Notices. Notice to award grant awards

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A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-07BG] Proposed Data Collections Submitted for Public Comment and Recommendations 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 Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Crime Prevention Through Environmental Design: Linking Observed School Environments with Student and School-wide Experiences of Violence and Fear—New—National Center for Injury Prevention (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description Among the goals of the Centers for Disease Control and Prevention (CDC), National Center for Injury Prevention (NCIPC) and Control is to reduce the prevalence of violence among youth. Several important priorities included in the Center's published research agenda focus on studying how physical environments influence behavior and risk for violence. The CDC has developed a tool called the Crime Prevention Through Environmental Design (CPTED) School Assessment

(CSA)to assess the extent to which the physical characteristics of schools are consistent with Crime Prevention Through Environmental Design (CPTED) principles. The proposed research will allow us to determine the validity of the CSA by examining the extent to which the CSA subscales, total CSA scores, and CPTED principles are related to typical variables related to fear and violence. If the CSA tool is shown to measure characteristics of the school environment that are associated with fear and violence-related behaviors in school, then it may be used as the basis for research, design, and evaluation of interventions for schools seeking to prevent or reduce the occurrence of crime and violence by providing information related to (re)designing physical features of the environment and changing policies and procedures related to using the school environment. In addition, an exploratory purpose of this research is to determine whether the CSA items can be divided reliably into supposedly distinct variables reflecting each of the CPTED principles. If we produce practical support for the assessment of these “CPTED variables,” then we will also assess validity by determining whether these variables are logically related to our measures of fear, violence and climate in schools. Survey data from one counselor and 75 students (25 each from 6th, 7th, and 8th grades) will be collected from 50 middle schools in metro-Atlanta, Georgia area (a total of approximately 50 counselor participants and 3,750 student participants), in addition to the observational

(CSA)data collection. The counselor and student survey will assess variables such as school climate, actual and perceived levels of school violence at each school. In addition, archival/administrative data will be collected from each of the 50 schools providing information on neighborhood and school characteristics from various sources (e.g., school data reported by the school on a “School Profile” form, school district data available on the web, U.S. Census data, and the FBI National Crime and Victimization Survey). There are no costs to respondents except for their time to participate in the surveys. Estimated Annualized Burden Hours Form name Number of respondents Number of responses per respondent Average burden response (in hours) Total burden (in hours) Student Survey 3,750 1 40/60 2,500 Counselor Survey 50 1 40/60 33 School Profile 50 1 120/60 100 Total 2,633 DATE: July 2, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer Centers for Disease Control and Prevention. [FR Doc. E7-13197 Filed 7-6-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-05CH] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention

(CDC)publishes a list of information collection requests under review by the Office of Management and Budget

(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at

(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project An assessment of the determinants of HIV risk factors for African-American and Hispanic women in the southeastern United States—New—the National Center for HIV/AIDS, STD and TB Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description In the United States, an estimated 1 million people are living with HIV. About 40,000 new HIV infections occur each year. Women account for about 27% of all new HIV/AIDS diagnoses, with women of color in the South being most affected. Women of color represent 80% of all women estimated to be living with HIV/AIDS. In 2004, the rate HIV/AIDS cases per 100,000 for non-Hispanic African-American adult and adolescent females (67.0) was 21 times higher than that for non-Hispanic white females (3.2). Similarly, the rate of HIV/AIDS cases reported in 2004 for Hispanic women (16.3) was 5 times higher than the rate for non-Hispanic white women. Limited research data suggest that the character and dynamics of women's sexual relationships, gender relationships, sex roles, and experiences related to race and ethnicity may be important determinants of risk, both for engaging in risk behaviors and for doing so with high-risk partners. In addition, women's vulnerability is connected to a variety of socioeconomic factors, including delayed access to care and support for HIV/AIDS. Accordingly, the specific aims of the study are to: • Enroll 850 African-American and 500 Hispanic women at risk for HIV infection in a one-time survey. • Conduct rapid oral HIV testing of all women and facilitate linkage to medical care among those identified as HIV-positive. • Characterize African-American and Hispanic women on demographic, psychological, behavioral, sociocultural, and environmental/contextual dimensions. • Assess and compare the prevalence of sexual and drug behaviors of African American and Hispanic women. • Identify characteristics of African-American and Hispanic women associated with sexual behaviors that place them at risk for contracting HIV. Similarly, identify characteristics that protect against becoming infected with HIV. • Recruit a sub-sample of survey respondents to take in a qualitative interview. • Use our findings to provide recommendations on the design of behavioral interventions for African American and Hispanic women. Women will complete a 10-minute eligibility screening interview. The survey interview will take approximately 45 minutes each to complete for those who agree to participate in the study and 10 minutes to complete for those who refuse to enroll. Women completing the survey will take part in a 45 minute HIV counseling and testing session, which will be followed by a 10-minute training for how to refer other women to the project. The qualitative interview will take approximately one hour to complete. The total response burden for the three-year period is estimated to be 2712.39 hours (904.13 annualized burden hours). There is no cost to respondents except for their time. Estimated Annualized Burden Hours Activity with women volunteers Number of respondents Number of responses per respondent Average burden per response (hours) Venue intercept interview 125 1 3/60 Eligibility screening interview 675 1 10/60 Refusal questionnaire 90 1 10/60 ACASI survey interview 450 1 45/60 HIV Testing & Counseling 450 1 45/60 RDS Training 450 1 10/60 Qualitative interview 20 1 1 Dated: June 29, 2007. Maryam I. Daneshvar, PhD, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-13243 Filed 7-6-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Grant to Forty-Nine Community Services State Associations; Office of Community Services AGENCY: Office of Community Services, ACF, HHS. ACTION: Notice to award grant awards. *CFDA Number:* 93.570. SUMMARY: Notice is hereby given that awards will be made to forty-nine Community Services State Associations (CAA), in the amount of $65,000 each for ongoing capacity-building within the Community Services Network of Federal, State and local organizations to continue their work of addressing CSBG program needs. State CAA Associations have developed a shared vision for addressing the causes and effects of poverty; established a framework to convene fragmented programs across State and local governments; and utilized technological advances to better serve communities and track program successes. The period of this funding will extend from September 30, 2007 through September 29, 2008. FOR FURTHER INFORMATION CONTACT: Peter Thompson, Office of Community Services, Administration for Children and Families, 370 L'Enfant Promenade, SW., Washington, DC 20447, Telephone: 202-401-4608, E-mail: *peter.thompson@acf.hhs.gov.* Dated: July 2, 2007. Yolanda J. Butler, Deputy Director, Office of Community Services. [FR Doc. E7-13151 Filed 7-6-07; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0229] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices: Current Good Manufacturing Practice Quality System Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(CGMP)quality system

(QS)regulation (CGMP/QS regulation). DATES: Submit written or electronic comments on the collection of information by September 7, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(OMB)for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on these topics:

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Medical Devices: Current Good Manufacturing Practice Quality System Regulations--21 CFR Part 820 (OMB Control Number 0910-0073)—Extension Under section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(f)), the Secretary of the Department of Health and Human Services (the Secretary) has the authority to prescribe regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety and effectiveness of a device), packing, storage, and installation of a device conform to CGMP, as described in such regulations, to assure that the device will be safe and effective and otherwise in compliance with the act. The CGMP/QS regulation implementing authority provided by this statutory provision is found under part 820 (21 CFR part 820) and sets forth basic CGMP requirements governing the design, manufacture, packing, labeling, storage, installation, and servicing of all finished medical devices intended for human use. The authority for this regulation is covered under sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, and 803 of the act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, and 383). The CGMP/QS regulation includes requirements for purchasing and service controls, clarifies recordkeeping requirements for device failure and complaint investigations, clarifies requirements for verifying/validating production processes and process or product changes, and clarifies requirements for product acceptance activities quality data evaluations and corrections of nonconforming product/quality problems. Requirements are compatible with specifications in the international standards “ISO 9001: Quality Systems Model for Quality Assurance in Design/Development, Production, Installation, and Servicing.” The CGMP/QS information collections will assist FDA inspections of manufacturers for compliance with quality system requirements encompassing design, production, installation, and servicing processes. Section 820.20(a) through

(e)requires management with executive responsibility to establish, maintain, and/or review the following topics:

(1)The quality policy;

(2)the organizational structure;

(3)the quality plan; and

(4)the quality system procedures of the organization. Section 820.22 requires the conduct and documentation of quality system audits and reaudits. Section 820.25(b) requires the establishment of procedures to identify training needs and documentation of such training. Section 820.30(a)(1) and

(b)through (j), requires in respective order, the establishment, maintenance, and/or documentation of the following topics:

(1)Procedures to control design of class III and class II devices, and certain class I devices as listed therein;

(2)plans for design and development activities and updates;

(3)procedures identifying, documenting, and approving design input requirements;

(4)procedures defining design output, including acceptance criteria, and documentation of approved records;

(5)procedures for formal review of design results and documentation of results in the design history file (DHF);

(6)procedures for verifying device design and documentation of results and approvals in the DHF;

(7)procedures for validating device design, including documentation of results in the DHF;

(8)procedures for translating device design into production specifications;

(9)procedures for documenting, verifying validating approved design changes before implementation of changes; and

(10)the records and references constituting the DHF for each type of device. Section 820.40 requires manufacturers to establish and maintain procedures controlling approval and distribution of required documents and document changes. Section 820.40(a) and

(b)requires the establishment and maintenance of procedures for the review, approval, issuance and documentation of required records (documents) and changes to those records. Section 820.50(a)(1), (a)(2), (a)(3), and

(b)requires the establishment and maintenance of procedures and requirements to ensure service and product quality, records of acceptable suppliers, and purchasing data describing specified requirements for products and services. Sections 820.60 and 820.65 require, respectively, the establishment and maintenance of procedures for identifying all products from receipt to distribution and for using control numbers to track surgical implants and life-sustaining or supporting devices and their components. Section 820.70(a)(1) through (a)(5),

(b)through (e), (g)(1) through (g)(3), (h), and

(i)requires the establishment, maintenance, and/or documentation of the following topics:

(1)Process control procedures;

(2)procedures for verifying or validating changes to specification, method, process, or procedure;

(3)procedures to control environmental conditions and inspection result records;

(4)requirements for personnel hygiene;

(5)procedures for preventing contamination of equipment and products;

(6)equipment adjustment, cleaning and maintenance schedules;

(7)equipment inspection records;

(8)equipment tolerance postings; procedures for utilizing manufacturing materials expected to have an adverse effect on product quality; and

(9)validation protocols and validation records for computer software and software changes. Sections 820.72(a), (b)(1), and (b)(2) and 820.75(a) through

(c)require, respectively, the establishment, maintenance, and/or documentation of the following topics:

(1)Equipment calibration and inspection procedures;

(2)national, international or in-house calibration standards;

(3)records that identify calibrated equipment and next calibration dates;

(4)validation procedures and validation results for processes not verifiable by inspections and tests;

(5)procedures for keeping validated processes within specified limits;

(6)records for monitoring and controlling validated processes; and

(7)records of the results of revalidation where necessitated by process changes or deviations. Sections 820.80(a) through

(e)and 820.86, respectively, require the establishment, maintenance, and/or documentation of the following topics:

(1)Procedures for incoming acceptance by inspection, test, or other verification;

(2)procedures for ensuring that in-process products meet specified requirements and the control of product until inspection and tests are completed;

(3)procedures for, and records that show, incoming acceptance or rejection is conducted by inspections, tests or other verifications;

(4)procedures for, and records that show, finished devices meet acceptance criteria and are not distributed until device master record

(DMR)activities are completed;

(5)records in the device history record

(DHR)showing acceptance dates, results, and equipment used; and

(6)the acceptance/rejection identification of products from receipt to installation and servicing. Sections 820.90(a), (b)(1), and (b)(2) and 820.100 require, respectively, the establishment, maintenance and/or documentation of the following topics:

(1)Procedures for identifying, recording, evaluating and disposing of nonconforming product;

(2)procedures for reviewing and recording concessions made for, and disposition of, nonconforming product;

(3)procedures for reworking products, evaluating possible adverse rework effect and recording results in the DHR;

(4)procedures and requirements for corrective and preventive actions, including analysis, investigation, identification and review of data, records, causes and results; and

(5)records for all corrective and preventive action activities. Section 820.100(a)(1) through (a)(7) states that procedures and requirements shall be established and maintained for corrective/preventive actions, including the following:

(1)Analysis of data from process, work, quality, servicing records; investigation of nonconformance causes;

(2)identification of corrections and their effectiveness;

(3)recording of changes made; and

(4)appropriate distribution and managerial review of corrective and preventive action information. Section 820.120 states that manufacturers shall establish/maintain procedures to control labeling storage/application; and examination/release for storage and use, and document those procedures. Sections 820.120(b) and (d), 820.130, 820.140, 820.150(a) and (b), 820.160(a) and (b), and 820.170(a) and (b), respectively, require the establishment, maintenance, and/or documentation of following topics:

(1)Procedures for controlling and recording the storage, examination, release and use of labeling;

(2)the filing of labels/labeling used in the DHR;

(3)procedures for controlling product storage areas and receipt/dispatch authorizations;

(4)procedures controlling the release of products for distribution;

(5)distribution records that identify consignee, product, date and control numbers; and

(6)instructions, inspection and test procedures that are made available, and the recording of results for devices requiring installation. Sections 820.180(b) and (c), 820.181(a) through (e), 820.184(a) through (f), and 820.186 require, respectively, the maintenance of records:

(1)That are retained at prescribed site(s), made readily available and accessible to FDA and retained for the device's life expectancy or for 2 years;

(2)that are contained or referenced in a DMR consisting of device, process, quality assurance, packaging and labeling, and installation, maintenance, and servicing specifications and procedures;

(3)that are contained in a DHR and demonstrate the manufacture of each unit, lot, or batch of product in conformance with DMR and regulatory requirements, include manufacturing and distribution dates, quantities, acceptance documents, labels and labeling, control numbers; and

(4)that are contained in a quality system record (QSR), consisting of references, documents, procedures, and activities not specific to particular devices. Sections 820.198(a) through

(c)and 820.200(a) through (d), respectively, require the establishment, maintenance, and/or documentation of the following topics:

(1)Complaint files and procedures for receiving, reviewing and evaluating complaints;

(2)complaint investigation records identifying the device, complainant, and relationship of the device to the incident;

(3)complaint records that are reasonably accessible to the manufacturing site or at prescribed sites;

(4)procedures for performing and verifying that device servicing requirements are met and that service reports involving complaints are processed as complaints; and

(5)service reports that record the device, service activity, and test and inspection data. Section 820.250 requires the establishment and maintenance of procedures to identify valid statistical techniques necessary to verify process and product acceptability; and sampling plans, when used, which are written and based on valid statistical rationale; and procedures for ensuring adequate sampling methods. The CGMP/QS regulation amends and revises the CGMP requirements for medical devices set out under part 820. The regulation adds design and purchasing controls; modifies previous critical device requirements; revises previous validation and other requirements; and harmonizes device CGMP requirements with QS specifications in the international standard “ISO 9001: Quality Systems Model for Quality Assurance in Design/Development, Production, Installation, and Servicing.” The rule does not apply to manufacturers of components or parts of finished devices, nor to manufacturers of human blood and blood components subject to 21 CFR part 606. With respect to devices classified in class I, design control requirements apply only to class I devices listed in § 820.30(a)(2) of the regulation. The rule imposes burden upon:

(1)Finished device manufacturer firms, which are subject to all recordkeeping requirements;

(2)finished device contract manufacturers; specification developers; and

(3)repacker, relabelers, and contract sterilizer firms, which are subject only to requirements applicable to their activities. In addition, remanufacturers of hospital single-use devices

(SUDs)will now be considered to have the same requirements as manufacturers in regard to this regulation. The establishment, maintenance and/or documentation of procedures, records, and data required by this regulation will assist FDA in determining whether firms are in compliance with CGMP requirements, which are intended to ensure that devices meet their design, production, labeling, installation, and servicing specifications and, thus are safe, effective and suitable for their intended purpose. In particular, compliance with CGMP design control requirements should decrease the number of design-related device failures that have resulted in deaths and serious injuries. The CGMP/QS regulation applies to approximately 8,963 respondents. These recordkeepers consist of 8,945 original respondents and an estimated 18 hospitals that remanufacture or reuse SUDs. They include manufacturers, subject to all requirements and contract manufacturers, specification developers, repackers, relabelers, and contract sterilizers, subject only to requirements applicable to their activities. Hospital remanufacturers of SUDs are now defined to be manufacturers under guidelines issued by FDA's Center for Devices and Radiological Health (CDRH), Office of Surveillance and Biometrics. Respondents to this collection have no reporting activities, but must make required records available for review or copying during FDA inspection. The regulation contains additional recordkeeping requirements in such areas as design control, purchasing, installation, and information relating to the remanufacture of SUDs. The estimates for this burden are derived from those incremental tasks that were determined when the new CGMP/QS regulation became final as well as those carry-over requirements. The carry-over requirements are based on decisions made by the agency on July 16, 1992, under OMB clearance submission 0910-0073, which still provides valid baseline data. FDA estimates respondents will have a total annual recordkeeping burden of approximately 3,076,370 hours. This figure also consists of approximately 143,052 hours spent on a startup basis by 650 new firms. FDA estimates the burden for this collection of information as follows: **Table 1.—Estimated Annual Recordkeeping Burden** 1 21 CFR Section No. of Recordkeepers Annual Frequency per Recordkeeping Total Annual Hours Hours per Record Total Hours 820.20(a) 8,963 1 8,963 6.58 58,977 820.20(b) 8,963 1 8,963 4.43 39,706 820.20(c) 8,963 1 8,963 6.17 55,302 820.20(d) 8,963 1 8,963 9.89 88,644 820.20(e) 8,963 1 8,963 9.89 88,644 820.22 8,963 1 8,963 32.72 293,269 820.25(b) 8,963 1 8,963 12.68 113,651 820.30(a)(1) 8,963 1 8,963 1.75 15,685 820.30(b) 8,963 1 8,963 5.95 53,330 820.30(c) 8,963 1 8,963 1.75 15,685 820.30(d) 8,963 1 8,963 1.75 15,685 820.30(e) 8,963 1 8,963 23.39 209,645 820.30(f) 8,963 1 8,963 37.42 335,395 820.30(g) 8,963 1 8,963 37.42 335,395 820.30(h) 8,963 1 8,963 3.34 29,936 820.30(i) 8,963 1 8,963 17.26 154,701 820.30(j) 8,963 1 8,963 2.64 23,662 820.40 8,963 1 8,963 8.91 79,860 820.40(a) and

(b)8,963 1 8,963 2.04 18,285 820.50(a)(1) through (a)(3) 8,963 1 8,963 21.90 196,290 820.50(b) 8,963 1 8,963 6.02 53,957 820.6 8,963 1 8,963 0.32 2,868 820.65 8,963 1 8,963 0.67 6,005 820.70(a)(1) through (a)(5) 8,963 1 8,963 1.85 16,582 820.70(b) and

(c)8,963 1 8,963 1.85 16,582 820.70(d) 8,963 1 8,963 2.87 25,724 820.70(e) 8,963 1 8,963 1.85 16,582 820.70(g)(1) through (g)(3) 8,963 1 8,963 1.43 12,817 820.70(h) 8,963 1 8,963 1.85 16,582 820.70(i) 8,963 1 8,963 7.50 67,223 820.72(a) 8,963 1 8,963 4.92 44,098 820.72(b)(1) and (b)(2) 8,963 1 8,963 1.43 12,817 820.75(a) 8,963 1 8,963 2.69 24,110 820.75(b) 8,963 1 8,963 1.02 9,142 820.75(c) 8,963 1 8,963 1.11 9,949 820.80(a) through

(e)8,963 1 8,963 4.80 43,022 820.86 8,963 1 8,963 0.79 7,081 820.90(a) 8,963 1 8,963 4.95 44,367 820.90(b)(1) and (b)(2) 8,963 1 8,963 4.95 44,367 820.100 (a)(1) through (a)(7) 8,963 1 8,963 12.48 111,858 820.100(b) 8,963 1 8,963 1.28 11,473 820.120(b) 8,963 1 8,963 0.45 4,033 820.120(d) 8,963 1 8,963 0.45 4,033 820.130 8,963 1 8,963 0.45 4,033 820.140 8,963 1 8,963 6.34 56,825 820.150(a) and

(b)8,963 1 8,963 5.67 50,820 820.160(a) and

(b)8,963 1 8,963 0.67 6,005 820.170(a) and

(b)8,963 1 8,963 1.50 13,445 820.180(b) and

(e)8,963 1 8,963 1.21 10,845 820.184(a) through

(f)8,963 1 8,963 1.41 12,638 820.186 8,963 1 8,963 0.40 3,585 820.198(a) through

(d)8,963 1 8,963 2.61 23,393 820.25 8,963 1 8,963 0.67 6,005 Totals 3,072,337 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Burden (labor) hour and cost estimates were originally developed under FDA contract by Eastern Research Group, Inc. (ERG), in 1996 when the CGMP/QS regulation became final. These figures are still accurate. Additional factors considered in deriving estimates included the following: • Establishment Type: Query has been made of CDRH's registration/listing databank and has counted 8,963 domestic firms subject to CGMPs. In addition, hospitals that reuse or remanufacture devices are now considered manufacturers under new FDA guidance. After investigations of many hospitals and the changes in enforcements of FDA's requirements for hospitals, the number of reuse or remanufactures of single-use medical devices have decreased from the estimated 66 to an estimated 18 hospitals. Because the total number of registered firms is not static, the number of respondents will fluctuate from year to year resulting in slight changes to the overall burden. Currently, there are 8,963 firms subject to the CGMPs; an increase from the last renewal of 8,254. • Potentially Affected Establishments: Except for manufacturers, not every type of firm is subject to every CGMP/QS requirement. For example, all are subject to FDA's quality policy regulations (§ 820.20(a)), document control regulations (§ 820.40), and other requirements, whereas only manufacturers and specification developers are subject to FDA's design controls regulations (§ 820.30). The type of firm subject to each requirement was identified by ERG. FDA estimates the burden hours (and costs) based on the last approved renewal for this information collection. FDA estimates that some 650 “new” establishments (marketing devices for the first time) will expend some 143,052 “development” hours on a one-time startup basis to develop records and procedures for the CGMP/QS regulation. FDA estimates that annual labor hours are apportioned as follows:

(1)40 percent goes to requirements dealing with manufacturing specifications, process controls, and the DHR;

(2)20 percent goes to requirements dealing with components and acceptance activities;

(3)25 percent goes to requirements dealing with equipment, records (the DMR and QSR), complaint investigations, labeling/packaging and reprocessing/investigating product nonconformance; and 15 percent goes to quality audit, traceability, handling, distribution, statistical, and other requirements. Dated: June 28, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13152 Filed 7-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0357] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of March 7, 2007 (72 FR 10222), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0354. The approval expires on June 30, 2010. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: June 28, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13153 Filed 7-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0236] Agency Information Collection Activities; Proposed Collection; Comment Request; Presubmission Conferences, New Animal Drug Applications and Supporting Regulations and Guidance 152, and Form FDA 356V AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on paperwork associated with applications for new animal drugs. DATES: Submit written or electronic comments on the collection of information by *September 7, 2007.* ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Presubmission Conferences, New Animal Drug Applications and Supporting Regulations and Guidance 152, and Form FDA 356V—21 CFR 514.5, 514.1, 514.4, 514.8, (OMB Control Numbers 0910-0555, 0910-0032, 0910-0356, 0910-0522, and 0910-0600)—Extension Under section 512(b)(3) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b(b)(3)), any person intending to file a New Animal Drug Application

(NADA)or supplemental NADA or a request for an investigational exemption under section 512(j) of the act is entitled to one or more conferences with FDA to reach an agreement acceptable to FDA establishing a submission or investigational requirement. FDA and industry have found that these meetings increased the efficiency of the drug development and drug review processes. Section 514.5 (21 CFR 514.5), describes the procedures for requesting, conducting, and documenting presubmission conferences. Section 514.5(b) describes the information that must be included in a letter submitted by a potential applicant requesting a presubmission conference, including a proposed agenda and a list of expected participants. Section 514.5(d) describes the information that must be provided by the potential applicant to FDA at least 30 days prior to a presubmission conference. This information includes a detailed agenda, a copy of any materials to be presented at the conference, a list of proposed indications and, if available, a copy of the proposed labeling for the product under consideration, and a copy of any background material that provides scientific rationale to support the potential applicant's position on issues listed in the agenda for the conference. Section 514.5(f) discusses the content of the memorandum of conference that will be prepared by FDA and gives the potential applicant an opportunity to seek correction to or clarification of the memorandum. The OMB control number for the collection of presubmission conference information is 0910-0555. Under section 512(b)(1) of the act, any person may file an NADA seeking approval to legally market a new animal drug. Section 512(b)(1) sets forth the information required to be submitted in an NADA. FDA allows applicants to submit a complete NADA or to submit information in support of an NADA for phased review followed by submission of an administrative NADA when FDA finds all the applicable technical sections are complete. Section 514.1 (21 CFR 514.1) interprets section 512(b)(1) of the act and further describes the information that must be submitted as part of a NADA and the manner and form in which the NADA must be assembled and submitted. The application must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety (including microbial food safety) and any methods used to determine residues of drug chemicals in edible tissue from food producing animals. Guidance 152 outlines a risk assessment approach for evaluating the microbial food safety of antimicrobial new animal drugs. FDA requests that an applicant accompany NADAs, supplemental NADAs, and requests for phased review of data to support NADAs, with the Form FDA 356V to ensure efficient and accurate processing of information to support new animal drug approval. The OMB control number for the NADA and the form 356V is 0910-0032, and the control number for Guidance 152 “Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern” is 0910-0522. This information collection also combines several other OMB control numbers: OMB control number 0910-0356 and OMB control number 0910- 0600 that will be assigned to the collection of information under revised § 514.8, effective February 12, 2007. The Animal Drug Availability Act of 1996 required FDA to further define the term “substantial evidence” of effectiveness. Following notice and comment rulemaking, FDA further defined substantial evidence at § 514.4 (21 CFR 514.4) (OMB control number 0910-0356). Because § 514.4 is only a definition, it should not be viewed as creating an additional collection burden; the collection of substantial evidence occurs as part of an NADA under § 514.1. FDA also recently revised § 514.8 (21 CFR 514.8) to implement the provisions of section 116 of the Food and Drug Administration Modernization Act of 1997 (71 FR 74766, December 13, 2006; OMB control number pending). Section 514.8 describes the information that must be submitted as part of a supplemental application to support proposed changes to an approved NADA. An applicant may reference existing information from the NADA in the supplemental NADA, but must submit some subset of information required in § 514.1 to support the proposed changes. The total burden hours for each of these CFR sections are found in table 1 of this document. FDA estimates the burden of the collections of information described in this notice as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section/FDA Form No. No. of Respondents Annual Frequency per Respondent Total Annual Responses Hours per Response Total Hours 514.5(b), (d),

(f)134 .7 93 50 4,650 514.1 and 514.6 134 .1 19 212 4,028 514.4 134 0 0 0 0 514.8(b) 134 3.2 425 35 14,875 514.8(c)(1) 134 0.1 14 71 994 514.8(c)(2) and (c)(3) 134 .4 53 20 1,060 514.11 134 .1 19 1 19 558.5(i) 134 .01 1.0 5 5 514.1(b)(8) and 514.8(c)(1) 2 134 .1 10 90 900 FDA Form 356V 134 5.8 778 5 3,890 Total Hours 30,421 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as part of the overall preapproval safety evaluation. *Number of respondents* . Based on the number of sponsors subject to animal drug user fees, FDA estimates that there are 134 respondents. We use this estimate consistently throughout the table and calculate the “annual frequency per respondent” by dividing the total annual responses by number of respondents. Following is a description of how we estimated the total annual responses and calculated total paperwork burden hours by type of submission. *Presubmission conferences (§ 514.5)* . Over the past 5 fiscal years, from October 1, 2001, through September 30, 2006, FDA estimates it has conducted an average of 93 presubmission conferences per year. FDA estimates that preparing the paperwork to request the meeting, providing the advance materials, and commenting on the memorandum of conference will take approximately 50 hours. Thus, the total burden hours for presubmission conferences is estimated to be 4,650 hours. *NADA (§ 514.1 and 21 CFR 514.6)* . Over the past 5 fiscal years, FDA has received an average of 19 NADAs per year. FDA estimates that preparing the paperwork required for an NADA under § 514.1, whether all of the information is submitted with the NADA or the applicant submits information for phased review followed by an Administrative NADA that references that information, will take approximately 212 hours. Thus, the total burden hours for the submission of an NADA with any amendments are estimated to be 4,028 hours. *Substantial evidence (§ 514.4)* . Because § 514.4 only defines substantial evidence, it should not be viewed as creating an additional collection burden. The collection of information to demonstrate substantial evidence occurs as part of an NADA under § 514.1. There is no additional paperwork burden under § 514.4. Supplements fall into one of three categories: • Manufacturing supplements described at § 514.8(b); • Section 514.8(b)(1) supplements (i.e., supplements seeking changes, other than in manufacturing or labeling, in an established condition of an approval beyond the variations already provided for in the approved application) described at § 514.8(c)(1); and • Labeling supplements described at 514.8(c)(2) and (c)(3). An applicant may rely on information and data already filed to support those aspects of the NADA for which there are no changes. Thus, an applicant submitting a supplement should only have to prepare supporting information for those aspects of the application for which there are changes and the paperwork burden will be a percentage of the burden of preparing an NADA. *Manufacturing supplements (§ 514.8(b))* . Over the past 5 fiscal years, FDA has received an average of 425 manufacturing supplements annually. FDA estimates that it takes on average 35 hours (1/6 of the time it takes to prepare the paperwork to support a full NADA) to prepare the paperwork to support approval of manufacturing changes. This results in total of 14,875 burden hours. *Supplements seeking approval of changes in intended uses or conditions of use (§ 514.8(c)(1))* . Over the past 3 fiscal years, October 1, 2003, through September 2006, FDA has received an average of 14 supplements annually seeking approval for changes in intended uses or conditions of use. FDA used a 3-year average for this calculation because data for the previous 2 years for this category of supplements was not tracked as an independent number. FDA estimates that it takes an average of 71 hours (approximately 1/3 of the time it takes to prepare the paperwork to support a full NADA) to prepare the paperwork to support approval for such changes. This results in a total of 994 burden hours. *Labeling Supplements (§ 514.8(c)(2) and (c)(3))* . Over the past 5 fiscal years, FDA has received an average of 53 labeling supplements annually. FDA estimates that it takes an average of 20 hours (approximately 1 percent of the time it takes to prepare the paperwork to support a full NADA) to prepare the paperwork to support approval of a labeling change. This results in a total of 1,060 burden hours. *Freedom of Information Summary (§ 514.11 (21 CFR 514.11))* . Regulations under § 514.11 require the preparation of a summary of the safety and effectiveness data and information submitted with or incorporated by reference in an approved NADA and that the summary be publicly released when the approval is published in the **Federal Register** . This summary, generally referred to as the Freedom of Information

(FOI)Summary, may be prepared by FDA or FDA may require the applicant to prepare the summary (§ 514.11(e)(ii)). In the past, FDA has required the applicant to prepare the FOI Summary. Currently, FDA generally takes responsibility for preparing the FOI Summary. Thus, the paperwork burden on applicants to prepare an FOI Summary has significantly decreased. Based on the estimate of 19 NADAs received annually and an estimate that applicants now spend little or no time preparing the FOI summary, the estimated burden hours are 19 hours. *Requirements for liquid medicated feeds (§ 558.5(i) (21 CFR 558.5(i))* . Generally, specific labeling is required to make sure that certain drugs, approved for use in animal feed or drinking water but not in liquid medicated feed, are not diverted to use in liquid feeds. Section 558.5(i) permits an applicant to seek a waiver from this requirement (§ 558.5(h)) if there is evidence that it is unlikely a new animal drug would be used in the manufacture of a liquid medicated feed. If FDA receives one NADA per year seeking approval of the use of a liquid medicated feed and on average it takes 5 hours to prepare the request for waiver, the estimated paperwork burden is 5 hours. *Risk assessment of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern. (§§ 514.1(b)(8) and 514.8(c)(1)).* FDA estimates that it receives 10 risk assessments evaluating the microbial food safety of antimicrobial new animal drugs per year. FDA estimates that it takes on average 90 hours to put together the references and other materials in the format recommended by Guidance 152 and to summarize the hazards and associated risk(s). Thus, the total burden hours for preparing such risk assessments for submission to FDA are estimated to be 900 hours. *Form FDA 356V* . FDA requests that an applicant fill out and send in with NADAs and supplemental NADAs, and requests for phased review of data to support NADAs, a Form FDA 356V to ensure efficient and accurate processing of information to support new animal drug approval. Over the past 5 fiscal years, FDA has received an average of 511 NADAs and supplements and 267 submissions of data to support NADAs. FDA estimates that it takes an average of 5 hours to read the instructions and fill out Form FDA 356V and organize the information that it will accompany. This results in a total of 3,890 burden hours. Dated: June 28, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13195 Filed 7-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0240] Agency Information Collection Activities; Proposed Collection; Comment Request, Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the **Federal Register** concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's patent term restoration regulations on due diligence petitions for regulatory review period revision. Where a patented product must receive FDA approval before marketing is permitted, the Office of Patents and Trademarks may add a portion of the FDA review time to the term of a patent. Petitioners may request reductions in the regulatory review time if FDA marketing approval was not pursued with “due diligence.” DATES: Submit written comments on the collection of information by September 7, 2007. ADDRESSES: Submit electronic comments on the collection of information to: *http://www.fda.gov/dockets/ecomments* . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget

(1)Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;

(2)the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(3)ways to enhance the quality, utility, and clarity of the information to be collected; and

(4)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions—21 CFR Part 60 (OMB Control Number 0910-0233—Extension) FDA's patent extension activities are conducted under the authority of the Drug Price Competition and Patent Term Restoration Act of 1984 (21 U.S.C. 355(j)) and the Animal Drug and Patent Term Restoration Act of 1988 (35 U.S.C. 156). New human drug, animal drug, human biological, medical device, food additive, or color additive products regulated by FDA must undergo FDA safety, or safety and effectiveness, review before marketing is permitted. Where the product is covered by a patent, part of the patent's term may be consumed during this review, which diminishes the value of the patent. In enacting the Drug Price Competition and Patent Term Restoration Act of 1984 and the Animal Drug and Patent Term Restoration Act of 1988, Congress sought to encourage development of new, safer, and more effective medical and food additive products. It did so by authorizing the U.S. Patent and Trademark Office

(PTO)to extend the patent term by a portion of the time during which FDA's safety and effectiveness review prevented marketing of the product. The length of the patent term extension is generally limited to a maximum of 5 years, and is calculated by PTO based on a statutory formula. When a patent holder submits an application for patent term extension to PTO, PTO requests information from FDA, including the length of the regulatory review period for the patented product. If PTO concludes that the product is eligible for patent term extension, FDA publishes a notice that describes the length of the regulatory review period and the dates used to calculate that period. Interested parties may request, under § 60.24 (21 CFR 60.24), revision of the length of the regulatory review period, or may petition under § 60.30 (21 CFR 60.30) to reduce the regulatory review period by any time where marketing approval was not pursued with “due diligence.” The statute defines due diligence as “that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period.” As provided in § 60.30(c), a due diligence petition “shall set forth sufficient facts, including dates if possible, to merit an investigation by FDA of whether the applicant acted with due diligence.” Upon receipt of a due diligence petition, FDA reviews the petition and evaluates whether any change in the regulatory review period is necessary. If so, the corrected regulatory review period is published in the **Federal Register** . A due diligence petitioner not satisfied with FDA's decision regarding the petition may, under § 60.40 (21 CFR 60.40), request an informal hearing for reconsideration of the due diligence determination. Petitioners are likely to include persons or organizations having knowledge that FDA's marketing permission for that product was not actively pursued throughout the regulatory review period. The information collection for which an extension of approval is being sought is the use of the statutorily created due diligence petition. Since 1992, nine requests for revision of the regulatory review period have been submitted under § 60.24. Four regulatory review periods have been altered. Two due diligence petitions have been submitted to FDA under § 60.30. There have been no requests for hearings under § 60.40 regarding the decisions on such petitions. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 60.24(a) 9 1 9 100 900 60.30 2 0 2 50 100 60.40 0 0 0 0 0 Total 1,000 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: June 28, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13269 Filed 7-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007C-0245] Nippon Oil Corp.; Filing of Color Additive Petition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that Nippon Oil Corp. has filed a petition proposing that the color additive regulations be amended to provide for the safe use of *Paracoccus carotinifaciens* granules as a color additive in the feed of salmonid fish to enhance the color of their flesh. FOR FURTHER INFORMATION CONTACT: Mical E. Honigfort, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1278. SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), notice is given that a color additive petition (CAP 7C0283) has been filed by Nippon Oil Corp., c/o Beckloff Assoc., 7400 West 110th St., suite 300, Overland Park, KS 66210. The petition proposes to amend the color additive regulations in 21 CFR part 73 to provide for the safe use of *Paracoccus carotinifaciens* granules as a color additive in the feed of salmonid fish to enhance the color of their flesh. The agency has determined under 21 CFR 25.32(r) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. Dated: June 28, 2007. Laura M. Tarantino, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. E7-13161 Filed 7-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0221] Otsuka Pharmaceutical Co., Ltd.; Withdrawal of Approval of a New Drug Application; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration

(FDA)is correcting a notice that appeared in the **Federal Register** of June 14, 2007 (72 FR 32852). The agency issued a withdrawal of a new drug application

(NDA)for RAXAR (grepafloxacin hydrochloride (HCl)) Tablets held by Otsuka Pharmaceutical Co., Ltd. (Otsuka), c/o Otsuka Pharmaceutical Development & Commercialization, Inc., 2440 Research Blvd., Rockville, MD 20850. The document published with typographical errors and cited a section of the Code of Federal Regulations that no longer exists. This document corrects those errors. The agency is also announcing the removal of RAXAR Tablets from the list of approved drug products in FDA's “Approved Drug Products With Therapeutic Equivalence Evaluations” (the Orange Book). DATES: Effective July 9, 2007. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy and Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010. SUPPLEMENTARY INFORMATION: In FR Doc. E7-11427, appearing on page 32852 in the **Federal Register** of Thursday, June 14, 2007, the following correction is made: 1. On page 32852, in the second and third columns, the SUPPLEMENTARY INFORMATION section is corrected to read: SUPPLEMENTARY INFORMATION: In a letter dated March 5, 2003, Otsuka requested that FDA withdraw approval of NDA 20-695 for RAXAR (grepafloxacin HCl) Tablets, stating that the product was no longer being marketed. In FDA's acknowledgment letter of June 20, 2003, the agency informed Otsuka that RAXAR (grepafloxacin HCl) Tablets, indicated for the treatment of a variety of infections, had been removed from the market because of safety concerns; in its followup letter of January 12, 2007, the agency also informed Otsuka that it had determined that the RAXAR NDA should be withdrawn under § 314.150(d) (21 CFR 314.150(d)) because of its effect on cardiac repolarization, manifested as QTc interval prolongation on the electrocardiogram, which could put patients at risk of Torsade de Pointes. In its letter of March 20, 2007, Otsuka concurred in the agency's determination to initiate withdrawal of the RAXAR NDA and waived its opportunity for a hearing, provided under § 314.150(a) and (b). Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)), § 314.150(d), and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner of Food and Drugs, approval of the NDA 20-695, and all amendments and supplements thereto, is withdrawn effective (see DATES ). Distribution of this product in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the act (21 U.S.C. 331(d)). Also, on the basis of the circumstances described in this document that led to the withdrawal of the approval of NDA 20-695, the agency will remove RAXAR (grepafloxacin HCl) Tablets from the list of drug products with effective approvals published in the Orange Book. Dated: June 28, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13160 Filed 7-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004D-0524] Guidance for Industry on ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a guidance for industry entitled “ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information.” The guidance is intended to assist applicants with the submission of abbreviated new drug applications (ANDAs) when a drug substance exists in polymorphic forms. DATES: Submit written or electronic comments on agency guidance documents at any time. ADDRESSES: Submit written requests for single copies of this guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Andre Raw, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-9310. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled “ANDAs: Pharmaceutical Solid Polymorphism; Chemistry, Manufacturing, and Controls Information.” This guidance provides:

(1)A framework for making regulatory decisions on drug substance sameness in terms of polymorphic form and

(2)decision trees which provide a recommended course to monitor and control polymorphs in the drug substance and/or drug product when the drug substance exists in relevant polymorphic forms. On December 20, 2004 (69 FR 75987), the FDA announced the availability of the draft version of this guidance. The public comment period closed on March 21, 2005. A number of comments were received, which the agency considered carefully as it finalized the guidance and made appropriate changes. Most of the changes to the guidance were made to clarify statements in the draft guidance. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on pharmaceutical solid polymorphism. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: June 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13171 Filed 7-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0249] Draft Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New Drug Applications for Products Intended to Repair or Replace Knee Cartilage; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft document entitled “Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage” dated July 2007. The draft guidance provides to sponsors recommendations about certain information that should be included in an investigational device exemption

(IDE)or investigational new drug application

(IND)for a product intended to repair or replace knee cartilage. The draft guidance, when finalized, will supplement other FDA publications on IDEs and INDs. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by October 9, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448; or the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) (HFZ-220), Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800; or by calling CDRH at 240-276-3150 or by faxing a request to CDRH at 240-276-3151. To receive an electronic copy, send an e-mail request to *dsmica@fda.hhs.gov* . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Brenda R. Friend, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210; or Aric D. Kaiser, Center for Devices and Radiological Health (HFZ-410), 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3676. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft document entitled “Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage” dated July 2007. The draft guidance document provides to sponsors recommendations about certain information that should be included in an IDE or IND for a product intended to repair or replace knee cartilage. For the purposes of the draft guidance, a product intended to repair or replace knee cartilage, as with other articular cartilage repair or replacement products, may include a biologic, device, or combination product whose components would be individually regulated by CDRH and CBER. FDA prepared this draft guidance to address issues that may arise in the development of articular cartilage repair or replacement products. The draft guidance also reflects input received from the public and the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) at the March 3 to 4, 2005, CTGTAC meeting. The draft guidance, when finalized, will supplement other FDA publications on IDEs and INDs. The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 (on INDs) have been approved under OMB control number 0910-0014; and those in 21 CFR part 812 (on IDEs) have been approved under OMB control number 0910-0078. III. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in the brackets in the heading of this document. A copy of the draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either *http://www.fda.gov/cber/guidelines.htm, http://www.fda.gov/cdrh/guidance.html* , or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: June 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13162 Filed 7-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0125] Draft Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a draft guidance entitled “Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims.” This draft guidance updates the agency's approach to the review of the publicly available scientific evidence for significant scientific agreement

(SSA)and qualified health claims. FDA is taking this action to inform interested persons of the system it intends to use to review the scientific evidence in the evaluation of SSA and qualified health claims. DATES: Submit written or electronic comments on the draft guidance document by September 7, 2007. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send one-self-addressed adhesive label to assist the office in processing your request, or include a fax number to which the draft guidance may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www/fda/gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Paula Trumbo, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 310-436-2579. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance entitled “Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims.” The Nutrition Labeling and Education Act of 1990

(NLEA)was designed to give consumers more scientifically valid information about foods they eat. Among other provisions, NLEA directed FDA to issue regulations providing for the use of statements that describe the relationship between a substance and a disease (“health claims”) in the labeling of foods, including dietary supplements, after such statements have been reviewed and authorized by FDA. For these health claims, that is, statements about substance/disease relationships, FDA has defined the term “substance” by regulation as a specific food or food component (§ 101.14(a)(2) (21 CFR 101.14(a)(2)). An authorized health claim may be used on both conventional foods and dietary supplements, assuming that the substance in the product and the product itself meet the appropriate standards in the authorizing regulation. Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices. In evaluating a petition for an SSA health claim submitted under § 101.70 (21 CFR 101.70), FDA considers whether the evidence supporting the relationship that is the subject of the claim meets the SSA standard. This standard derives from section 403(r)(3)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(3)(B)(i)), which provides that FDA shall authorize a health claim to be used on conventional foods if the agency “determines, based on the totality of the publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.” This scientific standard was prescribed by statute for conventional food health claims; by regulation, FDA adopted the same standard for dietary supplements health claims (see § 101.14(c)). The genesis of qualified health claims was the court of appeals decision in *Pearson* v. *Shalala* ( *Pearson* ). In that case, the plaintiffs challenged FDA's decision not to authorize health claims for four specific substance/disease relationships for dietary supplements. Although the district court ruled for FDA (14 F. Supp. 2d 10 (D.D.C. 1998)), the U.S. Court of Appeals for the DC Circuit reversed the lower court's decision (164 F.3d 650 (DC Cir. 1999)). The appeals court held that the First Amendment does not permit FDA to reject health claims that the agency determines to be potentially misleading unless the agency also reasonably determines that a disclaimer would not eliminate the potential deception. The appeals court also held that the Administrative Procedure Act required FDA to clarify the SSA standard for authorizing health claims. On December 22, 1999, FDA announced the issuance of a guidance entitled “Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements” (64 FR 71794). This guidance document was issued to clarify FDA's interpretation of the SSA standard in response to the court of appeals second holding in *Pearson* . On December 20, 2002, the agency announced its intention to extend *Pearson* to health claims for conventional foods (67 FR 78002). Recognizing the need for an approach for scientific evaluations for qualified health claims, the task force on “Consumer Health Information for Better Nutrition” was formed. As part of the task force's final report, 1 FDA developed an interim evidence-based review system that the agency intended to use to evaluate the substance/disease relationships that are subjects of qualified health claims. 1 See guidance entitled “Interim Evidence-based Ranking System for Scientific Data,” July 10, 2003 ( *http://www.cfsan.fda.gov/~dms/hclmgui4.html* ). In reviewing both the December 22, 1999, guidance document and the 2003 task force report, it became apparent to the agency that the components of the scientific review process for an SSA health claim and qualified health claim are very similar. Because of the similarity between the scientific reviews for SSA and qualified health claims, FDA intends to generally use the approach set out in this draft guidance for evaluating the scientific evidence in petitions that are submitted for an SSA health claim or qualified health claim. The primary purpose of this document is to set out FDA's current thinking on the process for evaluating the scientific evidence for a health claim, the meaning of the SSA standard in section 403(r)(3) of the act and § 101.14(c), and credible scientific evidence to support a qualified health claim. This draft guidance is being issued consistent with FDA's good guidance practice regulations (21 CFR 10.115). The draft guidance, when finalized, will represent the agency's current thinking on the scientific review process for SSA and qualified health claims. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in §§ 101.14 and 101.70 have been approved under OMB control number 0910-0381. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the draft guidance document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at *http://www.cfsan.fda.gov/guidance.html* . Dated: June 28, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13274 Filed 7-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities; Proposed Collection; Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration

(HRSA)publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer at

(301)443-1129. Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimated burden of the proposed collection of information;

(c)ways to enhance the quality, utility, and clarity of the information to be collected; and

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Office of Health Information Technology, Health Center Controlled Networks Progress Reports—New The Office of Health Information Technology (OHIT), Division of State and Community Assistance

(DSCA)plans to collect network outcome measures, conduct evaluation of those measures, and create an electronic reporting system for the following new 2007 grant opportunities: Health Information Technology Planning Grants, Electronic Health Record Implementation Health Center Controlled Networks, Health Information Technology Innovations for Health Center Controlled Networks, and High Impact Electronic Health Records Implementation for Health Center Controlled Networks and Large Multi Site Health Centers. In order to help carry out its mission, DSCA has created a set of performance measures that grantees will use to evaluate the effectiveness of their service programs and monitor their progress through the use of performance reporting data. OHIT will develop an electronic performance measurement reporting instrument with HRSA's Office of Information Technology. The instrument will be developed to accomplish the following goals: To monitor improved access to needed services, to evaluate the productivity and efficiency of the networks, and to monitor patient outcome measures. Grantees will submit their Progress Reports in a mid-year report and an accumulative annual progress report each fiscal year of the grant. The estimates of burden are as follows: Application Number of respondents Responses per respondent Total responses Hours per response Total burden hours Planning 12 2 24 18 432 Electronic Health Records Implementation 8 2 16 18 288 Innovations Category 1 7 2 14 18 252 Innovations Category 2 5 2 10 18 180 High Impact 8 2 16 18 288 Totals 40 80 1,440 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: June 28, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-13167 Filed 7-6-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(HRSA)publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on

(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Reporting Form for the MCHB National Hemophilia Program Grantees and Hemophilia Treatment Center

(HTC)Affiliates Having Factor Replacement Product

(FRP)Programs The Maternal and Child Health Bureau

(MCHB)of the Health Resources and Services Administration

(HRSA)is planning to implement an annual reporting form required of grantees of the MCHB National Hemophilia Program and their HTC affiliates having a factor replacement product

(FRP)program. The purpose of the form is to provide systematic information and data comprising a financial overview of the FRP programs of the HTCs receiving funding through grantees of the MCHB National Hemophilia Program. The proposed form will constitute a reporting requirement for the MCHB National Hemophilia Program grantees and their affiliate HTCs having FRP programs. Data from the form will provide quantitative information on the financial and services provision aspects of each of the HTC FRP programs under each of the MCHB National Hemophilia Program grantees, specifically:

(a)Patient FRP program participation,

(b)FRP program revenue,

(c)FRP program costs,

(d)FRP program net income, and

(e)use of FRP program net income. This form will provide data useful to grantees and their affiliate HTCs having FRP programs as well as to the MCHB National Hemophilia Program. The data will be used to assess FRP program performance including FRP program operational costs appropriateness, FRP program cost efficiency, and FRP program services benefits-information that is essential to evaluating HTCs having FRP programs, grantees, and the MCHB National Hemophilia Program. Each HTC having an FRP program is to submit its report to the grantee and each grantee is to submit the individual reports of each of their affiliate HTCs having an FRP program to the MCHB National Hemophilia Program as a part of their annual grant application. The estimated response burden for grantees is as follows: Form Number of respondents Average number of responses per respondent Total responses Hours per response Total burden hours Factor Replacement Product

(FRP)Data Sheet 68 1 68 30 2,040 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: June 28, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-13168 Filed 7-6-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: “Health Care and Other Facilities” Project Status Update Form: NEW The Health Resources and Services Administration's Health Care and Other Facilities

(HCOF)program provides earmarked funds to health-related facilities for construction-related activities and/or capital equipment purchases. Awarded facilities are required to provide a periodic (quarterly for construction-related projects, annually for equipment only projects) update of the status of the funded project until it is completed. The monitoring period averages about 3 years, although some projects take up to 5 years to complete. The information collected from these updates is vital to program management staff to determine whether projects are progressing according to the established timeframes, meeting deadlines established in the Notice of Grant Award (NGA), and drawing down funds appropriately. The data collected from the updates is also shared with the Division of Grants Management Operations

(DGMO)and the Division of Engineering Services

(DES)for their assistance in the overall evaluation of each project's progress. An electronic form has been developed for progress reporting for the HCOF program. This form will provide awardees access to directly input the required status update information in a timely, consistent, and uniform manner. The electronic form will minimize burden to respondents and will inform respondents when there are missing data elements prior to submission. The estimate of burden for the form is as follows: Project type Number of respondents Response per respondent Total responses Hours per response Total burden hours Construction-Related 395 4 1,580 .5 790 Equipment Only 523 1 523 .5 262 Total 918 2,103 1,052 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: June 28, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-13169 Filed 7-6-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Data System for Organ Procurement and Transplantation Network and Associated Forms (OMB No. 0915-0157)—Revision Section 372 of the Public Health Service

(PHS)Act requires that the Secretary, by contract, provide for the establishment and operation of an Organ Procurement and Transplantation Network (OPTN). The OPTN, among other responsibilities, operates and maintains a national waiting list of individuals requiring organ transplants, maintains a computerized system for matching donor organs with transplant candidates on the waiting list, and operates a 24-hour system to facilitate matching organs with individuals included in the list. Data for the OPTN data system are collected from transplant hospitals, organ procurement organizations, and tissue-typing laboratories. The information is used to indicate the disease severity of transplant candidates, to monitor compliance of member organizations with OPTN rules and requirements, and to report periodically on the clinical and scientific status of organ donation and transplantation in this country. Data are used to develop transplant, donation and allocation policies, to determine if institutional members are complying with policy, to determine member specific performance, to ensure patient safety when no alternative sources of data exist and to fulfill the requirements of the OPTN Final Rule. The practical utility of the data collection is further enhanced by requirements that the OPTN data must be made available, consistent with applicable laws, for use by OPTN members, the Scientific Registry of Transplant Recipients, the Department of Health and Human Services, and others for evaluation, research, patient information, and other important purposes. Revisions in the 26 data collection forms are intended to implement approved reduction in data collection for candidates and recipients, to provide additional information specific to pediatric patients, and to clarify existing questions. Estimates of Annualized Hour Burden Form Number of respondents Responses per respondents Total responses Hours per response Total burden hours Deceased Donor Registration 58 215 12,470 0.4200 5,237.4000 Death referral data 58 12 696 10.0000 6,960.0000 Living Donor Registration 711 10 7,110 0.4100 2,915.1000 Living Donor Follow-up 711 18 12,798 0.3300 4,223.3400 Donor Histocompatibility 154 95 14,630 0.0600 877.8000 Recipient Histocompatibility 154 172 26,488 0.1100 2,913.6800 Heart Candidate Registration 135 23 3,105 0.2800 869.4000 Lung Candidate Registration 67 27 1,809 0.2800 506.5200 Heart/Lung Candidate Registration 59 1 59 0.2800 16.5200 Thoracic Registration 135 27 3,645 0.4400 1,603.8000 Thoracic Follow-up 135 229 30,915 0.4130 12,767.8950 Kidney Candidate Registration 250 133 33,250 0.2800 9,310.0000 Kidney Registration 250 69 17,250 0.4400 7,590.0000 Kidney Follow-up 250 544 136,000 0.3332 45,315.2000 Liver Candidate Registration 125 89 11,125 0.2800 3,115.0000 Liver Registration 125 54 6,750 0.4000 2,700.0000 Liver Follow-up 125 383 47,875 0.3336 15,971.1000 Kidney/Pancreas Candidate Registration 146 12 1,752 0.2800 490.5600 Kidney/Pancreas Registration 146 7 1,022 0.5300 541.6600 Kidney/Pancreas Follow-up 146 65 9,490 0.5027 4,770.6230 Pancreas Candidate Registration 146 7 1,022 0.2800 286.1600 Pancreas Registration 146 3 438 0.4400 192.7200 Pancreas Follow-up 146 23 3,358 0.4133 1,387.8614 Intestine Candidate Registration 45 8 360 0.2400 86.4000 Intestine Registration 45 4 180 0.5300 95.4000 Intestine Follow-up 45 17 765 0.5059 387.0135 Post Transplant Malignancy 711 6 4,266 0.0800 341.2800 Total 923 388,628 131,472.4329 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: June 28, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-13170 Filed 7-6-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice Regarding the 340B Drug Pricing Program; Children's Hospitals AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: Section 340B of the Public Health Service Act (section 340B) and section 1927(a) of the Social Security Act (section 1927(a)) implement a drug pricing program in which manufacturers who sell covered outpatient drugs to covered entities must agree to charge a price that will not exceed an amount determined under a statutory formula. Section 6004 of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (section 6004) added children's hospitals to the list of covered entities eligible to access 340B discounted drugs. The purpose of this notice is to inform interested parties of proposed guidelines regarding the addition of children's hospitals that meet certain requirements, specifically:

(1)The process for the addition of children's hospitals to the 340B Program; and

(2)the obligation of manufacturers to provide the statutorily mandated discount to children's hospitals. These proposed guidelines will not take effect until final guidelines are issued. DATES: The public is invited to comment on the proposed guidelines by September 7, 2007. After consideration of the submitted comments, the Health Resources and Services Administration

(HRSA)will issue the final guidelines. ADDRESSES: Address all comments to Mr. Bradford R. Lang, Public Health Analyst, Office of Pharmacy Affairs (OPA), Healthcare Systems Bureau (HSB), HRSA, 5600 Fishers Lane, Parklawn Building, Room 10C-03, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Mr. Jimmy Mitchell, Director, OPA, HSB, HRSA, 5600 Fishers Lane, Parklawn Building, Room 10C-03, Rockville, MD 20857, or by telephone through the Pharmacy Services Support Center at 1-800-628-6297. SUPPLEMENTARY INFORMATION:

(A)Background Section 602 of Public Law 102-585, the Veterans Health Care Act of 1992, enacted section 340B, Limitation on Prices of Drugs Purchased by Covered Entities and added certain implementation provisions for the 340B Program to section 1927(a) of the Social Security Act. Section 340B contains the majority of the requirements for covered entities participating in the 340B Program, while the relevant provisions of section 1927(a) of the Social Security Act provide primarily for the requirement that manufacturers provide the statutorily mandated discount to covered entities. Section 340B contains a list of covered entities that are eligible to receive discounts through the 340B Program. The list includes entities such as Federally Qualified Health Centers, State-operated AIDS drug purchasing assistance programs, and certain disproportionate share hospitals. Children's hospitals were not included as covered entities under section 340B in the Veterans Health Care Act of 1992 as enacted. Section 6004 added children's hospitals as covered entities eligible to access 340B discounted drugs. To accomplish this, section 6004 did not amend section 340B (which contains many of the requirements for covered entities). Section 6004 amended section 1927(a) of the Social Security Act (which primarily contains requirements for manufacturers' participation) to add children's hospitals to the 340B Program. To be eligible for the 340B Drug Pricing Program, section 1927(a), as amended by section 6004, requires children's hospitals to meet the requirements of clauses

(i)and

(iii)of section 340B(a)(4)(L) of the Public Health Service Act, which contain provisions for State or local government affiliations and non-participation in group purchasing organizations. In addition, children's hospitals must meet the requirements of clause

(ii)of such section, which contains requirements for the provision of indigent care, if such section “were applied by taking into account the percentage of care provided by the hospital to patients eligible for medical assistance” under Medicaid.

(B)Obligation of Manufacturers To Provide 340B Discounts to Children's Hospitals Section 1927(a)(5)(A) of the Social Security Act requires manufacturers to enter into agreements with the Secretary that meet the requirements of section 340B with respect to covered outpatient drugs purchased by a covered entity. Section 1927(a)(5)(B), as amended by section 6004, defines covered entities for purposes of section 1927(a)(5) as those covered entities listed in the Public Health Service Act and certain children's hospitals. As section 1927(a)(5)(A) requires manufacturers to enter into agreements “with respect to covered outpatient drugs purchased by a covered entity,” and covered entity is defined as including children's hospitals for purposes of section 1927, manufacturers are required to extend 340B pricing to eligible children's hospitals. The Pharmaceutical Pricing Agreements

(PPA)between the Secretary and each manufacturer require manufacturers to provide 340B discounted covered outpatient drugs to covered entities. Given the clear congressional intent in Section 6004 to expand the category of covered entities, the PPAs currently in place effectively require manufacturers to provide 340B discounts to children's hospitals without need for further amendment to currently existing PPAs.

(C)Process for Admission of Children's Hospitals to the 340B Program

(1)Children's Hospitals Participation Children's hospitals participation in the 340B Drug Pricing Program is voluntary. Consistent with the participation of other covered entities, once a children's hospital has elected to participate in the program, it must wait to enter or withdraw from the program until the next official updating of the 340B covered entity database. OPA will update this list two weeks before the beginning of each calendar quarter. Participating children's hospitals must comply with all program guidelines for covered entities until the date they are removed from the 340B covered entity database. OPA will accept applications from children's hospitals for entry into the 340B Program as of the date of publication of the final notice of these guidelines.

(2)Certification by Children's Hospitals Prior to 340B Drug Pricing Program Entry As with other covered entities, prior to entry into the 340B Drug Pricing Program, children's hospitals will be required to provide OPA with a certification regarding several different program requirements. As a threshold matter, a hospital wishing to qualify for the 340B Program as a children's hospital must demonstrate that the hospital is a “children's hospital” as defined by section 6004. Section 6004 requires that a hospital wishing to qualify as a children's hospital covered entity must

(1)satisfy the definition of “children's hospital” contained in section 1886(d)(1)(B)(iii) of the Social Security Act; and

(2)meet minimum requirements for the receipt of an additional payment under Medicare pursuant to section 1886(d)(5)(F)(i) of the Social Security Act (if such clause were applied by taking into account the percentage of care provided by the hospital to Medicaid patients). Given the reliance of section 6004 on Medicare payment provisions for the definition of “children's hospital,” a hospital will need to demonstrate that it has been provided a Medicare provider number identifying the hospital as a “children's hospital” (i.e., a hospital with a 3300 series Medicare provider number). Prior to entry into the 340B Program, a children's hospital must certify that it will abide by all the requirements of section 340B that all other covered entities abide by (e.g., prohibition on resale of covered outpatient drugs; prohibition on duplicate discounts or rebates). While children's hospitals are not explicitly mentioned in section 340B, it is implicit in section 1927(a) of the Social Security Act that children's hospitals abide by the requirements of section 340B. Section 1927(a) provides that manufacturers must have entered into agreements with the Secretary that meet the requirements of section 340B and several of the provisions contained in these agreements concern covered entities' compliance with provisions of section 340B. Furthermore, it is within the Secretary's authority under section 340B to create guidelines necessary for the implementation of the program. Unless children's hospitals are subject to all of the same rules as other covered entities, the inclusion of children's hospitals in the 340B Program would be difficult, if not impossible. Prior to entry into the 340B Program a children's hospital must certify compliance (along with the date of compliance) with clauses (i), (ii), and

(iii)of section 340B(a)(4)(L) (in accordance with section 1927(a)(5)(B) of the Social Security Act). To comply with section 340B(a)(4)(L)(i), a children's hospital will have to certify (and include such supporting documentation as requested by OPA) that the children's hospital is:

(1)Owned or operated by a unit of State or local government;

(2)a public or private non-profit corporation which is formally granted governmental powers by a unit of State or local government; or

(3)A private non-profit hospital under contract with State or local government to provide health care services to low income individuals who are not eligible for Medicare or Medicaid. To comply with section 340B(a)(4)(L)(ii), a children's hospital will have to certify (and include such supporting documentation as requested by OPA) that the children's hospital:

(1)Is located in an urban area, has 100 or more beds, and can demonstrate that its net inpatient care revenues (excluding any of such revenues attributable to Medicare), during the cost reporting period in which the discharges occur, for indigent care from State and local government sources and Medicaid exceed 30 percent of its total of such net inpatient care revenues during the period; or

(2)for the most recent cost reporting period that ended before the calendar quarter involved, had a disproportionate share adjustment percentage (as determined under section 1886(d)(5)(F) of the Social Security Act) greater than 11.75 percent. To comply with section 340B(a)(4)(L)(iii), a children's hospital will have to certify that the children's hospital will not participate in a group purchasing organization or group purchasing arrangement for covered outpatient drugs as of the effective date in the 340B covered entity database. Prior to entry into the 340B Program, OPA requires certification of a children's hospital's compliance with section 340B(a)(4)(L)(ii). In addition to having a 3300 series Medicare provider identification number, initially, OPA will seek verification of compliance based on the Medicare cost report submitted by the children's hospital to the Centers for Medicare and Medicaid Services (CMS). Given that children's hospitals are not eligible for the prospective payment system, the materials submitted by any particular children's hospital may not provide the required verification. To the extent that OPA is unable to obtain independent verification, a children's hospital will be expected to verify that the children's hospital meets the requirements of section 340B(a)(4)(L)(ii) if requested by OPA. OPA is considering whether it would be appropriate to require a statement from an independent auditor certifying that a children's hospital meets the requirements of section 340B(a)(4)(L)(ii) in those cases where there is no established method of verification analogous to that utilized to annually certify DSH eligibility in the 340B Drug Pricing Program. OPA invites comments from stakeholders on the feasibility of an independent auditor to verify eligibility of children's hospitals. OPA also seeks comments from children's hospitals as to the relative burden that an independent auditor statement may entail and welcomes alternate proposals as to how to best ensure the integrity of the 340B Drug Pricing Program while minimizing costs.

(3)Eligibility for Retroactive Discounts Section 6004 indicates that the amendment authorizing entry of children's hospitals into the 340B Program “shall apply to drugs purchased on or after the date of the enactment of this Act.” Section 6004 was enacted on February 8, 2006. Therefore, once they are admitted to the 340B Program, children's hospitals are eligible for 340B drug pricing retroactive to February 8, 2006. However, a children's hospital will be eligible for retroactive discounts only to the extent that it has satisfied all requirements for participation in the 340B program back to the date discounts are requested. Similar to when the 340B Program was first started, children's hospitals that participate in the program will be eligible for retroactive discounts. Until 120 days after publication of the final notice, children's hospitals which have been included in OPA's database of covered entities may request retroactive discounts (discounts, rebates, or account credit) from pharmaceutical manufacturers for covered outpatient drugs that satisfy all the following conditions:

(1)The covered outpatient drugs must have been purchased on or after February 8, 2006;

(2)The covered outpatient drugs must not have generated Medicaid rebates (the children's hospital must have appropriate documentation to demonstrate this); and

(3)The covered outpatient drugs must have been purchased on or after the date on which the children's hospital satisfied all requirements for participation in the 340B Program as outlined in section (C)(2) of this notice. In order to satisfy the last condition listed above, a children's hospital must be able to demonstrate, at a minimum, that as required by section 340B(a)(4)(L)(iii) of the Public Health Service Act the children's hospital did not have a group purchasing agreement for covered outpatient drugs and satisfied the requirements of section 340B(a)(4)(L)(i) and 340B(a)(4)(L)(ii) at the time the covered outpatient drugs for which rebates are requested were purchased. Dated: June 29, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-13239 Filed 7-6-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service American Indians Into Medicine; Notice of Competitive Grant Applications for American Indians Into Medicine Program *Announcement Type:* Initial. *Funding Opportunity Number:* HHS-2007-IHS-INMED-0001. *CFDA Number:* 93.970. *Key Dates:* *Application Deadline:* August 16, 2007. *Application Review:* August 21, 2007. *Application Notification:* August 27, 2007. *Anticipated Award Start Date:* September 1, 2007. I. Funding Opportunity Description The Indian Health Service

(IHS)announces that competitive grant applications are being accepted for the American Indians into Medicine Program. These grants are established under the authority of 25 U.S.C. 1616g(a) of the Indian Health Care Improvement Act, as amended by Public Law (Pub. L.) 102-573. The purpose of the Indians into Medicine program is to augment the number of American Indian/Alaska Native (AI/AN) health professionals serving AI/AN by encouraging them to enter the health professions and removing the multiple barriers to their entrance into IHS and private practice among AI/AN communities. For the purpose of maintaining and expanding the Indians into Medicine program two grants will be funded. One grant will be funded at $300,000 and a second grant will be funded at $60,000. Each grant will have different criteria which will be listed separately in this announcement. This program is described at 93.970 in the Catalog of Federal Domestic Assistance. The Public Health Service

(PHS)is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS-led activity for setting priority areas. This program announcement is related to the priority area of Educational and Community-based programs. Potential applicants may obtain a copy of Healthy People 2010, summary report in print, Stock No. 017-001-00547-9, or via CD-ROM, Stock No. 107-001-00549-5, through the Superintendent of Documents, Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15250-7945,

(202)512-1800. You may access this information via the Internet at the following Web site: *www.health.gov/healthypeople.* The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of the facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. II. Award Information *Type of Awards:* Grant. *Estimated Funds Available:* The total amount identified for Fiscal Year 2007 is $360,000 to provide support for an estimated two awards. The awards are for 12 months in duration and the awards are approximately $300,000 for one grant award and $60,000 for a second grant award. Future awards issued under this announcement are subject to the availability of funds. *Anticipated Number of Awards:* An estimated two awards will be made under the program. Applicants may apply for both grants but only one grant will be awarded per applicant. *Project Period:* 36 months = $300,000 grant award; 12 months = $60,000 grant award. *Award Amount:* $300,000, per year for one grant award and $60,000, per year for a second grant award. III. Eligibility Information 1. *Eligible Applicants:* Public and nonprofit private colleges and universities with medical and other allied health programs are eligible to apply for the grants. Public and nonprofit private colleges that operate nursing programs are not eligible under this announcement since the IHS currently funds the Nursing Recruitment grant program. The existing INMED grant program at the University of North Dakota has as its target population Indian Tribes primarily within the States of North Dakota, South Dakota, Nebraska, Wyoming, and Montana. A college or university applying under this announcement must propose to conduct its program among Indian Tribes in States not currently served by the University of North Dakota INMED program. 2. *Cost Sharing/Matching:* This announcement does not require matching funds or cost sharing. 3. *Other Requirements:* Required Affiliations—The grant applicant must submit official documentation indicating Tribal cooperation with and support of the program within the schools on its reservation. Documentation must be in the form prescribed by the Tribes governing body, i.e., letter of support or Tribal resolution. Documentation must be submitted from every Tribe “affected” by the grant program. If application budgets exceed the stated dollar amount that is outlined within this announcement, it will not be considered for funding. One grant will be funded at $300,000 and a second grant will be funded at $60,000. Each grant will have different criteria which will be listed separately in this announcement. Please specify which grant you are applying for. Applicants may apply for both grants but only one grant will be awarded per applicant. IV. Application and Submission Information 1. Applicant package may be found in *www.grants.gov* (Grants.gov) or at *http://www.ihs.gov/NonMedicalPrograms/gogp/gogp_funding.asp.* Information regarding the electronic application process may be directed to Michelle G. Bulls, at 301-443-6528 or the *Grants.gov* Helpdesk 1-800-518-4726. The entire application package is available at: *http://www.grants.gov/Apply.* Detailed application instructions for this announcement are downloadable on *Grants.gov.* 2. Content and Form of Application Submission: • Be single spaced. • Be typewritten. • Have consecutively numbered pages. • Use black type not smaller than 12 characters per one inch. • Contain a narrative that does not exceed 7 typed pages that includes the other submission requirements below. The 7 page narrative does not include the work plan, standard forms, Tribal resolutions or letters of support (if necessary), table of contents, budget, budget justifications, narratives, and/or other appendix items. *Public Policy Requirements:* All Federal-wide public policies apply to the IHS grants with the exception of the Lobbying and Discrimination public policy. —Include Letter of Intent requirements under Public Policy Requirements. 3. *Submission Dates and Times:* Applications must be submitted electronically through *Grants.gov* by 12 midnight Eastern Standard Time (EST). If technical challenges arise and the applicant is unable to successfully complete the electronic application process, the applicant should contact Michelle G. Bulls, Grants Policy Staff, fifteen days prior to the application deadline and advise of the difficulties that your organization is experiencing. The grantee must obtain prior approval, in writing (e-mails are acceptable) allowing the paper submission. If submission of a paper application is requested and approved, the original and two copies may be sent to the appropriate grants contact that is listed in Section IV above. Applications not submitted through *Grants.gov* , without an approved waiver, may be returned to the applicant without review or consideration. Late applications will not be accepted for processing, will be returned to the applicant and will not be considered for funding. 4. *Intergovernmental Review:* Executive Order 12372 requiring intergovernmental review is not applicable to this program. 5. *Funding Restrictions:* • Pre award costs are allowable pending prior approval from the awarding agency. However, in accordance with 45 CFR Part 74 all pre award costs are incurred at the recipient's risk. The awarding office is under no obligation to reimburse such costs if for any reason the applicant does not receive an award or if the award to the recipient is less than anticipated. • The available funds are inclusive of direct and appropriate indirect costs. • Only one grant will be awarded per applicant. • IHS will not acknowledge receipt of applications. *Electronic Submission* —The preferred method for receipt of applications is electronic submission through *Grants.gov* . However, should any technical challenges arise regarding the submission, please contact *Grants.gov* Customer Support at 1

(800)518-4726 or *support@grants.gov* . The Contact Center hours of operation are Monday through Friday from 7 a.m. to 9 p.m. EST. If you require additional assistance please call

(301)443-6290 and identify the need for assistance regarding your *Grants.gov* application. Your call will be transferred to the appropriate grants staff member. The applicant must seek assistance at least fifteen days prior to the application deadline. Applicants that do not adhere to the timelines for Central Contractor Registry

(CCR)and/or *Grants.gov* registration and/or requesting timely assistance with technical issues will not be a candidate for paper applications. To submit an application electronically, please use the *http://www.Grants.gov/Apply* site. Download a copy of the application package, on the *Grants.gov* Web site, complete it offline and then upload and submit the application via the *Grants.gov* site. You may not e-mail an electronic copy of a grant application to IHS. Please be reminded of the following: • Under the new IHS application submission requirements, paper applications are not the preferred method. However, if you have technical problems submitting your application on line, please directly contact *Grants.gov* Customer Support at: *http://www.grants.gov/CustomerSupport.* • Upon contacting *Grants.gov* obtain a tracking number of proof of contact. The tracking number is helpful if there are technical issues that cannot be resolved and a waiver request from Grants Policy must be obtained. • If it is determined that a formal wavier is necessary, the applicant must submit a request, in writing (e-mails are acceptable), to *Michelle.Bulls@ihs.gov* that includes a justification for the need to deviate from the standard electronic submission process. Upon receipt of approval, a hard copy application package must be downloaded by the applicant from *Grants.gov* , and sent directly to the Division of Grants Operations (DGO), 801 Thompson Avenue, Suite 120, Rockville, MD 20852 by the due date, August 16, 2007. • Upon entering the *Grants.gov* site, there is information available that outlines the applicant requirements regarding electronic submission of an application through *Grants.gov* , as well as the hours of operation. Applicants must not wait until the deadline date to begin the application process through *Grants.gov* as the registration process for CCR could take up to fifteen working days. • To use *Grants.gov* you, as the applicant, must have a Duns and Bradstreet

(DUNS)Number and register in the CCR. You should allow a minimum of ten working days to complete CCR registration. See below on how to apply. • You must submit all documents electronically, including all information typically included on the SF 424 and all necessary assurances and certifications. • Please use the optional attachment feature in *Grants.gov* to attached additional documentation that may be requested by IHS. • If Tribal resolutions or letters of support are required, please include them as an attachment in your electronic application. • Your application must comply with any page limitation requirements described in the program announcement. • After you electronically submit your application, you will receive an automatic acknowledgement from *Grants.gov* that contains a *Grants.gov* tracking number. The Indian Health Service, DGO will retrieve your application from *Grants.gov* . DGO will not notify applicants that the application has been received. • You may access the electronic application for this program on *http://www.Grants.gov* . • You may search for the downloadable application package by either the CFDA number or the Funding Opportunity Number. Both numbers are identified in the heading of this announcement. • The applicant must provide the Funding Opportunity Number: HHS-2007-IHS INMED-0001. Again, e-mail applications will not be accepted under this announcement. DUNS Number Applicants are required to have a 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 *http://www.dunandbradstreet.com* or call 1-866-705-5711. Interested parties may wish to obtain their DUNS number by phone to expedite the process. Applications submitted electronically must also be registered with the CCR. A DUNS number is required before CCR registration can be completed. Many organizations may already have a DUNS number. Please use the number listed above to investigate whether or not your organization has a DUNS number. Registration with the CCR is free of charge. Applicants may register by calling 1-888-227-2423. Please review and complete the CCR Registration Worksheet located on *http://www.grants.gov/CCRRegister* . More detailed information regarding these registration processes can be found at *http://www.grants.gov* . V. Application Review Information 1. Criteria for Applicants Applying for the $300,000 Grant Award A. Introduction and Potential Effectiveness of Project (30 pts.)

(1)Describe your legal status and organization.

(2)State specific objectives of the project, which are measurable in terms of being quantified, significant to the needs of Indian people, logical, complete and consistent with the purpose of 25 U.S.C. 1616g.

(3)Describe briefly what the project intends to accomplish. Identify the expected results, benefits, and outcomes or products to be derived from each objective of the project.

(4)Provide a project specific work plan (milestone chart) which lists each objective, the tasks to be conducted in order to reach the objective, and the time frame needed to accomplish each task. Time frames should be projected in a realistic manner to assure that the scope of work can be completed within each budget period.

(5)In the case of proposed projects for identification of Indians with a potential for education or training in the health professions, include a method for assessing the potential of interested Indians for undertaking necessary education or training in such health professions.

(6)State clearly the criteria by which the project's progress will be evaluated and by which the success of the project will be determined.

(7)Explain the methodology that will be used to determine if the needs, goals, and objectives identified and discussed in the application are being met and if the results and benefits identified are being achieved.

(8)Identify who will perform the evaluation and when. B. Project Administration (20 pts.)

(1)Provide an organizational chart and describe the administrative, managerial and organizational arrangements and the facilities and resources to be utilized to conduct the proposed project (include in appendix).

(2)Provide the name and qualifications of the project director or other individuals responsible for the conduct of the project; the qualifications of the principle staff carrying out the project; and a description of the manner in which the application's staff is or will be organized and supervised to carry out the proposed project. Include biographical sketches of key personnel (or job descriptions if the position is vacant) (include in appendix).

(3)Describe any prior experience in administering similar projects.

(4)Discuss the commitment of the organization, i.e., although not required, the level of non-Federal support. List the intended financial participation, if any, of the applicant in the proposed project specifying the type of contributions such as cash or services, loans of full or part-time staff, equipment, space, materials or facilities or other contributions.

(5)Describe the ability to provide outreach and recruitment for health professions to Indian communities including elementary and secondary schools and community colleges located on Indian reservations which will be served by the program.

(6)To the maximum extent feasible, employ qualified Indians in the program. C. Accessibility to Target Population (20 pts.)

(1)Describe the current and proposed participation of Indians (if any) in your organization.

(2)Identify the target Indian population to be served by your proposed project and the relationship of your organization to that population.

(3)Describe the methodology to be used to access the target population.

(4)Identify existing university tutoring, counseling and student support services. D. Relationship of Objectives to Manpower Deficiencies (20 pts.)

(1)Provide data and supporting documentation to substantiate need for recruitment.

(2)Indicate the number of potential Indian students to be contacted and recruited as well as potential cost per student recruited. Those projects that have the potential to serve a greater number of Indians will be given first consideration.

(3)Describe methodology to locate and recruit students with educational potential in a variety of health care fields. Primary recruitment efforts must be in the field of medicine with secondary efforts in other allied health fields such as pharmacy, dentistry, medical technology, x-ray technology, etc. The field of nursing is excluded since the IHS does fund the IHS Nursing Recruitment grant program. Project Budget (10 pts.)

(1)Clearly define the budget. Provide a justification and detailed breakdown of the funding by category for the first year of the project. Information on the project director and project staff should include salaries and percentage of time assigned to the grant. List equipment purchases necessary for the conduct of the project.

(2)The available funding level of approximately $300,000 is inclusive of both direct and indirect costs. Indirect costs are calculated using 8 percent of the total direct costs as required by HHS Grants Policy for training grants. Because this project is for a training grant, the HHS Grants Policy Statement, Rev. 01/07 limits reimbursement of indirect costs to the lesser of the applicant's actual indirect costs or 8 percent of total direct costs (exclusive of tuition and related fees and expenditures for equipment) is applicable. This limitation applies to all institutions of higher education other than agencies of State and local government.

(4)Projects requiring a second and third year must include a program narrative and categorical budget and justification for each additional year of funding requested (this is not considered part of the 7-page narrative).

(5)Provide budgetary information for summary preparatory programs for Indian students, who need enrichment in the subjects of math and science in order to pursue training in the health profession. Multi-Year Project Requirements Applications must include a narrative, budget, and budget justification for the second and third years of funding. Appendix to include: a. Resumes and position descriptions b. Organizational Chart c. Work Plan d. Tribal Resolution(s)/letters of support e. Position Descriptions for Key Staff Criteria for Applicants Applying for the $60,000 Grant Award F. Introduction and Potential Effectiveness of Project (30 points)

(1)Describe your legal status and organization.

(2)State specific objectives of the project, which are measurable in terms of being significant to the needs of Indian people, logical, complete and consistent with the purpose of 25 U.S.C. 1612g.

(3)Describe briefly what the project intends to accomplish. Identify the expected results, benefits, and outcomes to be derived from each objective of the project.

(6)State clearly the criteria by which the project's progress will be evaluated and by which the success of the project will be determined.

(8)Identify who will perform the evaluation and when. G. Project Administration (20 pts.)

(1)Provide an organizational chart and describe the administrative, managerial and organization arrangements and the facilities and resources to be utilized to conduct the proposed project (include in appendix).

(2)Provide the name and qualifications of the project director and of other individuals responsible for the conduct of the project. Include biographical sketches of key personnel (or job descriptions if the position is vacant) (include in appendix).

(3)Discuss the commitment of the organization, i.e., although not required, the level of non-Federal support. List the intended financial participation, if any, of the applicant in the proposed project specifying the type of contributions such as cash or services, loans of full or part-time staff, equipment, space, materials or facilities or other contributions.

(4)To the maximum extent feasible, employ qualified Indians in the program. H. Accessibility to Target Population (20 pts.)

(1)Describe the current and proposed participation of Indians (if any) in your organization.

(2)Identify the target Indian population to be served by your proposed project and the relationship of your organization to that population.

(3)Describe the methodology to be used to access the target population.

(4)Identify existing university tutoring, counseling and student support services. I. Relationship of Objectives to Manpower Deficiencies (20 pts.)

(1)Provide data and supporting documentation to substantiate need for recruitment.

(2)Describe methodology to locate and recruit students with educational potential in a variety of health care fields. Primary recruitment efforts must be in the field of medicine with secondary efforts in other allied health fields such a pharmacy, dentistry, medical technology, x-ray technology, etc. The field of nursing is excluded since the IHS does fund the IHS Nursing Recruitment grant program. J. Project Budget (10 pts.)

(2)The available funding level of approximately $60,000 is inclusive of both direct and indirect costs. Indirect costs are calculated using 8 percent of the total direct costs as required by HHS Grants Policy for training grants. Because this project is for a training grant, the HHS Grants Policy Statement, Rev. 01/07 limits reimbursement of indirect costs to the lesser of the applicant's actual indirect costs or 8 percent of total direct costs (exclusive of tuition and related fees and expenditures for equipment) is applicable. This limitation applies to all institutions of higher education other than agencies of State and local government.

(3)The applicant may include as a direct cost student support costs related to tutoring, counseling, and support for students enrolled in a health career program of study at the respective college or university. Tuition and stipends for regular sessions are not allowable costs of the grant; however, students recruited through the INMED program may apply for funding from the IHS Scholarship Programs. Appendix to include: a. Resumes and position descriptions b. Organizational Chart c. Work Plan d. Tribal Resolution(s)/letters of support e. Position Descriptions for Key Staff 2. Review and Selection Process Applications meeting eligibility requirements that are complete, responsive, and conform to this program announcement will be reviewed by an Objective Review Committee

(ORC)in accordance with IHS objective review procedures. The objective review process ensures a nationwide competition for limited funding. The ORC will be comprised of IHS (60% or less) or other Federal individuals and (40% or more) non-Federal individuals with appropriate expertise. The ORC will review each application against established criteria. Based upon the evaluation criteria, the reviewer will assign a numerical score to each application, which will be used in making the final funding decision. Approved applications scoring less than 60 points will not be considered for funding. The results of the review are forwarded to the Director, Office of Public Health Support (OPHS), for final review and approval. The Director, OPHS, will also consider the recommendations from the Division of Health Professions Support and the Division of Grants Operations (DGO). 3. Anticipated Announcement and Award Dates The IHS anticipates an awards start date of September 1, 2007. VI. Award Administration Information 1. Award Notices The Notice of Award

(NoA)will be initiated by the DGO and will be mailed via postal mail on or before August 27, 2007 to each entity that is approved for funding under this announcement. The NoA will be signed by the Grants Management Officer and this is the authorizing document for which funds are dispersed to the approved entities. The NoA will serve as the official notification of the grant award and will reflect the amount of Federal funds awarded, the purpose of the grant, the terms and conditions of the award, the effective date of the award, and the budget/project period. The NoA is the legally binding document. Applicants who are approved but unfunded or disapproved based on their Objective Review score will receive a copy of the Executive Summary which identifies the weaknesses and strengths of the application submitted. 2. Administrative Requirements Grants are administered in accordance with the following documents: • This Program Announcement. • 45 CFR Part 92, A Uniform Administrative Requirements for Grants and Cooperative Agreements to State, Local and Tribal Governments, or 45 CFR Part 74, A Uniform Administrative Requirements for Awards to Institutions of Higher Education, Hospitals, Other Non Profit Organizations, and Commercial Organizations. • Grants Policy Guidance: HHS Grants Policy Statement, October 2006. • Cost Principles: OMB Circular A-87, State, Local and Indian (Title 2 Part 225). • Administrative Requirements: OMB Circular A-122, A Non profit Organizations (Title 2 Part 230). • Audit Requirements: OMB Circular A-133, Audits of States, Local Governments, and Non profit Organizations. 3. Indirect Costs This section applies to all grant recipients that request indirect cost in their application. In accordance with HHS Grants Policy Statement, Part II 27, IHS requires applicants to have a current indirect cost rate agreement in place prior to award. The rate agreement must be prepared in accordance with the applicable cost principles and guidance as provided by the cognizant agency or office. A current rate means the rate covering the applicable activities and the award budget period. If a current rate is not on file with the awarding office, the award shall include funds for reimbursement of indirect costs. However, the indirect cost portion will remain restricted until the current rate is provided to DGO. Generally, indirect costs rates for IHS Tribal organization grantees are negotiated with the Division of Cost Allocation

(DCA)*http://rates.psc.gov/* and indirect cost rates that are for IHS funded federally recognized Tribes are negotiation with the Department of Interior. If your organization has questions regarding the indirect cost policy, please contact the DGO at 301-443-5204. 4. Reporting A. *Progress Report.* Program progress reports are required semi-annually. These reports will include a brief comparison of actual accomplishments to the goals established for the period, reasons for slippage (if applicable), and other pertinent information as required. A final report must be submitted within 90 days of expiration of the budget/project period. B. *Financial Status Report.* Semi-annual financial status reports must be submitted within 30 days of the end of the half year. Final financial status reports are due within 90 days of expiration of the budget/project period. Standard Form 269 (long form) will be used for financial reporting. C. *Reports* . Grantees are responsible and accountable for accurate reporting of the Progress Reports and Financial Status Reports which are due semi-annually. Financial Status Reports (SF-269) are due 90 days after each budget period and the final SF-269 must be verified from the grantee records on how the value was derived. Grantees must submit reports in a reasonable period of time. Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in one or both of the following:

(1)The imposition of special award provisions; and

(2)the non-funding or non-award of other eligible projects or activities. This applies whether the delinquency is attributable to the failure of the grantee organization or the individual responsible for preparation of the reports. 5. Telecommunication for the Hearing Impaired Is Available at: TTY 301-443-6394 VII. Agency Contacts For program information, contact Ms. Jackie Santiago, Office of Public Health Support, Division of Health Professions Support, 801 Thompson Avenue, Suite 120, Rockville, Maryland 20852

(301)443-3396. For grant application and business management information, contact Ms. Martha Redhouse, Division of Grants Operations, Indian Health Service, 801 Thompson Avenue, Suite 120, Rockville, Maryland 20852

(301)443-5204. Dated: July 2, 2007. Robert G. McSwain, Deputy Director, Indian Health Service. [FR Doc. 07-3310 Filed 7-6-07; 8:45 am]

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