Department of Health and Human Services October 2010 – Federal Register Recent Federal Regulation Documents
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Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA
To reduce the risk that individuals with ill intent may exploit the application of nucleic acid synthesis technology to obtain genetic material derived from or encoding Select Agents or Toxins and, as applicable, agents on the Export Administration Regulations' (EAR's) Commerce Control List (CCL), the U.S. Government has developed Guidance that provides a framework for screening synthetic double-stranded DNA (dsDNA). This document, the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA (the Guidance), sets forth recommended baseline standards for the gene and genome synthesis industry and other providers of synthetic dsDNA products regarding the screening of orders so that they are filled in compliance with current U.S. regulations and to encourage best practices in addressing biosecurity concerns associated with the potential misuse of their products to bypass existing regulatory controls. Following this Guidance is voluntary, though many specific recommendations serve to remind providers of their obligations under existing regulations. The framework includes customer screening and sequence screening, follow-up screening as necessary, and consultation with U.S. Government contacts, as needed. A draft version of the Guidance was published as a Federal Register Notice (Federal Register, Vol. 74, No. 227, November 27, 2009, Screening Framework Guidance for Synthetic Double-Stranded DNA Providers) for public consideration and comment for a period of 60 days. Comments were reviewed and the Guidance was amended through a deliberative interagency process. The Response to Public Comments document, which precedes the final Guidance in the Supplementary Information section of this Notice, provides a general review of the decisions made to alter the Guidance in response to public comments. The Department of Health and Human Services (HHS) is issuing this document as the lead agency in a broad interagency process to draft the Guidance. The Guidance will be reviewed on a regular basis and revised, as necessary. For further details about the Guidance, to access public comments, and to provide ongoing feedback please refer to https:// www.phe.gov/preparedness/legal/guidance/syndna.
Award of a Single-Source Grant to Chapin Hall at the University of Chicago, Chicago, IL
The Administration for Children and Families (ACF), Office of Planning, Research and Evaluation (OPRE) announces the award of a single-source grant to Chapin Hall at the University of Chicago, Chicago, IL, to study the characteristics, dynamics, and context of the child-only Temporary Assistance for Needy Families (TANF) client population. Chapin Hall's application was received at ACF as an unsolicited proposal and underwent objective review on December 17, 2009, where the following criteria were applied: Objectives and Need for Assistance, Facilities and Resources, Cost, and Relevance to ACF. The Federal objective reviewers determined that the proposal evidenced a high technical quality, with well-qualified staff from respected institutions operating within a reasonable budget. Reviewers found that the proposal would add value compared to past research, through its focus on long-term child-only caseload dynamics, its use of State data, and its analysis of types of case that have not received as much attention in past research. The panel also pointed out that child- only cases are a high priority issue for ACF. The proposed project offers an updated and more detailed picture of the TANF child-only caseload, including the dynamics of client entry and exit from the caseload. It also provides a timely opportunity, in light of pending TANF reauthorization, to gather policy information about a vulnerable and important ACF client group. OPRE will administer the grant in collaboration with HHSOffice of the Assistant Secretary for Planning and Evaluation (ASPE).
Award of a Single-Source Expansion Supplement to the University of Southern Maine, Muskie School of Public Service
In order to provide more intensive technical assistance to Tribes, the Administration for Children and Families (ACF), Children's Bureau (CB) is awarding a single-source expansion supplement to the University of Southern Maine, Muskie School of Public Service, Portland, ME, to assist Tribes in building their capacity to operate their own foster care and adoption assistance agencies (title IV-E) program. The University of Southern Maine is a recipient of a cooperative agreement to administer the National Resource Center for Organizational Improvement, which is charged with building the organizational capacity of State, local, Tribal and other publicly supported child welfare agencies in order to improve the outcomes of child welfare activities and to achieve the Adoption and Safe Families Act of 1997 goals of safety, permanency and well-being of children and youth. The supplemental funding will support Regional Roundtables and build Tribal capacity in the following areas: 1. An overview of the Social Security Act and title IV-E provisions that provide foster care and adoption service funds. This presentation will be developed to be responsive to the cultural issues and needs of the audience. 2. Training for Tribal caseworkers on title IV-E requirements in order to continue the eligibility and funding of IV-E eligible children. Workers must be aware of the provisions of Fostering Connections to assure that all appropriate services are provided to children in care. 3. Proper foster care recruitment, training and retention is needed because placement of title IV-E eligible children must be made with licensed foster/kin families. It is important for Tribal leaders, child welfare and court staff to understand the link between licensing and maintaining title IV-E eligibility when children are placed. The Fostering Connections to Success and Increasing Adoptions Act of 2008 (Pub. L. 110-351) added Sec. 479B to the Act, which allows Indian Tribes the option to receive Federal funding to support the administration of their own foster care, adoption assistance, and guardianship assistance programs under title IV-E of the Social Security Act (the Act). The law also amended the Act at Sec. 476(c)(2)(iii) to allow Indian Tribes to receive one-time development grants to be used to offset the cost of developing a title IV-E plan to carry out the requirements of new Sec. 479B of the Act. As the designated National Resource Center for Organizational Improvement, the University of Southern Maine is qualified to provide training and technical assistance to Tribes because of their demonstrated commitment to meaningful stakeholder involvement by involving Tribes and other relevant stakeholders in program planning, implementation and evaluation and other systems change initiatives.
Award of a Single-Source Expansion Supplement to the Child Welfare League of America
The Administration for Children and Families (ACF), Children's Bureau (CB), announces the award of a single-source expansion supplement to the Child Welfare League of America, Arlington, VA, to support the provision of intensive technical assistance to States. The Child Welfare League of America is a recipient of a cooperative agreement to administer the National Resource Center for Child Welfare Data and Technology (NRC-CWDT) in order to ensure continued support to States in the development of the National Youth in Transition Database. The National Youth in Transition Database will assist States, Tribes, and courts to develop, implement and/or improve effective case management information systems, or data collection systems, and to use data to manage child welfare programs in order to improve outcomes for children, youth, and families. Section 477 of the Social Security Act authorizes the John H. Chafee Foster Care Independence Program (CFCIP) and the Chafee Education and Training Vouchers (ETV) program. It also requires the creation of a data collection and performance measurement system. The Federal regulation at 45 CFR 1356.80 establishes the National Youth in Transition Database (NYTD) implementing this provision. The NYTD regulation requires States to engage in two data collection activities: the collect of information on youth and the independent living services they receive that are paid for or provided by State agencies that administer the CFCIP and ETV programs and the collection of outcome information on certain youth in foster care. States must begin collecting NYTD data on October 1, 2010 and submit the first report period data to ACF by May 15, 2011. The supplemental funding will allow the NRC-CWDT to meet the increased demand for NYTD onsite technical assistance and sponsor regional meetings without reducing requested technical assistance from courts and Tribes in the areas of data collection and exchange.
Award of a Single-Source Expansion Supplement to the Research Foundation of CUNY on Behalf of Hunter College School of Social Work
The Administration for Children and Families (ACF), Children's Bureau (CB) announces the award of a single-source program expansion supplement to the Research Foundation of CUNY on behalf of Hunter College School of Social Work, New York, NY, to provide expanded technical assistance to address continuing challenges in the field as child welfare programs work to implement the requirements of new legislation. The Research Foundation of CUNY on behalf of Hunter College is the recipient of a cooperative agreement to act as the administrator for National Resource Center for Permanency and Family Connections (NRCPFC), which provides technical assistance services pursuant to the legislative authority of the Promoting Safe and Stable Families Amendments of the Social Security Act (42 U.S.C. 629e). The Fostering Connections to Success and Increasing Adoptions Act of 2008 (Pub. L. 110-351) provides for a discretionary matching grant program to implement projects in the areas of Kinship Navigator, Family Finding, Family Group Decision Making, and Residential Family Treatment. The law also added a new plan requirement at Sec. 471(a)(29) that directs State foster care and adoption agencies (title IV-E agencies) to exercise due diligence to identify and notify all adult relatives of a child, within 30 days of the child's removal, of the relative's options to become a placement resource for the child. The supplemental funding will allow the NRCPFC to do the following: 1. Provide focused technical assistance to Family Connections grantees. 2. Engage States that did not receive discretionary grants in on- site consultation regarding effectively involving relatives in child welfare practice. 3. Proactively transfer the knowledge developed under the discretionary grant program to States to assist in meeting new plan requirements. Under the proposed supplemental funding, the NRCPFC will increase technical assistance efforts to enhance the achievement of permanency by assisting agencies to better locate, notify and involve families and relatives in the engagement and planning process while maintaining awareness of confidentiality issues.
Award of a Single-Source Expansion Supplement to the University of Oklahoma, National Resource Center for Youth Services
The Administration for Children and Families (ACF), Children's Bureau (CB) announces the award of a single-source expansion supplement to the University of Oklahoma, National Resource Center for Youth Services, Tulsa, OK, to support expanded technical assistance to address emerging technical assistance needs for States and Tribes as they seek to implement legislation and changing programs dedicated to former foster youth. The grantee is the recipient of a cooperative agreement to administer the National Resource Center for Youth Development (NRCYD). The grantee has been providing technical assistance services through a cooperative agreement since September 30, 2009, pursuant to the legislative authority of the Promoting Safe and Stable Families Program, Section 435(d), Title IV-B, subpart 2, of the Social Security Act [42 U.S.C. 629e]. In February 2008, the National Youth in Transition Database (NYTD) final regulation was promulgated. NYTD requires States to begin collecting information from youth in foster care and young adults formerly in foster care every six months, beginning October 1, 2010. State representatives continue to identify implementation of NYTD as a significant challenge, particularly since it will require State agencies to remain in contact with youth who may no longer be receiving services from the agency. The implementation of NYTD over the next four years will require the NRCYD to continue to provide additional technical assistance to States to implement this regulation effectively. Additionally, many States see the implementation of NYTD as a method to engage youth and to strengthen youth involvement in services at the State and local level. This type of youth engagement work involves long-term systemic technical assistance. The expansion grant will allow the NRCYD to support these State initiatives over the long term. Another significant development affecting the provision of services to youth and young adults was the passage of the Fostering Connections to Success and Increasing Adoptions Act of 2008, Public Law 110-351, signed into law October 7, 2008. Among other provisions, the law added a provision requiring States to develop a transition plan for all youth emancipating from foster care. The law also provides States and Tribes an option to receive Federal reimbursement under title IV-E of the Social Security Act to extend foster care to older youth until age 21. In addition, the law for the first time provides an opportunity for certain Indian Tribes to receive direct funding for independent living services and education and training vouchers under the Chafee Foster Care Independence Program. The supplement will allow the NRCYD to provide more intensive technical assistance and on-site consultation to States and Tribes to continue to assist them in implementing these provisions.
Award of a Single-Source Program Expansion Supplement to Chapel Hill Training Outreach Project, Inc.
The Administration for Children and Families (ACF), Children's Bureau (CB) announces the award of a single-source program expansion supplement to Chapel Hill Training Outreach Project, Inc. in Chapel Hill, NC, the administrator of the FRIENDS National Resource Center for the Community-Based Child Abuse Prevention Program (NRCCBCAP), to support technical assistance and support for the implementation of the new home visiting program by ACF and Health Resources Services Administration (HRSA) grantees under the Maternal, Infant and Early Childhood Home Visiting program, authorized by the Patient Protection and Affordable Care Act. Supplemental funding will assist in the initial planning and implementation of this new program. Award funds will be used to: Provide logistical support for outreach, planning, executing, and follow-up with prospective applicants, ACF and HRSA grantees, and other stakeholders; Support consultation time with various experts on evidence-based home visitation and implementation science; Convene meetings/calls/webinars with ACF and HRSA grantees and various experts and stakeholders including national program model developers; Provide staff time for support for general communication, other meetings, transition information to new TA contractor; and, Develop a temporary Web site or other electronic tools for the program that would make key information available in a timely and accessible manner.
Award of a Single-Source Expansion Supplement to the Tribal Law and Policy Institute
The Administration for Children and Families (ACF), Children's Bureau (CB) announces the award of a single-source expansion supplement to the Tribal Law and Policy Institute, West Hollywood, CA, to provide more intensive technical assistance to Tribes. The Tribal Law and Policy Institute administers the National Resource Center for Tribes under a cooperative agreement where technical assistance is provided to Tribes to assist in building organizational capacity so that Tribes may operate their own foster care programs under title IV-E of the Social Security Act. Under the agreement, Tribal Law and Policy Institute identifies promising practices in Tribal child welfare systems, identifies and effectively implements community and culturally based strategies and resources that strengthen Tribal child and family services. The Fostering Connections to Success and Increasing Adoptions Act of 2008 (the Act) was amended in 2008 by the addition of Sec. 479B, which allows Indian Tribes the option to apply for Federal funding to support the administration of their own foster care, adoption assistance, and guardianship assistance programs under title IV-E of the Social Security Act (SSA). The Act was also amended at Sec. 476(c)(2)(iii) to allow Indian Tribes to receive one-time development grants to be used to offset the cost of developing a title IV-E plan to carry out the requirements of Sec. 479B. Supplemental funding will support Regional Roundtables and build Tribal capacity in the following areas: 1. Development of a presentation on the Social Security Act and title IV-E provisions that provide foster care and adoption service funds. The presentation will be developed to be responsive to the cultural issues and needs of the Tribal audience. 2. Training for Tribal caseworkers on title IV-E requirements in order to continue the eligibility and funding of IV-E eligible children. Caseworkers will be made aware of the provisions of Public Law 110-351 to insure that all appropriate services are provided to children in care. 3. Assistance in the development of training for appropriate foster care recruitment, and retention so that placement of title IV-E eligible children will be made with licensed foster/kin families. Training will emphasize the linkages between for Tribal leaders, child welfare and court staff in the licensing and maintaining of title I-VE eligibility when children are placed in foster care.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Cooperative Agreement To Support Building Global Capacity for the Surveillance and Monitoring of Counterfeit/Falsified Medicines and Supply Chain Threats
The Food and Drug Administration (FDA) is announcing its intention to accept and consider a single source application for award of a cooperative agreement to the World Health Organization (WHO) in support of building a global surveillance and monitoring system for combating counterfeit/falsified medicines and risks and breaches in the supply.
Health Insurance Reform; Announcement of Maintenance Changes to Electronic Data Transaction Standards Adopted Under the Health Insurance Portability and Accountability Act of 1996
This document announces maintenance changes to some of the Health Insurance Portability and Accountability Act of 1996 standards made by the Designated Standard Maintenance Organizations. The maintenance changes are non-substantive changes to correct minor errors, such as typographical errors, or to provide clarifications of the standards adopted in our regulations entitled ``Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards,'' published in the Federal Register on January 16, 2009. This document also instructs interested persons on how to obtain the corrections.
Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology
The Department of Health and Human Services (HHS) is issuing this interim final rule with a request for comment to remove the implementation specifications related to public health surveillance.
National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM): Workshop Series on Best Practices for Regulatory Safety Testing: Assessing the Potential for Chemically Induced Eye Injuries and Chemically Induced Allergic Contact Dermatitis (ACD)
NICEATM and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) announce a planned series of workshops on ``Best Practices for Regulatory Safety Testing.'' The first two workshops in this series, ``Best Practices for Assessing the Potential for Chemically Induced Eye Injuries'' and ``Best Practices for Assessing the Potential for Chemically Induced Allergic Contact Dermatitis,'' are planned for January 19 and 20, 2011, respectively. These one-day workshops will help participants gain a practical understanding of the theory and application of available in vitro and in vivo alternative test methods that can be used to evaluate the hazard potential of chemicals and products while avoiding or minimizing animal use and animal pain and distress. Participants will learn the strengths and weaknesses of available alternative test methods, become familiar with the types of data they provide, and learn how to use these data in regulatory safety assessments. Workshop topics will be of particular interest to those involved in conducting safety tests for chemically induced eye injuries and/or chemically induced ACD, those responsible for reviewing and approving study protocols prior to testing, and regulators who are expected to review data generated by the tests. The workshops are free and open to the public with attendance limited only by the space available. Those interested may register for one or both workshops.
Proposed Collection; Comment Request; the Atherosclerosis Risk in Communities Study (ARIC)
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 Heart, Lung, and Blood Institute (NHLBI), 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. Proposed Collection: Title: The Atherosclerosis Risk in Communities Study (ARIC). Type of Information Collection Request: Revision of a currently approved collection (OMB NO. 0925-0281). Need and Use of Information Collection: ARIC will conduct a clinical examination of the cohort over a 24-month period (May 2011 to April 2013). In addition, this project involves biennual follow-up by telephone of participants in the ARIC study, review of their medical records, and interviews with doctors and family to identify disease occurrence. Interviewers will contact doctors and hospitals to ascertain participants' cardiovascular events. Information gathered will be used to further describe the risk factors, occurrence rates, and consequences of cardiovascular disease in middle aged and older men and women. Frequency of Response: The participants will be contacted bi-annually for follow-up. A subset of the cohort may choose to volunteer for the clinical examination; these individually will be contacted once in a 3 year period. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows: Estimated Number of Respondents: 12,673; Estimated Number of Responses per Respondent: 2.7; Average Burden Hours Per Response: 0.5916; and Estimated Total Annual Burden Hours Requested: 20,434. The annualized cost to respondents is estimated at $355,882, assuming respondents time at the rate of $17.00 per hour and physician time at the rate of $75.00 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Proposed Collection; Comment Request; National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative
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 Center for Research Resources (NCRR), 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. Proposed Collection: Title: The National Evaluation of the Clinical and Translational Science Awards (CTSA) Initiative. Type of Information Collection Request: New. Need and Use of Information Collection: The CTSA Initiative is directed at transforming the way biomedical research is conducted nationwide by reducing the time it takes for basic science or laboratory discoveries to become treatments for patients, and for those treatments in turn to be incorporated and disseminated throughout community practice. The primary purpose of this data collection is to provide information about the process and early outcomes associated with 46 awardees participating in the first four cohorts of CTSA awards, in order to fulfill the congressional expectations for external program evaluation. NIH will use the results to understand the extent to which the CTSA Initiative is bringing about transformational changes in clinical and translational science among academic medical centers and their research partners, increasing the efficiency of the research process, and enhancing the capacity of the field to conduct clinical and translational research. All information collected will be used to provide analytical and policy support to NCRR, assisting NIH in making decisions about current CTSA programming, future funding, and other initiatives to improve clinical and translational science. It may also provide information for NIH's Government Performance and Results Act (GPRA) report. Frequency of Response: Biennial. Affected Public: Individuals. Type of Respondents: Scientific researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 3,563; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.13; Estimated Total Annual Burden Hours Requested: 451.5. The annualized cost to respondents is estimated at $14,056. There are no capital or start-up costs, and no maintenance or service cost components to report.
Implantation and Injectable Dosage Form New Animal Drugs; Ceftiofur Crystalline Free Acid
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for veterinary prescription use of ceftiofur crystalline free acid suspension in swine, by intramuscular injection, for the control of swine respiratory disease (SRD) in groups of pigs where SRD has been diagnosed.
Ferm Solutions, Inc.; Filing of Food Additive Petition (Animal Use); Virginiamycin
The Food and Drug Administration (FDA) is announcing that Ferm Solutions, Inc. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of virginiamycin as an antimicrobial processing aid in fuel-ethanol fermentations with respect to its consequent presence in by-product distiller grains used as an animal feed or feed ingredient.
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