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

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces fees for vessel sanitation inspections for Fiscal Year (FY) 2015. These inspections are conducted by HHS/CDC's Vessel Sanitation Program (VSP). VSP helps the cruise line industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly unannounced inspections and, when necessary, reinspection.

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: The necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and 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. 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 information collection request (ICR) currently approved under Office of Management and Budget (OMB) control number 0938-1187 to include account registration elements associated with submitting data through the Amazon Cloud EDGE Server or the On-Premise EDGE server. As a result of contractor changes and technical design changes to our distributed data collection (DDC) approach for implementing the risk adjustment and reinsurance programs, we must change the data elements that issuers will submit as part of the DDC information collection requirements. These modifications will permit us to register EDGE servers with the appropriate issuer accounts, permitting CMS to make risk adjustment and reinsurance payments to issuers.

This document corrects technical errors in the final rule that appeared in the August 19, 2013 Federal Register, entitled ``Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation; Payment Policies Related to Patient Status.''

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2015. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2015, which apply from October 1, 2014, through September 30, 2015. To avoid delay in the review of your application, you should pay the standard fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2015, you should not submit a FY 2015 Small Business Qualification and Certification request. This document provides information on how the fees for FY 2015 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

This notice announces an administrative hearing to be held on September 9, 2014, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid & Children's Health, Dallas Regional Office, 1301 Young Street, Room 801, 8th Floor Dallas, Texas 75202 to reconsider CMS' decision to disapprove Louisiana's Medicaid SPAs 13-23, 13-25 and 13-28. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by August 13, 2014.

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: ``Phase II of a Longitudinal Program Evaluation of Health and Human Services (HHS) Healthcare Associated Infections (HAI) National Action Plan (NAP).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 23rd 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.

The Food and Drug Administration (FDA or Agency) is establishing a public docket to discuss issues related to reserving proprietary names for drug products. During the negotiations for the 2007 reauthorization of the Prescription Drug User Fee Amendments Act (PDUFA IV), FDA agreed to several performance goals related to the review of drug and biological product proprietary names to reduce medication error. Among those goals, FDA and industry expressed an interest in exploring the possibility of ``reserving'' proprietary names for companies once the names have been tentatively accepted by the Agency. Accordingly, FDA is initiating a public process to discuss issues around reserving proprietary names.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Teri Brown, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W530, Rockville, MD 20850 or call non-toll-free number 240-276-5810 or Email your request, including your address to: brownte@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Progress Reports for Center for Global Health's Low and Mid-Income Countries (LMICs) Global Health Collaborations, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Center for Global Health's (CGH) Low and Mid-Income Countries (LMICs) Global Health Collaborations is proposing new program specific progress report guidelines. The CGH LMIC Global Health Collaborations are part of a pilot initiative and partnership, between the NCI CGH and the Office of Cancer Centers (OCC), to promote collaborations between the NCI designated Cancer Centers and foreign institutions from Low and Middle Income Countries (LMICs). This collaboration is designed to develop and implement mutually beneficial global cancer research programs by increasing the capability of these countries to participate and partner in cancer research. The proposed guidelines request information about award performance related to objectives, accomplishments, barriers and challenges, collaborators, and findings. The information is gathered six months into the award and 12 months after the award (upon expiry). This information is needed to monitor the performance of this special program within NCI, funded through three Request for Proposals (RFPs); the first was released April 18, 2013 and CGH expects to release another in 2014 and the final one in 2015. The respondents are the Principal Investigators of the awards. The information will be used to monitor individual award performance and the effectiveness of the program as a whole. Since these projects are funded through the contract mechanism, the PIs will not be required to submit interim and final progress reports like other National Institutes of Health grantees must. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 83.

This notice with comment period describes the general criteria we intend to use to evaluate the effectiveness and efficiency of Beneficiary and Family Centered Care (BFCC) Quality Improvement Organizations (QIOs) that will enter into contracts with CMS under the 11th Statement of Work (SOW) in May 2014 titled, ``Beneficiary and Family Centered Care (BFCC) Quality Improvement Organization (QIO) Contract'' (HHSM-500-2014-RFP-BFCC-QIO). This contract allows for a transition period from the incumbent QIOs to the successor QIOs. The activities for the BFCC-QIO SOW begin August 1, 2014. The evaluation of a BFCC-QIO's performance related to the SOW will be based on evaluation criteria specified for the tasks set forth in Attachment J-10 of the BFCC-QIOs' SOW contract.

A Plan developed by the State Council on Developmental Disabilities is required by federal statute. Each State Council on Developmental Disabilities must develop the plan, provide for public comments in the State, provide for approval by the State's Governor, and finally submit the plan on a five-year basis. On an annual basis, the Council must review the plan and make any amendments. The State Plan will be used (1) by any amendments. The State Plan will be used (2) by the Council as a planning document; (3) by the citizenry of the State as a mechanism for commenting on the plans of the Council; (4) by the Department as a stewardship tool, for ensuring compliance with the Developmental Disabilities Assistance and Bill of Rights Act of 2000, as one basis for providing technical assistance (e.g., during site visits), and as a support for management decision making.

The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its eighteenth meeting on August 20, 2014. At this meeting, the Commission will discuss the BRAIN Initiative and ongoing work in neuroscience.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Potential Tobacco Product Violations Reporting Form'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Annual Reporting for Custom Device Exemption'' 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 issuing a final order to reclassify implanted blood access devices, a preamendments class III device, into class II (special controls) based on new information and subject to premarket notification and to further clarify the identification.

The Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response (ASPR) Office of Policy and Planning (OPP), intends to provide a Single Source Cooperative Agreement Award to the Pasteur Foundation for project activities carried out by the Pasteur Institute to support global health security enhancements and International Health Regulations (IHR) (2005) implementation in select Sub-Saharan African and Southeast Asian countries. Specifically, ASPR, in close coordination with the HHS Centers for Disease Control and Prevention (CDC) and other U.S. Government (USG) stakeholders, will collaborate with the Pasteur Institute and select affiliate institutes within the Pasteur Institute International Network (IPIN) in Cameroon, Central African Republic, Ivory Coast, Madagascar, Senegal, and Cambodia to sustain and strengthen preparedness, detection, and communication capacities for pandemic influenza and other emerging and re-emerging infectious diseases in support of IHR (2005). Recognizing that the health security of the American people is intrinsically linked to the world's health security, and that international cooperation is critical to enhance global health security, this program is aligned with Article 44 of the IHR (2005), which directs State Parties to collaborate to detect, assess, and respond to events while developing, strengthening, and maintaining core public health surveillance and response capacities. The proposed cooperative agreement is also aligned with the Global Health Security Agenda that calls for action to accelerate progress toward a world safe and secure from infectious disease threats, and to promote global health security as an international security priority by preventing and reducing the likelihood of infectious diseases outbreaks, detecting threats early, and rapidly and effective responding to disease outbreaks that require multi-sectorial, international coordination and communication.\1\

The Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) intends to provide a Single Source Cooperative Agreement Award to the U.S.-Mexico Foundation for Science (Fundaci[oacute]n M[eacute]xico-Estados Unidos para la Ciencia [FUMEC]), who will be the awardee for project activities carried out by Mexico's Ministry of Health (MOH). This Cooperative Agreement will contribute to enhancing global health security and advancing the implementation and maintenance of International Health Regulations (IHR) (2005) core capacities in Mexico. Specifically, ASPR, in close coordination with the HHS Centers for Disease Control and Prevention (CDC) and other U.S. Government (USG) stakeholders, will collaborate with FUMEC and the Mexican MOH to sustain and strengthen preparedness, detection, and communication capacities for pandemic influenza and other emerging and re-emerging infectious diseases in Mexico, focusing on IHR National Focal Point and Points of Entry capacities. Recognizing that the health security of the American people is intrinsically linked to the world's health security and that international cooperation is critical to enhance global health security, this program is aligned with Article 44 of the IHR (2005), which directs state parties to collaborate to detect, assess, and respond to events, while developing, strengthening, and maintaining core public health surveillance and response capacities. Additionally, this program intends to support the collaboration with the Mexican MOH under the North American Plan for Animal and Pandemic Influenza (NAPAPI). Period Of Performance: September 30, 2014 to September 29, 2017.

HHS is announcing the availability of an interpretive rule providing HHS's interpretation of section 340B(e) of the Public Health Service Act (PHSA), entitled ``Implementation of the Exclusion of Orphan Drugs for Certain Covered Entities Under the 340B Program.'' The interpretive rule states that section 340B(e) of the PHSA excludes drugs with an orphan designation only when those drugs are transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information regarding pH of smokeless tobacco products.

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

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection in the regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring.

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 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 Behavioral Programs for Diabetes Mellitus, 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).

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Providing Submissions in Electronic FormatPostmarketing Safety Reports for Vaccines'' dated July 2014. The draft guidance document provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products marketed for human use with approved biologics license applications (BLAs), including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting System (VAERS). FDA recently published in the Federal Register a final rule requiring that certain postmarketing safety reports for human drug and biological products, including vaccines, 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 applicants required to submit postmarketing safety reports comply with the final rule. The draft guidance, when finalized, also will supersede the document entitled ``Guidance for Industry: How to Complete the Vaccine Adverse Event Report System Form (VAERS-1)'' dated September 1998.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Kelley Landy, Acting Director of the Office of Advocacy Relations (OAR), NCI, NIH, 31 Center Drive, Bldg. 31, Room 10A28, MSC 2580, Bethesda, MD 20892, call non-toll-free number 301-594-3194, or email your request, including your address, to kelley.landy@mail.nih.gov. 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: A Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at NCI, 0925-0641, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The Office of Advocacy Relations (OAR) disseminates cancer-related information to a variety of stakeholders, seeks input and feedback, and facilitates collaboration to advance NCI's authorized programs. It is beneficial for NCI, through the OAR, to pretest strategies, concepts, activities and materials while they are under development. Additionally, administrative forms are a necessary part of collecting demographic information and areas of interest for advocates. Pre-testing, or formative evaluation, helps ensure that the products and services developed by NCI have the greatest capacity of being received, understood, and accepted by their target audiences. Since OAR is responsible for matching advocates to NCI programs and initiatives across the cancer continuum, it is necessary to measure the satisfaction of both internal and external stakeholders with this collaboration. This customer satisfaction research helps ensure the relevance, utility, and appropriateness of the many initiatives and products that OAR and NCI produce. The OAR will use a variety of qualitative (focus groups, interviews) and quantitative (paper, phone, in-person, and web surveys) methodologies to conduct this research, allowing NCI to: (1) Understand characteristics (attitudes, beliefs, and behaviors) of the intended target audience and use this information in the development of effective strategies, concepts, activities; (2) use a feedback loop to help refine, revise, and enhance OAR's effortsensuring that they have the greatest relevance, utility, appropriateness, and impact for/to target audiences; and (3) expend limited program resource dollars wisely and effectively. The anticipated individual respondents will consist of: Adult cancer research advocates, members of the public, health care professionals, and organizational representatives. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,025.

This final notice announces our decision to approve The Compliance Team (TCT) for initial recognition as a national accrediting organization for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.

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 Management of Postpartum Hemorrhage, 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).

The Food and Drug Administration (FDA) is withdrawing approval of 7 abbreviated new drug applications (ANDAs) for prescription drug products containing more than 325 milligrams (mg) of acetaminophen. The holders of these ANDAs have waived their opportunity for a hearing.

The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office of Science is announcing an invitation for participation in its Site Tours Program. This program is intended to give CTP staff an opportunity to visit facilities involved in the growing, processing, or manufacturing of tobacco or currently regulated tobacco products (i.e., cigarettes, roll-your-own, and smokeless tobacco). These visits are intended to provide CTP staff with the opportunity to gain a better understanding of the tobacco industry and its operations and are not intended as regulatory inspections or facility visits for the purposes of developing Tobacco Product Manufacturing Practice regulations. The purpose of this notice is to alert parties interested in participating in the Site Tours Program to submit requests to CTP.

The Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and National Institutes of Health (NIH), all located within the Department of Health and Human Services, in collaboration with partner agencies, announce a public meeting concerning antimicrobial resistance. CDC, FDA, and NIH serve as Co- Chairs to the Interagency Task Force on Antimicrobial Resistance (ITFAR). The purpose of the meeting is to communicate the strategic direction of ITFAR in the fight against antimicrobial resistance, centering on current work and future direction in this area.

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

The Food and Drug Administration (FDA), Office of Health and Constituent Affairs (OHCA) is announcing a 1-day meeting to explore challenges related to pediatric product development. The meeting will serve as a forum for FDA's stakeholders (patients, caregivers, patient advocates, healthcare professional groups, the general public, academia, and industry) to learn about regulations that encourage pediatric product development; to discuss ways to advance pediatric product development, how health disparities impact pediatric product development, the importance of transparency in pediatric clinical trials, and how analysis of information from failed pediatric clinical trials might improve future designs for pediatric trials; and to identify ways patient input can benefit clinical trial design for pediatric trials. The 1-day meeting will also provide an opportunity to participate in panel discussions on the challenges related to development of products used to treat pediatric patients, including pediatric patients with rare diseases and explore ways that patients/caregivers, FDA, and industry may work together to incorporate patient input in future pediatric product development and regulatory decisionmaking.

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 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 (PRA).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Substantial Equivalence Reports: Manufacturer Requests for Extensions or To Change the Predicate Tobacco Product.'' This draft guidance provides information to tobacco product manufacturers about FDA's policies on manufacturer requests for extensions of time to respond to deficiencies that FDA has identified, and manufacturer requests to change the predicate tobacco product, in substantial equivalence (SE) reports.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 1, 2014 (Volume 79, Number 62), page 18300, 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 Office of Intramural Research (OIR), 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, OIRA_submission@omb.eop.gov; or sent 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 the availability of a draft guidance entitled ``Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.'' The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The draft guidance provides the Agency's recommendations and requirements for informed consent to assure the protection of the rights and welfare of human subjects in clinical investigations.

The Food and Drug Administration (FDA or we) is correcting a final rule that appeared in the Federal Register of June 10, 2014. The final rule revised our infant formula regulations by establishing requirements for current good manufacturing practices, including audits; establishing requirements for quality factors; and amending our quality control procedures, notification, and record and reporting requirements for infant formula. We issued the final rule to provide greater protection of infants who consume infant formula products. In this document, we correct some errors that appeared in the preamble to the final rule.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments And For Further Information: To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Brenda Kostelecky, Center for Global Health, National Cancer Institute, 9609 Medical Center Dr., RM 3W276, Rockville MD, 20850 or call non-toll-free number 240-276-5585 or Email your request, including your address to: brenda.kostelecky@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 Cancer Control Leadership Forums at the Center for Global Health (CGH) (NCI), 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This submission is a request for OMB to approve the Cancer Control Leadership Forums. These workshops are organized and funded by the National Cancer Institute's CGH in conjunction with various partners ranging from foreign Ministries of Health and research institutions, to international non- governmental organizations (NGOs) and U.S. academic institutions. The goal of the U.S. National Cancer Institute (NCI) Cancer Control Leadership Forums is to increase the capacity of participating countries to initiate or enhance cancer control planning and implementation in their respective countries. The Forums are an opportunity for countries to exchange experiences and ideas about creating and implementing comprehensive cancer control plans. The proposed evaluation requests information about the outcomes of the forums including (1) status of cancer control planning and implementation in each participating country, (2) outcomes related to the action plans (e.g. developing written materials, completion of action items, resources and support acquired),(3) successes and challenges related to the action plans, and (4) new cancer control partnerships and networks. Baseline information regarding the status of cancer control planning and implementation will be collected 3 months prior to the Forums in order to inform the development of each Forum. The evaluation information will be collected 3-24 months after each forum and is needed to evaluate the effectiveness of these workshops in order to inform future programming and funding decisions. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 108.

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. The meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/32822.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Rebecca A. Ferrer, Division of Cancer Control and Population Sciences, 9609 Medical Center Dr., Room 3E114, Bethesda, MD 20892 or call non-toll- free number 240-276-6914 or Email your request, including your address to: ferrerra@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

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 invites comments on the Health and Diet Survey as used by FDA to gauge and to track consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition, physical activity, and product labeling.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive evaluation option license to practice the inventions embodied in U.S. Provisional Application 61/094,318 filed September 4, 2008 entitled ``Method for detection of cancer based on spatial genome organization'' (HHS Ref No. E-283-2008/0-US-01); International Application PCT/US2009/055857 filed September 3, 2009 entitled ``Method for detection of cancer based on spatial genome organization'' (HHS Ref No. E-283-2008/0-PCT-02); U.S. Patent Application 13/062,247 filed March 4, 2011 entitled ``Method for detection of cancer based on spatial genome organization'' (HHS Ref No. E-283-2008/0-US-0; and foreign equivalents thereof to Radial Genomics, Ltd. (``RG''), a company located in Cambridge, U.K. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive evaluation option license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights for the diagnosis, prognosis, and prediction of cancer. Upon the expiration or termination of the exclusive evaluation option license, RG will have the exclusive right to execute an exclusive commercialization license which will supersede and replace the exclusive evaluation option license with no greater field of use and territory than granted in the exclusive evaluation option license.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Heragen, Inc., which is located in Benicia, California to practice the inventions embodied in the following patent applications:

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 (PRA).

The Food and Drug Administration (FDA) has determined the regulatory review period for HORIZANT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA SubmissionsAmendments and Easily Correctable Deficiencies Under GDUFA.'' The guidance document is intended to assist applicants in preparing to submit to FDA amendments to abbreviated new drug applications (ANDAs) or prior approval supplements (PASs) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by explaining how the Generic Drug User Fee Amendments of 2012 (GDUFA) performance metric goals apply to these submissions. When finalized, this guidance will replace the December 2001 guidance for industry entitled ``Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications'' in consideration of the new amendment review tier system and performance goals under GDUFA.

This Special Fraud Alert addresses compensation paid by laboratories to referring physicians and physician group practices (collectively, physicians) for blood specimen collection, processing, and packaging, and for submitting patient data to a registry or database. OIG has issued a number of guidance documents and advisory opinions addressing the general subject of remuneration offered and paid by laboratories to referring physicians, including the 1994 Special Fraud Alert on Arrangements for the Provision of Clinical Laboratory Services, the OIG Compliance Program Guidance for Clinical Laboratories, and Advisory Opinion 05-08. In these and other documents, we have repeatedly emphasized that providing free or below-market goods or services to a physician who is a source of referrals, or paying such a physician more than fair market value for his or her services, could constitute illegal remuneration under the anti-kickback statute. This Special Fraud Alert supplements these prior guidance documents and advisory opinions and describes two specific trends OIG has identified involving transfers of value from laboratories to physicians that we believe present a substantial risk of fraud and abuse under the anti- kickback statute.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This rule proposes to update and make revisions to the End- Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2015. This rule also proposes to set forth requirements for the ESRD quality incentive program (QIP), including payment years (PYs) 2017 and 2018. This rule also proposes to make a technical correction to remove outdated terms and definitions. In addition, this rule proposes to set forth the methodology for adjusting Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment amounts using information from the Medicare DMEPOS Competitive Bidding Program (CBP); make alternative payment rules for DME and enteral nutrition under the Medicare DMEPOS CBP; clarify the statutory Medicare hearing aid coverage exclusion and specify devices not subject to the hearing aid exclusion; update the definition of minimal self-adjustment regarding what specialized training is needed by suppliers to provide custom fitting services if they are not certified orthotists; clarify the Change of Ownership (CHOW) and provides for an exception to the current requirements; revise the appeal provisions for termination of a contract and notification to beneficiaries under the Medicare DMEPOS CBP, and add a technical change related to submitting bids for infusion drugs under the Medicare DMEPOS CBP.

The National Vaccine Program Office (NVPO), a program office within the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is extending the solicitation period for nominations of qualified candidates to be considered for appointment as public members to the National Vaccine Advisory Committee (NVAC). NVPO is taking this action to allow more time for qualified candidates to be identified to be considered for appointment as public members of the NVAC. NVPO is seeking additional candidates that meet the expertise and qualifications needed to constitute a balanced membership as outlined in the Committee's charter and to ensure that the membership will be fairly balanced in terms of the points of view represented and the Committee's function. Management and support of the NVAC and its activities are the responsibility of the NVPO. The NVAC serves an advisory role, providing peer review, consultation, advice, and recommendations to the Assistant Secretary for Health, in his capacity as Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non- government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) is publishing this issuance and enforcement guidance for dog confinement agreements under 42 CFR 71.51. Under 42 CFR 71.51(c)(2), the CDC Director may authorize admission into the United States of a dog that has not been vaccinated for rabies or that is inadequately immunized if the owner agrees to subsequently vaccinate and properly confine the dog. This guidance describes the factors that HHS/CDC will consider in determining whether it will issue a dog confinement agreement allowing entry of a dog that has not been adequately immunized against rabies, or whether the dog(s) will be denied entry. The notice also describes the steps that an importer may take if his/her imported dog is denied entry.