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

The Food and Drug Administration (FDA or we) has determined that JADELLE (levonorgestrel) implant, 75 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for JADELLE (levonorgestrel) implant, 75 mg, if all other legal and regulatory requirements are met.

Administration for Children and Families (ACF) is announcing its evaluation policy for research or demonstration projects as authorized by 42 U.S.C. 1310.

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.

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. 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. We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. We are, however, requesting an emergency review of the information collection reference below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. This is necessary to ensure compliance with an initiative of the Administration. We are requesting an emergency review under 5 CFR part 1320(a)(2)(i) because public harm is reasonably likely to result if the normal clearance procedures are followed. We are seeking emergency approval for modifications to the ICR currently approved under Office of Management and Budget (OMB) control number 0938-0760, entitled Medicare and Medicaid Programs OASIS Collection Requirements as Part of the CoPs for HHAs and Supporting Regulations. The revisions contained in this request pertain only to the Outcome Assessment and Information Set, C-1/ICD-9 Version (OASIS-C1/ICD-9 Version); therefore all other requirements in the currently approved PRA package are not being revised. The approval of this data collection instrument is essential because OASIS data is used in the calculation of provider payment as well as for measurement of the quality of care provided by Home Health Agencies (HHAs).

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive start-up option license to practice the inventions embodied in: (E-147- 1999/0 &1) US provisional patent application No. 60/128/898 filed 4/12/ 1999, and PCT application No. PCT/US00/09839 filed 4/12/2000, and U.S. patent No. 6,977,245 filed 02/06/2002 issued 12/20/2005, and U.S. patent No. 7,960,356 filed 05/17/2005 and issued 06/14/2011, and EP1176966 granted 4/3/2013, each entitled ``Oligodeoxynucleotide and Its Use to Induce an Immune Response''; and (E-036-2005/0) US provisional patent application No. 60/713,547 filed August 31, 2005, and PCT application No. PCT/US2006/033774 filed August 28, 2006, and US patent 7,892,569 filed 8/31/2005 issued 2/22/2011, and Canada application number 2620582 filed 2/28/08, and Australia patent 2006284889 filed 8/28/2006 issued 12/1/11, and Japan patent 5481068 filed 8/28/2006 issued 2/21/2014, each entitled ``Method of Altering an Immune Response Induced by CpG Oligodeoxynucleotides''; and (E-214- 2001/0) US provisional patent application No. 60/312,190 filed August 14, 2001, and PCT application No. PCT/US202/025732, and US patent 7,354,909 filed February 2, 2004 issued April 8, 2008, and US patent 7,959,934 filed March 28, 2008 issued June 14, 2011, each entitled ``Method for Rapid Generation of Mature Dendritic Cells'' by Klinman et al. (FDA), to Neuralexo, LLC, having a place of business at 17367 Canal Circle, Lake Oswego, Oregon 97035. The United States of America is an assignee to the patent rights of these inventions. The prospective exclusive start-up option licensed territory may be worldwide, and the field of use may be limited to: preventative treatment for ischemic injury in organs.

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient Safety and Quality Improvement Final Rule, 42 CFR Part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008, 73 FR 70732-70814, provide for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of NHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from Patient Safety Services, LLC of its status as a PSO, and has delisted the PSO accordingly.

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 in Volume 79, June 12, 2014 on page 33764 and allowed 60-days for public comment. One public comment was received that was a personal opinion regarding conducting research about the Chinese blood donation system. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health (NIH) 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 1, 1995, 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, OIRAsubmission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication. For Further Information: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Simone Glynn, MD, Project Officer/ICD Contact, Two Rockledge Center, Suite 9142, 6701 Rockledge Drive, Bethesda, MD 20892, or call 301-435-0065, or Email your request, including your address to: glynnsa@nhlbi.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: HIV Study in Blood Donors from Five Chinese Regions, 0925-0596 reinstatement with change, National Heart, Lung and Blood Institute (NHLBI). Need and Use of Information Collection: This Study is a reinstatement with change of OMB Number: 0925-0596 expiration date, January 31, 2012. To better understand the diversifying and changing Human Immunodeficiency Virus (HIV) epidemic, and contemporary HIV risk factors, especially those associated with recent HIV infections, this HIV risk factor study in China is proposed as part of the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). The major objectives of the study will be to evaluate the proportion of blood donors in China who test positive for HIV and have acquired their infection recently or more remotely; the risk of releasing a blood product that contains HIV (HIV residual risk); and the risk factors associated with HIV infection in China. The study will also assess the frequency of distinct HIV-1 viral lineages and drug resistant mutations among HIV-positive blood donors. In 2011, there were 780,000 people infected with HIV in China and it is estimated that over 300,000 HIV infected people in China are not aware of their infection status. The large migrating population and the complexity of HIV transmission routes in China make it difficult to implement a comprehensive and effective national HIV control strategy. Risk factors for infections can change over time; thus, identifying factors that contribute to the recent spread of HIV in a broad cross-section of an otherwise unselected general population, such as blood donors, is highly important for obtaining a complete picture of the epidemiology of HIV infection in China. Because the pace of globalization means infections can cross borders easily, the study objectives have direct relevance for HIV control in the US and globally. Recent years have seen an increase in blood donations from repeat donors in most Chinese regions. This increase permits longer-term follow-up and testing of repeat donors which allow for calculation of new HIV infection rates and residual risks. The HIV data, for both recently and remotely acquired infections, from the proposed study will complement existing data on HIV risks obtained from general and high risk populations to provide comprehensive HIV surveillance data for China. This study will also monitor genetic characteristics of recently acquired infections through genotyping and drug resistance testing, thus serving a US and global public health imperative to monitor the genotypes of HIV that have recently been transmitted. For HIV, the additional monitoring of drug resistance patterns in newly acquired infection is critical to determine if currently available antiretroviral medicines are capable of combating infection. Genotyping and host response information are scientifically important not only to China, but to the US and other nations since they provide a broader global understanding of how to most effectively manage and potentially prevent HIV, for example through vaccine development. Efforts to develop vaccines funded by the National Institutes of Health and other US-based organizations may directly benefit from the findings of this study. Blood donors are tested for transfusion-transmissible infections including HIV when they present to donate, and test result information as well as demographic data will be routinely collected in a database at the five blood centers participating in REDS-III studies (located in the cities of Chongqing, Liuzhou, Luoyang, Mianyang, and Urumqi). These data will allow for calculation of HIV incidence, prevalence, and residual risk. Additionally, a case-control study will be conducted over a 2 and \1/2\ year period to evaluate the risk factors associated with HIV infection among blood donors. Cases will be defined as potential donors who deny risks on the donor screening questionnaire but are found to be positive on HIV testing (their donation is discarded), HIV-positive donors who gave blood at one of the five blood centers as stated above (primary sites) or at blood centers located in the Guangxi Autonomous Region (peripheral sites, recruited through the Guangxi CDC for this study only but not other REDS-III studies) will be eligible to participate and complete a Risk Factor Questionnaire that will assess general demographic and risk factor information pertinent to HIV infection. Controls will be negative for HIV on confirmatory testing. Assuming 50% response rate, it is anticipated that 390 HIV- positive donors and 960 controls will participate in the case control study. The results of this study will contribute to global HIV surveillance and prevention, provide a broader global understanding of HIV epidemiology, and support public health efforts to most effectively manage and potentially prevent HIV transmission both worldwide and in the US. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated burden hours are 450.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis,'' dated September 2014. The guidance document provides recommendations for screening and testing of donors and management of donations based on screening tests for syphilis. The guidance is intended for blood establishments that collect Whole Blood or blood components, including Source Plasma. The guidance announced in this notice finalizes the draft guidance of the same title, dated March 2013 (2013 draft guidance), and supersedes the memorandum of December 12, 1991, entitled ``Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing.''

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) launches a challenge competition for the development of a method or process to accurately and efficiently identify, subtype, and characterize pathogenic microorganisms directly from clinical or environmental samples without the need for culture or culture-based enrichment. Laboratory-based infectious disease surveillance programs, such as PulseNet, the National Tuberculosis Surveillance System, and the Active Bacterial Core Surveillance program, rely on primary culture and microbiologic testing in community hospital and clinical laboratories. A new generation of non-culture-based diagnostic tests are now beginning to enter the marketplace offering physicians faster results and, in some cases, more types of information than were previously available. Unfortunately, these new tests do not typically result in isolates being available for public health purposes, and, as their use continues to grow, it will likely become increasingly difficult or impossible to detect and investigate outbreaks or other important infectious disease trends. New laboratory approaches that do not depend on isolates or culture for subtyping and characterization of microbes are needed to maintain and improve important public health activities across a range of pathogenic organisms. The Culture-Independent Straintyping and Characterization Challenge is an opportunity to develop novel approaches to identifying and characterizing pathogens similar to normal flora in a complex matrix in a process that does not require any culture, including pre-enrichment. Straintyping and characterization of the Shiga toxin-producing Escherichia coli (STEC) from clinical stool samples represents a significant challenge and has been selected as the target organism for this challenge. STEC are similar in most respects to the commensal E. coli that are carried in the intestinal tract of nearly everyone. Consistent identification, straintyping, and characterization of pathogenic STEC directly from a complex matrix, such as stool, requires the consistent identification of both a variable marker that can be used for subtyping and a second, more stable marker that can be used for definitive identification.

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: ``Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on May 29th 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

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 a new Information Collection Request (ICR), described below; to the Office of Management and Budget (OMB). 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.

The Food and Drug Administration (FDA) is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America Inc. for 10 tobacco products.

The Office of Rural Health Policy (ORHP) will award program expansion supplemental awards to the current Small Health Care Provider Quality Improvement (Quality) program grantees. The program expansion supplemental funds will allow current Quality program grantees: To provide education to those new to health care coverage about health care benefits to which they have access; to raise awareness about the importance of receiving routine primary care and regular preventive services; and to expand outreach and enrollment activities for the next Affordable Care Act's (ACA) Health Insurance Marketplace open enrollment period (November 15, 2014-February 15, 2015). The goals of this supplemental funding are to (1) increase the number of newly insured individuals educated about the benefits and primary care and preventive services to which they now have access, (2) increase the number of uninsured individuals educated about their coverage options, and (3) increase the number of uninsured individuals enrolled into the Health Insurance Marketplaces or other available sources of insurance, such as Medicaid and the Children's Health Insurance Program.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Amendments Act of 2007 (FDAAA), authorizes FDA to determine and collect priority review user fees for certain applications for approval of drug or biological products when those applications use a tropical disease priority review voucher awarded by the Secretary of Health and Human Services. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. The amount of the fee submitted to FDA with applications using a tropical disease priority review voucher is determined each FY based on the average cost incurred by FDA in the review of a human drug application subject to priority review in the previous FY. This notice establishes the tropical disease priority review fee rate for FY 2015.

The Food and Drug Administration is correcting a notice entitled ``Biosimilar User Fee Rates for Fiscal Year 2015'' that appeared in the Federal Register of August 1, 2014 (79 FR 44795). The document announced the rates for biosimilar user fees for fiscal year 2015. The document was published with the incorrect docket number. This document corrects that error.

The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) announces the award of a single-source program expansion supplement grant to U.S. Committee for Refugees and Immigrants in Arlington, Virginia for a total of $361,286. The supplemental funding will ensure sufficient that clients' essential needs, such as housing, transportation, communication, food, and medical care will be met.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices.'' This guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostic devices (HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture.

This document proposes a change to the definition of an eligible organization that can avail itself of an accommodation with respect to coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. Among these services are women's preventive health services, as specified in guidelines supported by the Health Resources and Services Administration (HRSA). As authorized by the current regulations, and consistent with the HRSA Guidelines, group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) are exempt from the otherwise applicable requirement to cover certain contraceptive services. Additionally, under current regulations, accommodations are available with respect to the contraceptive coverage requirement for group health plans established or maintained by eligible organizations (and group health insurance coverage provided in connection with such plans), and student health insurance coverage arranged by eligible organizations that are institutions of higher education, that effectively exempt them from this requirement. The regulations establish a mechanism for separately furnishing payments for contraceptive services on behalf of participants and beneficiaries of the group health plans of eligible organizations that avail themselves of an accommodation, and enrollees and dependents of student health insurance coverage arranged by eligible organizations that are institutions of higher education that avail themselves of an accommodation. These rules propose and seek comments on potential changes to the definition of ``eligible organization'' in the Departments' regulations in light of the Supreme Court's decision in Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751 (2014), to ensure that participants and beneficiaries in group health plans (and enrollees and dependents in student health insurance coverage arranged by institutions of higher education) obtain, without additional cost, coverage of the full range of Food and Drug Administration (FDA) approved contraceptive services, as prescribed by a health care provider, while respecting certain closely held for-profit entities' religion-based objections to contraceptive coverage. These proposed rules also seek comments on any additional steps the government should take to help ensure coverage of the full range of FDA-approved contraceptives, as prescribed by a health care provider, without cost sharing, for participants and beneficiaries in group health plans of such entities (and enrollees and dependents in student health insurance coverage arranged by such entities that are institutions of higher education).

HRSA is requesting nominations to fill three vacancies on the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). The action is to provide correction listed under addresses to provide more time for public input.

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 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 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 Indian Health Service published a document in the Federal Register on August 6, 2014 for the FY 2014 National Indian Health Outreach and Education IIMethamphetamine Suicide Prevention Intervention/Domestic Violence Prevention Initiative Program Announcement and Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome. The notice contained incorrect dates.

The Food and Drug Administration (FDA) has determined that SULAR (nisoldipine) extended-release tablets, 10 milligrams (mg), 20 mg, 25.5 mg, 30 mg, and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to approve ANDAs for nisoldipine extended-release tablets, 10 mg, 20 mg, 25.5 mg, 30 mg, and 40 mg, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is classifying hemoglobin A1c test system into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the hemoglobin A1c test system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

The Food and Drug Administration (FDA) is announcing the renewal of certain FDA advisory committees by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the charters of the committees listed in the following table for an additional 2 years beyond charter expiration date. The new charters will be in effect until the dates of expiration listed in the following table.

The Food and Drug Administration (FDA) has determined that FUSILEV (levoleucovorin calcium), Injection, 175 milligrams (mg)/17.5 milliliters (mL) and 250 mg/25 mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for levoleucovorin calcium, injection, 175 mg/17.5 mL and 250 mg/25 mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Evaluation of Sex-Specific Data in Medical Device Clinical Studies.'' This document provides guidance on the study and evaluation of sex-specific data in medical device clinical studies, and it outlines the Center for Devices and Radiological Health's (CDRH's) and Center for Biologics Evaluation and Research's (CBER's) expectations regarding sex-specific patient enrollment, data analysis, and reporting of device study information. The guidance is intended to improve the quality and consistency of available data regarding the performance of medical devices in both sexes by encouraging appropriate enrollment by sex in clinical studies of devices, and appropriate interpretation and assessment if data from such studies are analyzed by sex. Evaluation of sex-specific data in medical device clinical studies can benefit patients, their medical providers, clinical researchers, and others.

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by removing the general safety test (GST) requirements for biological products. FDA is proposing this action because the existing codified GST regulations are duplicative of requirements that are also specified in biologics licenses, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to an Executive order.

This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care Inc., (ACHC) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act (the Act) requires that within 60 days of receipt of an organization's complete application, CMS publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This final rule will update the hospice payment rates and the wage index for fiscal year (FY) 2015 and continue the phase-out of the wage index budget neutrality adjustment factor (BNAF). This rule provides an update on hospice payment reform analyses, potential definitions of ``terminal illness'' and ``related conditions,'' and information on potential processes and appeals for Part D payment for drugs while beneficiaries are under a hospice election. This rule will specify timeframes for filing the notice of election and the notice of termination/revocation; add the attending physician to the hospice election form, and require hospices to document changes to the attending physician; require hospices to complete their hospice aggregate cap determinations within 5 months after the cap year ends, and remit any overpayments; and update the hospice quality reporting program. In addition, this rule will provide guidance on determining hospice eligibility; information on the delay in the implementation of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM); and will further clarify how hospices are to report diagnoses on hospice claims. Finally, the rule will make a technical regulations text change.

As stipulated by the Federal Advisory Committee Act (FACA), the U.S. Department of Health and Human Services (HHS), in collaboration with the U.S. Department of Agriculture (USDA), is hereby giving notice that a meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC) will be held and will be open to the public.

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 May 13, 2014, page 27318, and allowed 60 days for public comment. The NIH received two requests to view the form and one comment expressing the opinion that chimpanzee research should be discontinued but did not receive any public comments on the form itself. The purpose of this notice is to allow an additional 30 days for public comment. The NIH Office of the Director (OD), Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), 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 1, 1995, 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 OMB Office of Regulatory Affairs at OIRA_ submission@omb.eop.gov; or by fax to 202-395-6974, Attention: NIH Desk Officer.

The Administration for Community Living (ACL) 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 requirements relating to the Help America Vote Act (HAVA), Public Law 107-252, Title II, Subtitle D, Part 2, Sections 261 to 265 (HAVA Narrative Annual Report).

The Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) intends to provide a Single Source Cooperative Agreement Award to the National Academy of Science to establish a rapid and agile process for convening subject matter experts to address adverse health effects of public health emergencies and disasters when they occur. The goal of the process will be to prioritize scientific research needs in the immediate aftermath of a disaster that culminates in a summary report of the strategic science research questions most relevant to promote better response, recovery or enhanced resilience in the affect community. Research results would also inform response to the next disaster event. Subject matter expertise would vary, depending on the nature of the emergency/disaster. This could include experts with background in public health, epidemiology, environmental health, emergency management, first response, emergency medicine, infectious diseases, nursing, emergency management, bioethics, medical countermeasures, state and local government, operations research national civic organizations, and risk communication. The process convened by the Institute of Medicine (IOM) would also provide a connection to the local communities affected by the disaster, and include important stakeholders, such as non-government funders or other organizations. This cooperative Agreement will support ASPR's Government Performance and Results Act goals that ``HHS will work with its Federal, state, local, tribal, and international partners to build community resilience and strengthen health and emergency response systems. Robust systems are essential to a secure and resilient. Nation with required capabilities to prevent, protect against, mitigate, respond to, and recover from the threats and hazards that pose the greatest risk. This includes strengthening the Federal medical and public health response capability''. Scientific research involved with preparedness and response is a key component of this endeavor.

The Food and Drug Administration (FDA) has determined that LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 milligrams (mg)/vial and 7.5 mg/vial; and LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for leuprolide acetate for depot suspension, injectable 3.75 mg/vial and 7.5 mg/vial; and injectable 7.5 mg/vial and 7.5 mg/vial, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for leuprolide acetate for depot suspension, future applicants are advised that they may not be able to obtain LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/ vial and 7.5 mg/vial, for bioequivalence testing because the product has not been commercially available for a number of years. An ANDA applicant who is unable to obtain LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and the same therapeutic effect.

The Indian Health Service published a document in the Federal Register on July 29, 2014, for the FY 2014 Office of Tribal Self- Governance Program, Planning Cooperative Agreement Announcement. The notice contained an incorrect date.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 2014. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA) is announcing a public hearing to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA), and the GDUFA Commitment Letter that accompanies the legislation. The public hearing also will provide an opportunity for public input on future policy priorities. FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, regulated industry, consumers, patients, caregivers, health care professionals, and patient groups.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.'' This guidance document was developed to promote the initiation of clinical investigations to evaluate medical devices under FDA's IDE regulations. The guidance is intended to provide clarification regarding the regulatory implications of the decisions that FDA may render based on review of an IDE and to provide a general explanation of the reasons for those decisions.

The Department of Health and Human Services (HHS) is issuing a final rule to amend its Federal Acquisition Regulation (FAR) Supplementthe HHS Acquisition Regulation (HHSAR)to add two clauses, Patent RightsExceptional Circumstances and, Rights in Data Exceptional Circumstances, and their prescriptions.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Nuclear Metals Inc. facility in West Concord, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Clinical Pharmacology Labeling for Human Prescription Drug and Biological ProductsConsiderations, Content, and Format.'' This draft guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and format of labeling for human prescription drug and biological products. The guidance describes the recommended information to include in the Clinical Pharmacology section of labeling that pertains to the safe and effective use of human prescription drug and biological products. This revised draft guidance replaces the 2009 draft guidance for industry entitled ``Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.''

The Food and Drug Administration (FDA) is announcing a public workshop regarding the clinical development of drugs for the prevention of serious infections caused by Staphylococcus aureus in the health care setting. This public workshop is intended to provide information for and gain perspective from health care providers, patients and patient advocacy organizations, academia, and industry on various aspects of clinical development of drugs to prevent Staphylococcus aureus infections including the design of clinical trials. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on September 5, 2014, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at the DoubleTree by Hilton Hotel Washington DC, 8727 Colesville Rd., Silver Spring, MD 20910. The hotel's phone number is 301-589-5200. Contact Persons: Carole Miller or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6217, Silver Spring, MD 20993-0002, 301- 796-1300. Registration: Registration is free for the public workshop. Interested parties are encouraged to register early. Seating is limited and will be available on a first-come, first-served basis. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) to FDASTAPHWORKSHOP@fda.hhs.gov. Onsite registration the day of the workshop will be available, but advanced registration is preferred. Persons without access to the Internet can call 301-796-1300 to register. If you need a sign language interpreter or other special accommodations, please notify Carole Miller or Lori Benner (see Contact Persons) at least 7 days in advance.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``De Novo Classification Process (Evaluation of Automatic Class III Designation).'' The purpose of this document is to provide FDA's proposals for guidance to FDA staff and industry on the process for the submission and review of petitions submitted under the Evaluation of Automatic Class III Designation section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the de novo classification process. FDA is issuing this draft guidance to provide proposed updated recommendations for efficient interaction with FDA, including what information to submit when seeking a path to market for a novel device via the de novo process. This draft guidance has been revised and is being reissued for comment because the Food and Drug Administration Safety and Innovation Act (FDASIA), which became law on July 9, 2012, amended the FD&C Act to provide for the submission of de novos without a preceding premarket notification (510(k)) submission. This draft guidance is not final nor is it in effect at this time.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill three vacancies on the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT).

This notice extends the comment period for a 60-day notice request for proposed information collection request associated with the notice [Document Identifier: CMS- 10305] entitled ``Medicare Part C and Part D Data Validation'' that was published in the June 13, 2014 (79 FR 33927) Federal Register. The comment period for the information collection request, which would have ended on August 12, 2014, is extended to August 26, 2014.

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. 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 invites comments on the information collection provisions of the labeling requirements for major food allergens in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the information collection provisions of the draft guidance entitled, ``Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications.''