80_FR_31157 80 FR 31053 - Proposed Collection; 60-day Comment Request; National Institute of Mental Health Recruitment and Milestone Reporting System (NIMH) [email protected] Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments received within 60 days of the date of this publication will receive fullest consideration. Proposed Collection: The National Institute of Mental Health Recruitment Milestone Reporting System (NIMH); REVISION; OMB Control Number 0925-0697. National Institute of Mental Health, National Institutes of Health. Need and Use of Information Collection: Recruitment Milestone Reporting (RMR) allows NIMH staff to monitor more accurately the required recruitment of participants in NIMH-sponsored clinical trials and other clinical research studies that plan to enroll 150 or more human subjects in a single study. Clinical studies can have difficulty recruiting, and accurate and timely reporting is the best way to ensure proper use of the grant funds. Investigators develop a recruitment plan that includes tri-yearly milestones for recruitment of the total study population, and for recruitment of racial and ethnic minority participants. Once recruitment is scheduled to begin, investigators report actual progress on recruitment milestones three times per year, by April 1, August 1, and December 1. Studies that fail to meet their milestones may be requested to provide interim monthly reports. The primary use of this information is to ensure that realistic recruitment targets are established from the onset of a project, and that these targets are met throughout the course of the research. By ensuring timely recruitment into clinical research studies, NIMH can reduce the need to extend timelines or supplement funds in order to complete the research project, and potentially increase efficiency in our funding process. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2295."> [email protected] Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments received within 60 days of the date of this publication will receive fullest consideration. Proposed Collection: The National Institute of Mental Health Recruitment Milestone Reporting System (NIMH); REVISION; OMB Control Number 0925-0697. National Institute of Mental Health, National Institutes of Health. Need and Use of Information Collection: Recruitment Milestone Reporting (RMR) allows NIMH staff to monitor more accurately the required recruitment of participants in NIMH-sponsored clinical trials and other clinical research studies that plan to enroll 150 or more human subjects in a single study. Clinical studies can have difficulty recruiting, and accurate and timely reporting is the best way to ensure proper use of the grant funds. Investigators develop a recruitment plan that includes tri-yearly milestones for recruitment of the total study population, and for recruitment of racial and ethnic minority participants. Once recruitment is scheduled to begin, investigators report actual progress on recruitment milestones three times per year, by April 1, August 1, and December 1. Studies that fail to meet their milestones may be requested to provide interim monthly reports. The primary use of this information is to ensure that realistic recruitment targets are established from the onset of a project, and that these targets are met throughout the course of the research. By ensuring timely recruitment into clinical research studies, NIMH can reduce the need to extend timelines or supplement funds in order to complete the research project, and potentially increase efficiency in our funding process. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2295." /> [email protected] Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments received within 60 days of the date of this publication will receive fullest consideration. Proposed Collection: The National Institute of Mental Health Recruitment Milestone Reporting System (NIMH); REVISION; OMB Control Number 0925-0697. National Institute of Mental Health, National Institutes of Health. Need and Use of Information Collection: Recruitment Milestone Reporting (RMR) allows NIMH staff to monitor more accurately the required recruitment of participants in NIMH-sponsored clinical trials and other clinical research studies that plan to enroll 150 or more human subjects in a single study. Clinical studies can have difficulty recruiting, and accurate and timely reporting is the best way to ensure proper use of the grant funds. Investigators develop a recruitment plan that includes tri-yearly milestones for recruitment of the total study population, and for recruitment of racial and ethnic minority participants. Once recruitment is scheduled to begin, investigators report actual progress on recruitment milestones three times per year, by April 1, August 1, and December 1. Studies that fail to meet their milestones may be requested to provide interim monthly reports. The primary use of this information is to ensure that realistic recruitment targets are established from the onset of a project, and that these targets are met throughout the course of the research. By ensuring timely recruitment into clinical research studies, NIMH can reduce the need to extend timelines or supplement funds in order to complete the research project, and potentially increase efficiency in our funding process. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2295." />

80 FR 31053 - Proposed Collection; 60-day Comment Request; National Institute of Mental Health Recruitment and Milestone Reporting System (NIMH)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 104 (June 1, 2015)

Page Range31053-31054
FR Document2015-13112

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 Institute of Mental Health (NIMH), 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. 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. To Submit Comments And For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Keisha Shropshire, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or call 301-443-4335 or Email your request, including your address to: [email protected] Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments received within 60 days of the date of this publication will receive fullest consideration. Proposed Collection: The National Institute of Mental Health Recruitment Milestone Reporting System (NIMH); REVISION; OMB Control Number 0925-0697. National Institute of Mental Health, National Institutes of Health. Need and Use of Information Collection: Recruitment Milestone Reporting (RMR) allows NIMH staff to monitor more accurately the required recruitment of participants in NIMH-sponsored clinical trials and other clinical research studies that plan to enroll 150 or more human subjects in a single study. Clinical studies can have difficulty recruiting, and accurate and timely reporting is the best way to ensure proper use of the grant funds. Investigators develop a recruitment plan that includes tri-yearly milestones for recruitment of the total study population, and for recruitment of racial and ethnic minority participants. Once recruitment is scheduled to begin, investigators report actual progress on recruitment milestones three times per year, by April 1, August 1, and December 1. Studies that fail to meet their milestones may be requested to provide interim monthly reports. The primary use of this information is to ensure that realistic recruitment targets are established from the onset of a project, and that these targets are met throughout the course of the research. By ensuring timely recruitment into clinical research studies, NIMH can reduce the need to extend timelines or supplement funds in order to complete the research project, and potentially increase efficiency in our funding process. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2295.

Federal Register, Volume 80 Issue 104 (Monday, June 1, 2015) 
[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 31053-31054]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13112]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-day Comment Request; National Institute 
of Mental Health Recruitment and Milestone Reporting System (NIMH)

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 Institute of Mental 
Health (NIMH), 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.
    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.
    To Submit Comments And For Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: Keisha 
Shropshire, NIMH Project Clearance Liaison, Science Policy and 
Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 
Executive Boulevard, MSC 9667, Rockville Pike, Bethesda, MD 20892, or 
call 301-443-4335 or Email your request, including your address to: 
nimhprapubliccomments@mail.nih.gov. Formal requests for additional 
plans and instruments must be requested in writing.
    Comment Due Date: Comments received within 60 days of the date of 
this publication will receive fullest consideration.
    Proposed Collection: The National Institute of Mental Health 
Recruitment Milestone Reporting System (NIMH); REVISION; OMB Control 
Number 0925-0697. National Institute of Mental Health, National 
Institutes of Health.
    Need and Use of Information Collection: Recruitment Milestone 
Reporting (RMR) allows NIMH staff to monitor more accurately the 
required recruitment of participants in NIMH-sponsored clinical trials 
and other clinical research studies that plan to enroll 150 or more 
human subjects in a single study. Clinical studies can have difficulty 
recruiting, and accurate and timely reporting is the best way to ensure 
proper use of the grant funds. Investigators develop a recruitment plan 
that includes tri-yearly milestones for recruitment of the total study 
population, and for recruitment of racial and ethnic minority 
participants. Once recruitment is scheduled to begin, investigators 
report actual progress on recruitment milestones three times per year, 
by April 1, August 1, and December 1. Studies that fail to meet their 
milestones may be requested to provide interim monthly reports. The 
primary use of this information is to ensure that realistic recruitment 
targets are established from the onset of a project, and that these 
targets are met throughout the course of the research. By ensuring 
timely recruitment into clinical research studies, NIMH can reduce the 
need to extend timelines or supplement funds in order to complete the 
research project, and potentially

[[Page 31054]]

increase efficiency in our funding process.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 2295.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
             Form                    Type of         Number of     Frequency of    per response     Annual hour
                                   respondent       respondents      response       (in hours)        burden
----------------------------------------------------------------------------------------------------------------
NIMH Recruitment Milestone      Principal                    900               3           45/60            2025
 Reporting.                      Investigators/
                                 Research
                                 Assistant.
NIMH Recruitment Milestone      Principal                     40               9           45/60             270
 Monthly Report.                 Investigators/
                                 Research
                                 Assistant.
----------------------------------------------------------------------------------------------------------------


    Dated: May 21, 2015.
Keisha L Shropshire,
Project Clearance Liaison, NIMH, NIH.
[FR Doc. 2015-13112 Filed 5-29-15; 8:45 am]
 BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices 31053 Hurricane Sandy recovery research to property such as patentable material, collected; and (4) Ways to minimize the the impacted communities. and personal information concerning burden of the collection of information DATES: The 2015 Hurricane Sandy individuals associated with the grant on those who are to respond, including Conference: Translating Research into applications, the disclosure of which the use of appropriate automated, Practice is scheduled on August 10 from would constitute a clearly unwarranted electronic, mechanical, or other 9 a.m. to 4:30 p.m. EST and on August invasion of personal privacy. technological collection techniques or 11 from 9 a.m. to 12:30 p.m. EST. Name of Committee: National Institute of other forms of information technology. Mental Health Special Emphasis Panel; Pilot To Submit Comments And For ADDRESSES: New York University’s Effectiveness Studies and Services Research Further Information: To obtain a copy of Kimmel Center for University Life, 60 Grants (R34). the data collection plans and Washington Square South, New York Date: June 15, 2015. instruments, submit comments in City, NY 10010. Registration is required Time: 9 a.m. to 5 p.m. writing, or request more information on for public attendance. Individuals who Agenda: To review and evaluate grant the proposed project, contact: Keisha wish to attend the meeting should applications. Shropshire, NIMH Project Clearance complete the registration via Place: Hyatt Regency Bethesda, One Liaison, Science Policy and Evaluation www.PHE.gov/Research2Practice. Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. Branch, OSPPC, NIMH, NIH, FOR FURTHER INFORMATION CONTACT: Neuroscience Center, 6001 Executive Contact Person: Karen Gavin-Evans, Ph.D., Please contact sciencepreparedness@ Scientific Review Officer, Division of Boulevard, MSC 9667, Rockville Pike, hhs.gov for additional information. Extramural Activities, National Institute of Bethesda, MD 20892, or call 301–443– SUPPLEMENTARY INFORMATION: Mental Health, NIH Neuroscience Center, 4335 or Email your request, including Background: Shortly after Hurricane 6001 Executive Boulevard, Room 6153, MSC your address to: Sandy, ASPR, CDC, and NIEHS each 9606, Bethesda, MD 20892, 301–451–2356, nimhprapubliccomments@mail.nih.gov. gavinevanskm@mail.nih.gov. funded a series of two-year research Formal requests for additional plans and grants and training awards under the (Catalogue of Federal Domestic Assistance instruments must be requested in Program No. 93.242, Mental Health Research Disaster Relief Appropriations Act of Grants, National Institutes of Health, HHS) writing. 2013 (Pub. L. 113–2) that examine the Comment Due Date: Comments long-term recovery of health systems, Dated: May 26, 2015. received within 60 days of the date of communities, and workers in the area of Carolyn A. Baum, this publication will receive fullest the country hardest hit by the storm. As Program Analyst, Office of Federal Advisory consideration. the projects near completion, ASPR is Committee Policy. Proposed Collection: The National hosting a public conference to share the [FR Doc. 2015–13049 Filed 5–29–15; 8:45 am] Institute of Mental Health Recruitment research products and outcomes broadly BILLING CODE 4140–01–P Milestone Reporting System (NIMH); with the impacted communities and REVISION; OMB Control Number 0925– other stakeholders. 0697. National Institute of Mental Availability of Materials: The meeting DEPARTMENT OF HEALTH AND Health, National Institutes of Health. agenda and materials will be posted on HUMAN SERVICES Need and Use of Information www.PHE.gov/Research2Practice prior Collection: Recruitment Milestone National Institutes of Health Reporting (RMR) allows NIMH staff to to the meeting. Registration for the Public Meeting: monitor more accurately the required Proposed Collection; 60-day Comment recruitment of participants in NIMH- Information about registration for the Request; National Institute of Mental meeting is available at www.PHE.gov/ sponsored clinical trials and other Health Recruitment and Milestone clinical research studies that plan to Research2Practice. Reporting System (NIMH) enroll 150 or more human subjects in a Dated: May 22, 2015. single study. Clinical studies can have SUMMARY: In compliance with the Nicole Lurie, requirement of Section 3506(c)(2)(A) of difficulty recruiting, and accurate and Assistant Secretary for Preparedness and the Paperwork Reduction Act of 1995, timely reporting is the best way to Response. for opportunity for public comment on ensure proper use of the grant funds. [FR Doc. 2015–13050 Filed 5–29–15; 8:45 am] proposed data collection projects, the Investigators develop a recruitment plan BILLING CODE 4150–28–P National Institute of Mental Health that includes tri-yearly milestones for (NIMH), National Institutes of Health recruitment of the total study (NIH), will publish periodic summaries population, and for recruitment of racial DEPARTMENT OF HEALTH AND of proposed projects to be submitted to and ethnic minority participants. Once HUMAN SERVICES the Office of Management and Budget recruitment is scheduled to begin, (OMB) for review and approval. investigators report actual progress on National Institutes of Health Written comments and/or suggestions recruitment milestones three times per National Institute of Mental Health: from the public and affected agencies year, by April 1, August 1, and Notice of Closed Meeting are invited on one or more of the December 1. Studies that fail to meet following points: (1) Whether the their milestones may be requested to Pursuant to section 10(d) of the proposed collection of information is provide interim monthly reports. The Federal Advisory Committee Act, as necessary for the proper performance of primary use of this information is to amended (5 U.S.C. App.), notice is the function of the agency, including ensure that realistic recruitment targets hereby given of the following meeting. whether the information will have are established from the onset of a Lhorne on DSK2VPTVN1PROD with NOTICES The meeting will be closed to the practical utility; (2) The accuracy of the project, and that these targets are met public in accordance with the agency’s estimate of the burden of the throughout the course of the research. provisions set forth in sections proposed collection of information, By ensuring timely recruitment into 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., including the validity of the clinical research studies, NIMH can as amended. The grant applications and methodology and assumptions used; (3) reduce the need to extend timelines or the discussions could disclose Ways to enhance the quality, utility, and supplement funds in order to complete confidential trade secrets or commercial clarity of the information to be the research project, and potentially VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1

31054 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices increase efficiency in our funding OMB approval is requested for 3 estimated annualized burden hours are process. years. There are no costs to respondents 2295. other than their time. The total ESTIMATED ANNUALIZED BURDEN HOURS Average time Number of Frequency of Annual hour Form Type of respondent per response respondents response burden (in hours) NIMH Recruitment Milestone Report- Principal Investigators/Research As- 900 3 45/60 2025 ing. sistant. NIMH Recruitment Milestone Month- Principal Investigators/Research As- 40 9 45/60 270 ly Report. sistant. Dated: May 21, 2015. during the past month, it will be listed HHS-Certified Laboratories: ACM Keisha L Shropshire, at the end and will be omitted from the Medical Laboratory, Inc., 160 Project Clearance Liaison, NIMH, NIH. monthly listing thereafter. Elmgrove Park, Rochester, NY [FR Doc. 2015–13112 Filed 5–29–15; 8:45 am] This notice is also available on the 14624, 585–429–2264. BILLING CODE 4140–01–P Internet at http://beta.samhsa.gov/ Aegis Analytical Laboratories, Inc., 345 workplace. Hill Ave., Nashville, TN 37210, FOR FURTHER INFORMATION CONTACT: 615–255–2400, (Formerly: Aegis DEPARTMENT OF HEALTH AND Giselle Hersh, Division of Workplace Sciences Corporation, Aegis HUMAN SERVICES Programs, SAMHSA/CSAP, Room 7– Analytical Laboratories, Inc., Aegis 1051, One Choke Cherry Road, Analytical Laboratories). Substance Abuse and Mental Health Rockville, Maryland 20857; 240–276– Alere Toxicology Services, 1111 Newton Services Administration 2600 (voice), 240–276–2610 (fax). St., Gretna, LA 70053, 504–361– 8989/800–433–3823, (Formerly: SUPPLEMENTARY INFORMATION: The Current List of HHS-Certified Kroll Laboratory Specialists, Inc., Laboratories and Instrumented Initial Mandatory Guidelines were initially Laboratory Specialists, Inc.). Testing Facilities Which Meet Minimum developed in accordance with Executive Alere Toxicology Services, 450 Standards To Engage in Urine Drug Order 12564 and section 503 of Public Southlake Blvd., Richmond, VA Testing for Federal Agencies Law 100–71. The ‘‘Mandatory 23236, 804–378–9130, (Formerly: Guidelines for Federal Workplace Drug Kroll Laboratory Specialists, Inc., AGENCY: Substance Abuse and Mental Testing Programs,’’ as amended in the Scientific Testing Laboratories, Inc.; Health Services Administration, HHS. revisions listed above, requires strict Kroll Scientific Testing ACTION: Notice. standards that laboratories and IITFs Laboratories, Inc.). must meet in order to conduct drug and Baptist Medical Center-Toxicology SUMMARY: The Department of Health and specimen validity tests on urine Laboratory, 11401 I–30, Little Rock, Human Services (HHS) notifies federal specimens for federal agencies. AR 72209–7056, 501–202–2783, agencies of the laboratories and To become certified, an applicant (Formerly: Forensic Toxicology Instrumented Initial Testing Facilities laboratory or IITF must undergo three Laboratory Baptist Medical Center). (IITF) currently certified to meet the rounds of performance testing plus an Clinical Reference Lab, 8433 Quivira standards of the Mandatory Guidelines on-site inspection. To maintain that Road, Lenexa, KS 66215–2802, 800– for Federal Workplace Drug Testing certification, a laboratory or IITF must 445–6917. Programs (Mandatory Guidelines). The participate in a quarterly performance DrugScan, Inc., 200 Precision Road, Mandatory Guidelines were first testing program plus undergo periodic, Suite 200, Horsham, PA 19044, published in the Federal Register on on-site inspections. 800–235–4890. April 11, 1988 (53 FR 11970), and Laboratories and IITFs in the Dynacare Medical Laboratories *, A subsequently revised in the Federal applicant stage of certification are not to Division of the Gamma-Dynacare Register on June 9, 1994 (59 FR 29908); be considered as meeting the minimum Laboratory Partnership, 245 Pall September 30, 1997 (62 FR 51118); requirements described in the HHS Mall Street, London, ONT, Canada April 13, 2004 (69 FR 19644); November Mandatory Guidelines. A HHS-certified N6A 1P4, 519–679–1630. 25, 2008 (73 FR 71858); December 10, laboratory or IITF must have its letter of ElSohly Laboratories, Inc., 5 Industrial 2008 (73 FR 75122); and on April 30, certification from HHS/SAMHSA Park Drive, Oxford, MS 38655, 662– 2010 (75 FR 22809). (formerly: HHS/NIDA), which attests 236–2609. A notice listing all currently HHS- that it has met minimum standards. Fortes Laboratories, Inc., 25749 SW certified laboratories and IITFs is In accordance with the Mandatory Canyon Creek Road, Suite 600, published in the Federal Register Guidelines dated November 25, 2008 Wilsonville, OR 97070, 503–486– during the first week of each month. If (73 FR 71858), the following HHS- 1023. any laboratory or IITF certification is certified laboratories and IITFs meet the Laboratory Corporation of America suspended or revoked, the laboratory or minimum standards to conduct drug Holdings, 7207 N. Gessner Road, Lhorne on DSK2VPTVN1PROD with NOTICES IITF will be omitted from subsequent and specimen validity tests on urine Houston, TX 77040, 713–856–8288/ lists until such time as it is restored to specimens: 800–800–2387. full certification under the Mandatory HHS-Certified Instrumented Initial Laboratory Corporation of America Guidelines. Testing Facilities: Dynacare Holdings, 69 First Ave., Raritan, NJ If any laboratory or IITF has Medical Laboratories, 6628 50th 08869, 908–526–2400/800–437– withdrawn from the HHS National Street NW., Edmonton, AB Canada 4986, (Formerly: Roche Biomedical Laboratory Certification Program (NLCP) T6B 2N7, 780–784–1190. Laboratories, Inc.). VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1


Document Created: 2015-12-15 15:18:57
Document Modified: 2015-12-15 15:18:57
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesComments received within 60 days of the date of this publication will receive fullest consideration.
FR Citation80 FR 31053 
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