Department of Health and Human Services 2007 – Federal Register Recent Federal Regulation Documents

Under the Medicaid program, Federal payment is available for the costs of administrative activities ``as found necessary by the Secretary for the proper and efficient administration of the State plan.'' The proposed rule would eliminate reimbursement under the Medicaid program for the costs of certain activities based on a Secretarial finding that these activities are not necessary for the proper and efficient administration of the State plan, nor do they meet the definition of an optional transportation benefit. Based on these determinations, under the proposed rule, Federal Medicaid payments would no longer be available for administrative activities performed by school employees or contractors, or anyone under the control of a public or private educational institution, and transportation from home to school and back for school-aged children with an Individualized Education Program (IEP) or an Individualized Family Services Plan (IFSP) established pursuant to the Individuals with Disabilities Education Act (IDEA).

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Rocky Flats Plant, Golden, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 6, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) has determined that the six drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the drug products, and it will allow FDA to continue to approve ANDAs that refer to the products.

The Office for Human Research Protections (OHRP), Office of Public Health and Science is seeking information and comments about whether guidance or additional regulations are needed to adequately protect adult individuals with impaired decision-making capacity who are potential subjects in research. This request for information and comments stems from the recommendation of an HHS working group, generated in response to the report published by the National Bioethics Advisory Commission (NBAC) entitled ``Research Involving Persons With Mental Disorders That May Affect Decision-making Capacity'' (December 1998), and from subsequent recommendations by the National Human Research Protections Advisory Committee (NHRPAC).\a\

This final rule is the third phase (Phase III) of a final rulemaking amending our regulations regarding the physician self- referral prohibition in section 1877 of the Social Security Act (the Act). Specifically, this rule finalizes, and responds to public comments regarding, the Phase II interim final rule with comment period published on March 26, 2004, which set forth the self-referral prohibition and applicable definitions, interpreted various statutory exceptions to the prohibition, and created additional regulatory exceptions for arrangements that do not pose a risk of program or patient abuse (69 FR 16054). In general, in response to public comments, in this Phase III final rule, we have reduced the regulatory burden on the health care industry through the interpretation of statutory exceptions and modification of the exceptions that were created using the Secretary's discretionary authority under section 1877(b)(4) of the Act to promulgate exceptions for financial relationships that pose no risk of program or patient abuse.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill two (2) vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).

The Interagency Working Group on Import Safety (Working Group) is announcing a public meeting to identify actions the public and private sectors can take to promote the safety of products imported into the United States. The Working Group was created by the Executive order on July 18, 2007.

Under the provision of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), National Cancer Institute (NCI), 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 June 28, 2007, page 43609 and allowed 60-days for public comment. One public comment was received asking about the possibility of doing studies of autism rather than the proposed survey. The comment was out of the scope of this current project. 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.

This final rule sets forth the State requirements to provide information to us for purposes of estimating improper payments in Medicaid and SCHIP. The Improper Payments Information Act of 2002 (IPIA) requires heads of Federal agencies to estimate and report to the Congress annually these estimates of improper payments for the programs they oversee, and submit a report on actions the agency is taking to reduce erroneous payments. This final rule responds to the public comments on the August 28, 2006 interim final rule (71 FR 51050) and sets forth State requirements for submitting claims and policies to the CMS Federal contractors for purposes of conducting fee-for-service and managed care reviews. This final rule also sets forth the State requirements for conducting eligibility reviews and estimating case and payment error rates due to errors in eligibility determinations.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of May 16, 2007 (72 FR 27573). The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. The document was published with an error. This document corrects that error.

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

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of July 9, 2007 (72 FR 37246). The document announced the availability for public comment of a draft guidance entitled ``Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims.'' The document was published with an incorrect Internet address for submitting electronic comments and an incorrect telephone number. This document corrects those errors.

This final rule with comment period sets forth an update to the 60-day national episode rates and the national per-visit amounts under the Medicare prospective payment system for home health services, effective on January 1, 2008. As part of this final rule with comment period, we are also rebasing and revising the home health market basket to ensure it continues to adequately reflect the price changes of efficiently providing home health services. This final rule with comment period also sets forth the refinements to the payment system. In addition, this final rule with comment period establishes new quality of care data collection requirements. Finally, this final rule with comment period allows for further public comment on the 2.71 percent reduction to the home health prospective payment system payment rates that are scheduled to occur in 2011, to account for changes in coding that were not related to an underlying change in patient health status (section III.B.6).

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Mound Plant, Dayton, Ohio, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Mound Plant. Location: Dayton, Ohio. Job Titles and/or Job Duties: All workers. Period of Employment: February 1, 1949 through the present.

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 Allergy and Infectious Diseases (NIAID), 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. Proposed Collection: Title: Pretesting of NIAID's HIV Vaccine Research Communications Messages. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for clearance to pretest messages, materials and program activities produced for the NIAID HIV Vaccine Research Education Initiative (NHVREI). The primary objectives of the pretests are to (1) Assess audience knowledge, attitudes, behaviors and other characteristics for the planning/development of health messages, education products, communication strategies, and public information programs; and (2) pretest these health messages, products, strategies, and program components while they are in developmental form to assess audience comprehension, reactions, and perceptions. The information obtained from audience research and pretesting results in more effective messages, materials, and programmatic strategies. By maximizing the effectiveness of these messages and strategies for reaching targeted audiences, the frequency with which publications, products, and programs need to be modified is reduced. Frequency of Response: On occasion. Affected Public: Individuals. Type of Respondents: Adults at risk for HIV/AIDS, particularly those who are Black/African-American, Hispanic/Latino, or men who have sex with men; healthcare providers; representatives of organizations disseminating HIV-related messages or materials. The annual reporting burden is shown in the table below. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of a new animal drug application (NADA) for a bacitracin zinc Type A medicated article. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of this NADA.

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 (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: PCT Application No. PCT/US2006/031208 (E-258-2005/0-PCT-02) filed August 10, 2006 claiming priority to U.S. Provisional Application No. 60/ 707,518 (E-258-2005/0-US-01), titled ``Method for Determining the Redox Status of a Tissue'' (Inventors: Dr James Mitchell et al.) to Mitos Pharmaceutical, Inc. (hereafter Mitos), having a place of business in Newport Beach, California. The patent rights in these inventions have been assigned to the United States of America.

The select agents and toxins listed in 42 CFR part 73 include those regulated only by the U.S. Department of Health and Human Services (HHS) (42 CFR 73.3), as well as those overlap select agents and toxins regulated by both HHS and the U.S. Department of Agriculture (USDA) (42 CFR 73.4). In response to USDA's proposal to no longer regulate ten select agents and toxins currently listed as ``overlap'' agents and toxins, we are proposing to move those ten select agents and toxins from the overlap select agents and toxins section to the HHS select agents and toxins section.

The Office of Refugee Resettlement, Anti-Trafficking in Persons Office, will award a non-competitive grant to Polaris Project, P.O. Box 77892, Washington DC, 20013, in the amount of $394,452 in Fiscal Year 2007 due to urgent and compelling circumstances. The award will be used to improve the systemic response to protect victims of human trafficking in the United States through the Training, Technical Assistance, and Strategic Planning (TTASP) Program. The specific goal of the TTASP program is to raise the standards of the anti-trafficking field through the development of new and cutting edge strategies, best practices, improved national levels of coordination and strategic planning, and capacity building for the field through practitioner-based training and technical assistance. The services obtained are intended to increase levels of victim identification through the creation of improved direct outreach strategies, enable localized best practice strategies to be shared on a national scale, provide around the clock technical assistance from leading human trafficking experts, and be a resource for strategic planning assistance at the local, State and Federal levels. Services will be provided via a centralized online clearinghouse of training and technical assistance resources, a dedicated technical assistance telephone hotline, on-site training and consulting services, and a peer-to-peer training and strategic planning event. Grant and Cooperative Agreement Program Authority for this activity is contained in section 106(b) and section 107(b)(1)(B) of the Trafficking Victims Protection Act of 2000 (TVPA), Public Law 106-386, Division A, 114 Stat. 1464 (2000) and in section 412(c)(1)(A) of the Immigration and Nationality Act (INA), (8 U.S.C. 1522(c)(1)(A)). The Recipient will: 1. Develop anti-trafficking materials covering topics not currently in circulation; 2. Create an online clearing house of training and technical assistance resources, including all TTASP training manuals, briefing materials, model strategic plans, sample outreach materials, user- driven worksheets, and summaries of best practices and model programs; 3. Provide targeted training and technical assistance on effective anti-trafficking strategies to anti-trafficking coalitions, task forces, direct outreach organizations, service providers, and others as needed; 4. Provide around the clock technical assistance via telephone on an emergency or on-demand basis for service providers or law enforcement officials that encounter trafficking victims; 5. Create a comprehensive strategic planning document for use by new and existing anti-trafficking coalitions that consolidates national best practices for implementing anti-trafficking activities at the local level; 6. Provide technical review of third-party materials, including, but not limited to client service protocols and forms, outreach protocols and materials, and organizational training documents; and 7. Provide consulting services to ORR in areas of strategic planning, staying abreast of the latest trends in the field, and any other technical assistance requested. After the appropriate reviews, it has been determined that the need to improve the systemic response to protect victims of human trafficking in the United States through the training, technical assistance, and strategic planning is urgent and compelling. The project period is September 30, 2007 to September 29, 2010.

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 requirements governing the registration of producers of drugs and listing of drugs in commercial distribution.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and FDA's Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs.

The Food and Drug Administration (FDA) is requiring establishments collecting Whole Blood or blood components, including Source Plasma and Source Leukocytes, to establish, maintain, and follow an appropriate system for identifying blood and blood components previously donated by a donor who tests reactive for evidence of hepatitis C virus (HCV) infection on a subsequent donation identified either by current testing or after a review of historical testing records, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HCV infection. Such collections may be at increased risk of transmitting HCV infection. FDA is requiring collecting establishments to quarantine prior in-date blood and blood components from such a donor, to notify consignees of prior in-date blood and blood components from such a donor for quarantine purposes, and to perform further testing on the donor. FDA is also requiring consignees to notify transfusion recipients of blood and blood components from such a donor, as appropriate. In addition, FDA is revising the human immunodeficiency virus (HIV) ``lookback'' requirements for greater consistency with the HCV ``lookback'' requirements, and extending the record retention period to 10 years. FDA is taking this action to help ensure the continued safety of the blood supply and to help ensure that information is provided to recipients of blood and blood components that may have been at increased risk of transmitting HIV or HCV infection. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV'' (the ``lookback'' guidance). We are also issuing this final rule in conjunction with a companion interim final rule published by the Centers for Medicare and Medicaid Services (CMS) elsewhere in this issue of the Federal Register.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV,'' dated August 2007. The guidance document provides recommendations for complying with the HCV ``Lookback'' requirements. This guidance document finalizes the guidance entitled, ``Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV)'' dated June 1999. Additionally, this guidance document supersedes the HCV sections of the FDA memorandum entitled, ``Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T-Lymphotropic Virus Type I (HTLV-I),'' dated July 19, 1996; and also supersedes the document entitled, ``Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV'' dated September 1998. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule entitled ``Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (`Lookback').''

This notice announces the seventh and final meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). In addition, this notice announces the selection of a new member of the EMTALA TAG. The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. The primary purpose of the seventh meeting is to enable the EMTALA TAG to hear additional testimony, to further consider written responses from medical societies and other organizations on specific issues considered by the TAG at previous meetings, and to finalize the recommendations for the Secretary. However, the public is permitted to attend this meeting and, to the extent that time permits and at the discretion of the Chairperson, the EMTALA TAG may hear comments from the floor.

In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) on September 20, 2007. The Panel advises and makes recommendations to the Secretary of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.

On September 5, 2007, the Office of the National Coordinator for Health Information Technology will lead a technical assistance public meeting to share information and answer detailed questions about plans to design and establish a successor to the American Health Information community, including information on the Notice of Funding Availability. The AHIC is a federally chartered advisory committee that provides input and recommendations to the Department of Health and Human Services (HHS) on how to make health records digital and interoperable, and how to assure that the privacy and security of those records are protected. (Please visit https://www.hhs.gov/healthit/community/ background/ for more information on the AHIC.) The AHIC charter specifies that the AHIC will develop and advance recommendations to the Secretary on a private-sector health information community initiative that will succeed the AHIC. The AHIC successor will bring together public and private, not-for-profit and for-profit entities that represent all sectors of the health community. This new public-private partnership will develop a unified approach to realize an effective, secure, interoperable nationwide health information system that improves the quality, safety, and efficiency of health care in the U.S. For the purposes of facilitating the establishment of the AHIC successor and convening a planning board, HHS will award a Cooperative Agreement that allows for substantial involvement by the Federal government. Once a new legal entity is established and after certain conditions are met, HHS will support that entity through additional funding that will enable initial operations and transition of specific AHIC responsibilities by late Fall 2008.

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 Food and Drug Administration (FDA) is announcing an opportunity for public comment on a 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 a study of consumer evaluations of variations in communicating risk information in direct- to-consumer (DTC) prescription drug broadcast advertisements.

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of glycerol ester of tall oil rosin (GETOR) to adjust the density of citrus oils used in the preparation of beverages and to provide for the use of steam stripping as a purification method for producing glycerol ester of wood rosin, gum rosin, or tall oil rosin. This action is in response to a petition filed by Georgia-Pacific Resins, Inc.

This notice announces those sites for which ATSDR has completed public health assessments and health consultations during the period from April 1, 2007, through June 30, 2007. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments or consultations were prepared in response to requests from the public.

In accordance with the requirements of the Privacy Act of 1974, we propose to modify an existing system titled, ``National Emphysema Treatment Trial (NETT), System No. 09-70-0531,'' established at 65 Federal Register 47995 (August 4, 2000). We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 4 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of routine uses number 5 and 6, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary or recipient practices that result in unnecessary cost to all federally-funded health benefit programs. Additionally, we will broaden the scope of this system by including the section titled ``Additional Circumstances Affecting Routine Use Disclosures,'' that addresses ``Protected Health Information (PHI)'' and ``small cell size.'' The requirement for compliance with HHS regulation ``Standards for Privacy of Individually Identifiable Health Information'' apply when ever the system collects or maintain PHI. This system may contain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through ``small cell size'' will apply to the data disclosed from this system. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system of records is to collect and maintain data that will allow CMS to provide secure data on participants in the randomized phase of the study, pay claims, and to monitor and evaluate the clinical trial. Information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement and policy functions performed within the agency or by a contractor, consultant, or CMS grantee; (2) assist another Federal or state agency 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 funds; (3) support research, evaluation, or epidemiological projects related to the prevention of disease or disability, or the restoration or maintenance of health, and for payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the new system in the Supplementary Information section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See EFFECTIVE DATE section for comment period.

The U.S. Department of Health and Human Services (HHS) announces the establishment of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 and invites nominations for membership for the Committee.

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 Heart, Lung, and Blood Institute (NHLBI), 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. Proposed Collection: Title: Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance. Type of Information Request: Renewal (OMB No. 0925-0493). Need and Use of Information Collection: The study, MESA, is identifying and quantifying factors associated with the presence and progression of subclinical cardiovascular disease (CVD) that is, atherosclerosis and other forms of CVD that have not produced signs and symptoms. The findings provide important information on subclinical CVD in individuals of different ethnic backgrounds and provide information for studies on new interventions to prevent CVD. The aspects of the study that concern direct participant evaluation received a clinical exemption from OMB clearance (CE-99-11-08) in April 2000. OMB clearance is being sought for the contact of physicians and participant proxies to obtain information about clinical CVD events that participants experience during the follow-up period. Frequency of Response: Once per CVD event. Affected Public: Individuals. Types of Respondents: Physicians and selected proxies of individuals recruited for MESA. The annual reporting burden is as follows: Estimated Number of Respondents: 550; Estimated Number of Responses per Respondent: 1.0; and Estimated Total Annual Burden Hours Requested: 36.7. There are no capital, operating, or maintenance costs to report.

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 Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of July 31, 2007 (FR Doc. E7-14680), on page 41759, regarding Bureau of Primary Health Care (BPHC) Uniform Data System (OMB No. 0915-0193). In the burden table, the total burden hours published are incorrect.

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of polydextrose as a bulking agent, formulation aid, humectant, and texturizer in all foods, except meat and poultry, baby foods, and infant formula. This action is in response to a petition filed by Danisco USA, Inc.

This notice announces the 16th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).

The Food and Drug Administration (FDA) is amending its food labeling regulations to permit the egg industry to place the safe handling statement for shell eggs on the inside lid of egg cartons if the statement ``Keep Refrigerated'' appears on the principal display panel (PDP) or information panel. This final rule will provide the industry greater flexibility in the placement of safe handling instructions on egg cartons, while continuing to provide consumers with this important information. This action is in response to numerous requests from the egg industry.

In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to establish a new system of records. The Stem Cell Therapeutic and Research Act of 2005 (the Act) authorizes the C.W. Bill Young Cell Transplantation Program (the Program) and provides for the collection, maintenance, and distribution of human blood stem cells for the treatment of patients and for research. The Program consists of four interrelated components each operated under a separate contract. The four components are: The Bone Marrow Coordinating Center; the Cord Blood Coordinating Center; the Office of Patient Advocacy/Single Point of Access; and the Stem Cell Therapeutic Outcomes Database. The contracts for operation of the Bone Marrow Coordinating Center, Cord Blood Coordinating Center, and Office of Patient Advocacy/Single Point of Access were awarded to the National Marrow Donor Program in September, 2006. A single contract for the Stem Cell Therapeutic Outcomes Database was awarded to the Center for International Blood and Marrow Transplant Research (CIBMTR) at the Medical College of Wisconsin in September, 2006 as well. As identified by the Act, the Program is charged with: Operating a system for identifying, matching, and facilitating the distribution of bone marrow that is suitably matched to candidate patients; operating a system for identifying, matching, and facilitating the distribution of donated umbilical cord blood units that are suitably matched to candidate patients; providing a means by which transplant physicians, other healthcare professionals, and patients can electronically search for and access all available adult marrow donors available through the Program; recruiting potential adult volunteer marrow donors; coordinating with other Federal programs to maintain and expand medical contingency response capabilities; carrying out informational and educational activities; providing patient advocacy services; providing case management services for potential donors; and collecting, analyzing, and publishing blood stem cell transplantation related data in a standardized electronic format. This system of records is required to comply with the implementation directives of the Act, Public Law 109-129. The records will be used for the C.W. Bill Young Cell Transplantation Program's planning, implementation, evaluation, monitoring, and document storage purposes.

The primary goal of this project is to assist Afghanistan in the development and strengthening of maternal and child health clinics/ hospital systems by creating equitable and high quality obstetrical and gynecological and infant care at RBH and developing an evidence-based and culturally appropriate Obstetrical/Gynecological residency program and continuing education program for practicing physicians. Projects requesting funding should aim to expand the capacity of Kabul Medical University to develop and implement curriculum reform in support of evidence-based medical knowledge and practice in maternal-child health at Kabul Medical University and to provide leadership and clinical expertise to strengthen the Obstetric and Gynecology Residency Program; residency training refers to a sustainable training of physicians and specialists in obstetrics and gynecology based on Western accreditation standards that have been modified for the Afghan situation. Announcement Type: Single EligibilityFY 2007 Initial Announcement. GSA Catalog of Federal Domestic Assistance: 93.017.

The primary goal of this project is to assist Afghanistan in the development and strengthening of maternal and child health clinics/ hospital systems by creating a solid, university-based, culturally- appropriate professional nursing educational program and building upon previous educational and training efforts. Funding is made available for the development of a basic baccalaureate program at Kabul Medical University and a registered nurse completion program at the Institute of Health Sciences (IHS) in Kabul, Afghanistan. The focus of both programs must be toward an emphasis on clinical training, to include the demonstration of direct patient care alongside Afghan health-care nurse providers. Announcement Type: Single EligibilityFY 2007 Initial Announcement. GSA Catalog of Federal Domestic Assistance: 93.017.

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 recordkeeping requirements for current good manufacturing practice (cGMP) regulations for Type A medicated articles.

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. We are taking this action as part of our continuing effort to reduce the burden of unnecessary regulations on industry and to revise outdated regulations without diminishing public health protection. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) has determined that ORUDIS KT (ketoprofen) tablets, 12.5 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 ketoprofen tablets, 12.5 mg.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork ReductionAct of 1995.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by B.L. Mitchell, Inc. The ANADA provides for the use of formalin in a water bath for the control of certain external parasites on finfish and shrimp and for the control of certain fungi on finfish eggs.

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 Cancer Institute, the National Cancer Institute (NIH) will publish periodic summaries to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Submitting and Reviewing Complete Responses to Clinical Holds'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

This notice announces the 18th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the 19th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the 18th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup [formerly Biosurveillance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

On August 17, 2007, Secretary Leavitt will lead a public meeting to raise awareness of the implementation strategy for the AHIC successor and encourage collaboration. The AHIC is a federally- chartered advisory committee that provides input and recommendations to the Department of Health and Human Services (HHS) on how to make health records digital and interoperable, and how to assure that the privacy and security of those records are protected. (Please visit https:// www.hhs.gov/healthit/community/background/ for more information on the AHIC.) The AHIC charter specifies that the AHIC will develop and advance recommendations to the Secretary on a private-sector health information community initiative that will succeed the AHIC. The AHIC successor will bring together public and private, not-for-profit and for-profit entities that represent all sectors of the health community. This new public-private partnership will develop a unified approach to realize an effective, secure, interoperable nationwide health information system that improves the quality, safety, and efficiency of health care in the U.S. For the purposes of facilitating the establishment of the AHIC successor and convening a planning board, HHS will award a Cooperative Agreement that allows for substantial involvement by the Federal Government. Once a new legal entity is established and after certain conditions are met, HHS will support that entity through additional funding that will enable initial operations and transition of specific AHIC responsibilities by late Fall 2008.