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

The Food and Drug Administration (FDA) is announcing that Durand-Wayland, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of a carbon dioxide laser for etching information on food, excluding meat and poultry.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, ``Master Demonstration, Evaluation, and Research Studies (DERS) for the Office of Research, Development and Information (ORDI),'' System No. 09-70- 0591. This notice serves as the Master system for all demonstration, evaluation, and research studies administered by ORDI. Sixteen existing ORDI demonstration, evaluation, and research studies will be included under this notice and the separate, existing systems of records notices for those studies will be deleted upon the effective date of this notice. DERS will become effective 30 days from the publication of the notice in the Federal Register, or 40 days from the date submitted to OMB and the Congress, whichever is later. With the publication of this master system, ORDI will only be deleting the systems of records listed below as separate stand alone notices to the public. Retention and destruction of the data contained in these systems will follow the schedules listed in this DERS system notice. The existing ORDI systems of records to be included under DERS and which will be deleted by this notice are as follows: ``Municipal Health Services Program System No. 09-70- 0022,'' 65 Federal Register (FR) 37792 (June 16, 2000); ``Monitoring of the Home Health Agency Prospective Payment Demonstration,'' System No. 09-70-0048, 65 FR 37792 (June 16, 2000); ``Person-Level Medicaid Data System, System No. 09-70- 0507'' last published at 71 FR 60726 (October 16, 2006); ``Medicare Cancer Registry Record System,'' System No. 09- 70-0509, last published at 71 FR 67133 (November 20, 2006); ``End Stage Renal Disease Program Management and Medical Information System,'' System No. 09-70-0520, last published at 67 FR 41244 (June 17, 2002); ``Evaluations of the Medicaid Reform Demonstrations,'' System No. 09-70-0523, last published at 71 FR 60540 (October 13, 2006); ``MMA Section 641 Prescription Drug Benefit Demonstration,'' System No. 09-70-0545, last published at 69 FR 32587 (June 10, 2004); ``Medicare Physician Group Practice Demonstration,'' System No. 09-70-0559, last published at 70 FR 58432 (October 6, 2005); ``Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities,'' System No. 09-70-0560, last published at 70 FR 57602 (October 3, 2005); ``Medicare Care Management Performance Demonstration,'' System No. 09-70-0562, last published at 70 FR 58442 (October 6, 2005); ``Rural Hospice Demonstration,'' System No. 09-70-0563, last published at 71 FR 57968 (October 2, 2006); ``Medicare Chiropractic Coverage Demonstration and Evaluation,'' System No. 09-70-0577, last published at 71 FR 41450 (July 21, 2006); ``Low Vision Rehabilitation Demonstration,'' System No. 09-70-0582, last published at 71 FR 58621 (October 4, 2006); ``Medicare Lifestyle Modification Program Demonstration,'' System No. 09-70-0585, last published at 71 FR 41807 (July 24, 2006); ``Competitive Bidding for Clinical Laboratory Services,'' System No. 09-70-0589, last published at 71 FR 60713 (October 16, 2006); and ``Senior Risk Reduction Demonstration and Evaluation,'' System No. 09-70-0592, last published at 71 FR 60718 (October 16, 2006). The purpose of this system is to document, track, monitor, evaluate, and conduct ORDI-administered demonstration, evaluation, and research studies. Information retrieved from this system may 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 with information to contribute to the accuracy of CMS's payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste and abuse in certain Federally-funded 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 Dates section for comment period.

This notice announces the 13th 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).

This final rule establishes competitive bidding programs for certain Medicare Part B covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) throughout the United States in accordance with sections 1847(a) and (b) of the Social Security Act. These competitive bidding programs, which will be phased in over several years, utilize bids submitted by DMEPOS suppliers to establish applicable payment amounts under Medicare Part B.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Orally Disintegrating Tablets.'' The draft guidance provides pharmaceutical manufacturers of new and generic drug products with an agency perspective on the definition of an orally disintegrating tablet (ODT) and also provides recommendations to applicants who would like to designate a proposed product as an ODT.

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is announcing a public hearing to obtain feedback on FDA's Medication Guide program, which provides for the distribution of FDA-approved written patient information for certain drug and biological products that pose serious and significant public health concerns. FDA is interested in obtaining public comment on ways to improve communication to patients who receive Medication Guides. The purpose of the public hearing is to solicit information and views from interested persons on specific issues associated with the development, distribution, comprehensibility, and accessibility of Medication Guides, which are required to convey risk information to patients. Dates and Times: The public hearing will be held on June 12 and 13, 2007, from 8:30 a.m. to 4:30 p.m. on both days. Submit written or electronic notices of participation by 4:30 p.m. on May 12, 2007. Written and electronic comments will be accepted until July 12, 2007. Location: The public hearing will be held at the National Transportation and Safety Board Boardroom and Conference Center, 429 L'Enfant Plaza SW., Washington, DC 20594 (Metro: L'Enfant Plaza Station on the Green, Yellow, Blue, and Orange Lines). Addresses: Submit written or electronic notices of participation to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or on the Internet at https://www.accessdata.fda.gov/scripts/oc/dockets/ meetings/meetingdocket.cfm. Submit written or electronic comments to https://www.accessdata.fda.gov/scripts/oc/dockets/commentdocke t.cfm or to the Division of Dockets Management. Transcripts of the hearing will be available for review at the Division of Dockets Management and on the Internet at https://www.fda.gov/ohrms/dockets approximately 21 days after the hearing. For Registration to Attend and/or to Participate in the Meeting: Seating at the meeting is limited. People interested in attending should register at https://www.accessdata.fda.gov/scripts/oc/dockets/ meetings/meetingdocket.cfm or submit a written request for registration to the Division of Dockets Management (see Addresses) by 4:30 p.m. on May 12, 2007. Registration is free and will be on a first-come, first- served basis. If you wish to make an oral presentation during the open session of the meeting, you must state this intention on your notice of participation (see Addresses) and provide an abstract of your presentation by May 12, 2007. In the notice, submit your name, title, business affiliation, address, telephone and fax numbers, and e-mail address. FDA has identified questions and subject matter of special interest in section II of this document. You should also identify the subject matter and question number you wish to address in your presentation, and the approximate time requested for your presentation. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and to request time for a joint presentation. FDA may require joint presentations by persons with common interests. We will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. You must submit final electronic presentations, if any, to Mary Gross (see Contacts) by no later than June 6, 2007. Contacts: Mary C. Gross, Safety Policy and Communication Staff (HFD-001), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5421, e-mail: mary.gross@fda.hhs.gov.

The Food and Drug Administration (FDA) is amending certain medical device regulations to correct typographical errors and to ensure accuracy and clarity in the agency's regulations.

HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of primary health care programs, including the Health Center Program. Therefore, we are requesting comments on the PIN referenced above. After review and consideration of all comments received, the PIN may be amended to incorporate certain recommendations from the public. Once the PIN is finalized, it will be made available on HRSA's Web site, along with the Agency's ``Response to Public Comments.'' That document will summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PIN. Where comments do not result in a revision to the PIN, explanations will be provided.

This notice announces an administrative hearing to be held on May 30, 2007, at 233 N. Michigan Avenue, Suite 600, the Indiana Room, Chicago, IL 60601, to reconsider CMS' decision to disapprove Minnesota State plan amendment 05-10.

The meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology scheduled for May 1 and 2, 2007, is cancelled. This meeting was announced in the Federal Register of March 16, 2007 (72 FR 12621).

This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with section 1871(a)(3)(B) of the Social Security Act, which allows us to extend the timeline for publication of the final rule.

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 Ivy Laboratories, Div. of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol and lasalocid to make two- way combination drug Type B or Type C medicated feeds for heifers fed in confinement for slaughter.

The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (the Task Force). The Task Force, a standing, independent panel of private-sector experts in prevention and primary care, is composed of members appointed to serve for four-year terms with an option for reappointment. New members are selected each year to replace (approximately) one fourth of the Task Force members, i.e., those who are completing their appointments. Individuals nominated but not appointed in previous years, as well as those newly nominated, are considered in the annual selection process. Task Force members meet three times a year for two days in the Washington, DC area. Member duties include reviewing and preparing comments (off site) on systematic evidence reviews prior to discussing and making recommendations on preventive services, drafting final recommendation documents, and participating in workgroups on specific topics or methods. AHRQ particularly encourages nominations of women, members of minority populations, and persons with disabilities. Interested individuals can self nominate. Organizations and individuals may nominate one or more persons qualified for membership on the Task Force. Qualification Requirements: The mission of the Task Force is to produce evidence-based recommendations on the appropriate screening, counseling, and provision of preventive medication for asymptomatic patients seen in the primary care setting. Therefore, in order to qualify for the Task Force, an applicant or nominee MUST demonstrate the following: 1. Knowledge and experience in the critical evaluation of research published in peer reviewed literature and in the methods of evidence review; 2. Understanding and experience in the application of synthesized evidence to clinical decision-making and/or policy; 3. Expertise in disease prevention and health promotion; 4. Ability to work collaboratively with peers; and, 5. Clinical expertise in the primary health care of children and/or adults, and/or expertise in counseling and behavioral interventions for primary care patients. Some Task Force members without primary health care clinical experience may be selected based on their expertise in methodological issues such as medical decision making, clinical epidemiology, behavioral medicine, and health economics. Strongest consideration will be given to individuals who are recognized nationally or intentionally for scientific leadership within their field of expertise. Applicants must have no substantial conflicts of interest that would impair the scientific integrity of the work of the Task Force including financial, intellectual, or other conflicts.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Preparation for ICH Meetings in Brussels, Belgium'' to provide information and receive comments on the International Conference on Harmonisation (ICH) as well as the upcoming meetings in Brussels, Belgium. The topics to be discussed are the topics for discussion at the forthcoming ICH steering committee meeting. The purpose of the meeting is to solicit public input prior to the next steering committee and expert working groups meetings in Brussels, Belgium May 5-10, 2007, at which discussion of the topics underway and the future of ICH will continue. Date and Time: The meeting will be held on Friday April 6, 2007, from 3:30 p.m. to 5 p.m. Location: The meeting will be held at 5600 Fishers Lane, third floor, Conference Room G, Rockville, MD 20857. For security reasons, all attendees are asked to arrive no later than 3:20 p.m., as you will be escorted from the front entrance of 5600 Fishers Lane to Conference Room G. Contact Person: Michelle Limoli, Office of the Commissioner (HFG- 1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-0908, e-mail: michelle.limoli@fda.hhs.gov, FAX: 301-827- 0003. Registration and Requests for Oral Presentations: Send registration information (including name, title, firm name, address, telephone, and fax number), written material, and requests to make oral presentations, to the contact person by April 5, 2007. If you need special accommodations due to a disability, please contact Michelle Limoli as soon as possible.

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.'' This guidance document describes a means by which herpes simplex virus type 1 and 2 (HSV 1 and 2) serological assays may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule reclassifying these devices from class III (premarket approval) into class II (special controls).

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

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

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

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.

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) request a review and approval of the information listed below. The proposed information collection was previously published in the Federal Register on October 26, 2006 on page 62597 and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised or implemented on or after October 1, 1995 unless it displays a currently valid OMB control number. Proposed Collection: Title: Health Information National Trends Survey 2007 (HINTS 2007). Type of Information Collection Request: NEW. Need and Use of Information Collection: Building on the first two rounds of HINTS data collection (HINTS 2003: OMB 0925-0507, Exp. Date: 8/31/03; and HINTS 2005: OMB 0925-0538, Exp. Date 11/30/2007), HINTS 2007 will continue to provide NCI with a comprehensive assessment of the American public's current access to, and use of, information about cancer, including cancer prevention, early detection, diagnosis, treatment, and prognosis. The content of the survey will focus on understanding the degree to which members of the general population understand vital cancer prevention messages. More importantly, this NCI survey will couple knowledge-related questions with inquiries into the communication channels through which understanding is being obtained. HINTS is intended to be the foundation of NCI's effort to build on the opportunities presented by a national shift in communication context (for example, the increase in information available on the Internet and the use of email as a method of communication), and by so doing, improve the nation's ability to reduce the national cancer burden. Data will be used (1) to understand individuals sources of and access to cancer-related information; (2) to measure progress in improving cancer knowledge and communication to the general public; (3) to develop appropriate messages for the public about cancer prevention, detection, diagnosis, treatment, and survivorship; and (4) to identify research gaps and guide decisions about NCI's research efforts in health promotion and health communication. Frequency of Response: One time. Affected Public: Individuals. Type of Respondents: U.S. Adults. The annual reporting burden is as follows: Estimated Number of Respondents: 11,670; Estimated Number of Responses per Respondent: 1.36; Average Burden Hours per Response: .24; and Estimated Total Annual Burden Hours Requested: 3,739. The annualized cost to respondents is estimated at: $59,824. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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

Briefly provide a statement of the proposed demonstration project indicating that it is a prevention demonstration project and whether it is for a local or statewide project; type of organization applying (school, state agency, voluntary agency, etc.); geographic area to be served (urban, rural, suburban); description of target population to be served; brief description of the proposed prevention demonstration project; and brief description of the evaluation-intensive design. Description of Applicant Organization (1-2 pages): Describe the decision-making authority and structure (e.g. relationship to the Board of Directors and organizational chart), its resources, experience, existing program units and/or those to be established if funding is obtained. This description should cover personnel, time and facilities and contain evidence of the organization's capacity to provide the rapid and effective use of resources needed to conduct the project, collect necessary data and evaluate it. It is recommended that applicants place an organizational chart in the Appendices. Need Statement (3 pages): Describe the need for prevention services in the proposed target area by describing the geographic area to be served. Document the incidence of adolescent pregnancy, sexually transmitted infections, a description of socio-economic conditions including income levels, existing services and unmet needs in the proposed service area. If the proposed population has unique challenges and barriers, these should be addressed as well. Rationale (2-4 pages): Describe the rationale for use of the proposed approach based upon previous practice and review of the literature and/or evaluation findings. This section should include discussion of previous youth service experience and how lessons learned from this experience helped develop the rationale for the proposed demonstration model. All previous AFL grantees should clearly describe their program and evaluation experience as it relates to past AFL funding. Program Outcome Objectives (4 pages): Provide a goal and 4-6 outcome objectives that clearly state expected results or benefits of the demonstration project. Two of the outcome objectives must address the required OAPP cross-site performance measures. Objectives should be specific, measurable, achievable, realistic, and time-framed. Please see ``Evaluation'' section for more information. Prevention Services Demonstration Model (8-10 pages): Thoroughly describe proposed program intervention activities and services as they relate to the outcome objectives by describing the project logic model. This section should include a description of all proposed curricula, types of supportive asset building and youth development activities and services proposed as part of the model, and a description of the parental involvement component. It should also include a clear plan for recruitment and retention of program participants, including parents. This description should clearly relate to program objectives and should address intensity of services (dosage). All components of the intervention must be consistent with the A-H definition of abstinence education. How the project will address the issue of sexual exploitation and coercion should also be included. Workplan and Timetable (1 page): Provide a year long detailed work plan and timetable for the first year. Within this plan include each program activity associated with the project and the proposed time frame for the start and completion of each activity. A separate and more generalized work plan should be included in the appendices for the 2nd and 3rd year of program implementation. Numbers and Types of Participants (2 pages): Provide estimates of who the project will serve and how many will be participating in the proposed demonstration project. Please describe how many participants are expected to participate during the first year and break out the types of participants into categories (e.g. pre-adolescents, adolescents and parents), including the race and ethnicity of participants to be served. Documentation of Community Support and Commitment (1-2 pages): Provide documentation of the support from other community agencies. If a community agency is partnering with the applicant to implement the proposed prevention demonstration project, a letter of commitment detailing the level of effort and commitment to this effort must be included. Continuation Funding (1 page): Describe the plan regarding continuation of services at the termination of this Federal funding opportunity. The OAPP cannot guarantee that funding will be available annually or at the end of the five-year grant cycle. Evaluation Plan (15-20 pages): Provide a clear and fully developed evaluation plan in accordance with the criteria laid out under the ``Evaluation'' section of this announcement. Include a letter of commitment and curriculum vitae from the independent evaluator in the appendices, how the AFL prevention core instruments will be included in the evaluation plan, and the understanding of the proposed project, if funded by OAPP, will participate in a formal cross site evaluation of the AFL program. Applicants are encouraged to identify anticipated problems with the evaluation and recommended solutions. Inclusion of a proposed 2-year follow-up based on randomized assignment will greatly strengthen an applicant's evaluation plan. Appendices: Include: (1) Articles of incorporation and mission statement for private nonprofit organizations; (2) Resumes of key staff and detailed position descriptions; (3) A program logic model that ties project objectives and intervention activities and services to expected results; (4) A description of how the A-H criteria are addressed in the project curricula and supportive activities and services in chart format (see ``A-H Compliance Strategies'' chart in the application kit for a suggested format); (5) A description of how the project will obtain parental consent including a copy of the proposed parental consent form, if developed; (6) Letters of commitment from partnering agencies; (7) Letters of support from other community agencies; (8) A letter of commitment and/or a memorandum of understanding with the independent evaluator affiliated with a college or university located in the applicant's State that includes willingness to participate and their role(s) described; (9) A copy of the curriculum vitae of the independent evaluator; (10) Copies of the table of contents of the proposed curricula, plus a list of any other instructional materials that will be an integral part of the proposed project; and (11) the workplan and timetable for years 2 and 3 of the proposed project. Please note, applicants must be familiar with Title XX in its entirety to ensure that they have complied with all applicable requirements. In addition, applicants must incorporate the definition of ``abstinence education,'' as set out in section 510(b)(2) of Title V of the Social Security Act, as amended, and ensure program activities and services are consistent and supportive of this language. A copy of both sets of legislation is included in the application kit. A Dun and Bradstreet Universal Numbering System (DUNS) number is required for all applications for Federal assistance. Organizations should verify that they have a DUNS number or take the steps necessary to obtain one. Instructions for obtaining a DUNS number are included in the application package, and may be downloaded from the OPA Web site (opa.osophs.dhhs.gov/duns.html).

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Target Product ProfileA Strategic Development Process Tool.'' The purpose of this guidance is to inform sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) of the availability and potential usefulness of a target product profile (TPP). A TPP can be prepared by a sponsor and then shared voluntarily with the appropriate FDA review staff to facilitate communication regarding a particular drug development program. This draft guidance describes the purposes of a TPP, provides guidance on how to complete a TPP, makes suggestions on how to best use a TPP, and relates case studies that demonstrate the potential usefulness of a TPP.

Amendments to the Federal Food, Drug, and Cosmetic Act (the act) necessitate several changes to the citations used in Food and Drug Administration (FDA) regulations regarding the prescription-exemption procedure and the list of new drugs that are exempted from the prescription-dispensing requirements. These changes are editorial, pertaining only to citations, and do not constitute a change in FDA regulation.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the mental models study of food bioterrorism risk awareness.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2006 through December 2006, 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 and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, and a list of Medicare-approved bariatric surgery 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.

The NTP continuously solicits and accepts nominations for toxicological studies to be undertaken by the program. Nominations of substances of potential human health concern are received from federal agencies, the public, and other interested parties. These nominations are subject to several levels of review before selections for testing are made and toxicological studies are designed and implemented. This notice (1) Provides brief background information and preliminary study recommendations regarding nine nominations for study by the NTP (Table 1), (2) solicits public comment on the nominations and study recommendations, and (3) requests the submission of additional relevant information for consideration by the NTP in its continued review of these nominations. An electronic copy of this announcement, supporting documents for each nomination, and further information on the NTP and the NTP Study Nomination and Review Process can be accessed through the NTP Web site (https://ntp.niehs.nih.gov/; select ``Nominations to the Testing Program'').

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

This notice announces the ninth meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the 15th 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. 92-463, 5 U.S.C., App.).

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

This 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. Patent Application No. 09/937,150, filed March 26, 2002, entitled ``Phenylalanine Derivatives'' [E-105-1999/0-US-07]; U.S. Patent Application No. 10/517,717, filed March 17, 2005, entitled ``SH2 Domain Binding Inhibitors'' [E-262-2000/1-US-03]; U.S. Patent Application No. 10/944,699, filed September 17, 2004, entitled ``SH2 Domain Binding Inhibitors'' [E-315-2003/0-US-02]; PCT Patent Application PCT/US05/ 35246, filed September 30, 2005, entitled ``A New Approach Toward Macrocyclization of Peptides'' [E-327-2004/0-PCT-02]; U.S. Provisional Patent Application No. 60/867,307, filed November 27, 2006, entitled ``Macrocyclic GRB2 SH2 Domain Binding Inhibitors Prepared Using Achiral Alkenyl Amines'' [E-305-2006/0-US-01]; U.S. Patent 6,977,241, issued December 20, 2005, entitled ``SH2 Domain Binding Inhibitors'' [E-262- 2000/0-US-03]; U.S. Patent 7,132,392, issued November 11, 2006, entitled ``Inhibition of Cell Motility and Angiogenesis by Inhibitors of the GRB2 SH2 Domain'' [E-265-1999/0-US-07]; to Angion Biomedica Corporation, having a place of business in Manhasset, New York. 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 cancer and the modulation of angiogenesis in inflammatory disease.

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 worldwide to practice the invention embodied in U.S. Patent Number 5,460,942 issued October 24, 1995 entitled, ``The Catalytic Moiety of the Glucose-6-Phosphatase System: the Gene and Protein and Related Mutations'' (HHS Ref. No. E-179-1993/0-US-01) to GlyGenix, Inc., having a place of business in Cheshire, CT 06410. The contemplated exclusive license may be limited to the following field of use: an FDA-approvable human therapeutic for Glycogen Storage Disease Type Ia. The United States of America is the assignee of the patent rights in this invention.

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 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 provisions in the guidance document entitled ``Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.''

This notice announces the estimated median income for four- person families in each State and the District of Columbia for FFY 2008 (October 1, 2007 to September 30, 2008). LIHEAP grantees may adopt the State median income estimates beginning with the date of publication in the Federal Register or at a later date as discussed below. This enables LIHEAP grantees to choose to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2007, or the beginning of a grantee's fiscal year, whichever is later, LIHEAP grantees using State median income estimates must adjust their income eligibility criteria to be in accord with the FFY 2008 State median income estimates. This listing of estimated State median incomes provides one of the maximum income criteria that LIHEAP grantees may use in determining a household's income eligibility for LIHEAP.

The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comment on a draft report to the Secretary of Health and Human Services (HHS) on pharmacogenomics. A copy of the draft report is available electronically at https:// www4.od.nih.gov/oba/sacghs/publiccomments.htm. A copy also may be obtained by e-mailing Ms. Suzanne Goodwin at goodwins@od.nih.gov or calling 301-496-9838.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Modifications to Devices Subject to Premarket Approval (PMA)The PMA Supplement Decision-Making Process.'' This draft guidance is intended to help the regulated industry determine whether submitting a PMA supplement or other notification to FDA is required for class III devices subject to PMA. This draft guidance is not final nor is it in effect at this time.