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

This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on November 13, 2014, entitled ``Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015.''

National Institute on Drug Abuse (NIDA), National Institutes of Health, 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: Genevieve deAlmeida, Ph.D., Health Research Evaluator, Office of Science Policy and Communications, National Institute on Drug Abuse, NIH, 6001 Executive Boulevard, Bethesda, MD, Bethesda, MD 20892-9557, or call non-toll-free number (301) 594-6802, or Email your request, including your address to: dealmeig@nida.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 (NIDA), 0925-0655, Expiration Date 3/31/2015, EXTENSION, National Institute on Drug Abuse (NIDA). Need and Use of Information Collection: The information collected under this clearance will be qualitative customer and stakeholder feedback informationtheir perceptions, experiences and expectations of services, issues with service, to focus attention on areas where communication, training or changes in operations might improve delivery of products or services. The information will be useful and will allow for collaborative and actionable communications between the Agency and its customers and stakeholders, and will contribute directly to improving the programs and management of them. The information will not yield data that can be generalized to the overall population. The information may also be formative for the purpose of developing a concept for a new service program or dissemination program. The collections may still be eligible for submission for other generic mechanisms designed to yield quantitative results. The primary objectives are to obtain feedback on programs from customers and stakeholders, that would help make positive changes to the programs, or to assist in developing a new program or dissemination initiative, or to test medical tools and devices for usability, feasibility, and pilot testing of survey questionnaires for understandability. Data collection methods to be used in these studies include web-based and mailed surveys, focus groups, interviews with small groups, ad hoc collections at Conferences. The findings will provide valuable information to assist in improving programs that serve the public, and in developing good tools and devices to serve the public. OMB approval is requested for 3 years. NIDA 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 1,312.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``DSCSA Implementation: Product Tracing RequirementsCompliance Policy.'' This guidance announces FDA's intention with regard to enforcement of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA). FDA does not intend to enforce these requirements against manufacturers, wholesale distributors, and repackagers who do not, prior to May 1, 2015, provide or capture the transaction information, transaction history, and transaction statement required by the FD&C Act (product tracing information) for transaction of certain human, finished prescription drugs that are covered in the statute.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the National Institute of Nursing Research 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.). 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: Dr. Rebecca Hawes, Division of Science Policy and Public Liaison, NINR, NIH, Democracy One, 6701 Democracy Blvd., Suite 710, Bethesda, MD 20892, by phone at (301) 594-0791 or email your request, including your address to: hawesr@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, 0925-0653, Expiration Date 3/31/2015, EXTENSION, National Institutes of Health (NIH), National Institute of Nursing Research (NINR). Need and Use of Information Collection: There are no changes being requested for this submission. The information collection activity will continue 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, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into 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 Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. Improving agency programs requires ongoing assessment of service delivery, by which we mean systematic review of the operation of a program compared to a set of explicit or implicit standards, as a means of contributing to the continuous improvement of the program. The Agency will collect, analyze, and interpret information gathered through this generic clearance to identify strengths and weaknesses of current services and make improvements in service delivery based on feedback. 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 Agency's services will be unavailable. NINR 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 will provide useful information, but it will 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. 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 an additional 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,025.

The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. These recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'', which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.

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 reprocessed, single-use device labeling.

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 Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2014.

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 final notice announces the general criteria we will use to evaluate the effectiveness and efficiency of Beneficiary and Family Centered Care (BFCC) Quality Improvement Organizations (QIOs) that entered into contracts with CMS under the 11th Statement of Work (SOW) in May 2014. The activities for the BFCC-QIO SOW began August 1, 2014. (This contract allows for a transition period from the incumbent QIOs to the successor QIOs.) In addition, this notice addresses the public comments received on the July 28, 2014 notice with comment period entitled, ``Evaluation Criteria and Standards for Beneficiary and Family Centered Care Quality Improvement Organization Contracts.''

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 Office of the Director (OD), 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: Ms. Kathy Hancock, Assistant Grants Compliance Officer, Division of Grants Compliance and Oversight, Office of Policy for Extramural Research Administration (OPERA), 6705 Rockledge Drive, Room 3523, Bethesda, MD 20892, or call non-toll-free number (301) 435-1962, or Email your request, including your address to: FCOICompliance@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

This document contains proposed regulations regarding the summary of benefits and coverage (SBC) and the uniform glossary for group health plans and health insurance coverage in the group and individual markets under the Patient Protection and Affordable Care Act. It proposes changes to the regulations that implement the disclosure requirements under section 2715 of the Public Health Service Act to help plans and individuals better understand their health coverage, as well as to gain a better understanding of other coverage options for comparison. It proposes changes to documents required for compliance with section 2715 of the Public Health Service Act, including a template for the SBC, instructions, sample language, a guide for coverage example calculations, and the uniform glossary.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Administration for Children and Families (ACF) published a notice in the Federal Register on October 23, 2014, (79 FR 63406) requesting public comments to inform its upcoming Report to Congress. The Report to Congress 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. ACF stated in the notice that the request for information would remain open until December 22, 2014, for the receipt of public comments. To provide the public with more time to comment, ACF extends the period of time for which the comments will remain open. To provide clarification on the first bullet point under the Background Section, which was truncated in the first Federal Register Notice, please consider the following: A review of the effectiveness of state child support programs and collection practices and an analysis of the extent to which the practices result in unintended consequences or performance issues.

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 a start-up exclusive commercialization license to practice the inventions embodied in U.S. Patent Application 61/172,099 entitled ``Anti-human ROR1 Antibodies'' [HHS Ref. E-097-2009/0-US-01], U.S. Patent Application No. 13/990,977 entitled, ``Chimeric Rabbit/Human ROR1 Antibodies'' filed June 7, 2013 [HHS Ref. No. E-039-2011/0], U.S. Patent Application 60/703,798 entitled ``Mutated Pseudomonas Exotoxins with Reduced Antigenicity'' [HHS Ref. E-262-2005/0-US-01], U.S. Patent Application 60/969,929 entitled ``Deletions in Domain II of Pseudomonas Exotoxin A that Remove Immunogenic Epitopes with Affecting Cytotoxic Activity'' [HHS Ref. E- 292-2007/0-US-01], U.S. Patent Application 61/241,620 entitled ``Improved Pseudomonas Exotoxin A with Reduced Immunogenicity'' [HHS Ref. E-269-2009/0-US-01], U.S. Patent Application 61/483,531 entitled ``Recombinant Immunotoxin Targeting Mesothelin'' [HHS Ref. E-117-2011/ 0-US-01], U.S. Patent Application 61/495,085 entitled ``Pseudomonas Exotoxin A with Less Immunogenic T-Cell/or B-Cell Epitopes'' [HHS Ref. E-174-2011/0-US-01], U.S. Patent Application 61/535,668 entitled ``Pseudomonas Exotoxin A with Less Immunogenic B-Cell Epitopes'' [HHS Ref. E-263-2011/0-US-01], and any PCT, US or foreign applications claiming benefit of the technology families, to Magnifygen, Inc. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the development and use of immunotoxins comprising an anti-tyrosine kinase-like orphan receptor 1 monoclonal antibody designated as 2A2, R11, R12, or Y31 and Pseudomonas exotoxin A for the treatment of human cancers as claimed within the scope of the Licensed Patent Rights. For avoidance of doubt, the Licensed Field of Use excludes the development of antibody-drug conjugates and bispecific antibodies comprising said antibodies.

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.