September 27, 2005 – Federal Register Recent Federal Regulation Documents

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. At this time, FDA is issuing proposed regulations to implement the act. These regulations propose procedures for designating a new animal drug as a minor use or minor species drug. Such designation establishes eligibility for the incentives provided by the MUMS act.

The Food and Drug Administration (FDA) is announcing that the following two petitions have been filed: A petition requesting that the agency revoke the standards of identity for goat's milk ice cream and mellorine, and amend the standards of identity for ice cream and frozen custard, sherbet, and water ices in numerous respects; and a petition requesting that the agency amend the standard of identity for parmesan and reggiano cheese to decrease the minimum curing time from 10 months to 6 months. The FDA is issuing an advance notice of proposed rulemaking (ANPRM) to request comments to determine whether the action proposed in the petitions would promote honesty and fair dealing in the interest of consumers.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 14, 2005 (Volume 70, Number 29, Pages 7508-7509, and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to the collection of information unless it displays a currently valid OMB control number. Proposed Collection: Title: Active Living by Design Program Evaluation. Type of Information Collection Request: NEW. Need and Use of Information Collection: The purpose of this study is to provide NIEHS with an overall evaluation of the Active Living by Design (ALbD) program to determine the extent to which program strategies to increase physical activity influence change, as measured by increased physical activity and reduction of Body Mass Index (BMI), in residents of participating communities. The objective of this study is to determine the degree to which the changes in the built environment, communication strategies and policy as a result of ALbD's program has impacted physical activity and BMI in residents within the twenty-five (25) participating communities relative to a set of ten (10) control communities. Two types of data collection will occur throughout the study. A telephone survey, which relies on self-reports, and a clinical survey, which will collect physical activity data using measures of physical activity such as, accelerometers; measures of BMI and an interview on respondents' perceptions of their neighborhood. The findings of this study will provide valuable information concerning (1) The Impact ALbD strategies have on increasing physical activity and bringing about positive changes in health associated with exercise, such as weight loss; and (2) possible reduction of health risks and diseases related to physical inactivity through implementation of ALbd strategies. Frequency of Response: Three times over a period of five (5) years, during three rounds of data collection. Affected Public: Individuals or households. Type of Respondents: Respondents includes adults and children ages 13 through 17 years and their parents. The clinical procedures require respondents under 18 years of age to be accompanied by their parent/guardian, therefore the burden has been doubled for these respondents. The annual reporting burden is respected in the following table:

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 Colorado River Basin Salinity Control Advisory Council (Council) was established by the Colorado River Basin Salinity Control Act of 1974 (Pub. L. 93-320) (Act) to receive reports and advise federal agencies on implementing the Act. In accordance with the Federal Advisory Committee Act, the Bureau of Reclamation announces that the Council will meet as detailed below. Dates and Location: The Council will conduct its annual meeting at the following time and location: Tuesday, October 25, 2005Riverside, CaliforniaThe meeting will be held in the Mission Inn located at 3649 Mission Inn Avenue. The meeting will begin at 8 a.m., recess at approximately 1 p.m., and reconvene briefly the following day at 1 p.m.

The FAA is adopting a new airworthiness directive (AD) for certain Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. This AD requires repetitive inspections of the intercostal webs, attachment clips, and stringer splice channels for cracks; and corrective action if necessary. This AD is prompted by reports of fatigue cracks on several Boeing Model 737-200 series airplanes. We are issuing this AD to detect and correct fatigue cracking of the intercostals on the forward and aft sides of the forward entry door, which could result in loss of the forward entry door and rapid decompression of the airplane.

The Fish and Wildlife Service published a document in the Federal Register on September 13, 2005 (70 FR 54146), amending 50 CFR part 32. This document related to the addition of refuges and wetland management districts to the list of areas open for hunting and/or sport fishing programs and increased the activities available at other refuges. We also developed pertinent refuge-specific regulations for those activities and amended certain regulations on other refuges that pertain to migratory game bird hunting, upland game hunting, big game hunting, and sport fishing for the 2005-2006 season. This document corrects the final regulations.

The FAA is adopting a new airworthiness directive (AD) for certain Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. This AD requires repetitive eddy current inspections for cracks of the countersunk rivet holes in the lower lobe, adjacent to the radio altimeter cutouts; additional inspections, for certain airplanes, for cracks and/or corrosion; and further investigative and corrective action if any crack is found. This AD also provides an optional terminating action for the repetitive inspections. This AD results from reports of cracks in the fuselage skin of the lower lobe. We are issuing this AD to detect and correct fatigue cracks of the countersunk rivet holes, which could result in cracks of the fuselage skin of the lower lobe, and consequent rapid depressurization of the cabin.

The FAA is adopting a new airworthiness directive (AD) for all BAE Systems (Operations) Limited Model ATP airplanes and Model HS 748 airplanes. This AD requires doing a detailed inspection of the drain pipes of the fuel cross feed system and certain electrical cables for chafe damage; doing an inspection to determine the clearance between the cable loom and the cross feed drain pipe; and doing corrective actions if necessary. This AD results from a fire in the dry area of the wing due to severe chafe damage between an electrical cable and the fuel cross feed drain pipe. We are issuing this AD to prevent chafe damage of the electrical cable and fuel cross feed drain pipe that could lead to fuel leakage from the drain pipe and an ignition source from the electrical cable, which could result in a fire in the dry area of the airplane wing.