National Institutes of Health, 53685-53686 [2011-21980]

Download as PDF 53685 Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Draft guidance on monitoring clinical investigations Number of respondents Number of responses per respondent Average burden per response Total annual responses Total hours Development of Comprehensive Monitoring Plan ............... Voluntary Submission of Monitoring Plans to FDA ............. 88 22 1.5 1.5 132 33 4 2 528 66 Total .............................................................................. N/A N/A N/A 6 594 1 There are no capital costs or operating and maintenance costs associated with this collection of information. III. Comments personnel: (1) To assess the quality of the modified operations and processes now used by CSR to review grant applications; (2) To assess the quality of service provided by CSR to our customers; (3) To enable identification of the most promising biomedical research that will have the greatest impact on improving public health by using a peer review process that is fair unbiased from outside influence, timely, and (4) To develop new modes of operation based on customer need and customer feedback about the efficacy of implemented modifications. These surveys will almost certainly lead to quality improvement activities to enhance and/or streamline CSR’s operations. The major mechanism by which CSR will request input is through surveys. The major initiatives ongoing at the present time include: Shortening the review and application process, shortening the grant application, recruiting the best reviewers by developing additional review modes, improving study section alignment to ensure the best reviews, and others. Surveys will be collected via Internet. Information gathered from these surveys will be presented to, and used directly by, CSR management to enhance the operations, processes, organization of, and services provided by the Center. Frequency of Response: The participants will respond once, unless there is a compelling reason for a subsequent survey. Affected public: Universities, not-forprofit institutions, business or other forprofit, small businesses and organizations, and individuals. Type of Respondents: Adult scientific professionals. DEPARTMENT OF HEALTH AND HUMAN SERVICES Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. National Institutes of Health Submission for OMB Review; Comment Request; Partner and Customer Satisfaction Surveys Under the provisions of Section 3507(a)(l)(D) of the Paperwork Reduction Act of 1995 for the opportunity for public comment on the proposed data collection projects, the Center for Scientific Review (CSR), National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on July 22, 2011 (Vol. 76, No. 141, p. 44020) and allowed 60-days for public comment. There was one public comment received during this time. The purpose of this notice is to allow 30 days for public comment. The 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. Proposed Collection: Title: Extension of Generic Clearance for Voluntary Partner and Customer Satisfaction Surveys. Type of Information Collection Request: Extension. Need and Use of Information Collection: The information collected in these surveys will be used by the Center for Scientific Review management and SUMMARY: IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm, http://www.fda.gov/ BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, http://www. fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm, or http://www.regulations.gov. Dated: August 23, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–21972 Filed 8–26–11; 8:45 am] BILLING CODE 4160–01–P ESTIMATES OF ANNUALIZED HOUR BURDEN Emcdonald on DSK2BSOYB1PROD with NOTICES [Totals rounded off to the nearest hour] Number of respondents Type of respondent Frequency of response Average time per response (Hr) Total annual hour burden Adult scientific professionals (via Mail/Telephone/Internet) ............................ Adult scientific professional (via focus groups) ............................................... 5000 75 1 1 0.25 1 1250 188 Total .......................................................................................................... 5075 ........................ ........................ 1438 VerDate Mar<15>2010 16:45 Aug 26, 2011 Jkt 223001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\29AUN1.SGM 29AUN1 53686 Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Notices Requests 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 functions of the CSR, 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 while maintaining their anonymity, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. 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: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact George Chacko, PhD, Center for Scientific Review, NIH, Room 3030, 6701 Rockledge Drive, Bethesda, MD 20892– 7776, or call non-toll-free number 301– 435–1133 or E-mail your request, including your address to: chackoge@csr.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of publication of this notice. Dated: August 22, 2011. George Chacko, Director of Planning, Analysis, and Evaluation, CSR, National Institutes of Health. [FR Doc. 2011–21980 Filed 8–26–11; 8:45 am] BILLING CODE 4140–01–P amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Child Health and Human Development Council. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The intramural programs and projects and discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the intramural programs and projects, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Child Health and Human Development Council; NACHHD Subcommittee on Planning and Policy. Date: September 6, 2011. Closed: 9 a.m. to 10:30 a.m. Agenda: To review and evaluate the Division of Intramural Research Laboratories site visit reports. Place: National Institutes of Health, Building 31, 31 Center Drive, Room 31 2A03, Bethesda, MD 20892 (Telephone Conference Call). Information is also available on the Institute’s/Center’s home page: http:// www.nichd.nih.gov/about/nachhd.htm, where an agenda and any additional information for the meeting will be posted when available. This notice is being published less than 15 days prior to the meeting due to the urgent need to meet timing limitations imposed by the intramural research review cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.864, Population Research; 93.865, Research for Mothers and Children; 93.929, Center for Medical Rehabilitation Research; 93.209, Contraception and Infertility Loan Repayment Program, National Institutes of Health, HHS) Dated: August 22, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–21967 Filed 8–26–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Emcdonald on DSK2BSOYB1PROD with NOTICES National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as VerDate Mar<15>2010 16:45 Aug 26, 2011 Jkt 223001 Center For Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Integrative, Functional and Cognitive Neuroscience Integrated Review Group, Somatosensory and Chemosensory Systems Study Section. Date: October 4–5, 2011. Time: 8 a.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: Westin Alexandria, 400 Courthouse Square, Alexandria, VA 22314. Contact Person: M Catherine Bennett, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5182, MSC 7846, Bethesda, MD 20892, 301–435– 1766, bennettc3@csr.nih.gov. Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group, Cellular, Molecular and Integrative Reproduction Study Section. Date: October 4, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Contact Person: Gary Hunnicutt, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6164, MSC 7892, Bethesda, MD 20892, 301–435– 0229, gary.hunnicutt@nih.gov. Name of Committee: Musculoskeletal, Oral and Skin Sciences Integrated Review Group, Oral, Dental and Craniofacial Sciences Study Section. Date: October 4–5, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Beacon Hotel and Corporate Quarters, 1615 Rhode Island Avenue, NW., Washington, DC 20036. Contact Person: Yi-Hsin Liu, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301–435– 1781, liuyh@csr.nih.gov. Name of Committee: Endocrinology, Metabolism, Nutrition and Reproductive Sciences Integrated Review Group, Pregnancy and Neonatology Study Section. Date: October 4, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency—Baltimore, 300 Light Street, Baltimore, MD 21202. Contact Person: Michael Knecht, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of E:\FR\FM\29AUN1.SGM 29AUN1

Agencies

[Federal Register Volume 76, Number 167 (Monday, August 29, 2011)]
[Notices]
[Pages 53685-53686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21980]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


National Institutes of Health

Submission for OMB Review; Comment Request; Partner and Customer 
Satisfaction Surveys

SUMMARY: Under the provisions of Section 3507(a)(l)(D) of the Paperwork 
Reduction Act of 1995 for the opportunity for public comment on the 
proposed data collection projects, the Center for Scientific Review 
(CSR), National Institutes of Health (NIH), has submitted to the Office 
of Management and Budget (OMB) a request to review and approve the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on July 22, 
2011 (Vol. 76, No. 141, p. 44020) and allowed 60-days for public 
comment. There was one public comment received during this time.
    The purpose of this notice is to allow 30 days for public comment. 
The 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.
    Proposed Collection: Title: Extension of Generic Clearance for 
Voluntary Partner and Customer Satisfaction Surveys.
    Type of Information Collection Request: Extension.
    Need and Use of Information Collection: The information collected 
in these surveys will be used by the Center for Scientific Review 
management and personnel: (1) To assess the quality of the modified 
operations and processes now used by CSR to review grant applications; 
(2) To assess the quality of service provided by CSR to our customers; 
(3) To enable identification of the most promising biomedical research 
that will have the greatest impact on improving public health by using 
a peer review process that is fair unbiased from outside influence, 
timely, and (4) To develop new modes of operation based on customer 
need and customer feedback about the efficacy of implemented 
modifications. These surveys will almost certainly lead to quality 
improvement activities to enhance and/or streamline CSR's operations. 
The major mechanism by which CSR will request input is through surveys. 
The major initiatives ongoing at the present time include: Shortening 
the review and application process, shortening the grant application, 
recruiting the best reviewers by developing additional review modes, 
improving study section alignment to ensure the best reviews, and 
others. Surveys will be collected via Internet. Information gathered 
from these surveys will be presented to, and used directly by, CSR 
management to enhance the operations, processes, organization of, and 
services provided by the Center.
    Frequency of Response: The participants will respond once, unless 
there is a compelling reason for a subsequent survey. Affected public: 
Universities, not-forprofit institutions, business or other forprofit, 
small businesses and organizations, and individuals. Type of 
Respondents: Adult scientific professionals.

                                       Estimates of Annualized Hour Burden
                                    [Totals rounded off to the nearest hour]
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
               Type of respondent                    Number of     Frequency of    per response    Total annual
                                                    respondents      response          (Hr)         hour burden
----------------------------------------------------------------------------------------------------------------
Adult scientific professionals (via Mail/                   5000               1            0.25            1250
 Telephone/Internet)............................
Adult scientific professional (via focus groups)              75               1               1             188
                                                 ---------------------------------------------------------------
    Total.......................................            5075  ..............  ..............            1438
----------------------------------------------------------------------------------------------------------------


[[Page 53686]]

    Requests 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 functions of the CSR, 
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 
while maintaining their anonymity, including the use of automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology.
    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: Desk Officer for NIH. To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact George Chacko, PhD, Center for Scientific Review, 
NIH, Room 3030, 6701 Rockledge Drive, Bethesda, MD 20892-7776, or call 
non-toll-free number 301-435-1133 or E-mail your request, including 
your address to: chackoge@csr.nih.gov.
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30-days 
of the date of publication of this notice.

    Dated: August 22, 2011.
George Chacko,
Director of Planning, Analysis, and Evaluation, CSR, National 
Institutes of Health.
[FR Doc. 2011-21980 Filed 8-26-11; 8:45 am]
BILLING CODE 4140-01-P