Agency Information Collection Activities: Submission for OMB Review; Comment Request, 9251-9252 [E9-4460]

Download as PDF 9251 Federal Register / Vol. 74, No. 40 / Tuesday, March 3, 2009 / Notices Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information related to the content and format of labeling have been approved under OMB control no. 0910–0572; the collections of information related to pharmacogenomic data have been approved under OMB control no. 0910– 0557. IV. Electronic Access Persons with access to the Internet may obtain the document at http:// www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/ guidelines.htm, or http:// www.regulations.gov. Dated: February 20, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–4372 Filed 3–2–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, e-mail paperwork@hrsa.gov or call the HRSA Reports Clearance Officer on (301) 443– 1129. Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the agency; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. In compliance with the requirement for opportunity for public comment on Number of respondents Form Responses per respondent Proposed Project: HRSA Office of Performance Review (OPR) Leading Practices Data Collection Initiative— NEW HRSA conducts performance reviews to assure that HRSA-funded grantees are successfully accomplishing their program purposes. While the Office of Performance Review’s (OPR) primary function is to conduct performance reviews, another core function is to identify leading practices through the performance review process. The purpose of this submission is to collect qualitative information from diverse grantees across HRSA and identify a program component (activity, strategy, process, or intervention) that has been shown to work effectively, and produce successful outcomes, supported by objective and/or subjective data sources. Some characteristics of the program components that grantees will be asked to describe are their ability to be replicable and adaptable, ability to be documented, and ability to lead to successful program outcomes. In order to document and evaluate leading practices, grantees with potential leading practices will be asked to complete both the Data Collection Tool and the Narrative. The information collected through these documents will be submitted to OPR. The estimated annual burden is as follows: Total responses Hours per response Total burden hours Data Collection Tool ............................................................ Narrative ............................................................................... 40 40 1 1 40 40 3 3 120 120 Total .............................................................................. ........................ ........................ ........................ ........................ 240 E-mail comments to paperwork@hrsa.gov or mail the HRSA Reports Clearance Officer, Room 10–33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: February 24, 2009. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E9–4459 Filed 3–2–09; 8:45 am] mstockstill on PROD1PC66 with NOTICES BILLING CODE 4165–15–P VerDate Nov<24>2008 16:42 Mar 02, 2009 Jkt 217001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, e-mail paperwork@hrsa.gov or call the HRSA PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 Reports Clearance Office on (301) 443– 1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Health Centers Patient Survey—New. The Health Center program supports Community Health Centers (CHCs), Migrant Health Centers (MHCs), Health Care for the Homeless (HCH) projects, and Public Housing Primary Care (PHPC) programs. Health Centers receive grants from HRSA to provide primary and preventive health care services to medically underserved populations. The proposed Patient Survey will collect in-depth information about health center patients, their health E:\FR\FM\03MRN1.SGM 03MRN1 9252 Federal Register / Vol. 74, No. 40 / Tuesday, March 3, 2009 / Notices status, the reasons they seek care at health centers, their diagnoses, the services they utilize at health centers and elsewhere, the quality of those services, and their satisfaction with the care they receive, through personal interviews of a stratified random sample of health center patients. Interviews are planned to take approximately 1 hour and six minutes each. The Patient Survey builds on previous periodic User-Visit Surveys which were conducted to learn about the process and outcomes of care in CHCs and HCH projects. The original survey questions were derived from the National Health Interview Survey (NHIS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS) conducted by the National Center for Health Statistics (NCHS). Conformance with the NHIS and NHAMCS allowed comparisons between these NCHS surveys and the previous CHC and HCH User-Visit Surveys. The new Patient Survey was developed using a questionnaire methodology similar to that used in the past, and will also allow some longitudinal comparisons for CHCs and HCH projects with the previous UserVisit survey data, including monitoring of process outcomes over time. In addition, this survey will include interviews of patients drawn from migrant populations and from residents of public housing; these populations were not included in the previous surveys. The annual estimate of burden is as follows: The estimated response burden for the survey is as follows: SURVEY Number of respondents Responses per respondent Grantee/Site Recruitment and Site Training .......................................... Patient Recruitment ............................................................................... Patient Survey ....................................................................................... 115 5,658 4,526 3 1 1 345 5,658 4,526 3.75 .167 1.1 1,294 945 4,979 Total ................................................................................................ 5,773 .................... 10,529 ...................... 7,218 Type of respondent; activity involved Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–6974. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ Dated: February 24, 2009. Alexandra Huttinger, Director, Division of Policy Review and Coordination. [FR Doc. E9–4460 Filed 3–2–09; 8:45 am] Prevention of Head and Neck Cancer Using Rapamycin and Its Analogs BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. mstockstill on PROD1PC66 with NOTICES ACTION: Notice. 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. VerDate Nov<24>2008 16:42 Mar 02, 2009 Jkt 217001 Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the 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. ADDRESSES: Description of Technology: It is frequently observed in head and neck squamous cell carcinoma (HNSCC), a cancer occurring mostly in the mouth, that the Akt/mTOR pathway is abnormally activated. Therefore, inhibiting this signaling pathway may help in treating this disease. Rapamycin and its analogs are known to inhibit the activity of mTOR so in principle they could serve as therapeutics for treating HNSCC. Researchers at the NIH have developed a method of potentially preventing or treating HNSCC through the inhibition of mTOR activity. The proof of this principle was demonstrated by rapid regression of mouth tumors in mice afflicted with Cowden syndrome with the administration of rapamycin. Like HNSCC, development of this disease is linked to over activation of the Akt/ mTOR pathway. Furthermore, the therapeutic potential of rapamycin was demonstrated using mice in PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Total number of responses Burden per response (hours) Total hour burden experiments that model chronic exposure to tobacco, which promotes the development of HNSCC. Therefore, inhibitors of mTOR have considerable potential in the prevention and treatment of HNSCC. Applications: Preventing the development of oral cancer using mTOR inhibitors to halt progression of precancerous lesions. Market: Approximately 500,000 new cases of squamous cell carcinomas of the head and neck arise every year making it the 6th most common cancer in the world. Frequently, prognosis is poor due to late detection of cancer. Development Status: Pre-clinical proof of principle. Inventors: J. Silvio Gutkind et al. (NIDCR). Publications: 1. CH Squarize, RM Castilho, JS Gutkind. Chemoprevention and treatment of experimental Cowden’s disease by mTOR inhibition with rapamycin. Cancer Res. 2008 Sep 1;68(17):7066–7072. 2. R Czerninski, P Amornphimoltham, V Patel, AA Molinolo, JS Gutkind. Targeting mTOR by rapamycin prevents tumor progression in an oral-specific chemical carcinogenesis model. Cancer Prevention Res. 2009 Jan;2(1):27–36. Patent Status: U.S. Patent Application No. 61/090/414 filed 20 Aug 2008 (HHS Reference No. E–302–2008/0-US–01). Licensing Status: Available for licensing. Licensing Contact: Whitney Hastings; 301–451–7337; hastingw@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Dental and E:\FR\FM\03MRN1.SGM 03MRN1

Agencies

[Federal Register Volume 74, Number 40 (Tuesday, March 3, 2009)]
[Notices]
[Pages 9251-9252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4460]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget (OMB), in compliance with 
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request 
a copy of the clearance requests submitted to OMB for review, e-mail 
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 
443-1129.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:
    Proposed Project: Health Centers Patient Survey--New.
    The Health Center program supports Community Health Centers (CHCs), 
Migrant Health Centers (MHCs), Health Care for the Homeless (HCH) 
projects, and Public Housing Primary Care (PHPC) programs. Health 
Centers receive grants from HRSA to provide primary and preventive 
health care services to medically underserved populations.
    The proposed Patient Survey will collect in-depth information about 
health center patients, their health

[[Page 9252]]

status, the reasons they seek care at health centers, their diagnoses, 
the services they utilize at health centers and elsewhere, the quality 
of those services, and their satisfaction with the care they receive, 
through personal interviews of a stratified random sample of health 
center patients. Interviews are planned to take approximately 1 hour 
and six minutes each.
    The Patient Survey builds on previous periodic User-Visit Surveys 
which were conducted to learn about the process and outcomes of care in 
CHCs and HCH projects. The original survey questions were derived from 
the National Health Interview Survey (NHIS) and the National Hospital 
Ambulatory Medical Care Survey (NHAMCS) conducted by the National 
Center for Health Statistics (NCHS). Conformance with the NHIS and 
NHAMCS allowed comparisons between these NCHS surveys and the previous 
CHC and HCH User-Visit Surveys. The new Patient Survey was developed 
using a questionnaire methodology similar to that used in the past, and 
will also allow some longitudinal comparisons for CHCs and HCH projects 
with the previous User-Visit survey data, including monitoring of 
process outcomes over time. In addition, this survey will include 
interviews of patients drawn from migrant populations and from 
residents of public housing; these populations were not included in the 
previous surveys.
    The annual estimate of burden is as follows:
    The estimated response burden for the survey is as follows:

                                                     Survey
----------------------------------------------------------------------------------------------------------------
                                                              Responses      Total      Burden per
     Type of respondent; activity involved       Number of       per       number of     response     Total hour
                                                respondents   respondent   responses      (hours)       burden
----------------------------------------------------------------------------------------------------------------
Grantee/Site Recruitment and Site Training....          115            3          345         3.75         1,294
Patient Recruitment...........................        5,658            1        5,658          .167          945
Patient Survey................................        4,526            1        4,526         1.1          4,979
                                               -----------------------------------------------------------------
    Total.....................................        5,773  ...........       10,529  ............        7,218
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to 
the desk officer for HRSA, either by e-mail to OIRA_
submission@omb.eop.gov or by fax to 202-395-6974. Please direct all 
correspondence to the ``attention of the desk officer for HRSA.''

    Dated: February 24, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and Coordination.
[FR Doc. E9-4460 Filed 3-2-09; 8:45 am]
BILLING CODE 4165-15-P