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

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Mental Health (NIMH), the National Institutes of Health, 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 24, 2013, Volume 78, Number 101, Pages 31568-31569 and allowed 60-days for public comment. One public comment was received; in this comment, a request was made for access to any data that is collected on autism projects that are funded. This comment was considered, but it did not result in alteration to the data collection or data management process because steps are already in place to make the data publicly accessible via an online Web Tool on the IACC Web site. No comments that specifically addressed cost and hour burden were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 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, OIRA_submission@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.

This notice updates the process we use for opening, deciding or reconsidering national coverage determinations (NCDs) under the Social Security Act (the Act). It addresses external requests and internal reviews for new NCDs or for reconsideration of existing NCDs. The notice further outlines an expedited administrative process to remove certain NCDs, thereby enabling local Medicare contractors to determine coverage under the Act. This notice does not alter or amend our regulations that establish rules related to the administrative review of NCDs.

On June 26, 2013, the Department of Health and Human Services (HHS) published in the Federal Register an announcement of a public meeting to be held on August 28, 2013, to discuss how certain provisions of the HHS protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context (78 FR 38343). In the June 26, 2013 meeting announcement, HHS stated that presenters will be scheduled to speak at the public meeting in the order in which they register. Notice is hereby provided that HHS may group presenters according to the topic of their presentation.

The Food and Drug Administration (FDA) is announcing an initiative in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010 to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized with only minor changes. Guidances that are no longer up to date, and for which more current information is available, will be withdrawn. Guidances that reflect CDER's current thinking, CDER will decide whether to revise or finalize. This notice describes CDER's initiative, announces the first group of guidances to be withdrawn, describes in general terms draft guidances under consideration for revision or finalization, and explains how CDER is making this process as transparent as possible.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Minimizing Risk for Children's Toy Laser Products.'' This draft guidance is to inform manufacturers of laser products, FDA headquarters and field personnel, and the public of the Center for Devices and Radiological Health's (CDRH) proposed approach on the safety of toy laser products. This draft guidance is not final nor is it in effect at this time.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice establishes a CMP that CMS plans to conduct with the Department of Defense (DoD).

The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for OXYCONTIN (oxycodone hydrochloride) Extended-Release Tablets, held by Purdue Pharma L.P. (Purdue), One Stamford Forum, Stamford, CT 06901-3431. Purdue has voluntarily requested that approval of this application (NDA 20-553) be withdrawn and has waived its opportunity for a hearing.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 031'' (Recognition List Number: 031), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

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 must publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and allow 60 days for public comment. This notice invites comments on the information collection provisions of our regulations requiring reporting and recordkeeping for processors and importers of fish and fishery products.

This final rule updates the payment rates used under the prospective payment system for skilled nursing facilities (SNFs) for fiscal year (FY) 2014. In addition, it revises and rebases the SNF market basket, revises and updates the labor related share, and makes certain technical and conforming revisions in the regulations text. This final rule also includes a policy for reporting the SNF market basket forecast error in certain limited circumstances and adds a new item to the Minimum Data Set (MDS), Version 3.0 for reporting the number of distinct therapy days. Finally, this final rule adopts a change to the diagnosis code used to determine which residents will receive the AIDS add-on payment, effective for services provided on or after the October 1, 2014 implementation date for conversion to ICD-10- CM.

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 collections projects, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the 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 to address 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) The quality, utility, and clarity of the information to be collected; and (4) 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 Joanne M. Gallivan, MS, RD, Director, National Diabetes Education Program, OCPL, NIDDK, 31 Center Drive, Room 9A06, Bethesda, MD, 20892 or call non toll-free number 301-496-6110 or Email your request including your address to joanne_gallivan@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: Community Evaluation of the National Diabetes Education Program's Diabetes HealthSense Web site. 0925-NEW, National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), National Institutes of Health (NIH). Need and Use of Information Collection: The National Diabetes Education Program (NDEP) is a partnership of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and more than 200 public and private organizations. The long-term goal of the NDEP is to reduce the burden of diabetes and pre-diabetes in the United States, and its territories, by facilitating the adoption of proven strategies to prevent or delay the onset of diabetes and its complications. The NDEP objectives are to: (1) Increase awareness and knowledge of the seriousness of diabetes, its risk factors, and effective strategies for preventing type 2 diabetes and complications associated with diabetes; (2) Increase the number of people who live well with diabetes and effectively manage their disease to prevent or delay complications and improve quality of life; (3) Decrease the number of Americans with undiagnosed diabetes; (4) Among people at risk for type 2 diabetes, increase the number who make and sustain effective lifestyle changes to prevent diabetes; (5) Facilitate efforts to improve diabetes-related health care and education, as well as systems for delivering care; (6) Reduce health disparities in populations disproportionately burdened by diabetes; and (7) Facilitate the incorporation of evidence-based research findings into health care practices. One product that NDEP has developed to address many of these objectives is Diabetes HealthSense, an online compendium of psychosocial and behavioral resources to support lifestyle changes. This study will be a multi-component 3-year evaluation of Diabetes HealthSense. The required forms will support the following evaluation tasks: (1) Assessing community educators' experience and satisfaction with NDEP resources such as the Diabetes HealthSense Web site; (2) Assess the extent to which, through participation in Diabetes HealthSense educational sessions, community educators can increase their knowledge and ability to promote and use NDEP resources; and (3) Assess the extent to which the Web site, with guided exploration, can facilitate changes in lifestyle to help prevent or manage diabetes. The data collected from this evaluation will provide NDEP with information about how community educators use NDEP-created resources in their communities and whether the Diabetes HealthSense resource has its intended effect on participants. Such data will help inform NDEP's future decisions about the Diabetes HealthSense Web site, including whether to make changes to Diabetes HealthSense, and whether to invest additional resources to support, promote or expand this resource. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 328.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain information from the public on preventing skin cancer through the reduction of UV exposure. The information obtained will be used for an anticipated Office of the Surgeon General response to the public health problem of skin cancer.

These correcting amendments update a cross reference cited in the Privacy Act regulations. The National Practitioner Data Bank (NPDB) system of records (09-15-0054) is exempt from certain provisions of the Privacy Act, and the cross reference cited refers to the regulations that govern the NPDB. As a result of Section 6403 of the Affordable Care Act, the regulations governing the NPDB were revised and certain section numbers in the NPDB regulations were changed, including the NPDB regulation that was cross referenced. This change is technical in nature and does not significantly alter the current NPDB exemption.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device User Fee Cover Sheet, Form FDA 3601'' 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 reopening the comment period for the notice of public meeting entitled ``Human Immunodeficiency Virus (HIV) Patient-Focused Drug Development and HIV Cure Research,'' published in the Federal Register of May 21, 2013 (78 FR 29755). In that notice, FDA requested public comment regarding patients' perspective on current approaches to managing HIV, symptoms experienced because of HIV or its treatment, and issues related to HIV cure research. FDA is reopening the comment period to allow interested persons additional time to submit comments.

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov.

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012, which was signed by the President on July 9, 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA V, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This document establishes fee rates for FY 2014 for application fees for an application requiring clinical data ($2,169,100), for an application not requiring clinical data or a supplement requiring clinical data ($1,084,550), for establishment fees ($554,600), and for product fees ($104,060). These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014. For applications and supplements that are submitted on or after October 1, 2013, the new fee schedule must be used. Invoices for establishment and product fees for FY 2014 will be issued in August 2013 using the new fee schedule.

The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2014 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2013, and will remain in effect through September 30, 2014.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2014 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013, which was signed by the President on June 13, 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2014.

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 concerning establishment notification of a consignee and consignee notification of a recipient's physician of record regarding a possible increased risk of Trypanosoma cruzi (T. cruzi) infection.

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

HHS is soliciting nominations for six non-Federal members of the Advisory Council on Alzheimer's Research, Care, and Services. The six positions are for each of the following categories, as specified in the National Alzheimer's Project Act: Alzheimer's patient advocate, Alzheimer's caregiver, health care provider, representative of state health department, researcher with Alzheimer's-related expertise, and voluntary health association representative. Nominations should include the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume.

The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code 300aa-5 (PDF-78 KB)). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The ASH charged the NVAC with reviewing the role of HHS in global vaccination, the effects of global vaccination on global populations, the effects of global vaccination on U.S. populations, and recommending how HHS can best continue to contribute, consistent with its newly established Global Health Strategy and Goal 5 of the National Vaccine Plan. The NVAC was also asked to make recommendations on how to best communicate this information to decision makers and the general public to ensure continued sufficient resources for the global vaccination efforts. The NVAC established the Global Immunizations Working Group to assist in addressing these charges. A draft report and draft recommendations have been developed by the working group for consideration by the NVAC and will be deliberated on by the NVAC when developing NVAC's final recommendations to the ASH. The National Vaccine Program Office (NVPO) is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public, for consideration by the NVAC as they develop their final recommendations to the ASH. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for adoption in September 2013 at the quarterly NVAC meeting.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for revision of a previously-approved information collection assigned OMB control number 0937-0025, which expired on 08/31/2013. 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.

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 a start-up exclusive license to practice the inventions embodied in: US provisional Applications 61/639,688 (E-294-2011/0-US-01) filed April 27, 2012 and PCT application PCT/US2013034639 (E-294-2011/0-PCT-02) filed March 29, 2013, each entitled ``Topical Antibiotic with Immune Stimulating oligodeoxynucleotide Molecules to Speed Wound Healing'' and US application 12/205,756 (E-328-2001/1-US-01) filed September 2008 and issued as US patent 8,466,116, each entitled ``Use of CpG Oligodeoxynucleotides to Induce Epithelial Cell Growth'' to Tollgene having a place of business at 2429 Ginny Way, Lafayette, CO 80026. The patent rights in these inventions have been assigned to the United States of America.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Environmental Impact Considerations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Health Resources and Services Administration's (HRSA) Office of Women's Health, located within the Department of Health and Human Services (HHS), and in collaboration with the HHS Office on Women's Health, announces the launch of the Care Counts: Educating Women and Families Challenge. Women are often at the center of healthy and resilient families; they make approximately 80 percent of all family health care decisions and are more likely to be the primary caregivers for children and elderly parents. To help make women aware of the important benefits available to them and their families through the Affordable Care Act, HHS is initiating this Challenge. The Affordable Care Act is already making a difference in the lives of millions of Americans. Starting October 1, 2013, millions of uninsured Americans will be able to find affordable health insurance that meets their needs at the new Health Insurance Marketplace (Marketplace). The Marketplace is a one stop shop where people can learn about health insurance, get accurate information on different plans, and make apples-to-apples comparisons of private insurance plans. For the first time, comprehensive information about benefits and quality, side-by-side with facts about price, will help each consumer make the best coverage decision. For more information about how the Marketplace will work, including important deadlines and milestones, visit HealthCare.gov (English) or CuidadoDeSalud.gov (Spanish). This Challenge will allow teams (the ``Contestants'') to create innovative, educational tools (``Tools'') to inform women consumers, particularly women living in medically underserved communities, about enrollment in new health plans, as well as key provisions of the Affordable Care Act to improve their own health and that of their families. For purposes of this Challenge, the key provision of the Affordable Care Act is coverage of 22 preventive services for women without copayment. See https://www.healthcare.gov/what-are-my-preventive-care- benefits#part=2. The Tool must refer to two or more of the 22 covered preventive services for women. The Tool must also direct consumers to HealthCare.gov (English) or CuidadoDeSalud.gov (Spanish), and the toll- free Centers for Medicare and Medicaid (CMS) call centers (1-800-318- 2596) (English and Spanish) to promote enrollment in the Marketplace. The Tool must also include the TTY/TTD call center number (1-888-871- 6594). The Tool may be designed to be used within systems of health care. For purposes of this Challenge, a system of health care is defined as the organization of people, institutions, and resources to deliver comprehensive culturally competent, quality, services to meet the health needs of the target audience. Examples include HRSA's Community Health Centers, Healthy Start programs, Ryan White Care service sites, National Health Service Corps sites, and HHS-supported Title X service sites. The Tool may also be designed to be used in community-based settings where women live, work, and purchase goods and services, such as schools, faith-based settings, recreation centers, and shopping centers. ``Tools'' are defined as print, web, or other social media (including Facebook, Twitter, Google+, Apps, and/or other innovative resources) used to educate the target audience to improve knowledge and abilities leading to action. The target audience for the Tools is adult women in the United States and its territories, particularly women living in medically underserved communities or who experience difficulty accessing health care. The Tools shall focus on communicating complex information in understandable, culturally competent, and relevant ways. Reading level, common language, and health literacy of the target audiences should be considered in development of the Tools. Contestants must also submit a Promotion/Outreach Plan for the tools. The Promotion/Outreach Plan shall: (1) Be no more than two pages in length; (2) demonstrate the Contestants' understanding of the target audience; and (3) demonstrate how they will use the Tools to reach the target audience.

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: ``Evaluation of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) Quality Demonstration Grant Program: Qualitative Data Collection.'' 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 Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research in cosponsorship with the American Association for the Study of Liver Diseases (AASLD) is announcing a 2-day public workshop entitled ``Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic fatty liver disease (NAFLD).'' There are no approved treatments for NAFLD and its complications of nonalcoholic steatohepatitis (NASH) and liver fibrosis and cirrhosis. This workshop will provide a forum to discuss trial design, including endpoints for clinical trials in NAFLD, to promote efficient drug development in this area and thus improved treatments for patients. Date and Time: The public workshop will be held on September 5 and 6, 2013, from 8 a.m. to 5 p.m. Location: The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, in the Great Room (room 1503), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation / ucm241740.htm. Contact Person: Anissa Davis, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5016, FAX: 301-796-9904, email: Anissa.Davis@fda.hhs.gov. Registration: There is no fee to attend the public workshop, but attendees must register online at https://www.aasld.org/ additionalmeetings/Pages/aasldfdanash.aspx before September 1, 2013. (FDA has verified this Web site address but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Space is limited, and registration will be on a first-come, first-served basis. Those without Internet access should contact Anissa Davis (see Contact Person) to register. Onsite registration will not be available. If you need special accommodations due to a disability, please contact Anissa Davis (see Contact Person) at least 7 days in advance. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate below, or any other aspect of the ICR.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Safety Labeling ChangesImplementation of Section 505(o)(4) of the FD&C Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA to require certain drug and biological product application holders to make safety-related labeling changes based upon new safety information that becomes available after the drug or biological product is approved under the FD&C Act or the Public Health Service Act (the PHS Act). This final guidance provides information on the implementation of section 505(o)(4) of the FD&C Act, including a description of the types of safety labeling changes that ordinarily might be required under this section; how FDA plans to determine what constitutes new safety information; the procedures involved in requiring safety labeling changes; and enforcement of the requirements for safety labeling changes.

NIDCR is developing a new strategic plan to guide the Institute's research efforts and priorities over the next six years (2014-2019). The purpose of this time-sensitive Request for Information (RFI) is to seek input from a broad range of stakeholders about prospective activities, areas of research emphasis, future research approaches, needs, and opportunities.

The Food and Drug Administration (FDA) is proposing to adopt regulations on foreign supplier verification programs (FSVPs) for importers of food for humans and animals. The proposed regulations would require importers to help ensure that food imported into the United States is produced in compliance with processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under the hazard analysis and risk-based preventive controls and standards for produce safety sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. We are proposing these regulations in accordance with the FDA Food Safety Modernization Act (FSMA). The proposed regulations would help ensure that imported food is produced in a manner consistent with U.S. standards.

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.

This notice sets forth the final allotments of federal funding available to each State, the District of Columbia, and each U.S. Territory and Commonwealth for fiscal year 2013. Title XXI of the Social Security Act (the Act) authorizes payment of federal matching funds to States, the District of Columbia, and the U.S. Territories and Commonwealths to initiate and expand health insurance coverage to uninsured, low-income children under the Children's Health Insurance Program (CHIP). The fiscal year allotments contained in this notice were determined in accordance with the funding provisions and final regulations published in the February 17, 2011 Federal Register (76 FR 9233).

This notice sets forth the States' final allotments available to pay the Medicare Part B premiums for Qualifying Individuals (QIs) for the Federal fiscal year (FY) 2012 and the preliminary QI allotments for FY 2013. The amounts of these QI allotments were determined in accordance with the methodology set forth in regulations and reflect funding for the QI program made available under recent legislation.

This notice announces a meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/32822.

The Food and Drug Administration (FDA) is proposing to amend its regulations regarding the prohibition on the sale, or other commercial or public distribution, of viable turtle eggs and live turtles with a carapace length of less than 4 inches to remove procedures for destruction as FDA believes it is not necessary to routinely demand this destruction to achieve the purpose of the regulations. This action would reduce the need for investigator training and the time for the care and humane destruction of these animals.

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 Secretary has made findings as to intussusceptions that can reasonably be determined in some circumstances to be caused or significantly aggravated by rotavirus vaccines. Based on these findings, the Secretary proposes to amend the Vaccine Injury Table (Table) by regulation. These proposed regulations will apply only for petitions for compensation under the National Vaccine Injury Compensation Program (VICP) filed after the final regulations become effective. The Secretary is seeking public comment on the proposed revisions to the Table.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pre-Launch Activities Importation Requests (PLAIR).'' This draft guidance describes FDA's policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for market launch based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA). This draft guidance also applies to biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research. This draft guidance further describes the procedures for making these requests and the criteria that FDA will consider in granting such requests.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access)'' (the draft guidance). The document provides guidance to egg producers on certain provisions contained in FDA's final rule entitled, ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' concerning the management of production systems that provide laying hens with access to the outdoors. Laying hens are provided outdoor access in some production systems, including certified organic production systems governed by the U.S. Department of Agriculture's National Organic Program regulations.

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 Institute of General Medical Sciences (NIGMS), the 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) Evaluate 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) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing or request more information on the proposed project, contact Ms. Tammy Dean-Maxwell, NIGMS, NIH, Natcher Building, Room 3AN.44, 45 Center Drive, MSC 6200, Bethesda, MD 20892-6200, or call non-toll-free number 301-594-2755 or email your request, including your address to: deanmat@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comments 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: Application for the Postdoctoral Research Associate Program, (NIGMS) Extension of a currently approved collection, OMB No. 0925-0378, expiration date September 30, 2013. Form Numbers: NIH 2721-1, NIH 2721-2. Need and Use of Information Collection: The Postdoctoral Research Associate (PRAT) Program will use the applicant and referee information to award opportunities for training and experience in laboratory or clinical investigation to individuals with an appropriate terminal degree who are seeking training in an NIGMS designated emerging area of science, through appointments as PRAT Fellows at the National Institutes of Health or the Food and Drug Administration. The goal of the program is to develop leaders in designated emerging areas of biomedical research for key positions in academic, industrial, and Federal research laboratories. Frequency of Response: Once a year. Affected Public: Individuals or households; businesses or other for- profit. Type of Respondents: Applicants and referees. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 331.

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 to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 7, 2013, Vol. 78, p. 26639 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 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, OIRA_submission@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.

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 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 standardized format and content requirements for the labeling of over-the-counter (OTC) drug products.

The Regulatory Flexibility Act of 1980 and Executive Order 12866 require the Department semiannually to issue an inventory of rulemaking actions under development to provide the public a summary of forthcoming regulatory actions. This information will help the public more effectively participate in the Department's regulatory activity, and the Department welcomes comments on any aspect of this agenda.

This document corrects technical, typographical, and cross- referencing errors in the final rule that appeared in the May 23, 2013 Federal Register titled ``Medicare Program; Medical Loss Ratio Requirements for the Medicare Advantage and the Medicare Prescription Drug Benefit Programs.''

The Food and Drug Administration (FDA) is announcing the withdrawal of the compliance policy guide (CPG) entitled ``Sec. 253.100Use of Units of Plasma and Fresh Frozen Plasma Which Have Been Thawed,'' issued October 1, 1980, and revised in March 1995.

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 Kidney Disease Education Program, the National Institute of Diabetes and Digestive and Kidney Diseases, the 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 to address 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: Eileen Newman, Associate Director, National Kidney Disease Education Program, OCPL, NIDDK, NIH, Building 31, Room 9A06, 9000 Rockville Pike, Bethesda, MD 20892, or call non-toll-free number 301-435-8116 or Email your request, including your address to: Eileen.newman@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: Evaluation of a Kidney Disease Education Program with Promotores in the Hispanic Community, 0925-NEW, National Kidney Disease Education Program, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH). Need and Use of Information Collection: NKDEP is developing a kidney disease education program to raise awareness among the Hispanic community at risk for kidney disease. Since diabetes is the most common cause of kidney disease, the program is being developed for inclusion in existing diabetes programs being conducted by ``promotores de salud'' (Spanish/English-speaking community health workers). A pilot evaluation will assess: (a) Overall quality of the program from the client and promotor/a perspective, including strengths and weaknesses of the program and the training, and areas for program improvement; (b) effectiveness of the program on the clients (the community members being educated); and (c) effectiveness of materials and training, including promotores' ability to deliver education to the client and administer the client pre-test/post-test surveys. The pilot study will deliver strategic and actionable guidance for refining the educational and training materials for national dissemination. Based on outcomes from the pilot study, a national evaluation is planned that will use the client pre-test/post-test surveys to assess: (a) Knowledge gains about kidney disease, (b) awareness of NKDEP resources and importance of kidney health, (c) reported behavior change outcomes and (d) reported health status. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 101 (see table below).

The Kidney Interagency Coordinating Committee (KICC) will hold a meeting on September 27, 2013, about interagency collaboration to improve outcomes in Chronic Kidney Disease (CKD). The meeting is open to the public.

The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for narcolepsy. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of narcolepsy on daily life as well as the available therapies for narcolepsy.

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 (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: (1) E-120-2001/0, Whitehead et al., ``Development of Mutations Useful for Attenuating Dengue Viruses and Chimeric Dengue Viruses'', European Patent Application Number 02739358.6 (now European Patent Number 1402075, validated in Austria, Belgium, Switzerland/Liechtenstein, Germany, Denmark, Spain, Finland, France, the United Kingdom, Ireland, Italy, the Netherlands, Sweden and Turkey), filed May 22, 2002, United States Patent Application Number 10/719,547 (now U.S. Patent Number 7,226,602), filed November 21, 2003, Canadian Patent Application Number 2448329 (now Canadian Patent Number 2448329), filed May 22, 2002, Australian Patent Application Number 20022312011 (now Australian Patent Number 20022312011), filed May 22, 2002, Australian Patent Application Number 2008203275 (now Australian Patent Number 2008203275), filed May 22, 2002, Australian Patent Application Number 2012200637, filed May 22, 2002, United States Patent Application Number 11/446,050, filed June 2, 2006, now U.S. Patent Number 7,560,118, issued July 14, 2009, United States Patent Application Number 12/396,376 (now United States Patent Number 8,039,003), filed March 2, 2009, United States Patent Application Number 13/240,849, filed September 22, 2011, European Patent Application Number 10181776.5, filed May 22, 2002, European Patent Application Number 10181786.4, filed May 22, 2002, and European Patent Application Number 10181804.5, filed May 22, 2002 (2) E-089-2002/0,1, Whitehead et al., ``Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion in The 3'-UTR of Dengue Types 1,2,3, And 4, or Antigenic Chimeric Dengue Viruses 1,2,3, And 4'', United States Patent Application Number 10/970,640 (now United States Patent Number 7,517,531), filed October 21, 2004, Canadian Patent Application Number 2483653, filed April 25, 2003, European Patent Application Number 03724319.3 (now European Patent Number 1554301, validated in Austria, Belgium, Bulgaria, Switzerland/Liechtenstein, Estonia, Finland, France, the United Kingdom, Ireland, Iceland, Italy, Lithuania, Malta, the Netherlands, Poland, Portugal, Romania, Sweden, Slovenia, Slovakia, Turkey, Cyprus, Croatia, Czech Republic, Denmark, Germany, Greece, Hungary, Latvia, Luxembourg, and Monaco), filed April 25, 2003, Japanese Patent Application Number 2004-50077, filed April 25, 2003, Australian Patent Application 2003231185 (now Australian Patent Number 2003231185), filed April 25, 2003, United States Patent Application Number 12/398,043 (now United States Patent Number 8,075,903), filed March 4, 2009, United States Patent Application Number 13/305,639, filed November 28, 2011, European Patent Application Number 10177735.7, filed April 25, 2003, and European Patent Application Number 10177740.7, filed April 25, 2003, and (3) E-139-2006/0, Whitehead et al., ``Development of Dengue Vaccine Components'', Australian Patent Application 2007285929, filed August 15, 2007, Canadian Patent Application Number 2661296, filed August 15, 2007, Chinese Patent Application Number 200780031489.4, filed August 15, 2007, European Patent Application Number 07840969.5, filed August 15, 2007, United States Patent Application Number 12/376,756 (now U.S. Patent Number 8,337,860), filed February 6, 2009, and United States Patent Application Number 13/692,557, filed December 3, 2012 to Merck Sharp & Dohme Corp., having a place of business in Whitehouse Station, New Jersey, U.S.A. The patent rights in this invention have been assigned to the United States of America.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award a programmatic supplement of approximately $583,330 (total costs) for up to one year to the current grantee of the Suicide Prevention Resource Center program. The current grantee is Education Development Center, Inc., Waltham, Massachusetts. This is not a formal request for applications. Assistance will be provided only to the Education Development Center, Inc. based on receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SM-13-008. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243. Authority: Section 520A and 520C of the Public Health Service Act, as amended. Justification: The purpose of this 1-year supplement is to support implementation of the National Strategy for Suicide Prevention (NSSP) and to support the infrastructure of the National Action Alliance (Action Alliance) for Suicide Prevention, with the overall goal of reducing suicides and suicidal behaviors in the country. Funds will be used to support implementation of the Action Alliance high priority area, to transform health care systems to significantly reduce suicide and suicide attempts. This will also build on the momentum of the 2011 report released by the Action Alliance's Clinical Care and Intervention Task Force, Suicide Care in Systems Framework, including the informal ``zero suicide'' learning collaborative, which currently involves six states and health care systems. Funds will also be used to directly support the infrastructure of the Action Alliance such as funding staff support for key Alliance initiatives, including the Action Alliance Executive Committee and task forces, and for direct meeting expenses of the Executive Committee and select task forces. SAMHSA funds only one Suicide Prevention Resource Center, SAMHSA's primary vehicle for providing technical assistance to the field. Therefore, this program supplement will be awarded to the grantee that manages the SPRC, specifically to the Education Development Center, Inc., Waltham, Massachusetts. There are no other sources with the available resources and expertise to successfully complete the tasks of this proposal within the one-year grant period. Contact: Cathy Friedman, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Room 8-1097, Rockville, MD 20857; Telephone: (240) 276-2316; Email: cathy.friedman@samhsa.hhs.gov.

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2014 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Hospital Value-Based Purchasing (VBP) Program. We are proposing changes to the conditions for coverage (CfCs) for organ procurement organizations (OPOs); revisions to the Quality Improvement Organization (QIO) regulations; changes to the Medicare fee-for-service Electronic Health Record (EHR) Incentive Program; and changes relating to provider reimbursement determinations and appeals.

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.