[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
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Frequency of    Average time     Annual hour
      Type of respondents           Form name       respondents      response      per response       burden
----------------------------------------------------------------------------------------------------------------
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.
                               ---------------------------------------------------------------------------------
    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