Department of Health and Human Services October 2010 – Federal Register Recent Federal Regulation Documents
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Withdrawal of Approval of New Animal Drug Applications; Aklomide; Levamisole Hydrochloride; Nitromide and Sulfanitran
The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs.
Notice of Listing of Members of the National Centers for Disease Control and Prevention's 2010 Performance Review Board (PRB)
The Centers for Disease Control and Prevention (CDC) announces the persons who will serve on the CDC's 2010 Performance Review Board. This action is being taken in accordance with Title 5, U.S.C., 4314(c)(4), which requires that members of performance review boards be appointed in a manner to ensure consistency, stability, and objectivity in performance appraisals and requires that notice of the appointment of an individual to serve as a member be published in the Federal Register. The following persons will serve on the CDC Performance Review Board, which is responsible for making recommendations on performance appraisal ratings, pay adjustments, and performance awards for CDC's Senior Executive Service (SES) members: Kevin Fenton (Co-Chair), Lynn Austin (Co-Chair), Ed Hunter, Rima Khabbaz, Crayton Lankford, Carolyn Black, Christine Branche, Anne Haddix, Barbara Harris, Jim Seligman, Walter Harris, Hazel Dean, Bill Porter. For further information about the CDC Performance Review Board, contact the Centers for Disease Control and Prevention, Human Capital Management Office, Human Capital Planning Branch, 1600 Clifton Road, NE., MS E-50, Atlanta, GA 30333. Telephone (404) 498-6709 (not a toll free number).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Special Protocol Assessment
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.
Award of a Single-source Program Expansion Supplement Grant to the Research Foundation of the State University of New York (SUNY) at Albany, NY, for the National Child Welfare Workforce Institute (NCWWI)
The Administration for Children and Families (ACF), Children's Bureau (CB) announces the award of a single-source program expansion supplement grant to the Research Foundation at the State University of New York (SUNY) at Albany, National Child Welfare Workforce Institute (NCWWI), Albany, NY, to support additional Bachelor's of Social Work (BSW) and Master's of Social Work (MSW) traineeship programs at three universities. The NCWWI was awarded a cooperative agreement in FY 2008 as the result of a competition. Under the cooperative agreement, NCWWI identifies promising practices in child welfare workforce development, identifies and facilitates leadership training for middle managers and child welfare supervisors, administers BSW and MSW traineeships at multiple universities, engages national peer networks, supports strategic dissemination of effective and promising workforce practices, and advances knowledge through collaboration and evaluation. As part of the program, NCWWI provides stipend to public and/or non-profit institutions of higher education with accredited social work education programs for traineeships for professional education for current or prospective child welfare practitioners enrolled in BSW or MSW social work programs. During the course of traineeship and after obtaining the degree for which the stipend was awarded, stipend recipients must participate in regular training at a child welfare agency and work for a child welfare agency for a period that is equivalent to the period of the supported traineeship. The three programs to be awarded traineeships with the expansion supplement award are: Northeastern State University, Tahlequah, OK. This program provides for a child welfare specialization at the BSW level. Students are recruited from American Indian Tribes for work in Tribal child welfare agencies. University of South Dakota, Vermillion, SD. The BSW program includes a special emphasis on serving rural and Native American populations. Distance education is being used to reach remote geographic areas. New Mexico State University, Las Cruces, NM. This combined BSW and MSW program is selecting trainees that are sensitive to Hispanic/ Chicano heritage and are Spanish speaking. With special field instructors who can address child welfare skills, Hispanic culture, and the Spanish language, this project is serving an overrepresented population in the child welfare system. Contact for Further Information: Jane Morgan, Children's Bureau, 1250 Maryland Avenue, SW., Washington, DC 20024. Telephone: 202-205- 8807. E-mail: jane.morgan@acf.hhs.gov.
Award of Three Single-Source Expansion Supplements to The University of Colorado Health Sciences Center in Aurora, CO, The University of Massachusetts (Institute for Community Inclusion) in Boston, MA, and The University of Minnesota (The Research and Training Center) in Minneapolis, MN
This notice announces that the Administration for Children and Families (ACF), Administration on Developmental Disabilities (ADD) has awarded three single-source expansion supplements for data collection, analyses, and reporting. The following projects will be funded: The University of Colorado Health Sciences Center, Aurora, CO. This cooperative agreement will allow for data collection, analysis and reporting on spending and services for individuals with intellectual and developmental disabilities, including disaggregation of data related to specific demographic groups. The project will analyze and report on trends in utilization of and spending for institutional services and home and community-based services. Project staff will also participate in collaborative efforts with ADD and other data collection projects to review and report on unmet needs in data collection, analyses, and reporting activities that would promote the self- determination, independence, productivity, and integration and inclusion of people with intellectual and developmental disabilities in all facets of community life. The University of Massachusetts (Institute for Community Inclusion), Boston, MA. This cooperative agreement will provide for data collection and analyses related to the effectiveness of State agencies in promoting community integrated employment for individuals with intellectual and developmental disabilities. The project will collect data, analyze, and report on the employment and economic status of individuals with intellectual and developmental disabilities including disaggregation of data related to specific demographic groups. The project will also make recommendations related to the standardization of data and reporting of employment outcomes. Project staff will also participate in collaborative efforts with ADD and other data collection projects to review and report on unmet needs in data collection, analyses, and reporting activities that would promote the self-determination, independence, productivity, and integration and inclusion of people with intellectual and developmental disabilities in all facets of community life. The University of Minnesota (The Research and Training Center), Minneapolis, MN. This cooperative agreement will provide for data collection, analyses, and reporting of national and State statistics on public and private residential services for individuals with intellectual and developmental disabilities, including disaggregation of data related to specific demographic groups. The project will conduct analyses that describe the movement of individuals with intellectual and developmental disabilities from institutional to community settings. Project staff will also participate in collaborative efforts with ADD and other data collection projects to review and report on unmet needs in data collection, analyses, and reporting activities that would promote the self-determination, independence, productivity, and integration and inclusion of people with intellectual and developmental disabilities in all facets of community life. Contact for Further Information: Ophelia McLain, Supervisory Program Specialist, Administration on Developmental Disabilities, 370 L'Enfant Promenade, SW., Mail Stop: HHH-405D, Washington, DC 20447. Telephone: 202-690-7025 E-mail: ophelia.mclain@acf.hhs.gov.
Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Qualification Process for Drug Development Tools.'' This draft guidance describes the qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple drug development programs. The draft guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and DDT sponsors to support work towards qualification of an identified DDT and creates a mechanism for formal review of data by CDER to qualify the DDT and ensure that the evaluation is comprehensive and reliable.
Agency Information Collection Activities; Proposed Collection; Comment Request; Information Request Regarding Dissolvable Tobacco Products
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on an information request regarding the use of dissolvable tobacco products.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guide To Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables
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.
Secretarial Review and Publication of the Annual Report to Congress Submitted by the Contracted Consensus-Based Entity Regarding Performance Measurement
This notice acknowledges the Department of Health and Human Services' (HHS) receipt and review of the annual report submitted to the Secretary and Congress by the contracted consensus-based entity regarding performance measurement as mandated by section 183 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The statute requires HHS to publish not later than six months after receiving the annual report to Congress in the Federal Register together with any Secretarial comments.
Basic Behavioral and Social Science Opportunity Network (OppNet)
A two-day meeting highlighting OppNet's activities and future goals is scheduled for Thursday, October 28, and Friday, October 29, 2010, at the Hyatt Regency Washington on Capitol Hill, 400 New Jersey Avenue, NW., Washington DC 20001. This is the first public meeting to promote and publicize the Basic Behavioral and Social Science Opportunity Network (OppNet) initiative. Attendance is limited to prior registration via https://www.regonline.com/oppnet. Background: The Basic Behavioral and Social Science Opportunity Network (OppNet) is a trans-NIH initiative to expand the agency's funding of basic behavioral and social sciences research (b-BSSR). OppNet prioritizes activities and initiatives that focus on basic mechanisms of behavior and social processes that are relevant to the missions and public health challenges of multiple NIH Institutes, Centers, and Offices (ICOs) and that build upon existing NIH investments without replicating them. https://www.oppnet.nih.gov. Participating: The meeting will take place on October 28, from 9 a.m. to 4:30 p.m., and October 29, from 8:30 a.m. to 2:30 p.m., at the Hyatt Regency Washington on Capitol Hill, 400 New Jersey Avenue, NW., Washington DC 20001.
Common Formats for Patient Safety Data Collection and Event Reporting
The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b-23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 70731-70814. As authorized by the Secretary of HHS, AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. The purpose of this notice is to announce the availability of a significant revision of a previously released Common Format for public review and comment.
Decision To Evaluate a Petition To Designate a Class of Employees From BWX Technologies Inc., Lynchburg, VA, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from BWX Technologies, Inc., Lynchburg, Virginia, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: BWX Technologies, Inc. Location: Lynchburg, Virginia. Job Titles and/or Job Duties: All Atomic Weapons Employer employees. Period of Employment: January 1, 1985 through November 30, 1994.
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