[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Pages 19633-19634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07960]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; Process Assessment 
Review of the Division of Acquired Immunodeficiency Syndrome (DAIDS) 
Critical Events Policy Implementation (CEPI) Program (NIAID)

    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: Lyndi 
Lahl, RN, MS, Office for Policy in Clinical Research Operations, DAIDS, 
NIAID, 6700B Rockledge Drive, Room 4254, Bethesda, MD 20852, or call 
non-toll-free number 301-435-3756, 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 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: 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 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 386.

[[Page 19634]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
      Type of respondents        Data collection     Number of    responses  per   Average time    Total annual
                                                    respondents      respondent    per response    burden hours
----------------------------------------------------------------------------------------------------------------
DAIDS Staff, ER/ES............  Survey..........             500               1           30/60             250
                                Focus Group-IC                81               1           10/60              14
                                 Review.
                                Focus Group.....              81               1           90/60             122
----------------------------------------------------------------------------------------------------------------


    Dated: April 3, 2014.
Brandie Taylor,
Project Clearance Liaison, NIAID, NIH.
[FR Doc. 2014-07960 Filed 4-8-14; 8:45 am]
BILLING CODE 4140-01-P