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Code · REGISTER · 2007-04-06 · DEPARTMENT OF HEALTH AND HUMAN SERVICES · Notices

Notices. Notice

16,054 words·~73 min read·/register/2007/04/06/07-1643

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BILLING CODE 6725-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: OS-0990-0000] Thirty-Day Notice AGENCY: Office of the Secretary. Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this 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. *Type of Information Collection Request:* Existing Collection without an OMB number. *Title of Information Collection:* National Blood Collection and Utilization Survey. *Form/OMB No.:* OS-0990-New. *Use:* The Advisory Committee on Blood Safety and Availability, Health and Human Services (HHS), was established to provide policy advice to the Secretary and the Assistant Secretary for Health. The advice of the committee is partly dependent on the analysis of relevant blood collection and utilization data which is also widely distributed and used by the transfusion medicine community. To that end, the Office of Public Health and Science
(OPHS)is responsible for conducting a bi-annual cross-sectional national blood products survey. OPHS performed the 2005 National Blood Collection and Utilization Survey (NBCUS) using a nationally representative sample of hospitals and blood collection centers. Previously private and government financed versions of the NBCUS have successfully surveyed greater than 90% of the U.S. blood collection and processing facilities and more than 2900 hospital based transfusion blood banks in the United States. The objective of the 2007 NBCUS is to produce reliable and accurate estimates of national and regional collections, utilization, and safety of all blood products—red blood cells, fresh frozen plasma, and platelets. New to the 2007 NBCUS is the identification and collection of baseline data for biovigilance blood safety monitoring. An important purpose of the survey is to help the federal government implement a blood safety public health monitoring system. The survey will be mailed to approximately 3000 institutions that include hospitals, blood collection facilities, and cord blood banks selected from the American Hospital Association annual survey database and AABB member list of blood collection facilities, respectively. The maximum length of the instrument will be approximately 20-21 pages and the estimated number of data elements will be 200 to 300. The survey will include general questions about the institution, questions about blood collection, processing, and testing, blood transfusion, special procedures and product disposition, cellular therapy products, and human tissue. The 2007 NBCUS will also include additional questions on issues of biovigilance patient safety monitoring. Facilities will be surveyed regarding their 2006 calendar year activities. A toll-free hotline service for survey inquiries will be made available. Follow-up procedures will be in place to address survey non-responders. Following data collection, statistical tabulations of results for each question will be performed. The survey data will be analyzed by institution type, services provided, USPHS region, etc. A final comprehensive report on blood collection and transfusion-related activities in the United States will be issued for publication by HHS. *Frequency:* One time. *Affected Public:* Business or other for-profit. *Annual Number of Respondents:* 3000. *Total Annual Responses:* 3000. *Average Burden Per Response:* 3 hours. *Total Annual Hours:* 9000. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to *Sherette.funncoleman@hhs.gov* , or call the Reports Clearance Office on
(202)690-6162. Written comments and recommendations for the proposed information collections must be received within 30 days of this notice directly to the Desk Officer at the address below: OMB Desk Officer: John Kraemer, OMB Human Resources and Housing Branch, Attention: (OMB #0990-New), New Executive Office Building, Room 10235, Washington, DC 20503. Dated: March 29, 2007. Alice Bettencourt, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E7-6415 Filed 4-5-07; 8:45 am] BILLING CODE 4150-41-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: OS-0990-0220] Thirty-Day Notice AGENCY: Office of the Secretary. Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this 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. *Type of Information Collection Request:* Extension. *Title of Information Collection:* Voluntary Academic and Industry Partner Surveys to Implement Executive Order 12862 and 5 U.S.C 305 for the Dept. of Health and Human Services. *Form/OMB No.:* OS-0990-0220. *Use:* The Office of Acquisition Management Policy
(OAMP)under the Assistant Secretary for Administration and Management
(ASAM)and the Office of Grants
(OG)under the Assistant Secretary for Resources and Technology (ASRT), Office of the Secretary, Department of Health and Human Services
(HHS)request that the Office of Management and Budget
(OMB)extend its existing approval under Clearance No. 0990-0220 for HHS to undertake voluntary surveys of HHS partners in academia and industry ( *e.g.* , Principal Investigators, business offices, and vendors) through January 31, 2010. To comply with Executive Order 12862, Setting Customer Service Standards (the EO), HHS again plans to systematically survey its grant recipients and contractors to compile their evaluations of the Department's grants and procurement processes, and to improve the way we conduct business with them. These voluntary surveys will continue to be a collaborative effort, with OAMP and OG providing leadership, oversight, and a methodology; and the HHS Operating Divisions (OPDIVs) conducting the surveys for their own operations. Each OPDIV will conduct web-based surveys of its partners to obtain feedback for improving business processes. The grant recipients and contractors to be surveyed are sufficiently familiar with the Department and its OPDIVs to make this feedback extremely useful. These surveys will give OAMP, OG, and each of the OPDIVs an opportunity to understand and evaluate grant and procurement quality standards, as well as to incorporate best industry or public sector standards into OPDIV practices. *Frequency:* Reporting every 3 years. *Affected Public:* Business or other for-profit, not-for-profit institutions, Federal Government. *Annual Number of Respondents:* 2133. *Total Annual Responses:* 2133. *Average Burden Per Response:* 10.75 minutes. *Total Annual Hours:* 382. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to *Sherette.funncoleman@hhs.gov* , or call the Reports Clearance Office on
(202)690-6162. Written comments and recommendations for the proposed information collections must be received within 30 days of this notice directly to the Desk Officer at the address below: OMB Desk Officer: John Kraemer, OMB Human Resources and Housing Branch, Attention: (OMB #0990-New), New Executive Office Building, Room 10235, Washington, DC 20503. Dated: March 29, 2007. Alice Bettencourt, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E7-6416 Filed 4-5-07; 8:45 am] BILLING CODE 4151-17-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Awareness of Embryo Donation and/or Adoption Public Awareness Campaign AGENCY: Office of Population Affairs, Office of Public Health and Science, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. *Announcement Type:* This is the initial announcement of a competitive funding opportunity for cooperative agreement projects. *Funding Opportunity Number:* OPA-2007-EA. *CFDA Number:* 93.007. DATES: To receive consideration, applications must be received no later than 5 p.m. Eastern Time on June 5, 2007. The application due date requirement in this announcement supercedes the instructions in the OPHS-1 form. A Letter of Intent
(LOI)is requested on or by May 7, 2007. ADDRESSES: To receive consideration, applications must be received in the Office of Grants Management, Office of Public Health and Science (OPHS), Department of Health and Human Services
(HHS)c/o WilDon Solutions, Office of Grants Management Operations Center, 1515 Wilson Blvd., Third Floor, Suite 310, Arlington, VA 22209: Attention: Office of Population Affairs. LOIs should be sent to the same address. *Executive Summary:* The Office of Population Affairs (OPA), within the Office of Public Health and Science
(OPHS)announces the availability of Fiscal Year
(FY)2007 funds to support a total of four to five new cooperative agreement projects, with the goal of increasing public awareness of embryo donation and/or adoption. OPA anticipates approximately $1,000,000 in funding will be available for four to five new cooperative agreements each in the range of $250,000 to $350,000 per year. Projects will be funded in annual increments (budget periods) and for a project period of two years. Funding for all budget periods beyond the first year of the cooperative agreement is contingent upon the availability of funds, satisfactory progress of the project, and adequate stewardship of Federal funds. Applicants must demonstrate experience with embryo donation and/or adoption programs that conform with professionally recognized standards governing embryo donation and/or adoption and other applicable Federal or State requirements. For the purposes of this announcement, embryo donation and/or adoption is defined as the donation of frozen embryo(s) from one party to a recipient who wishes to bear and raise a child or children. I. Funding Opportunity Description The OPA announces the availability of funds for FY 2007 and requests applications for cooperative agreement projects that will contribute to increasing public awareness of embryo donation and/or adoption. The OPA is under the direction of the Deputy Assistant Secretary for Population Affairs (DASPA), who serves as the senior advisor to the Assistant Secretary for Health
(ASH)on reproductive health science issues. The OPA established by PL 91-572 serves as the focal point on matters pertaining to population research and family planning, and is responsible for developing and making readily available information (including educational materials) on family planning and population growth to all persons desiring such information. The increasing success of assisted reproductive technologies
(ART)has resulted in a situation in which an infertile couple typically creates several embryos through in-vitro fertilization (IVF). During IVF treatments, couples may produce many embryos in an attempt to conceive with several being cryopreserved (frozen) for future use. If a couple conceives without using all of the stored embryos, they may choose to release the remaining unused embryos for donation and adoption allowing other infertile couples the experience of pregnancy and birth. Embryo donation and/or adoption is a relatively new process in which individuals who have extra frozen embryos agree to release the embryos for transfer to the uterus of another woman, either known or anonymous to the donor(s) for the purpose of the recipient(s) attempting to bear a child and be that child's parent. Legislative History On February 15, 2007, the President signed into law H.J. Res. 20, which provides fiscal year
(FY)2007 appropriations through September 30, 2007, for continuing projects and activities of the Federal Government. Public Law 110-5, the “Revised Continuing Appropriations Resolution, 2007”, which includes appropriations for DHHS. The bill does not include a statement addressing embryo adoption and/or donation public awareness campaign activities; however, the Revised Continuing Appropriations Bill for 2007 provides “ * * * such amounts as may be necessary, at the level specified in subsection
(c)and under the authority and conditions provided in the applicable appropriations Act for fiscal year 2006, for projects or activities (includes the costs of direct loans and loan guarantees) that are not otherwise provided for and for which appropriations, funds, or other authority were made available in the following appropriations Acts: * * *
(5)The Departments of Labor, Health and Human Services, and Education, and Related Appropriations Act, 2006.” Public Law 109-149, The Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations Act, 2006, authorized the Secretary to a conduct public awareness campaign to educate Americans about the existence of frozen embryos available for donation and/or adoption. The Conference Report (H.R. Conf. Rep. 109-337) accompanying the FY 2006 Appropriations for the Departments of Labor, Health and Human Services, and Education and Related Agencies did not include a statement addressing embryo donation and/or adoption awareness activities; however, the budget table accompanying the conference report allocated $2 million. Review of Grant Materials Grantees shall submit all materials proposed for use in the funded project (including, but not limited to, Web sites, videos, training materials, brochures, fact sheets, press releases, agendas, curricula, reports, journal articles, promotional pieces, advertisements, Public Service Announcements (PSA's), articles, mailings) to the OPA Project Officer for review and approval prior to use in the funded program. The review shall ensure that materials are consistent with the requirements of this announcement and other applicable grant requirements. Grant Attribution The OPA is interested in making available to the public the results and accomplishments of activities that it funds. Therefore, grantees will be required to place an acknowledgment of OPA grant support and a disclaimer, as appropriate, on any publication written or published with such support and, if feasible, on any publication reporting the results of or describing a grant-supported activity. II. Award Information *Funding Instrument Type:* Cooperative Agreement. *Anticipated Total Funding:* $1,000,000. *Anticipated Number of Awards:* A total of 4-5. OPA anticipates funding four to five new projects. *Expected Amounts of Individual Awards:* $250,000-$350,000. *Floor of Award Range:* None. *Ceiling of Award Range:* $350,000 for the first 12 month budget period. OPA will not accept and review applications with budgets greater than the ceiling of the award range. *Project Periods for Awards:* 24 months. The projects will be awarded for a project period of 24 months. The initial grant award will be for a 12-month budget period. The award of continuation funding beyond each 12-month budget period will be subject to the availability of funds, satisfactory progress on the part of the grantee, and a determination that continued funding would be in the best interest of the government. Applications are encouraged from organizations which are currently operating programs that have the capability of expanding and enhancing public awareness of embryo donation and/or adoption, and that have the capability to conduct a rigorous evaluation of the funded project. A cooperative agreement is a grant award instrument establishing an “assistance” relationship between OPA and a recipient, in which substantial programmatic involvement with the recipient is anticipated during the performance of the activity. The recipient will have lead responsibilities in all aspects of the project, including any modifications to the project, conduct of the project, and preparation of any publications. The OPA project officer will collaborate with the recipients, as appropriate, and provide consultation, assistance, and support in planning, implementing, and evaluating all aspects of the proposed project plan. OPA will have substantial programmatic involvement during conduct of the project, through technical assistance, advice and coordination. Substantial involvement as a partner would include, for example, assisting in planning an agenda, selecting speakers, organizing a symposium, determining the content of training curricula and related educational materials, determining the topics or data to be reviewed as part of an assessment, and determining the acceptability of articles or reports. OPA will provide assistance in the preparation and review of any reports that may be disseminated as part of a funded project. III. Eligibility Information 1. Eligible Applicants Eligible applicants must demonstrate previous experience with embryo donation and/or adoption and be knowledgeable in all elements of the process of embryo donation and/or adoption. Only agencies and organizations, not individuals, are eligible to apply. Eligible applicants include public agencies, non-profit organizations, and for-profit organizations. One agency must be identified as the applicant organization and will have legal responsibility for the project. Additional agencies and organizations can be included as co-participants, subgrantees, subcontractors, or collaborators if they will assist in providing expertise and in helping to meet the needs of the recipients. Any public or private nonprofit organization or agency is eligible to apply for a cooperative agreement grant. However, only those organizations or agencies which demonstrate the capability of providing the proposed services and meet the requirements of this announcement are considered for awards. Faith-based and community-based organizations that meet the eligibility requirements are encouraged to apply for these embryo donation and/or adoption public awareness cooperative agreement projects. Please note, however, that cooperative agreement funds may not be used for inherently religious activities, such as worship, religious instruction, and proselytization. If an organization engages in such activities, they must be offered separately in time or location from the cooperative agreement program and participation must be voluntary for program beneficiaries. A cooperative agreement program, in providing services and outreach related to program services, cannot discriminate against current or prospective program beneficiaries on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to actively participate in a religious practice. Applicants should note that section 74.81 of the DHHS grants administration regulations (45 CFR part 74) indicates that except for awards under certain small business programs, no grant funds may be paid as profit to any recipient even if the recipient is a commercial organization. Profit is any amount in excess of allowable direct and indirect costs. 2. Cost Sharing or Matching None. IV. Application and Submission Information 1. Address To Request Application Kit Application kits may be obtained by accessing Grants.gov at *http://www.grants.gov* or the GrantSolutions system at GrantSolution.gov. To obtain a hard copy of the application kit, contact WilDon Solutions at 1-888-203-6161. Applicants may fax a written request to WilDon Solutions at
(240)453-8823 or e-mail the request to *OPHSgrantinfo@teamwildon.com.* Applications must be prepared using Form OPHS-1, which can be obtained at the Web sites noted above. 2. Content and Form of Application Submission The OPA requests that you send a Letter of Intent
(LOI)if you intend to apply for this program. Although the LOI is not required, not binding, and does not enter into the review of your subsequent application, the LOI will be used to gauge the level of interest in this program, estimate the potential review workload, and allow OPA to plan the review process. The information will be used to determine the number of expert reviewers needed to evaluate the applications. The narrative should be not more than two double-spaced pages, printed on one side, with one-inch margins, and in 12-point font, unreduced. The LOI should include the following information: “Attention: Embryo Adoption Public Awareness Campaign Letter of Intent,” name and address of the applicant institution; name, address and telephone number of the contact person; and specific objectives to be addressed by the proposed project. Applications must be prepared on the forms supplied (OPHS-1) and in the manner prescribed in the application kits provided by the OPA. The application must be signed by an individual authorized to act for the applicant agency and to assume responsibility for the obligations imposed by the terms and conditions of the grant award. To be considered for funding, applicants must submit one signed original of the application and two photocopies in one package, including all forms and attachments. Please label the application envelope: “Attention: Embryo Adoption Public Awareness Campaign.” The application should be typed and should be no more than 50 double-spaced pages (excluding attachments), printed on one side, with one-inch margins, and in 12-point font, unreduced. All pages, including appendices should be numbered sequentially and stapled, or otherwise secured, in the upper left corner. Applications must include a one-page abstract of the proposed project. The abstract will be used to provide reviewers with an overview of the application, and will form the basis for the applications summary in grants management documents. Program Requirements/Application Content Applicants will be required to develop and implement programs for a public awareness campaign on embryo adoption. Applicants are required to submit a plan and time line that demonstrate that the proposed public awareness campaign:
(a)Will be competency-based,
(b)has experience with embryo adoption programs that conform to professionally-recognized guidelines and other relevant Federal or State requirements,
(c)will be pilot tested and appropriately modified, as necessary, before use, and
(d)can be reliably evaluated. In the narrative section of the application, applicants are advised to describe the strategies and processes that they will use to design a public awareness campaign. The applicant should document its capacity to undertake a public awareness campaign focused on potential donors and/or recipients. Applicants are encouraged to present a description of approaches that may be used, as well as any supplemental materials (brochures, handouts, visual aids, and other resources). Moreover, applicants are advised to demonstrate a familiarity with and understanding of professionally recognized standards or practices (both medical and legal issues) pertaining to embryo adoption, as well as supportive services for potential donor or recipient couples. The applicant organization should clearly demonstrate its professional knowledge and experience in embryo adoption whether with potential donor or recipient populations. Applicants must make reasonable efforts to ensure that the individuals who design and implement the public awareness campaign are knowledgeable in all elements of the embryo adoption process and are experienced in providing such information. Applicant organizations should demonstrate that they have access to frozen embryos for adoption either directly or through partnership arrangements. Applicants should include information about the number of frozen embryos to which they have access, their history in working with either potential donor or recipient couples, and the organization's capacity to facilitate an embryo adoption public awareness campaign. In the project narrative, applicants are encouraged to present a plan that may be used for working with potential donors and/or recipients under the proposed public awareness campaign. Application Narrative In the narrative section of the application, applicants are advised to describe the strategies and processes that they will use. The applicant should document its capacity to undertake a project that is focused on increasing public awareness of embryo donation and/or adoption. Applicants are encouraged to present a description of approaches that may be used, as well as any supplemental materials. Moreover, applicants are advised to demonstrate a familiarity with and understanding of professionally recognized standards or practices (both medical and legal issues) pertaining to embryo donation and/or adoption, as well as supportive services for potential donor or recipient couples. The applicant organization should clearly demonstrate its professional knowledge and experience in embryo donation and/or adoption. Applicants should include information about their history in working with embryo donation and/or adoption, and the organization's capacity to further the goal of increasing public awareness of embryo donation and/or adoption. As part of the project narrative, applicants are advised to describe the methods they will use to recruit, select, train and evaluate individuals who will implement the project. Applicants, in the project narrative, are encouraged to present a plan for evaluation of the project. The evaluation plan should be two tiered to address:
(1)Process, including the planning, content, and quality of the products (e.g., videos, pamphlets, journal articles, presentations, survey instruments, focus groups projects, pilot test reports, conference proceedings, etc.) produced and
(2)participant satisfaction and/or project effectiveness, as appropriate. Applicants that do not have the in-house capacity to conduct an evaluation are advised to propose contracting with a third party evaluator to conduct the evaluation. Applicants should prepare a project description statement in accordance with the following general instructions and use the information provided in this section and the evaluation criteria section to develop the application content. Applications will be evaluated on the criteria listed, so it is important to follow them in describing your program plan. The narrative should contain the following sections in the order presented below: 1. *Project Summary/Abstract:* Provide a summary of the project description not to exceed one page. Care should be taken to produce an abstract/summary that accurately and concisely reflects the proposed project since the abstract will be used to provide reviewers with an overview of the application, will form the basis for an application summary in official documents, and it may be posted on the OPA web site. It should describe the objectives of the project, the approach to be used, and the results or benefits expected. 2. *Objectives and Need for Assistance:* Clearly identify the physical, economic, social, legal, financial, institutional, and/or other problem(s) requiring a solution. The need for assistance must be demonstrated and the principal and subordinate objectives of the project must be clearly stated; supporting documentation, such as letters of support and testimonials from concerned interests other than the applicant, may be included. Describe the rationale for use of the proposed approach based upon previous practice and review of the literature and/or evaluation findings. Any relevant data based on studies should be included or referred to in the endnotes/footnotes. In developing the project description, the applicant may volunteer to provide information on the total range of related projects being conducted or supported (or to be initiated), some of which may be outside the scope of the program announcement. Describe the specific geographic region that will be served by the organization. This section should include a justification for the selection of the region, based on, for example, geographic size or the number and types of ART centers in the area. There are no geographic restrictions on where the prospective projects may be conducted. The OPA will accept applications for projects of national, regional, or local scope. The rationale for the project scope must be justified in detail. 3. *Approach:* Provide a detailed work plan and timetable for both the first and second year of the proposed project. Outline a plan of action, which describes the scope and detail of how the proposed work will be accomplished. Account for all functions or activities identified in the application. Cite factors that might accelerate or decelerate the work, and state your reason for taking the proposed approach rather than others. Describe any unusual features of the project such as design or technological innovations, reductions in cost or time, or extraordinary social and community involvement. Provide quantitative monthly or quarterly projections of the accomplishments to be achieved for each function or activity in such terms as the number of program activities to be held, or appropriate measurable outcomes. When accomplishments cannot be quantified by activity or function, list them in chronological order to show the schedule of accomplishments and their target dates. 4. *Evaluation:* Provide a narrative addressing how the results of the project and the conduct of the project will be evaluated. In addressing the evaluation of results, state how you will determine the extent to which the project has achieved its stated objectives and the extent to which the accomplishment of objectives can be attributed to the project. Discuss the criteria to be used to evaluate results, and explain the methodology that will be used to determine if the needs identified and discussed are being met and if the project results and benefits are being achieved. With respect to the conduct of the project, define the procedures to be employed to determine whether the project is being conducted in a manner consistent with the work plan presented and discuss the impact of the project's various activities on the project's effectiveness. 5. *Organizational Profiles:* Provide information on the applicant organization and cooperating partners such as organizational charts, financial statements, audit reports or statements from CPAs/Licensed Public Accountants, Employer Identification Numbers, names of bond carriers, contact persons and telephone numbers, and other documentation of professional accreditation, information on compliance with Federal/State/local government standards, documentation of experience in the program area, and other pertinent information. 6. *Budget and Budget Justification:* Provide a narrative budget justification that describes how the categorical costs are derived. Discuss the necessity, reasonableness, and allocability of the proposed costs. Identify the project director or principal investigator, if known. For each staff person, provide the title, time commitment to the project (in months), time commitment to the project (as a percentage or full-time equivalent), annual salary, grant salary, and wage rates. Do not include the costs of consultants or personnel costs of delegate agencies or of specific project(s) or businesses to be financed by the applicant. Provide a breakdown of the amounts and percentages that comprise fringe benefit costs such as health insurance, FICA, retirement insurance, and taxes, unless treated as part of an approved indirect cost rate. Include information on the costs of project-related travel by employees of the applicant organization (does not include costs of consultant travel). For each trip, show the total number of traveler(s), travel destination, duration of trip, per diem, mileage allowances, if privately owned vehicles will be used, and other transportation costs and subsistence allowances. For each type of equipment requested, provide a description of the equipment, the cost per unit, the number of units, the total cost, and a plan for use on the project, as well as use or disposal of the equipment after the project ends. An applicant organization that uses its own definition for equipment should provide a copy of its policy or section of its policy which includes the equipment definition. Specify general categories of supplies and their costs. Show computations and provide other information, which supports the amount requested. Include information on the costs of all contracts for services and goods except for those, which belong under other categories such as equipment, supplies, construction, etc. Third-party evaluation contracts (if applicable) and contracts with secondary recipient organizations, including delegate agencies and specific project(s) or businesses to be financed by the applicant, should be included under this category. Whenever the applicant intends to delegate part of the project to another agency, the applicant must provide a detailed budget and budget narrative for each delegate agency, by agency title, along with the required supporting information. 3. Submission Dates and Times To be considered for review, applications must be received by the Office of Public Health and Science, Office of Grants Management, c/o WilDon Solutions, by 5 p.m. Eastern Time on June 5, 2007. Applications will be considered as meeting the deadline if they are received on or before the deadline date. The application due date requirement in this announcement supercedes the instructions in the OPHS-1 form. Submission Mechanisms The Office of Public Health and Science
(OPHS)provides multiple mechanisms for the submission of applications, as described in the following sections. Applicants will receive notification via mail from the OPHS Office of Grants Management confirming the receipt of applications submitted using any of these mechanisms. Applications submitted to the OPHS Office of Grants Management after the deadlines described below will not be accepted for review. Applications which do not conform to the requirements of the grant announcement will not be accepted for review and will be returned to the applicant. While applications are accepted in hard copy, the use of the electronic application submission capabilities provided by the GrantSolutions system or the Grants.gov Website Portal is encouraged. Applications may only be submitted electronically via the electronic submission mechanisms specified below. Any applications submitted via any other means of electronic communication, including facsimile or electronic mail, will not be accepted for review. In order to apply for new funding opportunities which are open to the public for competition, you may access the Grants.gov website portal. All OPHS funding opportunities and application kits are made available on Grants.gov. If your organization has/had a grantee business relationship with a grant program serviced by the OPHS Office of Grants Management, and you are applying as part of ongoing grantee related activities, please access GrantSolutions.gov. Electronic grant application submissions must be submitted no later than 5 p.m. Eastern Time on the deadline date specified in the DATES section of the announcement using one of the electronic submission mechanisms specified below. All required hardcopy original signatures and mail-in items must be received by the OPHS Office of Grants Management no later than 5 p.m. Eastern Time on the next business day after the deadline date specified in the DATES section of the announcement. Applications will not be considered valid until all electronic application components, hardcopy original signatures, and mail-in items are received by the OPHS Office of Grants Management according to the deadlines specified above. Application submissions that do not adhere to the due date requirements will be considered late and will be deemed ineligible. Applicants are encouraged to initiate electronic applications early in the application development process, and to submit early on the due date or before. This will aid in addressing any problems with submissions prior to the application deadline. Electronic Submissions via the Grants.gov Website Portal The Grants.gov Website Portal provides organizations with the ability to submit applications for OPHS grant opportunities. Organizations must successfully complete the necessary registration processes in order to submit an application. Information about this system is available on the Grants.gov Web site, *http://www.grants.gov.* In addition to electronically submitted materials, applicants may be required to submit hard copy signatures for certain Program related forms, or original materials as required by the announcement. It is imperative that the applicant review both the grant announcement, as well as the application guidance provided within the Grants.gov application package, to determine such requirements. Any required hard copy materials, or documents that require a signature, must be submitted separately via mail to the OPHS Office of Grants Management, and, if required, must contain the original signature of an individual authorized to act for the applicant agency and the obligations imposed by the terms and conditions of the grant award. When submitting the required forms, do not send the entire application. Complete hard copy applications submitted after the electronic submission will not be considered for review. Electronic applications submitted via the Grants.gov Website Portal must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative and any appendices or exhibits. All required mail-in items must be received by the due date requirements specified above. Mail-In items may only include publications, resumes, or organizational documentation. When submitting the required forms, do not send the entire application. Complete hard copy applications submitted after the electronic submission will not be considered for review. Upon completion of a successful electronic application submission via the Grants.gov Website Portal, the applicant will be provided with a confirmation page from Grants.gov indicating the date and time (Eastern Time) of the electronic application submission, as well as the Grants.gov Receipt Number. It is critical that the applicant print and retain this confirmation for their records, as well as a copy of the entire application package. All applications submitted via the Grants.gov Website Portal will be validated by Grants.gov. Any applications deemed “Invalid” by the Grants.gov Website Portal will not be transferred to the GrantSolutions system, and OPHS has no responsibility for any application that is not validated and transferred to OPHS from the Grants.gov Website Portal. Grants.gov will notify the applicant regarding the application validation status. Once the application is successfully validated by the Grants.gov Website Portal, applicants should immediately mail all required hard copy materials to the OPHS Office of Grants Management to be received by the deadlines specified above. It is critical that the applicant clearly identify the organization name and Grants.gov Application Receipt Number on all hard copy materials. Once the application is validated by Grants.gov, it will be electronically transferred to the GrantSolutions system for processing. Upon receipt of both the electronic application from the Grants.gov Website Portal, and the required hardcopy mail-in items, applicants will receive notification via mail from the OPHS Office of Grants Management confirming the receipt of the application submitted using the Grants.gov Website Portal. Applicants should contact Grants.gov regarding any questions or concerns regarding the electronic application process conducted through the Grants.gov Website Portal. Electronic Submissions via the GrantSolutions System The electronic grants management system, GrantSolutions.gov, provides for applications to be submitted electronically. When submitting applications via the GrantSolutions system, applicants are required to submit a hard copy of the application face page (Standard Form 424) with the original signature of an individual authorized to act for the applicant agency and assume the obligations imposed by the terms and conditions of the grant award. If required, applicants will also need to submit a hard copy of the Standard Form LLL and/or certain Program related forms ( *e.g.* , Program Certifications) with the original signature of an individual authorized to act for the applicant agency. When submitting the required forms, do not send the entire application. Complete hard copy applications submitted after the electronic submission will not be considered for review. Electronic applications submitted via the GrantSolutions system must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative and any appendices or exhibits. The applicant may identify specific mail-in items to be sent to the Office of Grants Management separate from the electronic submission; however, these mail-in items must be entered on the GrantSolutions Application Checklist at the time of electronic submission, and must be received by the due date requirements specified above. Mail-In items may only include publications, resumes, or organizational documentation. When submitting the required forms, do not send the entire application. Complete hard copy applications submitted after the electronic submission will not be considered for review. Upon completion of a successful electronic application submission, the GrantSolutions system will provide the applicant with a confirmation page indicating the date and time (Eastern Time) of the electronic application submission. This confirmation page will also provide a listing of all items that constitute the final application submission including all electronic application components, required hardcopy original signatures, and mail-in items, as well as the mailing address of the OPHS Office of Grants Management where all required hard copy materials must be submitted. As items are received by the OPHS Office of Grants Management, the electronic application status will be updated to reflect the receipt of mail-in items. It is recommended that the applicant monitor the status of their application in the GrantSolutions system to ensure that all signatures and mail-in items are received. Mailed or Hand-Delivered Hard Copy Applications Applicants who submit applications in hard copy (via mail or hand-delivered) are required to submit an original and two copies of the application. The original application must be signed by an individual authorized to act for the applicant agency or organization and to assume for the organization the obligations imposed by the terms and conditions of the grant award. Mailed or hand-delivered applications will be considered as meeting the deadline if they are received by the OPHS Office of Grant Management on or before 5 p.m. Eastern Time on the deadline date specified in the DATES section of the announcement. The application deadline date requirement specified in this announcement supersedes the instructions in the OPHS-1. Applications that do not meet the deadline will be returned to the applicant unread. 4. Intergovernmental Review This program is not subject to the intergovernmental review requirements of Executive Order 12372, “Intergovernmental Review of Federal Programs,” as implemented by 45 CFR part 100. 5. Funding Restrictions The allowability, allocability, reasonableness, and necessity of direct and indirect costs that may be charged to OPHS grants are outlined in the following documents: OMB Circular A-21 (Institutions of Higher Education); OMB Circular A-87 (State and Local Governments); OMB Circular A-122 (Nonprofit Organizations); and 45 CFR part 74, Appendix E (Hospitals). Copies of the Office of Management and Budget
(OMB)Circulars are available on the Internet at *http://www.whitehouse.gov/omb/grants/grants_circulars.html.* Applicants for cooperative agreements are expected to anticipate and justify their funding needs and the activities to be carried out with those funds in preparing the budget and accompanying narrative portions of their applications. If applicants are uncertain whether a particular cost is allowable, they should contact the OPHS Office of Grants Management at 240-453-8822 for further information. V. Application Review Information 1. Criteria Each application for a cooperative agreement grant project will be evaluated individually according to the following criteria by a panel of independent reviewers appointed by the OPHS. Before the review panel convenes, each application will be screened for applicant organization eligibility, as well as to make sure the application contains all of the essential elements. Applicants that meet the requirements of this program announcement will be notified by the Office of Grants Management. A panel of at least three reviewers will use the evaluation criteria listed below to determine the strengths and weaknesses of each application, provide comments and assign numerical scores. Applicants should address each criterion in the project application. The point values (summing up to 100) indicate the maximum numerical weight each criterion will be accorded in the review process. Criterion 1: Objectives and Need for Assistance (30 Points) Applicants must demonstrate a clear understanding of the legislative goals and demonstrate how their approach to the project design will contribute to achieve the legislative goals. Applicants must also demonstrate an understanding of the information and skills needed by the designated staff, as well as of the intended audience. Applicants should provide letters of commitment or Memoranda of Understanding from organizations, agencies, and consultants that will be partners or collaborators in the proposed project. These documents should describe the role of the agency, organization, or consultant and detail specific tasks to be performed. Specific review criteria include:
(1)Extent to which the application reflects an understanding of the legislative goals of the public awareness campaign for embryo donation and/or adoption, and implementation will contribute to achieving the legislative goals;
(2)Extent to which the application clearly describes and documents an understanding of the need for assistance to support and/or enhance existing efforts regarding public awareness of embryo donation and/or adoption;
(3)Extent to which the application reflects a knowledge and understanding of the challenges involved with embryo donation and/or adoption, and in increasing public awareness about embryo donation and/or adoption;
(4)Extent to which the application reflects a knowledge and understanding of the medical and legal framework of embryo donation and/or adoption, and the services and resources in the geographic area in which the proposed project will be conducted;
(5)Extent to which the application explains how the proposed project will contribute to increased knowledge of the problems, issues, and effective strategies and best practices in the field of embryo donation and/or adoption; and,
(6)Extent to which the application presents a vision of how the project will advance embryo donation and/or adoption public awareness, and discusses broad contextual factors that will facilitate or impede increasing public awareness of embryo donation and/or adoption. Criterion 2: Approach (30 Points) In this section, applicants are expected to define goals and specific, measurable objectives for the project. Goals are an end product of an effective project. Objectives are measurable steps for reaching goals. Applicants are advised to describe a preliminary, yet appropriate and feasible plan of action pertaining to the scope of the proposed project and provide details on how the proposed project will be accomplished. If the project involves partnerships with other agencies and organizations, then the roles of each partner should be clearly specified. Applicants are required to describe how the project will be evaluated to determine the extent to which it has achieved its stated goals and objectives. Applicants are expected to present a project design that includes detailed procedures for documenting project activities that is sufficient to implement the goals and provide for an evaluation. The evaluation design is expected to include process and outcome analyses, if feasible. Applicants are expected to report on their evaluation results in their final report to the OPHS upon completion of the project period. Applicants are required to describe the activities that they will develop pursuant to the project. Applicants should discuss the intended audiences for these activities (e.g., ART centers, adoption organizations, practitioners, professional organizations that work with infertile couples, potential recipients, or donors) and present a dissemination plan specifying the venues for conveying the information. This criterion consists of four broad topics:
(A)project design,
(B)implementation,
(C)evaluation, and
(D)dissemination. Specific review criteria include:
(A)*Design of the Project.*
(1)Extent to which the application reflects a familiarity with and understanding of professionally recognized standards and/or other relevant Federal or State requirements pertaining to embryo donation and/or adoption.
(2)Extent to which the proposed project goals, objectives, and outcomes are clearly specified and measurable, and reflect an understanding of the context in which embryo donation and/or adoption operates; and,
(3)Extent to which the application presents an approach that is:
(a)Competency based,
(b)consistent with the nationally recognized guidelines, and
(c)can be evaluated.
(B)*Implementation.*
(1)Extent to which the application clearly describes and provides a justification for the selection of the geographic region that will be served by the project;
(2)Extent to which the application presents an appropriate, feasible, and realistic plan for conducting the project;
(3)Extent to which the application presents an appropriate, feasible and realistic plan for recruiting, selecting, and training individuals to conduct the project;
(4)Extent to which the application provides an appropriate, feasible and realistic plan for documenting project activities and results, that can be used to describe and evaluate the project, and participant satisfaction; and,
(5)Extent to which the proposed project will establish and coordinate linkages with other appropriate agencies and organizations.
(C)*Evaluation.*
(1)Extent to which the methods of evaluation are feasible, comprehensive, and appropriate to the goals, objective, and context of the project;
(2)Extent to which the applicant provides an appropriate, feasible, and realistic plan for evaluating the project, including performance feedback and assessment of program progress that can be used as a basis for program adjustments;
(3)Extent to which the methods of evaluation include process and outcome analyses, as appropriate, for assessing the effectiveness of program strategies and the implementation process; and,
(4)Extent to which the methods of evaluation include the use of objective performance measures that are clearly related to the intended outcomes of the program and will produce quantitative and qualitative results.
(D)*Dissemination.*
(1)Extent to which the application provides an appropriate, feasible and realistic plan for dissemination of information and related educational materials;
(2)Extent to which the intended audience is clearly identified and defined and is appropriate to the goals of the proposed program;
(3)Extent to which the program's products will be useful to the respective audiences;
(4)Extent to which the applicant presents a realistic schedule for developing these products, and provides a dissemination plan that is appropriate in scope and budget to each of the audiences; and,
(5)Extent to which the products to be developed during the program are described clearly and will address the goal of dissemination of information and are designed to support evidence-based improvements of practices in the field. Criterion 3: Organizational Profile (20 Points) Applicants need to demonstrate that they have the capacity to implement the proposed program. Capacity includes:
(1)Previous experience with similar projects;
(2)experience with the target audience;
(3)qualifications and experience of the project leadership;
(4)experience and commitment of any consultants and subcontractors; and,
(5)appropriateness of the organizational structure. This criterion consists of three broad topics:
(A)management plan,
(B)staff qualifications, and
(C)organizational capacity and resources. Applicants are expected to present a sound and feasible management plan for implementing the proposed program. This section should detail how the program will be structured and managed, how the timeliness of activities will be ensured, how quality control will be maintained, and how costs will be controlled. The role and responsibilities of the lead agency should be clearly defined and, if appropriate, applicants should discuss the management and coordination of activities carried out by any partners, subcontractors, and consultants. Applicants should include a list of organizations and consultants who will work with the project, along with a short description of the nature of their contribution or effort. Applicants are also expected to produce a time line that presents a reasonable schedule of target dates, and accomplishments. The time line should include the sequence and timing of the major tasks and subtasks, important milestones, reports, and completion dates. The application should also discuss factors that may affect project implementation or the outcomes and present realistic strategies for the resolution of these difficulties. Applicants must provide evidence that project staff have the requisite experience, and expertise to carry out the proposed project on time, within budget, and with a high degree of quality. Include information on staff knowledge of the medical and legal issues concerning embryo donation and/or adoption, and experience working in this area. Brief resumes of current and proposed staff, as well as job descriptions, should be included. Resumes must indicate the position that the individual will fill, and each position description must specifically describe the job as it relates to the proposed project. Applicants must show that they have the organizational capacity and resources to successfully carry out the project on time and to a high standard of quality, including the capacity to resolve a variety of technical and management problems that may occur. If the proposed project involves partnering and/or subcontracting with other agencies/organizations, then the application should include an organizational capability statement for each participating organization documenting the ability of the partners and/or subcontractors to fulfill their assigned roles and functions. Specific review criteria include:
(A)*Management Plan.*
(1)Extent to which the management plan presents a realistic approach to achieving the objectives of the proposed project on time and within budget, including clearly defined responsibilities, time lines, and milestones for accomplishing project tasks;
(2)Extent to which the role and responsibilities of the lead agency are clearly defined and the time commitments of the project director and other key project personnel (including consultants) are appropriate and adequate to meet the objectives of the proposed project; and,
(3)Extent to which the applicant discusses factors that may affect the development and implementation of the project and presents realistic strategies for the resolution of these difficulties.
(B)*Staff Qualifications.*
(1)Extent to which the proposed project director, key project staff, and consultants have the necessary technical skill, knowledge, and experience to successfully carry out their responsibilities; and,
(2)Extent to which staffing is adequate for the proposed project, including administration, program services, data processing and analysis, evaluation, reporting and implementation of the project.
(C)*Organizational Capacity and Resources.*
(1)Extent to which the applicant and partnering organizations collectively have experience in embryo donation and/or adoption consistent with professionally recognized guidelines;
(2)Extent to which the applicant has experience in developing and implementing similar projects; and,
(3)Extent to which the applicant has adequate organizational resources for the proposed project, including administration, program operations, data processing and analysis, and evaluation. Criterion 4: Budget and Budget Justification (20 Points) Applicants are expected to present a detailed budget for both the first and second year budget periods. The budget should present reasonable project costs, appropriately allocated across component areas and sufficient to accomplish the objectives. Consideration shall be given to project delays due to start-up when preparing the budget. Applicants are expected to allocate sufficient funds in the budget to provide for two meetings each year with the Project Officer in Rockville, Maryland, and regular conference calls for programmatic collaboration during the performance of the project. Specific review criteria include:
(1)Extent to which applicant demonstrates that the project costs and budget information submitted for the proposed program are reasonable and justified in terms of the proposed tasks and the anticipated results and benefits; and,
(2)Extent to which the fiscal control and accounting procedures are adequate to ensure prudent use, proper and timely disbursement, and an accurate accounting of funds received under this announcement. Review and Selection Process Each application submitted to the OPHS Office of Grants Management will be screened to determine whether it was received by the closing date and time. The results of a competitive review are a primary factor in making funding decisions. In addition, Federal staff will conduct administrative reviews of the applications and, in light of the results of the competitive review, will recommend applications for funding to the Deputy Assistant Secretary for Population Affairs (DASPA). The DASPA may also solicit and consider comments from others within DHHS in making funding decisions. Final grant awards decisions will be made by the DASPA. The DASPA will fund those projects which will, in his/her judgment, best promote the purposes of this program, within the limits of funds available for such projects. VI. Award Administration Information 1. Award Notices The OPA does not release information about individual applications during the review process. When final decisions have been made, successful applicants will be notified by letter of the outcome of the final funding decisions. The official document notifying an applicant that a project as been approved for funding is the Notice of Grant Award (NGA), signed by the OPHS Grants Management Officer, which sets forth the amount of funds granted, the terms and conditions of the award, the effective date of the grant, the budget period for which initial support will be given, and the total project period for which support is contemplated. Every effort will be made to notify all unsuccessful applicants as soon as possible after final decisions are made. 2. Administrative and National Policy Requirements In accepting this award, the grantee stipulates that the award and any activities thereunder are subject to all provisions in 45 CFR parts 74 (non-governmental) and 92 (governmental) currently in effect or implemented during the period of the grant. The DHHS Appropriations Act requires that when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with Federal money, grantees shall clearly state the percentage and dollar amount of the total costs of the program or project which will be financed with Federal money and the percentage and dollar amount of the total costs of the project or program that will be financed by non-governmental sources. 3. Reporting Requirements A successful applicant under this notice will submit:
(a)Progress reports;
(b)annual Financial Status Reports; and
(c)a final performance report, including an evaluation report, and Financial Status Report. Reporting formats are established in accordance with provisions of the general regulations which apply under 45 CFR parts 74 and 92. Applicants must submit all required reports in a timely manner, in recommended formats, and submit a final report on the project, including any information on evaluation results, at the completion of the project period. The final performance report should contain an overview of the program from start to finish, including information on:
(a)Summary of the project,
(b)state of the major goals and objectives of the project,
(c)list of significant accomplishments,
(d)description of innovative features,
(e)statement of significant problems encountered and solutions developed,
(f)a complete written disclosure of any invention, curriculum, publication, video, pamphlet conceived or produced as part of the grant funded project,
(g)a copy of any products developed in association with the project. The final evaluation report should reflect an assessment of the program. It should describe factors contributing to both program success and problem areas. The report should include a description of the project's objectives, interventions, evaluation model and hypotheses, findings, and conclusions. The report should include a summary of the program statistics and findings. It should discuss the implications of project findings as they relate to the project objectives, as well as a set of recommendations based on the findings (where appropriate). The appendices to the evaluation report should include any data collection instruments and relevant references. Copies of any published articles, based on the project or project evaluation findings are also requested. Agencies receiving $500,000 or more in total Federal funds are required to undergo an annual audit as described in OMB Circular A-133, “Audits of States, Local Governments, and Non-Profit Organizations.” VII. Agency Contacts For application kits, submission of applications, and information on budget and business aspects of the application, please contact: WilDon Solutions, Office of Grants Management Operations Center, 1515 Wilson Blvd., Third Floor Suite 310, Arlington, VA 22209 at 1-888-203-6161, e-mail *OPHSgrantinfo@teamwildon.com,* or fax 703-351-1138. *Program Office Contact:* Evelyn Kappeler, Department of Health and Human Services, Office of Public Health and Science, Office of Population Affairs, 1101 Wootton Parkway, Suite 700, Rockville, Maryland 20852. E-mail: *Evelyn.Kappeler@hhs.gov;* telephone: 240-453-2837. Dated: April 2, 2007. Evelyn M. Kappeler, Acting Director, Office of Population Affairs. [FR Doc. E7-6433 Filed 4-5-07; 8:45 am] BILLING CODE 4150-28-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Research Cooperative Agreement To Promote the Health of People With Intellectual Disabilities, Request for Application
(RFA)DD07-012 In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following meeting of the aforementioned SEP: *Time and Date:* 12 p.m.-4 p.m., May 31, 2007 (Closed). *Place:* Teleconference. *Status:* The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463. *Matters to be Discussed:* The meeting will include the review, discussion, and evaluation of applications received in response to RFA DD07-012, “Research Cooperative Agreement to Promote the Health of People with Intellectual Disabilities.” *Contact Person for More Information:* Juliana Cyril, Ph.D., Associate Director for Policy and Peer Review, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop D72, Atlanta, GA 30333, Telephone 404.639.4639. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-6444 Filed 4-5-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-10003, CMS-901A and D, CMS-9044, CMS-R-193 and CMS-10066] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this 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 function;
(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. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Notice of Denial of Medical Coverage (NDMC), and the Notice of Denial of Payment
(NDP)and supporting regulations in 42 CFR 422.568; *Use:* Section 1852(g)(1)(B) of the Statute requires Medicare Health organizations (Medicare Advantage, cost, and Health Care Prepayment Plans) to provide determinations to deny coverage ( *i.e.* , medical services or payment) in writing and include a statement in understandable language of the reasons for the denial and a description of the reconsideration and appeals processes. These notices fulfill the regulatory requirement. *Form Number:* CMS-10003 (OMB#: 0938-0829); *Frequency:* Reporting: Yearly; *Affected Public:* Business or other for-profit and not-for-profit institutions; *Number of Respondents:* 454; *Total Annual Responses:* 105,138; *Total Annual Hours:* 26285. 2. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* CMS Application for Federal Qualification (901A); CMS Medicare Agreement Application
(901D)and Supporting Regulations in 42 CFR Section 417.143 and 422.6; *Use:* Prepaid health plans must meet certain regulatory requirements to be federally qualified health maintenance organizations or to enter into a contract with CMS to provide health benefits to Medicare beneficiaries. The application forms are used by CMS to collect information about a health plan to determine their compliance with Federal regulations. *Form Number:* CMS-901A and D (OMB#: 0938-0470); *Frequency:* Reporting: Once; *Affected Public:* Business or other for-profit and not-for-profit institutions; *Number of Respondents:* 55; *Total Annual Responses:* 55; *Total Annual Hours:* 2,200. 3. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Medicare ESRD Exceptions; *Use:* This information is collected in accordance with section 2145 of the Omnibus Budget Reconciliation Act of 1981 and section 623 of the Medicare Prescription Drug Improvement and Modernization Act of 2003. End Stage Renal Disease
(ESRD)facilities can file for an exception to its composite payment rate. CMS uses the information submitted to determine whether an ESRD facility qualifies for a rate increase and the amount of the increase. *Form Number:* CMS-9044 (OMB#: 0938-0296); *Frequency:* Reporting: Occasionally; *Affected Public:* Business or other for-profit and not-for-profit institutions; *Number of Respondents:* 10; *Total Annual Responses:* 10; *Total Annual Hours:* 400. 4. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* Medicare and Medicare Advantage Programs; Notification Procedures for Hospital Discharges—Important Message from Medicare *Use:* Requirements that hospitals notify beneficiaries in inpatient hospital settings of their rights as a hospital patient including their discharge appeal rights are referenced in Section 1866(a)(1)(M) of the Social Security Act (The Act). The authority for the right to an expedited determination is set forth at Section 1869(c)(3)(C)(iii)(III) of the Act. Under sections 42 CFR 405.1205 and 422.620, the hospital must deliver valid, written notice, the Important Message from Medicare (IM), of a patient's rights as a hospital patient including the discharge appeal rights, within 2 calendar days of admission. A follow-up copy of the signed IM is given again as far as possible in advance of discharge, but no more than 2 calendar days before. Follow-up notice is not required if the provision of the admission IM, falls within 2 calendar days of discharge. Several changes are being proposed to the IM, including but not limited to the following: 1. Patient Information section: CMS removed the “Date of Notice” line. 2. Your Rights as Hospital Inpatient section:
(a)There are several proposed clarifying language updates.
(b)CMS added a bullet stating that the beneficiary can call the Quality Improvement Organization
(QIO)for quality of care concerns based on information currently contained in the Medicare and You 2007 booklet. 3. Your Hospital Discharge and Medicare Appeal Rights section: CMS added a bullet stating that the beneficiary may call 1-800 Medicare and added supporting rational for when to call. 4. CMS added instructions for the beneficiary or representative to both sign and date the notice and, 5. CMS added an “Additional Information” space requesting that hospitals be able to add signature lines for hospital staff documentation. *Form Number:* CMS-R-193 (OMB#: 0938-0692); *Frequency:* Reporting: Yearly; *Affected Public:* Business or other for-profit and not-for-profit institutions; *Number of Respondents:* 6000; *Total Annual Responses:* 13,000,000; *Total Annual Hours:* 3,250,000. 5. *Type of Information Collection Request:* New Collection; *Title of Information Collection:* Medicare and Medicare Advantage Programs; Notification Procedures for Hospital Discharges—Detailed Notice of Discharge; *Use:* The authority for the right to an expedited determination is set forth at Section 1869(c)(3)(C)(iii)(III) of the Social Security Act. This collection has been revised and now pertains to sections 42 CFR 405.1206 and 42 CFR 422.622. When a Quality Improvement Organization
(QIO)notifies a hospital or Medicare Advantage
(MA)organization that a beneficiary/enrollee has requested an expedited determination, the hospital or MA organization must deliver a detailed notice to the beneficiary/enrollee by noon of the day after the QIO's notification. In addition, the title has been revised, and the wording of the notice has been revised to more clearly convey the purpose of the notice. This revised notice fulfills the regulatory requirement; *Form Number:* CMS-10066 (OMB#: 0938-New); *Frequency:* Yearly; *Affected Public:* Business or other for-profit and not-for-profit institutions; *Number of Respondents:* 6057; *Total Annual Responses:* 130,000; *Total Annual Hours:* 130,000. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web Site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on
(410)786-1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number:
(202)395-6974. Dated: March 29, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7-6310 Filed 4-5-07; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on
(240)276-1243. Proposed Project: National Evaluation of the Comprehensive Community Mental Health Services for Children and Their Families Program: Phase IV—(OMB No. 0930-0257)—Revision The Substance Abuse and Mental Health Services Administration (SAMHSA), Center of Mental Health is responsible for the national evaluation of the Comprehensive Community Mental Health Services for Children and Their Families Program that will collect data on child mental health outcomes, family life, and service system development and performance. The national evaluation of the Comprehensive Community Mental Health Services for Children and Their Families Program will collect data on child mental health outcomes, family life, and service system development and performance. Data will be collected on 27 service systems, and roughly 5922 children and families. Data collection for this evaluation is conducted over a five-year period. The core of service system data will be collected every 18 months throughout the 5-year evaluation period, with a sustainability survey conducted in selected years. Service delivery and system variables of interest include the following: Maturity of system of care development, adherence to the system of care program model, and client service experience. The length of time that individual families will participate in the study ranges from 18 to 36 months depending on when they enter the evaluation. Child and family outcomes of interest will be collected at intake and during subsequent follow-up sessions at six-month intervals. The outcome measures include the following: child symptomatology and functioning, family functioning, material resources, and caregiver strain. Time-limited studies addressing the cultural competence of services and the role of primary care providers in systems of care will be conducted at selected points during the evaluation period. Internet-based technology will be used for collecting data via Web-based surveys and for data entry and management. The average annual respondent burden is estimated below for the final three years of data collection. The estimate reflects the average number of respondents in each respondent category, the average number of responses per respondent per year, the average length of time it will take for each response, and the total average annual burden for each category of respondent, and for all categories of respondents combined. This revision to the currently approved information collection activities includes:
(1)The addition of a Primary Care Study and
(2)the addition of a Treatment Effectiveness Study. The Primary Care Study seeks to investigate the role of primary health care practitioners
(PCPs)in systems of care and to further understand the impact of services provided within primary care on child and family outcomes. One goal of this study is to identify strategies that help primary care and mental health care providers to work together effectively. Another is to identify ways to integrate PCPs into systems of care. The treatment effectiveness study will examine the relative impact of community-based treatments focused within system of care sites. This study will focus on a community-based practice that has not accumulated research evidence, but rather through community-based implementation has accumulated practice-based evidence. Instrument Respondent Number of respondents Total average number of responses per respondent Hours per response Total burden hours System of Care Assessment Interview Guides and Data Collection Forms Key site informants 1 648 2 1.000 1296 Interagency Collaboration Scale
(IACS)Key site informants 648 2 0.133 173 Caregiver Information Questionnaire (CIQ-IC) Caregiver 3 5,922 1 0.283 1676 Caregiver Information Questionnaire Followup (CIQ-FC) Caregiver 5,922 3 0.200 3553 Caregiver Strain Questionnaire
(CGSQ)Caregiver 5,922 5 4 0.167 3956 Child Behavior Checklist (CBCL)/ Child Behavior Checklist 1 1/2 -5 (CBCL 1 1/2 -5) Caregiver 5,922 4 0.333 7888 Education Questionnaire—Revised (EQ-R) Caregiver 5,922 4 0.100 2369 Living Situations Questionnaire
(LSQ)Caregiver 5,922 4 0.083 1966 The Family Life Questionnaire
(FLQ)Caregiver 5,922 4 0.050 1184 Behavioral and Emotional Rating Scale—Second Edition, Parent Rating Scale (BERS-2C) Caregiver 6 5,626 4 0.167 3758 Columbia Impairment Scale
(CIS)Caregiver 5,922 4 0.083 1966 The Vineland Screener
(VS)Caregiver 7 2,369 4 0.250 2369 Delinquency Survey—Revised
(DS)Youth 8 3,553 4 0.167 2374 Behavioral and Emotional Rating Scale—Second Edition, Youth Rating Scale (BERS-2) Youth 3,553 4 0.167 2374 GAIN Quick—R: Substance Problem Scale
(GAIN)Youth 3,553 4 0.083 1180 Substance Use Survey—Revised
(SUS)Youth 3,553 4 0.100 1421 Revised Children's Manifest Anxiety Scales (RCMAS) Youth 3,553 4 0.050 711 Reynolds Adolescent Depression Scale—Second Edition (RADS-2) Youth 3,553 4 0.050 711 Youth information Questionnaire—Baseline (YIQ-I) Youth 3,553 1 0.167 593 Youth information Questionnaire—Follow-up (YIQ-F) Youth 3,553 3 0.167 1780 Service Experience Study Multi-Sector Service Contacts—Revised (MSSC-RC) Caregiver 5,992 10 3 0.250 4442 Cultural Competence and Service Provision Questionnaire
(CCSP)Caregiver 5,992 3 0.167 2967 Youth Services Survey (YSS—F) Caregiver 5,922 3 0.117 2079 Cultural Competence Practices Study (Focus Groups—F) Caregiver 36 1 1.500 54 Youth Services Survey (YSS—Y) Youth 3,553 4 0.083 1180 Cultural Competence Practices Study (Focus Groups—Y) Youth 36 1 1.500 54 Cultural Competence Practices Study (Focus Groups—P) Provider 60 1 1.500 90 Treatment Effectiveness Study Diagnostic Interview Schedule for Children (DISC—Predictive Scales) Caregiver 262 1 1.000 262 Conflict Behavior Questionnaire
(CBQ)Caregiver 240 4 .167 160 Family Assessment Measure
(FAM)Caregiver 240 4 .250 240 Therapeutic Alliance Scale—caregiver
(TAS)Caregiver 240 3 .167 120 Ohio Scales (caregiver) Caregiver 240 4 .250 240 Therapy Adherence Form—Revised Caregiver 240 1 .167 40 Therapeutic Alliance Scales—youth (TAS-Y) Youth 192 4 .167 128 Ohio Scales—youth Youth 192 4 .250 192 Evidence-Based Practices Provider Attitudes Scale Provider 50 1 .083 4 Family Education and Support Study Beck Depression Inventory
(BDI)Caregiver 300 3 .117 105 Parenting Sense of Competence Scale
(PSOC)Caregiver 300 3 .167 150 Alabama Parenting Questionnaire
(APQ)Caregiver 300 3 .117 105 Duke Social Support Scale Caregiver 300 3 .067 60 Vanderbilt Mental Health Services Self-Efficacy Questionnaire Caregiver 300 3 .050 45 FES—Focus groups Caregiver 54 1 1.500 81 FES—Focus groups Provider 54 1 1.500 81 FES—Interview Provider/Administrator 12 1 1.000 12 Primary Care Provider Study Primary Care Provider Survey Provider 540 1 .500 270 Sustainability Study Sustainability Survey—Caregiver Caregiver 12 27 2 0.500 27 Sustainability Survey—Provider Provider/Administrator 12 81 2 0.500 81 Number of distinct respondents Number of responses per respondent Average 3-year burden per response (hours) Total burden (hours) Summary of Annualized Burden Estimates for 3 Years Caregivers 5,922 1.13 2.08 13,954 Youth 3,553 1.19 1.00 4,220 Provider/Administrators 648 .542 1.90 669 Total Summary 10,123 18,844 Total Annual Average Summary 3,374 6,281 1 An average of 24 stakeholders in up to 27 grantee sites will complete the System of Care Assessment interview. These stakeholders will include site administrative staff, providers, agency representatives, family representatives, youth and youth coordinators. 2 Assuming the average annual income across all types of staff/service providers/administrators is $40,000, the wage rate was estimated using the following formula: $40,000 (annual income)/2080 (hours worked per year) = $19.25 (dollars per hour). 3 Number of respondents across 27 grantees. Average based on a 5 percent attrition rate at each data collection point. These data are collected as part of the grantees' routine intake processes. Hence, burden is calculated only for the subset of the Cross-Sectional Descriptive Study sample that also participates in the Child and Family Outcome Study. 4 Given that 65 percent of the families in the Phase III evaluation sample fall at or below the 2005 DHHS National Poverty Level of $19,350 (based on family of four), the wage rate was estimated using the following formula: $19,350 (annual family income)/2080 (hours worked per year) = 9.30 (dollars per hour). 5 Average number of responses per respondent based on 6 data collection points for children recruited in year 3, 4 for children recruited in year 4, 2 for children recruited in year 5 (of grantee funding). 6 Estimated number of caregivers with children over age 5, based on Phase IV preliminary needs-assessment that 95 percent of children served will be over age 5. 7 Estimated number of caregivers with children under age 12, based on Phase IV preliminary needs-assessment that 40 percent of children served will be under age 12. 8 Based on Phase III finding that approximately 60 percent of the children in the evaluation were 11 years old or older. 9 Based on the Federal minimum wage rate of $5.15 per hour. 10 Respondents only complete Service Experience Study measures at follow-up points. Average number of follow-up responses per respondent based on 6 follow-up data collection points for children recruited in year 3, 4 for children recruited in year 4, and 2 for children recruited in year 5 (of grantee funding). 11 Assuming the average annual income across all types of staff/service providers is $31,200, the wage rate was estimated using the following formula: $31,200 (annual income)/2080 (hours worked per year) = $15.00 (dollars per hour). 12 25 respondents will be caregiver and 75 respondents will be administrators/providers. Written comments and recommendations concerning the proposed information collection should be sent May 7, 2007 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202-395-6974. Dated: April 3, 2007 Elaine Parry, Acting Director, Office of Program Services. [FR Doc. E7-6481 Filed 4-5-07; 8:45 am] BILLING CODE 4162-20-P DEPARTMENT OF HOMELAND SECURITY Office of the Secretary [Docket Number DHS 2006-0082] Privacy Act; Biometric Storage System of Records AGENCY: Privacy Office, Department of Homeland Security. ACTION: Notice of Privacy Act system of records. SUMMARY: Pursuant to the Privacy Act of 1974, the Department of Homeland Security, U.S. Citizenship and Immigration Services, proposes to add a new system of records to the Department's inventory, entitled Biometric Storage System. This new system will replace the following existing legacy systems, the Image Storage and Retrieval System (ISRS), 64 FR 18052, and portions of the Biometric Benefit Support System (BBSS). DATES: The established system of records will be effective May 7, 2007 unless comments are received that result in a contrary determination. ADDRESSES: You may submit comments, identified by Docket Number DHS 2006-0082 by one of the following methods: • *Federal e-Rulemaking Portal: http://www.regulations.gov.* Follow the instructions for submitting comments. • Fax: 1-866-466-5370. • Mail: Hugo Teufel III, Chief Privacy Officer, Department of Homeland Security, Washington, DC 20528. FOR FURTHER INFORMATION CONTACT: For system related questions please contact: Phyllis Howard, Branch Chief of Application Support for Office of Field Operations, U.S. Citizenship and Immigration Services, Department of Homeland Security, 20 Massachusetts Avenue, NW., Washington, DC 20529. For privacy issues please contact: Hugo Teufel III, Chief Privacy Officer, Privacy Office, U.S. Department of Homeland Security, Washington, DC 20528. SUPPLEMENTARY INFORMATION: The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) has been tasked by Congress with processing all immigration benefit applications and petitions. Many applications, petitions, and other benefits (hereinafter referred to as “applications”) require that fingerprints and other biometrics be captured in order to conduct background checks, to verify the applicant's, petitioner's, or beneficiary's (hereinafter referred to as “applicants”) identity, and to produce benefit cards with biometrics and documents. In order to fulfill its statutory mandate, USCIS is establishing a new system of records that will consolidate all biometrics collected by USCIS into one centralized system. This new system of records is called the Biometric Storage System (BSS). I. USCIS Biometric Storage Implemented as a part of a USCIS enterprise-wide “Transformation Program,” BSS will help transition the agency's data management practices to a paperless, more centralized, and unique identity driven methodology. BSS will become the centralized repository for all biometric data captured by USCIS from applicants filing immigration applications. This new system will eventually replace existing legacy systems, including the Image Storage and Retrieval System (ISRS), 64 FR 18052, and portions of the Biometric Benefit Support System (BBSS). USCIS captures biometric data from applicants to facilitate three key operational functions:
(1)Conducting fingerprint-based background checks;
(2)verifying an applicant's identity; and
(3)producing benefit cards/documents. Currently, USCIS does not have a centralized, long-term storage program for fingerprint biometrics. Accordingly, applicants are sometimes required to return to an USCIS Application Support Center
(ASC)to provide fingerprints again during the case adjudication process. BSS will store the biometric information, thereby decreasing the burden on applicants by negating the need to provide multiple sets of biometric data. Further, BSS will consolidate storage of information from multiple, separate systems into a centralized database, allowing for greater control, security, and management of the data. BSS also will provide increased functionality over current systems, and improved communication between government databases and personnel, facilitating more efficient processing of applications. This furthers USCIS's goals of reducing immigration benefit and petition case backlog, and improving the process for vetting and resolving applications for immigration benefits. a. Fingerprint-Based Background Checks Under BSS, biometric and associated biographic information will be collected from the applicant in order to conduct fingerprint-based background checks through the Federal Bureau of Investigation
(FBI)and United States Visitor and Immigrant Status Indicator Technology (US-VISIT). Fingerprints will be taken electronically at an USCIS ASC or from hard copy fingerprint cards (FD-258) that are submitted for those applicants who are unable to go to an ASC. These fingerprints, along with other biometric and limited biographical data collected from the applicant, will be assembled into a National Institute of Standard and Technology
(NIST)approved Electronic Fingerprint Transmission Specification
(EFTS)file and transferred to BSS from the ASCs. BSS will then submit the 10-print fingerprints and limited biographic information to, and receive results from, the FBI's Integrated Automated Fingerprint Identification System (IAFIS). The FBI fingerprint check is a search of the FBI's Criminal Master File, which will identify applicants and petitioners who have arrest records. The fingerprint check responses received from the FBI are interpreted as “classifiable” or “unclassifiable,” and that classification is stored in BSS. A classifiable fingerprint set denotes that the FBI was able to utilize the fingerprints in the course of their matching processes. An unclassifiable fingerprint set denotes that the FBI was unable to utilize the fingerprints in the course of their matching processes. If applicable, the FBI Identification Record, which details an applicant's criminal history, will be transmitted by BSS to USCIS's Background Check Service (BCS), 71 FR 70414, for storage and not retained in BSS. BSS will also submit the 10-print fingerprints, photograph, and limited biographic information to, and receive results from, US-VISIT/IDENT 71 FR 42651. The US-VISIT/IDENT fingerprint check is a search of US-VISIT's entire fingerprint database, which will identify applicants and petitioners who have entered or exited the country previously, as well as those for whom wants and warrants may be outstanding, or who otherwise may be the subjects of ongoing law enforcement or investigative activity. This information, referred to as the US-VISIT/IDENT information file, will be transmitted by BSS to USCIS's BCS for storage and not retained in BSS. The US-VISIT/IDENT check will also return a unique enumerator for any currently enrolled 10-print fingerprints. The unique enumerator is based on and assigned to an applicant's unique fingerprint biometric signature. If US-VISIT/IDENT does not find a match, the system will enroll the 10-print fingerprints, generate a unique enumerator, and return that number to BSS. The results of these fingerprint checks will be used to make eligibility determinations, which will result in the approval or denial of a benefit. If fraudulent or criminal activity is detected as a result of the fingerprint check, information may be referred to appropriate law enforcement agencies including Immigration and Customs Enforcement (ICE), Customs and Border Protection (CBP), FBI, or other federal, state, local, tribal, foreign, or international law enforcement agencies. b. Card Production Information in BSS USCIS issues cards to individuals who have been granted immigration benefits such as Permanent Resident Cards and Border Crossing Cards. BSS will store information regarding benefit card and document production, including but not limited to photographs, signatures, press-prints (one fingerprint image, typically the index finger), and card production status. BSS also will interface with the National Card Production System II / Integrated Card Production System (NPS II/ICPS) and the Computer-Linked Application Information System 3 (CLAIMS 3) 62 FR 64132 system of records. Specifically, BSS and NPS II/ICPS will share data linked with benefit cards and documents, including but not limited to: Card serial number; receipt number; production site; production date; class of admission; type of benefit card or document; and expiration date. BSS and CLAIMS 3 will share data related to benefit case adjudication, including the case status and card production status. c. Collection and Use of Information in BSS The data collected in BSS during the background check process provides USCIS with information about an applicant or petitioner that may have national security or public safety implications, or which may contain indicia of fraud. Collection and use of this information will enable DHS to take action to prevent potentially undesirable and often dangerous people from staying in this country, thereby supporting two primary missions of DHS:
(1)Preventing terrorist attacks within the United States and reducing America's vulnerability to terrorism; and
(2)facilitating the adjudication of lawful benefit applications. All information to be stored in BSS is currently collected as part of the established USCIS application/petition process. The requested data is required to verify the applicant's identity and eligibility for the benefit being sought. ICE, CBP, and the Department of State
(DoS)also will have read-only access to the BSS through a web-based user interface. This interface will allow the stated users to access and view biometric and limited biographic information for identity verification purposes. Consistent with DHS's information sharing mission, information collected and stored in the BSS may be provided by USCIS to appropriate federal, state, local, tribal or foreign governmental agencies or multi-lateral government organizations where DHS determines that sharing the information will assist in the enforcement of civil or criminal laws. As mentioned previously, US-VISIT/IDENT will also receive a copy of the applicant's 10-print fingerprints, photograph, and limited biographic information. The information stored in US-VISIT/IDENT, including information received from BSS, may be shared with other DHS components, as well as appropriate Federal, state, local, tribal, foreign, or international government agencies. This sharing will only take place after DHS determines that the receiving component or agency has a need to know the information to carry out national security, law enforcement, immigration, intelligence, or other functions consistent with the routine uses set forth in this system of records notice and the US-VISIT/IDENT system of records notice (71 FR 42651). II. The Privacy Act The Privacy Act embodies fair information principles in a statutory framework governing the means by which the United Stated Government collects, maintains, uses and disseminates personally identifiable information. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other particular assigned to an individual. The Privacy Act requires each agency to publish in the **Federal Register** a description denoting the type and character of each system of records that the agency maintains, and the routine uses that are contained in each system to make agency recordkeeping practices transparent, to notify individuals reading the uses to which personally identifiable information is put, and to assist the individual to more easily find such files within the agency. In accordance with 5 U.S.C. 552a(r), a report on this system has been sent to Congress and to the Office of Management and Budget. DHS/USCIS-2006-0082 System name: DHS/USCIS—003 Biometric Storage System
(BSS)Security Classification: Sensitive; Unclassified. System location: The primary BSS system is located at a Department of Homeland Security
(DHS)approved data center in the Washington, DC, metropolitan area. Backups are maintained offsite. BSS will be accessible worldwide from all USCIS field offices, service centers, and application support centers in the DHS Network. Categories of individuals covered by the system: All individuals who are applying for benefits and/or who are petitioning on behalf of individuals applying or petitioning for benefits pursuant to the Immigration and Nationality Act. 8 U.S.C. 1101 *et seq.* Categories of records in the system: BSS maintains three general categories of records:
(a)Applicant and Petitioner Biometric information;
(b)Applicant and Petitioner Biographic Identification information; and
(c)Card Production information. A. *Applicant and Petitioner Biometric information* contains data necessary to perform a fingerprint-based background check through the FBI and US-VISIT/IDENT fingerprint check services, as well as data for verifying an applicant's identity and card production. This data may include: 10-print fingerprint images; photographs; signatures; transaction control numbers associated with FBI fingerprint checks; receipt numbers; date/time of submission; physical description of subject; and a reason for the submission of the application (i.e., a USCIS Form Code). This category also covers the applicants' US-VISIT/IDENT assigned enumerator. The unique enumerator is based on and assigned to an applicant's unique fingerprint biometric signature. If US-VISIT/IDENT does not find a match, the system will enroll the 10-print fingerprints, generate a unique enumerator, and return it to BSS. Lastly, this category covers logs associated with the requests of background checks, which may include requesting location and requesting person. B. *Applicant and Petitioner Biographic Identification information* includes basic biographic information associated with each applicant or petitioner, including but not limited to: Name; date of birth; country of birth; address; employment status; aliases; application type; height; weight; eye color; gender; hair color; and race. The applicant and petitioner information also includes uniquely identifiable numbers, including but not limited to: Alien Registration Number; Z-number; Receipt Number; Social Security Number; and Armed Forces Identification Number. This information would be obtained from multiple sources, including from the applicant at the time the fingerprints are taken, as well as from the applicant's preexisting case file. C. *Card Production information* encompasses data received from and sent to NPS II/ICPS and CLAIMS 3. This data may include identifying transactional information (i.e., transaction control number), biographical information used for card production, card production status, benefit card/document type, and class of admission. Authority for maintenance of the system: 8 U.S.C. 1103 *et seq.* Purpose(s): BSS is a single centralized system that stores all biometric and associated biographic data that USCIS collects. Biometric data and associated biographic data are used by USCIS to conduct background checks, facilitate card production, and accurately identify applicants. Currently, no system exists that centrally manages all of this data. BSS will replace the following existing legacy systems, the Image Storage and Retrieval System, 64 FR 180526, and portions of the Biometric Benefit Support System (BBSS). BBSS is a legacy system that transfers biometric data from USCIS to the FBI to conduct fingerprint-based background checks. BBSS does not store the 10-print fingerprint images. ISRS is a legacy system that stores a limited amount of information related to an applicant's 10-print fingerprint images and card production information. BSS also will add new functionality so the collection of biometric data for USCIS applications may become centrally managed. US-VISIT/IDENT will also receive a copy of the applicant's 10-print fingerprints, photograph, and limited biographic information. Consistent with DHS's information sharing mission, information stored in US-VISIT/IDENT, including information received from BSS, may be shared with other DHS components, as well as appropriate Federal, state, local, tribal, foreign, or international government agencies. This sharing will only take place after DHS determines that the receiving component or agency has a need to know the information to carry out national security, law enforcement, immigration, intelligence, or other functions consistent with the routine uses set forth in this system of records notice. Routine uses of records maintained in the system, including categories of users and the purposes of such uses: In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows: A. To the United States Department of Justice (including United States Attorney offices) or other federal agency conducting litigation or in proceedings before any court, adjudicative or administrative body, or to the court or administrative body, when it is necessary to the litigation and one of the following is a party to the litigation or has an interest in such litigation:
(1)DHS;
(2)any employee of DHS in his or her official capacity;
(3)any employee of DHS in his or her individual capacity where DOJ or DHS has agreed to represent said employee; or
(4)the United States or any agency thereof; B. To an agency, organization, or individual for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function. C. To the Department of State in the processing of petitions or applications for benefits under the Immigration and Nationality Act, and all other immigration and nationality laws including treaties and reciprocal agreements; D. To the National Archives and Records Administration or other Federal government agencies pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906. E. To contractors, grantees, experts, consultants, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for the Federal Government, when necessary to accomplish a DHS mission function related to this system of records, in compliance with the Privacy Act of 1974, as amended. F. To appropriate federal, state, local, tribal, or foreign governmental agencies or multilateral governmental organizations responsible for investigating or prosecuting the violations of, or for enforcing or implementing, a statute, rule, regulation, order, license, or treaty where DHS determines that the information would assist in the enforcement of civil or criminal laws; G. To federal and foreign government intelligence or counterterrorism agencies when DHS reasonably believes there to be a threat or potential threat to national or international security for which the information may be useful in countering the threat or potential threat, when DHS reasonably believes such use is to assist in anti-terrorism efforts, and disclosure is appropriate to the proper performance of the official duties of the person making the disclosure; H. To employers participating in the Basic Pilot Verification Program or any successor program thereof, in order to verify the employment eligibility of all newly hired employees in the United States. I. To a Congressional office, from the record of an individual in response to an inquiry from that Congressional office made at the request of the individual to whom the record pertains. J. To appropriate agencies, entities, and persons when:
(1)It is suspected or confirmed that the security or confidentiality of information in the system of records has been compromised;
(2)USCIS has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by USCIS or another agency or entity) that rely upon the compromised information; and
(3)the disclosure is made to such agencies, entities, and persons when reasonably necessary to assist in connection with USCIS's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm. Disclosure to Consumer Reporting Agencies: None. Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Storage: Records in the system will be stored in a central computer database. Retrievability: A combination of the following BSS data elements may be used to initiate a query in order to retrieve data from the BSS User Interface: An individual's Alien Registration Number; name; date of birth; receipt number; and unique enumerator. Safeguards: Information in this system is safeguarded in accordance with applicable laws and policies, including the DHS information technology security policies and the Federal Information Security Management Act (FISMA). All records are protected from unauthorized access through appropriate administrative, physical, and technical safeguards. These safeguards include restricting access to authorized personnel who have a need-to-know, using locks, and password protection features. The system is also protected through a multi-layer security approach. The protective strategies are physical, technical, administrative and environmental in nature, which provide access control to sensitive data, physical access control to DHS facilities, confidentiality of communications, authentication of sending parties, and personnel screening to ensure that all personnel with access to data are screened through background investigations commensurate with the level of access required to perform their duties. Retention and disposal: The following proposal for retention and disposal is pending approval by the National Archives and Records Administration. Records are stored and retained in the BSS Repository for seventy-five
(75)years, from the date of last action on the file. BSS is utilizing ISRS' retention schedule as a model. Biometric-based background checks are conducted on individuals and/or petitioners from the age of fourteen
(14)and up. The 75-year retention rate comes from the length of time USCIS may interact with a customer. Further, retaining the data for this period of time will enable USCIS to fight identity fraud and misappropriation of benefits. System manager(s) and address: Branch Chief of Application Support for Office of Field Operations, U.S. Citizenship and Immigration Services, Department of Homeland Security, 20 Massachusetts Avenue, NW., Washington, DC 20529. Notification procedure: To determine whether this system contains records relating to you, write the USCIS Freedom of Information Act/Privacy Act officer. Mail requests to: U.S. Citizenship and Immigration Services, National Records Center, FOIA/PA Office, P.O. Box 648010, Lee's Summit, MO 64064-8010. Record access procedures: Follow “Notification procedures” above. Contesting record procedures: Redress procedures are established and operated by the program through which the data was originally collected. In the case of redress requests for DHS organizations, if an individual is not satisfied with the response, an individual can appeal his or her case to the DHS Chief Privacy Officer, who will conduct a review and provide final adjudication on the matter. Record source categories: Information contained in this system of records is obtained from other USCIS Systems of Records; including, CLAIMS3, NPS II/ICPS, and electronic live scan devices located at ASCs. Information contained in the system is also obtained from the Federal Bureau of Investigation, and the United States Visitor and Immigrant Status Indicator Technology. All information contained in BSS is derived from the above systems. Exemptions claimed for the system: None. Dated: March 28, 2007. Hugo Teufel III, Chief Privacy Officer. [FR Doc. 07-1643 Filed 4-5-07; 8:45 am]
Connectionstraces to 7
10 references not yet in our index
  • Pub. L. 110-5
  • Pub. L. 109-149
  • 45 CFR 74
  • 45 CFR 100
  • Pub. L. 92-463
  • 42 CFR 422.568
  • 42 CFR 417.143
  • 42 CFR 405.1205
  • 42 CFR 405.1206
  • 42 CFR 422.622
Citation graph
cites case law
Notices
Notice
Fed. Reg.Notices
U.S.C.§ 305
Fed. Reg.Notices
U.S.C.§ 552a
U.S.C.§ 1101
U.S.C.§ 1103
U.S.C.§ 2904
Pub. L.Pub. L. 110-5
Pub. L.Pub. L. 109-149
Cite45 CFR 74
Cite45 CFR 100
Pub. L.Pub. L. 92-463
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