Draft Guidance for Industry on Contract Manufacturing Arrangements for Drugs: Quality Agreements; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality Agreements.'' This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.
International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 13 on Bulk Density and Tapped Density of Powders General Chapter; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Annex 13: Bulk Density and Tapped Density of Powders General Chapter.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides the results of the ICH Q4B evaluation of the Bulk Density and Tapped Density of Powders General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions (core ICH Q4B guidance).
Government-Owned Inventions; Availability for Licensing
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. 207 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.
Medicare Program; Second Semi-Annual Meeting of the Advisory Panel on Hospital Outpatient Payment (HOP Panel) August 26-27, 2013
This notice announces the second semi-annual meeting of the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel) for 2013. The purpose of the panel is to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights, and hospital outpatient therapeutic services supervision issues.
Medicare and Medicaid Programs; Survey, Certification and Enforcement Procedures; Extension of Comment Period
This notice extends the comment period for the Survey, Certification and Enforcement Procedures proposed rule, which was published in the April 5, 2013 Federal Register (78 FR 20564 through 20581). In the proposed rule, we proposed to revise the survey, certification, and enforcement procedures related to CMS oversight of national accreditation organizations (AOs). These revisions would implement certain provisions under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The proposed revisions would also clarify and strengthen our oversight of AOs that apply for, and are granted, recognition and approval of an accreditation program in accordance with the Social Security Act. The comment period for the proposed rule, which would have ended on June 4, 2013, is extended to July 5, 2013.
Announcement of Requirements and Registration for the “Technology-based Products to Prevent High-Risk Drinking Among College Students Challenge”
The Substance Abuse and Mental Health Services Administration (SAMHSA), an operating division of the U.S. Department of Health and Human Services, announces a new opportunity for individuals and organizations to help prevent high-risk drinking among college students. Excessive and underage drinking among college students are significant public health problems on college and university campuses across the United States, which often result in life-altering consequences such as death, injury, assault, sexual abuse, unintended pregnancy, sexually transmitted diseases, academic difficulties, suicide attempts, and alcohol dependence. This challenge seeks technology-based products to decrease the acceptability of and engagement in high-risk drinking among college students. SAMHSA is seeking solutions to this problem through cost-effective, portable, technology-based products that effectively reach a diverse population of college students and their parents, as well as administrators, faculty, and staff, and that can be adapted to meet the local needs of these institutions throughout the United States. Technology-based products may include, but are not limited to, web applications, mobile apps, short message services (SMS), and podcasts. This challenge aligns with SAMHSA's mission to reduce the impact of substance abuse and mental illness on America's communities. SAMHSA recognizes that preventing high-risk drinking among college students will save lives, improve academic success, and decrease other risks to students' health and safety. The statutory authority for this challenge competition is Section 105 of the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science Reauthorization Act of 2010 (COMPETES Act).
Proposed Collection; 60-day Comment Request: Autism Spectrum Disorder Research Portfolio Analysis
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Mental Health (NIMH), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: The Office of Autism Research Coordination, NIMH, NIH, Neuroscience Center, 6001 Executive Blvd., MSC 9663, Room 6184, Bethesda, MD 20892 or Email your request, including your address to: email@example.com. 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: Autism Spectrum Disorder (ASD) Research Portfolio Analysis, 0925NEWNational Institute of Mental Health (NIMH), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of the ASD portfolio analysis is to collect research funding data from U.S. and international ASD research funders, to assist the Interagency Autism Coordinating Committee (IACC) in fulfilling the requirements of the Combating Autism Act, and to inform the committee and interested stakeholders of the funding landscape and current directions for ASD research. Specifically, these analyses will examine the extent to which current funding and research topics align with the IACC Strategic Plan for ASD Research. The findings will help guide future funding priorities by outlining current gaps and opportunities in ASD research as well as serving to highlight annual activities and research progress. OMB approval is requested for three years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 419.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should register at http://www.hhs.gov/nvpo/nvac, email firstname.lastname@example.org, or call 202-690-5566 and provide name, organization, and email address.
Prospective Grant of a Start-Up Exclusive Patent License Agreement: Treatment of Graves' Disease, Hyperthyroidism and Thyroid Cancer
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Patent License to Nova Therapeutics LLC, a company having a place of business in Delaware, to practice the inventions embodied in the following patent applications:
Ryan White HIV/AIDS Program Core Medical Services Waiver; Application Requirements
Title XXVI of the Public Health Service Act, as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Ryan White Program or RWP), requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the statute. The statute also grants the Secretary authority to waive this requirement if there are no waiting lists for the AIDS Drug Assistance Program (ADAP) and core medical services are available to all individuals identified and eligible under Title XXVI in an applicant's service area. Prior to this policy announcement, grantees seeking a waiver of the 75 percent requirement have been required to submit core medical services waiver requests at the same time as the annual grant application. Recognizing RWP grantees' request for additional flexibility in the timing of waiver applications, the Health Resources and Services Administration (HRSA) is providing grantees additional options for making waiver requests. HRSA is amending the uniform waiver standards for RWP grantees requesting a core medical services waiver for fiscal year (FY) 2014 and beyond. The amended standards will allow grantees to apply for a waiver (a) at the same time as their annual Part A, B, or C application submission, (b) at any time up to their annual Part A, B, or C application submission, or (c) up to four months after their grant award for that funding year. This Federal Register notice seeks to make public the revised policy and provide an opportunity for public comment before its implementation.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. HRSA especially requests comments on: (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.
Ryan White HIV/AIDS Program, Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
To prevent a lapse in comprehensive primary care services for persons living with HIV/AIDS, HRSA will provide a one-time noncompetitive Ryan White HIV/AIDS Program Part C funds award to the Genesis Health Group (GHG), Davenport, Iowa.
National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Discretionary Grant Program
HRSA will be issuing a non-competitive award to the National Center for Community Based Services program. The 1-year award for $449,125 will be made available in the form of a cooperative agreement to the current grantee, University of Massachusetts, during the budget period July 1, 2013, through June 30, 2014. This will provide feasible time for the Maternal and Child Health Bureau (MCHB) to align fiscal resources and programmatic goals with the least disruption to the states, communities, and constituencies that currently receive leadership, assistance, and services.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
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). 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.
Medicare Program; Public Meeting in Calendar Year 2013 for New Clinical Laboratory Test Payment Determinations
This notice announces a public meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HCPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule (CLFS) for calendar year (CY) 2014.
Proposed Collection; 60-Day Comment Request: Generic Clearance To Support Programs and Administrative Operations at the National Cancer Institute (NCI)
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: Vivian Horovitch-Kelley, PRA/OMB Project Clearance Liaison, Office of Management Policy and Compliance (OMPC), National Cancer Institute, 11400 Rockville Pike, Room 707, Rockville, MD 20852 or call non-toll- free number 301-480-0541 or Email your request, including your address to: Horovitchkellv@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: Generic Clearance to Support Programs and Administrative Operations At the National Cancer Institute (NCI), 0925- NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: This is a request for a new, generic submission that would be used for administrative and program-related submissions. Administrative submissions are defined as information collections (ICs) wherein the primary content is used for administrative purposes (e.g., an application) or to monitor or improve a program. These ICs may involve little if any, subsequent analysis and/or the use of simple, descriptive statistics. Some ICs are forms used to source and aggregate contact information, history, preferences, opinions, and/or other data that does not necessitate further inquiry but allow the respondents to maintain contact, indicate preferences, and respond to data calls of information that has not already been collected. Other ICs may be program-related requests for the purpose of monitoring, improving or assessing the effectiveness of the program. NCI program staff who have submitted sub-projects that have been reviewed and returned by OMB, have contributed ideas and comments to this request. Along with the analysis, NCI's ongoing education and outreach effort has increased the awareness and the need for the request of a generic, administrative and program-related information collection. NCI's current scope and capacity for administrative generic sub-studies is non-existent and this request would fill this gap. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 5,000.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medicare Program; Medical Loss Ratio Requirements for the Medicare Advantage and the Medicare Prescription Drug Benefit Programs
This final rule implements new medical loss ratio (MLR) requirements for the Medicare Advantage Program and the Medicare Prescription Drug Benefit Program established under the Patient Protection and Affordable Care Act.
Partnerships To Advance the National Occupational Research Agenda (NORA)
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Partnerships to Advance the National Occupational Research Agenda (NORA)''. Public Meeting Time and Date: 1 p.m.-3 p.m. EDT, June 20, 2013. Place: Patriots Plaza, 395 E Street SW., Derek Dunn Conference Room (9250), Washington, DC 20201. Purpose of the Meeting: The National Occupational Research Agenda (NORA) has been structured to engage partners with each other and/or with NIOSH to advance NORA priorities. The NORA Liaison Committee continues to be an opportunity for representatives from organizations with national scope to learn about NORA progress and to suggest possible partnerships based on their organization's mission and contacts. This opportunity is now structured as a public meeting via the Internet to attract participation by a larger number of organizations and to further enhance the success of NORA. Some of the types of organizations of national scope that are especially encouraged to participate are employers, unions, trade associations, labor associations, professional associations, and foundations. Others are welcome. This meeting will include updates from NIOSH leadership on NORA and on plans for evaluating the second decade of NORA. Brief written updates will be available from approximately half of the NORA Sector Councils on their progress, priorities, and implementation plans to date, likely including the NORA Construction; Manufacturing; Public Safety; Services and Wholesale and Retail Trade Councils. There will be time to ask questions and discuss partnership opportunities. Status: The meeting is open to the public, limited only by the capacities of the conference call and conference room facilities. There is limited space available in the meeting room (capacity 20). Everyone is encouraged to participate through the Internet (to see the slides) and a teleconference call (capacity 50). Each participant is requested to register for the free meeting by sending an email to email@example.com containing the participant's name, organization name, contact telephone number on the day of the meeting, and preference for participation in-person or by Web meeting (requirements include: computer, Internet connection, and telephone, preferably with `mute' capability). An email confirming registration will include the details needed to participate in the Web meeting. Non-US citizens are encouraged to participate in the Web meeting. Non-US citizens who do not register to attend in person on or before June 3, 2013, will not be granted access to the meeting site and will not be able to attend the meeting in-person due to mandatory security clearance procedures at the Patriots Plaza facility. Background: NORA is a partnership program to stimulate innovative research in occupational safety and health leading to improved workplace practices. Unveiled in 1996, NORA has become a research framework for the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing those needs and to move the research results into practice. The NIOSH role is facilitator of the process. For more information about NORA, see http:/ /www.cdc.gov/niosh/nora/about.html. Since 2006, NORA has been structured according to industrial sectors. Ten major sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the Web and town hall meetings, ten NORA Sector Councils defined sector-specific strategic plans for conducting research and moving the results into widespread practice. To view the National Sector Agendas, see http://www.cdc.gov/niosh/nora/.
Pre-Existing Condition Insurance Plan Program
This interim final rule with comment period sets the payment rates for covered services furnished to individuals enrolled in the Pre-Existing Condition Insurance Plan (PCIP) program administered directly by HHS beginning with covered services furnished on June 15, 2013. This interim final rule also prohibits facilities and providers who, with respect to dates of service beginning on June 15, 2013, accept payment for most covered services furnished to an enrollee in the federally-administered PCIP from charging the enrollee an amount greater than the enrollee's out-of-pocket cost for the covered service as calculated by the plan. The PCIP program was established under Section 1101 of Title I of the Patient Protection and Affordable Care Act (Affordable Care Act).
Oral Dosage Form New Animal Drugs; Clindamycin; Enrofloxacin
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 April 2013. FDA is also informing the public of the availability of summaries for the basis of approval and of environmental review documents, where applicable.
Standardizing and Evaluating Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Request for Comments
The Food and Drug Administration (FDA) is announcing a 2-day public meeting to obtain input on issues and challenges associated with the standardization and assessment of risk evaluation and mitigation strategies (REMS) for drug and biological products. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into, and reduce their burden to, the existing and evolving health care system. As part of the PDUFA commitments, FDA will also seek to develop evidence-based methodologies for assessing the effectiveness of REMS. To obtain input from stakeholders about REMS standardization and evaluation, FDA will hold a public meeting to give stakeholders, including health care providers, prescribers, patients, pharmacists, distributors, drug manufacturers, vendors, researchers, standards development organizations, and the public an opportunity to provide input on ways to standardize and assess REMS.