Proposed Collection; 60-Day Comment Request; Assessment of DAIDS Training Resources, 12203-12204 [2014-04728]

Download as PDF 12203 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Notices review activities; copies of all correspondence between investigators and the IRB; (5) statement of significant new findings provided to subjects of the research; and (6) a list of IRB members by name, showing each member’s earned degrees, representative capacity, and experience in sufficient detail to describe each member’s contributions to the IRB’s deliberations, and any employment relationship between each member and the IRB’s institution. This information is used by FDA in conducting audit inspections of IRBs to determine whether IRBs and clinical investigators are providing adequate protections to human subjects participating in clinical research. The recordkeeping requirement burden is based on the following: The burden for each of the paragraphs under 21 CFR 56.115 has been considered as one estimated burden. FDA estimates that there are approximately 2,500 IRBs. The IRBs meet on an average of 14.6 times annually. The Agency estimates that approximately 100 hours of persontime per meeting are required to meet the requirements of the regulation. In the Federal Register of October 1, 2013 (78 FR 60286), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 21 CFR section Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 56.115 .................................................................................. 2,500 14.6 36,500 100 3,650,000 1There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 27, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–04707 Filed 3–3–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; 60-Day Comment Request; Assessment of DAIDS Training Resources 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 Allergy and Infectious Diseases (NIAID), 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 tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:07 Mar 03, 2014 Jkt 232001 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: Jacquelyn Burns, Office for Policy in Clinical Research Operations, DAIDS, NIAID, 6700B Rockledge Drive, Room 4118, Bethesda, MD 20852, or call non-toll-free number 301–402–0143, or Email your request, including your address to: Jburns@ niaid.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment 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. Proposed Collection: Assessment of DAIDS Training Resources, 0925-New, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). Need and Use of Information Collection: This is a new data collection in order to assess the efficacy of training resources and their impact on NIAIDsupported and/or sponsored research operations. The generic OMB clearance will allow collecting information about the knowledge, attitudes, and behaviors from target audiences (e.g., research staff) to help improve and inform these PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 training resources. Information collected will be used to determine the future direction for training resources, including which resources should be continued, enhanced, added, or discontinued in order to utilize resources efficiently. Findings will provide data to inform and guide the optimal development, dissemination, and revisions to improve NIAID trainings and resources. Various types of data will be collected, including post-assessment tests, questionnaires, interviews, and focus groups. Post-assessment tests will be administered at the time of the trainings to assess trainees’ immediate knowledge gained, as well as reactions and satisfaction to the content. Select trainees will be queried at later time points (e.g., three-months, six-months) after they have participated in a training to understand if they have been able to apply their knowledge at the workplace, and identify facilitators or hindrances to implementing this new knowledge. The assessment team will conduct repeated data collections for these select trainees to determine any changes throughout time. In order to obtain information beyond self-reported data, select managers and supervisors will also be queried to assess if they have observed any changes in their staff after attending trainings, and if the work environment is conducive for trainees to implement knowledge from trainings. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 847. E:\FR\FM\04MRN1.SGM 04MRN1 12204 Federal Register / Vol. 79, No. 42 / Tuesday, March 4, 2014 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Data collection Investigator ........................................................................ Survey .............. Interviews ......... Focus Groups ... Survey .............. Interviews ......... Focus Groups ... Survey .............. Interviews ......... Focus Groups ... Survey .............. Interviews ......... Focus Groups ... Survey .............. Interviews ......... Focus Groups ... Survey .............. Interviews ......... Focus Groups ... Survey .............. Interviews ......... Focus Groups ... Survey .............. Interviews ......... Focus Groups ... Survey .............. Interviews ......... Focus Groups ... Survey .............. Interviews ......... Focus Groups ... Survey .............. Interviews ......... Focus Groups ... Study Coordinator ............................................................. Pharmacy Staff ................................................................. Laboratory Staff ................................................................ Data Management Staff .................................................... Quality Assurance/Quality Control Personnel .................. Regulatory Coordinator ..................................................... Community Member .......................................................... Counselor .......................................................................... IRB Member ...................................................................... Clinical Researcher ........................................................... Dated: February 20, 2014. Brandie Taylor, Project Clearance Liaison, NIAID, NIH. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 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 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 VerDate Mar<15>2010 19:07 Mar 03, 2014 Jkt 232001 Name of Committee: Center for Scientific Review Special Emphasis Panel; TME Study Section—Special Review. Date: March 14, 2014. Time: 11:30 a.m. to 12:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Angela Y, Ng, MBA, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6200, MSC 7804, Bethesda, MD 20892, 301–435– 1715, nga@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Healthcare Delivery and Methodologies. Date: March 18, 2014. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Number of responses per respondent 120 12 4 120 11 4 140 9 4 170 11 4 30 9 4 75 11 4 75 11 4 23 6 4 30 6 4 23 6 4 45 12 4 would constitute a clearly unwarranted invasion of personal privacy. [FR Doc. 2014–04728 Filed 3–3–14; 8:45 am] tkelley on DSK3SPTVN1PROD with NOTICES Number of respondents 5 1 1 5 1 1 5 1 1 5 1 1 3 1 1 5 1 1 5 1 1 3 1 1 3 1 1 3 1 1 5 1 1 Average burden per response (in hours) 10/60 1 90/60 10/60 1 90/60 10/60 1 90/60 10/60 1 90/60 10/60 1 90/60 10/60 1 90/60 10/60 1 90/60 10/60 1 90/60 10/60 1 90/60 10/60 1 90/60 10/60 1 90/60 Total annualized burden (in hours) 100 12 6 100 11 6 117 9 6 142 11 6 15 9 6 63 11 6 63 11 6 12 6 6 15 6 6 12 6 6 38 12 6 Contact Person: Ping Wu, Ph.D., Scientific Review Officer, HDM IRG, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3166, Bethesda, MD 20892, 301–615–7401, wup4@ csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Non-HIV Diagnostics, Food Safety, Sterilization/Disinfection and Bioremediation. Date: March 27–28, 2014. Time: 8:00 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Garden Inn, 7301 Waverly Street, Bethesda, MD 20814. Contact Person: Gagan Pandya, Ph.D., Scientific Review Officer, National Institutes of Health, Center for Scientific Review, 6701 Rockledge Drive, RM 3200, MSC 7808, Bethesda, MD 20892, 301–435–1167, pandyaga@mai.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Small Business: Non-HIV Anti-Infective Therapeutics. Date: March 27–28, 2014. Time: 8:00 a.m. to 5:00 p.m. E:\FR\FM\04MRN1.SGM 04MRN1

Agencies

[Federal Register Volume 79, Number 42 (Tuesday, March 4, 2014)]
[Notices]
[Pages 12203-12204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04728]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; 60-Day Comment Request; Assessment of DAIDS
Training Resources

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 Allergy
and Infectious Diseases (NIAID), 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: Jacquelyn
Burns, Office for Policy in Clinical Research Operations, DAIDS, NIAID,
6700B Rockledge Drive, Room 4118, Bethesda, MD 20852, or call non-toll-
free number 301-402-0143, or Email your request, including your address
to: Jburns@niaid.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
Comment 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.
Proposed Collection: Assessment of DAIDS Training Resources, 0925-
New, National Institute of Allergy and Infectious Diseases (NIAID),
National Institutes of Health (NIH).
Need and Use of Information Collection: This is a new data
collection in order to assess the efficacy of training resources and
their impact on NIAID-supported and/or sponsored research operations.
The generic OMB clearance will allow collecting information about the
knowledge, attitudes, and behaviors from target audiences (e.g.,
research staff) to help improve and inform these training resources.
Information collected will be used to determine the future direction
for training resources, including which resources should be continued,
enhanced, added, or discontinued in order to utilize resources
efficiently.
Findings will provide data to inform and guide the optimal
development, dissemination, and revisions to improve NIAID trainings
and resources. Various types of data will be collected, including post-
assessment tests, questionnaires, interviews, and focus groups. Post-
assessment tests will be administered at the time of the trainings to
assess trainees' immediate knowledge gained, as well as reactions and
satisfaction to the content. Select trainees will be queried at later
time points (e.g., three-months, six-months) after they have
participated in a training to understand if they have been able to
apply their knowledge at the workplace, and identify facilitators or
hindrances to implementing this new knowledge. The assessment team will
conduct repeated data collections for these select trainees to
determine any changes throughout time. In order to obtain information
beyond self-reported data, select managers and supervisors will also be
queried to assess if they have observed any changes in their staff
after attending trainings, and if the work environment is conducive for
trainees to implement knowledge from trainings.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 847.

[[Page 12204]]

Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average Total
Number of Number of burden per annualized
Type of respondent Data collection respondents responses per response (in burden (in
respondent hours) hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Investigator................................... Survey................................. 120 5 10/60 100
Interviews............................. 12 1 1 12
Focus Groups........................... 4 1 90/60 6
Study Coordinator.............................. Survey................................. 120 5 10/60 100
Interviews............................. 11 1 1 11
Focus Groups........................... 4 1 90/60 6
Pharmacy Staff................................. Survey................................. 140 5 10/60 117
Interviews............................. 9 1 1 9
Focus Groups........................... 4 1 90/60 6
Laboratory Staff............................... Survey................................. 170 5 10/60 142
Interviews............................. 11 1 1 11
Focus Groups........................... 4 1 90/60 6
Data Management Staff.......................... Survey................................. 30 3 10/60 15
Interviews............................. 9 1 1 9
Focus Groups........................... 4 1 90/60 6
Quality Assurance/Quality Control Personnel.... Survey................................. 75 5 10/60 63
Interviews............................. 11 1 1 11
Focus Groups........................... 4 1 90/60 6
Regulatory Coordinator......................... Survey................................. 75 5 10/60 63
Interviews............................. 11 1 1 11
Focus Groups........................... 4 1 90/60 6
Community Member............................... Survey................................. 23 3 10/60 12
Interviews............................. 6 1 1 6
Focus Groups........................... 4 1 90/60 6
Counselor...................................... Survey................................. 30 3 10/60 15
Interviews............................. 6 1 1 6
Focus Groups........................... 4 1 90/60 6
IRB Member..................................... Survey................................. 23 3 10/60 12
Interviews............................. 6 1 1 6
Focus Groups........................... 4 1 90/60 6
Clinical Researcher............................ Survey................................. 45 5 10/60 38
Interviews............................. 12 1 1 12
Focus Groups........................... 4 1 90/60 6
--------------------------------------------------------------------------------------------------------------------------------------------------------

Dated: February 20, 2014.
Brandie Taylor,
Project Clearance Liaison, NIAID, NIH.
[FR Doc. 2014-04728 Filed 3-3-14; 8:45 am]
BILLING CODE 4140-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.