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

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Document Number: 2014-20635
Type: Notice
Date: 2014-08-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Electronic Submission of Lot Distribution Reports'' dated August 2014. The draft guidance document provides information and recommendations pertaining to the electronic submission of lot distribution reports for applicants with approved biologics license applications (BLAs). FDA recently published in the Federal Register a final rule requiring that, among other things, lot distribution reports be submitted to FDA in an electronic format that the Agency can process, review, and archive. The draft guidance, when finalized, is intended to help licensed manufacturers of products distributed under approved BLAs (henceforth referred to as applicants) comply with the final rule.
Document Number: 2014-20634
Type: Notice
Date: 2014-08-29
Agency: Food and Drug Administration, Department of Health and Human Services
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and Drug Administration (FDA or we) has determined that JADELLE (levonorgestrel) implant, 75 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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.
Document Number: 2014-20620
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on September 29, 2014. The topic for this meeting will be ``Implementing the Department of Health and Human Services National Action Plan for Hypoglycemic Safety.'' The meeting is open to the public.
Document Number: 2014-20616
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, Administration for Children and Families
Administration for Children and Families (ACF) is announcing its evaluation policy for research or demonstration projects as authorized by 42 U.S.C. 1310.
Document Number: 2014-20599
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, Health Resources and Service Administration
Document Number: 2014-20598
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, Health Resources and Service Administration
Document Number: 2014-20594
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-20590
Type: Notice
Date: 2014-08-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Document Number: 2014-20589
Type: Notice
Date: 2014-08-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Document Number: 2014-20577
Type: Notice
Date: 2014-08-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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).
Document Number: 2014-20553
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20552
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20551
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20548
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
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.
Document Number: 2014-20547
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20546
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services
Document Number: 2014-20545
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20544
Type: Notice
Date: 2014-08-29
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20425
Type: Notice
Date: 2014-08-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Health Information Exchange, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
Document Number: 2014-20424
Type: Notice
Date: 2014-08-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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.
Document Number: 2014-20423
Type: Notice
Date: 2014-08-29
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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 changes to the currently approved information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
Document Number: 2014-20528
Type: Notice
Date: 2014-08-28
Agency: Department of Health and Human Services, National Institutes of Health
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.
Document Number: 2014-20489
Type: Notice
Date: 2014-08-28
Agency: Department of Health and Human Services, National Institutes of Health
In accordance with the National Environmental Policy Act, 42 U.S.C. 4321-4347, the National Institutes of Health (NIH) is issuing this notice to advise the public that an environmental impact statement will be prepared for the Assure/Expand Chilled Water Capacity project located on the National Institutes of Health, Bethesda Campus, Bethesda, Maryland.
Document Number: 2014-20483
Type: Notice
Date: 2014-08-28
Agency: Food and Drug Administration, Department of Health and Human Services
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.''
Document Number: 2014-20482
Type: Notice
Date: 2014-08-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI 225) entitled ``Draft Guidance for Industry, Electronic Exchange of Documents: File Format Recommendations'' (VICH GL53). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance is intended to provide recommendations to industry on electronic file format specifications for individual documents and collections of multiple related documents that need no subsequent editing and are utilized for electronic exchange between industry and regulators in the context of regulatory approval of veterinary medicinal products.
Document Number: 2014-20481
Type: Notice
Date: 2014-08-28
Agency: Food and Drug Administration, Department of Health and Human Services
Document Number: 2014-20477
Type: Notice
Date: 2014-08-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Document Number: 2014-20428
Type: Notice
Date: 2014-08-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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.
Document Number: 2014-20421
Type: Notice
Date: 2014-08-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Generic Clearance for Questionnaire and Data Collection Testing, Evaluation, and Research 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. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment.
Document Number: 2014-20420
Type: Notice
Date: 2014-08-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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.
Document Number: 2014-20385
Type: Notice
Date: 2014-08-28
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) announces the final Genomic Data Sharing (GDS) Policy that promotes sharing, for research purposes, of large-scale human and non-human genomic \1\ data generated from NIH-funded research. A summary of public comments on the draft GDS Policy and the NIH responses are also provided.
Document Number: 2014-19793
Type: Notice
Date: 2014-08-28
Agency: Department of Health and Human Services
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.
Document Number: 2014-20446
Type: Notice
Date: 2014-08-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to renew the Medicare Advantage ``deeming authority'' of the National Committee for Quality Assurance (NCQA) for a period of 6 years. This new term of approval would begin October 19, 2014 and end October 18, 2020.
Document Number: 2014-20394
Type: Notice
Date: 2014-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Document Number: 2014-20393
Type: Notice
Date: 2014-08-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The meeting of the Interagency Task Force on Antimicrobial Resistance (ITFAR) is cancelled. The purpose of the meeting was to communicate the strategic direction of ITFAR in the fight against antimicrobial resistance, centering on current work and future direction in this area. This meeting will be rescheduled at a future date.
Document Number: 2014-20389
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
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.
Document Number: 2014-20370
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award a single-source cooperative agreement in the amount of $220,000 to the National Association of State Units on Aging and Disability (NASUAD) to support and stimulate the expansion of work already under way by NASUAD to create a valid and reliable National Core Indicator (NCI) Survey for older adults and people with physical disabilities.
Document Number: 2014-20360
Type: Notice
Date: 2014-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Document Number: 2014-20359
Type: Notice
Date: 2014-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development.'' The guidance document provides information regarding the process by which human generic drug manufacturers and related industry can submit correspondence to FDA requesting information on generic drug development. This guidance also describes FDA's process for providing communications related to such correspondence.
Document Number: 2014-20357
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20356
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20355
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, National Institutes of Health
Document Number: 2014-20352
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-20351
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-20350
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-20332
Type: Notice
Date: 2014-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Document Number: 2014-20331
Type: Notice
Date: 2014-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled ``Outsourcing Facility Fee Rates for Fiscal Year 2015'' that appeared in the Federal Register of August 1, 2014 (79 FR 44805). The document announced the rates for fiscal year 2015 for the establishment and reinspection fees related to human drug compounding outsourcing facilities that elect to register under the Federal Food, Drug, and Cosmetic Act. The document was published with the incorrect docket number. This document corrects that error.
Document Number: 2014-20326
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
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.
Document Number: 2014-20314
Type: Notice
Date: 2014-08-27
Agency: Department of Health and Human Services, Administration for Children and Families
Document Number: 2014-20291
Type: Notice
Date: 2014-08-27
Agency: Food and Drug Administration, Department of Health and Human Services
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.