Submission for OMB Review; 30-Day Comment Request; National Institute of Mental Health Recruitment and Milestone Reporting System, 10816-10817 [2014-04194]

Download as PDF 10816 Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Notices TABLE 1—REGISTRATION FEES 1 Early rate (through 3/11/14) Attendee Type Industry ........................................................................................ Small Business (<100 employees) .............................................. Startup Manufacturer ................................................................... Academic ..................................................................................... FDA/Government Employee ........................................................ tkelley on DSK3SPTVN1PROD with NOTICES 1 The Advanced rate (3/12/14 to 4/8/14) $1,195 $900 $200 $200 Fee Waived $1,495 $1,000 $250 $250 Fee Waived Standard rate (4/9/14 to 5/9/14) $1,695 $1,200 $300 $300 Fee Waived. following forms of payment will be accepted: American Express, Visa, Mastercard, and company checks. To register online for the public conference, please visit the ‘‘Registration’’ link on the conference Web site at https:// www.XavierMedCon.com. FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register. To register by mail, please send your name, title, firm name, address, telephone and fax numbers, email, and payment information for the fee to Xavier University, Attention: Mason Rick, 3800 Victory Parkway, Cincinnati, OH 45207. An email will be sent confirming your registration. Attendees are responsible for their own accommodations. The conference headquarters hotel is the Cincinnati Hilton Netherlands Plaza, 35 West 5th Street, Cincinnati, OH, 45202, 513–421– 9100. Special conference block rates are available through April 16, 2014. To make reservations online, please visit the ‘‘Venue/Logistics’’ link at https:// www.XavierMedCon.com. If you need special accommodations due to a disability, please contact Marla Phillips (see Contact Persons) at least 7 days in advance of the conference. SUPPLEMENTARY INFORMATION: The public conference helps fulfill the Department of Health and Human Services and FDA’s important mission to protect the public health. The conference will provide those engaged in FDA-regulated medical devices (for humans) with information on the following topics: • Center for Devices and Radiological Health Future Vision and Strategy Keynote Address; • European Union Regulations: New Regulations, Company Strategy, and Open Discussion Forum; • How to Implement the Unique Device Identification Requirements; • Update from the Office of Device Evaluation; • FDA Regulation of Health Information Technology: Medical Apps, Cybersecurity, and ‘‘the Cloud’’; • Managing Scientific and Regulatory Disagreement; • Combination Products; VerDate Mar<15>2010 17:24 Feb 25, 2014 Jkt 232001 • FDA Inspectional Approach—Panel with current FDA investigators; • Operationalizing Post-Market Surveillance; • 510(k) Process; • Risk Management; • Purchasing Controls; • Office of Compliance Update; and • Strategic Thinking on Access in China. FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The conference helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The conference also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121) by providing outreach activities by Government Agencies to small businesses. Dated: February 20, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–04134 Filed 2–25–14; 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; National Institute of Mental Health Recruitment and Milestone Reporting System Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) 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 August 2, 2013, page 46994 and allowed 60-days for public comment. One public comment SUMMARY: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 was received regarding human subjects research recruitment and retention and the perception of coercion. The recruitment and enrollment procedures proposed by a NIMH-funded clinical trial are reviewed and approved by an IRB of record, which has agreed to review human subject research projects in accordance with 45 CFR Part 46 and its Federal-wide Assurance. The IRB of record ensures that the possibility of coercion or undue influence is minimized, that an investigator seeks consent only under circumstances that provide the prospective subject/ representative sufficient opportunity to consider whether or not to participate. To address these concerns, we plan to add a statement about human subject protections to the policy and add a link to the human subjects training on the policy Web page. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Mental Health (NIMH), 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: Keisha Shropshire, NIMH Project Clearance Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9667, E:\FR\FM\26FEN1.SGM 26FEN1 10817 Federal Register / Vol. 79, No. 38 / Wednesday, February 26, 2014 / Notices 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. Proposed Collection National Institute of Mental Health Recruitment Milestone Reporting System-Existing collection in use without OMB control number—National Institute of Mental Health (NIMH), National Institute of Health (NIH). Need and Use of Information Collection: The Recruitment Milestone Reporting (RMR) System allows NIMH staff to monitor more accurately the recruitment of participants in NIMHsponsored 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. 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 2,531. ESTIMATED ANNUALIZED BURDEN HOURS Form Type of respondent Number of respondents Frequency of response Average burden per response (in hours) Total annual burden hours NIMH Recruitment Milestone Reporting. Principal Investigators/Research Assistant. 675 3 75/60 2,531 Dated: February 18, 2014. Keisha Shropshire, Project Clearance Officer, NIMH, NIH. [FR Doc. 2014–04194 Filed 2–25–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meetings tkelley on DSK3SPTVN1PROD with NOTICES 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 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: National Institute on Aging Special Emphasis Panel Drug Development for Alzheimer’s Disease. Date: March 19, 2014. Time: 12:00 p.m. to 2:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Aging, Room 2C212, VerDate Mar<15>2010 17:24 Feb 25, 2014 Jkt 232001 Gateway Building, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Alexander Parsadanian, Ph.D., Scientific Review Officer, National Institute On Aging, Gateway Building 2C/ 212, 7201 Wisconsin Avenue, Bethesda, MD 20892, 301–496–9666, PARSADANIANA@NIA.NIH.GOV. Name of Committee: National Institute on Aging Special Emphasis Panel, Genetic Factors. Date: March 26, 2014. Time: 12:30 p.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute on Aging, Gateway Building, 2C212, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Alicja L. Markowska, Ph.D., DSC, Scientific Review Branch, National Institute On Aging, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301–496–9666, markowsa@nia.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS) Dated: February 20, 2014. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2014–04082 Filed 2–25–14; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; 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 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: National Institute of Allergy and Infectious Diseases Special Emphasis Panel NIAID Investigator Initiated Program Project Applications (P01). Date: March 13, 2014. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Room 3254, 6700B Rockledge Drive, Bethesda, MD 20817, (Telephone Conference Call). Contact Person: Susana Mendez, Ph.D., DVM, Scientific Review Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, 6700B Rockledge Drive, MSC–7616, E:\FR\FM\26FEN1.SGM 26FEN1

Agencies

[Federal Register Volume 79, Number 38 (Wednesday, February 26, 2014)]
[Notices]
[Pages 10816-10817]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04194]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; National 
Institute of Mental Health Recruitment and Milestone Reporting System

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institutes of Health (NIH) 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 August 2, 2013, page 46994 and allowed 60-days for public 
comment. One public comment was received regarding human subjects 
research recruitment and retention and the perception of coercion. The 
recruitment and enrollment procedures proposed by a NIMH-funded 
clinical trial are reviewed and approved by an IRB of record, which has 
agreed to review human subject research projects in accordance with 45 
CFR Part 46 and its Federal-wide Assurance. The IRB of record ensures 
that the possibility of coercion or undue influence is minimized, that 
an investigator seeks consent only under circumstances that provide the 
prospective subject/representative sufficient opportunity to consider 
whether or not to participate. To address these concerns, we plan to 
add a statement about human subject protections to the policy and add a 
link to the human subjects training on the policy Web page. The purpose 
of this notice is to allow an additional 30 days for public comment. 
The National Institute of Mental Health (NIMH), 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: Keisha Shropshire, NIMH Project Clearance 
Liaison, Science Policy and Evaluation Branch, OSPPC, NIMH, NIH, 
Neuroscience Center, 6001 Executive Boulevard, MSC 9667,

[[Page 10817]]

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.

Proposed Collection

    National Institute of Mental Health Recruitment Milestone Reporting 
System-Existing collection in use without OMB control number--National 
Institute of Mental Health (NIMH), National Institute of Health (NIH).
    Need and Use of Information Collection: The Recruitment Milestone 
Reporting (RMR) System allows NIMH staff to monitor more accurately the 
recruitment of participants in NIMH-sponsored 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. 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 2,531.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                         Average burden
                      Form                                Type of respondent             Number of       Frequency of     per response     Total annual
                                                                                        respondents        response        (in hours)      burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
NIMH Recruitment Milestone Reporting............  Principal Investigators/Research               675                3            75/60            2,531
                                                   Assistant.
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: February 18, 2014.
Keisha Shropshire,
Project Clearance Officer, NIMH, NIH.
[FR Doc. 2014-04194 Filed 2-25-14; 8:45 am]
BILLING CODE 4140-01-P

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