Department of Health and Human Services 2013 – Federal Register Recent Federal Regulation Documents

The Secretary of Education and Secretary of Health and Human Services (``the Secretaries'') propose priorities, requirements, definitions, and selection criteria under the Race to the TopEarly Learning Challenge (RTT-ELC) Grant program. The Secretaries may use one or more of these priorities, requirements, definitions, and selection criteria for competitions in fiscal year (FY) 2013 and later years. The U.S. Department of Education (ED) and the U.S. Department of Health and Human Services (HHS) (collectively, ``the Departments'') conducted the first competition under the RTT-ELC program in FY 2011 and awarded grants to nine States. In FY 2012, the five next highest- rated applicants on the slate of high-scoring applications from the FY 2011 competition were funded at up to 50 percent of the funds each requested in their FY 2011 applications. We propose to maintain the overall purpose and structure of the FY 2011 RTT-ELC competition in future competitions. These proposed priorities, requirements, definitions, and selection criteria are almost identical to the ones used in the FY 2011 competition. We describe the changes at the beginning of each section of this document.

This notice announces an open period for additional organizations to be considered for participation in Model 1 of the Bundled Payments for Care Improvement initiative.

Section 3003(b)(3) of the American Recovery and Reinvestment Act of 2009 mandates that the HIT Standards Committee develop a schedule for the assessment of policy recommendations developed by the HIT Policy Committee and publish it in the Federal Register. This notice fulfills the requirements of Section 3003(b)(3) and updates the schedule posted in the Federal Register on April 11, 2012. In anticipation of receiving recommendations originally developed by the HIT Policy Committee, the HIT Standards Committee has created six (6) workgroups to analyze the areas of clinical quality, clinical operations, implementation, consumer technology, nationwide health information networks and privacy and security. Other groups will be convened to address specific issues as needed. HIT Standards Committee's Schedule for the Assessment of HIT Policy Committee Recommendations is as follows: The National Coordinator will establish priority areas based in part on recommendations received from the HIT Policy Committee regarding health information technology standards, implementation specifications, and/or certification criteria. Once the HIT Standards Committee is informed of those priority areas, it will: (A) Direct the appropriate workgroup or other special group to develop a report for the HIT Standards Committee, to the extent possible, within 90 days, which will include, among other items, the following: (1) An assessment of what standards, implementation specifications, and certification criteria are currently available to meet the priority area; (2) an assessment of where gaps exist (i.e., no standard is available or harmonization is required because more than one standard exists) and identify potential organizations that have the capability to address those gaps; and (3) a timeline, which may also account for NIST testing, where appropriate, and include dates when the HIT Standards Committee is expected to issue recommendation(s) to the National Coordinator. (B) Upon receipt of a report from a workgroup or other special group, the HIT Standards Committee will: (1) accept the timeline provided by the subcommittee, and, if necessary, revise it; and (2) assign subcommittee(s) to conduct research and solicit testimony, where appropriate, and issue recommendations to the full committee in a timely manner. (C) Advise the National Coordinator, consistent with the accepted timeline in (B)(1) and after NIST testing, where appropriate, on standards, implementation specifications, and/or certification criteria, for the National Coordinator's review and determination whether or not to endorse the recommendations, and possible adoption of the proposed recommendations by the Secretary of the Department of Health and Human Services. The standards and related topics which the HIT Standards Committee is expected to address over the coming year include, but may not be limited to standards to support: Transport of data to and from patients, image exchange, current content gaps, securing data at rest, digital signature, longitudinal record sharing, advanced care preferences, application programming interfaces, measuring and reporting quality, clinical decision support, defect reporting and registry support. For a listing of upcoming HIT Standards Committee meetings, please visit the ONC Web site at https://healthit.gov. Notice of this schedule is given under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.'' This draft document provides CDRH's proposed interpretation of key provisions of the Federal Food Drug and Cosmetic Act (FD&C Act), which were added by the FDA Safety and Innovation Act (FDASIA), as those provisions pertain to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by CDRH. This draft guidance is not final nor is it in effect at this time.

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 information collection requirements for postmarket surveillance of medical devices.

The ``Data Rx: Prescription Drug Abuse Infographic Challenge Concept'' challenges the general public to create an infographic that presents information, rooted in the current research, concerning the growing trend of prescription drug abuse. The infographic should be designed to inform and educate the general public in interesting, novel, and creative ways about the dangers involved with the abuse of prescription drugs.

This document is a request for comment on the revised draft of the Federal Guidelines for Opioid Treatment. These guidelines elaborate upon the Federal opioid treatment standards set forth under 42 CFR part 8.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the existing reporting requests in CVM Guidance 108, ``How to Register with the CVM Electronic Submission System to Submit Information in Electronic Format using the FDA Electronic Submissions Gateway.''

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 is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to Advanced Personalized Diagnostics, LLC, a company having a place of business in Alexandria, Virginia, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/976,732, entitled ``Stably Transfected Multicolored Fluorescent Cells'', filed October 1, 2007 (HHS Ref. No. E-281-2007/0-US-01); U.S. Patent Application No. 12/ 060,752, entitled ``Multiplex Assay Method for Mixed Cell Populations'', filed April 1, 2008, (HHS Ref. No. E-281-2007/0-US-02); and U.S. Patent Application No. 12/802,666, entitled ``Methods of Monitoring Angiogenesis and Metastasis in Three Dimensional Co- Cultures'', filed June 10, 2010 (HHS Ref. No. E-281-2007/1-US-01). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to ``The use of the Licensed Patent Rights limited to an FDA-approved Class III in vitro diagnostic device for prediction of therapeutic efficacy in cancer and other angiogenesis-mediated diseases.'' Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, Advanced Personalized Diagnostics, LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Hospital Survey on Patient Safety Culture Comparative Database.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

The statute, as amended by the Affordable Care Act, requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually from fiscal year (FY) 2014 through FY 2020. This proposed rule delineates a methodology to implement the annual reductions for FY 2014 and FY 2015. The rule also proposes to add additional DSH reporting requirements for use in implementing the DSH health reform methodology.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Prescription Drug Product Labeling; Medication Guide Requirements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ``Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data.'' The guidance is intended to describe best practices pertaining to conducting and documenting pharmacoepidemiologic safety studies that use electronic healthcare data. The guidance includes recommendations for documenting the design, analysis, and results of such studies to optimize FDA's review of protocols and final reports that are submitted to the Agency.

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: Dorothy Farrell, Center for Strategic Scientific Initiatives, Office of Cancer Nanotechnology Research, National Cancer Institute, 31 Center Drive, Bldg. 31 A, Rm. 10A52, Bethesda, MD 20892 or call non-toll-free number 301-496-5652 or Email your request, including your address to: farrelld@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: National Cancer Institute (NCI) Alliance for Nanotechnology in Cancer Platform Partnership Scientific Progress Reports, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: National Institutes of Health grantees are required to submit interim and final progress reports and other post-award documents associated with the monitoring, oversight, and closeout of an award. This submission represents a request for OMB to approve new program specific progress report guidelines for Cancer Nanotechnology Platform Partnerships (CNPP) awarded by the National Cancer Institute (NCI). The CNPPs are part of the Alliance for Nanotechnology in Cancer, a network of awards funded by NCI to promote the application of nanotechnology to cancer research and care. The proposed guidelines request information about award performance related to trans-Alliance collaboration, scientific milestones, progress towards clinical translation and technology commercialization, and education and outreach efforts. The report also gathers information on leveraged funding, patents and publications. The information is gathered every six months. This information is needed to monitor the performance of this special program within NCI, funded through Requests for Applications (RFA CA-09-013, released May 29, 2009) using the cooperative agreement mechanism (U01). The information will be used to monitor individual award performance and the effectiveness of the program as a whole. The respondents are the Principal Investigators of the awards, along with their institutional business officials. The awards are administered by and the reports reviewed by the Office of Cancer Nanotechnology Research (OCNR), part of the Center for Strategic Scientific Initiatives within NCI. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The estimated annualized burden hours are 72.

The Food and Drug Administration (FDA) has determined that REV-EYES (dapiprazole hydrochloride ophthalmic solution), 0.5%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dapiprazole hydrochloride ophthalmic solution, 0.5%, if all other legal and regulatory requirements are met.

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 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443-1984.

The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is independent and nonfederal. Its members are nationally known leaders in public health practice, policy, and research, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to assess the effectiveness of community, environmental, population, and healthcare system interventions in public health and health promotion. During this meeting, the Task Force will consider the findings of systematic reviews and issue findings and recommendations to help inform decision making about policy, practice, and research in a wide range of U.S. settings. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).

The Food and Drug Administration (FDA) is amending the regulations for irradiation of animal feed and pet food to provide for the safe use of electron beam and x-ray sources for irradiation of poultry feed and poultry feed ingredients. This action is in response to a food additive petition filed by Sadex Corp.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in the requirements for reporting information about authorized generic drugs in an annual report.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice announces the issuance of the updated Provider Self-Disclosure Protocol (the SDP), originally published in the Federal Register on October 30, 1998 (63 FR 58399). In 1998, the Office of Inspector General published the SDP to establish a process for health care providers to voluntarily identify, disclose, and resolve instances of potential fraud involving the Federal health care programs (as defined in section 1128B(f) of the Social Security Act (the Act), 42 U.S.C. 1320a-7b(f)). The SDP provides guidance on how to investigate this conduct, quantify damages, and report the conduct to OIG to resolve the provider's liability under OIG's civil monetary penalty (CMP) authorities. Since the original publication, we identified areas where additional guidance would be beneficial to the health care community and would improve the efficient resolution of SDP matters. To that end, we issued three Open Letters to Health Care Providers in 2006, 2008, and 2009. Since the last Open Letter, we continued to evaluate our SDP process. We also solicited comments about the SDP on June 18, 2012, and we received numerous helpful comments from the public. On the basis of our experience and the comments we received, we have decided to revise the SDP in its entirety at this time. This revised SDP supersedes and replaces the 1998 Federal Register Notice and the Open Letters. OIG has posted the full revision of the SDP on its Web site: http:/ /oig.hhs.gov/compliance/self-disclosure-info/index.asp.

We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems. Some of the proposed changes implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act) and other legislation. These proposed changes would be applicable to discharges occurring on or after October 1, 2013, unless otherwise specified in this proposed rule. We also are proposing to update the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The proposed updated rate-of-increase limits would be effective for cost reporting periods beginning on or after October 1, 2013. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) and implement certain statutory changes made by the Affordable Care Act. Generally, these proposed changes would be applicable to discharges occurring on or after October 1, 2013, unless otherwise specified in this proposed rule. In addition, we are proposing a number of changes relating to direct graduate medical education (GME) and indirect medical education (IME) payments. We are proposing to establish new requirements or revised requirements for quality reporting by specific providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities (IPFs)) that are participating in Medicare. We are proposing to update policies relating to the Hospital Value- Based Purchasing (VBP) Program and the Hospital Readmissions Reduction Program. In addition, we are proposing to revise the conditions of participation (CoPs) for hospitals relating to the administration of vaccines by nursing staff as well as the CoPs for critical access hospitals relating to the provision of acute care inpatient services.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443-1984.

This notice announces the release of an updated Special Advisory Bulletin on the effect of exclusion from participation in Federal health care programs by OIG. The updated Special Advisory Bulletin describes the scope and effect of the legal prohibition on payment by Federal health care programs for items or services furnished (1) by an excluded person or (2) at the medical direction or on the prescription of an excluded person. For purposes of OIG exclusion, payment by a Federal health care program includes amounts based on a cost report, fee schedule, prospective payment system, capitated rate, or other payment methodology. The updated Bulletin describes how exclusions can be violated and the administrative sanctions OIG can pursue against those who have violated an exclusion. The updated Bulletin also provides guidance to the health care industry on the scope and frequency of screening employees and contractors to determine whether they are excluded persons. OIG has posted the full revision of the Special Advisory Bulletin on its Web site: https://oig.hhs.gov/exclusions/advisories.asp.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Expanded Access to Investigational Drugs for Treatment UseQs & As.'' This guidance is intended to provide information for industry, researchers, physicians, and patients about certain aspects of FDA's implementation of its regulations on expanded access to investigational drugs for treatment use. FDA has received a number of questions about implementation of its expanded access regulations. Therefore, FDA is providing this draft guidance in a question and answer format, addressing the most frequently asked questions.

On January 29, 2013, the Health Resources and Services Administration (HRSA) issued a Request for Information (RFI) to solicit ideas and information related to ways in which the U.S. Department of Health and Human Services (HHS) can work with interested partners to disseminate and apply TXT4Tots, a library of short, evidence-based messages on nutrition and physical activity targeted to parents, caregivers, and health care providers of children ages 1-5 years. HRSA released the TXT4Tots library in English and Spanish on February 19, 2013; and followed with an Open Forum on February 20, 2013, to provide further opportunity for input on dissemination and application of the library of messages. HHS received over 25 written responses to the RFI, and approximately 100 individuals participated in the Open Forum. Comments and Responses: The written responses to the RFI as well as the comments received through the Open Forum indicate that TXT4Tots aligns with the activities of many existing organizations and programs. Several of the respondents expressed an interest in collaborative opportunities to incorporate the messages into current outreach and educational efforts. Some examples of current programs that could leverage the TXT4Tots messages include initiatives at the federal, state, and local levels. The majority of the suggested organizations and programs focus on promoting healthy choices for children and their families. Recommendations included integrating the TXT4Tots messages into their programs and services or using the internet to disseminate the information through Web sites and social media. Respondents also emphasized that mobile health, social media, and other innovative strategies are a valuable resource to reach a diverse population and can be effectively leveraged to support equitable access to health information. With regard to vehicles for dissemination of the TXT4Tots messages, respondents suggested that they needn't be complicated, but should be user friendly. In addition, respondents noted that the most effective tools for dissemination are those that can fully engage the end users. Specific suggestions for dissemination of the TXT4Tots messages included social media, existing tools and applications, existing Web sites and web services, and text messages, as well incorporating messages into baby product packaging, curricula, health fairs, emails, newsletters, and print materials. Emphasis was placed on leveraging existing platforms that promote healthy choices for young children and could readily integrate the TXT4Tots message content. Respondents also recommended that the TXT4Tots messages be linked to additional sources of information; for example, if utilized as a text message program, URLs could be included to link the message recipients to Web sites with additional information. In addition, social media posts could link to Web sites with ideas for healthy recipes and age-appropriate activities to compliment the messages. Some respondents indicated that the use of certain technology-based platforms may restrict access to the underserved, who might have limited access to smartphones or the internet. One additional concern that was voiced by numerous respondents was confusion regarding the purpose of TXT4Tots and how it is intended to be used. Specifically, it was unclear that this is a library of messages that could be used in a variety of existing platforms and products and not exclusively a text messaging service. Guidance regarding specific details about the use of the TXT4Tots messages has been added to the TXT4Tots Web page (https:// www.hrsa.gov/healthit/txt4tots). HRSA appreciates all of the thoughtful comments received either via the RFI or Open Forum. Guidance regarding specific details about the use of the TXT4Tots messages has been added to the TXT4Tots Web page (https://www.hrsa.gov/healthit/txt4tots). It is our hope that the thoughtful recommendations and comments will spur others to explore innovative ways for disseminating the TXT4Tots content.

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 document entitled ``Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components'' dated May 2013. The guidance document recognizes the abbreviated donor history questionnaire and accompanying materials (aDHQ documents), version 1.3 dated December 2012, prepared by the AABB Donor History Task Force, as an acceptable mechanism for collecting blood donor history information from frequent donors of blood and blood components that is consistent with FDA's requirements and recommendations for collecting donor history information. The aDHQ documents will provide blood establishments that collect blood and blood components with a specific process for administering questions to frequent donors of blood and blood components to determine their eligibility to donate. The guidance announced in this notice finalizes the draft guidance of the same title dated October 2011.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Public Health Service Guideline on Infectious Disease Issues on Xenotransplantation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Department of Health and Human Services (HHS), Administration for Children and Families (ACF) will host a tribal consultation to consult on ACF programs and tribal priorities.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. provisional patent application No. 60/176/115 (E-078-2000/0-US-01) filed 1/14/2000; PCT application No. PCT/US01/01122 (E-078-2000/0-PCT- 02) filed 1/12/2001; U.S. patent No. 7,521,063 (E-078-2000/1-US-01) filed 07/12/2002 and issued 04/21/2009; U.S. patent No. 7,919,477 (E- 078-2000/1-US-02) filed 05/10/2007and issued 04/05/2011; U.S. patent No. 8,232,259 (E-078-2000/1-US-03) filed 02/11/2011 and issued 07/31/ 2012; E.U. patent No. 1322655 (E-078-2000/0-EP-03) filed 1/12/2001 and issued 11/14/2007 and validated in AT, GB, and IE (E-078-2000/0-AT-05, E-078-2000/0-GB-07, & E-078-2000/0-IE-08) and issued 12/13/2007 as patent No. 6031430 and validated in Germany (E-078-2000/0-DE-06); and E.U. patent application No. 07021557.9 (E-078-2000/0-EP-04) filed 11/ 05/2007; each entitled ``Oligodeoxynucleotide and Its Use to Induce an Immune Response''; by Klinman et al. (FDA) to Oregon Health Sciences University having a place of business at 3181 SW. Sam Jackson Park Rd. Portland, Oregon 97239. The patent rights in this invention have been assigned to the United States of America.

This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2014 (for discharges occurring on or after October 1, 2013 and on or before September 30, 2014) as required by the statute. We are also proposing to revise the list of diagnosis codes that are used to determine presumptive compliance under the ``60 percent rule,'' update the IRF facility-level adjustment factors, revise sections of the Inpatient Rehabilitation Facility-Patient Assessment Instrument, revise requirements for acute care hospitals that have IRF units, clarify the IRF regulation text regarding limitation of review, update references to previously changed sections in the regulations text, and revise and update quality measures and reporting requirements under the IRF quality reporting program.

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 or request more information on the proposed project contact: Chana Rabiner, Ph.D., Biorepositories and Biospecimen Research Branch, Cancer Diagnosis Program, 9609 Medical Center Drive, Rockville, MD 20892 or call non-toll-free number 240-276- 5715 or Email your request, including your address to: chana.rabiner@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: Financial Sustainability of Human Tissue Biobanking, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this web- based survey is to collect information regarding the challenges that human tissue biobanks encounter in achieving financially sustainable operations. The information will be used to assist the National Cancer Institute (NCI) in strategizing program plans to provide increased and tailored support for national and international biobanks. The survey will collect a combination of structured, quantitative, and free-text descriptive data that characterize the type and maturity of respondent biobanks, their sources of funding, and their usage of funding in conducting operations. The survey will also collect information describing the difficulties in maintaining funding sources and establishing new ones. Finally, the survey will elicit descriptions of techniques used to overcome the difficulties. It is expected that the information generated by this survey will be used to inform published guidance to biobanks regarding the financial hazards to sustained operations and the means by which these hazards can be avoided or overcome. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 822.

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a 2-day workshop on June 6-7, 2013. The workshop will be open to the public, with attendance limited to space available.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a start-up exclusive patent license to practice the inventions embodied in:

42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Seven current members' terms will expire in November 2013. To fill these positions, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in activities specified in the summary above.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on information voluntarily submitted to the Center for Devices and Radiological Health (CDRH) on actual or potential health risk concerns about a medical device or radiological product or its use.

This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2014, would revise and rebase the SNF market basket, and would make certain technical and conforming revisions in the regulations text. This proposed rule also includes a proposed policy for reporting the SNF market basket forecast error correction in certain limited circumstances and a proposed new item for the Minimum Data Set (MDS), Version 3.0.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2013, relating to the Medicare and Medicaid programs and other programs administered by CMS.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (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. Information Collection Request Title: Health Center Program Application Forms: (OMB No. 0915-0285 Revision). Abstract: Health centers (section 330 grant funded and Federally Qualified Health Center Look-Alikes) deliver comprehensive, high quality, cost-effective primary health care to patients regardless of their ability to pay. Health centers have become an essential primary care provider for America's most vulnerable populations. Health centers advance the preventive and primary medical/health care home model of coordinated, comprehensive, and patient-centered care, coordinating a wide range of medical, dental, behavioral, and social services. More than 1,200 health centers operate nearly 9,000 service delivery sites that provide care in every state, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin. The Health Centers Program is administered by HRSA's Bureau of Primary Health Care (BPHC). HRSA/BPHC uses the following application forms to oversee the Health Center Program. These application forms are used by new and existing Health centers to apply for various grant and non-grant opportunities, renew their grant or non-grant designation, and change their scope of project. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. 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. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows:

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443-1984. Information Collection Request Title: The Health Education Assistance Loan (HEAL) Program Regulations (OMB No. 0915-0108) Extension. Abstract: The Health Education Assistance Loan (HEAL) Program has regulations that contain notification, reporting, and recordkeeping requirements to ensure that the lenders and holders participating in the HEAL program follow sound management procedures in the administration of federally-insured student loans. While the regulatory requirements are approved under the OMB number referenced above, much of the burden associated with the regulations is cleared under separate OMB numbers for the HEAL forms and electronic submissions used to report required information. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. 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. The total annual burden hours estimated for this ICR are summarized in the table below.