[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