May 23, 2006 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 23, 2006, page 3312 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: Actigraph Accelerometer Validation Study Type of Information Collection Request: New. Need and Use of Information Collection: The NCI is collaborating with other NIH Institutes on a proposed longitudinal study of Hispanic subpopulations in the United States referred to as the Hispanic Community Health Study. The Hispanic population is now the largest minority population in the U.S. with a projected three-fold growth by 2050. Hispanic subgroups are influenced by a number of chronic disease risk factors associated with immigration from different cultural settings and environments. These factors include diet, physical activity, community support, working conditions, and access to health care. Hispanic groups have higher rates of obesity and diabetes than non-Hispanic groups, but have lower coronary disease and cancer (all sites) mortality. There are also observed differences in health outcomes between Hispanic subgroups. For example, Puerto Ricans have a four-fold higher asthma prevalence than Mexican-Americans. Hispanic populations are understudied with respect to many diseases and risk factors. Their projected population growth underscores the need for accurate evaluation of their disease burden and risk. A vast amount of research suggests that the level of physical activity influences many of the chronic diseases and conditions of interest, including obesity, diabetes, cardiovascular disease, and cancer. To better understand the relationship between physical activity and chronic disease, and to make specific activity prescriptions, it is necessary to be able to accurately assess levels and types of activity. In particular, better methods are needed to improve the validity and reliability of physical activity assessment instruments to better assess the frequency, duration, and intensity of physical activity. For that reason, NCI plans to evaluate the use of a new type of accelerometer, a small device worn on a belt at the waist that measures and records movement, capturing movement intensity and duration and associating it with clock-time. This new accelerometer will be used in the Hispanic Community Health Study and will allow examination of levels as well as patterns of activity. Physical activity was measured with accelerometers in the nationally representative 2003-2006 National Health and Nutrition Examination Survey (NHANES) (OMB: 0920- 0237, October 15, 2004, Vol 69, pp. 61253-61254). NHANES provides estimates for Mexican-American, but not other Hispanic subgroups. Between the time of the NHANES and the Hispanic Community Health Study, there has been a change in the technology of the accelerometer used in NHANES. To allow comparison of the physical activity data that will be collected from the four Hispanic subgroups in the Hispanic Community Study to the data collected with the previous technology used in NHANES, a cross-validation study is needed. The proposed study, the ActiGraph Accelerometer Validation Study, will serve this purpose. It is a cross-validation study comparing the two ActiGraph accelerometer models under different circumstances of walking or jogging in differing age groups and for both genders. Frequency of response: One-time study. Affected Public: Individuals. Type of Respondents: Healthy adults between the ages of 18-74 years. The annual reporting burden is as follows: Estimated Number of Respondents: 144; Estimated Number of Responses per Respondent: 1.14; Average Burden Hours Per Response: 0.66; and Estimated Total Annual Burden Hours Requested: 62. The annualized cost to respondents is estimated at: $1116.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials.'' This draft guidance provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. This draft guidance is neither final nor is it in effect at this time.

This program is authorized by 42 U.S.C. 300u-2(a). The Office on Women's Health (OWH) is the focal point for women's health within the Department of Health and Human Services (DHHS). Under the direction of the Deputy Assistant Secretary for Women's Health, OWH provides leadership to promote health equity for women and girls through gender-specific approaches. To that end, OWH has established activities to address critical women's health issues nationwide. These include: developing and implementing model public/private partnerships that address the health issues of incarcerated and newly released women, largely women of color, living with HIV/AIDS/STDs or at increased risk for sexually transmitted infections. These may include piloting a comprehensive system of health related support services, such as ensuring access to health care and most current therapies, pre- release discharge planning, case managing transition processes, and establishing linkages to various community based support and prevention services. The OWH HIV/AIDS program began in 1999 with funding from the Minority AIDS Fund (formerly Minority AIDS Initiative) to address the gaps in services provided to women who are at risk or living with HIV. Since the inception of the HIV/AIDS programs, the program focus has expanded from two to seven. These programs include: (1) HIV Prevention for Women Living in the Rural South, (2) Prevention and Support for Incarcerated/ Newly Released Women, (3) Model Mentorship for Strengthening Organizational Capacity, (4) HIV Prevention for Young Women Attending Minority Institutions (e.g. Historically Black Colleges and Universities, Hispanic Serving Institutions, and Tribal Colleges and Universities), (5) HIV Prevention for Women Living in the U.S. Virgin Islands, (6) Prevention and Support for HIV Positive Women Living in Puerto Rico, and (7) Inter- generational Approaches to HIV/AIDS Prevention Education with Women across the Lifespan. Funding will be directed at activities designed to improve the delivery of services to women disproportionately impacted by HIV/AIDS.

On April 28, 2006, the Department of State certified, pursuant to Section 609 of Public Law 101-162 (``Section 609''), that 14 nations have adopted programs to reduce the incidental capture of sea turtles in their shrimp fisheries comparable to the program in effect in the United States. The Department also certified that the fishing environments in 24 other countries and one economy, Hong Kong, do not pose a threat of the incidental taking of sea turtles protected under Section 609. Shrimp imports from any nation not certified were prohibited effective May 1, 2006 pursuant to Section 609.

The Office on Women's Health (OWH) within the Department of Health and Human Services (DHHS) is the government's champion and focal point for women's health issues, and works to redress inequities in research, health care services, and education that have historically placed the health of women at risk. The OWH coordinates women's health efforts within DHHS to eliminate disparities in health status and supports culturally sensitive educational programs that encourage women to take personal responsibility for their own health and wellness. To that end, OWH has established public/private partnerships to address critical women's health issues nationwide, namely mentoring partnerships (prot[eacute]g[eacute] and mentor) meant to strengthen the capacity of non-profit organizations that provide HIV/AIDS prevention services to women at risk and/or living with HIV/AIDS. Women of color represent over 80 percent of the reported AIDS cases. Younger women are increasingly at higher risk for HIV/AIDS. Thus, the Mentoring Partnership ProgramProt[eacute]g[eacute] intends to demonstrate how small, non-profit, community-based, faith-based, and women's service organizations will be strengthened, programs/service effectiveness increased, and gender-focused and culturally competent practices instituted so that efforts to reach women most at risk and/or living with HIV/AIDS are increased. The non-profit community-based, faith- based, and women's service organizations receive training to increase their competencies in operating a sound organization. Moreover, mentors prepare prot[eacute]g[eacute]s to compete for additional public and private funding. During the funding period, prot[eacute]g[eacute] organizations will demonstrate a gain in knowledge and skills by reaching more women with HIV/AIDS prevention education and support services. In order to improve HIV/AIDS program services to women, prot[eacute]g[eacute] grantees are also required to receive additional training by attending two HIV/AIDS prevention conferences (regional and national) and establish collaborative partnerships with the local health and social service departments for referral resources in areas such as primary health care, housing, education, job and/or trade training, to name a few.

EPA is announcing that Versar, Inc., an EPA contractor for external scientific peer review, plans to convene an independent panel of experts and organize and conduct an external peer review meeting to review the draft document titled, ``Harmonization in Interspecies Extrapolation: Use of BW3/4 as Default Method in Derivation of the Oral RfD'' (EPA/630/R-06/001). The peer review meeting is planned to take place by teleconference. On Februrary 15, 2006, EPA announced a 60-day public comment period for the draft document (71 FR 7958). The draft document was prepared by the Agency's Risk Assessment Forum. The public comment period and the external peer review are separate processes that provide opportunities for all interested parties to comment on the document. In addition to considering public comments submitted in accordance with the February 15, 2006, announcement of a public comment period, EPA intends to forward those comments to Versar, Inc. for the external peer review panel prior to the teleconference. EPA is releasing this draft document solely for the purpose of pre- dissemination peer review under applicable information quality guidelines. This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination. The public will be given an opportunity to observe and provide oral comments at this teleconference by registering with Versar, Inc. (see FOR FURTHER INFORMATION CONTACT, below). The draft document and the charge questions for EPA's external peer review are available primarily via the Internet on the Risk Assessment Forum's home page under the External Review Drafts menu at https://cfpub.epa.gov/ncea/raf/index.cfm. In preparing a final report, EPA will consider Versar Inc.'s report of the comments and recommendations from the external peer review meeting and any public comments that EPA receives in accordance with the February 15, 2006, notice (71 FR 7958).

EPA today, pursuant to section 209(e) of the Clean Air Act (Act), 42 U.S.C. 7543(b), is authorizing California to enforce its regulations setting emission standards and other requirements for large off-road spark-ignition engines.

The EPA Human Studies Review Board (HSRB) announces a public teleconference meeting to discuss its draft HSRB report from the April 4-6, 2006 HSRB meeting.

We propose to adopt a new airworthiness directive (AD) for certain Raytheon Aircraft Company Model 390 airplanes. This proposed AD would require you to inspect the spigot bearing, part number (P/N) MS14104-16, for the proper position in the spigot fitting assembly and to install the wing spigot bearing retainer kit, P/N 390-4304-0001. This proposed AD results from two reports of the spigot bearing not being positioned flush with the fitting assembly, but protruding outside of the fitting assembly. We are proposing this AD to detect spigot bearings that are not positioned flush with the fitting assembly. This condition could result in the spigot bearing becoming disengaged from the fitting assembly, which could cause motion between the wing and the fuselage and degrade the structural integrity of the wing attachment to the fuselage. This could lead to wing separation and loss of control of the airplane.

This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed highway project that relocates SR-73 from near Mitchell Road northwest of the City of Wilmington, to near Airborne Road east of the City of Wilmington, in Clinton County, Ohio. Those actions grant licenses, permits, and approvals for the project.

The U.S. Fish and Wildlife Service (Service) intends to gather information necessary to prepare a Comprehensive Conservation Plan (CCP) and associated environmental documents for Sullys Hill National Game Preserve (NGP) located in Devils Lake, North Dakota. The Service is issuing this notice in compliance with its policy to advise other organizations and the public of its intentions, and to obtain suggestions and information on the scope of issues to be considered in the planning process.

We are announcing receipt of a proposed amendment to the Pennsylvania regulatory program (hereinafter, the ``Pennsylvania program'') under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Pennsylvania submitted separate letters proposing as effective as determinations to remove four OSM-issued required amendments. Pennsylvania asserts that its program, in the case of these required amendments, is as effective as the corresponding Federal regulations and SMCRA and can be removed. We are also providing discussions to remove three more required amendments. This document gives the times and locations that the Pennsylvania program and this submittal are available for your inspection, the comment period during which you may submit written comments, and the procedures that we will follow for the public hearing,

This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Oak Ridge Reservation. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

This is a notice of an Administrative declaration of a disaster for the State of Massachusetts dated 5/16/2006. Incident: Condominium Complex Fire. Incident Period: 4/15/2006. Effective Date: 5/16/2006. Physical Loan Application Deadline Date: 7/17/2006. Economic Injury (EIDL) Loan Application Deadline Date: 2/16/2007.

NARA is giving public notice that the agency proposes to request extension of three currently approved information collections. This information collection is used for requesting permission to use NARA facilities for events. The public is invited to comment on the proposed information collection pursuant to the Paperwork Reduction Act of 1995.

In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Automated Survey Processing Environment (ASPEN) Complaints/Incidents Tracking System (ACTS),'' System No. 09-70-1519, last published at 68 FR 50795 (August 22, 2003). CMS is reorganizing its databases because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173) provisions and the large volume of information the Agency collects to administer the Medicare program. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained the system of records. The new assigned identifying number for this system should read: System No. 09-70-0565. We propose to delete published routine uses number 5 authorizing disclosures to the agency of a state government, number 8 authorizing disclosure to researchers, and number 12 authorizing disclosure to another agency or instrumentality of any governmental jurisdiction. Disclosures permitted under routine uses number 5 and 12 will be made a part of proposed routine use number 2. The scope of routine use number 2 will be broadened to allow for release of information to ``another Federal and/or state agency, an agency established by state law, or its fiscal agent.'' Routine use number 8 is being deleted because disclosure of ACTS data for research and evaluation purposes will be restricted to the release of aggregate data rather than individual- specific data. CMS proposes to exempt this system from the notification, access, correction and amendment provisions of the Privacy Act of 1974 (5 U.S.C. 552a (k) (2)) due to investigatory and law enforcement activities. 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 MMA provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to track and process complaints and incidents reported against Medicare and/or Medicaid certified providers and suppliers, and CLIA-certified laboratories, these include: skilled nursing facilities, nursing facilities, hospitals, home health agencies, end-stage renal disease facilities, hospices, rural health clinics, comprehensive outpatient rehabilitation facilities, outpatient physical therapy services, community mental health centers, ambulatory surgical centers, suppliers of portable X-Ray services, and intermediate care facilities for persons with mental retardation. The 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 grantee; (2) assist another Federal or state agency, an agency established by state law, or its fiscal agent; (3) assist Quality Improvement Organizations; (4) support constituent requests made to a Congressional representative; (5) support litigation involving the agency; (6) assist a national accreditation organization that has been granted deeming authority by CMS; (7) assist a state- mandated Protection and Advocacy System that provides legal representation and other advocacy services to beneficiaries; and (8) combat fraud and abuse in certain Federally-funded health benefits programs. We have provided background information about the modified 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 modified or altered routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

Notice is hereby given that the comment period on the proposed United States Standards for Grades of Pea Pods is reopened and extended.