Proposed Collection; Comment Request; Inventory and Evaluation of Clinical Research Networks, 15530-15531 [E8-5816]

Download as PDF 15530 Federal Register / Vol. 73, No. 57 / Monday, March 24, 2008 / Notices Estimated Total Annual Burden Hours: 13.75. Additional Information Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Fax: 202–395–6974, Attn: Desk Officer for the Administration for Children and Families. Dated: March 17, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–5761 Filed 3–21–08; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on PROD1PC66 with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on April 24 and 25, 2008, from 8:30 a.m. to 5 p.m. VerDate Aug<31>2005 16:33 Mar 21, 2008 Jkt 214001 Location: Gaithersburg Holiday Inn, Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD. Contact Person: Karen F. Warburton, Center for Devices and Radiological Health, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4238, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512396. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On April 24, 2008, the committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by VisionCare Technologies, Inc., for an implantable miniature telescope (IMT). The IMT, a visual prosthetic device, is indicated for monocular implant in patients with stable, moderate to profound central vision impairment due to bilateral central scotomas associated with endstage macular degeneration with geographic atrophy or disciform scar, foveal involvement, and cataract. On April 25, 2008, the committee will discuss general issues concerning the post market experience with phakic intraocular lenses and laser-assisted in situ keratomileusis (LASIK). FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before April 15, 2008. Oral presentations from the public will be scheduled on April 24, 2008, between approximately 9:30 a.m. and 10 a.m. and between approximately 3:30 p.m. PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 and 4 p.m.; and on April 25, 2008, between approximately 10 a.m. and 11:15 a.m. and between approximately 3 p.m. and 4 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 7, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 8, 2008. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management staff, at 240–276–8932, at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ default.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 14, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–5810 Filed 3–21–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; Inventory and Evaluation of Clinical Research Networks 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 Center for Research Resource E:\FR\FM\24MRN1.SGM 24MRN1 15531 Federal Register / Vol. 73, No. 57 / Monday, March 24, 2008 / Notices (NCRR), 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: Inventory and Evaluation of Clinical Research Networks. Type of Information Collection Request: Revision of OMB # 0925–0550. Expiration: 07/31/08. Need and Use of Information Collection: Through the original data collection, the IECRN project identified and surveyed clinical research networks to obtain data for two purposes: (1) To create a webbased inventory of clinical research networks that can be accessed by the clinical research community and the general public and (2) to prepare a detailed description of existing network practices from a sample of identified networks. The current request is to continue collecting data for the first purpose only. The instrument known as the Core Survey will be used to collect information to confirm that the respondent is truly a clinical research network, plus basic characteristics about each identified clinical research network to be included in the webbased inventory. The information for the inventory database includes the network’s name, address, contact information, funding sources, age, geographic coverage, size, composition, and populations and diseases of focus. Permission to post the network’s data in the web-based public inventory will be requested, and only those networks that agree will have their information posted. Currently the inventory includes ‘‘network profiles’’ for approximately 270 clinical research networks. While this number is believed to represent most of the existing networks, some networks have not yet been identified, are unaware of the existence of the inventory, or are newly formed since the original data collection occurred. In addition, each network in the inventory is requested annually to update the information posted in its ‘‘network profile’’ to ensure that the inventory is complete and accurate. Frequency of Response: Once (Core Survey), Annually (Network Updates). Affected Public: Individuals. Type of Respondents: Health Professionals (Physicians and others involved in research networks). TABLE A 12.1—ESTIMATE OF ANNUAL HOUR BURDEN AND ANNUALIZED COST TO RESPONDENTS Number of responses Type of respondent Frequency of response Length of response Annual hour burden Hourly wage rate Respondent cost 20 1 0.25 (15 minutes) ............. 5 $70.00 $350.00 280 1 .1667 (10 minutes) ........... 46.7 70.00 3,269.00 Total .................... mstockstill on PROD1PC66 with NOTICES Core Survey: Principal Investigator Annual Update: PI/network contact ..... ........................ ........................ ........................................... 51.7 ........................ 3,619.00 The annualized cost to respondents is estimated at: $3,619.00. 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, 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 Dr. Jody Sachs, National Center for Research Resources, NIH, Room 917, 6701 Rockledge Drive, VerDate Aug<31>2005 16:33 Mar 21, 2008 Jkt 214001 Bethesda, MD 20892–4874, or call 301– 435–0802. 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: March 18, 2008. Jody Sachs, Project Officer, NCRR, National Institutes of Health. [FR Doc. E8–5816 Filed 3–21–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing 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 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 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. HIV Monoclonal Antibodies Description of Technology: This technology describes several hybridomas that produce monoclonal antibodies (mAbs) useful in HIV research applications. The mAbs are specific for either gp41 or gp120. In particular, the hybridomas producing mAbs designated D19, D56, M12, T8 and T24 (all anti-gp120), and T32 and T33 (gp41 specific) were found to be of particular utility. Additional hybridomas expressing mAbs disclosed in the publications may also be available. Applications: HIV research. Development Status: Murine hybridomas available; T32 mAb available. E:\FR\FM\24MRN1.SGM 24MRN1

Agencies

[Federal Register Volume 73, Number 57 (Monday, March 24, 2008)]
[Notices]
[Pages 15530-15531]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-5816]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Inventory and Evaluation of 
Clinical Research Networks

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 Center for Research 
Resource

[[Page 15531]]

(NCRR), 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: Inventory and Evaluation of Clinical 
Research Networks. Type of Information Collection Request: Revision of 
OMB  0925-0550. Expiration: 07/31/08. Need and Use of 
Information Collection: Through the original data collection, the IECRN 
project identified and surveyed clinical research networks to obtain 
data for two purposes: (1) To create a web-based inventory of clinical 
research networks that can be accessed by the clinical research 
community and the general public and (2) to prepare a detailed 
description of existing network practices from a sample of identified 
networks. The current request is to continue collecting data for the 
first purpose only. The instrument known as the Core Survey will be 
used to collect information to confirm that the respondent is truly a 
clinical research network, plus basic characteristics about each 
identified clinical research network to be included in the web-based 
inventory. The information for the inventory database includes the 
network's name, address, contact information, funding sources, age, 
geographic coverage, size, composition, and populations and diseases of 
focus. Permission to post the network's data in the web-based public 
inventory will be requested, and only those networks that agree will 
have their information posted. Currently the inventory includes 
``network profiles'' for approximately 270 clinical research networks. 
While this number is believed to represent most of the existing 
networks, some networks have not yet been identified, are unaware of 
the existence of the inventory, or are newly formed since the original 
data collection occurred. In addition, each network in the inventory is 
requested annually to update the information posted in its ``network 
profile'' to ensure that the inventory is complete and accurate. 
Frequency of Response: Once (Core Survey), Annually (Network Updates). 
Affected Public: Individuals. Type of Respondents: Health Professionals 
(Physicians and others involved in research networks).

                                     Table A 12.1--Estimate of Annual Hour Burden and Annualized Cost to Respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Number of     Frequency of                                  Annual hour     Hourly wage
            Type of respondent                responses       response          Length of response          burden           rate        Respondent cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Core Survey:
    Principal Investigator...............              20               1  0.25 (15 minutes)..........               5          $70.00           $350.00
Annual Update:
    PI/network contact...................             280               1  .1667 (10 minutes).........            46.7           70.00          3,269.00
                                          --------------------------------------------------------------------------------------------------------------
        Total............................  ..............  ..............  ...........................            51.7  ..............          3,619.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The annualized cost to respondents is estimated at: $3,619.00. 
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, 
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 Dr. Jody Sachs, National Center for Research 
Resources, NIH, Room 917, 6701 Rockledge Drive, Bethesda, MD 20892-
4874, or call 301-435-0802.
    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: March 18, 2008.
Jody Sachs,
Project Officer, NCRR, National Institutes of Health.
 [FR Doc. E8-5816 Filed 3-21-08; 8:45 am]
BILLING CODE 4140-01-P