Change Request Justfication Document

Change Request Justification for Select Instructions in 0925-0002

0925-0002 received clearance in August 2012. Since then several Federal-wide and agency-specific initiatives have begun that require modification to instructions used for progress reports cleared in this package, specifically the PHS 2590 and the NIH Research Performance Progress Report (RPPR). There is no new data collection being proposed. Changes are described below for those source documents within 0925-0002 that are being revised; with corresponding information explaining the background and nature of the change.

NIH Implementation of the RPPR

Section Being Modified	Background and Description of Change
B. 4 What opportunities for training and professional development has the project provided?	Background: Based on advice received from a working group under the auspices of the Advisory Committee to the Director, NIH (ACD), the NIH is undertaking a variety of initiatives to develop a model for a sustainable and diverse U.S. biomedical research workforce that will inform decisions about training the optimal number of people for the appropriate types of positions that will advance science and promote health. These initiatives are referred to as The Biomedical Workforce Development (BMW) effort. This requirement directs the applicant institution to have a process in place that assures that an Individual Development Plan (IDP) is developed for all individuals working on a NIH-funded research grant as a graduate student or postdoctoral scientist. Further, they will be encouraged to report on the existence of such a plan and how it is used to help manage the training for these individuals. Description of Change: Question B.4 of the RPPR focuses on training and professional development. NIH will expand the existing use of this question to include this optional information on the existence of the IDP. See Item 1 in Attachment A for revised instructional text and screen shot with on-screen revised instructional text.
D. Participants	Registration in the eRA Commons has previously been required for individuals holding the PD/PI role and/or Postdoctoral role on NIH-funded projects. This registration gives NIH the data necessary to satisfy a number of reporting requirements including those in section 489 of the PHS Act that require NIH to perform a continuing assessment of research personnel needs. In addition, section 402 of the 2007 NIH Reform Act requires NIH to report to Congress specifically on the outcomes and effectiveness of various types of training programs, including training supported through research grants. While this training report initially focused on individuals at a postdoctoral level, under the auspices of the Biomedical Workforce Development initiative, these reporting needs are now expanded to include data on students at the undergraduate and graduate student levels. Therefore the Commons Registration for individuals supported on NIH-funded grants will be extended to cover these student categories. This is not new data collection; merely an expansion of existing data to cover additional categories of individuals already working on NIH-funded grants. However, the burden hours increased due to the addition of expanding the data collection to include undergraduate and graduate students.* The eRA Commons registration requirement is managed through the creation of a Personal Profile for an individual. It is a one-time registration process that collects specific data about the individual and is updatable by the individual as their relationship with NIH changes throughout their career. At the time an individual initially creates their Person Profile, answers to certain demographic data are required. The requirement for certain data items is also expanding to accommodate NIH reporting requirements to Congress. Note, in some cases an acceptable response is “Do Not Wish to Provide”. *See Attachment A-1 for burden increase calculations. See Item II in Attachment A for revised instruction text and proposed revised screen shot.

PHS 2590

Section Being Modified	Background and Description of Change
All Personnel Report—Form Page 7 & Corresponding Instructions	This change is identical to the one noted in Section D. Participants of the RPPR. The change is needed in the PHS2590 as well so that all progress report requirements (paper and electronic) are aligned. In the PHS2590, this same change affects the All Personnel Report. Registration in the eRA Commons has previously been required for individuals holding the PD/PI role and/or Postdoctoral role on NIH-funded projects. This registration gives NIH the data necessary to satisfy a number of reporting requirements including those in section 489 of the PHS Act that require NIH to perform a continuing assessment of research personnel needs. In addition, section 402 of the 2007 NIH Reform Act requires NIH to report to Congress specifically on the outcomes and effectiveness of various types of training programs, including training supported through research grants. While this training report initially focused on individuals at a postdoctoral level, under the auspices of the Biomedical Workforce Development initiative, these reporting needs are now expanded to include data on students at the undergraduate and graduate student levels. Therefore the Commons Registration for individuals supported on NIH-funded grants will be extended to cover these student categories. This is not new data collection; merely an expansion of existing data to cover additional categories of individuals already working on NIH-funded grants. The eRA Commons registration requirement is managed through the creation of a Personal Profile for an individual. It is a one-time registration process that collects specific data about the individual and is updatable by the individual as their relationship with NIH changes throughout their career. At the time an individual initially creates their Person Profile, answers to certain demographic data are required. The requirement for certain data items is also expanding to accommodate NIH reporting requirements to Congress. Note, in some cases an acceptable response is “Do Not Wish to Provide”. See Item I in Attachment B for revised Form Page 7 and corresponding instructions.
Collection of Personal Demographic Data	This section of the general instructions is also being modified to reflect the expanded data collection for students at the Undergraduate and Graduate Student levels. Like the Commons ID noted above, this section previously focused only on individuals with the roles of PD/PI and Postdoctoral. This expansion of existing data collection for this cohort of individuals is necessary to satisfy the NIH reporting requirements to Congress. See Item II in Attachment B for revised Form Page 7 and corresponding instructions.