Department of Health and Human Services 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that CIBA Vision Corp. has filed three petitions proposing that the color additive regulations be amended to provide for the safe use of Color Index (C.I.) Pigment Violet 19, C.I. Pigment Yellow 154, and C.I. Pigment Red 122 as color additives in contact lenses.

The Food and Drug Administration (FDA) is requesting nominations for voting consumer representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) in the Center for Devices and Radiological Health (CDRH). FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

The Food and Drug Administration (FDA) is reopening until September 23, 2005, the comment period for the May 23, 2005, public meeting on the therapeutic equivalence of levothyroxine sodium drug products that was announced in the Federal Register of April 20, 2005 (70 FR 20574). The public meeting included FDA staff and representatives of three medical societies: The American Thyroid Association (ATA), the Endocrine Society, and the American Association of Clinical Endocrinologists (AACE). FDA is taking this action in response to a request for an extension.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Food and Drug Administration (FDA) is announcing a series of public meetings entitled ``Vision 2006A Conversation With the American Public,'' in three cities. This forum will be an open format in which consumers can interact directly with the agency's leadership to discuss what is on the public's mind. It will also be an opportunity for the agency to update the public on current agency programs, engage the public in discussion, and obtain consumer input on specific issues. We may use the public input we receive to evaluate and to propose modifications, if necessary, to our programs and activities.

The Food and Drug Administration (FDA) is amending its regulation regarding the intrastate and interstate distribution of turtles to reflect a change in responsibility for administering the provisions of the regulations from FDA's Center for Food Safety and Applied Nutrition (CFSAN) to FDA's Center for Veterinary Medicine (CVM). FDA is taking this action to enable the agency to more effectively administer the provisions of this regulation.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, regarding the opportunity for public comment on proposed data collection projects, the National institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Field Test of the Discovering the Science of Alcohol Curriculum. Type of Information Collection Request: New. Need and Use of Information Collection: The Discovering the Science of Alcohol curriculum (DSA) was developed with a Phase II SBIR grant to bring accurate, research-based information to high school students in biology and science classrooms. The curriculum includes standards-based content objectives and assessment activities. Curriculum materials include a teacher's guide and website. The field test is necessary to estimate the DSA curriculum's effectiveness in conveying information to students and teachers. Specifically, the field study is designed to enable NIAAA to determine whether teachers and students who complete the DSA curriculum demonstrate significantly greater knowledge of the topics covered in the curriculum than teachers and students who do not use the DSA curriculum. In addition, the study is designed to enable NIAAA to determine whether the students who are exposed to the curriculum components self-report different beliefs, attitudes, and intentions regarding alcohol use than their counterparts who are not exposed to the curriculum at their schools. Participating in this field test will be an experimental group of 30 high school biology classrooms with a total of approximately 400 to 500 students and a control group of 30 high school biology classrooms with approximately 400 to 500 students. Teachers and students from grades 9, 10, 11, and 12 will comprise both groups. The field test will include two surveys: (1) An online, computerized survey that measures teachers' knowledge of the DSA curriculum components and teacher satisfaction with the DSA curriculum components. (2) For students, an anonymous, online, computerized survey that measures three factors: (a) student knowledge of the DSA components, (b) student attitudes, beliefs, and intentions, and (c) student satisfaction with the DSA curriculum components. Frequency of response: Once per respondent. Affected Public: Individuals. Type of Respondents: Biology/Science teachers and high school students. The reporting burden is as follows: Estimated Number of Respondents: It is estimated that we will be able to recruit approximately 60 teachers and approximately 1000 students. Estimated Number of Responses per Respondent: One response per respondent. Average Burden Hours per Response: 15 minutes per individual in the control group and 30 minutes per individual in the experimental group, for a total respondent burden of 662.5 hours. Estimated Total Annual Burden Hours Requested: 662.5 hours. Estimated Costs to Respondents: Assuming an hourly rate of $22 for teachers, we estimate the total costs to be $825. There are no Capital Costs to report. There are no Operating or Maintenance costs to report. Request for Comments: Written comments and suggestions from the public and affected agencies are invited on the following points: (1) Whether the data collection is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions; (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 those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. For further information contact: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Jason Lazarow, M.Ed., NIH/NIAAA/ORTC/HSEB, 5635 Fishers Lane, Room 3101, MSC 9304, Bethesda, MD 20892-9304, or e-mail your request to: jlazarow@mail.nih.gov. Mr. Lazarow can be contacted by telephone at 301-435-8043. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This final rule will update the prospective payment rates for inpatient rehabilitation facilities for Federal fiscal year 2006 as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish the classification and weighting factors for the inpatient rehabilitation facilities case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. In addition, we are implementing new policies and are changing existing policies regarding the prospective payment system within the authority granted under section 1886(j) of the Act.

The Advisory Committee on Blood Safety and Availability will meet to review progress and solicit additional comments from the Committee regarding numerous recommendations made over the past year. Specifically, the Committee will hear updates of previous recommendations. In addition, the Committee will be asked to continue its deliberation on strategies for vigilant detection and management of emerging or re-emerging infectious diseases, since it is a necessary first step toward the goal of reducing the risk of transfusion- transmitted diseases as well as disease transmission through other vital products such as bone marrow, progenitor cells, tissues, and organs.

The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance for industry entitled ``Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence.'' FDA is withdrawing the draft guidance because the published methodology limits the submission of scientifically valid information to the agency that may be based on different methodologies. FDA does not want to dictate the scientific approach for developing adequate methods.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems. In addition, in the Addendum to this final rule, we describe the changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital- related costs. We also are setting forth rate-of-increase limits as well as policy changes for hospitals and hospital units excluded from the IPPS that are paid in full or in part on a reasonable cost basis subject to these limits. These changes are applicable to discharges occurring on or after October 1, 2005, with one exception: The changes relating to submittal of hospital wage data by a campus or campuses of a multicampus hospital system (that is, the changes to Sec. 412.230(d)(2) of the regulations) are effective on August 12, 2005. Among the policy changes that we are making are changes relating to: The classification of cases to the diagnosis-related groups (DRGs); the long-term care (LTC)-DRGs and relative weights; the wage data, including the occupational mix data, used to compute the wage index; rebasing and revision of the hospital market basket; applications for new technologies and medical services add-on payments; policies governing postacute care transfers, payments to hospitals for the direct and indirect costs of graduate medical education, submission of hospital quality data, payment adjustment for low-volume hospitals, changes in the requirements for provider-based facilities; and changes in the requirements for critical access hospitals (CAHs).

Provide a clear and concise summary of the proposed goals, major objectives and activities required for achievement of program goals, and amount of funding requested for budget year one of this cooperative agreement. Project Context and Background (Understanding and Need) Project StrategyDescription and Methodologies Project Goals Project Outputs Project Contribution to the Goals and Objectives of the Emergency Plan for AIDS Relief Work Plan and Description of Project Components and Activities Performance Measures Timeline (e.g., GANNT Chart) Management of Project Funds and Reporting. You may include additional information in the application appendices. The appendices will not count toward the narrative page limit. This additional information includes the following: Budget Justification (only for Year 01) Curricula Vitae Organizational Charts Letters of Support You must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access https://www.dunandbradstreet.com or call 1-866-705-5711. For more information, see the HHS/CDC web site at: https://www.cdc.gov/od/pgo/ funding/grantmain.htm. If your application form does not have a DUNS number field, please write your DUNS number at the top of the first page of your application, and/or include your DUNS number in your application cover letter. Additional requirements that could require you to submit additional documentation with your application are listed in section ``VI.2. Administrative and National Policy Requirements.''

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2006. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), authorizes FDA to collect user fees for certain medical device applications. The FY 2006 fee rates are provided in this notice. For all applications submitted on or after October 1, 2005, and through September 30, 2006, fees must be paid at the FY 2006 rates at the time the applications are submitted to FDA. The fee you must pay is the fee that is in effect on the date your application is received by FDA or on the date your check is received, whichever is later. This notice provides details on how fees for FY 2006 were determined and payment procedures for medical device applications subject to user fees.

Notice is hereby given that a noncompetitive grant award is being made to Urban Family Council, Pennsylvania, to provide Abstinence-Only Education and related services for adolescents in public school, age 12-19 and their parents and guardians, in Philadelphia, Center, Cumberland, and Lycoming Counties of Pennsylvania. The amount of the grant is $229,152. This noncompetitive award was recommended by the Congress.

Notice is hereby given that the Office of Research Integrity (ORI), the Acting Assistant Secretary for Health, and the Director, Office of Acquisition Management and Policy, have taken final agency action in the following case: Randall Luce, University at Buffalo, State University of New York: Based on the report of an investigation conducted by the University of Buffalo (UB), State University of New York (SUNY) (UB Report), and a conviction of the criminal offense of grand larceny, as defined in section 110-155.30 of the New York Penal Law, in the Buffalo City Court of Erie County, State of New York (Case 2004ER009612M), the Department of Health and Human Services (HHS) debarred Mr. Randall Luce, former research technician in the UB Research Institute for Addictions (RIA), for a period of three (3) years, beginning on July 26, 2005, and ending on July 25, 2008. Mr. Luce pled guilty to grand larceny and admitted to the misappropriation of funds and the fabrication of research subject interviews in the conduct of an RIA study supported by the United States Public Health Service (PHS), National Institutes of Health (NIH), National Institute on Alcoholism and Alcohol Abuse (NIAAA), grant RO1 AA12452, ``A harm reduction approach for reducing DWI recidivism.'' This action is taken pursuant to the HHS nonprocurement debarment and suspension regulation at 45 CFR part 76.

Notice is hereby given that it has been proposed that a noncompetitive single-source program expansion supplement to an ongoing competitive award be made to the Hebrew Immigrant Aid Society (HIAS) in response to an unsolicited application. This application proposes to provide additional training and technical assistance to organizations implementing Refugee Marriage Enrichment projects. The application is not within the scope of any existing or expected to be issued program announcement for the Fiscal Year 2006. HIAS's application is expected to address issues critical to the development and implementation of marriage education programs for refugees by providing valuable on-site training and technical assistance to grantees and sub-grantees that offer marital communication training to refugee couples. In September of 2003, ORR awarded HIAS a grant of $200,000 to develop a Refugee Family Enrichment program which included technical assistance to subgrantees. Because of their success in the development of their marriage enrichment program, in 2004 HIAS was awarded a noncompetitive single source program expansion supplement to an ongoing competitive award to expand its Technical Assistance Services Program to Refugee Family Enrichment project sites specified by ORR. HIAS has since provided over 600 hours of technical assistance to project sites operated by organizations across the country. Their technical assistance primarily supports the work of small Mutual Assistance Associations, and without it, these agencies might struggle to provide refugee clients with the programs they need in order to achieve self sufficiency. The proposed project period is 9/30/2005-9/29/2006. Technical assistance to support grantees in developing better approaches to the delivery of services provided to refugees is authorized by section 412(c)(1)(A) of the Immigration and Nationality Act (8 U.S.C. 1522(c)(1)).

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q9 Quality Risk Management.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides principles and examples of tools for quality risk management that can be applied to all aspects of pharmaceutical quality throughout the lifecycle of drug substances, drug products, and biological and biotechnological products. The draft guidance is intended to enable regulators and industry to make more effective and consistent risk- based decisions.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Electronic Records; Electronic Signatures'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting and hearing of the Citizens' Health Care Working Group mandated by section 1014 of the Medicare Modernization Act. In addition, the Working Group will sponsor a community forum in which members of the working group will participate.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application 60/508,750, filed October 3, 2003 [DHHS Ref. E-075- 2003/0-US-01] and PCT Application PCT/US04/32649 [DHHS Ref. E-075-2003/ 0-PCT-02], entitled Use of Cripto-1 as a Biomarker for Neurodegenerative Disease and Method of Inhibiting Progression Thereof, to Neuronascent, Inc., which is located in Clarksville, Maryland. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to the development and use of Cripto small molecule inhibitors to treat and prevent Alzheimer's disease in humans.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled ``Federal Reimbursement of Emergency Health Services Furnished to Undocumented Aliens (Section 1011),'' System No. 09-07-0546. The system will contain enrollment and payment request information, in support of a short-term program which pays hospitals, certain physicians, and ambulance providers (including Indian Health Service (IHS) facilities whether operated by the IHS or by an Indian Tribe or tribal organization) for their otherwise un-reimbursed costs of services provided under the provisions of section 1867 (Emergency Medical Treatment and Labor Act) (EMTALA) of the Social Security Act (the Act) and related hospital inpatient and outpatient services and ambulance services furnished to undocumented aliens, aliens paroled into the United States (U.S.) at a U. S. port of entry for the purposes of receiving such services, and Mexican citizens permitted temporary entry to the U.S. for not more than 30 days under the authority of a biometric machine readable border crossing identification card (also referred to as a ``laser visa'') issued in accordance with the requirements of regulations prescribed under the Immigration and Nationality Act. This system is being established under provisions of Section 1011 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 Modernization Act of 2003 (MMA). The primary purpose of the system is to maintain information collected on individuals who submit an enrollment application and make payment requests associated with Section 1011 of the MMA, and other information designed to support the enrollment, claims payment, and research reporting functions of the Section 1011 program. Information retrieved from this system will also be disclosed to: (1) Support regulatory, payment activities, and policy functions performed within the agency or by a designated contractor or consultant; (2) combat fraud and abuse in certain health benefits programs; (3) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal; (4) funds support constituent requests made to a Congressional representative; and, (5) support litigation involving the agency. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that the ``routine use'' portion of the system be published for comment, CMS invites comments on all portions of this notice. See DATES section for comment period.

This proposed rule sets forth the general requirements and procedures that would allow certain entities who are identified for exclusion from the Medicare program to request that CMS act on their behalf to recommend to the Inspector General that their exclusion from Medicare be waived because of a hardship that would result on Medicare beneficiaries. This proposed rule would implement section 949 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).

In this final rule we update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs), for fiscal year (FY) 2006. Annual updates to the PPS rates are required by section 1888(e) of the Social Security Act (the Act), as amended by the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), relating to Medicare payments and consolidated billing for SNFs. This final rule also responds to public comments submitted on the proposed rule published on May 19, 2005 (70 FR 29070), and promulgates provisions set forth in that proposed rule, along with several additional technical revisions to the regulations.

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 information collection provisions for the Importer's Entry Notice.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in: 1. E-013-1998/0-US-01, ``Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number 60/076,330 (filed February 27, 1998); 2. E-013-1998/0-PCT-02, ``Disubstituted Lavendustin A Analogs and Pharmaceutical Compositions Comprising the Analogs'', by Venkatachala Narayanan, Edward Sausville, Kaur Gurmeet, Varma Ravi, application number PCT/US99/04002 (filed February 24, 1999);

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent Application No. 60/498,238, filed August 26, 2003, entitled ``Anti- cancer Vaccines'' (E-179-2004/0-US-01); U.S. Patent Application No. 10/ 926,852, filed August 26, 2004, entitled ``Anti-cancer Vaccines'' (E- 179-2004/0-US-03); and PCT Application No. PCT/US04/27790, filed August 26, 2004, entitled ``Anti-cancer Vaccines'' (E-179-2004/0-PCT-02), to Vaccine Company, having a place of business in Carmel-by-the-Sea, California. The patent rights in these inventions have been assigned to the United States of America and MD Anderson Cancer Center (Part of the University of Texas System). The prospective exclusive license territory may be worldwide, and the field of use may be limited to development and sale of diagnostic and pharmaceutical products useful in diagnosis and treatment of myeloid neoplasms.

The Food and Drug Administration (FDA) is planning a 2-day workshop to explore approaches and potential obstacles to developing drugs, disease biomarkers, medical devices, and vaccines to prevent or reduce the risk of illness. The agency plans to hold the workshop as part of its Critical Path Initiative. Speakers at the workshop will be asked to discuss the challenges in developing chemoprevention therapies (i.e., prevention therapies other than lifestyle changes, dietary supplements, or dietary choices that could reduce the risk of certain illnesses such as cancer, diabetes, and obesity). Because prevention of illness is widely recognized to be an important goal and the possible scope of this workshop is very broad, FDA welcomes comments related to the scope of this workshop.

The Department of Health and Human Services, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested date can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Indian Health Service (IHS) is providing a 60-day advance opportunity for public comment on a proposed extension of current information collection activity to be submitted to the Office of Management and Budget for review. Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan Repayment Program.'' Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917- 0014, ``Indian Health Service Loan Repayment Program.'' Form Number: None. Forms: The IHS Loan Repayment Program Information Booklet contains the instructions and the application formats. Need and Use of Information Collection: The IHS Loan Repayment Program (LRP) identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract under which the IHS agrees to repay part or all of their indebtedness for professional training education. In exchange, the health professionals agree to serve for a specified period of time in IHS health care facilities. Eligible health professionals that wish to apply must submit an application to participate in the program. The application requests personal, demographic and educational training information, including information on the educational loans of the individual for which repayment is being requested (i.e., date, amount, account number, purpose of each loan, interest rate, the current balance, etc.). The data collected is needed and used to evaluate applicant eligibility; rank and prioritize applicants by speciality; assign applicants to IHS health care facilities; determine payment amounts and schedules for paying the lending institutions; and to provide data and statistics for program management review and analysis. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides the estimated burden hours for this information collection:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of Behavioral and Social Sciences Research (OBSSR), the National Institutes of Health (NIH) has submitted to the Office of management and Budget (OMB) a request for review and approval of the information collection listed below. This Proposed information collection was previously published in the Federal Register on January 11, 2005, page 1898 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Training Tomorrow's Scientists: Linking Minorities and Mentors Through the Web. Type of Information Collection Request: Revision, OMB control number 0925-0475, Expiration Date 3/31/ 2005. Need and Use of Information Collection: This Web site allows federally-funded researchers supported by any of the 27 Institutes and Centers of the NIH to submit an electronic form describing his or her research areas, as well as interests in mentoring minority students or junior faculty. The researcher's description is posted on the Web site for searching by interested minority applicants. Minority students or junior faculty search the Web site to identify researchers with whom they would like to work. The research projects in the database are located all over the country and involve cutting edge research activities by scientists funded through the Institutes and Centers of the NIH. These research projects range from studies of children to research on older adults, from laboratory research to field research, from social research to a combination of biological and behavioral research. Applicants conduct an electronic search using categories such as research areas of interest, desired geographic location of the researcher, and their level of education. The primary objective of the program is to ensure that, in the coming decades, a concentration of minority researchers will be available to address behavioral and social factors important in improving the public health and eliminating racial disparities. Increasing the number of minority scientists in the U.S. will expand our currently limited knowledge about the epidemiology and treatment of diseases in minority population. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Students, Post-doctorals, Junior Faculty, and Principal Investigators. The annual reporting burden is as follows: Estimated Number of Respondents: 400; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 10 minutes; and Estimated Total Annual Burden Hours Requested: 148. There is no annualized cost to respondents. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing the portions reflecting approval of a new animal drug application (NADA) for which FDA has withdrawn approval. NADA 140-828, sponsored by Bayer Corp., provides for use of enrofloxacin to treat poultry. In a notice published elsewhere in this issue of the Federal Register, FDA is announcing the availability of the final decision withdrawing approval of this NADA.

This notice is to inform interested parties of a correction made to the Head Start Family Literacy Project program announcement that was published on July 25, 2005. The following correction should be noted: Under Section IV. Application and Submission Information, 1. Address to Request Application Package, please delete the following phone number for The Dixon Group: 1-800-351-2293. Please replace the deleted phone number with the following: 1-866- 796-1591. All other information in this notice of correction is accurate and replaces information specified in the July 25 notice. Applications are still due by the deadline date that was published in the July 25 notice (due date for applications is September 8, 2005).

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2006. The Federal Food, Drug, and Cosmetic Act (the FD& C Act), as amended by the Prescription Drug User Fee Amendments of 2002 (Title 5 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PHSBPRA or PDUFA III)), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts for application fees, establishment fees, and product fees for FY 2006 were established by PDUFA III. Fees for applications, establishments, and products are to be established each year by FDA so that revenues from each category will approximate the revenue levels established in the statute, after those amounts have been first adjusted for inflation and workload. This notice establishes fee rates for FY 2006 for application fees for an application requiring clinical data ($767,400), for an application not requiring clinical data or a supplement requiring clinical data ($383,700), for establishment fees ($264,000), and for product fees ($42,130). These fees are effective on October 1, 2005, and will remain in effect through September 30, 2006. For applications and supplements that are submitted on or after October 1, 2005, the new fee schedule must be used. Invoices for establishment and product fees for FY 2006 will be issued in August 2005, using the new fee schedule.

The Food and Drug Administration (FDA) is announcing a delay in the publication of the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2006.

The Administration on Aging (AoA) 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 the information collection requirements contained in the annual consumer assessment survey which is used by AoA to measure program performance for programs funded under Title III of the Older Americans Act.

The Food and Drug Administration (FDA) has determined the regulatory review period for ZUBRIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.

The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ADDERALL XR (mixed salts of a single-entity amphetamine product), AVANDIA (rosiglitazone), AVAPRO (irbesartan), RAPAMUNE (sirolimus), and ZOFRAN (ondansetron). These summaries are being made available consistent with section 9 of the Best Pharmaceuticals for Children Act (BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.