01-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Current Good Manufacturing Practice Requirements for Combination Products.'' The guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products, including presenting general considerations for CGMP compliance as well as analysis of hypothetical scenarios.
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