Proposed Collection; Comment Request; Women's Health Initiative Observational Study, 79889-79890 [E8-30848]

Download as PDF 79889 Federal Register / Vol. 73, No. 250 / Tuesday, December 30, 2008 / Notices attitudes (because this is not needed in an experimental design and we are using a fictitious drug for the stimulus materials), or (7) get industry approval and public comment on the mocked up ads. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents 21 CFR Section Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 21 U.S.C. 393(b)(2)(c) Screener, pretesting 1,600 1 1,600 .03 48 21 U.S.C. 393(b)(2)(c) Questionnaire, pretesting 800 1 800 .16 128 21 U.S.C. 393(b)(2)(c) Screener, study 4,800 1 4,800 .03 144 21 U.S.C. 393(b)(2)(c) Questionnaire, study 2,400 1 2,400 .25 600 Total 1 There 920 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: December 18, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–31057 Filed 12–29–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Women’s Health Initiative Observational Study SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), 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 Women’s Health Initiative (WHI) Observational Study. Type of Information Collection Request: Revision OMB #0925–0414. Need and Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: Annually. Affected Public: Individuals or households and health care providers. Type of Respondents: Individuals or households; health care providers. The annual reporting burden is as follows: ESTIMATE OF ANNUAL HOUR BURDEN Number of respondents Type of response Average hours per response Frequency of response Observational Study Participants ................................................................ Next of Kin 1 ................................................................................................. Health Care Providers 1 ............................................................................... 63,230 1163 9 1.1 1 1 .338 .083 .083 Total ...................................................................................................... 64,402 .......................... ........................ Annual hour burden 23,509 97 .77 23,607 1 Annual pwalker on PROD1PC71 with NOTICES burden is placed on health care providers and respondent relatives/informants through requests for information which will help in the compilation of the number and nature of new fatal and nonfatal events. The annualized cost to respondents is estimated at $377,725, assuming respondents time at the rate of $16 per hour and physician time at the rate of $50 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the VerDate Aug<31>2005 22:55 Dec 29, 2008 Jkt 217001 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 PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 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, E:\FR\FM\30DEN1.SGM 30DEN1 79890 Federal Register / Vol. 73, No. 250 / Tuesday, December 30, 2008 / Notices mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Ms. Shari Eason Ludlam, MPH, Project Officer, NIH, NHLBI, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892–7934, or call non-toll-free number 301–402–2900 or E-mail your request, including your address to: Ludlams@nhlbi.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Dated: December 16, 2008. Michael S. Lauer, Director, Division of Prevention and Population Sciences, NHLBI, National Institutes of Health. Dated: December 16, 2008. Suzanne Freeman, Chief, FOIA, NHLBI, National Institutes of Health. [FR Doc. E8–30848 Filed 12–29–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing pwalker on PROD1PC71 with NOTICES AGENCY: National Institutes of Health, Public Health Service, HHS. 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. 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 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. VerDate Aug<31>2005 22:55 Dec 29, 2008 Jkt 217001 Doxycycline-Inducible B16 Melanoma Cell Lines Expressing CXCR4 or CCR10 Description of Technology: The chemokine receptor CXCR4 functions in normal cells, but has been shown to be the most common chemokine receptor expressed on cancer cells, including melanoma, colon, breast, and lung cancers. It plays roles in angiogenesis and cancer cell survival as well as metastasis. CCR10 has also been shown to be expressed by melanoma cells. Like CXCR4, expression of CCR10 can enhance cancer cell survival and block immune recognition of cancer cells. Antagonists of CXCR4 and CCR10, under various conditions, have decreased metastasis or prevented tumor formation after implantation of cancer cells in mice. These cell lines are based on the widely used B16 murine melanoma cell line. The cell lines were transduced with retroviral vectors encoding cDNA for either CXCR4 or CCR10 under control of a TET-dependent promoter. Both lines achieve greater than 10 fold induction of the respective genes (proteins), which has been confirmed by surface antibody staining using flow cytometry. These cell lines are ideally suited for studying the effect of these chemokine receptors in tumor growth or metastasis. They are also useful for developing a mouse model for studying the effect of down-regulating these receptors specifically in melanoma cells. This would mimic the effect of antagonists without the confounding effects of systemically inhibiting CXCR4 or CCR10. By either adding or removing dietary administered doxycycline, receptor expression can be regulated to assess the role of these two receptors in a variety of cancer-related assays. Applications: • Study the effect of chemokine receptors in tumor growth or metastasis • Test CXCR4 and CCR10 antagonists in preclinical studies • Develop B16 melanoma mouse model mimicking the effect of chemokine receptor antagonists Advantages: • Ability to regulate in vitro and in vivo expression of the chemokine receptor • Ability to investigate the in vivo role in cancer cells of doxycycline control of chemokine receptor expression Market: Cancer is the second leading cause of death in the U.S. and it is estimated that more than 1 million Americans develop cancer in a year. Development Status: The technology is currently in the preclinical stage of development. PO 00000 Frm 00102 Fmt 4703 Sfmt 4703 Inventors: Sam T. Hwang (NCI) . Publication: T Kakinuma, ST Hwang. Chemokines, chemokine receptors, and cancer metastasis. J Leukoc Biol. 2006 Apr;79(4):639–651. Patent Status: HHS Reference No. E– 345–2008/0—Research Material. Patent protection is not being sought for either technology. Licensing Status: Available for nonexclusive licensing under a Biological Materials License Agreement. Licensing Contact: Adaku Nwachukwu, J.D.; 301–435–5560; madua@mail.nih.gov. Monoclonal Antibodies to the TumorSpecific Antigen, Human ROR1 Description of Technology: B–cell chronic lymphocytic leukemia (B–CLL) is an incurable disease developed by more than 15,000 Americans each year and currently, there are no therapeutic monoclonal antibodies (mAbs) that specifically recognize B–CLL tumor cells. Receptor tyrosine kinase-like orphan receptor 1 (ROR1) is a constitutively expressed tumor-specific cell surface antigen and an ideal target for therapeutic antibodies. Available for licensing are four mouse anti-human ROR1 mAbs (hybridomas designated 2A2, 2D11, 1A1, and 1A7). All four mAbs bind specifically to the extracellular domain of human ROR1 and have good potential for therapeutic development by either humanization, conversion to chimeric mouse/human antibodies, or conjugation to a radioisotope, chemical drug or bacterial toxin. Applications: • Therapeutic antibodies against ROR1-expressing cancers like B–CLL and possibly other hematologic and solid malignancies • Research tools for the study of ROR1 in cancer biology Advantages: • Hybridomas provide a continuous source of mAb • Target extracellular domain of ROR1 Market: • Currently, mAbs alemtuzumab® and rituximab®, which are not tumor cell-specific, are used for treating B– CLL. Rituximab® generated sales of 5.2 billion U.S. dollars in 2007. • MAb market is estimated to be worth $30.3 billion in 2010 and it is one of the fastest growing sectors of the pharmaceutical industry with a 48.1% growth rate between 2003 and 2004. Inventors: Christoph Rader and Sivasubramanian Baskar (NCI). Publication: S Baskar et al. Unique cell surface expression of receptor tyrosine kinase ROR1 in human B-cell E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 73, Number 250 (Tuesday, December 30, 2008)]
[Notices]
[Pages 79889-79890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-30848]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Women's Health Initiative 
Observational Study

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Heart, Lung, and 
Blood Institute (NHLBI), 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 Women's Health Initiative (WHI) 
Observational Study. Type of Information Collection Request: Revision 
OMB 0925-0414. Need and Use of Information Collection: This 
study will be used by the NIH to evaluate risk factors for chronic 
disease among older women by developing and following a large cohort of 
postmenopausal women and relating subsequent disease development to 
baseline assessments of historical, physical, psychosocial, and 
physiologic characteristics. In addition, the observational study will 
complement the clinical trial (which has received clinical exemption) 
and provide additional information on the common causes of frailty, 
disability and death for postmenopausal women, namely, coronary heart 
disease, breast and colorectal cancer, and osteoporotic fractures. 
Continuation of follow-up for ascertainment of medical history update 
forms will provide essential data for outcomes assessment for this 
population of aging women. Frequency of Response: Annually. Affected 
Public: Individuals or households and health care providers. Type of 
Respondents: Individuals or households; health care providers. The 
annual reporting burden is as follows:

                                         Estimate of Annual Hour Burden
----------------------------------------------------------------------------------------------------------------
                                                    Number of      Frequency of    Average hours    Annual hour
                Type of response                   respondents       response      per response       burden
----------------------------------------------------------------------------------------------------------------
Observational Study Participants...............          63,230              1.1            .338       23,509
Next of Kin \1\................................            1163              1              .083           97
Health Care Providers \1\......................               9              1              .083             .77
                                                ----------------------------------------------------------------
    Total......................................          64,402  ...............  ..............      23,607
----------------------------------------------------------------------------------------------------------------
\1\ Annual burden is placed on health care providers and respondent relatives/informants through requests for
  information which will help in the compilation of the number and nature of new fatal and nonfatal events.

    The annualized cost to respondents is estimated at $377,725, 
assuming respondents time at the rate of $16 per hour and physician 
time at the rate of $50 per hour. There are no Capital Costs to report. 
There are no Operating 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,

[[Page 79890]]

mechanical, or other technological collection techniques or other forms 
of information technology.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact Ms. Shari Eason Ludlam, MPH, Project Officer, NIH, 
NHLBI, 6701 Rockledge Drive, MSC 7936, Bethesda, MD 20892-7934, or call 
non-toll-free number 301-402-2900 or E-mail your request, including 
your address to: Ludlams@nhlbi.nih.gov.
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.

    Dated: December 16, 2008.
Michael S. Lauer,
Director, Division of Prevention and Population Sciences, NHLBI, 
National Institutes of Health.
    Dated: December 16, 2008.

Suzanne Freeman,
Chief, FOIA, NHLBI, National Institutes of Health.
 [FR Doc. E8-30848 Filed 12-29-08; 8:45 am]
BILLING CODE 4140-01-P