Department of Health and Human Services October 2014 – Federal Register Recent Federal Regulation Documents

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify an existing SOR titled, ``Chronic Condition Data Repository (CCDR), System No. 09-70-0573'' last published at 71 FR 54495, September 15, 2006. The current name of the SOR, Chronic Condition Data Repository, was developed during the planning and development stages of the system. Upon the implementation and throughout the operations and maintenance stages of the system, the system has been referred to as the Chronic Condition Warehouse (CCW) in common usage and written references. In keeping with this current usage, we will modify the name of this SOR to read, and from this point forward will refer to the system as: ``Chronic Condition Warehouse (CCW).'' We propose to broaden the scope of the system to include data that can be easily linked, at the individual patient level, to all Medicare and Medicaid claims, enrollment and/or eligibility data, nursing home and home health assessments, and CMS beneficiary survey data. Accordingly, we are updating the Authority Section to include Title XVIII of the Social Security Act as amended (the Act); Section 1902(a)(6) of the Act; Section 1142(c)(6) of the Act; and Title IV of the Balanced Budget Act (Pub. L. 105-33). The Record Source Categories section will be modified to include data from two new systems of records: the CMS Encounter Data System, System No. 09-70-0506, and the National Death Index, System No. 09-20-0166. These modifications will make the CCW a more useful tool by which to support research, policy analysis, quality improvement activities, and demonstrations that attempt to foster a better understanding of how to improve the quality of life and contain the health care costs of the chronically ill. We propose to modify existing Routine Use Number 1, to limit disclosures only to contractors of CMS. We also propose to add two new routine uses. Specifically, we propose adding a routine use to permit disclosures to healthcare providers who seek patient information for use in care coordination and quality improvement activities as described at 45 CFR 164.506(c)(4). This routine use will be added as Routine Use Number 4. We also propose adding a routine use to support public or private Qualified Entities (QEs) that use Medicare claims data to evaluate the performance of providers of services and suppliers on measures of quality, efficiency, effectiveness, and resource use. This routine use will be added as routine use number 6. Finally, we are modifying the language in Routine Use Number 3 to include grantees of CMS administered grant programs and have made minor grammatical changes to Routine Use Number 10. These modifications will provide a better explanation as to the need for the routine use, and to clearly state CMS's intention when making disclosures of individually identifiable information contained in this system. We have provided background information about the modified system in the Supplementary Information section below. Although the Privacy Act requires only that the ``Routine Use'' section of the system of records notice be published for comment, CMS invites comments on all portions of this notice. See the Effective Dates section for information on the comment period.

This notice provides public announcement of CDC's intent to award Ebola appropriations to select Ministries of Health and their bona fide agents for response to the Ebola outbreak funding. This award was proposed in Fiscal Year (FY) 2015 under funding opportunity announcement GH14-1418, ``Protecting and Strengthening Public Health Impact, Systems, Capacity, and Security.'' This notice replaces the Notice of Intent to award Ebola Response outbreak funding to eligible Ministries of Health and their bona fide agents which was published on October 22, 2014 (79 FR 63126, October 22, 2014). CDC is correcting the application date, award dates, amount of funding available, and one of the points of contact. Catalogue of Federal Domestic Assistance Number (CFDA): 93.318.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 14, 2014. The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. In this document, we correct some errors that appeared in the notice.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Bijan Ahvazi, Ph.D., National Institutes of Health: Based on the report of an investigation conducted by the National Institutes of Health (NIH) and additional analysis by ORI in its oversight review, ORI found that Dr. Bijan Ahvazi, former Director of the Laboratory of X-ray Crystallography, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH, engaged in research misconduct in research supported by the Intramural Program at NIAMS, NIH. ORI found that Respondent engaged in research misconduct by falsifying data related to or in the following published papers: 1. Ahvazi, B., Boeshans, K.M., Idler, W., Baxa, U., & Steinert, P.M. ``Structural basis for the coordinated regulation of transglutaminase 3 by guanine nucleotides and calcium/magnesium.'' J. Biol. Chem. 279(8):7180-92, 2004 Feb 20 (withdrawn) (hereinafter ``JBC 2004a'') 2. Ahvazi, B., Boeshans, K.M., & Steinert, P.M. ``Crystal structure of transglutaminase 3 in complex with BMP: Structural basis for nucleotide specificity.'' J. Biol. Chem. 279:26716-25, 2004 (withdrawn) (hereinafter ``JBC 2004b'') 3. Ahvazi, B., Boeshans, K.M., Idler, W.,& Cooper, A.J.L. ``Crystal structure of transglutaminase 3-cystamine complex: Binding of two cystamines to the nucleotide-binding pocket. M6:06060, Submitted to J. Biol. Chem., 2006 (rejected) (hereinafter ``JBC 2006''). Specifically, ORI finds that Respondent: 1. Falsely labeled Figure 3A in JBC 2004b representing an isothermal calorimetric titration (ITC) experiment using guanine monophosphate (GMP) and transglutaminase 3 (TGase 3) when the figure was actually a relabeled version of an unrelated experiment that Respondent previously published as Figure 1A in JBC 2004a. 2. falsified Figure 4B, Figure 4C, and Figure 6D in JBC 2004b and Figure 5E in JBC 2006, by altering the original data in the following ways to represent the desired experiment:

The Substance Abuse and Mental Health Services Administration (SAMHSA) announces that it will hold a public listening session on Wednesday, November 12, 2014, to solicit information concerning the Criteria for Certified Community Behavioral Health Clinics (CCBHC) to participate in Demonstration Programs. The scheduled listening session provides an opportunity for SAMHSA to seek public input on the criteria development process. The scope of this session will be on the development of the Criteria only. The session will be held in Rockville, MD, to obtain direct input from stakeholders on the development of criteria for state certification of Community Behavioral Health Clinics.

The Food and Drug Administration (FDA) is requesting that any small business tobacco manufacturing industry organizations interested in participating in the selection of nonvoting industry representatives to represent the interests of the small business tobacco manufacturing industry, to serve on the Tobacco Products Scientific Advisory Committee for the Center for Tobacco Products notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to be included in a pool of individuals to represent the interests of the small business tobacco manufacturing industry on the Tobacco Products Scientific Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. This position may be filled on a rotating, sequential basis by representatives of different small business tobacco manufacturers based on areas of expertise relevant to the topics being considered by the Advisory Committee. Nominations will be accepted for current vacancies effective with this notice.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of the AHRQ Healthcare Horizon Scanning System.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104- 13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 12th, 2014 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA) is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties, including academic institutions, regulated industry, and other interested organizations on best practices for communication between FDA and investigational new drug application (IND) sponsors during drug development. These comments will help FDA identify and ultimately establish best practices to be included in a draft guidance for industry and review staff.

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.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email OMH-ACMH@hhs.gov by November 19, 2014. Instructions regarding participating in the call and how to provide verbal public comments will be given at the time of preregistration. Information about the meeting is available from the designated contact and will be posted on the Web site for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH Web site under the heading About OMH.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, Department of Health and Human Services has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).

The Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) is announcing the availability of a draft guidance for the research community entitled ``Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care.'' OHRP is specifically addressing what risks to subjects are presented by research evaluating or comparing risks associated with standards of care, and which of these risks are reasonably foreseeable and should be disclosed to prospective research subjects as part of their informed consent. OHRP is soliciting written comments from all interested parties, including, but not limited to IRB members, IRB staff, institutional officials, research institutions, investigators, research subject advocacy groups, ethicists, the regulated community, and the public at large. This draft guidance represents OHRP's current thinking on this topic. Certain treatments and procedures that are commonly used in health care for a given type of disease or condition have come to be known as ``standards of care.'' Multiple ``standards of care'' involving widely differing treatments and risks may be available for the same disease or medical condition. Where multiple ``standard of care'' options are available for a given disease or condition, the use of the term does not imply that the options will produce similar benefits or incur similar risks. Furthermore, patients may not find those options equally acceptable, nor do physicians always use them interchangeably. Importantly there is not necessarily a limit on how different the risks from two versions of a standard of care might be. For example, it may already be known that one of those versions imposes a significantly higher risk of death than the other. Adequate knowledge about the effectiveness and risks of standards of care and how these standards compare to each other is sometimes lacking. In recent years research studies designed to evaluate such treatments and procedures have become commonplace. These studies are often called ``comparative effectiveness research'' or ``standard of care research.'' As this type of research has become more common, so too have questions about how the HHS human subject protection regulations (45 CFR part 46) apply to such research. There is uncertainty in the research community about which risks of the research should be determined to be reasonably foreseeable risks of research and how they should be described to prospective subjects in the process of informed consent. OHRP's interpretation of the HHS research regulations has been that if people are being asked to undergo procedures in a research study that involve risks that they would not otherwise be exposed to, these are `research risks' that people must be informed about. Only in that way are they able to make a truly informed decision about whether they are willing to participate. For comparative effectiveness or standard of care research, OHRP's general position is that the reasonably foreseeable risks of research include already-identified risks of the standards of care being evaluated as a purpose of the research when the risks being evaluated are different from the risks subjects would be exposed to outside of the study. This guidance addresses these issues in the form of frequently asked questions. OHRP will consider comments received before issuing the final guidance document.

The Food and Drug Administration (FDA) is announcing a public meeting to discuss proposed revisions to four rules originally proposed in 2013 to implement the FDA Food Safety Modernization Act (FSMA). In response to the comments received on these foundational FSMA proposed rules, FDA issued supplemental notices of proposed rulemaking that propose significant changes to four of the proposed rules including: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food); Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety); Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Preventive Controls for Animal Food); and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Foreign Supplier Verification Programs). The purpose of the public meeting is to solicit oral stakeholder and public comments on the new content of the supplemental proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the supplemental proposed rules.

This document provides the methodology and data sources necessary to determine federal payment amounts made in program year 2016 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.

The Department of Health and Human Services, Administration for Children and Families, Office of Child Support Enforcement requests public comments to inform its upcoming Report to Congress. The Report to Congress (``Report'') is required to be submitted no later than June 30, 2015 under Title III, Section 305 of H.R. 4980 (Pub. L. 113-183), Preventing Sex Trafficking and Strengthening Families Act of 2014. The legislation was signed into law on September 29, 2014. This Request for Information offers the opportunity for interested individuals and organizations to provide input on specific Report requirements or other information that would be valuable to the Report development.

This notice provides public announcement of CDC's intent to award Ebola appropriations to select Ministries of Health and their bona fide agents for response to the Ebola outbreak funding. This award was proposed in Fiscal Year (FY) 2015 under funding opportunity announcement GH14-1418, ``Protecting and Strengthening Public Health Impact, Systems, Capacity, and Security.''

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.

Pursuant to the NIH Reform Act of 2006 (42 U.S.C. 281(d)(4)), notice is hereby given that the National Eye Institute will host a meeting to enable public discussion of the Institute's proposal to rename its Division of Extramural Research to the Division of Extramural Science and establish a new Division of Extramural Activities. The proposal seeks to clearly delineate functions and streamline the services provided by adding focus to scientific programs and extramural operations. This proposed change aligns NEI with the structure of other NIH Institutes and Centers.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Migraine: Developing Drugs for Acute Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of drugs for the acute treatment of migraine. This guidance is intended to serve as a focus for continued discussions among the Division of Neurology Products, pharmaceutical sponsors, the academic community, and the public.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a provision to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that makes a drug adulterated. This guidance defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.

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.

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.

The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations of individuals to serve as non-federal public members on the Interagency Autism Coordinating Committee. The Office of the Secretary has directed the Office of Autism Research Coordination (OARC) of the National Institute of Mental Health, National Institutes of Health to assist the Department in conducting an open and transparent nomination process.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Kelvin Soto from providing services in any capacity to a person that has an approved or pending drug product application for a period of 6 years. We base this order on a finding that Mr. Soto was convicted of four felony counts under Federal law for conduct involving health care fraud and conspiracy to commit health care fraud and that this pattern of conduct is sufficient to find that there is reason to believe he may violate requirements under the FD&C Act relating to drug products. Mr. Soto was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Soto failed to request a hearing. Mr. Soto's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #227) entitled ``Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections.'' The purpose of this document is to provide recommendations to sponsors submitting CMC data submissions. For review efficiency, the Center for Veterinary Medicine (CVM) prefers that CMC information be submitted in a single technical section. However, there may be instances when a two-phased technical submission process is more beneficial to improve the overall time to drug approval. Sponsors may submit the phased CMC technical section as a single technical section or a two-phased technical section. This guidance describes the use of the two-phased technical section submission process.

This notice announces the spring meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2015. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights, and hospital outpatient therapeutic services supervision issues.

This document announces the continuation of effectiveness of an interim final rule and the extension of the timeline for publication of the final rule. This document is issued in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act if the Secretary publishes a notice of continuation prior to the expiration of the timeline.

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.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by DSM Nutritional Products, proposing that the food additive regulations be amended to provide for the safe use of Schizochytrium sp. dried algae as a source of docosahexaenoic acid for use in standard pelleted foods for adult dogs.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the establishment of a probability-based panel of tobacco users.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Kite Pharma, Inc., which is located in Los Angeles, California to practice the inventions embodied in the following patent applications and applications claiming priority to these applications:

A conference to identify issues surrounding evidence-based decision making for vitamin D in primary care will be held December 2- 3, 2014, on the main campus of the National Institutes of Health (NIH) in Bethesda, Maryland. It will also be broadcast as a webinar. The conference discussions will serve to highlight research gaps as well as data and methodological needs relevant to reducing uncertainties surrounding vitamin D in primary care practice. All persons are invited to attend, especially clinical educators, those who develop clinical recommendations, health care providers and researchers. Persons wishing to attend are required to register in advance of the conference.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled, ``Distinguishing Medical Device Recalls From Medical Device Enhancements.'' This guidance is intended to clarify when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and explain reporting requirements.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Animal Drug User Fee Cover Sheet'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with a survey of pharmacists and patients about their experiences resulting from changes in generic drug pill appearance.

The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its nineteenth meeting on November 5-6, 2014. At this meeting, the Commission will conclude discussions related to the BRAIN Initiative and ongoing work in neuroscience, and begin discussions about the role of deliberation and education in bioethics.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Flow Cytometric Devices.'' This draft guidance addresses the current major review concerns regarding submissions for flow cytometric devices used as in vitro diagnostic devices for leukocyte immunophenotyping and provides suggestions on the content of submissions for these types of devices. This draft guidance is not final nor is it in effect at this time.

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.

This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2015. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2015, for these individuals will be $407. The premium for certain other individuals as described in this notice will be $224.

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.

The Administration for Children and Families (ACF), Office of Community Services (OCS) announces the award of a single-source grant for $686,000 to the Lao Family Community Development, Inc., in Oakland, CA, to support the renovation of a former warehouse, located in the Fruitvale district, into a mixed-use building.