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Code · REGISTER · 2007-01-30 · Food and Drug Administration, HHS · Notices

Notices. Notice

5,234 words·~24 min read·/register/2007/01/30/07-386

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BILLING CODE 4150-24-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee (HICPAC): Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following meeting of the aforementioned committee. *Name:* Healthcare Infection Control Practices Advisory Committee (HICPAC). *Times and Dates:* 8:30 a.m.-5 p.m., February 15, 2007. 8:30 a.m.-4 p.m., February 16, 2007. *Place:* Centers for Disease Control and Prevention
(CDC)Roybal Campus, Bldg 19, Auditorium B3, 1600 Clifton Road, Atlanta, GA 30333. *Status:* Open to the public, limited only by the space available. *Purpose:* The Committee is charged with providing advice and guidance to the Secretary, the Assistant Secretary for Health, the Director, CDC, and the Director, National Center for Infectious Diseases (NCID), regarding
(1)the practice of hospital infection control;
(2)strategies for surveillance, prevention, and control of infections (e.g., nosocomial infections), antimicrobial resistance, and related events in settings where healthcare is provided; and
(3)periodic updating of guidelines and other policy statements regarding prevention of healthcare-associated infections and healthcare-related conditions. *Matters to Be Discussed:* Agenda items will include: Information Technology Standards Update; National Quality Forum Update and Prevention Epidemiology Centers Update. Agenda items are subject to change as priorities dictate. *Contact Person for More Information:* Harriette Lynch, Committee Management Specialist, HICPAC, Division of Healthcare Quality Promotion, NCID, CDC, 1600 Clifton Road, NE, M/S A-07, Atlanta, Georgia 30333, telephone 404-639-4035. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: January 23, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-1393 Filed 1-29-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0421] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget
(OMB)for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 1, 2007. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. 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 compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A (OMB Control Number 0910-0458)—Extension Under section 351 of the Public Health Service Act (42 U.S.C. 262), all biological products, including human blood and blood components, offered for sale in interstate commerce must be licensed and meet standards designed to ensure the continued safety, purity, and potency of such products. In addition, the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351) provides that drugs and devices (including human blood and blood components) are adulterated if they do not conform with Current Good Manufacturing Practice
(CGMP)assuring that they meet the requirements of the act. All establishments manufacturing biological products including human blood and blood components must comply with the applicable CGMP regulations (parts 211, 606, and 820 (21 CFR parts 211, 606, and 820)). Transfusion services are required under 42 CFR 493.1271 to comply with 21 CFR parts 606 and 640 as they pertain to the performance of manufacturing activities. FDA regards biological product deviation
(BPD)reporting to be an essential tool in its directive to protect public health by establishing and maintaining surveillance programs that provide timely and useful information. Section 600.14 requires the manufacturer who holds the biological product license, for other than human blood and blood components, and who had control over the product when the deviation occurred, to report to the Center for Biologics Evaluation and Research
(CBER)or to the Center for Drugs Evaluation and Research
(CDER)as soon as possible but not to exceed 45 calendar days after acquiring information reasonably suggesting that a reportable event has occurred. Section 606.171 requires a licensed manufacturer of human blood and blood components, including Source Plasma; an unlicensed registered blood establishment; or a transfusion service who had control over the product when the deviation occurred, to report to CBER as soon as possible but not to exceed 45 calendar days after acquiring information reasonably suggesting that a reportable event has occurred. The BPD reporting under 21 CFR 1271.350(b) for human cells, tissues, and cellular and tissue-based products is approved under OMB control number 0910-0559 (expires November 30, 2007). Form FDA 3486 is used to submit BPDs under these regulations. Respondents to this collection of information are the licensed manufacturers of biological products other than human blood and blood components, licensed manufacturers of blood and blood components including Source Plasma, unlicensed registered blood establishments, and transfusion services. Based on information from FDA's database, there are an estimated 147 licensed manufacturers of biological products other than human blood and blood components, 194 licensed manufacturers of human blood and blood components, including Source Plasma, and 1,230 unlicensed registered blood establishments. Based on the Center for Medicare and Medicaid Services records, there are an estimated 4,980 transfusion services. The number of licensed manufacturers and total annual responses under § 600.14 include the estimates for both CBER and CDER. The number of total annual responses is based on the number of BPD reports FDA received in fiscal year 2005. The rate of submission is not expected to change significantly in the next few years. Based on information from industry, the estimated average time to complete a deviation report is 2 hours. The availability of the standardized report form, Form FDA 3486, and the ability to submit this report electronically to CBER (CDER does not currently accept electronic filings) further streamlines the report submission process. CBER is developing an addendum to Form FDA 3486. The web-based addendum (Form FDA 3486A) would request additional information when a BPD report has been reviewed by FDA and evaluated as a possible recall. The additional information requested would include information not contained in the Form FDA 3486 such as:
(1)Distribution pattern,
(2)method of consignee notification,
(3)consignee(s) of products for further manufacture,
(4)additional product information, and
(5)updated product disposition. This information would be requested by CBER through e-mail notification to the submitter of the BPD report. This information would be used by CBER for purposes of recall classification. We plan to use Form FDA 3486A for only biological products regulated by CBER. We do not plan to use this form for biological products regulated by CDER because they receive very few BPD reports and do not accept electronic filings. CBER estimates that 5 percent of the total BPD reports submitted to CBER would need additional information submitted in the addendum. CBER estimates it would take between 15 to 45 minutes to complete the addendum. For calculation purposes, CBER is using one-half hour. Activities such as investigating, changing standard operating procedures or processes, and followup are currently required under part 211 (approved under OMB control no. 0910-0139, expires September 30, 2008); part 606 (approved under OMB control no. 0910-0116, expires December 31, 2008); and part 820 (approved under OMB control no. 0910-0073, expires September 30, 2007) and, therefore, are not included in the burden calculation for the separate requirement of submitting a BPD report to FDA. In the **Federal Register** of October 31, 2006, (71 FR 63772), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 21 CFR Section FDA Form Number No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Responses Total Hours 600.14 3486 147 2.73 401 2.0 802 606.171 2 3486 194 169.89 32,958 2.0 65,916 606.171 3 3486 6,210 1.50 9,311 2.0 18,622 3486A 4 6,551 0.33 2,133 0.5 1,067 Total 86,407 1 There are no capital costs or maintenance costs associated with this collection of information. 2 Licensed manufacturers of human blood and blood components, including Source Plasma. 3 Unlicensed registered blood establishments and transfusion services (1,230 + 4,980 = 6,210). 4 Five percent of the total annual responses to CBER (42,653 x 0.05 = 2,133). Dated: January 24, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-1415 Filed 1-29-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0105] James T. Kimball; Denial of Hearing; Final Debarment Order AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is denying Mr. James T. Kimball's request for a hearing and is issuing a final order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Mr. James T. Kimball from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Kimball was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the act. In addition, Mr. Kimball has failed to file with the agency information and analyses sufficient to create a basis for a hearing concerning this action. DATES: This order is effective January 30, 2007. ADDRESSES: Submit applications for termination of debarment to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Mary Catchings, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: I. Background On May 24, 2000, a jury found Mr. Kimball guilty of one count of conspiring to commit offenses against the United States and the Florida Department of Health, a Federal felony offense under 18 U.S.C. 371; six counts of distributing a misbranded drug into interstate commerce, a Federal felony offense under 21 U.S.C. 331(a); and one count of making a false statement in a matter within the jurisdiction of a Federal agency, a Federal felony offense under 18 U.S.C. 1001. On October 19, 2000, the U.S. District Court for the Middle District of Florida entered judgment and sentenced Mr. Kimball for these offenses. The bases for these convictions were Mr. Kimball's knowing and willful participation, including conspiring, to violate Federal laws in connection with the distribution of a misbranded drug, deprenyl, into interstate commerce, and false statements he made to the U.S. Customs Service about shipments of deprenyl for export. The drug deprenyl was misbranded because it contained selegiline, the active ingredient of a prescription drug Eldepryl, but was dispensed without a prescription issued by a licensed practitioner. As a result of these convictions, FDA served Mr. Kimball by certified letter on April 25, 2005, 1 a proposal to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The notice also offered Mr. Kimball an opportunity to request a hearing on the debarment proposal. The debarment proposal was based on a finding, under section 306(a)(2)(B) of the act (21 U.S.C. 335a(a)(2)(B)), that Mr. Kimball was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the act. 1 The certified letter was mailed to the prison facility where records indicated that Mr. Kimball was incarcerated, and the return receipt was signed on April 25, 2005, by an employee at the facility. In his request for hearing, Mr. Kimball stated that he received the letter on May 5, 2005. The delivery dates do not alter the nature of Mr. Kimball's request for a hearing or our application of summary judgement in this matter. The certified letter also informed Mr. Kimball that his request for a hearing could not rest upon mere allegations or denials, but must present specific facts showing that there was a genuine and substantial issue of fact requiring a hearing. The letter also informed Mr. Kimball that the only material issue of fact was whether he was convicted as alleged in the letter, and that the facts underlying his conviction are not at issue in this proceeding. Finally, the letter informed Mr. Kimball that if it conclusively appeared from the face of the information and factual analyses in his request for a hearing that there was no genuine and substantial issue of fact that precluded the order of debarment, FDA would enter summary judgment against him and deny his request for a hearing. In a letter dated May 16, 2005, Mr. Kimball responded to the certified letter by requesting a hearing. II. Denial of Hearing In his May 16, 2005, request for a hearing, Mr. Kimball does not present any arguments or information to show why he should not be debarred. Mr. Kimball merely states that:
(1)He “was not convicted pursuant to the statements set forth in FDA's alleged notice”,
(2)the allegations of his convictions are incorrect, and
(3)his conviction does not mandate his debarment. Such statements do not create a basis for a hearing because hearings will not be granted on mere allegations, denials, or general descriptions of positions (see 21 CFR 12.24(b)(2)). Although FDA's proposal to debar Mr. Kimball explained that he had the opportunity to file a request for a hearing and then submit factual information within 60 days from receipt of the letter, Mr. Kimball did not submit any factual information. Mr. Kimball has failed to present any arguments or information to show why he should not be debarred. Therefore, FDA finds that Mr. Kimball has failed to identify any genuine and substantial issue of fact requiring a hearing. Accordingly, FDA denies Mr. Kimball's request for a hearing. III. Findings and Order Therefore, the Associate Commissioner for Regulatory Affairs, under section 306(a) of the act and under authority delegated to him, finds that Mr. James T. Kimball has been convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the act (section 306(a)(2)(B) of the act). As a result of the foregoing findings, Mr. James T. Kimball is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES ) (sections 306(c)(1)(B) and (c)(2)(A)(iii) and 201(dd) of the act (21 U.S.C. 321(dd))). Any person with an approved or pending drug product application who knowingly uses the services of Mr. Kimball in any capacity, during his period of debarment, will be subject to civil money penalties (section 307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Mr. Kimball, during his period of debarment, provides services in any capacity to a person with an approved or pending drug product application, he will be subject to civil money penalties (section 307(a)(7) of the act). In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Mr. Kimball during his period of debarment. Any application by Mr. Kimball for termination of debarment under section 306(d)(4) of the act should be identified with Docket No. 2005N-0105 and sent to the Division of Dockets Management (see ADDRESSES ). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: January 22, 2007. Margaret O'K. Glavin, Associate Commissioner for Regulatory Affairs. [FR Doc. E7-1416 Filed 1-29-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0029] Indevus Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is withdrawing approval of a new drug application
(NDA)for REDUX (dexfenfluramine hydrochloride (HCl)) Capsules held by Indevus Pharmaceuticals, Inc. (Indevus), 33 Hayden Ave., Lexington, MA 02421-7971. Indevus has requested that approval of this application be withdrawn because the product is no longer marketed, thereby waiving its opportunity for a hearing. DATES: Effective January 30, 2007. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: In 1997, FDA asked that REDUX (dexfenfluramine HCl) be withdrawn from the market because of safety concerns; Indevus (formerly Interneuron Pharmaceuticals, Inc.) discontinued marketing this product. REDUX (dexfenfluramine HCl)Capsules, a treatment for obesity, was withdrawn from the market after review of safety data showed that the product is associated with valvular heart disease (see FDA press releases on “Health Advisory on Fenfluramine/Phentermine for Obesity,” dated July 8, 1997, ( *http://www.fda.gov/opacom/hpnews.html* ), and “FDA Announces Withdrawal of Fenfluramine and Dexfenfluramine,” dated September 15, 1997, ( *http://www.fda.gov/opacom/hpnews.html* )). In a letter dated January 16, 2006, Indevus requested that FDA withdraw approval, under § 314.150(d) (21 CFR 314.150(d)), of NDA 20-344 for REDUX (dexfenfluramine HCl) Capsules, stating that it had discontinued marketing the product. The letter also stated that Indevus believes that the risk/benefit ratio for the use of dexfenfluramine is unfavorable and that withdrawal of approval of NDA 20-344 is in the best interest of public health. Indevus voluntarily waived its opportunity for a hearing, provided under § 314.150(a) and (b). Therefore, under section 505(e) of 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 NDA 20-544, and all amendments and supplements thereto, is withdrawn, effective January 30, 2007. 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)). Dated: January 12, 2007. Douglas C. Throckmorton, Deputy Director, Center for Drug Evaluation and Research. [FR Doc. E7-1414 Filed 1-29-07; 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, Public Law 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 on
(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 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. Proposed Project: The Health Education Assistance Loan
(HEAL)Program: Physician's Certification of Borrower's Total and Permanent Disability Form (OMB No. 0915-0204): Extension The Health Education Assistance Loan
(HEAL)program provided federally-insured loans to students of allopathic medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatric medicine, pharmacy, public health, allied health, or chiropractic, and graduate students in health administration or clinical psychology through September 30, 1998. Eligible lenders, such as banks, savings and loan associations, credit unions, pension funds, State agencies, HEAL schools, and insurance companies, make new refinanced HEAL loans which are insured by the Federal Government against loss due to borrower's death, disability, bankruptcy, and default. The basic purpose of the program was to assure the availability of funds for loans to eligible students who needed to borrow money to pay for their educational loans. Currently, the program monitors the federal liability, and assists in default prevention activities. The HEAL borrower, the borrower's physician, and the holder of the loan complete the Physician's Certification form to certify that the HEAL borrower meets the total and permanent disability provisions. The Department uses this form to obtain detailed information about disability claims which includes the following:
(1)The borrower's consent to release medical records to the Department of Health and Human Services and to the holder of the borrower's HEAL loans;
(2)pertinent information supplied by the certifying physician;
(3)the physician's certification that the borrower is unable to engage in any substantial gainful activity because of a medically determinable impairment that is expected to continue for a long and indefinite period of time or to result in death; and,
(4)information from the lender on the unpaid balance. Failure to submit the required documentation will result in disapproval of a disability claim. No changes have been made to the current form. The estimate of burden for the Physician's Certification form is as follows: Respondent Number of respondents Responses per respondent Total responses Hours per response (minutes) Total burden hours Borrower 80 1 80 5 7 Physician 80 1 80 30 40 Loan Holder 17 5 85 10 14 Total 177 425 61 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: January 24, 2007. Caroline Lewis, Acting Associate Administrator for Administration and Financial Management. [FR Doc. E7-1437 Filed 1-29-07; 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: HRSA AIDS Education and Training Centers Evaluation Activities (OMB No. 0915-0281)—Revision The AIDS Education and Training Centers
(AETC)Program, under the Ryan White HIV/AIDS Treatment Modernization Act of 2006, supports a network of regional and cross-cutting national centers that conduct targeted, multi-disciplinary education and training programs for health care providers treating persons with HIV/AIDS. The purpose of the AETCs is to increase the number of health care providers who are effectively educated and motivated to counsel, diagnose, treat, and medically manage individuals with HIV infection, and to help prevent high risk behaviors that lead to HIV transmission. As part of an ongoing evaluation effort of AETC activities, information is needed on AETC training sessions, consultations, and technical assistance activities. Each regional center collects forms on AETC training events, and centers are required to report aggregate data on their activities to HRSA and the HIV/AIDS Bureau (HAB). This data collection provides information on the number of training events, including clinical trainings and consultations, as well as technical assistance activities conducted by each regional center, the number of health care providers receiving professional training or consultation, and the time and effort expended on different levels of training and consultation activities. In addition, information is obtained on the populations served by the AETC trainees, and the increase in capacity achieved through training events. Collection of this information allows HRSA/HAB to provide information on training activities, types of education, and training provided to Ryan White CARE Act grantees, resource allocation, and capacity expansion. Trainees are asked to complete the Participant Information Form
(PIF)for each activity they complete, and trainers are asked to complete the Event Record (ER). The estimated annual response burden to the attendees of training programs is as follows: Form Number of respondents Responses per respondent Total responses Hours per response Total burden hours PIF 94,641 1 94,641 0.2 18,928.2 Total 94,641 94,641 18,928.2 The estimated annual burden to AETCs is as follows: Form Number of respondents Responses per respondent Total responses Hours per response Total burden hours Event Record 16,417 1 16,417 0.2 3,283 Aggregate Data Set 12 2 24 32 768 Total 16,429 16,441 4,051 The total burden hours are 22,979.2. 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: January 24, 2007. Caroline Lewis, Acting Associate Administrator for Administration and Financial Management. [FR Doc. E7-1438 Filed 1-29-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on the National Health Service Corps; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting: *Name:* National Advisory Council on the National Health Service Corps. *Dates and Times:* March 8, 2007, 2 p.m.-5 p.m.; March 9, 2007, 8:30 a.m.-5 p.m.; and March 10, 2007, 9 a.m.-5 p.m. *Place:* Embassy Suites DC Convention Center, 900 10th Street, NW., Washington, DC 20001. *Status:* The meeting will be open to the public. *Agenda:* The Council will be finalizing a report outlining some recommendations for the National Health Service Corps Program. Discussions will be focused on the impact of these recommendations on the program participants, communities served by these clinicians and in the administration of the program. *For Further Information Contact:* Tira Patterson, Division of National Health Service Corps, Bureau of Health Professions, Health Resources and Services Administration, Parklawn Building, Room 8A-55, 5600 Fishers Lane, Rockville, MD 20857; e-mail: *TPatterson@hrsa.gov;* telephone: 301-594-4140. Dated: January 24, 2007. Caroline Lewis, Acting Associate Administrator for Administration and Financial Management. [FR Doc. E7-1439 Filed 1-29-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service [Funding Announcement Number: HHS-2007-IHS-HPDP1-0001] Office of Clinical and Preventive Services Chronic Care Collaborative *Announcement Type:* Cooperative Agreement. *Catalog of Federal Domestic Number:* 93.443. *Intended Recipient:* Institute for Healthcare Improvement. *Award Amount:* $600,000 for year 1; $800,000 for years 2 and 3. *Application Deadline:* February 1, 2007. *Authorities:* Snyder Act, 25 U.S.C. 13, Public Health Service
(PHS)Act, 42 U.S.C. 301(a). I. Purpose In this cooperative agreement, the Indian Health Service
(IHS)will work closely with the Institute for Healthcare Improvement
(IHI)on innovating and testing new designs of care delivery systems, leveraging results for thousands of patients, and creating a system-wide emphasis on improvement. The IHI's senior leaders and faculty will work closely with the senior leadership team of the Indian health care system to design an improvement strategy to meet the following agreed upon aims: To test adaptations and innovations in chronic conditions management in the IHS. • To develop a strategy for spreading the lessons learned to all IHS sites as well as Tribal and urban sites. • To create a more robust improvement infrastructure. • To nurture the image of the IHS as an innovator in healthcare by publicizing successes. Leadership is the critical driver for change and the IHI will work with the IHS, Tribal and Urban health programs leadership to build a culture and structure to support improved levels of performance in the delivery of health care. The IHI and the IHS will work collaboratively to build new models of care and care processes, with the intent of disseminating such learning and “best practices” throughout the Indian health care system. The IHS will have the opportunity to showcase the results of this work by publishing them on shared websites as well as in jointly authored publications. II. Justification The IHI is a non-profit organization that is leading improvement in health care throughout the world. IHI has unparalleled experience and expertise in working with health systems that care for underserved populations to improve the quality of care for their patients and build capacity for continuing improvement. IHI developed and employs a Breakthrough Series methodology (Learning Model Collaborative) to provide programmatic guidance and focus through coordinated training and support, communication, and sharing of lessons learned. They are world leaders in this area and have worked with other programs in similar settings to improve chronic illness systems of care for underserved and vulnerable populations, including the Health Resources and Services Administration/Bureau of Primary Health Care's health center program for eight years. The IHI's intellectual capital and operational capacity are essential to the IHS. The IHI has the resources and access to an international network of experts in the area of chronic disease management and implementing chronic care models in various settings. Most other improvement agencies and organizations focus on specific steps and methodologies while IHI takes a much more comprehensive and strategic approach to improvement. Over the past 15 years they have become the recognized world leader in system change in healthcare. They have moved beyond the specifics of software into process development using a variety of techniques to make the best use of technologies and existing organizational capabilities. Their methodologies include improvement advisors who act as peer to peer coaches for organizations implementing change. This personal approach and the IHI's considerable expertise are critical to expand existing Indian Country efforts, where personal connection and effective relationships are often the difference between project success and failure. This single source cooperative agreement will allow IHS to expedite learning from their organization as well as expedite access to IHI's vast network of strategic partners. III. Award Information *Type of Awards:* Cooperative Agreement. *Estimated Funds Available:* The award is for three years. For year one $600,000 is available and for years two and three—$800,000 is available for each year for a continuation award. Award under this announcement is subject to availability of funds. *Anticipated Number of Awards:* One single source award will be made under the Program. *Project Period:* February 16, 2007-February 15, 2010. *Award Amount:* $600,000 in year 1; $800,000 in years 2 and 3. For information regarding the notification, please contact: Candace M. Jones, MPH, National Programs (NPABQ), 5300 Homestead Road, NE., Albuquerque, NM 87110, 505-248-4961 or *candace.jones@ihs.gov* . *Electronic Submission:* The preferred method for receipt of applications is electronic submission through Grants.gov. Please refer to the following links for complete application instructions: applicant package may be found in Grants.gov ( *www.grants.gov* ) or *http://www.ihs.gov/NonMedicalPrograms/gogp/gogp_fund.asp* . Dated: January 18, 2007. Robert G. McSwain, Deputy Director, Indian Health Service. [FR Doc. 07-386 Filed 1-29-07; 8:45 am]
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