Department of Health and Human Services November 21, 2014 – Federal Register Recent Federal Regulation Documents

Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities for Continued Approval of Its Accreditation Program for Organizations That Provide Outpatient Physical Therapy and Speech Language Pathology Services
Document Number: 2014-27649
Type: Notice
Date: 2014-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities for continued recognition as a national accrediting organization for organizations that provide outpatient physical therapy and speech language pathology services that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-27640
Type: Notice
Date: 2014-11-21
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.
Proposed Collection; 60-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIH)
Document Number: 2014-27637
Type: Notice
Date: 2014-11-21
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH), Office of the Director (OD), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.). This collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. This notice announces our intent to submit this collection to OMB for approval and solicits comments on specific aspects for the proposed information collection. 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: Ms. Mikia P. Currie, Program Analyst, Office of Policy for Extramural Research Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892, or call a non-toll-free number 301-435-0941 or Email your request, including your address to curriem@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment 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: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIH), 0925-0648, Expiration Date 1/31/2015, EXTENSION, National Institutes of Health (NIH), Office of the Director (OD). Need and Use of Information Collection: We are not requesting changes for this submission. The proposed information collection activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions. This information, however, is not statistical surveys that yield quantitative results, which can be generalized to the population of study. This feedback will provide information about the NIH's customer or stakeholder perceptions, experiences, and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training, or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative, and actionable communications between the NIH and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. The solicitation of feedback will target areas such as: timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on the NIH's services will be unavailable. The NIH will only submit a collection for approval under this generic clearance if it meets the following conditions: The collections are voluntary; The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government; The collections are non-controversial and do not raise issues of concern to other Federal agencies; Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future; Personally identifiable information (PII) is collected only to the extent necessary and is not retained; Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency; Information gathered will not be used for the purpose of substantially informing influential policy decisions; and Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study. Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 4,358.
Proposed Collection; 60-Day Comment Request; Application for Collaboration With the Therapeutic Development Branch (TDB), Division of Preclinical Innovation (DPI), National Center for Advancing Translational Sciences (NCATS)
Document Number: 2014-27636
Type: Notice
Date: 2014-11-21
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 Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted 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: Dr. Nora Yang, Therapeutic Development Branch, DPI, NCATS, NIH, 9800 Medical Center Drive, Building B, Rockville, MD 20850, or call non-toll-free number (301) 217-1077, or Email your request, including your address to: TRND@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment 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: Application for Collaboration with the Therapeutic Development Branch (TDB), Division of Preclinical Innovation (DPI), National Center for Advancing Translational Sciences (NCATS), 0925-0658, Expiration Date 06/30/2015EXTENSION, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH). Need and Use of Information Collection: The Therapeutic Development Branch (TDB) provides opportunities to partner with and gain access to a variety of programs delivering assay development, screening, hit-to- lead chemistry, lead optimization, chemical biology studies, drug development capabilities, expertise, and clinical/regulatory resources in a collaborative environment, with the goal of moving promising therapeutics into human clinical trials for both common and specifically rare and/or neglected diseases. The TDB uses an application and evaluation process to select collaborators. Selected investigators provide the drug project starting points and ongoing biological/disease expertise throughout the project. The application and evaluation process is necessary to determine amount and quality of current data, select meritorious projects for adoption, and to serve as a basis for determining specific scientific gaps to be filled. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The estimated annualized burden hours are 510.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-27619
Type: Notice
Date: 2014-11-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Town Hall Meeting on FY 2016 Applications for New Medical Services and Technology Add-On Payments
Document Number: 2014-27579
Type: Notice
Date: 2014-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2016 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment systems (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2016 new medical services and technologies applications meet the substantial clinical improvement criterion.
Medicare Program; Prior Authorization of Non-Emergent Hyperbaric Oxygen (HBO) Therapy
Document Number: 2014-27578
Type: Notice
Date: 2014-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a 3-year Medicare Prior Authorization model for non-emergent hyperbaric oxygen therapy services in the states of Illinois, Michigan, and New Jersey where there have been high incidences of improper payments for these services.
Medicare and Medicaid Programs: Continued Approval of The Joint Commission's Ambulatory Surgical Center Accreditation Program
Document Number: 2014-27577
Type: Notice
Date: 2014-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve The Joint Commission (TJC) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs; Continued Approval of DNV GL-Healthcare (DNV GL) Critical Access Hospital (CAH) Accreditation Program
Document Number: 2014-27576
Type: Notice
Date: 2014-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve DNV GL Healthcare (DNV GL) \1\ for continued recognition as a national accrediting organization (AO) for critical access hospitals (CAH) that wish to participate in the Medicare or Medicaid programs.
Anti-Infective Drugs Advisory Committee; Notice of Meeting
Document Number: 2014-27573
Type: Notice
Date: 2014-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
Statement of Organization, Functions and Delegations of Authority
Document Number: 2014-27563
Type: Notice
Date: 2014-11-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2014-27561
Type: Notice
Date: 2014-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2014-27558
Type: Notice
Date: 2014-11-21
Agency: Department of Health and Human Services, Administration for Children and Families
Developing and Using Precision Therapies in the “Omics” Era: Generating and Interpreting Evidence for Rare Subsets; Public Workshop
Document Number: 2014-27523
Type: Notice
Date: 2014-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a public workshop entitled ``Developing and Using Precision Therapies in the `Omics' Era: Generating and Interpreting Evidence for Rare Subsets.'' This public workshop is being cosponsored with the Center for Translational and Regulatory Sciences at the University of Virginia (UVA). The goals of this public workshop are to facilitate discussion on current scientific approaches using rare subsets during drug development programs and to further seek input from multiple stakeholders on approaches to obtain evidence that inform the regulatory evaluation of therapeutic products in rare subsets of patients identified through in-vitro diagnostic testing when specific, controlled trials are not feasible.
Report on the Standardization of Risk Evaluation and Mitigation Strategies; Correction
Document Number: 2014-27522
Type: Notice
Date: 2014-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice entitled ``Report on the Standardization of Risk Evaluation and Mitigation Strategies'' that appeared in the Federal Register of September 23, 2014. The document misstated the name of an organization. This document corrects that error.
Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry; Availability
Document Number: 2014-27521
Type: Notice
Date: 2014-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture; Guidance for Industry'' dated December 2014. The guidance document provides manufacturers of licensed whole blood and blood components intended for transfusion or for further manufacture, including source plasma, with recommendations concerning submission of changes to an approved biologics license application (BLA). The guidance document also provides manufacturers of licensed whole blood and blood components recommendations in connection with the applicability and content of comparability protocols and labeling changes. The guidance applies to the manufacture and distribution of licensed products. The guidance announced in this notice finalizes the draft guidance of the same title dated June 2013 and supersedes the document of the same title dated July 2001 (July 2001 guidance).
Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed
Document Number: 2014-27518
Type: Notice
Date: 2014-11-21
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 recordkeeping requirements for substances prohibited for use in animal food or feed.
Agency Information Collection Activities; Proposed Collection; Comment Request; Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body
Document Number: 2014-27517
Type: Notice
Date: 2014-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our 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. This notice invites comments on the collection of information associated with the submission of notifications of health claims or nutrient content claims based on authoritative statements of scientific bodies of the U.S. Government.
Clinical Trials Registration and Results Submission
Document Number: 2014-26197
Type: Proposed Rule
Date: 2014-11-21
Agency: Department of Health and Human Services
This Notice of Proposed Rulemaking proposes requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drugs (including biological products) and devices and for pediatric postmarket surveillances of a device to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM). This proposed rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to enhance patient enrollment, provide a mechanism to track subsequent progress of clinical trials, provide more complete results information, and enhance patient access to and understanding of the results of clinical trials. The proposed requirements would apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drugs (including biological products) and devices that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device that are ordered by FDA.