Department of Health and Human Services March 2009 – Federal Register Recent Federal Regulation Documents

NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), announces a public meeting of an independent scientific peer review panel (Panel) on alternative ocular safety testing methods. The Panel will evaluate (1) the validation status of a testing strategy that proposes the use of three in vitro test methods to assess the eye irritation potential of antimicrobial cleaning products (AMCPs), (2) the validation status of four in vitro test methods for identifying moderate (EPA Category II, UN Globally Harmonized System of Classification and Labeling of Chemicals (GHS) Category 2A) and mild (EPA Category III, GHS Category 2B) ocular irritants and substances not classified as ocular irritants (EPA Category IV, GHS Not Classified), (3) the validation status of the in vivo Low Volume Eye Test, and (4) a proposal for the routine use of topical anesthetics, systemic analgesics, and humane endpoints to avoid and minimize pain and distress during in vivo ocular irritation testing.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(1), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in United States Patent No. 5,554,603, issued September 10, 1996, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-US-01); PCT Application No. PCT/US94/10393, filed September 15, 1994, now expired, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-PCT-02); Australian Patent No. 700576, issued April 22, 1999, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137- 1993/0-AU-03); Canadian Patent No. 2171740, issued July 26, 2005, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-CA-04); European Patent No. 719276, issued November 26, 1997, entitled ``Orally Active Derivatives of 1, 3, 5(10)- Estratriene'' (HHS Ref. No. E-137-1993/0-EP-05) and validated in Austria, Switzerland, Germany, Denmark, Spain, France, Greece, Ireland, Italy, Luxembourg, Monaco, the Netherlands, Portugal, Sweden, Belgium, and Great Britain; and Japanese Patent No. 3993228, issued August 3, 2007, entitled ``Orally Active Derivatives of 1, 3, 5(10)-Estratriene'' (HHS Ref. No. E-137-1993/0-JP-06) to Evestra, Inc., having a place of business in San Antonio, Texas. The patent rights in this invention have been assigned to the United States of America.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``CAHPS Field Test of Proposed Health Information Technology Questions and Methodology.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.

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.

This notice announces the application of the College of American Pathologists (CAP) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for all specialties and subspecialties. In this notice, we announce the approval and grant the CAP deeming authority for all CLIA specialties and subspecialties for a period of 6 years. We have determined that the CAP meets or exceeds the applicable CLIA requirements.

This final notice announces the approval of a deeming application from the Joint Commission for continued recognition as a national accreditation program for hospices that request participation in the Medicare or Medicaid programs.

This notice announces a request for nominations for consideration for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other things, the MEDCAC advises the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services on whether medical items and services are ``reasonable and necessary'' and therefore eligible for coverage under Title XVIII of the Social Security Act.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October 2008 through December 2008, 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, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery facilities.

The Food and Drug Administration (FDA) is amending its

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Developing a Consolidated Pediatric Rheumatology Observational Registry.'' This 2-day public workshop is intended to seek constructive input from key stakeholders in the pediatric rheumatology community, the pharmaceutical industry and the public to explore the value and feasibility of developing a consolidated pediatric rheumatology observational registry.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated March 2009. The draft guidance document notifies establishments that manufacture Whole Blood and blood components intended for use in transfusion, and establishments that make eligibility determinations for donors of HCT/Ps about FDA approval of a biologics license application for an enzyme-linked immunosorbent assay (ELISA) test system for the detection of antibodies to Trypanosoma cruzi (T. cruzi). The draft guidance also notifies establishments that make donor eligibility determinations for HCT/P donors that FDA has determined T. cruzi to be a relevant communicable disease under current regulations. In addition, the guidance provides recommendations for using a licensed test for antibodies to T. cruzi to test individual human donors, including donors of Whole Blood and blood components for transfusion and HCT/P donors (living and cadaveric (non-heart beating)), for antibodies to T. cruzi in plasma and serum samples. The guidance document does not apply to Source Plasma.

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.

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Baker Perkins Atomic Weapons Employer facility in Saginaw, Michigan, 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:

In accordance with the memorandum of January 20, 2009, from the Assistant to the President and Chief of Staff, entitled ``Regulatory Review,'' this action temporarily delays until May 22, 2009, the effective date of the final rule entitled ``State Parent Locator Service; Safeguarding Child Support Information,'' published in the Federal Register on September 26, 2008 [73 FR 56422]. The temporary delay in effective date is necessary to give Department officials the opportunity for further review of the issues of law and policy raised by this rule.

This notice announces that the Office of Child Support Enforcement (OCSE), will award a Non-Competitive Successor Award to the State Information Technology Consortium (SITC) in Raleigh, North Carolina. The award will enable the SITC to educate judges on effective problem-solving court strategies to deal with parents who do not make their child support payments.

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 Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for changing scientific nomenclature for a bovine pathogen on labeling for tylosin injectable solution.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 021'' (Recognition List Number: 021), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Food and Drug Administration (FDA) Chicago District, in cosponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public workshop entitled ``Drugs and DevicesPromoting and Protecting the Public Health Through Risk Management and Product Cycle Improvement.'' This 2-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry. Date and Time: The public workshop will be held on Monday, June 8, 2009, from 10:20 a.m. to 5 p.m. and Tuesday, June 9, 2009, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Doubletree Hotel ChicagoOakbrook, 1909 Spring Rd., Oak Brook, IL 60523, 800-222-TREE, 800-222-8733, or 630-472-6000, FAX: 630-573-1909. Attendees are responsible for their own accommodations. To make reservations at the Doubletree Hotel ChicagoOakBrook, at the reduced conference rate, contact the Doubletree Hotel ChicagoOakBrook before May 5, 2009, citing meeting code ``AFDO Conference''. Contact: William Weissinger, Food and Drug Administration, 550 W. Jackson Blvd., 15th Fl., Chicago, IL 60661, 312-596-4210, FAX: 312-596- 4242, e-mail: William.weissinger@fda.hhs.gov. Registration: You are encouraged to register by May 12, 2009. The AFDO registration fees cover the cost of facilities, materials, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 7:30 a.m. The cost of registration follows:

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following document which encompasses progress to-date and planned future activities of the NIOSH Childhood Agricultural Injury Prevention Initiative. The document, NIOSH Childhood Agricultural Injury Prevention Initiative: Progress and Proposed Future Activities, can be found at https://www.cdc.gov/niosh/ review/public/145/. Public Comment Period: March 16, 2009 to May 15, 2009. Purpose: To seek comments on the progress and proposed future activities of the Childhood Agricultural Injury Prevention Initiative begun by NIOSH in October 1996, in order to ensure that the program is meeting the needs of stakeholders (e.g., national youth agricultural injury prevention organizations, agricultural youth injury prevention groups, individuals, etc.) and other interested members of the public, and to identify ways in which the program can be improved to increase its impact on the safety of children in agriculture. A review of progress and public comment on the proposed future activities of the NIOSH Childhood Agricultural injury Prevention Initiative is desired periodically to assess whether the NIOSH Childhood Agricultural Injury Prevention Initiative is addressing the most pressing issues and areas of childhood agricultural injury prevention. NIOSH will compile and consider all comments received through the NIOSH docket and use them in making decisions on how to proceed with the Childhood Agricultural Injury Prevention Initiative. Background: The problem of children being injured while living, working, or visiting agricultural work environments (farms) has been recognized for several decades. The most recent data suggest about 100 youths under the age of 20 die on farms each year and about 27,600 farm-related injuries occur to the same age group. Many individuals and groups have advocated for the prevention of agricultural injuries experienced by youths, and media attention has been generated on the issue, but until 1996 a national coordinated effort to address the problem had not existed. In April 1996, the National Committee for Childhood Agricultural Injury Prevention (NCCAIP) published a report entitled Children and Agriculture: Opportunities for Safety and Health, A National Action Plan to promote the health and safety of children exposed to agricultural hazards. The National Action Plan recommends leadership, surveillance, research, education, and public policy. The plan specifically recommended that NIOSH serve as the lead federal agency in preventing childhood agricultural injury. Due in large part to the efforts by NCCAIP to raise awareness and concern about childhood agricultural injury issues, in October 1996, NIOSH began implementing a Childhood Agricultural Injury Prevention Initiative. In July, 1999, a review was conducted by NIOSH to seek input on the progress and direction of the Childhood Agricultural Injury Prevention Initiative to date. The input provided by stakeholders at that meeting was useful in providing insight into stakeholder needs and in helping to improve the Childhood Agricultural Injury Prevention Initiative. In 2001, a Childhood Agricultural Injury Prevention Summit was organized and convened by the National Children's Center for Rural and Agricultural Health and Safety (NCCRAHS), an extramurally funded component, five years after the implementation of the NIOSH Childhood Agricultural Injury Prevention Initiative. The goal of the summit was to conduct a five-year review of the 1996 National Action Plan and to use a consensus development process to generate strategies for the future. Specifically, participants were asked to consider: (a) Successes to date, (b) gaps and barriers in achieving objectives, (c) current and potential effective interventions not addressed in the National Action Plan, and (d) strategies for the future. To date, NIOSH has undertaken a number of activities, both intramurally and extramurally, to address the recommendations in the 1996 National Action Plan and the 2001 Childhood Agricultural Injury Prevention Summit. Status: The Document, NIOSH Childhood Agricultural Injury Prevention Initiative: Progress and Proposed Future Activities, will be available for comment by stakeholders and other interested members of the public. Written comments should be submitted to the NIOSH Docket Office as outlined in the next section. Docket: Written comments on the usefulness of the Childhood Agricultural Injury Prevention Initiative for improving childhood agricultural safety and suggestions for enhancing or improving the impact of the Initiative should be mailed to the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone (513) 533-8303, facsimile (513) 533-8285. Comments may also be submitted by e-mail to niocindocket@cdc.gov. E- mail attachments should be formatted in Microsoft Word. All materials submitted to the Agency should reference NIOSH docket number 145 and must be submitted by May 15, 2009 to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. After the comment period has closed, comments may be accessed electronically at https:// www.cdc.gov/niosh under the link to the NIOSH docket. As appropriate, NIOSH will post comments with the commenters' names, affiliations, and other information, on the Internet. Contact Person for Technical Information: David Hard, Health Scientist, Analysis and Field Investigations Branch, Division of Safety Research, telephone (304) 285-6068, E-mail DHard@cdc.gov, facsimile (304) 285-6235.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. app. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

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.

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.

The National Science Advisory Board for Biosecurity (NSABB), an advisory committee of the Federal Government, is hosting a public consultation to engage the scientific community and general public in a discussion of personnel reliability, with a focus on optimal characteristics of individuals with access to Select Agents. This public consultation is an opportunity for members of the scientific community and general public to provide input on these important issues.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 30, 2008, page 79889- 79890 and allowed 60-days for public comment. One comment was received and appropriate response was made. 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 current valid OMB control number. Proposed Collection: Title: Women's Health Initiative (WHI) Observational Study. Type of Information Collection Request: REVISION: OMB No. 0925-0414, Expiration date: 05/31/2009. Need and Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up years for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: Annually. Affected Public: Individuals and physicians. Type of Respondents: Women, next-of-kin, and physician's office staff. The annual reporting burden is as follows:

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 announces to LIHEAP grantees the estimated median income of four-person families in each State and the District of Columbia for FFY 2010 (October 1, 2009, to September 30, 2010). LIHEAP grantees that choose to base their income eligibility criteria on these State median income estimates may adopt these estimates (up to 60 percent) on the estimates' date of publication in the Federal Register or on a later date as discussed below. This enables these grantees to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2009, or the beginning of the grantees' fiscal years, whichever is later, these grantees must adjust their income eligibility criteria so that such criteria are in accord with the FFY 2010 State median income estimates. This listing of 60 percent 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 Food and Drug Administration (FDA) has determined the regulatory review period for PROFENDER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.