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

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 U.S. Provisional Patent Application Serial No. 60/024,213, entitled ``Spatially And Temporal Control Of Gene Expression Using A Heat Shock Protein Promoter In Combination With Local Heat'' filed August 15, 1996 (E-235-1995/0-US-01), and all related foreign patents/patent applications, to New England OncoTherapeutics, Inc., having a place of business in Cambridge, Massachusetts. 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 gene-based therapeutics which incorporate focused ultrasound heating technologies to treat cancer.

The Food and Drug Administration (FDA) is requesting nominations for nonvoting industry representatives to serve on certain device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the State of South Carolina, Department of Health and Environmental Control, Bureau of Radiological Health. The purpose is to authorize the State of South Carolina, through the South Carolina Department of Health and Environmental Control (DHEC), to conduct a State as certifiers program in South Carolina under the Mammography Quality Standards Act (MQSA) as amended by the Mammography Quality Standards Reauthorization Act of 1998 (MQSRA).

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration and the University of Houston (UH). The purpose of the MOU is to implement an integrated system of shared interest in scientific progress through an exchange of scientific capital, in the diverse fields of science that directly, and indirectly affect human and animal health and medicine.

This notice is to inform interested parties of a clarification made to Services to Unaccompanied Alien Children funding announcement published on Monday, June 17, 2005. The following clarifications should be noted: Section I, Group I, Chart I on Page 32345:

The Office on Women's Health (OWH) is the focal point for women's and girls' health within the OPHS, DHHS. Under the direction of the Deputy Assistant Secretary for Women's Health, OWH works to improve the health of women across the life cycles and increase awareness and understanding of women's health issues. In addition to its central office, OWH has regional offices located throughout the U.S. staffed by a Regional Women's Health Coordinator (RWHC). Chartered by the U.S. Congress in 1950, Girl Scouts of the USA (GSUSA) is a national nonprofit organization dedicated to helping all girls build character and gain skills for success in the real world in an accepting and nurturing environment. GSUSA operates from its national headquarters in New York City along with its 300 local Girl Scout councils or offices, 236,000 troops/groups, and 986,000 adult volunteers. OWH in collaboration with GSUSA is planning to provide grant support for a Steps to Healthier Girls Program. The purpose is to improve the health of diverse girls ages 11 years to 17 years through educational and experiential activities related to physical activity/ fitness, good nutrition and healthy lifestyles consistent with the Steps to a HealthierUS initiative of the DHHS and the Memorandum of Understanding between DHHS and GSUSA. This project is based on the premise that motivating girls and adolescents to learn about and participate in activities that address these three subject areas can have a significant effect on increasing the quality and years of healthy life and on eliminating health disparities. The Steps to Healthier Girls Program will be a collaborative effort among the Regional Women's Health Coordinators (RWHC), GSUSA, and the selected Girl Scout Councils in each of the eight (8) Regions of the DHHS, OPHS, OWH. The Women's Health Coordinators from two Regions (II and III) will provide overall oversight for the grant, and Region III will be the primary contact, while the RWHC's will provide the technical assistance and local oversight of the project at the regional level. The Federal Government will: a. Conduct an orientation meeting for the grantee within the first month of funding. b. Review and resolve requested project modifications. c. Review the design of the Steps to Healthier Girls programs. d. Make site visits to Steps to Healthier Girls program sites. e. Review and resolve all initial, 3 month after award and final progress reports. f. Participate in meetings with grantee and councils.

This interim final rule with comment period implements provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 that require the implementation of a competitive acquisition program for certain Medicare Part B drugs not paid on a cost or prospective payment system basis. Beginning January 1, 2006, physicians will generally be given a choice between obtaining these drugs from vendors selected through a competitive bidding process or directly purchasing these drugs and being paid under the average sales price system.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Objectives: To provide funds to States to create or expand statewide systems change for Family Support. To allow for the award of competitive grants to conduct training, technical assistance, and other activities designed to address the problems that impede the self-sufficiency of individuals with developmental disabilities and families of children with developmental disabilities. This program announcement will provide funds for the development phase of the Family Support Initiative. This is the last program announcement related to statewide systems change begun in 1999. This is not a funding opportunity related to Family Support 360. Eligible States and territorial entities under this announcement are: Alabama, Iowa, California and Puerto Rico. States and territories not listed above are not eligible to apply. I. Funding Opportunity Description

The purpose of these grants is to support a fourth implementation phase of the Consortium for Longitudinal Studies of Child Abuse and Neglect, which is conducting and coordinating prospective studies of young children who are at risk or who have already experienced maltreatment. These studies are expected to contribute to the knowledge of the etiology and consequences of child maltreatment, and provide new insights into the prevention, identification and treatment of maltreatment.

In accordance with section 431 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Public Law 108- 173, this proposed rule would establish regulatory standards for the new safe harbor under the Federal anti-kickback statute for certain goods, items, services, donations, and loans provided by individuals and entities to certain health centers funded under section 330 of the Public Health Service Act. Under this proposed safe harbor, the goods, items, services, donations, or loans must contribute to the health center's ability to maintain or increase the availability, or enhance the quality, of services available to a medically underserved population.

HIV/AIDS surveillance data have been used for describing the epidemic, planning prevention and treatment activities, developing treatment guidelines, advocating for resources, and allocating and prioritizing available resources within communities. The Health Resources Services Administration (HRSA) uses HIV/AIDS surveillance data from states to estimate severity of need to allocate nearly two billion in funding for HIV-related ambulatory care and support services available annually through the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act. A committee from the Institute of Medicine (IOM) recently reviewed, at the request of Congress, the status of HIV/AIDS surveillance. In the resulting report, three populations of interest were outlined; Persons infected with HIV, who do not have a diagnosis of HIV and are not receiving care. Persons infected with HIV, who have a diagnosis of HIV but are not receiving care. Persons infected with HIV, who have a diagnosis of HIV and are receiving care. Understanding how many and which persons in a community have a diagnosis of HIV but are not receiving care is critically important for estimating the community's resource needs. Of the estimated 850,000- 950,000 HIV-infected persons in the United States, an estimated 75 percent know they are infected. Of these, an estimated 50 percent do not have evidence of having received any medical care for their HIV infection. One of the goals of CDC's Advancing HIV Prevention initiative is to provide HIV testing outside of traditional medical settings, and to increase linkage to HIV care for those whose HIV test results are positive. Because of treatment advances, more people with HIV infection are living longer and healthier lives. Persons who know they are infected can benefit from prophylaxis for opportunistic infections, monitoring of their immune status, and, when recommended, treatment with antiretroviral drugs. Additionally, new HIV therapies may reduce the degree of infectiousness by lowering viral load and thereby reducing HIV transmission. Therefore, to determine the extent of medical services and resources that will be needed for persons who are infected with HIV, but who have not received medical care, it is critically important to quantify and describe the number in this population. In addition, determining factors related to not receiving care will be important in designing effective interventions for linking persons to care. A supplemental surveillance system designed to produce population- based estimates of persons who have a diagnosis of HIV and are receiving care has been developed. Federal awards were made to 26 health departments to collect clinical and behavioral data among persons who have a diagnosis of HIV and are receiving care. Supplemental surveillance systems that collect data about those persons infected with HIV who are and are not receiving care will provide critically needed information on the quality of care and severity of need for care; barriers to receiving care; prevention; and support services at the local level. This information will assist local planning groups (i.e., community planning groups and local planning councils) in determining local allocation of CDC and Ryan White CARE Act funds. Additionally, this type of supplemental surveillance data will provide a means of evaluating new prevention initiatives (e.g., Advancing HIV Prevention) that focus on the provision of prevention services and linkage to care for persons living with HIV (PLWHA) infection. I. Funding Opportunity Description

This amendment corrects technical errors in the interim final rule with comment period that appeared in the Federal Register, entitled ``Medicare Program: Changes to the Medicare Claims Appeal Procedures.''

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance entitled ``Guidance for Industry: Discontinuation of Donor Deferral Related to Recent Fever with Headache as a Symptom of West Nile Virus Infection'' (May 2005 guidance) that was issued on May 6, 2005. A guidance entitled `` Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,'' dated June 2005, is being announced elsewhere in this issue of the Federal Register, and supersedes the May 2003 guidance entitled ``Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection'' (May 2003 guidance) (68 FR 25897).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Performance Standard for Diagnostic X-Ray Systems and Their Major Components'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined that ZYVOX (linezolid) tablets, 400 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for linezolid tablets, 400 mg.

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

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Iowa Army Ammunition Plant (IAAP), in Burlington, Iowa as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 20, 2005, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

This notice announces those sites for which ATSDR has completed public health assessments during the period from January through March 2005. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments were prepared in response to requests from the public.

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement bars, other- type bars, and soy-protein based meal replacement beverages represented for special dietary use in reducing or maintaining body weight. This action is in response to a petition filed by Unilever United States, Inc. (Unilever).

The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance that was issued on August 3, 2001.

Under the provisions of Section 3507(a)(1)(D) of the of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 7, 2004, pages 7069770698, 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 NIH may not conduct or sponsor, and the respondent is not required to respond to, an information 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: National Institutes of Health Construction Grants42 CFR Part 52b (Final Rule). Type of Information Collection Request: Extension of No. 0925-0424, expiration date 3/31/ 2005. Need and Use of the Information Collection: This request is for OMB review and approval of an extension for the information collection and recordkeeping requirements contained in the regulation codified at 42 CFR part 52b. The purpose of the regulation is to govern the awarding and administration of grants awarded by NIH and its components for construction of new buildings and the alteration, renovation, remodeling, improvement, expansion, and repair of existing buildings, including the provision of equipment necessary to make the buildings (or applicable part of the buildings) suitable for the purpose for which it was constructed. In terms of reporting requirements: Section 52b.9(b) of the regulation requires the transferor of a facility which is sold or transferred, or owner of a facility, the use of which has changed, to provide written notice of the sale, transfer or change within 30 days. Section 52b.10(f) requires a grantee to submit an approved copy of the construction schedule prior to the start of construction. Section 52b.10(g) requires a grantee to provide daily construction logs and monthly status reports upon request at the job site. Section 52b.11(b) requires applicants for a project involving the acquisition of existing facilities to provide the estimated cost of the project, cost of the acquisition of existing facilities, and cost of remodeling, renovating, or altering facilities to serve the purposes for which they are acquired. In terms of recordkeeping requirements: Section 52b.10(g) requires grantees to maintain daily construction logs and monthly status reports at the job site. Frequency of Response: On occasion. Affected Public: Non-profit organizations and Federal agencies. Type of respondents: Grantees. The estimated respondent burden is as follows:

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2005 through March 2005, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Finally, for the first time, this notice includes a list of Medicare-approved carotid stent facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

This notice announces the third public meeting of the Advisory Board on the Demonstration of a Bundled Case-Mix Adjusted Payment System for End-Stage Renal Disease (ESRD) Services. Notice of this meeting is required by the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Advisory Board will provide advice and recommendations with respect to the establishment and operation of the demonstration mandated by section 623(e) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

Title XXI of the Social Security Act (the Act) authorizes payment of Federal matching funds to States, the District of Columbia, and U.S. Territories and Commonwealths to initiate and expand health insurance coverage to uninsured, low-income children under the State Children's Health Insurance Program (SCHIP). This notice sets forth the final allotments of Federal funding available to each State, the District of Columbia, and each U.S. Territory and Commonwealth for fiscal year 2006.

The National Centers of Excellence in Women's Health and the National Community Centers of Excellence in Women's Health programs provide funding to academic health centers and community-based organizations to enhance their women's health program through the integration of these components: (1) Leadership development for women, (2) training for lay, allied health, and professional health care providers, (3) public education and outreach with special emphasis on outreach to minority women, (4) comprehensive health service delivery that includes gender and age-appropriate preventive services and allied health professionals as members of the comprehensive care team, and (5) basic science, clinical and community-based research. In addition, the community centers must replicate their National Community Center of Excellence in Women's Health (CCOE) model in another community.

The invention named in this notice is owned by agencies of the United States Government and is available for licensing in the United States (U.S.) in accordance with 35 U.S.C. 207, and is available for cooperative research and development agreements (CRADAs) in accordance with 15 U.S.C. 3710, to achieve expeditious commercialization of results of federally funded research and development. A U.S. provisional patent application has been filed and foreign patent applications are expected to be filed within the year to extend market coverage for U.S. companies and may also be available for licensing.

Notice is hereby given that noncompetitive grant awards are being made to multiple organizations to conduct demonstration and implement service provision projects on a wide range of issues relating to social services. The number of grants is 114 for a total amount of $20,083,653. These noncompetitive awards were recommended by the Congress and were listed in the FY 2005 Senate-House conference agreement.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Fort Dodge Animal Health. The NADA provides for use of an injectable moxidectin solution for the treatment and control of various internal and external parasites of cattle.

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``General Principles for Evaluating the Safety of Compounds Used in Food- Producing Animals (GFI 3).'' This version of the guidance replaces the version that was made available in July 1994. This has been revised to remove outdated information on toxicological testing and to provide references to other available guidance on the topic. In addition, the document has been revised to address minor formatting issues.

This announcement is made by the United States Department of Health and Human Services (HHS or Department), Office of Minority Health (OMH) located within the Office of Public Health and Science (OPHS), and working in a ``One-Department'' approach collaboratively with participating HHS agencies and programs (entities). The mission of the OMH is to improve the health of racial and ethnic minority populations through the development of policies and programs that address disparities and gaps. OMH serves as the focal point in the HHS for leadership, policy development and coordination, service demonstrations, information exchange, coalition and partnership building, and related efforts to address the health needs of racial and ethnic minorities. As part of a continuing HHS effort to improve the health and well being of racial and ethnic minorities, the Department announces availability of FY 2005 funding for the State Partnership Grant Program To Improve Minority Health.

The Food and Drug Administration (FDA or agency) is announcing the availability of a revised guidance document entitled ``Guidance for Industry and FDA: Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile.'' The guidance explains that FDA has established a list that is provided to the government of Chile and posted on FDA's Internet site, which identifies U.S. dairy product manufacturers that have expressed interest to FDA in exporting dairy products to Chile, are subject to FDA jurisdiction, and are not the subject of a pending judicial enforcement action (e.g., injunction or seizure) or a pending warning letter. Application for inclusion on the list is voluntary. However, Chile has advised that dairy products from firms not on this list could be delayed or prevented by Chilean authorities from entering commerce in Chile. The revised guidance document describes the recommended process for U.S. manufacturers to follow to be included on the list and explains FDA's request, on Chile's behalf, that this information be updated every 2 years.

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 the information collection requirements contained in FDA's current good manufacturing practice (CGMP) and related regulations for blood and blood components; and requirements for donor testing, donor notification, and ``lookback''.

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.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on January 24, 2005, page 3376 and allowed 60-days for public comment. Three requests for more information were received. Additional information on the proposed collection was sent to each requestor. The purpose of this notice is to allow an additional 30 days for public comment. 5 CFR 1320.5 (General requirements) Reporting and Recordkeeping Requirements: Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. This information is required to be stated in the 30-day Federal Register Notice. Proposed Collection: Title: Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. Type of Information Collection Request: Revision, OMB control number 0925-0407, expiration date July 31, 2005. Need and Use of Information Collection: This trial is designed to determine if screening for prostate, lung, colorectal and ovarian cancer can reduce mortality from these cancers which currently cause an estimated 263,000 deaths annually in the U.S. The design is a two-armed randomized trial of men and women aged 55 to 74 at entry. The total sample size t is 154,938. The primary endpoint of the trial is cancer- specific mortality for each of the four cancer sites (prostate, lung, colorectum, and ovary). In addition, cancer incidence, stage shift, and case survival are to be monitored to help understand and explain results. Biologic prognostic characteristics of the cancers will be measured and correlated with mortality to determine the mortality predictive value of these intermediate endpoints. Basic demographic data, risk factor data for the four cancer sites and screening history data, as collected from all subjects at baseline, will be used to assure comparability between the screening and control groups and make appropriate adjustments in analysis. Further, demographic and risk factor information may be used to analyze the differential effectiveness of screening in high versus low risk individuals. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Adult men and women. The annual reporting burden is as follows: Estimated Number of Respondents: 145,852; Estimated Number of Responses Per Respondent: 1.14; Average Burden Hours Per Response: 0.14; and Estimated Total Annual Burden Hours Requested: 23,278. The annualized cost to respondents is estimated at: $232,780. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) has determined that PYRIDOSTIGMINE BROMIDE tablets, 30 milligrams (mg), for the treatment of myasthenia gravis, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for PYRIDOSTIGMINE BROMIDE tablets, 30 mg, for the treatment of myasthenia gravis.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals.'' The purpose of this draft guidance is to provide recommendations to industry for designing nonclinical toxicity studies to determine potential late radiation toxicities (radiation- induced injuries occurring after a latency period of several months to years) of therapeutic radiopharmaceuticals administered systemically. The purpose of such studies is to help minimize the risk of late- occurring irreversible radiation toxicities in clinical studies of therapeutic radiopharmaceuticals.

Funds are provided for Area Poverty Research Center cooperative agreements for qualified institutions to provide a focused agenda expanding our understanding of the causes, consequences and effects of poverty in local geographic areas or specific substantive areas, especially in states or regional areas of high concentrations of poverty. These cooperative agreements are intended to create a research opportunity for scholars and institutions otherwise unlikely to participate extensively in HHS programs to support the Nation's poverty research effort. I. Funding Opportunity Description

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Rhodia Limited to Rhodia UK Limited.

This proposed rule would establish the Medicare Integrity Program (MIP) and implement program integrity activities that are funded from the Federal Hospital Insurance Trust Fund. This proposed rule would set forth the definition of eligible entities; services to be procured; competitive requirements based on Federal acquisition regulations and exceptions (guidelines for automatic renewal); procedures for identification, evaluation, and resolution of conflicts of interest; and limitations on contractor liability. This proposed rule would bring certain sections of the Medicare regulations concerning fiscal intermediaries and carriers into conformity with the Social Security Act (the Act). The rule would distinguish between those functions that the statute requires to be included in agreements with fiscal intermediaries and those that may be included in the agreements. It would also provide that some or all of the functions may be included in carrier contracts. Currently all these functions are mandatory for carrier contracts.