Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Loan Repayment Program, 29520-29521 [E8-11184]

Download as PDF 29520 Federal Register / Vol. 73, No. 99 / Wednesday, May 21, 2008 / Notices electronic comments to http:// www.regulations.gov. Paul E. Levine, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc)’’ dated May 2008. FDA is providing recommendations to establishments that collect human blood or blood components for a requalification method or process for the reentry of deferred donors into the donor pool based on a determination that previous tests that were repeatedly reactive for anti-HBc were falsely positive and that there is no evidence of infection with HBV. Due to the availability of this licensed HBV nucleic acid test and the improved specificity of anti-HBc assays, we are recommending a reentry algorithm for donors deferred due to a falsely positive repeatedly reactive test for anti-HBc in this guidance. Until now FDA has not recommended a requalification method or process for reentry of donors deferred due to reactive test results for hepatitis B core antigen (anti-HBc) due to the lack of licensed tests that could be recommended for use in a suitable algorithm for this purpose. The draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations. cprice-sewell on PROD1PC69 with NOTICES II. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified VerDate Aug<31>2005 15:18 May 20, 2008 Jkt 214001 with the docket number found in the brackets in the heading of this document. A copy of the draft guidance and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. The petition proposes to amend the food additive regulations in part 172, Food Additives Permitted for Direct Addition to Food for Human Consumption (21 CFR part 172) to provide for the safe use of cassia gum as a stabilizer in frozen dairy desserts, and to improve texture and water retention in cheeses, meat products, and poultry products. The agency has determined under 21 CFR 25.32(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. III. Electronic Access Dated: May 13, 2008. Laura M. Tarantino, Director, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. [FR Doc. E8–11279 Filed 5–20–08; 8:45 am] Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/cber/guidelines.htm or http://www.regulations.gov. Dated: May 12, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–11433 Filed 5–20–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES BILLING CODE 4160–01–S Indian Health Service DEPARTMENT OF HEALTH AND HUMAN SERVICES Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Loan Repayment Program Food and Drug Administration AGENCY: [Docket No. FDA–2008–F–0290] ACTION: Lubrizol Advanced Materials, Inc.; Filing of Food Additive Petition SUMMARY: In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917– 0014, ‘‘Indian Health Service Loan Repayment Program.’’ Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917– 0014, ‘‘Indian Health Service Loan Repayment Program.’’ Form(s): The IHS Loan Repayment Program Information Booklet contains the instructions and the application formats. Need and Use of Information Collection: The IHS Loan Repayment Program (LRP) identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract under which the IHS agrees to repay AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that Lubrizol Advanced Materials, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of cassia gum as a stabilizer in frozen dairy desserts, and to improve texture and water retention in cheeses, meat products, and poultry products. FOR FURTHER INFORMATION CONTACT: Raphael A. Davy, Center for Food Safety and Applied Nutrition (HFS–265), Food and Drug Administration, 5100 Paint Branch Pkwy, College Park, MD 20740– 3835, 301–436–1272. SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 8A4772) has been filed by Lubrizol Advanced Materials, Inc., c/o Keller & Heckman LLP, 1001 G St., NW., suite 500 West, Washington, DC 20001. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM Indian Health Service, HHS. Notice. 21MYN1 29521 Federal Register / Vol. 73, No. 99 / Wednesday, May 21, 2008 / Notices part or all of their indebtedness for professional training time in IHS health care facilities. This program is necessary to augment the critically low health professional staff at IHS health care facilities. Any health professional wishing to have their health education loans repaid may apply to the IHS Loan Repayment Program. A two-year contract obligation is signed by both parties, and the individual agrees to work at an IHS location and provide health services to Native American and Alaska Native individuals. The information collected from individuals is analyzed and a score is given to each applicant. This score will determine which applicants will be awarded each fiscal year. The administrative scoring system assigns a score to the geographic location according to vacancy rates for that fiscal year and also considers whether the location is in an isolated area. When an applicant takes employment at a location, they in turn ‘‘pick-up’’ the score of that location. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s). ESTIMATED BURDEN HOURS Estimated number of respondents Data collection instrument 510 510 510 510 510 2,000 Total .......................................................................................................... cprice-sewell on PROD1PC69 with NOTICES Section I ........................................................................................................... Section II .......................................................................................................... Section III ......................................................................................................... Contract ........................................................................................................... Affidavit ............................................................................................................ Lender’s Certification ....................................................................................... Responses per respondent Average burden hour per response 4,650 There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. Request for Comments: Your written comments and/or suggestions are invited on one or more of the following points: (a) Whether the information collection activity is necessary to carry out an agency function; (b) whether the agency processes the information collected in a useful and timely fashion; (c) the accuracy of public burden estimate (the estimated amount of time needed for individual respondents to provide the requested information); (d) whether the methodology and assumptions used to determine the estimates are logical; (e) ways to enhance the quality, utility, and clarity of the information being collected; and (f) ways to minimize the public burden through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Send Comments and Requests for Further Information: Send your written comments, requests for more information on the proposed collection, or requests to obtain a copy of the data collection instrument(s) and instructions to: Ms. Chria Rouleau, IHS Reports Clearance Officer, 801 Thompson Avenue, TMP 450, Rockville, MD 20852–1627; call non-toll free (301) 443–5938; send via facsimile to (301) 594–0899; or send your e-mail requests, comments, and return address to: Christina.Rouleau@ihs.gov. VerDate Aug<31>2005 15:18 May 20, 2008 Jkt 214001 Comment Due Date: Your comments regarding this information collection are best assured of having full effect if received within 60 days of the date of this publication. Dated: May 13, 2008. Robert G. McSwain, Director, Indian Health Service. [FR Doc. E8–11184 Filed 5–20–08; 8:45 am] BILLING CODE 4165–16–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: 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. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 1 1 4 1 1 18/60 30/60 15/60 20/60 10/60 15/60 Total annual burden hours 153.0 255.0 128.0 170.0 85.0 500.0 1,282.0 Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301/ 496–7057; fax: 301/402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Synthetic Analogs of Juxtamembrane Domain of IGF–1 Receptor as AntiCancer Agents Description of Technology: Insulinlike growth factor receptor type one (IGF–1R), part of the receptor tyrosine kinase (RTKs) family, is integral to cancer cell growth and metastasis. Juxtamembrane domains (JM) of RTKs are located in the cytoplasm between the transmembrane and kinase domains. JMs play a crucial role in the inhibition of the regulation of receptor activity. Studies on other small molecules tyrosine kinase inhibitors (TKIs) indicate non-specific binding with the insulin receptor which has high homology with IGF–1R. The current invention describes synthetic analogs of IGF–1R JM which were found to be potent inhibitors of IGF–1–mediated cell signaling and cancer cell growth. These analogs provide more binding specificity with less likelihood of significant toxic effects. Applications and Modality: New inhibitors can be used to treat many types of tumors. E:\FR\FM\21MYN1.SGM 21MYN1

Agencies

[Federal Register Volume 73, Number 99 (Wednesday, May 21, 2008)]
[Notices]
[Pages 29520-29521]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-11184]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service


Request for Public Comment: 60-Day Proposed Information 
Collection: Indian Health Service Loan Repayment Program

AGENCY: Indian Health Service, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995, which requires 60 days for public comment on 
proposed information collection projects, the Indian Health Service 
(IHS) is publishing for comment a summary of a proposed information 
collection to be submitted to the Office of Management and Budget (OMB) 
for review.
    Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan 
Repayment Program.'' Type of Information Collection Request: Extension, 
without revision, of currently approved information collection, 0917-
0014, ``Indian Health Service Loan Repayment Program.'' Form(s): The 
IHS Loan Repayment Program Information Booklet contains the 
instructions and the application formats. Need and Use of Information 
Collection: The IHS Loan Repayment Program (LRP) identifies health 
professionals with pre-existing financial obligations for education 
expenses that meet program criteria and who are qualified and willing 
to serve at, often remote, IHS health care facilities. Under the 
program, eligible health professionals sign a contract under which the 
IHS agrees to repay

[[Page 29521]]

part or all of their indebtedness for professional training time in IHS 
health care facilities. This program is necessary to augment the 
critically low health professional staff at IHS health care facilities.
    Any health professional wishing to have their health education 
loans repaid may apply to the IHS Loan Repayment Program. A two-year 
contract obligation is signed by both parties, and the individual 
agrees to work at an IHS location and provide health services to Native 
American and Alaska Native individuals.
    The information collected from individuals is analyzed and a score 
is given to each applicant. This score will determine which applicants 
will be awarded each fiscal year. The administrative scoring system 
assigns a score to the geographic location according to vacancy rates 
for that fiscal year and also considers whether the location is in an 
isolated area. When an applicant takes employment at a location, they 
in turn ``pick-up'' the score of that location. Affected Public: 
Individuals and households. Type of Respondents: Individuals.
    The table below provides: Types of data collection instruments, 
Estimated number of respondents, Number of responses per respondent, 
Annual number of responses, Average burden hour per response, and Total 
annual burden hour(s).

                                             Estimated Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                     Estimated                        Average
           Data collection instrument                number of     Responses per    burden hour    Total annual
                                                    respondents     respondent     per response    burden hours
----------------------------------------------------------------------------------------------------------------
Section I.......................................             510               1           18/60           153.0
Section II......................................             510               1           30/60           255.0
Section III.....................................             510               4           15/60           128.0
Contract........................................             510               1           20/60           170.0
Affidavit.......................................             510               1           10/60            85.0
Lender's Certification..........................           2,000  ..............           15/60           500.0
                                                 ---------------------------------------------------------------
    Total.......................................           4,650  ..............  ..............         1,282.0
----------------------------------------------------------------------------------------------------------------

    There are no Capital Costs, Operating Costs, and/or Maintenance 
Costs to report.
    Request for Comments: Your written comments and/or suggestions are 
invited on one or more of the following points: (a) Whether the 
information collection activity is necessary to carry out an agency 
function; (b) whether the agency processes the information collected in 
a useful and timely fashion; (c) the accuracy of public burden estimate 
(the estimated amount of time needed for individual respondents to 
provide the requested information); (d) whether the methodology and 
assumptions used to determine the estimates are logical; (e) ways to 
enhance the quality, utility, and clarity of the information being 
collected; and (f) ways to minimize the public burden through the use 
of automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology.
    Send Comments and Requests for Further Information: Send your 
written comments, requests for more information on the proposed 
collection, or requests to obtain a copy of the data collection 
instrument(s) and instructions to: Ms. Chria Rouleau, IHS Reports 
Clearance Officer, 801 Thompson Avenue, TMP 450, Rockville, MD 20852-
1627; call non-toll free (301) 443-5938; send via facsimile to (301) 
594-0899; or send your e-mail requests, comments, and return address 
to: Christina.Rouleau@ihs.gov.
    Comment Due Date: Your comments regarding this information 
collection are best assured of having full effect if received within 60 
days of the date of this publication.

    Dated: May 13, 2008.
Robert G. McSwain,
Director, Indian Health Service.
 [FR Doc. E8-11184 Filed 5-20-08; 8:45 am]
BILLING CODE 4165-16-M