Department of Health and Human Services February 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for FDA staff and industry entitled ``Compliance Policy Guide (CPG) Sec. 310.210 Blood Pressure Measurement Devices (Sphygmomanometers)Accuracy (CPG 7124.23).'' This draft CPG provides guidance concerning accuracy and exhaust rate criteria for sphygmomanometers. This draft guidance is being issued for public comment only and will not be implemented until a final CPG is announced in the Federal Register.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The supplemental ANADA provides for an additional dose of trenbolone acetate and estradiol implant for use in feedlot heifers for increased rate of weight gain and improved feed efficiency.

This notice announces the estimated median income for four- person families in each State and the District of Columbia for FFY 2006 (October 1, 2005 to September 30, 2006). LIHEAP grantees may adopt the State median income estimates beginning with the date of this publication of the estimates in the Federal Register or at a later date as discussed below. This means that LIHEAP grantees could choose to implement this notice during the period between the heating and cooling seasons. However, by October 1, 2005, or by 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 2006 State median income estimates. This listing of estimate 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 Office of Population Affairs, Office of Public Health and Science, Department of Health and Human Services, published a notice in the Federal Register July 7, 2004, announcing the anticipated availability of funds for family planning services grants. This notice contained an error. An eligible Population/area was not listed as available for competition in 2005. A document correcting the omission of the Seattle, Washington Population/area as competitive in 2005 was published in the Federal Register August 10, 2004. Later, two additional Populations/areas, Illinois, Chicago area and Arizona, Navajo Nation, became available for competition in 2005. A second correction notice was published in the Federal Register November 22, 2004, which included all Populations/areas available for competition in 2005. Since that time, it has been recognized that the project period start date indicated in Table I for the Seattle, Washington Population/ area is incorrect. This notice corrects the project period start date to 09/30/2005 for the FY 2005 competitive year. However, the first year of the project period beginning 09/30/2005 will be abbreviated. The budget period for the 01-year will end on 06/30/2006. In subsequent years, the annualized budget period will begin on 07/01 of each project period year, and will end on 06/30 of each project period year. The purpose of this change is to modify the project period start and end dates for the Seattle, Washington Population/area in order to enhance project oversight.

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a generally recognized as safe (GRAS) affirmation petition (GRASP 3G0287) proposing that the use of gum acacia (arabic) in alcoholic beverages up to a maximum level of 20 percent in the finished preparation (liqueur) is GRAS.

The Indian Health Service published a document in the Federal Register on January 19, 2005. The document contained two errors.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 3, 2005 (70 FR 5686). The document announced a public workshop. The document was published with a typographical error in the Supplementary Information section. This document corrects that error.

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 Institutes 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 December 8, 2004, pages 71061-71062, 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, 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: Hazardous Waste Worker Training42 CFR Part 65. Type of Information Collection Request: Revision of OMB No. 0925-0348, expiration date February 28, 2005. Need and Use of Information Collection: This request for OMB review and approval of the information collection is required by regulation 42 CFR part 65(a)(6). The National Institute of Environmental Health Sciences (NIEHS) has been given major responsibility for initiating a worker safety and health training program under Section 126 of the Superfund Amendments and Reauthorization Act of 1986 (SARA) for hazardous waste workers and emergency responders. A network of non-profit organizations that are committed to protecting working and their communities by delivering high-quality, peer-reviewed safety and health curricula to target populations of hazardous waste workers and emergency responders has been developed. In seventeen years (FY 1987-2004), the NIEHS Worker Training program has successfully supported 20 primary grantees that have trained more than 1.3 million workers across the country and presented over 69,000 classroom and hands-on training courses, which have accounted for nearly 18 million contact hours of actual training. Generally, the grant will initially be for one year, and subsequent continuation awards are also for one year at a time. Grantees must submit a separate application to have the support continued for each subsequent year. Grantees are to provide information in accordance with S65.4 (a), (b), (c) and 65.6 (b) on the nature, duration, and purpose of the training, selection criteria for trainees' qualifications and competency of the project director and staff, cooperative agreements in the case of joint applications, the adequacy of training plans and resources, including budget and curriculum, and response to meeting training criteria in OSHA's Hazardous Waste Operations and Emergency Response Regulations (29 CFR 1910.120). As a cooperative agreement, there are additional requirements for the progress report section of the application. Grantees are to provide their information in hard copy as well as enter information into the WETP Grantee Data Management System. The information collected is used by the Director through officers, employees, experts, and consultants to evaluate applications based on technical merit to determine whether to make awards. Frequency of Response: Biannual. Affected Public: Non-profit organizations. Type of Respondents: Grantees. The annual reporting burden is as follows: Estimated Number of Respondents: 18; Estimated Number of Responses per Respondent: 2; Average Burden Hours Per Response: 10; and Estimated Total Annual Burden Hours Requested: 360. The annualized cost to respondents is estimated at: $10,764. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Joseph T. Hughes, Jr., Director, Worker Education and Training Program, Division of Extramural Research and Training, NIEHS, P.O. Box 12233, Research Triangle Park, NC 27709 or call non-toll-free number (919) 541-0217 or E-mail your request, including your address to wetp@niehs.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``The Open Public Hearing; FDA Advisory Committee Meetings.'' This draft guidance is for members of the public who choose to participate in the open public hearing (OPH) session of an FDA advisory committee meeting. The draft guidance is intended to answer more fully questions about how the public may participate at an OPH session, and it includes topics such as meeting logistics and administrative requirements.

In compliance with the requirement of Section 3506(c0(2)(A) 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) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Agricultural Health StudyA Prospective Cohort Study of Cancer and Other Diseases Among Men and Women in Agriculture: Phase III. Type of Information Collection Request: New. Need and Use of Information Collection: The purpose of this information collection is to update occupational and environmental exposure information as well as medical history information for subjects enrolled in the in the Agriculture Health Study. The primary objectives of the study are to determine the health effects resulting from occupational and environmental exposures in the agricultural environmental. The findings will provide valuable information concerning the potential link between agricultural exposures and cancer and other chronic diseases among agricultural Health Study cohort members, and this information may be generalized to the entire agricultural community. Frequency of Response: Single time reporting. Affected Public: Individuals or households; farms; Type of Respondents: Licensed pesticide applicators and their spouses. The annual reporting burden is as follows: Estimated Number of Respondents: 74,714; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 0.6179; and Estimated Total Annual Burden Hours Requested: 46,166. The annualized cost to respondents is estimated at: $461,660.00. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.