[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Notices]
[Pages 56380-56381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22306]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request, Process
Assessment Review of the Division of Acquired Immunodeficiency Syndrome
(DAIDS) Critical Events, Policy Implementation (CEPI) Program (NIAID)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health, 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 April 9, 2013, page 19633 and allowed 60-days for public comment. No
comments were received. The purpose of this notice is to allow an
additional 30 days for public comment. The National Institute of
Allergy and Infectious Diseases (NIAID), 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, [email protected] 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: Lynda Lahl, RN, MS, Office for Policy in
Clinical Research Operations, DAIDS, NIAID, 5601 Fishers Lane, 9B25,
Rockville, MD 20852, or call non-toll-free number 240-292-4887, or
Email your request, including your address to: [email protected].
Formal requests for additional plans and instruments must be requested
in writing.
Proposed Collection: Process Assessment Review of the Division Of
Acquired Immunodeficiency Syndrome (DAIDS) Critical Events Policy
Implementation (CEPI) Program, 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 to assess the CEPI program's progression to fulfillment of
its program goals and will assess whether the CEPI program is
implemented and functioning as intended. The program goals for CEPI
are: 1) Awareness & Accessibility--The target populations (DAIDS Staff,
extramural researchers, external stakeholders) are aware of the DAIDS
Critical Events (CE) policy and manual and associated documents and
whether the policy and associated documents are readily accessible.; 2)
Understandability--The Critical Events policy and manual clearly
articulate DAIDS expectations for CE policy implementation by the
target populations. The CE policy and manual should establish a common
base of understanding and promote positive attitudes towards event
reporting; and 3) Applicability--Target populations are able to
correctly identify which Critical Events have occurred at their sites
and are able to apply the CE policy and manual to their events.
Findings will provide data to inform DAIDS and Protection of
Participants, Evaluation and Policy (ProPEP) leadership regarding
further policy deployment decisions. Information collected will be used
to determine how effectively the CEPI Program meets extramural
researchers' needs. By assessing the CEPI Program, DAIDS will
[[Page 56381]]
determine how successfully it is reaching its goals--to facilitate and
improve the quality of clinical research conducted within the division.
In addition, the CEPI Program assessment will determine whether
previously recommended improvements included in the DPIP assessment
were successfully incorporated into the policy rollout process. The
results may be used as a model for policy development to facilitate
compliance in reporting certain incidents and implementation in other
National Institutes of Health (NIH) Institutes and Centers (ICs) and
will be shared with all interested divisions and institutes within the
NIH. There are no plans to share this information with the public.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 470.
Estimated Annualized Burden Hours
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Number of Frequency of Average time Annual hour
Type of respondents Form name respondents response per response burden
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DAIDS staff surveys IC review. Webpage Study 100 1 5/60 8
Details and
Informed
Consent DAIDS
Staff
screenshots.
DAIDS staff surveys........... DAIDS Staff 100 1 30/60 50
Survey
screenshots.
ER/ES--web surveys IC review.. Webpage Study 400 1 5/60 33
Details and
Informed
Consent for
Extramural
Researchers and
External
Stakeholders
screenshots.
ER/ES--web surveys............ Extramural 400 1 30/60 200
Researcher
External
Stakeholder
Survey
screenshots.
DAIDS staff--web survey Reminder email 100 1 5/60 8
reminder. to T2 web-
survey
participants.
ER/ES--web survey reminder.... Reminder email 400 1 5/60 33
to T2 web-
survey
participants.
DAIDS staff focus group IC DAIDS staff 18 1 10/60 3
review. focus group
consent form.
ER/ES--focus group IC review.. Extramural 63 1 10/60 11
researcher
external
stakeholders
focus group
consent form.
ER/ES--focus group............ Incentive 63 1 2/60 2
distribution
log for focus
group
participants.
DAIDS staff focus groups...... Focus group 18 1 90/60 27
opening script
and questions.
ER/ES--focus groups........... Focus group 63 1 90/60 95
opening script
and questions.
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Totals.................... ................ 1162 .............. .............. 470
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Dated: September 12, 2014.
Dione Washington,
Project Clearance Liaison, NIAID, NIH.
[FR Doc. 2014-22306 Filed 9-18-14; 8:45 am]
BILLING CODE 4140-01-P