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

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The Food and Drug Administration (FDA) has determined that ZYVOX (linezolid) tablets, 400 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness.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.

The Children's Bureau announces the availability of funds and requests applications to develop, implement, evaluate and disseminate a training curriculum for public child welfare agency supervisors. This curriculum will strengthen supervision of staff interventions with older youth who are in foster care and/or in independent living programs. These youth, mostly ages 16 to 21, need assistance in making a successful transition to adulthood, as well as achieving self-sufficiency to avoid long-term dependency on the social welfare system. These youth often face decisions with regard to personal housing, transportation, employment and education. They need workers who can guide them and who understand these challenges. The target youth also need workers who have a working knowledge of adolescent transition programs. ``In the continuing work of the Muskie School of Public Service, University of Southern Maine and National Resource Center for Youth Services, College of Continuing Education University of Oklahoma, four core principles have emerged as essential in order for adolescent transitional living programs to be successful.'' It is the thinking of current experts in the field that programs for youth are more likely to be successful when these four principles are incorporated into the program design regardless of the type of services provided. The principles are: (1) Positive youth development; (2) Collaboration; (3) Cultural competence; and (4) Permanent connections.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Application for FDA Approval to Market a New Drug'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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.

This notice is to inform interested parties of clarifications made to the Discretionary Funds for Projects to Establish Individual Development Account (IDA) Programs for Refugees published on Monday, June 6, 2005. The following clarifications should be noted: Section IV.3 stated the following: ``3. Submission Dates and Times Due Date for Applications: August 5, 2005.'' The language in section IV.3 is replaced with: ``3. Submission Dates and Times Due Date for Applications: July 21, 2005.'' Executive Summary: A footnote was omitted in relation to the word ``refugee''. The omitted footnote in the Executive Summary should state: Refugee [1] [1] Eligibility for refugee social services includes: (1) Refugees; (2) asylees; (3) Cuban and Haitian entrants under section 501 of the Refugee Education Assistance Act of 1980 (Pub. L. 96-422); (4) certain Amerasians from Vietnam who are admitted to the U.S. as immigrants under section 584 of the Foreign Operations, Export Financing, and Related Programs Appropriations Act, as included in the FY 1988 Continuing Resolution (Pub. L. 100-202); (5) certain Amerasians from Vietnam who are U.S. citizens under Title II of the Foreign Operations, Export Financing, and Related Programs Appropriations Act of 1989 (Pub. L. 100-461), 1990 (Pub. L. 101-167), and 1991 (Pub. L. 101-513); and (6) victims of a severe form of trafficking who receive certification or eligibility letters from ORR (see 45 CFR 400.43 and ORR State Letters Number 01-13 as modified by Number 02-01 and Number 04-12 on trafficking victims). For convenience, the term ``refugee'' is used in this notice to encompass all such eligible persons. Additional information on eligibility is available at: https://www.acf.hhs.gov/ programs /orr/policy/sl01-13.htm and https://www.acf.hhs.gov/programs / orr/policy/sl02-01.htm.

The Food and Drug Administration (FDA) is confirming the effective date of July 13, 2005, for the direct final rule that appeared in the Federal Register of February 28, 2005 (70 FR 9516). The direct final rule revised the medical device reporting regulations into plain language in order to make the regulations easier to understand. This document confirms the effective date of the direct final rule.

The Administration for Children and Families, Administration on Children, Youth and Families, Child Care Bureau (CCB) announces the availability of funds and request for applications for its FY 2005 Early Learning Opportunities Act (ELOA) grants. Funds will be awarded to eligible Local Councils that have been designated as the Local Council for the purposes of applying for an ELOA grant, as evidenced in a letter of designation, signed by an entity of local government, an Indian Tribe, Regional Corporation, or Native Hawaiian entity.

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 following two programs: Technical Assistance and Capacity Development Demonstration Grant Program for HIV/AIDS-Related Services in Minority Communities; and National Umbrella Cooperative Agreement Program. The purpose of this single announcement is to make it easier for organizations such as community-based organizations, minority-serving organizations, faith-based organizations, and tribal governments and organizations, that meet the eligibility criteria for each program, to identify and apply for FY 2005 OMH funding. As eligibility criteria vary for each program under this announcement, a single notice of funding availability may assist potential applicants to better identify the programs for which they can compete and to target proposals to the program(s) most suitable to the issues faced by their population(s). This announcement should also assist eligible applicants to understand the range of issues that may be supported by the programs and encourage collaborations among organizations that provide services to racial and ethnic minorities. Interested applicants should note the Notice is organized in the manner below. Each section contains the information for both programs, thus applicants should read each section for the applicable information. Sections I (Funding Opportunities), II (Award Information), and III (Eligibility Information) contain program specific information for both of the programs included in this notice of funding availability; Sections IV (Application and Submission Information) and V (Application Review Information) contain information that is both program specific and common to both programs: Sections VI (Award Administration Information), VII (Agency Contacts) and VIII (Other Information) contain common information that applies to both programs.

The purposes of this funding announcement are as follows: (1) To develop and implement programs of comprehensive community-based support services for the target population as described in Public Law 100-505, as amended; (2) to evaluate the implementation and outcomes of these comprehensive support services; and (3) to develop these programs as identifiable sites that other States/locales seeking to implement comprehensive support services for this population can look to for guidance, insight, and possible replication.

On February 9, 2005, the Office of Community Services, Administration for Children and Families, U.S. Department of Health and Human Services published an announcement seeking applications for the Assets for Independence Program. The announcement appeared in Volume 70, pages 6879-6888 of the Federal Register. This document announces one additional application due date of July 15, 2005, which is in addition to the three due dates listed in the February 9 standing announcement (March 15, June 15 and November 1). To be considered timely for this additional due date only, applications must be received at the OCS Operations Center by July 15. (For more details, see submission dates and times section below.) This document also announces two informational telephone conference calls concerning the Assets for Independence Program and the process for submitting a grant application. Submission Dates and Times: The new additional closing date for the Assets for Independence Program is July 15, 2005. (This closing date is in addition to three other valid closing datesMarch 15, June 15 and November 1as noted in the current standing announcement.) Applications received after 4:30 p.m. eastern time on the July 15 closing date will be classified as late, and will not be reviewed this cycle. Deadline: Applications shall be considered as meeting an announced deadline if they are received on or before the due date. Applicants are responsible for ensuring applications are mailed or submitted electronically well in advance of the application due date. Applications hand carried by applicants, applicant couriers, other representatives of the applicant, or by overnight/express mail couriers shall be considered as meeting an announced deadline if they are received on or before the deadline date, between the hours of 8 a.m. and 4:30 p.m., eastern time, between Monday and Friday (excluding Federal holidays). ACF cannot accommodate transmission of applications by facsimile. Therefore, applications transmitted to ACF by fax will not be accepted regardless of date or time of submission and time of receipt. Receipt acknowledgement for application packages will not be provided to applicants who submit their package via mail, courier services, or by hand delivery. Applicants will receive an electronic acknowledgement for applications that are submitted via Grants.gov. Late Applications: Applications that do not meet the criteria above are considered late applications. ACF shall notify each late applicant that its application will not be considered in the current competition. Any application received after 4:30 p.m. eastern time on the deadline date will not be considered for competition. Applicants using express/overnight mail services should allow two working days prior to the deadline date for receipt of applications. Applicants are cautioned that express/overnight mail services do not always deliver as agreed. Extension of Deadlines: ACF may extend application deadlines when circumstances such as acts of God (floods, hurricanes, etc.) occur, or when there are widespread disruptions of mail service, or in other rare cases. A determination to extend or waive deadline requirements rests with the Chief Grants Management Officer. Other Submission Requirements: Submission by Mail: An applicant must provide an original application with all attachments, signed by an authorized representative and two copies. The application must be received at the address below by 4:30 p.m. eastern time on or before the closing date. Applications should be mailed to: Administration for Children and Families, Office of Community Services' Operations Center, 1515 Wilson Boulevard, Suite 100, Arlington, VA 22209, Attention: Administration for Children and Families, Office of Community Services, Assets for Independence Program. Hand Delivery: An applicant must provide an original application with all attachments signed by an authorized representative and two copies. The application must be received at the address below by 4:30 p.m. eastern time on or before the closing date. Applications that are hand delivered will be accepted between the hours of 8 a.m. to 4:30 p.m. eastern time, Monday through Friday. Applications should be delivered to: Administration for Children and Families, Office of Community Services' Operations Center, 1515 Wilson Boulevard, Suite 100, Arlington, VA 22209; Attention: Administration for Children and Families, Office of Community Services, Assets for Independence Program. Electronic Submission: https://www.Grants.gov. Please see Section IV.2 Content and Form of Application Submission of the February 9 announcement, for guidelines and requirements when submitting applications electronically. Informational Conference Calls: The Office of Community Services will host two informational telephone conference calls concerning the Assets for Independence Program and the grant application process on June 20 and 21, 2005 at 2 p.m. until approximately 3 p.m. These calls will be open to all interested individuals. Please call the Office of Community Services on (202) 401-4626 or go to the OCS Asset Building Web site at https://www.acf.hhs.gov to register for a call and for dial- in information. Participants are strongly encouraged to register, as the number of lines is limited. OCS plans to make handout materials available to all individuals who register for either of the informational calls. Announcement Availability: The Assets for Independence Program announcement and all application materials are available at https:// www.Grants.gov. Standard forms and certifications may also be found at https://www.acf.hhs.gov/programs/ofs/forms.htm. Finally, the OCS Asset Building Web site at https://www.acf.hhs.gov/assetbuilding provides much information about the Assets for Independence Program and the application process. The page includes links to all required forms as well as to a guidebook for developing an AFI Project and applying for an AFI grant.

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 renewal of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting and recordkeeping requirements for distribution and use of Veterinary Feed Directive (VFD) drugs and animal feeds containing VFD drugs.

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.

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.