Development of Revised Need for Assistance Criteria for Assessing Community Need for Comprehensive Primary and Preventive Health Care Services Under the President's Health Centers Initiative, 6016-6023 [05-2215]

Download as PDF 6016 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices FOR FURTHER INFORMATION CONTACT: Regarding the administrative and financial management aspects of this notice: Michelle N. Caraffa (see ADDRESSES). Regarding the programmatic aspects of this notice: Stephen Toigo, Division of Federal-State Relations (DFSR), Office of Regulatory Affairs, Food and Drug Administration (HFC–150), 5600 Fishers Lane, rm. 12–07, Rockville, MD 20857, 301– 827–6906, or access the Internet at: http://www.fda.gov/ora/fed_state/ default.htm. For general ORA program information contact your Regional Food Specialists at http:// www.fda.gov/ora/fed_state/ DFSR_Activities/ food_specialists.htm On page 35653 in the first column, under section V.A, a sentence is added at the end of the paragraph that reads: ‘‘A Current Listing of SPOCs can be found at http://www.whitehouse.gov/ omb/grants/spoc.html.’’ On page 35653 in the third column, under section VII, the paragraph is revised to read: ‘‘Applicants are encouraged to apply electronically (see ADDRESSES). If not, the original and two copies of the completed grant application Form PHS–5161–1 (Revised 7/00) for State and local governments should be delivered to the Grants Management Office. The receipt date is March 15, 2005. No supplemental material or addenda will be accepted after the receipt date.’’ On page 35653 in the third column, under section VIII.A in the second paragraph, the last sentence should read: ‘‘FDA is now accepting applications via the Internet.’’ Dated: January 31, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–2209 Filed 2–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Oncologic Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. VerDate jul<14>2003 18:52 Feb 03, 2005 Jkt 205001 Name of Committee: Oncologic Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on March 3, 2005, from 8 a.m. to 5 p.m. and March 4, 2005, from 8 a.m. to 1 p.m. Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Johanna M. Clifford, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827– 7001, FAX: 301–827–6776, e-mail: cliffordj@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting. Agenda: On March 3, 2005, the committee will do the following: (1) Discuss new drug application (NDA) 21–115, COMBIDEX (ferumoxtran–10), Advanced Magnetics, Inc., proposed indication for intravenous administration as a magnetic resonance imaging contrast agent to assist in the differentiation of metastatic and nonmetastatic lymph nodes in patients with confirmed primary cancer who are at risk for lymph node metastases, and (2) discuss prostate cancer endpoints as a followup to the June 2004 FDA workshop. On March 4, 2005, the committee will do the following: (1) Discuss the results of a confirmatory trial for NDA 21–399, IRESSA (gefitinib) AstraZeneca Pharmaceticals LP, for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of both platinum-based and docetaxel chemotherapies, and (2) discuss safety concerns, specifically osteonecrosis of the jaw (ONJ), associated with two bisphosphonates, NDA 21–223, ZOMETA (zoledronic acid) Injection and AREDIA (pamidronate disodium for injection), both from Novartis Pharmaceuticals Corp. ZOMETA is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. It is also approved for hypercalcemia of malignancy. AREDIA is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 metastases of breast cancer and osteolytic lesions of multiple myeloma. It is also indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, and treatment of patients with moderate to severe Paget’s disease of bone. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by February 28, 2005. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. on March 3, 2005, and between approximately 10:30 a.m. to 11 a.m. on March 4, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 28, 2005, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Trevelin Prysock at 301–827–7001, at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 27, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–2208 Filed 2–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Development of Revised Need for Assistance Criteria for Assessing Community Need for Comprehensive Primary and Preventive Health Care Services Under the President’s Health Centers Initiative Health Resources and Services Administration, HHS. AGENCY: E:\FR\FM\04FEN1.SGM 04FEN1 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices ACTION: Solicitation of comments. SUMMARY: Currently, application scores for New Access Point (NAP) applications under the President’s Health Centers Initiative (Program) cluster at the high end of the scoring range, providing little distinction among applicants. Since the intent of the Program is to provide grants to the neediest communities, HRSA is considering placing more emphasis on assessing the need for comprehensive primary and preventive health care services in the service area or for the population for which the applicant is seeking support, by revising the Need for Assistance Criteria and changing the relative weights of the review criteria used in evaluating such applications. This notice offers public and private nonprofit entities an opportunity to comment on the proposed changes in the Need for Assistance Criteria (NFA), and on the degree to which need should be weighted relative to other criteria used in evaluating future applications. In order to solicit comments from the public on these proposed changes, HRSA is delaying the due date (May 23, 2005) for the second round of fiscal year (FY) 2005 New Access Point applications. Authorizing Legislation: Section 330(e)(1)(A) of the Public Health Service Act, as amended, authorizes support for the operation of public and nonprofit private health centers that provide health services to medically underserved populations. Reference: For the current Need for Assistance (NFA) criteria and other application review criteria, including weights used most recently, see Program Information Notice (PIN) 2005–01, titled ARequirements of Fiscal Year 2005 Funding Opportunity for Health Center New Access Point Grant Applications,’’ are available on HRSA’s Bureau of Primary Health Care (BPHC) Web site at http://bphc.hrsa.gov/pinspals/pins.htm. That PIN detailed the eligibility requirements, review criteria, and awarding factors for applicants seeking support for the operation of New Access Points in FY 2005. Background: The goal of the President’s Health Centers Initiative, which began in FY 2002, is to increase access to comprehensive primary and preventive health care services to 1,200 of the Nation’s neediest communities through new and/or significantly expanded health center access points over five years. These health center access points are to provide comprehensive primary and preventive health care services in areas of high need that will improve the health status VerDate jul<14>2003 18:52 Feb 03, 2005 Jkt 205001 of the medically underserved populations to be served and decrease health disparities. Services at these new access points may be targeted toward an entire community or service area or toward a specific population group in the service area that has been identified as having unique and significant barriers to affordable and accessible health care services. While it is extremely important that NAP grant awards be made to entities that will successfully implement a viable and compliant program for the delivery of comprehensive primary health services to the populations or communities they propose to serve, HRSA also needs to assure that all applicants seeking support for a NAP applicant can demonstrate the need for such services in the community (area or population group) to be served and be evaluated on that need. Under the current guidance, NFA criteria are used to quantify barriers to access and identify health disparities. The NFA process also establishes a threshold which applicants must meet in order for their applications to be reviewed by the Objective Review Committee (ORC). Description of Current NFA process. The current NFA process (as described in Form 9-Part A of PIN 2005–01) involves two major groups of indicators. First, from eight (8) ‘‘Barriers and Access to Care’’ measures, the applicant must select five (5). These measures are: Shortage of primary care physicians, as measured by whether the target service area has been designated as a geographic or population group Health Professions Shortage Area (HPSA); Percent of the population with incomes below 200% of the Federal poverty level; Life expectancy of target population (in years); percentage of target population uninsured; unemployment rate of target population; average travel time or distance to nearest source of primary care for target population; percentage of target population age 5 or older who speak a language other than English at home; and length of waiting time for public housing and Section 8 certificates for target population. For the first of these measures, the applicant receives 14 points if HPSA-designated and zero otherwise; for each of the other measures, the NFA criteria define a 6-level scale from 0 to 14 points. The applicant provides data for its service area or target population for each of the 5 measures selected, and identifies the source of data used. Given 5 indicators and a maximum of 14 points for each, there are a possible 70 points for the ‘‘Barriers and Access to Care’’ indicators. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 6017 Second, from 28 ‘‘Health Disparity Factors’’, the applicant selects 10 and provides data on each for its service areas or target populations. For each factor selected, the applicant can receive 3 points if the value for the target population exceeds the benchmark used. The applicant defines the benchmark, and gives a source for that benchmark as well as a source for the target population data provided. The guidance lists 27 specific factors, plus an ‘‘other’’ category allowing the applicant to select one additional locally-relevant factor not anticipated by the guidance. This approach produces a possible 30 points for the ‘‘Health Disparities Factors’’ section; combined with the possible 70 for ‘‘Barriers and Access to Care’’ section, allowing a possible 100 total points are possible. In current guidance, the threshold for having the application reviewed has been set at an NFA score of 70 out of the possible 100 total points. Need for Assistance Worksheets and the Application Review Process In accordance with the guidance, all applicants are required to complete an NFA Worksheet, identifying the NFA indicators they have selected from the options available and providing the data on these indicators for their proposed service area or target population. The Worksheet is reviewed by an Objective Review Committee (ORC), and only those applicants that achieve a score of 70 or higher out of the possible 100 points have the merits of their application evaluated by the ORC. To date, under the President’s Initiative, HRSA has found that most applicants achieve the minimum of 70 NFA points required in the current process for consideration of their application. Furthermore, under the current application review process, only 10% of the total (100) possible points are allocated to the applicant’s description of the need for additional primary care services in the community or target population to be served. Currently, application scores cluster at the high end of the scoring range, providing little discrimination among applications. For these reasons, HRSA arranged for an external evaluation of the NFA criteria and the use of need factors in the overall application review process. (The evaluation was conducted by a team of HSR, Inc., and the University of North Carolina’s Cecil G. Sheps Center for Health Services Research.) Key results of the evaluation analyses are presented below, followed by recommendations for proposed changes on which we are soliciting comments. E:\FR\FM\04FEN1.SGM 04FEN1 6018 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices Current NFA Access Barriers— Frequency of Applicant Use; Scores Achieved An analysis of applications received during FY 2004 indicated that, with respect to the eight ‘‘Barriers and Access to Care’’ indicators, 92% of applicants selected the indicator percent of target population below 200% poverty; 79% selected percent of target population uninsured; 78% selected shortage of primary care physicians; and 75% selected unemployment rate for the target population, while only 36% selected life expectancy of the target population and 34% selected travel time or distance. Language other than English and shortage of Public Housing were selected by 55% and 50% of the applicants respectively. Since applicants naturally chose the variables that gave them the highest scores, the average scores achieved on all of the ‘‘Barriers and Access to Care’’ indicators ranged from 12 to 14 for each, except for life expectancy, which had an average score of about 11. As a result, scores of 60 or more for the ‘‘Barriers and Access to Care’’ section were routinely obtained. Current NFA Disparity Factors— Frequency of use by applicants. A similar analysis of the ‘‘Health Disparity Factors’’ selected by the same group of applicants showed that 8 indicators were selected by 50% or more of the applicants, and another 7 indicators were selected by one-third or more applicants. Twelve indicators were selected by 25% or fewer of the applicants. Ninety-five percent of the time a selected indicator received 3 points; only 5% of the time did an applicant receive 0 rather than 3 points for a disparity indicator supplied. Therefore, typically, at least 27 points were received for the ‘‘Health Disparities Factors’’ section. Combining at least 60 points for the ‘‘Barriers and Access to Care’’ section access barriers and 27 points for the ‘‘Health Disparities Factors’’ section, a typical application would get 87 points, easily exceeding the threshold of 70. Distribution of All U.S. Counties on Current NFA Barrier Score Levels. To arrive at an understanding of why the scores for access barriers ran so high for most applications, an analysis of the scores that would be achieved by all 3,141 U.S. counties or countyequivalents was conducted. This analysis showed that, given the existing scales: • On Percent Below 200% of Poverty, 665 of 3141 counties receive 14 points, another 993 receive 12 points, and 946 VerDate jul<14>2003 18:52 Feb 03, 2005 Jkt 205001 receive 10 points. The average county score is 11 points. • On Life Expectancy, only 17 counties receive 14 points, but 601 counties receive 12 points, and 2,140 receive 10 points. The average county score is 10.1 points. • On Unemployment Rate, the counties are distributed more evenly along the scoring scale, but only 2 counties receive zero points, and the average county score is 9.5 points. • On Percent Uninsured, 1,609 counties receive 10 points, while 1,327 receive 8 points. The average county score is 9 points. • By contrast, Travel Time/Distance shows better distinctions among counties using its existing scale; while 1,527 counties receive zero points, 950 receive 6 points, 294 receive 8 points, 112 receive 10 points, 52 receive 12 points and 51 receive 14 points. The average score is 3.5. HRSA is requesting feedback as to whether the scale should be adjusted to increase the numbers of counties getting 10, 12 or 14 points? • In the case of Language other than English, the current scale seems to err in the direction of overly minimizing the points received: 2,410 counties receive zero points, and the average county score is only 1.8 points. • On Shortage of Primary Care Physicians, 2,565 counties receive no points while 576 receive 14 points. This means that about one-sixth of counties are getting the maximum points, because they are wholly designated as HPSAs. This does not provide any flexibility in terms of the rest of the counties, some of which may be closer to eligibility for HPSA designation than others, while others contain part-county HPSAs. Recommendations for Revising NFA Criteria/Worksheet. Based on the analysis described above, feedback from communities, applicants and several focus group sessions, HRSA is proposing the following changes to the NFA criteria and process: • Require that three (3) major access barriers be measured for all applicants. These three would be (a) percent of the population with incomes below 200 percent of the poverty level, (b) percent of population uninsured, and (c) shortage of primary care physicians, the three barriers that are most frequently selected by applicants. • Use the population-to-primary care physician ratio for the applicant’s service area or target population as the measure of shortage of primary care physicians, rather than a simple yes/no response based on presence or absence of a HPSA designation, with a scale of PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 the type used for the other access indicators. • Allow the applicant to select two additional access barriers from the following five (5): Unemployment Rate of Population, Percent Linguistically Isolated Population (replacing language other than English), Standardized Mortality Rate for Population (replacing Life Expectancy Rate), Travel Time/ Distance to Nearest Provider accepting Medicaid and/or Uninsured Patients, and (for Homeless or Public Housing applicants only) Waiting time for Public Housing. • Choose the scale for each of the access indicators based on comparison to the national county distribution of that indicator. (The scales proposed to be used are displayed below.) No points would be awarded for a barrier value better than the national county median. • Require that 5 ‘‘core’’ disparity factors closely related to health center primary care activities be measured for all applicants. The core indicators proposed are: asthma rate, diabetes rate, and cardiovascular disease rate among the population; one birth outcome measure (infant mortality rate or low live birthweight rate), and one mental health measure (depression rate or suicide rate) among population. [Of these factors, all but one (depression rate) were in the group of current indicators selected at least 33% of the time.] • Allow 2 points for each core disparity factor on which the community value exceeds the national benchmark for that factor, which would be provided in HRSA’s application guidance (rather than by the applicant). Allow an additional point if a higher ‘‘severe’’ benchmark, also specified in the guidance, is also exceeded. (Benchmarks proposed are appended below.) • Have the applicant select 5 additional disparity factors from a list of 7 factors previously used that are closely related to health center primary care activities. The factors proposed are: immunization rate, hypertension rate, rate of respiratory infection, obesity, teenage pregnancy, substance abuse, and percent elderly population. Alternatively, the applicant may select 4 of these plus an ‘‘other’’ indicator specified by the applicant. • Allow 2 points for each selected measure on which the community value exceeds the national benchmark. (Benchmarks proposed are appended below.) If ‘‘other’’ is selected, the applicant would need to both define the measure and suggest a benchmark for it as well. If the measure and the benchmark are accepted (or if the E:\FR\FM\04FEN1.SGM 04FEN1 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices measure is accepted but the benchmark is redefined), 2 points would be allowed if the benchmark is exceeded. • Maximum possible total points for access barriers here is 75; and for disparities is 25 points, totaling 100 possible total points for NFA. • A threshold of 50 points on this revised index is under consideration. Only those applicants with a NFA score of 50 or more would have their application reviewed by the ORC. HRSA is considering whether this threshold should be changed annually to maintain a certain ratio of number of applications reviewed to number of awards available. • The NFA scores achieved could be factored into the application review process. VerDate jul<14>2003 18:52 Feb 03, 2005 Jkt 205001 Relative Importance of Need as an Application Review Factor The evaluation team also recommended that the relative need score from the NFA worksheet should be the basis for 20 percent of total application score, replacing the previous 10% for ‘‘description of service area/community and target population.’’ To accommodate this change, the evaluation team suggested reducing the proportion of the total application score now assigned to ‘‘Governance’’ from 10% to 5%, and reducing the proportion of total score assigned to ‘‘Service Delivery Strategy and Model’’ from 20% to 15%. However, HRSA has not taken a position on what new relative weighting might be most appropriate. Instead, by this notice, we are requesting public comments on this issue. Specifically, how should Need PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 6019 considerations be weighted in the application review process? What is the relative importance of Need versus such other factors as applicant Readiness to operate a health center, understanding of and connections to the local health care Environment, service delivery Strategy for addressing the needs of the community, plan for provision of specific required health Services, Organizational capabilities and expertise, Budget plan, and Governance? Rather than providing specific suggested percentages for weighting all these different factors, commenters are encouraged to isolate how Need should be weighted relative to all other factors, and whether this should be done by applying that weight to an objective index of relative community need such as that proposed above, or in some other manner. BILLING CODE 4165–15–P E:\FR\FM\04FEN1.SGM 04FEN1 VerDate jul<14>2003 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices 18:52 Feb 03, 2005 Jkt 205001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4725 E:\FR\FM\04FEN1.SGM 04FEN1 EN04FE05.002</GPH> 6020 VerDate jul<14>2003 18:52 Feb 03, 2005 Jkt 205001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4725 E:\FR\FM\04FEN1.SGM 04FEN1 6021 EN04FE05.003</GPH> Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices Please send comments no later than COB March 7, 2005. The comments DATES: VerDate jul<14>2003 18:52 Feb 03, 2005 Jkt 205001 should be addressed to Dr. Sam Shekar, Associate Administrator for Primary PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Health Care, Health Resources and Services Administration, Room 17–99, E:\FR\FM\04FEN1.SGM 04FEN1 EN04FE05.004</GPH> 6022 6023 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices 5600 Fishers Lane, Rockville, Maryland 20857. FOR FURTHER INFORMATION CONTACT: Ms. Lynn Spector, Division of Health Center Development, Bureau of Primary Health Care, HRSA. Ms. Spector may be contacted by e-mail at lspector@hrsa.gov or via telephone at (301) 594–4300. Dated: February 1, 2005. Elizabeth M. Duke, Administrator. [FR Doc. 05–2215 Filed 2–1–05; 4:24 pm] BILLING CODE 4165–15–C DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Physical Activity and Its Components In Relation To Plasma Inflammatory Markers of Cancer Risks Among Chinese Adults SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection Title: Physical Activity And Its Components In Relation To Plasma Inflammatory Markers Of Cancer Risks Among Chinese Adults. Type of Information Collection Request: NEW. Need and Use of Information Collection: The specific objectives of the current study are to: (1) Develop a comprehensive physical activity questionnaire that includes standardized questions about all types of physical activity (e.g., recreational, household, occupational, and transportation), and all parameters of physical activity (e.g., frequency, intensity; and duration in hours per week; (2) to assess the validity and reliability of this comprehensive physical activity questionnaire and the currently used baseline physical activity questionnaire in two existing study cohorts using objective measures of physical activity/physical fitness (activity monitors and step test), and; (3) to evaluate whether types and parameters of physical activity are associated with circulating levels of specific inflammatory markers that have been linked to cancer risk, independent of body mass and other potentially confounding variables. The specific markers are C-reactive protein (CRP), interleukin 6 (IL–6), and soluble tumor necrosis factor alpha (TNF-’’). The findings of this study will contribute to research in several important ways. They will allow the collection of objective physical activity measurements using activity monitors within a population with a wide range of between-person variation in physical Number of participants activity; add to our understanding of the relationship of individual types of physical activity (e.g., recreational, household, occupational, and transportation), and parameters of physical activity (e.g., frequency, intensity, and duration in hours per week) to cancer outcomes; allow the use of physical activity information together with detailed, prospectively collected information regarding other lifestyle factors, such as diet and body mass, factors that are highly correlated with physical activity and also represent strong independent determinants of inflammatory mediator production, and; should the anticipated associations be found, the current study will likely stimulate future studies aimed at independently and jointly evaluating physical activity and chronic low-grade systemic inflammation in relation to cancer of several sites. Frequency of Response: Once a month during a twelve-month period. Affected Public: Approximately 600 men and women from a current cohort study among 75,000 women and 73,000 men and residing in Shanghai, China who agree to participate in this study. Type of Respondents: Adult men and women aged 40 to 70 years old who are residents of Shanghai, China and current participants in another ongoing study. The annual reporting burden is as follows: Estimated Number of Respondents: 600. Estimates of Respondent Hour Burden and Annualized Cost to Respondents: Frequency of response Average burden hours per response Total annual hour burden Type of respondents Survey instruments per respondents Adults (40–70 yrs old) ....................... Physical Activity Questionnaire ........ 7-Day Physical Activity Record ........ 1-Week Physical Activity Recall ....... 600 600 600 2 4 12 0.5 1.4 0.25 600 3360 1800 TOTAL ....................................... ........................................................... 600 ........................ ........................ 5,760 There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance VerDate jul<14>2003 18:52 Feb 03, 2005 Jkt 205001 the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Michael F. Leitzmann, M.D., Dr. P.H., Nutritional Epidemiology Branch, Division of FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 Cancer Epidemiology and Genetics, National Cancer Institute, NIH, DHHS, 6120 Executive Blvd., EPS–MSC 7232, Bethesda, MD, 20892, U.S.A. or call non-toll-free number 301–402–3491 or E-mail your request, including your address to: leitzmann@mail.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. E:\FR\FM\04FEN1.SGM 04FEN1

Agencies

[Federal Register Volume 70, Number 23 (Friday, February 4, 2005)]
[Notices]
[Pages 6016-6023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2215]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Development of Revised Need for Assistance Criteria for Assessing 
Community Need for Comprehensive Primary and Preventive Health Care 
Services Under the President's Health Centers Initiative

AGENCY: Health Resources and Services Administration, HHS.

[[Page 6017]]


ACTION: Solicitation of comments.

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SUMMARY: Currently, application scores for New Access Point (NAP) 
applications under the President's Health Centers Initiative (Program) 
cluster at the high end of the scoring range, providing little 
distinction among applicants. Since the intent of the Program is to 
provide grants to the neediest communities, HRSA is considering placing 
more emphasis on assessing the need for comprehensive primary and 
preventive health care services in the service area or for the 
population for which the applicant is seeking support, by revising the 
Need for Assistance Criteria and changing the relative weights of the 
review criteria used in evaluating such applications. This notice 
offers public and private nonprofit entities an opportunity to comment 
on the proposed changes in the Need for Assistance Criteria (NFA), and 
on the degree to which need should be weighted relative to other 
criteria used in evaluating future applications. In order to solicit 
comments from the public on these proposed changes, HRSA is delaying 
the due date (May 23, 2005) for the second round of fiscal year (FY) 
2005 New Access Point applications.
    Authorizing Legislation: Section 330(e)(1)(A) of the Public Health 
Service Act, as amended, authorizes support for the operation of public 
and nonprofit private health centers that provide health services to 
medically underserved populations.
    Reference: For the current Need for Assistance (NFA) criteria and 
other application review criteria, including weights used most 
recently, see Program Information Notice (PIN) 2005-01, titled 
ARequirements of Fiscal Year 2005 Funding Opportunity for Health Center 
New Access Point Grant Applications,'' are available on HRSA's Bureau 
of Primary Health Care (BPHC) Web site at http://bphc.hrsa.gov/
pinspals/pins.htm. That PIN detailed the eligibility requirements, 
review criteria, and awarding factors for applicants seeking support 
for the operation of New Access Points in FY 2005.
    Background: The goal of the President's Health Centers Initiative, 
which began in FY 2002, is to increase access to comprehensive primary 
and preventive health care services to 1,200 of the Nation's neediest 
communities through new and/or significantly expanded health center 
access points over five years. These health center access points are to 
provide comprehensive primary and preventive health care services in 
areas of high need that will improve the health status of the medically 
underserved populations to be served and decrease health disparities. 
Services at these new access points may be targeted toward an entire 
community or service area or toward a specific population group in the 
service area that has been identified as having unique and significant 
barriers to affordable and accessible health care services.
    While it is extremely important that NAP grant awards be made to 
entities that will successfully implement a viable and compliant 
program for the delivery of comprehensive primary health services to 
the populations or communities they propose to serve, HRSA also needs 
to assure that all applicants seeking support for a NAP applicant can 
demonstrate the need for such services in the community (area or 
population group) to be served and be evaluated on that need. Under the 
current guidance, NFA criteria are used to quantify barriers to access 
and identify health disparities. The NFA process also establishes a 
threshold which applicants must meet in order for their applications to 
be reviewed by the Objective Review Committee (ORC).
    Description of Current NFA process. The current NFA process (as 
described in Form 9-Part A of PIN 2005-01) involves two major groups of 
indicators. First, from eight (8) ``Barriers and Access to Care'' 
measures, the applicant must select five (5). These measures are: 
Shortage of primary care physicians, as measured by whether the target 
service area has been designated as a geographic or population group 
Health Professions Shortage Area (HPSA); Percent of the population with 
incomes below 200% of the Federal poverty level; Life expectancy of 
target population (in years); percentage of target population 
uninsured; unemployment rate of target population; average travel time 
or distance to nearest source of primary care for target population; 
percentage of target population age 5 or older who speak a language 
other than English at home; and length of waiting time for public 
housing and Section 8 certificates for target population. For the first 
of these measures, the applicant receives 14 points if HPSA-designated 
and zero otherwise; for each of the other measures, the NFA criteria 
define a 6-level scale from 0 to 14 points. The applicant provides data 
for its service area or target population for each of the 5 measures 
selected, and identifies the source of data used. Given 5 indicators 
and a maximum of 14 points for each, there are a possible 70 points for 
the ``Barriers and Access to Care'' indicators.
    Second, from 28 ``Health Disparity Factors'', the applicant selects 
10 and provides data on each for its service areas or target 
populations. For each factor selected, the applicant can receive 3 
points if the value for the target population exceeds the benchmark 
used. The applicant defines the benchmark, and gives a source for that 
benchmark as well as a source for the target population data provided. 
The guidance lists 27 specific factors, plus an ``other'' category 
allowing the applicant to select one additional locally-relevant factor 
not anticipated by the guidance. This approach produces a possible 30 
points for the ``Health Disparities Factors'' section; combined with 
the possible 70 for ``Barriers and Access to Care'' section, allowing a 
possible 100 total points are possible. In current guidance, the 
threshold for having the application reviewed has been set at an NFA 
score of 70 out of the possible 100 total points.

Need for Assistance Worksheets and the Application Review Process

    In accordance with the guidance, all applicants are required to 
complete an NFA Worksheet, identifying the NFA indicators they have 
selected from the options available and providing the data on these 
indicators for their proposed service area or target population. The 
Worksheet is reviewed by an Objective Review Committee (ORC), and only 
those applicants that achieve a score of 70 or higher out of the 
possible 100 points have the merits of their application evaluated by 
the ORC. To date, under the President's Initiative, HRSA has found that 
most applicants achieve the minimum of 70 NFA points required in the 
current process for consideration of their application. Furthermore, 
under the current application review process, only 10% of the total 
(100) possible points are allocated to the applicant's description of 
the need for additional primary care services in the community or 
target population to be served. Currently, application scores cluster 
at the high end of the scoring range, providing little discrimination 
among applications.
    For these reasons, HRSA arranged for an external evaluation of the 
NFA criteria and the use of need factors in the overall application 
review process. (The evaluation was conducted by a team of HSR, Inc., 
and the University of North Carolina's Cecil G. Sheps Center for Health 
Services Research.) Key results of the evaluation analyses are 
presented below, followed by recommendations for proposed changes on 
which we are soliciting comments.

[[Page 6018]]

Current NFA Access Barriers--Frequency of Applicant Use; Scores 
Achieved

    An analysis of applications received during FY 2004 indicated that, 
with respect to the eight ``Barriers and Access to Care'' indicators, 
92% of applicants selected the indicator percent of target population 
below 200% poverty; 79% selected percent of target population 
uninsured; 78% selected shortage of primary care physicians; and 75% 
selected unemployment rate for the target population, while only 36% 
selected life expectancy of the target population and 34% selected 
travel time or distance. Language other than English and shortage of 
Public Housing were selected by 55% and 50% of the applicants 
respectively. Since applicants naturally chose the variables that gave 
them the highest scores, the average scores achieved on all of the 
``Barriers and Access to Care'' indicators ranged from 12 to 14 for 
each, except for life expectancy, which had an average score of about 
11. As a result, scores of 60 or more for the ``Barriers and Access to 
Care'' section were routinely obtained.
    Current NFA Disparity Factors--Frequency of use by applicants. A 
similar analysis of the ``Health Disparity Factors'' selected by the 
same group of applicants showed that 8 indicators were selected by 50% 
or more of the applicants, and another 7 indicators were selected by 
one-third or more applicants. Twelve indicators were selected by 25% or 
fewer of the applicants. Ninety-five percent of the time a selected 
indicator received 3 points; only 5% of the time did an applicant 
receive 0 rather than 3 points for a disparity indicator supplied. 
Therefore, typically, at least 27 points were received for the ``Health 
Disparities Factors'' section. Combining at least 60 points for the 
``Barriers and Access to Care'' section access barriers and 27 points 
for the ``Health Disparities Factors'' section, a typical application 
would get 87 points, easily exceeding the threshold of 70.
    Distribution of All U.S. Counties on Current NFA Barrier Score 
Levels. To arrive at an understanding of why the scores for access 
barriers ran so high for most applications, an analysis of the scores 
that would be achieved by all 3,141 U.S. counties or county-equivalents 
was conducted. This analysis showed that, given the existing scales:
     On Percent Below 200% of Poverty, 665 of 3141 counties 
receive 14 points, another 993 receive 12 points, and 946 receive 10 
points. The average county score is 11 points.
     On Life Expectancy, only 17 counties receive 14 points, 
but 601 counties receive 12 points, and 2,140 receive 10 points. The 
average county score is 10.1 points.
     On Unemployment Rate, the counties are distributed more 
evenly along the scoring scale, but only 2 counties receive zero 
points, and the average county score is 9.5 points.
     On Percent Uninsured, 1,609 counties receive 10 points, 
while 1,327 receive 8 points. The average county score is 9 points.
     By contrast, Travel Time/Distance shows better 
distinctions among counties using its existing scale; while 1,527 
counties receive zero points, 950 receive 6 points, 294 receive 8 
points, 112 receive 10 points, 52 receive 12 points and 51 receive 14 
points. The average score is 3.5. HRSA is requesting feedback as to 
whether the scale should be adjusted to increase the numbers of 
counties getting 10, 12 or 14 points?
     In the case of Language other than English, the current 
scale seems to err in the direction of overly minimizing the points 
received: 2,410 counties receive zero points, and the average county 
score is only 1.8 points.
     On Shortage of Primary Care Physicians, 2,565 counties 
receive no points while 576 receive 14 points. This means that about 
one-sixth of counties are getting the maximum points, because they are 
wholly designated as HPSAs. This does not provide any flexibility in 
terms of the rest of the counties, some of which may be closer to 
eligibility for HPSA designation than others, while others contain 
part-county HPSAs.
    Recommendations for Revising NFA Criteria/Worksheet. Based on the 
analysis described above, feedback from communities, applicants and 
several focus group sessions, HRSA is proposing the following changes 
to the NFA criteria and process:
     Require that three (3) major access barriers be measured 
for all applicants. These three would be (a) percent of the population 
with incomes below 200 percent of the poverty level, (b) percent of 
population uninsured, and (c) shortage of primary care physicians, the 
three barriers that are most frequently selected by applicants.
     Use the population-to-primary care physician ratio for the 
applicant's service area or target population as the measure of 
shortage of primary care physicians, rather than a simple yes/no 
response based on presence or absence of a HPSA designation, with a 
scale of the type used for the other access indicators.
     Allow the applicant to select two additional access 
barriers from the following five (5): Unemployment Rate of Population, 
Percent Linguistically Isolated Population (replacing language other 
than English), Standardized Mortality Rate for Population (replacing 
Life Expectancy Rate), Travel Time/Distance to Nearest Provider 
accepting Medicaid and/or Uninsured Patients, and (for Homeless or 
Public Housing applicants only) Waiting time for Public Housing.
     Choose the scale for each of the access indicators based 
on comparison to the national county distribution of that indicator. 
(The scales proposed to be used are displayed below.) No points would 
be awarded for a barrier value better than the national county median.
     Require that 5 ``core'' disparity factors closely related 
to health center primary care activities be measured for all 
applicants. The core indicators proposed are: asthma rate, diabetes 
rate, and cardiovascular disease rate among the population; one birth 
outcome measure (infant mortality rate or low live birthweight rate), 
and one mental health measure (depression rate or suicide rate) among 
population. [Of these factors, all but one (depression rate) were in 
the group of current indicators selected at least 33% of the time.]
     Allow 2 points for each core disparity factor on which the 
community value exceeds the national benchmark for that factor, which 
would be provided in HRSA's application guidance (rather than by the 
applicant). Allow an additional point if a higher ``severe'' benchmark, 
also specified in the guidance, is also exceeded. (Benchmarks proposed 
are appended below.)
     Have the applicant select 5 additional disparity factors 
from a list of 7 factors previously used that are closely related to 
health center primary care activities. The factors proposed are: 
immunization rate, hypertension rate, rate of respiratory infection, 
obesity, teenage pregnancy, substance abuse, and percent elderly 
population. Alternatively, the applicant may select 4 of these plus an 
``other'' indicator specified by the applicant.
     Allow 2 points for each selected measure on which the 
community value exceeds the national benchmark. (Benchmarks proposed 
are appended below.) If ``other'' is selected, the applicant would need 
to both define the measure and suggest a benchmark for it as well. If 
the measure and the benchmark are accepted (or if the

[[Page 6019]]

measure is accepted but the benchmark is redefined), 2 points would be 
allowed if the benchmark is exceeded.
     Maximum possible total points for access barriers here is 
75; and for disparities is 25 points, totaling 100 possible total 
points for NFA.
     A threshold of 50 points on this revised index is under 
consideration. Only those applicants with a NFA score of 50 or more 
would have their application reviewed by the ORC. HRSA is considering 
whether this threshold should be changed annually to maintain a certain 
ratio of number of applications reviewed to number of awards available.
     The NFA scores achieved could be factored into the 
application review process.

Relative Importance of Need as an Application Review Factor

    The evaluation team also recommended that the relative need score 
from the NFA worksheet should be the basis for 20 percent of total 
application score, replacing the previous 10% for ``description of 
service area/community and target population.'' To accommodate this 
change, the evaluation team suggested reducing the proportion of the 
total application score now assigned to ``Governance'' from 10% to 5%, 
and reducing the proportion of total score assigned to ``Service 
Delivery Strategy and Model'' from 20% to 15%. However, HRSA has not 
taken a position on what new relative weighting might be most 
appropriate. Instead, by this notice, we are requesting public comments 
on this issue. Specifically, how should Need considerations be weighted 
in the application review process? What is the relative importance of 
Need versus such other factors as applicant Readiness to operate a 
health center, understanding of and connections to the local health 
care Environment, service delivery Strategy for addressing the needs of 
the community, plan for provision of specific required health Services, 
Organizational capabilities and expertise, Budget plan, and Governance? 
Rather than providing specific suggested percentages for weighting all 
these different factors, commenters are encouraged to isolate how Need 
should be weighted relative to all other factors, and whether this 
should be done by applying that weight to an objective index of 
relative community need such as that proposed above, or in some other 
manner.
BILLING CODE 4165-15-P

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DATES: Please send comments no later than COB March 7, 2005. The 
comments should be addressed to Dr. Sam Shekar, Associate Administrator 
for Primary Health Care, Health Resources and Services Administration, 
Room 17-99,

[[Page 6023]]

5600 Fishers Lane, Rockville, Maryland 20857.

FOR FURTHER INFORMATION CONTACT: Ms. Lynn Spector, Division of Health 
Center Development, Bureau of Primary Health Care, HRSA. Ms. Spector 
may be contacted by e-mail at lspector@hrsa.gov or via telephone at 
(301) 594-4300.

    Dated: February 1, 2005.
Elizabeth M. Duke,
Administrator.
[FR Doc. 05-2215 Filed 2-1-05; 4:24 pm]
BILLING CODE 4165-15-C