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

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Select Updates for Non- Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems.'' FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA's thinking regarding certain non-clinical testing for these devices. While FDA is considering more substantial updates to the ``Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems'' guidance (https://www.fda.gov/medicaldevices/ deviceregulationandguidance/guidancedocuments/ucm071863.htm), we are issuing this update on select sections in order to notify the industry in a timely manner of our revised recommendations. This draft guidance is not final nor is it in effect at this time.

This final notice announces our decision to approve American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.

The Food and Drug Administration is correcting a notice entitled ``Prescription Drug User Fee Rates for Fiscal Year 2014'' that appeared in the Federal Register of August 2, 2013 (78 FR 46980). The document announced the Fiscal Year 2014 fee rates for the Prescription Drug User Fee Act. The document was published with four errors. This document corrects those errors.

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.

This notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Antares Pharma Inc., a company having a place of business in Ewing, New Jersey, to practice the inventions embodied in the following patent applications and patents: 1. U.S. Patent Application 11/137,114, filed May 25, 2005, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-US-01]; 2. European Patent 1896025, issued December 28, 2011, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-EP-03]; 3. German Patent 1896025, issued December 28, 2011, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-DE-07]; 4. French Patent 1896025, issued December 28, 2011, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-FR-08]; 5. British Patent 1896025, issued December 28, 2011, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-GB-09]; and 6. Canadian Patent Application 2610025, filed May 18, 2006, titled ``Scopolamine for the Treatment of Depression and Anxiety'' [HHS Ref. No. E-175-2004/0-CA-04. The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Exclusive Patent License may be worldwide, and the field of use may be limited to: ``The use of scopolamine for treatment of depression, including major depressive disorder, wherein the route of administration is subcutaneous, intramuscular, or transdermal delivery such as through injection or a patch or topical gel-based product''. This announcement is the second notice to grant an exclusive license to this technology.

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: ``Assessing the Impact of the National Implementation of TeamSTEPPS Master Training Program.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Center for Drug Evaluation and Research (CDER) Data Standards Program. The goal of the CDER Data Standards Program is to strengthen and support the Coalition for Accelerating Standards and Therapies (CFAST) Initiative in its efforts to establish and maintain clinical data standards that will enable FDA reviewers to more efficiently perform efficacy analysis of potential new drugs in therapeutic areas that are important to public health.

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.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting on September 12, 2013.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2013. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.

The National Institutes of Health (NIH) is providing guidance to Public Health Service (PHS) awardee institutions on implementation of the revised International Guiding Principles for Biomedical Research Involving Animals (``Guiding Principles''). The NIH is seeking input from the public on any concerns they may have regarding the revised Guiding Principles.

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, 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 procedure by which a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit information to us upon which it has based its conclusion that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe.

The Food and Drug Administration (FDA) is announcing the availability on the Agency Web site of revised final versions of the following four documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: ``The eCTD Backbone Files Specification for Module 1,'' version 2.2 (which includes the U.S. regional document type definition (DTD), version 3.2); ``The Comprehensive Table of Contents Headings and Hierarchy,'' version 2.2; ``Specifications for eCTD Validation Criteria,'' version 3.0; and ``Example Submissions using eCTD Backbone Files Specification for Module 1,'' version 1.2. Technical files that support these documents are also available on the Agency Web site. A complete summary of the revisions made is included in the updated documents. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.2 by June 2014, and will give 30 days' advance notice to industry.

The Food and Drug Administration (FDA) is withdrawing approval of four new animal drug applications (NADAs) held by Quali-Tech Products, Inc., at the sponsor's request because the products are no longer manufactured or marketed.

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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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) 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: Ms. Sarah L. Glavin, Deputy Director, Office of Science Policy, Analysis and Communication, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, 31 Center Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free number (301) 496-7898 or Email your request, including your address to glavins@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: The National Children's Study, Vanguard (Pilot) Study, 0925-0593, Expiration 8/31/2014Revision, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this request is to continue data collection activities for the NCS Vanguard Study and receive a renewal of the Vanguard Study clearance. The NCS also proposes the initiation of a new enrollment cohort, the addition of new Study visits, revisions to existing Study visits, and the initiation of methodological substudies. The NCS Vanguard Study is a prospective, longitudinal pilot study of child health and development that will inform the design of the Main Study of the National Children's Study. Background: The National Children's Study is a prospective, national longitudinal study of the interaction between environment, genetics on child health, and development. The Study defines ``environment'' broadly, taking a number of natural and man-made environmental, biological, genetic, and psychosocial factors into account. Findings from the Study will be made available as the research progresses, making potential benefits known to the public as soon as possible. The National Children's Study (NCS) has several components, including a pilot or Vanguard Study, and a Main Study to collect exposure and outcome data. The NCS Vanguard Study continues to follow the children and families enrolled in the Vanguard Study, conducting Study visits in participants' homes and over the telephone. Data Collection visits may include the administration of questionnaires, neurodevelopmental assessments, physical measures, and the collection of biospecimens and environmental measures. The Vanguard Study has yielded valuable data and field experience related to participant recruitment, the conduct of Study assessments, and operational requirements associated with NCS infrastructure and field efforts. The purpose of the proposed data collection is to obtain further operational and performance data on processes and administration Study visit measures. Research Questions: The primary research goal is to systematically pilot additional study visit measures and collections for scientific robustness, burden to participants and study infrastructure, and cost for use in the Vanguard (Pilot) Study and to inform the Main Study. A secondary goal is to increase enrollment in the Vanguard Study through the identification of subsequent pregnancies among enrolled women. Methods: The NCS Vanguard Study data collection schedule includes pre-pregnancy, pregnancy, and birth periods, as well as post-natal collection points at defined intervals between 3 and 60 months. We propose to add or modify the selected measures below to address analytic goals of assessing feasibility, acceptability, and cost of specific study visit measures. Enrollment of Sibling Birth Cohort: We will enroll approximately 1,000 sibling births identified among currently enrolled women. Following new pregnancies will allow us to pilot the collection of biospecimens, environmental samples, and standardized neurodevelopmental assessments on sufficient numbers of participants to understand what activities are feasible in specific settings, participants' willingness to complete requested measures, and whether measures are useful and scalable. Participants will be administered the same protocol as approved for the NCS Vanguard Study by the Office of Information and Regulatory Affairs within the Office of Management and Budget, including the collection of environmental samples, biospecimens and physical measurements during pre-pregnancy and pre- and post-natal visits. Those who report that they are trying to conceive will be initially administered the protocols approved for preconception data collection. Others who self-report a pregnancy at a later time will receive pregnancy visit instrumentation and collections.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of three new animal drug applications (NADAs) at the sponsors' request because the products are no longer manufactured or marketed.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' This guidance is intended to help small entities and other stakeholders comply with FDA's regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents.

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 PRA).

In an effort to enroll the maximum number of uninsured young Americans into individual health plans in the upcoming open enrollment period, multiple mediums and methods of reaching the uninsured population are necessary. HHS and Young Invincibles are co-sponsoring the ``Healthy Young America'' Video Contest with two primary goals: First, directly reaching the uninsured population through video views and votes; and second, the production of high-quality videos that can be further promoted to the target population.

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: CAPT Michael Montello, Pharm. D., MBA, Cancer Therapy Evaluation Program, Operations and Informatics Branch, 9609 Medical Center Drive, Rockville, MD 20850 or call non-toll-free number (240) 276-6080 or Email your request, including your address to: mike.montello@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: NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI), 0925-0625, Revision, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The National Cancer Institute (NCI) Central Institutional Review Board (CIRB) provides a centralized approach to human subject protection and provides a cost efficient approach avoiding duplication of effort at each institution. The CIRB provides the services of a fully constituted IRB and provides a comprehensive and efficient mechanism to meet regulatory requirements pertaining to human subject protections including: Initial reviews, continuing reviews, review of amendments, and adverse events. The Initiative consists of three central IRBs: Adult CIRBlate phase emphasis, Adult CIRBearly phase emphasis, and Pediatric CIRB. CIRB membership includes oncology physicians, surgeons, nurses, patient advocates, ethicists, statisticians, pharmacists, attorneys and other health professionals. The benefits of the CIRB Initiative reaches research participants, investigators and research staff, Institutional Review Boards (IRB), and Institutions. Benefits include: Study participants having dedicated review of NCI-sponsored trials for participant protections, access to more trials more quickly and access to trials for rare diseases, accrual to trials begin more rapidly, ease of opening trials, elimination of need to submit study materials to local IRBs, and elimination of the need for a full board review. The benefits to the National Clinical Trials Network and Experimental Therapy-Clinical Trials Network include a cost efficient approach that avoids duplication of efforts at each institution. A variety of information collection tools are needed to support NCI's CIRB activities which include: Worksheets, forms and a survey that is provided to all customers contacting the CIRB helpdesk. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,199.

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

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) 2014. 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 inspections and, when necessary, re-inspection.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Department of Homeland Security (DHS), United States Citizenship and Immigration Services (USCIS).

Under the National Environmental Policy Act of 1969 (NEPA), as implemented by the Council on Environmental Quality (CEQ) regulations, the Food and Drug Administration (FDA) announces its intent to prepare an Environmental Impact Statement (EIS) to evaluate the potential environmental effects of the proposed rule, Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. By this notice, FDA is announcing the beginning of the scoping process to solicit public comments and identify issues to be analyzed in an EIS. Information on the proposed rule may be accessed using the docket number found in brackets in the heading of this document.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.

This is notice, in accordance with 35 U.S.C. 209 and 37 CFR Part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in the following U.S. Patents and Patent Applications to Bavarian Nordic Immunotherapeutics (``BNIT'') located in Mountain View, CA, USA. Intellectual Property: U.S. Provisional Patent Application No. 61/ 701,528 [HHS Ref. No. E-054-2011/0-US-01] filed September 17, 2012, entitled ``Methods and Compositions for the Treatment of Cancer,'' as well as all international applications, continuation applications and divisional applications. The patent rights in these inventions have been assigned to the government of the United States of America. The prospective exclusive license territory may be worldwide and the field of use will be limited to the use of Licensed Patent Rights for development of pox virus-based immunotherapeutics for colorectal cancer.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria'' dated August 2013. The guidance document provides blood establishments that collect blood and blood components with recommendations for questioning and deferring donors of blood and blood components, allowing their reentry, and product management to reduce the risk of transfusion-transmitted malaria. This guidance finalizes the draft guidance of the same title dated June 2012, and supersedes the FDA memorandum to all registered blood establishments entitled ``Recommendations for Deferral of Donors for Malaria Risk'' dated July 26, 1994. The recommendations contained in the guidance are not applicable to donors of Source Plasma.

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 Food and Drug Administration (FDA or we) is announcing a public meeting to discuss two proposed rules aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically. The Foreign Supplier Verification Programs (FSVP) proposal establishes requirements for importers to verify that their foreign suppliers are implementing the modern, prevention- oriented food safety practices called for by the Food Safety Modernization Act (FSMA) and achieving the same level of food safety as domestic growers and processors. The second proposed rule on the Accreditation of Third-Party Auditors/Certification Bodies would strengthen the quality, objectivity, and transparency of foreign food safety audits on which many U.S. food companies and importers currently rely to help manage the safety of their global food supply chains. The purpose of the public meeting is to solicit oral stakeholder and public comments on the proposed rules and to inform the public about the rulemaking process (including how to submit comments, data, and other information to the rulemaking dockets), and to respond to questions about the proposed rules.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition submitted by the Dean Foods Company and the WhiteWave Foods Company proposing that the food additive regulations be amended to provide for the expanded safe uses of vitamin D2 and vitamin D3 as nutrient supplements in food.

A natural re-emergence of smallpox is not deemed possible, but if it were to occur as a result of a terrorist or deliberate event, it would be a potentially devastating threat to public health worldwide and would constitute a public health emergency of international concern (PHEIC) under the International Health Regulations (IHR) (2005). A case of smallpox detected by a member state requires notification to World Health Organization (WHO) as soon as possible, and any confirmed smallpox case would generate an immediate global public health response. WHO must rely on fast and reliable laboratory diagnostic capacity worldwide to be able to identify a re-emergence of smallpox, particularly in countries where systemic orthopoxvirus infections, such as monkeypox, vaccinia virus infection or cowpox, and other non-pox viral rash illnesses, such as chicken pox, may cause clinical diagnostic confusion. Over the past 10 years, clinical virology laboratory diagnostics has been evolving and increasingly relies on molecular techniques. This is also true with laboratory diagnoses of poxvirus infections. Precise and consistent identification of orthopoxviruses, in particular variola viruses, is now achievable using such molecular techniques as real-time Polymerase Chain Reaction (PCR), unlike earlier techniques that may have relied on direct virus isolation and identification. WHO must be alerted when there is a potential or actual smallpox infection. Early detection and confirmation of smallpox cannot rely solely on the two WHO Collaborating Centres for smallpox and other poxvirus infections. In order to facilitate and support a prompt and effective response to mitigate the spread of the disease, these two Centres should be supported by a worldwide network of reliable laboratories able to perform PCR and real-time PCR diagnostics enabling initial detection and identification of smallpox events. Additionally, the U.S. Government supports the development of other medical products, including vaccines and drugs, for use within the U.S. upon verification of a smallpox case. The U.S. Government, through the Office of the Assistant Secretary for Preparedness and Response (ASPR), has successfully developed vaccine products, and is actively engaged in the development of several drug candidates for smallpox therapies, which require access to the Variola virus to satisfy regulatory requirements for product approvals. Justification: WHO is the only eligible applicant; it is the only organization that is allowed by international agreements to address the issues outlined in this proposal. WHO is the directing and coordinating authority for health within the United Nations (U.N.) system. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. In the 21st century, health is a shared responsibility, involving equitable access to essential care and collective defense against transnational threats. States Parties to the U.N. have agreed to international standards on reporting public health incidents of concern under IHR (2005). Additionally, a majority of States Parties have also agreed to specific work-frames for pathogens such as smallpox under the Biological Weapons Convention. Since May 1999, when the 52nd World Health Assembly (WHA) resolved to postpone the destruction of the Variola virus to allow for essential research (WHA 52.10), WHO has been charged with convening a group of experts to advise on the need for continuing such research, to review proposals for research involving viable Variola virus, to review the progress of such research, and to report to the WHA each year. The need to support the activities described in this project has not changed. In fact, WHO Member States continue to exert pressure for the WHO Secretariat to carry out this work. The WHO Advisory Committee on Variola Virus Research (ACVVR) was established in 1999 to determine what essential research, if any, must be carried out with live Variola virus. The ACVVR monitored the research progress in order to reach global consensus on the timing for the destruction of existing Variola virus stocks. In 2007, the WHA requested the ACVVR undertake a thorough review of the approved research program with a report presented in 2010. The results were presented at the 64th WHA meeting in May of 2011. The ACVVR continues to serve a critically important function for global public health, and to oversee research requested specifically by the U.S. to complete its national strategic goals. This includes convening a group of experts, the ACVVR, to advise on the need for continuing such research, to review proposals for research involving viable Variola virus, and to review the progress of such research. Additional Information: The agency program contact is George Korch, who can be contacted by phone at (202) 690-5760 or via email at George.Korch@hhs.gov.

The Department of Health and Human Services is hereby giving notice that the National Vaccine Advisory Committee (NVAC) has been rechartered.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Internal Revenue Service (IRS), a Bureau of the Department of the Treasury.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on imaging techniques for the surveillance, diagnosis, and staging of hepatocellular carcinoma. Scientific information is being solicited to inform our review of Imaging Techniques for the Surveillance, Diagnosis, and Staging of Hepatocellular Carcinoma, 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 on imaging techniques for the surveillance, diagnosis, and staging of hepatocellular carcinoma will improve the quality of this review. AHRQ is conducting this comparative effectiveness 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 the guidance entitled ``Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff.'' This guidance document is intended to assist industry and FDA staff in identifying and appropriately addressing specific considerations related to the incorporation and integration of radio frequency (RF) wireless technology in medical devices. This guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including selection of wireless technology, quality of service, coexistence, security, and electromagnetic compatibility, and provides recommendations for information to be included in FDA premarket submissions for such devices.

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD Foundation, is announcing a 2-day public workshop entitled ``Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II).'' Partners and stakeholders planning the workshop also include patients and representatives from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. The purpose of this workshop is to provide a forum to consider issues related to endpoints that can support drug development in the following disease areas: Pediatric and adult inflammatory bowel diseases.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Conformity Assessment Meeting on Non-Respiratory Personal Protective Equipment (PPE).'' To view the notice and related materials, visit www.regulations.gov and enter CDC-2013-0015 in the search field and click ``search.'' Stakeholder Meeting Time and Date: 8:00 a.m. to 12:00 p.m. EDT, September 17, 2013. Place: NIOSH Pittsburgh Research Center located at 626 Cochrans Mill Road, Building 140, Pittsburgh, Pennsylvania 15236. This meeting will also be available by remote participation through ``live meeting.'' Purpose of the Meeting: This meeting is being held to provide 1) a summary of the work conducted by the NIOSH Personal Protective Technology (PPT) Conformity Assessment Working Group 2) provide an overview of model Conformity Assessment programs, and 3) solicit input to define a national framework for PPE conformity assessment. This meeting will include presentations on Product and Standards, Risk Assessment, Surveillance and Compliance and Enforcement targeting General Industry, Healthcare, Public Safety, and Mining stakeholders. Moderated breakout sessions will discuss preferred Conformity Assessment (CA) components (as detailed in the background below); existing U.S. CA infrastructure capabilities; and gaps in legislation, standards, and infrastructure that need to be filled to define the framework. These breakout discussions will not be available through remote participation; however, the breakout reports will be available to remote participants when the groups reconvene. Status: The meeting is open to the public, limited only by the capacity (150) of the conference room. Registration will be accepted on a first-come first-served basis. Participants are encouraged to consider remote participation through ``live meeting.'' Registration by September 13, 2013 is required for both attendance in person and ``live meeting'' participation. Registration for both options is available on the NIOSH Web site. Non-U.S. citizens, attending in person, need to register on or before August 16, 2013, to allow sufficient time for mandatory CDC facility security clearance procedures to be completed. An email confirming registration will be sent from NIOSH to all participants. Government-issued photo identification is required to obtain entrance to the NIOSH location. An opportunity for individuals or organization representatives wishing to offer verbal comments (five minute time limit) will be provided as time permits after the breakout reports. Time slots are limited and available on a first-come first-served basis. Preregistration for providing verbal comment can be requested when registering for the meeting. Submit electronic comments through www.regulations.gov. All information received in response to this notice and meeting must include the agency name and docket number (CDC-2013-0015; NIOSH 237-A). All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided. All electronic comments should be formatted in Microsoft Word. Please make reference to CDC-2013-0015 and NIOSH Docket Number 237-A. Background: In response to recommendations made by the National Academies of Science during a programmatic review, the NIOSH Personal Protective Technology Conformity Assessment Working Group was established in 2011. The goal of this group is to prepare a national framework establishing criteria, including comprehensive and consistent processes, to address conformity assessment of non-respiratory personal protective equipment. Conformity assessment is defined as the ``demonstration that specified requirements relating to a product, process, system, person or body are fulfilled.'' Conformity assessment processes for PPT products are focused on product effectiveness and include the following primary components: Certification (ISO/IEC 17065), Inspection (ISO/IEC 17020), Testing (ISO/IEC 17025), Accreditation (ISO/IEC 17011), Surveillance (ISO/IEC 17011, ISO/IEC 17065), Supplier's Declaration of Conformity (ISO/IEC 17050), Registration (ISO/IEC 17021) and Quality Management Systems (ISO/9001). The Conformity Assessment Project Report and preliminary framework documents will be available at www.regulations.gov.

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.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting to discuss the Ryan White Program. The meeting will be open to the public.

The Administration for Children and Families within the U.S. Department of Health and Human Services (HHS) is reopening and extending the period to submit comments on the proposed rule for the Child Care and Development Fund (CCDF), published in the Federal Register of May 20, 2013. The proposed rule makes changes to the CCDF regulatory provisions in order to strengthen health and safety requirements for child care providers, reflect current State and local practices to improve the quality of child care, infuse new accountability for Federal tax dollars, and leverage the latest knowledge and research in the field of early care and education to better serve low-income children and families.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Committee on Organ Transplantation (ACOT). The ACOT was established by the Amended Final Rule of the Organ Procurement and Transplantation Network (OPTN) (42 CFR Part 121) and, in accordance with Public Law 92-463, was chartered on September 1, 2000.

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis), as a color additive in candy and chewing gum. This action is in response to a petition filed by Mars, Inc.

The Food and Drug Administration (FDA or we) is announcing the availability of the draft guidance for industry entitled ``Frequently Asked Questions About Medical Foods; Second Edition.'' The draft guidance, when finalized, will provide responses to additional questions regarding the definition, labeling, and availability of medical foods and updates to some of the existing responses.

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, National Cancer Institute (NCI), 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 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, contact: Jessica Faupel- Badger, Ph.D., MPH, Cancer Prevention Fellowship Program, National Cancer Institute, 9609 Medical Center Drive, Room 2W136 MSC 9712, Bethesda, Maryland 20892-9712 or call non-toll-free number 240-276-5650 or Email your request, including your address to: badgerje@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing.

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 Food and Drug Administration (FDA or we) is extending the comment period for the proposed rule, and for the information collection related to the proposed rule, ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption,'' that appeared in the Federal Register of January 16, 2013. We are taking this action to allow interested persons an opportunity to consider the interrelationships between this proposal and the two proposals announced in July 2013 on the Foreign Supplier Verification Program and on Accreditation of Third-Party Auditors/Certification Bodies. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR Part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing a meeting for patients, caregivers, patient advocates, as well as patient advocate and health professional groups, to provide a primer on drug product development and explore patient involvement in drug development. The meeting will serve as a forum for FDA's patient stakeholders and the general public, including health professionals, academia, and industry to learn about FDA's role in, and various regulatory issues related to drug development, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to incorporating meaningful patient input that will represent broad patient perspectives in drug development and regulatory decision making. Specifically, this meeting will provide information and facilitate a discussion about: FDA's role in drug development and where and how patients can take an active role.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the Million Hearts[supreg] Hypertension Control Challenge on August 9, 2013. The challenge will be open until September 9, 2013. Million Hearts[supreg] is a national initiative to prevent 1 million heart attacks and strokes by 2017. Achieving this goal means that 10 million more Americans must have their blood pressure under control. Million Hearts[supreg] is working to control high blood pressure through clinical approaches, such as using health information technology to its fullest potential and integrating team-based approaches to care, as well as community approaches, such as strengthening tobacco control, and lowering sodium consumption. To support improved blood pressure control, HHS/CDC is announcing the Million Hearts[supreg] Hypertension Control Challenge. This challenge recognizes organizations that invest in hypertension control, improve understanding of successful implementation strategies at the health system level, and motivate providers and health systems to strengthen their hypertension control efforts. The challenge will identify clinicians, clinical practices, and health systems that have achieved exceptional rates of hypertension control and recognize them as Million Hearts[supreg] Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts[supreg] will document the systems, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions. Champions will receive a cash prize and local and national recognition.

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 renewal of the approved information collection assigned OMB control number 0990-0001, scheduled to expire on September 30, 2013. 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.

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.