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

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Contract Manufacturing Arrangements for Drugs: Quality Agreements.''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.

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).

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 https://www.hhs.gov/nvpo/nvac, email nvpo@hhs.gov, or call 202-690-5566 and provide name, organization, and email address.

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:

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.

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.

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.

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.

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.

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 noracoordinator@cdc.gov 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 https://www.cdc.gov/niosh/nora/.

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).

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.