Submission for OMB Review; 30-Day Comment Request: Customer and Other Partners Satisfaction Surveys, 3833-3834 [2014-01343]

Download as PDF Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices sroberts on DSK5SPTVN1PROD with NOTICES 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: May 14, 2010. FDA has verified the applicant’s claim that the new drug application (NDA) for GADAVIST (NDA 201–277) was initially submitted on May 14, 2010. 3. The date the application was approved: March 14, 2011. FDA has verified the applicant’s claim that NDA 201–277 was approved on March 14, 2011. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the U.S. Patent and Trademark Office applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,470 days of patent term extension. Anyone with knowledge that any of the dates as published are incorrect may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments and ask for a redetermination by March 24, 2014. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by July 22, 2014. To meet its burden, the petition must contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) electronic or written comments and written or electronic petitions. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. If you submit a written petition, you must submit two copies of the written petition. A petition submitted electronically must be submitted to https:// www.regulations.gov, Docket No. FDA 2013–S–0610. Comments and petitions that have not been made publicly available on https://www.regulations.gov may be viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. VerDate Mar<15>2010 21:50 Jan 22, 2014 Jkt 232001 Dated: January 16, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–01307 Filed 1–22–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: Customer and Other Partners Satisfaction Surveys Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health Clinical Center (CC) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on November 6, 2013, pp. 66750–66751, 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 Clinical Center (CC), 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. 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, OIRA_submission@ omb.eop.gov or by fax to 202–395–6974, Attention: NIH Desk Officer. Comment 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. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact Dr. David K. Henderson, Deputy Director for Clinical Care, National SUMMARY: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 3833 Institutes of Health Clinical Center, Building 10, Room 6–1480, 10 Center Drive, Bethesda, Maryland 20892, or call non-toll free: 301–496–3515, or email your request or comments, including your address to: < dkh@ nih.gov >. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Title: Generic Clearance for Surveys of Customers and Other Partners, 0925–0458, Expiration Date 12/31/2013, Type of Submission: REINSTATEMENT WITHOUT CHANGE, National Institutes of Health Clinical Center (CC), National Institutes of Health (NIH). Need and Use of Information Collection: The information collected in these surveys will be used by Clinical Center personnel: (1) To evaluate the perceptions of various Clinical Center customers and other partners of Clinical Center services; (2) to assist with the design of modifications of these services, based on customer input; (3) to develop new services, based on customer need; (4) to evaluate the perceptions of various Clinical Center customers and other partners of implemented service modifications, and (5) for hospital accreditation. These surveys are voluntary and necessary for the proper performance of Clinical Center functions and will almost certainly lead to quality improvement activities that will enhance and/or streamline the Clinical Center’s operations. The major mechanisms by which the Clinical Center will request customer input is through surveys and focus groups. The surveys will be tailored specifically to each class of customer and to that class of customer’s needs. Surveys will either be collected as written documents, as faxed documents, mailed electronically or collected via the web or by telephone from customers. Information gathered from these surveys of Clinical Center customers and other partners will be presented to, and used directly by, Clinical Center management to enhance the services and operations of our organization. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 4,900. E:\FR\FM\23JAN1.SGM 23JAN1 3834 Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondent Number of responses per respondent Average time per response (in hours) Total annual hour burden FY 2014 Clinical Center Patients ................................................................................... Family Members of Patients ............................................................................ Visitors to the Clinical Center .......................................................................... NIH Intramural Collaborators ........................................................................... Vendors and Collaborating Commercial Enterprises ...................................... Professionals and Organizations Referring Patients ....................................... Regulators ........................................................................................................ Volunteers ........................................................................................................ 5000 2000 500 2000 500 2000 30 275 1 1 1 1 1 1 1 1 30/60 30/60 10/60 10/60 20/60 20/60 20/60 30/60 2500 1000 84 334 167 667 10 138 5000 2000 500 2000 500 2000 30 275 1 1 1 1 1 1 1 1 30/60 30/60 10/60 10/60 20/60 20/60 20/60 30/60 2500 1000 84 334 167 667 10 138 5000 2000 500 2000 500 2000 30 275 1 1 1 1 1 1 1 1 30/60 30/60 10/60 10/60 20/60 20/60 20/60 30/60 2500 1000 84 334 167 667 10 138 FY 2015 Clinical Center Patients ................................................................................... Family Members of Patients ............................................................................ Visitors to the Clinical Center .......................................................................... NIH Intramural Collaborators ........................................................................... Vendors and Collaborating Commercial Enterprises ...................................... Professionals and Organizations Referring Patients ....................................... Regulators ........................................................................................................ Volunteers ........................................................................................................ FY 2016 Clinical Center Patients ................................................................................... Family Members of Patients ............................................................................ Visitors to the Clinical Center .......................................................................... NIH Intramural Collaborators ........................................................................... Vendors and Collaborating Commercial Enterprises ...................................... Professionals and Organizations Referring Patients ....................................... Regulators ........................................................................................................ Volunteers ........................................................................................................ Dated: January 14, 2014. David K. Henderson, Deputy Director for Clinical Care, CC, National Institutes of Health. FOR FURTHER INFORMATION CONTACT: 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. [FR Doc. 2014–01343 Filed 1–22–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: Improved Therapeutic Immunotoxins National Institutes of Health, HHS. ACTION: Notice. 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. 209 and 37 CFR part 404 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. sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 21:50 Jan 22, 2014 Jkt 232001 Description of Technology: Immunotoxins kill cancer cells while allowing healthy, essential cells to survive. As a result, patients receiving immunotoxins are less likely to experience the deleterious side-effects associated with non-discriminate therapies, such as chemotherapy or radiation therapy. Unfortunately, the continued administration of immunotoxins often leads to a reduced patient response due to the formation of neutralizing antibodies against immunogenic epitopes contained within the toxin. One such toxin is Pseudomonas exotoxin A (PE). To improve the therapeutic effectiveness of PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 PE-based immunotoxins through multiple rounds of drug administration, NIH inventors previously reduced the immunogenicity of PE through the removal of B-cell and T-cell epitopes by mutation or deletion. Although this resulted in immunotoxins with improved therapeutic activity, the modifications to reduce immunogenicity decreased the activity of PE. Through further specific modification, the inventors have now created a PE that has reduced immunogenicity with limited loss of activity. The resulting PE-based immunotoxins have increased resistance to the formation of neutralizing antibodies, while retaining greater activity, and are expected to have improved therapeutic efficacy. Potential Commercial Applications: • Essential payload component of immunotoxins • Treatment of any disease associated with increased or preferential expression of a specific cell surface receptor • Specific diseases include hematological cancers, lung cancer, ovarian cancer, breast cancer, and head and neck cancers Competitive Advantages: E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3833-3834]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01343]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request: Customer and 
Other Partners Satisfaction Surveys

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health Clinical 
Center (CC) has submitted to the Office of Management and Budget (OMB) 
a request for review and approval of the information collection listed 
below. This proposed information collection was previously published in 
the Federal Register on November 6, 2013, pp. 66750-66751, 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 Clinical Center (CC), 
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.
    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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment 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.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, or request more information on the 
proposed project, contact Dr. David K. Henderson, Deputy Director for 
Clinical Care, National Institutes of Health Clinical Center, Building 
10, Room 6-1480, 10 Center Drive, Bethesda, Maryland 20892, or call 
non-toll free: 301-496-3515, or email your request or comments, 
including your address to: < dkh@nih.gov >. Formal requests for 
additional plans and instruments must be requested in writing.
    Proposed Collection: Title: Generic Clearance for Surveys of 
Customers and Other Partners, 0925-0458, Expiration Date 12/31/2013, 
Type of Submission: REINSTATEMENT WITHOUT CHANGE, National Institutes 
of Health Clinical Center (CC), National Institutes of Health (NIH).
    Need and Use of Information Collection: The information collected 
in these surveys will be used by Clinical Center personnel: (1) To 
evaluate the perceptions of various Clinical Center customers and other 
partners of Clinical Center services; (2) to assist with the design of 
modifications of these services, based on customer input; (3) to 
develop new services, based on customer need; (4) to evaluate the 
perceptions of various Clinical Center customers and other partners of 
implemented service modifications, and (5) for hospital accreditation. 
These surveys are voluntary and necessary for the proper performance of 
Clinical Center functions and will almost certainly lead to quality 
improvement activities that will enhance and/or streamline the Clinical 
Center's operations. The major mechanisms by which the Clinical Center 
will request customer input is through surveys and focus groups. The 
surveys will be tailored specifically to each class of customer and to 
that class of customer's needs. Surveys will either be collected as 
written documents, as faxed documents, mailed electronically or 
collected via the web or by telephone from customers. Information 
gathered from these surveys of Clinical Center customers and other 
partners will be presented to, and used directly by, Clinical Center 
management to enhance the services and operations of our organization.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 4,900.

[[Page 3834]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of     Average time
               Type of respondent                    Number of     responses per   per response    Total annual
                                                    respondents     respondent      (in hours)      hour burden
----------------------------------------------------------------------------------------------------------------
                                                     FY 2014
----------------------------------------------------------------------------------------------------------------
Clinical Center Patients........................            5000               1           30/60            2500
Family Members of Patients......................            2000               1           30/60            1000
Visitors to the Clinical Center.................             500               1           10/60              84
NIH Intramural Collaborators....................            2000               1           10/60             334
Vendors and Collaborating Commercial Enterprises             500               1           20/60             167
Professionals and Organizations Referring                   2000               1           20/60             667
 Patients.......................................
Regulators......................................              30               1           20/60              10
Volunteers......................................             275               1           30/60             138
----------------------------------------------------------------------------------------------------------------
                                                     FY 2015
----------------------------------------------------------------------------------------------------------------
Clinical Center Patients........................            5000               1           30/60            2500
Family Members of Patients......................            2000               1           30/60            1000
Visitors to the Clinical Center.................             500               1           10/60              84
NIH Intramural Collaborators....................            2000               1           10/60             334
Vendors and Collaborating Commercial Enterprises             500               1           20/60             167
Professionals and Organizations Referring                   2000               1           20/60             667
 Patients.......................................
Regulators......................................              30               1           20/60              10
Volunteers......................................             275               1           30/60             138
----------------------------------------------------------------------------------------------------------------
                                                     FY 2016
----------------------------------------------------------------------------------------------------------------
Clinical Center Patients........................            5000               1           30/60            2500
Family Members of Patients......................            2000               1           30/60            1000
Visitors to the Clinical Center.................             500               1           10/60              84
NIH Intramural Collaborators....................            2000               1           10/60             334
Vendors and Collaborating Commercial Enterprises             500               1           20/60             167
Professionals and Organizations Referring                   2000               1           20/60             667
 Patients.......................................
Regulators......................................              30               1           20/60              10
Volunteers......................................             275               1           30/60             138
----------------------------------------------------------------------------------------------------------------


    Dated: January 14, 2014.
David K. Henderson,
Deputy Director for Clinical Care, CC, National Institutes of Health.
[FR Doc. 2014-01343 Filed 1-22-14; 8:45 am]
BILLING CODE 4140-01-P
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