Department of Health and Human Services September 2, 2005 – Federal Register Recent Federal Regulation Documents

This document corrects the notice that appeared in the Federal Register on August 29, 2005, (70 FR 51065), entitled ``Federal Guidelines for Requesting, Stockpiling, Distributing Potassium Iodide (KI) From the Strategic National Stockpile (SNS)'. We inadvertently omitted the DATES section of the notice to inform the public of how long we will be receiving comments. We are adding the DATES section to read as follows:

The Office of Global Health Affairs (OGHA) announces that up to $475,000 in fiscal year (FY) 2005 of funds is available for one (1) cooperative agreement to provide support to strengthen the management of women's and children's hospitals by the Afghan Ministry of Public Health (MOPH) in Kabul. This effort is an undertaking by the Department of Health and Human Services (HHS) in partnership with the Afghan MOPH. The primary goal of this project is to improve the quality of care at women's and children's health institutions in Afghanistan. The OGHA anticipates substantial HHS scientific and programmatic involvement in the administration of the quality improvement program. The project will be approved for up to a one-year period for a total of $475,000 (including indirect costs). Funding for the cooperative agreement is contingent upon the availability of funds

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 medical device recall authority.

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director (OD), Office of Extramural Research (OER), 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. Proposed information collection was previously published in the Federal Register on May 12, 2005, Volume 70, No. 91, page 25095 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: Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors42 CFR Part 50, Subpart F; Type of Information Collection Request: Extension, OMB 0925-0417, Expiration Date 8/31/05. Need and Use of Information Collection: This is a request for OMB approval for the information collection and recordkeeping requirements contained in the final rule 42 CFR Part 50 Subpart F and Responsible Contractors: 45 CFR Part 94. Frequency of response: On occasion. Affected Public: Individuals or households; business or other for-profit; not-for-profit institutions; and State, Local or Tribal Government. Type of Respondents: Any public or private entity or organization. The annual reporting burden is as follows: Estimated Number of Respondents: 42,800; Estimated Number of Responses per Respondent: 1.60; Average Burden Hours Per Response: 3.40; and Estimated Total Annual Burden Hours Request: 232,000. 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 NIR. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Ms. Diane Dean, Division of Grants Policy, Office of Policy for Extramural Research Administration, NIH, Rockledge 1 Building, Room 3525, 6705 Rockledge Drive, Bethesda, MD 20892-7974, or call non-toll-free number 301-435-0930, or E-mail your request, including your address to: hahnm@od.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.

This final notice announces the availability of funds and award procedures for FY 2005 Targeted Assistance Program (TAP) grants to States for services to refugees under the Refugee Resettlement Program (RRP). These grants are for service provision in localities with large refugee populations, high refugee concentrations, and where specific needs exist for supplementation of currently available resources. Qualification of counties for eligibility for targeted assistance program grants is determined once every three years as stated in the FY 1999 Notice of Proposed Availability of Targeted Assistance Allocations to States which was published in the Federal Register on March 10, 1999 (64 FR 11927). The FY 2002-FY 2004 three-year project cycle has expired. FY 2005 is the year for the re-qualification of counties for the three-year project cycle, FY 2005, FY 2006, and FY 2007 for TAP funds. Qualifications of counties are based on the arrivals of refugees (see Footnote 1, eligible population) during the 5-year period from FY 2000 through FY 2004, and on the concentration of the arrivals population as a percentage of the general population. Counties that qualify for TAP FY 2005 funds on the basis of the most current 5-year population are listed in this proposed notice in Table 1, Table 2, Table 4, and Table 6. Under this final notice, a total of 48 counties (Table 1) qualify for targeted assistance grants. Of these, 6 new counties (Table 2) qualify for targeted assistance grants, and 11 counties (Table 3) which previously received targeted assistance grants no longer qualify for targeted assistance program funding. Application Deadline: Application deadline for targeted assistance program funding will be September 12, 2005. A full application is required this qualifying year, FY 2005. Six (6) new counties are eligible for targeted assistance. Counties that have received TAP funds in the past and will continue to qualify for TAP have not been required to submit a full application since FY 2002. Application requirements in the second and third of a 3-year project cycle will be less extensive.