Notice of Funding Opportunity, 15317-15322 [05-5945]

Download as PDF Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices shares of F&C Bancorp, Inc., and thereby indirectly acquire voting shares of Farmers and Commercial Bank, Holden, Missouri. B. Federal Reserve Bank of Dallas (W. Arthur Tribble, Vice President) 2200 North Pearl Street, Dallas, Texas 752012272: 1. Rodney A. Abrams, Northbrook, Illinois, the Abrams Family Trust, Stephanie H. Denby, trustee, Buffalo Grove, Illinois; Funeral Financial Services, Ltd., Northfield, Illinois; Mortuary Financial Services, Inc., Richardson, Texas; Richard N. Abrams, Fort Worth Texas; Karen Abrams Fox, Northbrook, Illinois; Jodie Abrams Engfer, North Oaks, Minnesota; and Beverly Adams, Highland Park, Illinois; to acquire voting shares of Surety Capital Corporation, Fort Worth, Texas, and thereby indirectly acquire voting shares of Surety Bank, National Association, Fort Worth, Texas. Board of Governors of the Federal Reserve System, March 21, 2005. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. 05–5899 Filed 3–24–05; 8:45 am] BILLING CODE 6210–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice of Funding Opportunity Department of Health and Human Services, Office of Public Health and Science, Office of Population Affairs. ACTION: Notice. AGENCY: Funding Opportunity Title: Announcement of Availability of Funds for Grants for Family Planning Service Delivery Improvement Research. Announcement Type: This is a standing program announcement to remain in effect through May 15, 2007, unless it is withdrawn or modified, with an annual application receipt date of May 15. Funding Opportunity Number: PAR– 05–185. CFDA Number: 93.974. Authority: Section 1004 of the Public Health Service (PHS) Act. This standing program announcement will remain in effect through May 15, 2007, unless it is withdrawn or modified. To receive consideration a package containing a signed typewritten application, including the checklist, and two photocopies of the application must be received at the address below no later than May 15 and no earlier than April DATES: VerDate jul<14>2003 16:11 Mar 24, 2005 Jkt 205001 15 of each year the program announcement remains in effect. Letters of intent should be received by April 30 of the year in which an application will be submitted. Up to two amended applications may be submitted in years subsequent to the year in which the original grant application was submitted but did not receive funding. SUMMARY: The Office of Population Affairs (OPA) requests applications for family planning service delivery improvement research grants. Applied research projects are encouraged in one or more of the following priority areas: (1) Quality of care in the delivery of family planning services; (2) effective approaches and interventions for addressing the reproductive health needs of adolescents and incorporating family members (particularly parents or guardians) into decisions of adolescents regarding relationships and sex; (3) reproductive health needs of males, prevention-related decisions by males and appropriate strategies for reaching male clients; (4) knowledge base for incorporating a ‘‘couples’’ perspective into the delivery of family planning services; (5) effective organizational approaches for delivery of family planning services in conjunction with related services, particularly HIV prevention services; (6) dissemination of findings and translation of service delivery research into practice; (7) factors associated with increasing costs and the impact of such increasing costs on service delivery; and (8) effectiveness of Title X non-clinical services with regard to information and education activities. Regulations pertaining to grants for research projects are set out at 42 CFR part 52. Section 1008 of the PHS Act provides that ‘‘none of the funds appropriated under this title shall be used in programs where abortion is a method of family planning.’’ I. Funding Opportunity Description This announcement invites applications from public and non-profit private entities for research on selected topic areas for family planning service delivery improvement. The purpose is to support relevant research which will promote improvements in family planning services. Therefore, funds available under this announcement are for projects to conduct applied research which will be useful to family planning administrators and providers, researchers, and officials of local, State, and the Federal government, including OPA, in order to improve the delivery of family planning services to persons needing and desiring such services. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 15317 Research projects supported under this announcement are expected to be consistent with one or more of the following performance goals for the Family Planning Program in the Department of Health and Human Services: (1) Improve health outcomes, (2) Increase utilization of preventive health care, particularly among vulnerable and special needs populations, (3) Increase the proportion of pregnancies that are intended, or (4) Reduce pregnancies among unmarried adolescent females. ‘‘Healthy People 2010’’ is a Department of Health and Human Services initiative to achieve health promotion and disease prevention objectives. Applicants for funding under this announcement should relate proposed plans to Healthy People objectives. A copy of ‘‘Healthy People 2010’’ is available at the following Web site location: https://www.health.gov/ healthypeople Background The Family Planning Program, authorized by Title X of the Public Health Service Act (42 U.S.C. 300, et seq.) is the only federal program devoted solely to funding family planning and related preventive health care services. This program supports a nationwide network of approximately 4,500 clinics and provides family planning services and supplies as well as relevant preventive health services to approximately 5 million persons per year. Family planning, like many health care services, faces continuing and emerging challenges to delivering quality care. This announcement calling for service delivery improvement research applications is intended to help family planning programs meet those challenges. The research emphases identified for attention in this announcement are consistent with the purpose of the Title X family planning services program, which is to provide family planning services to persons from low-income families and others. Section 1001 of the Act, as amended, authorizes grants ‘‘to assist in the establishment and operation of voluntary family planning projects which shall offer a broad range of acceptable and effective family planning methods and services (including natural family planning methods, infertility services, and services for adolescents).’’ This announcement also draws on a report issued by OPA in July, 2004: Future Directions for Family Planning Research: A Framework for Title X Family Service Delivery Improvement Research. This report was the E:\FR\FM\25MRN1.SGM 25MRN1 15318 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices culmination of a project that assembled experts to review the existing research literature, discuss the key research issues facing the field and identify future research needed to better inform family planning practitioners. Hard copies of the report are available through the OPA Clearinghouse at P.O. Box 30686, Bethesda, MD 20824–0686; ph: 866–640–PUBS (7827); fax: 866– 592–FAXX (3299); e-mail: clearinghouse@dhhsopa.net The experts identified future studies to address three broad concerns: (1) How can high-priority populations be reached? (2) How can family planning practices be strengthened? and (3) How can the organization and administration of services be improved? Based on Family Planning Program priorities, OPA selects and highlights below priority topics for the service delivery improvement research grants program that reflect all three of these concerns. Purposes of the Grant The purpose of this grant program is to expand the knowledge base in areas identified for applied research attention in this announcement. To that end, this announcement invites applications in one or more of the following areas: 1. Quality of Care Quality of care has many components. A report issued by the Institute of Medicine (IOM), Crossing the Quality Chasm (2001), addresses health care in general and calls for attention to six key dimensions of service quality in order to improve service delivery on each dimension: • Safety—Health care should be safe and should avoid injuries to patients • Effectiveness—Health care should provide services based on scientific knowledge to all who could benefit from the services and should avoid providing services to those who are unlikely to benefit • Patient-centeredness—Health care should provide services that are respectful and responsive to individual patient preferences, needs, and values and ensure that patient values guide all clinical decisions. • Timeliness—Health care should reduce waits and sometimes harmful delays for both those who receive and give care. • Efficiency—Health care should avoid waste, including waste of equipment, supplies, ideas, and energy. • Equity—Health care should be provided that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, or socioeconomic status. VerDate jul<14>2003 16:11 Mar 24, 2005 Jkt 205001 These quality dimensions are present in health care delivered in family planning clinic settings. Therefore, investigation of approaches which address any of these six dimensions in the family planning context is encouraged. Research that adapts approaches and builds on findings, tools or measures from service quality research in other health care sectors or other countries is similarly encouraged. 2. Reproductive Health Care to Adolescents/Parental Involvement Adolescents are among the hard-toreach populations identified for attention in the current Family Planning Program priorities. These program priorities also have the goal of encouraging family participation (particularly that of parents or guardians) in the decision of minors to seek family planning services, including activities that promote positive family relationships. Key issues for the Family Planning Program are: Providing adolescents with information, skills and support to encourage abstinence from or delay of sexual activity. Two significant questions quoted in the Future Directions report are: (1) ‘‘What are effective practices that clinics can use to assist adolescents and young adults in sexual decision making?’’ and (2) ‘‘How can adolescents be better connected to their families and schools, and will these connections result in decreased sexual activity?’’ These perspectives provide a context for the applied research topic of adolescent reproductive health that may be addressed by applicants to this program announcement. Over the last several years, amid growing concerns about adolescent pregnancy and high rates of sexually transmitted diseases (STDs), local communities have developed abstinence programs. Family planning practitioners can contribute to this wider effort to help teens avoid risky behaviors and make a healthy transition to adulthood, if they are provided with relevant information from service delivery improvement research. Such information will be most useful if it pertains not only to adolescent clients, but also to the parents who have such a critical role in shaping their child’s development. There is interest in a range of studies that might be designed to develop useful approaches and evaluate tailored interventions in this area. Intervention studies that target parental involvement are of particular interest. Possible studies include: • Identification of effective clinic techniques for counseling and PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 encouraging adolescent abstinence, return to abstinence, or similarlyresponsible decision making regarding sexual behavior, including training for adolescents in needed skills to behaviorally carry out their decisions; • Evaluation of abstinence programs in the family planning setting which teach abstinence knowledge, attitudes and skills in the context of preparation for future healthy family relationships; • Evaluation of clinic strategies for promoting parent-adolescent communication about preparation for future family life through current decision-making about reproductive health matters; • Identification of approaches to enhance the role of parents in providing information to their adolescents about sex; • Evaluation of various kinds of outreach strategies to parents by family planning providers; and • Evaluation of youth advocate strategies for supporting/guiding adolescents and their families in navigation of the reproductive health care system. 3. Reproductive Health Services to Males Males also are among the hard-toreach populations identified for attention in the current priorities of the Family Planning Program. Although men play a vital role in decision-making around sexual relationships, reproductive health, and family planning, most of the attention in the past has been focused on women. A fundamental building block in the development of any program is understanding the population to be served. While we have learned much about program interventions directed at women, little is known about how to deliver reproductive health services to men. The lack of information about the knowledge, attitudes, and behavior of males regarding family planning and related preventive health needs has made it difficult to design programs that appropriately serve males. Priority questions about males raised by the Future Directions report include: ‘‘What information do we need about men in their early 20s and 30s who need STD and family planning services? How do we create more male clinics? How do we look for alternative sites for these clinics?’ In order to advance our understanding in this area, research is encouraged on one or more of the following topics: • Information about the characteristics of men who seek reproductive health services, their pattern of use, awareness of the E:\FR\FM\25MRN1.SGM 25MRN1 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices availability of family planning services, and intention to use such services. • Men’s experiences with the existing reproductive health care system and factors influencing or inhibiting men’s use of provided services. • Services valued by males of different age groups and their preferred context for such services, e.g., couples; male-only; traditional family planning clinic setting or other contexts, etc. • Evaluation of outreach strategies and approaches to males by family planning clinics. • Factors that influence preventionrelated choices of males such as abstinence, return to abstinence, committed marital/monogamous relationships, or use of a condom when engaging in widespread sexual activity. For the first time, data on males were obtained in the National Survey of Family Growth which was in the field in 2002 (Cycle 6). Please see fuller description of this data set under ‘‘Data Resources’’ section below. This new cycle provides an opportunity to explore male reproductive health characteristics and motivations that could improve our understanding of how best to meet the reproductive health needs of men. 4. Family Planning Services to Couples While reproductive and family planning choices likely represent a joint decision between couples, scant attention has been given to couplefocused approaches for reproductive health care. The Future Directions report indicates that the development and testing of approaches to serving couples in the family planning setting is a promising new area of research, given that most sexual, contraceptive, and childbearing decisions are made jointly. It also points out that there is emerging policy interest at the Federal level in enhancing the quality of relationships between intimate partners to encourage the establishment of healthy committed relationships and marriages. Some evidence indicates that the involvement of partners in reproductive health care could result in more effective use of contraceptives. Cooperation of partners is also key for the effectiveness of natural family planning. Providers oriented toward meeting the needs of couples would find results of partners research useful. There is a heightened need to focus on how couples communicate regarding the use of condoms for disease protection. Given the complex dynamics that may be present in sexual relationships, women particularly may be in need of assistance from the family planning VerDate jul<14>2003 16:11 Mar 24, 2005 Jkt 205001 counseling context in order to conduct couples negotiations. Thus, there are a number of ways to approach the building of a knowledge base for incorporating a ‘‘couples’’ perspective into the delivery of family planning services. There is a research literature on the role that the couple relationship plays in contraceptive decision-making, which could be usefully expanded. Almost completely unexplored is the topic of how healthy couple relationships could be fostered in family planning settings or through referral to appropriate care services such as family services or marriage and relationship education services. The goal of such care would be to benefit the health of the individual members of the couple as well as the couple unit. Overall, studies are encouraged which investigate innovative approaches for serving couples in family planning clinics or through coordination of complimentary care settings, as well as studies which evaluate strategies for involving the partner in effective reproductive health decision-making. 5. Organizational Approaches to Integrated Services Although integrated services can take many forms, this announcement directs particular attention to the integration of HIV prevention and family planning services. The Future Directions report indicates that research about how to integrate successfully these two types of reproductive health services is very limited and should be given the highest priority. Family planning clinics are an ideal site for integrating HIV prevention activities because they serve sexually active, nonpregnant women, many of whom may be at great risk of becoming infected. The increased incidence of HIV infection among women, especially those whose demographic characteristics match those of the women served in publicly-funded family planning clinics, underscores the need for the Title X program to intensify efforts to provide both education and counseling regarding HIV/AIDS to users of Title X services. These important prevention considerations have made integration of early HIV prevention programs into ongoing family planning services a major public health imperative. Studies are needed to examine the impact on the family planning service delivery system of such HIV prevention service integration. In what ways does this development impinge on the concerns and routine functioning of family planning clinics and clinic personnel? In addition to assessing what PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 15319 HIV-related activities have been implemented, studies are needed to determine which strategies have been effective, and to disseminate information about successful integration approaches being implemented in the family planning setting. 6. Translating Research into Practice (TRIP) There is an increasing need for the worlds of research and practice to be in closer relationship for the mutual benefit of each. In the purely medical context, the practice of medicine is becoming increasingly evidence-based, with practice guidelines for clinicians driven by research findings about treatment effectiveness. For healthrelated programs with an expanded mission beyond the strictly medical, interventions and service practices are increasingly based on the best available evidence regarding what works. Like the rest of the health care system, family planning faces the challenge of utilizing practice guidelines and recommendations that are evidencebased in the delivery of clinical services and of translating knowledge into practice more generally. Dissemination research is a first step in meeting this challenge, especially research that identifies effective strategies for disseminating tested practice innovations to the practitioner field. Areas that need exploration include: Descriptive research about where family planning practitioners actually obtain information utilized in the service delivery arena; professionalorganization collaboration in conducting research about practices; and evaluations of dissemination interventions. Of additional interest to OPA are implementation studies that provide needed details about how a given service innovation can be effectively implemented elsewhere or how a more general research finding can be given concrete expression in the service setting, using appropriately-selected ‘‘translational’’ clinic sites. The service innovation or research finding may initially emanate from other than family planning settings or populations, provided the proposed study bases the translation/implementation effort on sound theoretical constructs regarding transferability. For example, the applicability of findings about the utility of information technology to increase efficiency and effectiveness of medical and social services other than family planning may be explored in an implementation study utilizing a family planning clinic site. E:\FR\FM\25MRN1.SGM 25MRN1 15320 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices 7. Increasing Costs and Their Impact Research is needed that would shed light on a number of unanswered questions related to costs including: • How are costs affected by different types of services, the characteristics of the clients served and the setting where services are provided? • What strategies have been employed to reduce costs while still maintaining the quality of services provided? • What impact has the newer, more technologically advanced methods of care had on the ability to maintain the quality and level of services? Areas of interest include, but are not limited to the following: • The increasing cost of providing specific contraceptive methods, including the actual cost of the method(s), shifts in the demand for the method(s), and staff level and time required; • The cost of using advanced diagnostics technologies, including the actual cost of the technology, staff level and time required, and the long range cost implications to the provider of adopting the technology; • The cost of providing services to under-served population(s), including outreach efforts and the specific mix of services required; • The cost involved in recruiting and retaining adequate numbers of qualified staff; and • Factors affecting revenue, including increases in the number of clients requiring subsidized services, changes in third party reimbursement to providers, and shifts in Federal, State, and local funding sources. 8. Effectiveness of Title X Information and Education Activities Promoting individual and community health is a Family Planning Program priority. Increasingly, information and education strategies have been employed by family planning practitioners to accomplish this goal. There is a need for corresponding evaluations of the effectiveness of such efforts. A great diversity of information strategies and educational approaches have been employed by family planning practitioners. A number of OPA-funded projects provide family planning information and education services to many individuals in non-clinical and non-traditional settings. Not only has it been difficult to track thousands of nonmedical users being served throughout the country by these Title X information and education projects, but it also presents a challenge to evaluate the VerDate jul<14>2003 16:11 Mar 24, 2005 Jkt 205001 effectiveness of these approaches. Therefore, rigorous evaluations of these activities, utilizing appropriate methodologies, is encouraged in this program announcement. Data Resources When appropriate to the proposed topics, applicants may wish to consider using nationally-representative data sets such as the National Survey of Family Growth (NSFG). The NSFG is a crosssectional survey of family formation and reproductive health conducted by the National Center for Health Statistics, Centers for Disease Control and Prevention. Previous cycles have consisted of personal interviews with a national sample of women 15–44 years of age in the United States, but with the latest cycle, Cycle 6, data from men ages 15–49 were also collected. The NSFG is a source of national data, which provides information on the level of sexual activity among adolescents, incidence of unintended pregnancy, contraceptive behavior, use of family planning services, trends in marriage, divorce, and cohabitation and rates of infertility. More information on the NSFG is available at https:// www.cdc.gov/nchs/nsfg.htm OPA encourages applications which utilize data from Cycle 6 of the NSFG, as appropriate to the particular research approach. However, whether this type of data set is used or not used is completely at the discretion of the applicant and will not influence funding decisions on applications submitted under this announcement. II. Award Information The OPA, subject to the availability of funds, intends to make available approximately $750,000 each year (Fiscal Years 2005, 2006 and 2007) to support an estimated three to four new research projects in each of the three years. Awards will range from $150,000 to $200,000 in total costs (both direct and indirect costs) per year. The awards to be made are for applied research and do not cover costs of delivering services that the applied research project may propose to evaluate. Accordingly, the mechanism of support for this program announcement will generally be the research project grant (R01), although other mechanisms may be supported. Research applications requesting less than $150,000 in total costs (both direct and indirect costs) per year for no more than a total of two years will be considered small research project grants (R03). Small research project grants (R03) will be subject to the review criteria listed in the ‘‘Application Review Information’’ section below, but PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 reviewers will be instructed to take into account the smaller scope of the proposed project. OPA encourages New Investigators (as defined in the PHS 398 application instructions) to apply as Principal Investigators. New Investigator applications (whatever the funding level request) will be evaluated by the review criteria listed in the ‘‘Application Review Information’’ section below, but the reviewers will be instructed to take into account the Principal Investigator’s stage of career development. Grants will be funded in annual increments (budget periods) and may be approved for a project period of up to three years. Funding for all budget periods beyond the first year of the grant is contingent upon the availability of funds, satisfactory progress of the project, and adequate stewardship of Federal funds. Earliest anticipated start date: Four months after application receipt date. III. Eligibility Information 1. Eligible Applicants Any public or private nonprofit entity located in a State (which includes one of the 50 United States or the District of Columbia, Commonwealth of Puerto Rico, U.S. Virgin Islands, Commonwealth of the Northern Mariana Islands, American Samoa, Guam, Republic of Palau, Federated States of Micronesia, and the Republic of the Marshall Islands) is eligible to apply for a grant under this announcement. Faithbased organizations are eligible to apply for these service delivery improvement research grants. 2. Cost Sharing or Matching There is no cost sharing or matching requirement. IV. Application and Submission Information 1. Address to Request Application Package Applications must be submitted on the research application form PHS 398 (revised 9/04), which is available online at: https://grants1.nih.gov/grants/ oer.htm. This form contains instructions for the submission of amended as well as new grant applications. For additional information about obtaining the research application form PHS 398, please call Eugenia Eckard at (301) 594– 4001. 2. Content and Form of Application Submission Applicants are encouraged to read all PHS Form 398 instructions prior to preparing an application in response to E:\FR\FM\25MRN1.SGM 25MRN1 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices this announcement. The instructions given are a useful guide to application preparation. Pay close attention to font size, page limits, and other format specifications. However, OPA is not using the Modular Grant Application and Award Process. Applicants for OPA funding should ignore instructions concerning the Modular Grant Application and Award Process, following budget instructions otherwise provided in PHS Form 398. When submitting the application check ‘‘yes’’ in Block 2 of the face page, and provide PAR–05–185 for the number and ‘‘Family Planning Service Delivery Improvement (SDI) Research’’ as the title. The application content should include the following: (1) A well-organized statement of the applied research problem to be addressed; (2) a detailed description of the research project design; (3) the conceptual framework within which the design has been developed; (4) the methodology to be employed; (5) the evidence upon which the analysis will rely; and (6) the manner in which the evidence will be analyzed. Applications should also clearly address how findings from the proposed study will have general applicability to the improvement of the delivery of family planning services, and a plan should be presented on how information from the research findings will be disseminated. 3. Submission Dates and Times To receive consideration, applications must be received by the Center for Scientific Review, NIH, by the deadline listed in the DATES section of this announcement. Applications submitted via U.S. Postal Service will be considered as meeting the deadline if they are postmarked no later than 1 week prior to the deadline date given in the DATES section. A legibly dated receipt from a commercial carrier or U.S. Postal Service will be accepted in lieu of a postmark. Private metered postmarks will not be accepted as proof of timely mailing. As soon as possible after the receipt date, usually within 6 weeks, the principal investigator/ program director and the applicant organization will receive by electronic notification the application assignment number and the name, address, and telephone number of the Scientific Review Administrator (SRA) who will be directing the review group to which the application has been assigned. The SRA is located at the Agency for Healthcare Research and Quality VerDate jul<14>2003 16:11 Mar 24, 2005 Jkt 205001 (AHRQ) which is serving as the review organization for these applications. Applications that do not meet the deadline will not be accepted for review, and will be returned. Applications sent via facsimile or by electronic mail will not be accepted for review. The application package must be submitted to: Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1040–MSC 7710, Bethesda, MD 29892–7710 (20817 for express/courier service). Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, and the title of this program announcement. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows OPA staff to estimate the potential review workload and plan the review. The letter of intent should be sent to Eugenia Eckard, at the address listed under the ‘‘Agency Contacts’’ section below and received by the date indicated in the DATES section of this announcement. Applicants are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access https:// www.dunandbradstreet.com or call 1– 866–705–5711. For more information, see the OPA Web site at: https:// opa.osophs.dhhs.gov/duns.html. 4. Intergovernmental Review This program is not subject to the review requirements of Executive Order 12372, ‘‘Intergovernmental Review of Federal Programs.’’ 5. Funding Restrictions The allowability, allocability, reasonableness, and necessity of direct and indirect costs that may be charged to 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 https://www.whitehouse.gov/ omb/grants/grants_circulars.html. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 15321 The Title X program is intended to address the health needs of all men and women, including all subgroups as characterized by age, class, race, and ethnicity. It is the policy of OPA that women and members of minority groups be included in all OPA supported research projects unless a clear and compelling rationale or justification establishes that such inclusion is inappropriate. Applicants should approach their research and analysis with considerations of class, race, and ethnicity in mind whenever possible. V. Application Review Information 1. Technical Review Criteria Eligible applications will be reviewed by a panel of independent peer reviewers and assessed according to the following technical merit criteria: (1) Significance. If the aims of the project are achieved, how much will applied research knowledge be advanced? Does the project employ novel or creative concepts, approaches, or methods that are insightful and likely to move forward the applied research area addressed in the application? (2) Scientific Merit. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? (3) Feasibility and Likelihood of Producing Meaningful Results. Are the plans for organizing and carrying out the project, including the responsibilities of key staff, the time line, and the proposed project period, adequately specified and appropriate? Does the application acknowledge potential problem areas and consider alternative tactics? For intervention evaluation studies, is adequate funding for the intervention already in place or assured for the intervention period to be evaluated, making the proposed evaluation feasible? (4) Competency of Staff. Are the principal investigator, and other key research staff, appropriately trained and well suited to carry out this project? (5) Adequacy of Facilities and Resources. Are the facilities and resources of the applicant institution and other study sites adequate? (6) Adequacy of Budget. Is the budget reasonable and adequate in relation to the proposed project? 2. Review and Selection Process Each of the above technical review criteria will be addressed and considered by independent peer reviewers in assigning an overall or global priority score, using a score range from 1.0 to 5.0 (with 1.0 indicating E:\FR\FM\25MRN1.SGM 25MRN1 15322 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices highest priority and 5.0, lowest priority). Final grant award decisions will be made by the Deputy Assistant Secretary for Population Affairs (DASPA) on the basis of priority score, program relevance, and the availability of funds. VI. Award Administration Information 1. Notification of Award The OPA does not release information about individual applications during the review process. When a final funding decision has been made, each applicant will be notified by letter of the outcome. The official document notifying an applicant that a project application has been approved for funding is the Notice of Grant Award, which specifies the amount of money awarded, the purpose of the grant, the length of the project period, and the terms and conditions of the award. 2. Administrative and National Policy Requirements In accepting this award, the recipient stipulates that the award and any activities thereunder are subject to all provisions of 45 CFR parts 74 and 92, currently in effect or implemented during the period of the grant. A Notice providing information and guidance regarding the ‘‘Governmentwide Implementation of the President’s Welfare-to-Work Initiative for Federal Grant Programs’’ was published in the Federal Register on May 16, 1997. This initiative was designated to facilitate and encourage grant recipients and their sub-recipients to hire welfare recipients and to provide additional needed training and/or mentoring as needed. The text of the Notice is available electronically on the OMB home page at https://www.whitehouse.gov/omb. 3. Reporting Requirement At the completion of the project, the grant recipient must submit a brief summary in 2,500 to 4,000 words, written in non-scientific (laymen’s) terms and Financial Status Report (SF– 269). The narrative should highlight the findings and their implications for improving family planning service delivery. A plan for disseminating research findings should accompany the narrative. This plan should indicate how products of the research will be made accessible to the Office of Population Affairs, as well as to the Title X family planning administrators and practitioners, researchers, and State and local policy-makers. The summary, plan, and Financial Status Report must be mailed to the Grants Management Specialist identified on the Notice of VerDate jul<14>2003 16:11 Mar 24, 2005 Jkt 205001 Grant Award within 90 days of the project’s completion. VII. Agency Contacts For information on specific research or program requirements, contact Eugenia Eckard, Office of Population Affairs, 1101 Wootton Parkway, Suite 700 Rockville, MD 20852, (301) 594– 4001, or via e-mail at eeckard@osophs.dhhs.gov. For assistance on administrative and budgetary requirements, contact the OPHS Grants Management Office, 1101 Wootton Parkway, Suite 550, Rockville, MD, (301) 594–0758, or via e-mail at kcampbell@osophs.dhhs.gov. Dated: March 21, 2005. Alma L. Golden, Deputy Assistant Secretary for Population Affairs. [FR Doc. 05–5945 Filed 3–24–05; 8:45 am] BILLING CODE 4150–34–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Protection of Human Subjects, Proposed Criteria for Determinations of Equivalent Protection Department of Health and Human Services, Office of the Secretary. AGENCY: ACTION: Notice. SUMMARY: The Office of Public Health and Science, Department of Health and Human Services (HHS) solicits public comment on criteria that have been recommended to the Office for Human Research Protections (OHRP) for making determinations of whether procedures prescribed by institutions outside the United States afford protections that are at least equivalent to those provided in the Federal Policy for the Protection of Human Subjects (codified by HHS as 45 CFR part 46, subpart A, and equivalent regulations of 14 Departments and Agencies, collectively referred to as the Federal Policy or the Common Rule). Submit written or electronic comments on the recommended criteria for making determinations of equivalent protection on or before May 24, 2005. DATES: Submit written comments to Ms. Gail Carter, Division of Policy and Assurances, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, The Tower Building, Rockville, MD 20852, telephone number (301) 402–4521 (not a toll-free number). Comments also may be sent via facsimile to (301) 402–0527 or by e-mail to: EQFRN@osophs.dhhs.gov. ADDRESSES: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 Glen Drew, Office for Human Research Protections, Office of Public Health and Science, The Tower Building, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, (301) 402–4994, facsimile (301) 402–2071; e-mail: gdrew@osophs.dhhs.gov. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Background The HHS codification of the Federal Policy states at 45 CFR 46.101(h): (h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. [An example is a foreign institution which complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.] In these circumstances, if a Department or Agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the Department or Agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the Department or Agency head, notices of these actions as they occur will be published in the Federal Register or will be otherwise published as provided in Department or Agency procedures. No formal findings of equivalent protection have been published in the Federal Register since the Federal policy was finalized in June, 1991. Use of the authority provided by 45 CFR 46.101(h) has been advocated by various parties, including the National Bioethics Advisory Commission in its April, 2001 report ‘‘Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries,’’ and the HHS Inspector General in the September, 2001 Report ‘‘The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects.’’ The authority of the Secretary of Health and Human Services has been delegated to OHRP (68 FR 60392), and in considering use of the 45 CFR 46.101(h) authority, OHRP recognized a need for using consistent criteria as a basis for decisions regarding equivalent protections. During 2002, the OHRP Director established a working group of representatives from interested HHS agencies, with staff support from OHRP, to consider potential criteria for use in making such decisions. The working group delivered its report in July 2003. That report recommends a framework E:\FR\FM\25MRN1.SGM 25MRN1

Agencies

[Federal Register Volume 70, Number 57 (Friday, March 25, 2005)]
[Notices]
[Pages 15317-15322]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5945]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Notice of Funding Opportunity

AGENCY: Department of Health and Human Services, Office of Public 
Health and Science, Office of Population Affairs.

ACTION: Notice.

-----------------------------------------------------------------------

    Funding Opportunity Title: Announcement of Availability of Funds 
for Grants for Family Planning Service Delivery Improvement Research.
    Announcement Type: This is a standing program announcement to 
remain in effect through May 15, 2007, unless it is withdrawn or 
modified, with an annual application receipt date of May 15.
    Funding Opportunity Number: PAR-05-185.
    CFDA Number: 93.974.

    Authority: Section 1004 of the Public Health Service (PHS) Act.

DATES: This standing program announcement will remain in effect through 
May 15, 2007, unless it is withdrawn or modified. To receive 
consideration a package containing a signed typewritten application, 
including the checklist, and two photocopies of the application must be 
received at the address below no later than May 15 and no earlier than 
April 15 of each year the program announcement remains in effect. 
Letters of intent should be received by April 30 of the year in which 
an application will be submitted. Up to two amended applications may be 
submitted in years subsequent to the year in which the original grant 
application was submitted but did not receive funding.

SUMMARY: The Office of Population Affairs (OPA) requests applications 
for family planning service delivery improvement research grants. 
Applied research projects are encouraged in one or more of the 
following priority areas: (1) Quality of care in the delivery of family 
planning services; (2) effective approaches and interventions for 
addressing the reproductive health needs of adolescents and 
incorporating family members (particularly parents or guardians) into 
decisions of adolescents regarding relationships and sex; (3) 
reproductive health needs of males, prevention-related decisions by 
males and appropriate strategies for reaching male clients; (4) 
knowledge base for incorporating a ``couples'' perspective into the 
delivery of family planning services; (5) effective organizational 
approaches for delivery of family planning services in conjunction with 
related services, particularly HIV prevention services; (6) 
dissemination of findings and translation of service delivery research 
into practice; (7) factors associated with increasing costs and the 
impact of such increasing costs on service delivery; and (8) 
effectiveness of Title X non-clinical services with regard to 
information and education activities. Regulations pertaining to grants 
for research projects are set out at 42 CFR part 52. Section 1008 of 
the PHS Act provides that ``none of the funds appropriated under this 
title shall be used in programs where abortion is a method of family 
planning.''

I. Funding Opportunity Description

    This announcement invites applications from public and non-profit 
private entities for research on selected topic areas for family 
planning service delivery improvement. The purpose is to support 
relevant research which will promote improvements in family planning 
services. Therefore, funds available under this announcement are for 
projects to conduct applied research which will be useful to family 
planning administrators and providers, researchers, and officials of 
local, State, and the Federal government, including OPA, in order to 
improve the delivery of family planning services to persons needing and 
desiring such services.
    Research projects supported under this announcement are expected to 
be consistent with one or more of the following performance goals for 
the Family Planning Program in the Department of Health and Human 
Services: (1) Improve health outcomes, (2) Increase utilization of 
preventive health care, particularly among vulnerable and special needs 
populations, (3) Increase the proportion of pregnancies that are 
intended, or (4) Reduce pregnancies among unmarried adolescent females.
    ``Healthy People 2010'' is a Department of Health and Human 
Services initiative to achieve health promotion and disease prevention 
objectives. Applicants for funding under this announcement should 
relate proposed plans to Healthy People objectives. A copy of ``Healthy 
People 2010'' is available at the following Web site location: https://
www.health.gov/healthypeople

Background

    The Family Planning Program, authorized by Title X of the Public 
Health Service Act (42 U.S.C. 300, et seq.) is the only federal program 
devoted solely to funding family planning and related preventive health 
care services. This program supports a nationwide network of 
approximately 4,500 clinics and provides family planning services and 
supplies as well as relevant preventive health services to 
approximately 5 million persons per year. Family planning, like many 
health care services, faces continuing and emerging challenges to 
delivering quality care. This announcement calling for service delivery 
improvement research applications is intended to help family planning 
programs meet those challenges.
    The research emphases identified for attention in this announcement 
are consistent with the purpose of the Title X family planning services 
program, which is to provide family planning services to persons from 
low-income families and others. Section 1001 of the Act, as amended, 
authorizes grants ``to assist in the establishment and operation of 
voluntary family planning projects which shall offer a broad range of 
acceptable and effective family planning methods and services 
(including natural family planning methods, infertility services, and 
services for adolescents).''
    This announcement also draws on a report issued by OPA in July, 
2004: Future Directions for Family Planning Research: A Framework for 
Title X Family Service Delivery Improvement Research. This report was 
the

[[Page 15318]]

culmination of a project that assembled experts to review the existing 
research literature, discuss the key research issues facing the field 
and identify future research needed to better inform family planning 
practitioners. Hard copies of the report are available through the OPA 
Clearinghouse at P.O. Box 30686, Bethesda, MD 20824-0686; ph: 866-640-
PUBS (7827); fax: 866-592-FAXX (3299); e-mail: 
clearinghouse@dhhsopa.net
    The experts identified future studies to address three broad 
concerns: (1) How can high-priority populations be reached? (2) How can 
family planning practices be strengthened? and (3) How can the 
organization and administration of services be improved? Based on 
Family Planning Program priorities, OPA selects and highlights below 
priority topics for the service delivery improvement research grants 
program that reflect all three of these concerns.

Purposes of the Grant

    The purpose of this grant program is to expand the knowledge base 
in areas identified for applied research attention in this 
announcement. To that end, this announcement invites applications in 
one or more of the following areas:
1. Quality of Care
    Quality of care has many components. A report issued by the 
Institute of Medicine (IOM), Crossing the Quality Chasm (2001), 
addresses health care in general and calls for attention to six key 
dimensions of service quality in order to improve service delivery on 
each dimension:
     Safety--Health care should be safe and should avoid 
injuries to patients
     Effectiveness--Health care should provide services based 
on scientific knowledge to all who could benefit from the services and 
should avoid providing services to those who are unlikely to benefit
     Patient-centeredness--Health care should provide services 
that are respectful and responsive to individual patient preferences, 
needs, and values and ensure that patient values guide all clinical 
decisions.
     Timeliness--Health care should reduce waits and sometimes 
harmful delays for both those who receive and give care.
     Efficiency--Health care should avoid waste, including 
waste of equipment, supplies, ideas, and energy.
     Equity--Health care should be provided that does not vary 
in quality because of personal characteristics such as gender, 
ethnicity, geographic location, or socioeconomic status.

These quality dimensions are present in health care delivered in family 
planning clinic settings. Therefore, investigation of approaches which 
address any of these six dimensions in the family planning context is 
encouraged. Research that adapts approaches and builds on findings, 
tools or measures from service quality research in other health care 
sectors or other countries is similarly encouraged.
2. Reproductive Health Care to Adolescents/Parental Involvement
    Adolescents are among the hard-to-reach populations identified for 
attention in the current Family Planning Program priorities. These 
program priorities also have the goal of encouraging family 
participation (particularly that of parents or guardians) in the 
decision of minors to seek family planning services, including 
activities that promote positive family relationships. Key issues for 
the Family Planning Program are: Providing adolescents with 
information, skills and support to encourage abstinence from or delay 
of sexual activity. Two significant questions quoted in the Future 
Directions report are: (1) ``What are effective practices that clinics 
can use to assist adolescents and young adults in sexual decision 
making?'' and (2) ``How can adolescents be better connected to their 
families and schools, and will these connections result in decreased 
sexual activity?'' These perspectives provide a context for the applied 
research topic of adolescent reproductive health that may be addressed 
by applicants to this program announcement.
    Over the last several years, amid growing concerns about adolescent 
pregnancy and high rates of sexually transmitted diseases (STDs), local 
communities have developed abstinence programs. Family planning 
practitioners can contribute to this wider effort to help teens avoid 
risky behaviors and make a healthy transition to adulthood, if they are 
provided with relevant information from service delivery improvement 
research. Such information will be most useful if it pertains not only 
to adolescent clients, but also to the parents who have such a critical 
role in shaping their child's development.
    There is interest in a range of studies that might be designed to 
develop useful approaches and evaluate tailored interventions in this 
area. Intervention studies that target parental involvement are of 
particular interest.
    Possible studies include:
     Identification of effective clinic techniques for 
counseling and encouraging adolescent abstinence, return to abstinence, 
or similarly-responsible decision making regarding sexual behavior, 
including training for adolescents in needed skills to behaviorally 
carry out their decisions;
     Evaluation of abstinence programs in the family planning 
setting which teach abstinence knowledge, attitudes and skills in the 
context of preparation for future healthy family relationships;
     Evaluation of clinic strategies for promoting parent-
adolescent communication about preparation for future family life 
through current decision-making about reproductive health matters;
     Identification of approaches to enhance the role of 
parents in providing information to their adolescents about sex;
     Evaluation of various kinds of outreach strategies to 
parents by family planning providers; and
     Evaluation of youth advocate strategies for supporting/
guiding adolescents and their families in navigation of the 
reproductive health care system.
3. Reproductive Health Services to Males
    Males also are among the hard-to-reach populations identified for 
attention in the current priorities of the Family Planning Program. 
Although men play a vital role in decision-making around sexual 
relationships, reproductive health, and family planning, most of the 
attention in the past has been focused on women. A fundamental building 
block in the development of any program is understanding the population 
to be served. While we have learned much about program interventions 
directed at women, little is known about how to deliver reproductive 
health services to men. The lack of information about the knowledge, 
attitudes, and behavior of males regarding family planning and related 
preventive health needs has made it difficult to design programs that 
appropriately serve males.
    Priority questions about males raised by the Future Directions 
report include: ``What information do we need about men in their early 
20s and 30s who need STD and family planning services? How do we create 
more male clinics? How do we look for alternative sites for these 
clinics?'
    In order to advance our understanding in this area, research is 
encouraged on one or more of the following topics:
     Information about the characteristics of men who seek 
reproductive health services, their pattern of use, awareness of the

[[Page 15319]]

availability of family planning services, and intention to use such 
services.
     Men's experiences with the existing reproductive health 
care system and factors influencing or inhibiting men's use of provided 
services.
     Services valued by males of different age groups and their 
preferred context for such services, e.g., couples; male-only; 
traditional family planning clinic setting or other contexts, etc.
     Evaluation of outreach strategies and approaches to males 
by family planning clinics.
     Factors that influence prevention-related choices of males 
such as abstinence, return to abstinence, committed marital/monogamous 
relationships, or use of a condom when engaging in widespread sexual 
activity.

For the first time, data on males were obtained in the National Survey 
of Family Growth which was in the field in 2002 (Cycle 6). Please see 
fuller description of this data set under ``Data Resources'' section 
below. This new cycle provides an opportunity to explore male 
reproductive health characteristics and motivations that could improve 
our understanding of how best to meet the reproductive health needs of 
men.
4. Family Planning Services to Couples
    While reproductive and family planning choices likely represent a 
joint decision between couples, scant attention has been given to 
couple-focused approaches for reproductive health care. The Future 
Directions report indicates that the development and testing of 
approaches to serving couples in the family planning setting is a 
promising new area of research, given that most sexual, contraceptive, 
and childbearing decisions are made jointly. It also points out that 
there is emerging policy interest at the Federal level in enhancing the 
quality of relationships between intimate partners to encourage the 
establishment of healthy committed relationships and marriages. Some 
evidence indicates that the involvement of partners in reproductive 
health care could result in more effective use of contraceptives. 
Cooperation of partners is also key for the effectiveness of natural 
family planning. Providers oriented toward meeting the needs of couples 
would find results of partners research useful. There is a heightened 
need to focus on how couples communicate regarding the use of condoms 
for disease protection. Given the complex dynamics that may be present 
in sexual relationships, women particularly may be in need of 
assistance from the family planning counseling context in order to 
conduct couples negotiations.
    Thus, there are a number of ways to approach the building of a 
knowledge base for incorporating a ``couples'' perspective into the 
delivery of family planning services. There is a research literature on 
the role that the couple relationship plays in contraceptive decision-
making, which could be usefully expanded. Almost completely unexplored 
is the topic of how healthy couple relationships could be fostered in 
family planning settings or through referral to appropriate care 
services such as family services or marriage and relationship education 
services. The goal of such care would be to benefit the health of the 
individual members of the couple as well as the couple unit. Overall, 
studies are encouraged which investigate innovative approaches for 
serving couples in family planning clinics or through coordination of 
complimentary care settings, as well as studies which evaluate 
strategies for involving the partner in effective reproductive health 
decision-making.
5. Organizational Approaches to Integrated Services
    Although integrated services can take many forms, this announcement 
directs particular attention to the integration of HIV prevention and 
family planning services. The Future Directions report indicates that 
research about how to integrate successfully these two types of 
reproductive health services is very limited and should be given the 
highest priority.
    Family planning clinics are an ideal site for integrating HIV 
prevention activities because they serve sexually active, nonpregnant 
women, many of whom may be at great risk of becoming infected. The 
increased incidence of HIV infection among women, especially those 
whose demographic characteristics match those of the women served in 
publicly-funded family planning clinics, underscores the need for the 
Title X program to intensify efforts to provide both education and 
counseling regarding HIV/AIDS to users of Title X services. These 
important prevention considerations have made integration of early HIV 
prevention programs into ongoing family planning services a major 
public health imperative.
    Studies are needed to examine the impact on the family planning 
service delivery system of such HIV prevention service integration. In 
what ways does this development impinge on the concerns and routine 
functioning of family planning clinics and clinic personnel? In 
addition to assessing what HIV-related activities have been 
implemented, studies are needed to determine which strategies have been 
effective, and to disseminate information about successful integration 
approaches being implemented in the family planning setting.
6. Translating Research into Practice (TRIP)
    There is an increasing need for the worlds of research and practice 
to be in closer relationship for the mutual benefit of each. In the 
purely medical context, the practice of medicine is becoming 
increasingly evidence-based, with practice guidelines for clinicians 
driven by research findings about treatment effectiveness. For health-
related programs with an expanded mission beyond the strictly medical, 
interventions and service practices are increasingly based on the best 
available evidence regarding what works. Like the rest of the health 
care system, family planning faces the challenge of utilizing practice 
guidelines and recommendations that are evidence-based in the delivery 
of clinical services and of translating knowledge into practice more 
generally.
    Dissemination research is a first step in meeting this challenge, 
especially research that identifies effective strategies for 
disseminating tested practice innovations to the practitioner field. 
Areas that need exploration include: Descriptive research about where 
family planning practitioners actually obtain information utilized in 
the service delivery arena; professional-organization collaboration in 
conducting research about practices; and evaluations of dissemination 
interventions.
    Of additional interest to OPA are implementation studies that 
provide needed details about how a given service innovation can be 
effectively implemented elsewhere or how a more general research 
finding can be given concrete expression in the service setting, using 
appropriately-selected ``translational'' clinic sites. The service 
innovation or research finding may initially emanate from other than 
family planning settings or populations, provided the proposed study 
bases the translation/implementation effort on sound theoretical 
constructs regarding transferability. For example, the applicability of 
findings about the utility of information technology to increase 
efficiency and effectiveness of medical and social services other than 
family planning may be explored in an implementation study utilizing a 
family planning clinic site.

[[Page 15320]]

7. Increasing Costs and Their Impact
    Research is needed that would shed light on a number of unanswered 
questions related to costs including:
     How are costs affected by different types of services, the 
characteristics of the clients served and the setting where services 
are provided?
     What strategies have been employed to reduce costs while 
still maintaining the quality of services provided?
     What impact has the newer, more technologically advanced 
methods of care had on the ability to maintain the quality and level of 
services?
    Areas of interest include, but are not limited to the following:
     The increasing cost of providing specific contraceptive 
methods, including the actual cost of the method(s), shifts in the 
demand for the method(s), and staff level and time required;
     The cost of using advanced diagnostics technologies, 
including the actual cost of the technology, staff level and time 
required, and the long range cost implications to the provider of 
adopting the technology;
     The cost of providing services to under-served 
population(s), including outreach efforts and the specific mix of 
services required;
     The cost involved in recruiting and retaining adequate 
numbers of qualified staff; and
     Factors affecting revenue, including increases in the 
number of clients requiring subsidized services, changes in third party 
reimbursement to providers, and shifts in Federal, State, and local 
funding sources.
8. Effectiveness of Title X Information and Education Activities
    Promoting individual and community health is a Family Planning 
Program priority. Increasingly, information and education strategies 
have been employed by family planning practitioners to accomplish this 
goal. There is a need for corresponding evaluations of the 
effectiveness of such efforts.
    A great diversity of information strategies and educational 
approaches have been employed by family planning practitioners. A 
number of OPA-funded projects provide family planning information and 
education services to many individuals in non-clinical and non-
traditional settings. Not only has it been difficult to track thousands 
of non-medical users being served throughout the country by these Title 
X information and education projects, but it also presents a challenge 
to evaluate the effectiveness of these approaches. Therefore, rigorous 
evaluations of these activities, utilizing appropriate methodologies, 
is encouraged in this program announcement.

Data Resources

    When appropriate to the proposed topics, applicants may wish to 
consider using nationally-representative data sets such as the National 
Survey of Family Growth (NSFG). The NSFG is a cross-sectional survey of 
family formation and reproductive health conducted by the National 
Center for Health Statistics, Centers for Disease Control and 
Prevention. Previous cycles have consisted of personal interviews with 
a national sample of women 15-44 years of age in the United States, but 
with the latest cycle, Cycle 6, data from men ages 15-49 were also 
collected. The NSFG is a source of national data, which provides 
information on the level of sexual activity among adolescents, 
incidence of unintended pregnancy, contraceptive behavior, use of 
family planning services, trends in marriage, divorce, and cohabitation 
and rates of infertility. More information on the NSFG is available at 
https://www.cdc.gov/nchs/nsfg.htm OPA encourages applications which 
utilize data from Cycle 6 of the NSFG, as appropriate to the particular 
research approach. However, whether this type of data set is used or 
not used is completely at the discretion of the applicant and will not 
influence funding decisions on applications submitted under this 
announcement.

II. Award Information

    The OPA, subject to the availability of funds, intends to make 
available approximately $750,000 each year (Fiscal Years 2005, 2006 and 
2007) to support an estimated three to four new research projects in 
each of the three years. Awards will range from $150,000 to $200,000 in 
total costs (both direct and indirect costs) per year. The awards to be 
made are for applied research and do not cover costs of delivering 
services that the applied research project may propose to evaluate. 
Accordingly, the mechanism of support for this program announcement 
will generally be the research project grant (R01), although other 
mechanisms may be supported.
    Research applications requesting less than $150,000 in total costs 
(both direct and indirect costs) per year for no more than a total of 
two years will be considered small research project grants (R03). Small 
research project grants (R03) will be subject to the review criteria 
listed in the ``Application Review Information'' section below, but 
reviewers will be instructed to take into account the smaller scope of 
the proposed project.
    OPA encourages New Investigators (as defined in the PHS 398 
application instructions) to apply as Principal Investigators. New 
Investigator applications (whatever the funding level request) will be 
evaluated by the review criteria listed in the ``Application Review 
Information'' section below, but the reviewers will be instructed to 
take into account the Principal Investigator's stage of career 
development.
    Grants will be funded in annual increments (budget periods) and may 
be approved for a project period of up to three years. Funding for all 
budget periods beyond the first year of the grant is contingent upon 
the availability of funds, satisfactory progress of the project, and 
adequate stewardship of Federal funds.
    Earliest anticipated start date: Four months after application 
receipt date.

III. Eligibility Information

1. Eligible Applicants

    Any public or private nonprofit entity located in a State (which 
includes one of the 50 United States or the District of Columbia, 
Commonwealth of Puerto Rico, U.S. Virgin Islands, Commonwealth of the 
Northern Mariana Islands, American Samoa, Guam, Republic of Palau, 
Federated States of Micronesia, and the Republic of the Marshall 
Islands) is eligible to apply for a grant under this announcement. 
Faith-based organizations are eligible to apply for these service 
delivery improvement research grants.

2. Cost Sharing or Matching

    There is no cost sharing or matching requirement.

IV. Application and Submission Information

1. Address to Request Application Package

    Applications must be submitted on the research application form PHS 
398 (revised 9/04), which is available online at: https://
grants1.nih.gov/grants/oer.htm. This form contains instructions for the 
submission of amended as well as new grant applications. For additional 
information about obtaining the research application form PHS 398, 
please call Eugenia Eckard at (301) 594-4001.

2. Content and Form of Application Submission

    Applicants are encouraged to read all PHS Form 398 instructions 
prior to preparing an application in response to

[[Page 15321]]

this announcement. The instructions given are a useful guide to 
application preparation. Pay close attention to font size, page limits, 
and other format specifications. However, OPA is not using the Modular 
Grant Application and Award Process. Applicants for OPA funding should 
ignore instructions concerning the Modular Grant Application and Award 
Process, following budget instructions otherwise provided in PHS Form 
398.
    When submitting the application check ``yes'' in Block 2 of the 
face page, and provide PAR-05-185 for the number and ``Family Planning 
Service Delivery Improvement (SDI) Research'' as the title.
    The application content should include the following:
    (1) A well-organized statement of the applied research problem to 
be addressed;
    (2) a detailed description of the research project design;
    (3) the conceptual framework within which the design has been 
developed;
    (4) the methodology to be employed;
    (5) the evidence upon which the analysis will rely; and
    (6) the manner in which the evidence will be analyzed.
    Applications should also clearly address how findings from the 
proposed study will have general applicability to the improvement of 
the delivery of family planning services, and a plan should be 
presented on how information from the research findings will be 
disseminated.

3. Submission Dates and Times

    To receive consideration, applications must be received by the 
Center for Scientific Review, NIH, by the deadline listed in the Dates 
section of this announcement. Applications submitted via U.S. Postal 
Service will be considered as meeting the deadline if they are 
postmarked no later than 1 week prior to the deadline date given in the 
Dates section. A legibly dated receipt from a commercial carrier or 
U.S. Postal Service will be accepted in lieu of a postmark. Private 
metered postmarks will not be accepted as proof of timely mailing. As 
soon as possible after the receipt date, usually within 6 weeks, the 
principal investigator/program director and the applicant organization 
will receive by electronic notification the application assignment 
number and the name, address, and telephone number of the Scientific 
Review Administrator (SRA) who will be directing the review group to 
which the application has been assigned. The SRA is located at the 
Agency for Healthcare Research and Quality (AHRQ) which is serving as 
the review organization for these applications. Applications that do 
not meet the deadline will not be accepted for review, and will be 
returned. Applications sent via facsimile or by electronic mail will 
not be accepted for review.
    The application package must be submitted to: Center for Scientific 
Review, National Institutes of Health, 6701 Rockledge Drive, Room 1040-
MSC 7710, Bethesda, MD 29892-7710 (20817 for express/courier service).
    Prospective applicants are asked to submit a letter of intent that 
includes a descriptive title of the proposed research, the name, 
address, and telephone number of the Principal Investigator, and the 
title of this program announcement. Although a letter of intent is not 
required, is not binding, and does not enter into the review of a 
subsequent application, the information that it contains allows OPA 
staff to estimate the potential review workload and plan the review. 
The letter of intent should be sent to Eugenia Eckard, at the address 
listed under the ``Agency Contacts'' section below and received by the 
date indicated in the Dates section of this announcement.
    Applicants are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. The DUNS number is a nine-digit 
identification number which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge. To obtain a 
DUNS number, access https://www.dunandbradstreet.com or call 1-866-705-
5711. For more information, see the OPA Web site at: https://
opa.osophs.dhhs.gov/duns.html.

4. Intergovernmental Review

    This program is not subject to the review requirements of Executive 
Order 12372, ``Intergovernmental Review of Federal Programs.''

5. Funding Restrictions

    The allowability, allocability, reasonableness, and necessity of 
direct and indirect costs that may be charged to 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 https://www.whitehouse.gov/
omb/grants/grants_circulars.html.
    The Title X program is intended to address the health needs of all 
men and women, including all subgroups as characterized by age, class, 
race, and ethnicity. It is the policy of OPA that women and members of 
minority groups be included in all OPA supported research projects 
unless a clear and compelling rationale or justification establishes 
that such inclusion is inappropriate. Applicants should approach their 
research and analysis with considerations of class, race, and ethnicity 
in mind whenever possible.

V. Application Review Information

1. Technical Review Criteria

    Eligible applications will be reviewed by a panel of independent 
peer reviewers and assessed according to the following technical merit 
criteria:
    (1) Significance. If the aims of the project are achieved, how much 
will applied research knowledge be advanced? Does the project employ 
novel or creative concepts, approaches, or methods that are insightful 
and likely to move forward the applied research area addressed in the 
application?
    (2) Scientific Merit. Are the conceptual framework, design, 
methods, and analyses adequately developed, well-integrated, and 
appropriate to the aims of the project?
    (3) Feasibility and Likelihood of Producing Meaningful Results. Are 
the plans for organizing and carrying out the project, including the 
responsibilities of key staff, the time line, and the proposed project 
period, adequately specified and appropriate? Does the application 
acknowledge potential problem areas and consider alternative tactics? 
For intervention evaluation studies, is adequate funding for the 
intervention already in place or assured for the intervention period to 
be evaluated, making the proposed evaluation feasible?
    (4) Competency of Staff. Are the principal investigator, and other 
key research staff, appropriately trained and well suited to carry out 
this project?
    (5) Adequacy of Facilities and Resources. Are the facilities and 
resources of the applicant institution and other study sites adequate?
    (6) Adequacy of Budget. Is the budget reasonable and adequate in 
relation to the proposed project?

2. Review and Selection Process

    Each of the above technical review criteria will be addressed and 
considered by independent peer reviewers in assigning an overall or 
global priority score, using a score range from 1.0 to 5.0 (with 1.0 
indicating

[[Page 15322]]

highest priority and 5.0, lowest priority). Final grant award decisions 
will be made by the Deputy Assistant Secretary for Population Affairs 
(DASPA) on the basis of priority score, program relevance, and the 
availability of funds.

VI. Award Administration Information

1. Notification of Award

    The OPA does not release information about individual applications 
during the review process. When a final funding decision has been made, 
each applicant will be notified by letter of the outcome. The official 
document notifying an applicant that a project application has been 
approved for funding is the Notice of Grant Award, which specifies the 
amount of money awarded, the purpose of the grant, the length of the 
project period, and the terms and conditions of the award.

2. Administrative and National Policy Requirements

    In accepting this award, the recipient stipulates that the award 
and any activities thereunder are subject to all provisions of 45 CFR 
parts 74 and 92, currently in effect or implemented during the period 
of the grant.
    A Notice providing information and guidance regarding the 
``Government-wide Implementation of the President's Welfare-to-Work 
Initiative for Federal Grant Programs'' was published in the Federal 
Register on May 16, 1997. This initiative was designated to facilitate 
and encourage grant recipients and their sub-recipients to hire welfare 
recipients and to provide additional needed training and/or mentoring 
as needed. The text of the Notice is available electronically on the 
OMB home page at https://www.whitehouse.gov/omb.

3. Reporting Requirement

    At the completion of the project, the grant recipient must submit a 
brief summary in 2,500 to 4,000 words, written in non-scientific 
(laymen's) terms and Financial Status Report (SF-269). The narrative 
should highlight the findings and their implications for improving 
family planning service delivery. A plan for disseminating research 
findings should accompany the narrative. This plan should indicate how 
products of the research will be made accessible to the Office of 
Population Affairs, as well as to the Title X family planning 
administrators and practitioners, researchers, and State and local 
policy-makers. The summary, plan, and Financial Status Report must be 
mailed to the Grants Management Specialist identified on the Notice of 
Grant Award within 90 days of the project's completion.

VII. Agency Contacts

    For information on specific research or program requirements, 
contact Eugenia Eckard, Office of Population Affairs, 1101 Wootton 
Parkway, Suite 700 Rockville, MD 20852, (301) 594-4001, or via e-mail 
at eeckard@osophs.dhhs.gov. For assistance on administrative and 
budgetary requirements, contact the OPHS Grants Management Office, 1101 
Wootton Parkway, Suite 550, Rockville, MD, (301) 594-0758, or via e-
mail at kcampbell@osophs.dhhs.gov.

    Dated: March 21, 2005.
Alma L. Golden,
Deputy Assistant Secretary for Population Affairs.
[FR Doc. 05-5945 Filed 3-24-05; 8:45 am]
BILLING CODE 4150-34-P
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