Department of Health and Human Services 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.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry'' dated December 2014. The draft guidance document provides sponsors, clinicians, and other establishments that manufacture and use adipose tissue, with recommendations for complying with the regulatory framework for HCT/Ps. For purposes of applying the HCT/P regulatory framework, FDA considers connective tissue, including adipose tissue, to be a structural tissue. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Methylphenidate Hydrochloride Extended-Release Oral Suspension.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for methylphenidate hydrochloride (HCl) extended- release oral suspension.

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 Dietary Reference Intakes (DRI) Committees of the U.S. and Canadian governments will hold a workshop entitled ``Options for Consideration of Chronic Disease Endpoints for Dietary Reference Intakes.'' The objective of the workshop is to critically evaluate key scientific issues involved in using chronic disease endpoints for setting DRIs and, in this context, to provide information for future decisions as to whether and/or how chronic disease endpoints can be incorporated into the setting of DRI values. In preparation for this meeting, the DRI Committees are asking for public comment on the set of questions that the meeting panelists will discuss.

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.

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This guidance is intended to inform manufacturers of laser products, FDA headquarters and field personnel, and the public of the Center for Devices and Radiological Health's (CDRH) current thinking on the safety of children's toy laser products and to provide specific safety recommendations for the manufacture and labeling of children's toy laser products.

The Food and Drug Administration (FDA) is announcing a public conference entitled ``Serious Drug-Induced Liver Injury (DILI): The Importance of Getting It Right: How to Measure and Interpret DILI Information and Make Correct Diagnoses.'' This conference will be cosponsored with the Critical Path Institute (C-Path) and the Pharmaceutical Research and Manufacturers of America. The purpose of the public conference is to discuss, debate, and share views among stakeholders in the pharmaceutical industry, academia, health care providers, patient groups, and regulatory bodies on how best to detect and assess the severity, extent, and likelihood of drug causation of liver injury and dysfunction in people using drugs for any medical purpose.

This joint interim final rule implements for all Federal award-making agencies the final guidance Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) published by the Office of Management and Budget (OMB) on December 26, 2013. This rule is necessary in order to incorporate into regulation and thus bring into effect the Uniform Guidance as required by OMB. Implementation of this guidance will reduce administrative burden and risk of waste, fraud, and abuse for the approximately $600 billion per year awarded in Federal financial assistance. The result will be more Federal dollars reprogrammed to support the mission, new entities able to compete and win awards, and ultimately a stronger framework to provide key services to American citizens and support the basic research that underpins the United States economy.

On October 20, 2014, the Administrator of the World Trade Center (WTC) Health Program received a petition to add primary biliary cirrhosis (Petition 006) to the List of WTC-Related Health Conditions (List). The Administrator has not found sufficient scientific evidence to conduct an analysis of whether to add primary biliary cirrhosis to the List. Accordingly, the Administrator finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.

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) is announcing the availability of a guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatStandardized Study Data.'' The guidance announced in this document is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on that topic. The guidance describes how FDA plans to implement the requirements for the electronic submission of standardized study data contained in certain submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs). This finalizes the revised draft guidance that was issued on February 6, 2014.

The Food and Drug Administration (FDA or the Agency) is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or within the package from which a prescription drug or biological product is dispensed. FDA is also proposing that prescribing information intended for health care professionals will no longer be permitted to be distributed in paper form with the package from which a prescription drug or biological product is dispensed, except as provided by this regulation. We are proposing these actions to help ensure that the most current prescribing information is publicly accessible for the safe and effective use of human prescription drugs.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

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.

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 August 21, 2014, page 49523 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to request an additional 30 days for public comment and reinstatement without change. The Center for Scientific Review (CSR), National Institutes of Health, 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 31, 2014, 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.

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) is correcting a notice that appeared in the Federal Register of December 8, 2014. The document misstated the effective date of the new system of records. This notice corrects that error.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for FDA staff entitled ``Compliance Policy Guide CrabmeatFresh and FrozenAdulteration with Filth, Involving the Presence of Escherichia coli.'' The draft Compliance Policy Guide (CPG), when finalized, will update the previously issued ``CPG CrabmeatFresh and FrozenAdulteration with Filth, Involving the Presence of the Organism Escherichia coli.'' This revised draft provides guidance for FDA staff on the level of Escherichia coli (E. coli) in crabmeat at which we may consider the crabmeat to be adulterated with filth.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: James P. Warne, Ph.D., University of California San Francisco: Based on an assessment conducted by the University of California San Francisco (UCSF), the Respondent's admission, and additional analysis conducted by ORI in its oversight review, ORI found that Dr. James P. Warne, former Senior Scientist, Diabetes Center, UCSF School of Medicine, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants DK080427, DK007161, and DK063720. ORI found that Respondent engaged in research misconduct by falsifying data that were included in the following two (2) publications and two (2) grant applications:

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: H. Rosie Xing, Ph.D., University of Chicago: Based on the report of an investigation conducted by the University of Chicago (UC) and additional analysis by ORI in its oversight review, ORI found that Dr. H. Rosie Xing, former Assistant Professor, UC, engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA098022. ORI found that Respondent engaged in research misconduct (42 CFR 93.103-104) by using images that had been among a set of manipulated images produced while at another institution, which had been found to be false by that institution. ORI found that Respondent falsely reported these images in Figures 1D, 2A, and Supplementary Figures 1B and 1C in Molecular Cancer Therapeutics 9:2724-36, 2010. The Respondent does not agree with ORI's finding of research misconduct and asserts that there are extenuating circumstances for her actions. Specifically, ORI found that Respondent: 1. included falsely labeled immunoblots in Figures 1D and 2A as follows: a. Figure 1D (lower panel), representing the total ERK levels in extracts from cells exposed to 15 Gy of gamma radiation for 0-120 minutes, by using results from an unrelated experiment for MAPK levels in extracts from cells exposed to 2, 12, or 20 Gy of gamma irradiation for 1, 5, 20, or 60 minutes b. Figure 2A (KSR1 panel), representing a control Flag-KSR1 immunoblot for extracts of cells transfected with control (TRE), wild- type KSR (KSR-S), or dominant negative inactive KSR (DN-KSR) exposed to no radiation or 5 minutes gamma irradiation, by using results form an unrelated experiment for KSR-transfected cells (KSR-S) irradiated with 0, 2, 5, 20, 15, 20 Gy irradiation c. Figure 2A (ERK panel), representing a control ERK immunoblot for extracts of cells transfected with control (TRE), wild-type KSR (KSR- S), or dominant negative inactive KSR (DN-KSR) exposed to no radiation or 5 minutes gamma irradiation, by using results from an unrelated experiment for KSR-transfected cells (KSR-S) irradiated with 0, 2, 5, 10, 15, 20 Gy irradiation 2. included falsified images in Figures 1D, 2A, and Supplementary Figures 1B and 1C by duplicating bands within the figures as follows: a. Figure 1D (top panel) for an immunoblot for p-ERK in A431 cells, by using the same bands to represent cells treated with ionizing radiation for 5 and 10 minutes with the bands for 60 and 90 minutes b. Figure 2A (top) for an in vitro kinase assay for p-GST-Elk-1, by duplicating lanes 2 and 5 to represent the control plasmid (TRE) at 5 minutes post radiation (lane 2) and the dominant negative inactive KSR (DN-KSR) NT lane (lane 5) c. Supplementary Figure 1B (middle panel) for an in vitro kinase assay for p-GST-MEK, by using the same bands to represent cells exposed to 5 and 20 Gy ionizing radiation d. Supplementary Figure 1C (top panel) for an immunoblot for p- MEK1/2, by using the same bands to represent cells exposed to 2 and 20 Gy ionizing radiation Dr. Xing has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed: (1) that if within three (3) years from the effective date of the Agreement, Respondent receives or applies for U.S. Public Health Service (PHS) support, Respondent agrees to have her PHS-supported research supervised for a period of three (3) years beginning on the date of her employment in which she receives or applies for PHS support, and to notify her employer(s)/institution(s) of the terms of this supervision; Respondent agrees that prior to the submission of an application for PHS support for a research project on which the Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent's research; Respondent agrees that she shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) that if within three (3) years from the effective date of this Agreement, Respondent receives or applies for PHS support, for a period of three (3) years beginning on the date of her employment in which she receives or applies for PHS support, any institution employing her to work on PHS-supported projects shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; and (3) to exclude herself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three (3) years beginning on November 13, 2014.

The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) for an oxytetracycline soluble powder used to make medicated drinking water for livestock and poultry. This action is being taken at the sponsor's request because this product is no longer manufactured or marketed.

This proposed rule would revise the applicable conditions of participation (CoPs) for providers, conditions for coverage (CfCs) for suppliers, and requirements for long-term care facilities, to ensure that certain requirements are consistent with the Supreme Court decision in United States v. Windsor, 570 U.S.12, 133 S.Ct. 2675 (2013), and HHS policy. Specifically, we propose to revise certain definitions and patient's rights provisions, in order to ensure that same-sex spouses in legally-valid marriages are recognized and afforded equal rights in Medicare and Medicaid participating facilities.

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 revisions to Forms FDA 3500, 3500A, and 3500B used in the FDA Medical Products Reporting Program.

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. This notice solicits comments on the information collection provisions of FDA's consultation procedures for foods derived from new plant varieties, including the information collection provisions in the guidance entitled, ``Guidance on Consultation Procedures: Foods Derived From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final Consultation For Food Derived From a New Plant Variety (Biotechnology Final Consultation),'' which developers may use to prepare the final consultation in a standard format.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Budesonide Extended-Release Tablets.'' The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for budesonide extended-release tablets.

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 Patent License to Nova Therapeutics LLC, a company having a place of business in Delaware, to practice the inventions embodied in the following patent applications:

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' The recommendations in this guidance are intended to assist applicants in developing the ``Patient Counseling Information'' section of labeling and to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format. This guidance finalizes the draft guidance issued on September 18, 2013.

The Secretary is issuing a declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide liability protection for activities related to Ebola Virus Disease Vaccines consistent with the terms of the declaration.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (GFI #214) entitled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data'' (VICH GL35). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide recommended standards to construct a single Adverse Event Report (AER) electronic message to transmit VICH GL42 contents to all member regions and Product Problem Reports (PPR) to FDA for veterinary medicinal products. Please note that VICH GL42 has been harmonized in GFI #188, ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.''

The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for Chagas disease. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The meeting is intended to allow FDA to obtain patients' perspectives on the impact that Chagas disease has on their daily lives, as well as their perspectives on the available therapies for Chagas disease. FDA is also interested in discussing issues related to scientific challenges in developing drugs to treat Chagas disease. In the afternoon, FDA will provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to treat Chagas disease. The input from this public meeting will help in developing topics for further discussion.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Kaushik Deb, Ph.D., University of Missouri-Columbia: Based upon the evidence and findings of an investigation report by the University of Missouri-Columbia (UM) transmitted to the United States Department of Health and Human Services (HHS), Office of Research Integrity (ORI) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Kaushik Deb, former Postdoctoral Fellow, Life Sciences Center, UM, engaged in misconduct in science in research that was supported by National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), grants 2 R01 HD021896 and 5 R01 HD042201-05 and National Center for Research Resources (NCRR), NIH, grant 5 R01 RR013438-07. ORI found that the Respondent intentionally, knowingly, and recklessly fabricated and falsified data reported in the following published paper: Deb, K., Sivarguru, M., Yong, H., & Roberts, R.M. ``Cdx2 gene expression and trophectoderm lineage specification in mouse embryos.'' Science 311:992-996, 2006 (hereafter referred to as ``Science 311''); this paper was retracted on July 27, 2007 An earlier version of Science 311 had been previously submitted to Nature on or about June 24, 2005 (hereafter referred to as ``Nature #1''). It was revised and resubmitted to Nature on or about August 24, 2005, and ultimately was rejected by Nature on September 14, 2005 (hereafter referred to as ``Nature #2''). Specifically, ORI finds by a preponderance of the evidence that the Respondent engaged in misconduct in science by intentionally, knowingly, and recklessly: 1. Falsifying and/or fabricating three panels of data in Figure 1 (Figures 1C, 1D, and 1E) in Science 311 and in Nature #1 and Nature #2, by photo-manipulating confocal fluorescent images to falsely represent three-, four-, and six-cell embryos, thereby supporting the paper's central premise that cells derived from a late-dividing blastomere would be positive for a transcription factor, Cdx2, while the cells derived from a leading blastomere would be Cdx2 negative 2. using photo-manipulation to falsify and fabricate at least 13 panels of confocal image data in Figures 2, 3, and S2, including Figures 2K, 2L, 2Q, 2R, 2V, 2X, 3G, 3H, 3I, S2s, S2t, S2u, and 2W, in Science 311 and in corresponding figures in Nature #1 and Nature #2 so that these images falsely supported the central premise in Science 311 that Cdx2-expressing cells were peripherally located in the embryo 3. falsifying Figures 2G, 3J, 3L, S2V, S2X, S6I, S6J, and S6K in Science 311, Figures 2A, 2C, S4v, and S4x in Nature #1, and Figures 2G, 3I, 3J, and 3K in Nature #2 by reusing and re-labelling the same image to represent different embryos and different experimental conditions 4. falsifying Figure 4 in Science 311 and corresponding figures submitted in Nature #1 and Nature #2 to falsely illustrate that the first dividing cell of a two-cell mouse embryo will ultimately differentiate into the trophoblast; specifically, Respondent: Falsely colored and photomanipulated a single bright-phase image of a three-cell embryo to make it appear as four separate embryos that had been differentially injected with TRD falsely colored and photomanipulated a four-cell embryo to make TRD appear distinctly located in the lagging cell and in its descendent cell, when the actual embryo contained diffuse staining within the sub-zonal, extracellular space photomanipulated a damaged, non-viable two-cell embryo to make it appear viable re-used, falsely colored, and relabeled seven images from an unrelated experiment to falsely represent a time lapse course of eight different images 5. falsifying Figures 5K, 5L, 5N, and 5O in Science 311 by photo- manipulating a single confocal image to falsely represent four different images at two different stages of embryonic development. The images also were presented as Figures 4k, 4l, 4n, and 4o in Nature #1. The Respondent failed to take responsibility for the fabrication and falsification described in ORI's findings. The following administrative actions have been implemented for a period of three (3) years, beginning on November 17, 2014: (1) Respondent is debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement programs of the United States Government referred to as ``covered transactions'' pursuant to HHS' Implementation (2 CFR part 376 et seq) of Office of Management and Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ``Debarment Regulations''); and (2) Respondent is prohibited from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

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 the availability of a draft guidance for industry entitled ``General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.'' The draft guidance is intended to assist those sponsors of new drug applications (NDAs), biologics license applications (BLAs) for therapeutic biologics, and supplements to such applications who are planning to conduct clinical studies in pediatric populations. Effectiveness, safety, or dose finding studies in pediatric patients involve gathering clinical pharmacology information, such as information regarding a product's pharmacokinetics and pharmacodynamics pertaining to dose selection and individualization. This draft guidance addresses general clinical pharmacology considerations for conducting studies so that the dosing and safety information for drugs and biologic products can be sufficiently characterized, leading to well-designed trials to evaluate effectiveness.

The Food and Drug Administration (FDA) is extending the comment period for a notice of availability of draft guidance for industry (GFI #227) entitled ``Two-Phased Chemistry, Manufacturing, and Controls Technical Sections'' that appeared in the Federal Register of October 20, 2014. In that notice, FDA made available for comment the draft guidance, which provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for revision of the approved information collection assigned OMB control number 0990- 0390 which expires on February 28, 2015. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Preparedness and Response Science Board (NPRSB), also known as the National Biodefense Science Board will be holding a public meeting on January 30, 2015.

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 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 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.

This proposed rule addresses changes to the Medicare Shared Savings Program (Shared Savings Program), including provisions relating to the payment of Accountable Care Organizations (ACOs) participating in the Shared Savings Program. Under the Shared Savings Program, providers of services and suppliers that participate in an ACO continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements.

The Food and Drug Administration (FDA) is withdrawing approval of 23 new drug applications (NDAs) and 68 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

This proposed rule would amend Indian Health Service (IHS) Purchased and Referred Care (PRC), formally known as the Contract Health Services (CHS), regulations to apply Medicare payment methodologies to all physician and other health care professional services and non-hospital-based services that are either authorized under such regulations or purchased by urban Indian organizations. Specifically, it proposes that the health programs operated by IHS, Tribe, Tribal organization, or urban Indian organization (collectively, I/T/U programs) will pay the lowest of the amount provided for under the applicable Medicare fee schedule, prospective payment system, or Medicare waiver; the amount negotiated by a repricing agent, if available; or the usual and customary billing rate. Repricing agents may be used to determine whether IHS may benefit from savings by utilizing negotiated rates offered through commercial health care networks. This proposed rule seeks comment on how to establish reimbursement that is consistent across Federal health care programs, aligns payment with inpatient services, and enables the IHS to expand beneficiary access to medical care.

This notice announces a $553.00 calendar year (CY) 2015 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2015 and on or before December 31, 2015.

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 Cancer Institute (NCI), 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: Anthony Dickherber, NCI Center for Strategic Scientific Initiatives, 31 Center Drive, Rm10A33, Bethesda, MD 20892 or call non-toll-free number 301- 547-9980 or Email your request, including your address to: dickherberaj@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: Surveys and Interviews to Support an Evaluation of the Innovative Molecular Analysis Technologies (IMAT) Program (NCI), 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of the proposed evaluation is to pursue a comprehensive process and outcome assessment of the 15-year old Innovative Molecular Analysis Technologies (IMAT) program. While the program consistently offers promising indicators of success, the full program has not been evaluated since 2008, and never in as comprehensive a manner as has been formulated in the current evaluation plan. An outcome evaluation of the long-standing National Cancer Institute's (NCI) IMAT program presents a rich and unique opportunity likely to serve institutes across the National Institutes of Health (NIH), and perhaps other federal agencies, considering the costs and benefits of directing resources towards supporting technology development. An award through the NIH Evaluation Set-Aside program to support this evaluation, for which NIH-wide relevance is a principle element of determining merit for support, is testament to this. The evaluation serves as an opportunity to gauge the impact of investments in technology development and also to assess the strengths and weaknesses of phased innovation award mechanisms. Like all institutes and centers (ICs) of the NIH, NCI seeks opportunities for improving their programs' utility for the broad continuum of researchers, clinicians and ultimately patients. NCI Director Harold Varmus and other leadership across NCI, as well as the NCI Board of Scientific Advisors, will be the primary users of the evaluation results. Findings are primarily intended for considering the long-term strategy to support innovative technology development and how to more efficiently translate emerging capabilities through such technologies into the promised benefits for cancer research and clinical care. Interviews with grantees, program officers, review officers, and other NIH awardees make up a crucial component of the evaluation plan and will largely follow set survey protocols. Specific near-term aims include the use of this information to consider the utility of continued investment through existing solicitations and in strategic planning generally for institute support for innovative technology development. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 575.

The Administration for Children and Families (ACF) has reorganized the Administration for Native Americans (ANA). This reorganization creates the Division of Policy and makes other technical changes to reflect the current functions within ANA. The realignment of functions better reflects the current work environment and priorities within ANA, manifests ANA's commitment to Federal/Tribal government-to- government relationships, and promotes self-determination for all Native Americans. The statement of mission, organization, functions, and delegations of authority conforms to and carries out the statutory requirements of the Native American Programs Act (NAPA).

The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the ``Pregnancy,'' ``Labor and delivery,'' and ``Nursing mothers'' subsections of the ``Use in Specific Populations'' section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the ``Labor and delivery'' subsection because information about labor and delivery is included in the ``Pregnancy'' subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.